Management Discussion and Analysis
Economic Overview
The global economic environment in 2026 is expected to remain broadly stable, albeit characterised by divergent and evolving forces. According to the IMFs World Economic Outlook Update, April 2026 global GDP growth is projected at 3.1% in 2026 and 3.2% in 2027. This outlook reflects the balancing of headwinds from shifting global trade policies, tariff related uncertainty and geopolitical risks, offset by continued momentum in technology led investment, accommodative financial conditions and the adaptability of the private sector.
Global inflation is expected to pause its earlier disinflationary trend, with headline inflation projected to rise from 4.1% in 2025 to 4.4% in 2026 before moderating to 3.7% in 2027 contributing to a more predictable cost environment for global supply chains. While investment activity has been increasingly influenced by the ongoing AI led cycle, the broader pharmaceutical and life sciences sectors are operating in an environment characterised by resilient underlying demand, alongside a gradual reconfiguration and regionalisation of trade and production networks.
Beyond macroeconomic conditions, geopolitical developments and heightened policy uncertainty have become increasingly influential in shaping global trade dynamics. Since the beginning of 2026, geopolitical tensions have intensified in certain regions, contributing to renewed volatility in energy markets, logistics and trade flows. While these developments have introduced additional layers of uncertainty and episodic supply chain disruptions, global trade volumes have, to date, remained relatively resilient. Trade flows are increasingly reorienting towards geopolitically aligned partners, with businesses accelerating supply chain diversification and resilience initiatives. Tariff actions, counter measures and evolving trade frameworks continue to drive trade readjustments, reinforcing the importance of operational agility and geographic flexibility for globally integrated businesses.
Two structural forces have been particularly prominent. First, technology led investment, especially in artificial intelligence (AI) related infrastructure, has emerged as a key driver of global trade growth. Semiconductors, data centre equipment and related advanced manufacturing categories account for a significant share of incremental trade volumes. This has strengthened the role of Asian technology supply hubs, while demand has remained most pronounced in advanced economies.
Second, heightened trade policy uncertainty and tariff volatility continue to reshape traditional trade corridors. Reduced reliance on concentrated bilateral trade relationships has been accompanied by the diversification and rerouting of supply chains, with alternative sourcing locations across ASEAN economies and select segments in India gaining share. In parallel, non-tariff measures such as export controls, local content requirements, investment screening and targeted incentives have become more prevalent globally, particularly in strategic and technology intensive sectors.
Among advanced economies, growth is expected to remain modest. The United States continues to outperform its peers, supported by sustained capital expenditure and technology driven investment, even as consumption trends gradually normalise and labour markets show early signs of moderation. In contrast, the Eurozone continues to experience a subdued recovery, constrained by structural challenges, elevated energy costs and weaker manufacturing momentum, despite increased public spending initiatives in select economies. The region also faces competitive pressures from rising imports and constrained access in certain export markets, resulting in a more challenging operating environment for manufacturers.
Emerging market and developing economies are expected to demonstrate relatively stronger and more resilient growth, supported by improving trade dynamics, domestic demand and technology linked exports. India remains the fastest growing major economy, underpinned by robust consumption, continued government focus on infrastructure development, and sustained fiscal and regulatory support for high technology manufacturing and research driven sectors. Growth outcomes across other emerging markets remain varied, reflecting differences in commodity exposure, policy frameworks and the pace of structural reforms.
Global Pharmaceutical Market
Overview
The global pharmaceutical market continues to demonstrate resilient medium-term growth, supported by sustained innovation, expanding patient access across emerging markets, and rising demand for chronic and specialty therapies. The global medicines market is projected to grow at a compound annual growth rate (CAGR) of approximately ~7.5%, reaching around USD 1.7 trillion by 2029. Growth is expected to be led by continued expansion in innovative and specialised therapies, particularly in oncology, immunology, diabetes and obesity, partially offset by slower volume growth in more mature segments.
The United States remains the worlds largest and most innovation intensive pharmaceutical market. Growth expectations for the U.S. market have been revised upward, with net market growth projected at 3-6% CAGR through 2029. This is driven by increased adoption of high value therapies, including GLP-1 based treatments for diabetes and obesity, alongside continued innovation across specialty categories. These are likely to be partially offset by ongoing policy scrutiny, pricing pressures and market access considerations. European markets are expected to contribute approximately USD 85 billion in incremental spending through 2029, largely driven by new product launches and growth in existing branded therapies, supported by ageing demographics and continued investment in healthcare systems.
Pharmaceuticals Market by Therapy Area
Oncology, Diabetes, Immunology and Obesity are expected to be the strongest contributors to market growth over the next five years. Collectively, these therapy areas are reshaping the global pharmaceutical landscape, reinforcing the shift towards innovation led growth, higher value therapies and specialised care models.
Oncology remains the largest and fastest expanding specialty therapy area, with global spending projected to reach approximately USD 441 billion* by 2029, representing an increase of around 75%* from 2024 levels. Growth is underpinned by a strong innovation pipeline, with nearly 100 new oncology drugs anticipated to be introduced during the forecast period.
Obesity treatments represent the fastest growing therapy segment globally. Global spending in this category is forecast to increase by over 200% by 2029, translating into a CAGR of approximately 23-26%*, driven by next generation GLP-1 and other metabolic therapies.
Immunology continues to exhibit robust underlying demand, supported by expanding patient base and ongoing therapeutic advances. While volume growth is expected to remain strong at 6-9%* annually, increased biosimilar penetration is likely to moderate overall spending growth to 3.5-6.5%* CAGR.
Diabetes markets are also experiencing accelerated expansion across major regions, driven by rising incidence and strong uptake of GLP-1 therapies.
Trends within the Pharmaceutical Sector
The global pharmaceutical industry is at an important point of transition. Advances in science continue to expand therapeutic possibilities and patient outcomes, even as companies operate within an increasingly complex landscape shaped by policy intervention, pricing discipline, geopolitical uncertainty and heightened expectations around access, quality and trust.
Against this backdrop, industry momentum is being shaped not by any single factor, but by the interplay of evolving healthcare needs, innovation led growth in selected therapy areas, accelerating adoption of digital and analytical capabilities, and the need to operate efficiently and resiliently across global markets. The following sections highlight the key structural trends influencing the pharmaceutical sector today and provide context for how companies are navigating this changing environment while balancing innovation, affordability and long-term sustainability.
Key trends are as below
Healthcare Coverage and Consumer Expectations: Shifting Towards Convenience, Access and Trust
The global healthcare landscape is undergoing a structural shift, shaped by evolving coverage frameworks and rising consumer expectations around convenience, access and trust. Across markets, healthcare systems and payers continue to balance affordability pressures with the need to expand coverage and improve patient outcomes. Policy reforms, reimbursement redesign and increased scrutiny of healthcare costs are influencing access pathways, treatment choices and stakeholder behaviour, particularly in chronic and long-term disease management, where sustainability of care and outcomes are central considerations.
At the same time, patients are increasingly adopting a more consumer centric approach to healthcare. Expectations have expanded beyond clinical efficacy to include ease and continuity of access, transparency, reliability of supply and overall experience across the care pathway. Digital engagement, simplified treatment regimens, alternative care channels and faster, more predictable access to therapies are becoming important determinants of treatment adoption and persistence. These shifts are especially relevant in chronic disease segments, where long term adherence, convenience and patient confidence play a critical role in therapeutic outcomes and realization of value.
Coverage dynamics continue to vary across regions. In developed markets, reimbursement decisions are increasingly shaped by value-based assessments, real world evidence and budget impact considerations, while emerging markets remain focused on expanding basic access and affordability through public health programmes and broadening insurance penetration. As a result, disparities persist in coverage decisions, time to access and patient out of pocket costs, influencing demand patterns, market penetration and commercial strategies across geographies. These trends are reinforcing the importance of pricing discipline, supply reliability and constructive engagement with payers, providers and policymakers.
Trust has emerged as a central pillar in healthcare decision making, encompassing product quality, regulatory compliance, data integrity and ethical business practices. Patients, healthcare providers and payers are placing greater emphasis on the credibility, consistency and long-term reliability of healthcare partners, particularly in an environment characterised by increased information availability, heightened regulatory oversight and greater accountability. Consequently, pharmaceutical companies are required to align scientific innovation and commercial execution with evolving coverage models and rising consumer expectations, while maintaining a strong and sustained focus on quality, compliance and longterm value creation.
GLP-1 Therapies and the Evolving Obesity Treatment Landscape
Obesity continues to be recognised as a chronic disease with far reaching clinical and economic implications, including its strong correlation with type 2 diabetes, cardiovascular disease and other comorbidities. Obesity and related metabolic disorders treatment are driven by the rapid adoption of glucagon-like peptide-1 (GLP-1) based therapies. Recent and upcoming patent cliffs in metabolic and diabetes therapies have intensified industry focus on effective, scalable and long-term treatment options for obesity, positioning GLP-1 based therapies as a key area of emphasis within the broader metabolic care landscape.
The GLP-1 market represents one of the fastest-growing segments within the global pharmaceutical industry. Global sales are projected to increase from approximately USD 54 billion in 2024 to USD 133 billion by 2029, reflecting strong underlying demand and broadening clinical applications. Initially centred on diabetes management, the use of GLP-1 therapies has expanded significantly into obesity treatment, supported by a growing body of clinical evidence, increasing physician acceptance and rising patient awareness. Market growth, however, remains influenced by factors such as pricing, reimbursement coverage, supply constraints and the capacity of healthcare systems to absorb rising demand. As a result, access to GLP-1 therapies continues to vary significantly across geographies, with adoption in emerging markets remaining at a relatively early stage compared to developed markets.
The rapid uptake of GLP-1 therapies is also prompting increased attention on manufacturing scaleup, supply chain robustness and long-term sustainability of treatment. Given the chronic nature of obesity, stakeholders are increasingly evaluating treatment persistence, real world outcomes and the overall cost effectiveness of therapy over extended periods. These considerations are expected to shape regulatory, payer and policy discussions in the near term.
Looking ahead, industry commentary highlights that while GLP-1 therapies represent a meaningful advancement in obesity management, the segment is likely to remain competitive and closely regulated, with continued emphasis on affordability, supply reliability and clinical differentiation. Consequently, pharmaceutical companies are approaching this space with a balanced focus on scientific innovation, operational execution and disciplined capital allocation.
Digital Transformation and AI Adoption: Building Scalable, Resilient Pharmaceutical Enterprises
Across the global pharmaceutical industry, digital transformation and the adoption of advanced analytics and artificial intelligence (AI) continue to accelerate, driven by sustained productivity pressures, increasing regulatory and quality expectations, and the need for faster, more informed decision-making. Industry adoption has progressively shifted from fragmented experimentation towards focused, value-driven deployment of digital and AI solutions, particularly across manufacturing, quality management, supply chain planning and regulatory operations. Recent industry experience indicates that targeted digital and AI interventions have delivered early efficiency gains in the range of 10-20% in pilot and scaled-pilot environments. At the same time, heightened regulatory scrutiny around data integrity, system validation, cybersecurity and business continuity has reinforced the need for disciplined, well-governed digital adoption.
Against this backdrop, Biocon continued to advance its digital transformation agenda with a strong emphasis on manufacturing digitisation, quality systems strengthening and enterprise modernisation. During the year, the Company expanded paperless and digitally integrated manufacturing operations through the rollout of Manufacturing Execution Systems (MES), Electronic Logbooks and a next-generation Quality Management System (QMS) across its global network. These initiatives supported greater process standardisation, real-time operational visibility, improved data integrity and enhanced regulatory readiness, while enabling more consistent execution across sites and markets.
Industry-wide focus on enterprise integration and real-time analytics has also driven renewed emphasis on modern, scalable core platforms to strengthen data consistency, process harmonisation and decision-support capabilities across finance, supply chain, manufacturing and commercial functions. In parallel, targeted automation and Al-enabled solutions were deployed across select enterprise and regulatory processes. These initiatives delivered material reductions in manual effort and cycle times, including an approximately 90% reduction in manual stock-reconciliation activities in key European markets, while strengthening controls, productivity and compliance outcomes.
As AI adoption expands across the pharmaceutical value chain, industry focus is increasingly centred on responsible, use-case-led deployment underpinned by robust data foundations and governance frameworks. Reflecting this approach, Biocon established a structured Office of AI to drive prioritisation, governance and capability building, while ensuring alignment with regulatory requirements and business objectives. In parallel, the Company continued to strengthen cybersecurity, technology risk management and enterprise resilience through globally aligned standards, proactive monitoring and regular assessments. During the year, digital resilience initiatives were supported by workforce awareness programmes, including 88% completion of information-security and data-privacy training and 100% participation in phishing-awareness campaigns.
Collectively, these initiatives position the Company to respond effectively to accelerating digital and AI-led change across the pharmaceutical industry. By anchoring technology adoption in strong governance, scalable platforms and disciplined execution, digital transformation is increasingly serving as an enabler of operational resilience, regulatory confidence and sustainable long-term value creation.
Policy-Driven Changes in Global Pharmaceutical Pricing Dynamics
Pricing pressure has become a structural and enduring feature of the global pharmaceutical industry, driven by sustained policy intervention aimed at improving affordability and supporting the long-term sustainability of healthcare systems. Across key developed markets, governments and payers are exercising increasing influence over pricing and reimbursement through negotiated frameworks, reference pricing mechanisms and more stringent formulary controls. In the United States, while overall medicine consumption continues to expand, net realised prices are increasingly moderated by rebates and discounts, marking a clear shift away from historical price led revenue growth and reducing long term pricing visibility across product lifecycles.
This policy led emphasis on pricing discipline is reshaping the underlying drivers of growth. While global medicine usage continues to rise, reflecting broader access, ageing populations and higher prevalence of chronic diseases, pricing mechanisms within healthcare systems are limiting the translation of volume growth into proportional revenue expansion. Incremental growth is therefore increasingly driven by product mix, efficiency led volume gains and the accelerated transition towards off patent alternatives, rather than pricing actions. These dynamics reinforce the importance of scale, cost management and ongoing portfolio optimisation across the industry.
Generics and biosimilars play a central role in government led cost containment strategies, as healthcare systems seek to manage the growing expenditure associated with innovative therapies in areas such as oncology, immunology and metabolic diseases. Their accelerated adoption following loss of exclusivity has intensified competitive dynamics, resulting in faster and deeper price erosion compared to earlier cycles. While this supports broader patient access and affordability, it has also placed sustained pressure on industry margins, increasing reliance on operational efficiency, manufacturing excellence and disciplined execution to deliver sustainable returns.
Pricing dynamics are further influenced by increasing buyer consolidation and procurement driven purchasing models, particularly in the United States and Europe, where negotiating power is increasingly concentrated among a limited number of large payers and intermediaries. In parallel, evolving trade and manufacturing policies, including localisation incentives and proposed tariff measures, are adding complexity to pricing and access decisions by linking them more closely to supply chain configuration and manufacturing footprints. Overall, policy intervention and pricing pressure are expected to remain defining features of the operating environment, favouring business models anchored in efficiency, scale and the ability to operate sustainably within disciplined and increasingly intervention led pricing frameworks.
The Next Patent Cliff and Its Implications for Industry Growth
The global biopharmaceutical industry is approaching a historically significant patent cliff, with an estimated USD 275 billion* of revenue at risk among the top global companies due to upcoming losses of market exclusivity. A large number of high-revenue, mature therapies across multiple therapeutic categories are expected to face generic and biosimilar competition over the coming years, materially increasing exposure to price erosion and accelerated revenue decline. This wave of expiries represents one of the most pronounced shifts in industry revenue composition in recent decades.
As blockbuster products transition off patent protection, the pace and depth of post-exclusivity erosion have intensified compared with prior cycles. Faster uptake of generics and biosimilars, greater buyer consolidation and more active payer intervention are compressing product lifecycles and shortening the period over which originator revenues can be sustained. In parallel, policy-led cost-containment strategies are reinforcing rapid substitution, particularly in chronic and high-spend therapy areas, further increasing the proportion of industry revenues exposed to competitive pressure.
These dynamics are compelling pharmaceutical companies to reassess portfolio strategy and capital allocation priorities. Greater emphasis is being placed on disciplined portfolio management, accelerated lifecycle innovation, and selective investment in assets with stronger clinical differentiation or longer-term durability. At the same time, the industry is increasingly relying on external innovation through partnerships, licensing and targeted acquisitions to supplement internal pipelines and mitigate revenue gaps created by patent expiries.
The patent cliff is also reshaping industry growth drivers by elevating the strategic importance of generics and biosimilars within the broader healthcare ecosystem. Their accelerated adoption plays a central role in expanding patient access and affordability following loss of exclusivity, while structurally lowering system-wide treatment costs. However, this also reinforces a more competitive post-patent environment, where scale, manufacturing efficiency and execution discipline are critical to sustaining economic returns in mature product segments.
Looking ahead, the confluence of heightened revenue-at-risk, pricing pressure and policy intervention is expected to keep portfolio churn elevated across the industry. Companies are therefore increasingly focused on balancing investments in breakthrough science with the need for near-term revenue stability, while maintaining financial discipline and strategic selectivity. In this environment, the ability to actively manage the transition from exclusivity-driven growth to diversified, access-led and efficiency-anchored business models will be central to sustaining long-term performance and shareholder confidence.
Geopolitics and Trade Policies Are Reshaping Global Pharmaceutical Supply Chains
Global pharmaceutical supply chains continue to undergo structural realignment amid heightened geopolitical uncertainty and evolving trade and tariff regimes. In recent years, governments across key markets have placed greater emphasis on domestic and regional manufacturing of pharmaceuticals and critical inputs, increasingly viewing medicines, active pharmaceutical ingredients (APIs) and intermediates as strategically important to public health and national resilience. This has resulted in greater policy intervention through a combination of tariffs, trade controls, procurement preferences and incentives for local production, materially influencing the global operating environment for pharmaceutical manufacturers.
Evolving trade actions and policy proposals increasingly affect not only finished dosage formulations but also APIs, intermediates and key raw materials. These developments have introduced higher volatility in input costs, altered sourcing economics and increased complexity in managing cross border supply chains. At the same time, regulatory and market access considerations in several markets are becoming more closely linked to manufacturing location and supply reliability, influencing long term capacity planning and investment decisions.
In response to these shifts, pharmaceutical companies are progressively recalibrating their supply chain and manufacturing footprint strategies to balance cost efficiency with resilience and continuity of supply. Industry practices increasingly include diversification of sourcing geographies, selective regionalisation or near shoring of critical manufacturing stages, dual sourcing of essential inputs and greater engagement with regional contract development and manufacturing organisations. Manufacturing and location decisions are now evaluated over longer planning horizons, incorporating considerations such as geopolitical stability, tariff exposure, regulatory predictability and proximity to key markets, alongside traditional cost factors.
While these adjustments may result in incremental costs and operational complexity in the near term, they are expected to enhance supply reliability, mitigate disruption risks and support sustained access to global markets over the medium to long term. As a result, geopolitical risk, trade policy developments and supply chain resilience considerations have become integral elements of strategic planning, enterprise risk management and capital allocation decisions across the pharmaceutical industry.
Business Review
Biocon operates as a global biopharmaceutical group with a diversified operating model spanning two distinct business segments:
• Biopharmaceuticals (Biosimilars and Generics)
• CRDMO
Our operating model is underpinned by deep scientific capabilities, integrated manufacturing platforms, and a strong commitment to improving access to high-quality, affordable healthcare. Over the years, we have built scalable businesses across complex pharmaceuticals and research services, with a growing international footprint across developed and emerging markets.
During FY26, we completed the integration of Biocon Biologics Limited (BBL), our biosimilars subsidiary, into the parent company, resulting in a simplified and fully consolidated operating structure. This integration brings together our biosimilars and generics portfolios while Research Services continue to be operated through Syngene, a separately listed subsidiary. The resulting structure strengthens governance, enhances capital allocation discipline, and supports a more integrated approach to portfolio development, manufacturing, and commercial execution across global markets.
Our Biopharmaceuticals business comprises biosimilars and generics operations, while our Services business provides end-to-end research, development, and manufacturing solutions to global pharmaceutical and biotechnology companies. Across both businesses, our strategy is anchored in translating scientific innovation into measurable patient impact, while operating at scale with a focus on quality, reliability, and long-term sustainability.
The following sections provide an overview of our individual businesses, highlighting their strategic positioning, operating context, and performance during the year.
Biopharmaceuticals
Our Biopharmaceuticals business encompasses the Groups Biosimilars and Generics businesses that address large, structurally growing therapeutic areas with high unmet need. Anchored in deep scientific capability and an integrated development-to-commercialisation model, this business is focused on delivering high-quality, affordable therapies at scale, while maintaining strong standards of quality, reliability, and regulatory compliance.
Following the full consolidation of the biosimilars business during FY26, we now function as a unified, globally scaled platform, spanning complex large molecules and specialty small molecules across the product lifecycle" with "across key therapy segments. This structure enhances strategic coherence across portfolio planning, manufacturing, regulatory execution, and capital allocation, while preserving the distinct operating characteristics and market dynamics of individual product categories.
Biosimilars is our largest and most globally scaled segment, reflecting our long-standing investments in biologics research, large-scale manufacturing, and international commercial infrastructure. The biosimilars platform has transitioned from a phase of capacity build-out and geographic expansion into one increasingly defined by execution, operating leverage, and sustained value creation, supported by a broad commercial portfolio and a deep development pipeline. The Generics business complements this platform through specialty formulations and complex APIs, reinforcing our vertically integrated biopharmaceutical model.
Our portfolio is centred on chronic and specialty care, with a strong presence across oncology, immunology, diabetes, and metabolic diseases therapy areas characterised by sustained long-term demand and increasing emphasis on affordability and access. Our capabilities across biosimilars, insulins, peptides, and complex formulations position us to participate across multiple stages of these therapeutic ecosystems, from loss-of-exclusivity opportunities to long-term access-led markets.
The following sections provide a detailed review of the Biopharmaceuticals business, beginning with Biosimilars, and outline portfolio breadth, pipeline progress, manufacturing and R&D capabilities, and operating performance during the year.
a. Biosimilars
Our biosimilars business is a cornerstone of Biocons evolution into a global biopharmaceutical company and reflects nearly two decades of sustained investment in science, scale, and global execution. We began building biosimilar capabilities early, with a clear objective of expanding access to high-quality biologic medicines by combining strong in-house R&D, globally benchmarked manufacturing, and partnerships that enabled international reach. Over time, this deliberate and long-term approach has transformed our biosimilars operations from a development-focused platform into a globally scaled, integrated commercial enterprise.
A major milestone in this journey was the acquisition of Viatris biosimilars business in 2022, which significantly expanded our portfolio and international footprint. This was followed in FY26 by the integration of Biocon Biologics Limited into the parent company, creating a fully consolidated biosimilars platform within Biocon. The integration has simplified the operating structure, strengthened governance and capital allocation discipline, and enabled tighter alignment across portfolio strategy, manufacturing, regulatory execution, and commercial operations, while preserving the specialised capabilities required for biologics development and supply.
Today, our biosimilars business operates as part of a unified, end-to-end biopharmaceutical platform spanning development, manufacturing, and commercialisation across geographies. We have established capabilities across monoclonal antibodies, insulins, and other complex biologics, supported by a robust regulatory track record and a diversified global manufacturing network. As the business has matured, our focus has progressively shifted from capacity build-out and geographic expansion to disciplined execution, operating leverage, and long-term value creation, supported by an expanding commercial base and a deep pipeline.
Biosimilar Market: Entering a High-Growth Decade
The global biosimilars market continues to expand, supported by the growing burden of chronic and specialty diseases, the high cost of biologic therapies, and sustained policy focus on improving healthcare affordability. As several high-value biologics approach or move beyond loss of exclusivity, biosimilars are increasingly integral to treatment pathways across major therapy areas, with adoption deepening across both developed and emerging markets. The global market for biosimilars stood at approximately USD 23 billion in 2024 and is forecast to reach approximately USD 67 billion by 2029, growing at a CAGR of 24% over this period.
Growth has been particularly pronounced in large, regulated markets such as the United States and Europe, which together account for a significant share of global biologics spend. In the United States, biosimilars are gaining wider acceptance across oncology, immunology, and endocrinology, supported by expanding formulary access and evolving reimbursement frameworks. Europe remains one of the most mature biosimilars markets globally, with structured tendering mechanisms and broad stakeholder acceptance driving sustained penetration. Emerging markets continue to represent an important growth opportunity, with adoption shaped by affordability considerations, regulatory readiness, and public-sector procurement frameworks.
As the biosimilars market has expanded, the operating environment has also become more demanding. The focus has shifted from initial market entry to execution at scale, with sustained pricing pressure, consolidated procurement, and heightened expectations around quality, regulatory compliance, and reliability of supply. At the same time, regulatory pathways have evolved towards a science-and-risk-based approach, reflecting increased confidence in biosimilar development and accumulated real-world evidence. These developments increasingly favour platforms with established experience, integrated manufacturing, and proven regulatory credibility.
Against this backdrop, therapy areas such as diabetes, oncology, immunology, and ophthalmology remain central to the biosimilars opportunity globally, given their scale, chronic nature, and long-term sustainability considerations for healthcare systems.
Strategic Focus Area: Diabetes and Insulins
Diabetes represents one of the largest and most enduring opportunities within biosimilars, given its chronic nature, rising global prevalence, and long-term cost burden on healthcare systems. Insulins have been a foundational pillar of our biosimilars strategy, reflecting early investment across development, manufacturing, devices, and global commercialisation.
Over time, we have built scale across multiple insulin analogues, expanding beyond basal insulins to include rapid-acting and differentiated formulations. The chronic and life-sustaining nature of insulin therapy places a premium on long-term reliability, quality consistency, and continuity of supply, making operating resilience a key differentiator.
Regulatory and policy developments across markets have supported broader adoption of biosimilar insulins, particularly as healthcare systems balance affordability with continuity of care. Our long operating history in this category and integrated delivery model position us well to serve both institutional and public-sector channels, while advancing access across geographies.
Commercial Performance and Launch Progress
During FY26, our biosimilars business delivered broad-based commercial progress, supported by the scale-up of recent launches, resilience of the base portfolio, and disciplined execution across markets.
Advanced Markets - North America
In the United States, our established oncology biosimilars such as Ogivri? and Fulphila? continued to maintain meaningful and stable market positions. During the year, we further broadened our presence in immunology, with Yesintek? (ustekinumab) securing broad formulary access providing a solid foundation for longer-term scale-up. We also secured approvals for Yesafili? (aflibercept) and Bosaya™/Vevzuo™ (denosumab), with commercialization in FY27, in line with agreed settlement frameworks.
Our diabetes franchise continued to gain traction across markets, with biosimilar insulins forming an increasingly important part of our North American offering. During FY26, Semglee? (biosimilar insulin glargine) remained a key product for us, while the launch of Kirsty™, the first and only interchangeable biosimilar insulin aspart in the United States, marked a significant milestone and expanded our insulin franchise.
In Canada, we continued to maintain market presence across key biosimilars while preparing for future portfolio expansion driven by upcoming launches.
Advanced Markets - Europe
In Europe, performance was led by steady execution in oncology, with products such as Abevmy? (bevacizumab) and Ogivri? performing well in tender-led markets. Our immunology portfolio also expanded during the year, with Yesintek? launched across several European countries and gaining early traction. Yesafili? strengthened our presence in ophthalmology following launch in key markets.
Advanced Markets - Japan, Australia and New Zealand (JANZ)
In the JANZ region, we continued to strengthen our partner-led commercial model. In Japan, biosimilar ustekinumab, developed and manufactured by Biocon Biologics, was commercialised through our exclusive partner, marking our entry into the immunology segment in the region.
In Australia, our oncology portfolio continued to benefit from participation in hospital tenders, while efforts remained focused on expanding access and broadening the portfolio across the region through collaboration with local partners.
Emerging Markets
Emerging Markets continued to demonstrate stable performance, supported by leadership positions in insulin and oncology biosimilars across several geographies. Public-sector tenders and affordability-led procurement frameworks remained key drivers of demand, reinforcing the scale and resilience of the portfolio.
We remained a leading provider of human insulin and insulin analogues in markets such as Malaysia and Mexico, where we continue to hold very strong market positions, reflecting long-standing engagement with healthcare systems and reliable supply execution. Our oncology biosimilars portfolio also continued to perform well, with products such as trastuzumab and bevacizumab maintaining high levels of adoption in countries including South Africa, Malaysia, the Philippines and Brazil, underlining the breadth and resilience of our presence across therapy areas and regions.
Market Shares by Volume for Commercialized Products in key Emerging Markets
Region |
Country |
Product Market Share |
| LATAM | Brazil | bTrastuzumab 35% |
| Mexico | rh-Insulin 95% | |
| rh-Insulin 97% | ||
| Malaysia | bTrastuzumab 39% | |
| bBevacizumab 34% | ||
| APAC | Philippines | bTrastuzumab 50% |
| bBevacizumab 58% | ||
| Thailand | bPegfilgrastim 32% | |
| Indonesia | bTrastuzumab 88% | |
| bTrastuzumab 85% | ||
| South Africa | bBevacizumab 73% | |
| bPegfilgrastim 49% | ||
| AFMET | Tunisia | bTrastuzumab 100% |
| bBevacizumab 100% | ||
| Saudi Arabia | bAdalimumab 70% | |
| Egypt | bPegfilgrastim 92% |
Note: The data presented hereunder inter alia volumes, projections, market share, is based solely on our study, interpretation and conclusion derived through analysis of different data sets from varied sources inter alia IQVIA, April CY 26
FY26 also saw continued launch momentum and portfolio renewal. Several biosimilars introduced over the past 12-18 months moved into their early scale-up phase, contributing incrementally to revenues as market access widened and supply chains stabilised. At the same time, regulatory approvals across regions supported a steady cadence of new introductions, helping to offset pricing pressure in more mature assets and enhance overall portfolio resilience.
Product Launches FY26
| Advanced Markets | |
| Ustekinumab | Spain, Portugal, France, Hungary, Croatia, |
| Sweden, Finland, Czech, Slovakia, Italy, | |
| Belgium, Netherland | |
| Aflibercept | Canada, UK |
| Aspart | U.S. |
| Etanercept | Poland, Switzerland, Australia |
| Bevacizumab | Bulgaria, Netherlands, U.S., Switzerland |
| Adalimumab | Latvia |
| Trastuzumab | Netherlands |
| Denosumab | Germany, Czech |
| Insulin Glargine | France, Poland |
| Emerging Markets | |
| Bevacizumab | Mauritius, Bangladesh, Chile, Belarus, Jordan |
| Trastuzumab | Philippines, Sri Lanka, Malaysia, Afghanistan, Paraguay |
| Insulin Glargine | Guyana, Panama, Bolivia, Mauritius, Chile, Nepal, Brazil, Libya |
| rh-Insulin | Guyana, Panama, Peru |
| Adalimumab | Tunisia, Paraguay |
| Aflibercept | Turkey, Malaysia |
| Aspart | Nepal, Brazil |
| Pegfilgrastim | Tunisia |
| Etanercept | Tunisia |
Throughout the year, commercial execution remained closely aligned with manufacturing and regulatory readiness, ensuring that launch timing, supply availability, and market access were synchronised. This disciplined, integrated approach enabled us to support multiple concurrent launches while sustaining performance across the base business, an important differentiator in chronic and specialty therapies where reliability and continuity are critical.
Overall, commercial performance in FY26 reflects the continued transition of the biosimilars business into a phase driven by scale-up, execution discipline, and portfolio depth. As recent launches mature and additional products enter the market over time, we remain focused on balancing growth with sustainability, leveraging our integrated platform to navigate competitive intensity while expanding patient access across geographies.
Portfolio Expansion and Regulatory Progress
FY26 marked a year of strong regulatory execution for our biosimilars business, supporting both near-term launches and medium-term growth visibility across multiple therapy areas and geographies. During the year, we delivered against our planned expansion strategy through a series of approvals and launches across immunology, ophthalmology, oncology, bone health and diabetes, further strengthening the breadth and resilience of the portfolio.
bUstekinumab
In immunology, Yesintek? (bUstekinumab) progressed meaningfully during the year, achieving multiple regulatory filings and approvals across major markets including Australia, Canada and UK. Commercialisation commenced in select markets, including Japan, through our strategic partner, enabling entry into the immunology segment. During the year, we also achieved important regulatory milestones for additional presentations, including approval of the auto-injector format in Europe, supporting broader patient access and convenience. In U.S, Yesintek? continued to gain meaningful traction, maintaining leading market share among biosimilars and over 70% market access commercial coverage.
bDenosumab
Our biosimilar denosumab portfolio across oncology and bone health advanced significantly during the year. We received regulatory approvals in key markets, including the European Union and the United Kingdom, for Vevzuo? and Bosaya?. In the United States, biosimilar denosumab was approved in FY26, and we entered into a licence agreement with Amgen, the innovator, enabling future commercialisation in the market and strengthening our medium-term growth potential in oncology-adjacent indications. Subsequent to the end of the financial year, we launched Bosaya™ and Aukelso™ (denosumab biosimilars) in the United States, marking a strategic expansion of our biosimilars portfolio and building on our established leadership in oncology and immunology. During the year, we also launched denosumab for bone health in Germany. In addition, we received regulatory approval for denosumab in Canada, expanding patient access to high-quality biosimilar options.
bAflibercept
In ophthalmology, Yesafili? (bAflibercept) recorded strong regulatory momentum, with approvals across major markets and settlement agreements providing a clear path to commercialisation in the United States and Canada. During the year, Yesafili? was launched in Canada as the first biosimilar aflibercept in the market, representing our tenth biosimilar to be commercialised globally. Additional regulatory milestones, including positive CHMP opinion and approvals for pre-filled syringe presentations in Europe and the United Kingdom, further enhanced the products global readiness. Yesafili? was also successfully launched in select Emerging Markets, achieving good, early traction.
bAspart
Within diabetes, we further broadened our insulin portfolio through the launch of Kirsty™, the first and only interchangeable biosimilar insulin aspart in the United States, strengthening our position in providing high-quality, affordable insulin therapies. In parallel, we entered a multi-year arrangement with the State of California under the CalRx initiative to supply affordable insulin glargine - an important public-sector access programme that reflects the evolving role of biosimilar insulins in addressing system-wide affordability challenges.
Collectively, these regulatory outcomes supported a steady cadence of launches and portfolio expansion across markets, reinforcing the transition of the biosimilars business from portfolio build-out to execution at scale.
Pipeline Updates
We also continued to strengthen pipeline visibility and strategic flexibility during FY26. The completion of patent settlement agreements with Regeneron, Bayer and Amgen provided clarity on global market entry for key assets, including Yesafili? (biosimilar aflibercept) and Vevzuo?/Bosaya? (biosimilar denosumab). These developments enhance predictability of launch sequencing and position us to participate meaningfully in two large and clinically significant therapeutic categories.
During the year, we also took a strategic step to enhance portfolio control and operating leverage by securing full and exclusive global rights for Hulio? (biosimilar adalimumab) from Fujifilm Kyowa Kirin Biologics. Under this arrangement, Biocon Biologics will assume end-to-end responsibility for manufacturing, commercialisation, and any future development activities, improving cost efficiency and providing greater flexibility across markets.
We further strengthened our medium-term pipeline through the disclosure of three new biosimilar assets viz. trastuzumab subcutaneous (SC), nivolumab and pembrolizumab. These represent some of the largest oncology biologics expected to lose exclusivity over the coming years. These additions reinforce our long-standing strategic focus on this therapy area and support sustained portfolio renewal over the medium to long term.
In addition, we received multiple approvals across Emerging Markets for biosimilars including bevacizumab, trastuzumab, pegfilgrastim, adalimumab, etanercept and insulin glargine, further broadening geographic reach and reinforcing a diversified, risk-balanced growth strategy.
Product Approvals across Markets in FY26
| Advanced Markets | |
| Denosumab | U.S, EU, UK, Switzerland |
| Aspart | U.S. |
| Ustekinumab | Australia, Canada, UK, Switzerland |
| Aflibercept | Canada, Switzerland |
| Bevacizumab | U.S., Switzerland |
Emerging Markets
| Adalimumab | Argentina |
| Aflibercept | Algeria, Bosnia, Guatemala, Israel, Saudi Arabia, Thailand |
| Aspart | Armenia, Chile, Uruguay, Hong Kong, Saudi Arabia |
| Bevacizumab | Jordan, Uzbekistan |
| Denosumab | Algeria, Bosnia, Malaysia, Israel |
| Etanercept | Aruba, Costa Rica, Guyana, Honduras, Kosovo, Malaysia, Nicaragua, Panama, Paraguay, Sri Lanka, Trinidad & Tobago, Tunisia, Uruguay |
| Glargine | Armenia, Albania, Kosovo, Hong Kong |
| Insulin | Paraguay, Madagascar |
| Pegfilgrastim | Bosnia, Ghana, Jordan, Tunisia |
| Trastuzumab | Bosnia, Kosovo, Tunisia |
| Ustekinumab | Bosnia, Israel, Malaysia, Saudi Arabia, Guatemala |
Facility and Audit Updates
Manufacturing excellence, regulatory compliance, and quality governance remained foundational to our biosimilars strategy during FY26. Throughout the year, the Quality function continued to focus on strengthening governance structures, enhancing enterprise-wide consistency, and reinforcing a culture of inspection readiness and accountability across the organisation.
All our biologics and formulation facilities in Bengaluru, India, as well as our Malaysia insulin facility, were classified as Voluntary Action Indicated (VAI) following inspections by the U.S. Food and Drug Administration. These outcomes reflect the maturity of our quality systems and support the commercialisation and scale-up of multiple biosimilar products in the United States, including biosimilar ustekinumab, bevacizumab and insulin aspart.
In Europe, the European Medicines Agency (EMA) renewed Good Manufacturing Practice (GMP) Certificates of Compliance for our biosimilars manufacturing facility in Bengaluru and our insulin facility in Malaysia following routine inspections. As a result, none of our approved products require a pre-licensing inspection for the next three years, enhancing operational flexibility and launch readiness across the region.
We also received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for our monoclonal antibody manufacturing facility in Bengaluru, further strengthening regulatory credentials in one of the worlds most stringent markets.
To date, our facilities have secured numerous cGMP approvals from regulatory agencies worldwide, including the U.S. FDA, EMA and PMDA. These approvals underscore our adherence to the highest international regulatory standards and unlock significant manufacturing capacity to support both current commercial needs and future pipeline requirements.
Financial Update
In FY26, our biosimilars business recorded revenues of Rs.104,312 million, representing 16% year-on-year growth on a like-to-like basis adjusted for BFI divestment gain in Q1FY25, driven by continued momentum across both Advanced and Emerging Markets. Performance during the year reflected the combined contribution of established products and the progressive ramp-up of recent launches.
The business delivered Rs.27,508 million in EBITDA, translating into an EBITDA margin of 26%. We have remained committed to investing in future growth, with R&D expenditure at approximately 6% of revenues, directed towards advancing the biosimilars pipeline.
We also materially derisked our capital structure by fully repaying acquisition related debt and extending maturity profile. This was reflected in external credit assessments, with leading rating agencies recognising the businesss improved earnings momentum and strengthening financial position. These developments underscore the resilience of the biosimilars platform and provide additional confidence in our ability to sustain growth while maintaining a prudent balance sheet.
Biosimilars FY27 Outlook
In summary, FY26 represented a year of continued progress, with emphasis on strengthening commercial execution, expanding market access, and advancing the biosimilars pipeline. These efforts have further reinforced our position as a global biopharmaceutical organisation with a diversified and scalable portfolio.
Looking ahead to FY27, our focus remains on the next phase of execution-led growth, with increasing contribution from products approved and launched during FY26 as they continue to scale across markets. Alongside this, we expect to benefit from the operating leverage inherent in our vertically integrated platform. These elements position the biosimilars business to pursue sustainable and profitable growth, while continuing to advance our objective of improving patient access to high-quality, affordable biologics globally.
b. Generics
Our Generics business has evolved over several decades into a diversified, vertically integrated platform, anchored in complex and differentiated manufacturing capabilities. We started with a fermentation-based, cholesterol-lowering statin API, and have since scaled across active pharmaceutical ingredients (APIs) and finished dosage formulations, serving global markets with a strong focus on quality, reliability, and affordability.
A key milestone in this evolution was our forward integration into generic formulations in 2013, leveraging internally developed, complex APIs to enhance value capture while ensuring greater control over quality, supply continuity and cost efficiency. This integrated model has allowed us to support customers and healthcare systems across regulated and emerging markets, while aligning with our broader objective of expanding patient access to affordable medicines at scale.
Today, our Generics operations span six API manufacturing facilities across Bengaluru, Hyderabad and Visakhapatnam, complemented by oral solid dosage (OSD) facilities in Bengaluru and Cranbury, New Jersey. These assets support the manufacture of both potent and non-potent formulations and are being complemented by the development of an injectables facility in Bengaluru to enable sterile fill-finish and drug-device assembly for complex products.
Our current manufacturing capacity comprises approximately 3,500+ KL* reactor volume MT of APIs, 2.5+ billion oral solid dosages unites and more than 10 million injectable units per annum, supporting global demand across therapy areas such as statins, immunosuppressants, anti-diabetics and oncology. As of March 31,2026, we had received over 125+ cGMP approvals from leading regulatory agencies including the U.S. FDA, EMA, TGA (Australia), Health Canada, ANVISA (Brazil) and COFEPRIS (Mexico). Where appropriate, we also utilise contract manufacturing organisations (CMOs) to augment formulation capacity and ensure flexibility.
The Generics business served over 500+ customers across more than 60 countries during the year, reflecting its broad geographic reach and diversified customer base.
Generic API Business
Portfolio and Capabilities
The Generic API business forms the foundation of Biocons Generics platform and is characterised by a well-balanced portfolio of synthetic and fermentation-based APIs, supported by strong regulatory credentials and deep process expertise. Our portfolio spans more than 10 therapeutic areas, with strengths in cardiovascular, anti-diabetics, immunosuppressants, oncology and other specialty segments.
As of March 31, 2026, our API pipeline comprised more than 60 products, reflecting a strategic mix of established large-volume APIs and higher-complexity, value-added molecules. During the year, the portfolio was further strengthened through the addition of oncology-focused HPAPIs and peptides, including GLP-1 receptor agonists that address diabetes and weight-management indications. These additions align with long-term industry trends towards complex, science-driven therapies and reinforce the relevance of our fermentation and peptide technology platforms.
The portfolio currently includes 49 active APIs, supported by 68 active U.S. Drug Master Files (USDMFs) and 29 valid Certificates of Suitability (CEPs). This regulatory base enables sustained participation in regulated markets and supports forward integration into formulations across multiple geographies.
We are also a key global supplier of fermentation-based APIs, including statins and immunosuppressants, and are among a limited number of Indian companies with a meaningful portfolio approved in highly regulated markets such as the United States, Europe and Japan. This positions the API business as both a standalone growth engine and a critical enabler for the broader Generics and formulations strategy.
Market Context and Growth Drivers
The global API market continues to expand, driven by rising chronic disease incidence, increased emphasis on complex and high-value APIs, and ongoing patent expiries across both small-molecule drugs and large biologics. In 2024, the API market is estimated to be valued at approximately USD 263 billion and is expected to grow at a CAGR of ~8.9% over the medium term.
Structural changes in global manufacturing and sourcing patterns are further shaping the industry. During the year, Indias Production Linked Incentive (PLI) programme continued to support domestic manufacturing, reducing reliance on single-source imports and enhancing capacity creation for oncology and complex therapeutic APIs. In parallel, pharmaceutical companies globally are increasingly adopting integrated development and manufacturing models - combining API and finished dosage capabilities - to improve speed-to-market, quality oversight, and supply resilience.
These trends are particularly relevant for peptides and GLP-1 class APIs, where scientific complexity, manufacturing know-how and regulatory compliance represent meaningful barriers to entry. Our continued investments in fermentation, peptides and HPAPIs position the API business to participate in these structurally expanding segments, while also supporting internal formulations and external customer demand.
FY26 Operating Progress - API Business
Following the pricing headwinds and demand contraction experienced during the previous year, the API business continued its volume-led recovery in FY26. Higher API volumes supported Generics revenues during FY26 alongside the ramp-up of formulations.
During the year, the business advanced three strategic priorities:
• Cost improvement, through process optimisation and scale benefits
• Operational efficiency enhancement, across manufacturing and quality systems
• New capacity ramp-up, aligned with medium-term demand visibility
Operational and regulatory execution remained strong. In FY26, we achieved a positive U.S. FDA inspection outcome at the Visakhapatnam API Site 6 and filed 37 API DMFs across global markets, strengthening the regulatory pipeline for future formulations. Commercial supplies of Tacrolimus to China continued to scale through the year via our regional partner, providing incremental revenue from a new geography. We remain focused on further geographic diversification of the API business to reduce dependence on any single markets pricing dynamics.
Biocon API Portfolio*
| Therapeutic Area | Molecule | Therapeutic Area | Molecule |
| Diabesity | Liraglutide | Atorvastatin | |
| Semaglutide | Rosuvastatin | ||
| Tirzepatide | Simvastatin | ||
| Dapagliflozin Empagliflozin |
Cardiovascular | Pravastatin Fluvastatin |
|
| Sitagliptin Phosphate & HCl | Ivabradine | ||
| Linagliptin | Sacubitril | ||
| Vildagliptin | Valsartan sodium | ||
| Orlistat + Orlistat Pellets | Pimecrolimus | ||
| Repaglinide | Micafungin | ||
| Olaparib | Anti - Infective | Posaconazole | |
| Nintedanib | Anidulafungin intermediate | ||
| Cabozantinib | Dabigatran + Dabigatran pellets | ||
| Everolimus | Apixaban | ||
| Oncology | Trametinib | Anti-Thrombotic | Rivaroxaban |
| Lenalidomide | Eltrombopag | ||
| Dasatinib | Edoxaban | ||
| Relugolix | Deferasirox | ||
| Enzalutamide | Brinzolamide | ||
| Mycophenolic acid | Mirabegron | ||
| Mycophenolate Mofetil | Others | Ivacaftor | |
| Immunology | Tacrolimus | Lurasidone | |
| Sirolimus | Teduglutide | ||
| Fingolimod | |||
| Teriflunomide |
*Commercial portfolio as on March 31,2026; does not include molecule under development
Generic Formulations Business
Our Generic Formulations business represents the value-capture layer of the Generics platform, built on Biocons deep capabilities in complex and differentiated APIs. Since our entry into generic formulations in 2013, through forward integration of in-house APIs, the business has scaled into a diversified global operation, competing on quality, cost, reliability of supply, and regulatory compliance across both regulated and emerging markets.
The formulations portfolio spans oral solid dosages (OSDs) including tablets and capsules across immediate and modified-release formats as well as injectables and complex drug-device combinations, such as vials, pre-filled syringes (PFS), pens and auto-injectors. Vertical integration across APIs and formulations gives us enhanced control over the value chain, allowing us to ensure continuity of supply, consistent quality, and faster response to market and regulatory requirements.
Our formulations manufacturing footprint includes OSD facilities in Bengaluru and Cranbury, New Jersey, supporting both potent and non-potent products. In addition, we are developing injectable and device-assembly capabilities in Bengaluru to support the growing share of complex and specialty formulations within the portfolio.
Since the commercialisation of our first generic formulation in the United States in 2017, we have launched 27 drug products in the U.S., seven products in Europe (including the U.K.), and additional products across Most-of-the-World markets, leveraging U.S. approvals where appropriate. As of March 31, 2026, the generic formulations portfolio comprised more than 65+ products across cardiology, anti-diabetics, obesity, oncology, immunology and autoimmune indications.
| 27 | 7 |
| Products Launched in the U.S. | Products Launched Europe (incl. UK) |
The business continued to scale during FY26, crossing USD 125+ million in annual sales during the year. We expect to maintain a steady flow of new products in the U.S., while progressively strengthening our presence across Europe and selected emerging markets.
Across launched and pipeline products, 17 formulations correspond to the top 100 generic molecules globally by sales (Source: IQVIA MAT March 2026). This reflects a deliberate strategy to focus on large, durable molecules, where complexity and scale provide meaningful entry barriers.
Strategic Focus Area: GLP-1s and Peptides
Peptides, particularly GLP-1 receptor agonists, represent a key strategic growth vector within the Generic Formulations business. These products combine high scientific complexity with significant manufacturing, regulatory and device-integration requirements, aligning well with Biocons technology platforms and long-term capability investments.
GLP-1 s are injectable formulations requiring complex characterisation, stringent quality systems and integration with drug-delivery devices. Over recent years, we have invested in peptide technology, analytical capabilities and manufacturing infrastructure to address this opportunity at scale. The global GLP-1 market is projected to expand significantly over the coming years, driven by rising prevalence of diabetes and obesity and increasing physician and patient adoption.
During FY26, we expanded the commercial footprint of Liraglutide across select European markets, including direct-to-market launches of gVictoza? and gSaxenda? in the Netherlands and the U.K. This momentum continued with key regulatory approvals in the U.S., where the FDA approved gSaxenda? (February 2026) and gVictoza? (March 2026), marking Biocons entry into the U.S. GLP-1 market.
In parallel, we advanced the next phase of the GLP-1 pipeline, initiating regulatory filings for Semaglutide (generic Ozempic?/Wegovy?) across multiple geographies and other key markets. These developments position the formulations business to participate meaningfully across the expanding metabolic and obesity treatment landscape.
Generic Formulations Portfolio*
| Therapeutic Area | Molecule | Therapeutic Area | Molecule |
| Liraglutide (Victoza) | Daptomycin | ||
| Diabesity | Liraglutide (Saxenda) | Micafungin | |
| Orlistat pellets | Posaconazole | ||
| Lenalidomide (Revlimid) | Dabigatran pellets | ||
| Oncology | Dasatinib Everolimus (Afinitor) Everolimus (Disperz) | Others | Liothyronin Triamterene Nitrofurantoin |
| Everolimus (Zortress) | Esomeprazole | ||
| Immunology | Mycophenolic acid | Prazosin | |
| Tacrolimus | Aminocaproic acid (Tab & OS) | ||
| Fingolimod | Sertraline | ||
| Atorvastatin | Oxcarbazepine | ||
| Simvastatin | |||
| Cardiovascular | Pravastatin Rosuvastatin | ||
| Sacubitril + Valsartan | |||
| Norepinephrine | |||
| Labetelol |
*Commercial portfolio as on March 31,2026; does not include molecule under development
FY26 Commercial and Operating Highlights
The United States remained the primary market for the Generic Formulations business during FY26. The year saw sustained new-product momentum across oncology, cardiology, transplant and anti-infective therapies. Key U.S. approvals and launches during the year included:
• Micafungin injectable (anti-fungal)
• Sacubitril + Valsartan (Cardiovascular)
• Everolimus oral suspension and tablets (Oncology and Immunosuppressants)
• Norepinephrine Bitartrate injection (Cardiovascular)
• Sertraline
Additional products continued to ramp up following approvals received in prior periods. Tentative approvals were also secured for selected products, pending patent expiry.
Manufacturing capability expansion in the U.S. represented another important milestone. During FY26, we inaugurated Biocons first Oral Solid Dosage manufacturing facility in Cranbury, New Jersey, enabling local manufacturing and direct supply for the U.S. generics portfolio. This facility complements our Indian formulations network and enhances speed-to-market, supply resilience and customer responsiveness. The Cranbury site received a U.S. FDA Establishment Inspection Report (EIR) with a VAI outcome, confirming GMP readiness for commercial operations.
The formulations ramp-up during FY26 coincided with a volume-led recovery in the API business, following pricing pressures experienced in early FY25. Higher API volumes supported formulations supply and contributed to overall Generics revenue growth. The Generics platform continues to progress on three parallel priorities:
• improving cost competitiveness,
• enhancing operational efficiency, and
• ramping up new and expanded capacity aligned with demand visibility.
This integrated API-formulations model, supported by strong regulatory outcomes and expanding manufacturing platforms, underpins the scalability and durability of the Generics business.
Manufacturing Infrastructure and Supply Readiness
Manufacturing capability and supply reliability remain central to the execution of our Generics strategy, particularly as the portfolio increasingly tilts towards complex APIs, injectables, peptides and specialised formulations. During FY26, we continued to strengthen manufacturing platforms across APIs and formulations, ensuring alignment with evolving regulatory, market and customer requirements.
Our Generics manufacturing network comprises six API facilities across Bengaluru, Hyderabad and Visakhapatnam, supported by formulations facilities in India and the United States. A key milestone during the year was the commissioning of Biocons first Oral Solid Dosage (OSD) manufacturing facility in the United States, located in Cranbury, New Jersey. This site enables local manufacturing and direct supply for the U.S. generics portfolio, reducing supply-chain dependencies and improving speed-to-market and responsiveness to customer needs.
The Cranbury facility complements our existing Indian formulations network and supports deeper participation in the U.S. market through a vertically integrated supply model. The facility received a U.S. FDA Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) outcome following an inspection in FY26, confirming GMP compliance and readiness for commercial operations.
Alongside formulations, the API manufacturing network supported increased volumes during the year, in line with the recovery in demand and the ramp-up of formulations supply. Investments in capacity, process optimisation and operational efficiency continue to be aligned with medium-term demand visibility and portfolio complexity.
Quality Systems and Regulatory Execution
Quality and compliance remain fundamental enablers of scale and sustainability in the Generics business. During FY26, we continued to reinforce a strong quality-first culture, underpinned by robust governance, process discipline and inspection readiness across sites.
Multiple manufacturing locations within the Generics network underwent regulatory inspections during the year, aligned with new product approvals and routine compliance requirements. These inspections yielded successful outcomes, reaffirming the robustness of our quality systems and execution capabilities.
Key Regulatory Outcomes during FY26 included
• U.S. FDA inspections of the Cranbury OSD facility and API Site 6 at Visakhapatnam, both concluding with issuance of Establishment Inspection Reports (EIRs).
• ANVISA inspections of Bengaluru Site 1 and API Sites 5 and 6 at Visakhapatnam, completed without significant or critical observations.
• Successful inspections by additional regulatory agencies, including the Saudi Food and Drug Authority (SFDA) and the Malta Medicines Authority (MMA).
These outcomes strengthened regulatory confidence across both APIs and formulations and supported the continued expansion of the regulatory pipeline for the Generics business.
Generics FY26 Financial Performance
During FY26, the Generics business contributed Rs.31,681 million to the Groups consolidated revenues during the year, representing 17% year-on-year growth adjusted for one-time exclusivity sales of generic lenalidomide in FY25. Growth was supported by improving volumes in the API business, continued ramp-up of the generic formulations portfolio, and increasing contribution from complex and differentiated products. The business benefited from the progressive rollout of generic liraglutide in Europe, increased contribution from formulations in the United States, and a stabilisation in API pricing following the volume-led recovery that began in the second half of FY25.
EBITDA stood at Rs.1,654 million, with margins influenced by portfolio mix, operating leverage from higher volumes, and continued investments to support capacity expansion. Capital expenditure was primarily directed towards capacity expansion and capability enhancement, including commissioning of the U.S. OSD facility and investments in injectables, peptides and complex formulations. R&D expenditure remained focused on sustaining a robust pipeline across APIs, formulations and GLP-1s.
Generics FY27 Outlook
Looking ahead, the Generics business is positioned to build on the operational progress made during FY26, supported by a more diversified portfolio, improving volume visibility, and expanding manufacturing and regulatory capabilities. The operating environment is expected to remain competitive, with continued pricing pressure in certain segments. Scale, complexity and vertical integration are expected to remain important differentiators.
Growth in FY27 is expected to be driven by a combination of higher base business volumes and continued expansion of the generic formulations portfolio in the U.S. and Europe. From an execution perspective, focus will remain centred on operating discipline, cost optimisation and reliability of supply, alongside selective investments in regulatory filings and technology platforms that support long-term competitiveness.
Overall, the Generics business remains aligned with Biocons broader objective of expanding access to affordable medicines globally, while strengthening its role as a scalable and resilient contributor to long-term value creation. Our vertically integrated model, spanning APIs, formulations and complex injectables, positions the business to pursue sustainable growth while maintaining financial prudence.
Building an Inclusive and High-Performance Culture
We believe meaningful progress begins with people. Our human capital philosophy is anchored in three commitments — Own. Shape. Elevate. We invest in individuals who take ownership of their growth, shape the organisations future, and elevate standards across every function.
Our learning philosophy reflects this commitment by building capability with rigour, developing leaders at every level, and fostering a culture of continuous growth. Learning at Biocon is a career-long journey that spans induction, technical and scientific capability building, digital literacy, and executive leadership development.
At the core of this approach is BioLead, our comprehensive leadership development architecture, designed across five leadership tiers and four development levels to build a strong pipeline of future-ready leaders.
For more details please refer Human Capital section forming part of this Report on page no. 98
Environment, Social and Governance (ESG)
For Biocon, ESG practices are integral to business strategy and long-term value creation. During FY26, the Company continued to strengthen its ESG framework with a focused emphasis on expanding access to affordable medicines, enhancing environmental stewardship, and reinforcing governance and compliance practices.
During the year, progress was made through expanded regulatory approvals and product launches across both emerging and developed markets, supporting broader and more equitable patient access. Environmental initiatives delivered tangible outcomes during the year, including progress in water stewardship, circularity, and renewable energy adoption. The group made continued progress against its emission reduction targets, our Biosimilars business, has submitted near-term targets to the Science Based Targets Initiative (SBTi), marking a significant step towards aligning the Groups climate ambitions with globally recognized decarbonisation pathways.
Governance practices were further strengthened through enhanced risk disclosures, policy updates, a Group-wide double materiality assessment (DMA), and improvements in ESG transparency, supported by digital and AI-enabled tools. These efforts were reflected in improved external ESG scores, including higher S&P Global CSA and CDP scores and continued inclusion in the S&P Global Sustainability Yearbook.
Looking ahead, Biocon remains focused on embedding ESG more deeply across functions and decision-making, supporting organizational resilience, stakeholder trust and sustainable long-term growth.
c. CRDMO (Syngene International Ltd.)
Syngene is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngenes team of over 8,300 employees, including more than 5,700 scientists, brings deep scientific expertise together with the capability to deliver scientific excellence, robust data security and worldclass manufacturing at speed, enabling faster time to market and lower cost of innovation for its customers.
With over 2.5 million sq. ft. of specialised discovery, development and manufacturing infrastructure across India and the U.S., Syngene has worked with over 400 global customers across industry segments. The Company provides end-to-end services across the drug discovery, development and commercial manufacturing value chain as a Contract Research Organisation (CRO) and Contract Development and Manufacturing Organisation (CDMO).
Contract Research Organization (CRO)
CRO Market
Contract Research Organizations provide outsourced research services to pharmaceutical, biotechnology, medical devices and other life sciences companies, covering activities from early discovery through candidate selection and preclinical and clinical development. The CRO industry has experienced sustained growth over the past decade, driven by continued investment in R&D, increasing scientific complexity and the need to improve productivity and reduce development timelines.
The global CRO market (pre-clinical + clinical) was valued at USD ~84 billion in 2024 and is expected to grow at a ~11% CAGR to ~USD 140 billion by 2029. The growth of the CRO market is driven by factors such as increasing R&D activities in the pharmaceutical and biotechnology industries, rising demand for outsourcing activities and improving technological capabilities and global expertise.
Biotech funding showed a recovery in the second half of 2025 following a period of volatility; however, the translation of funding into CRO revenues typically occurs with a lag of 6-12 months. As a result, CRO demand remains uneven, with customers adopting cautious capital allocation approaches, slower decisionmaking cycles and a preference for smaller work packages.
Notwithstanding near term uncertainty, longterm structural drivers remain intact. Pharmaceutical companies continue to face productivity pressures, pipeline replenishment needs and cost optimisation imperatives. Geopolitical developments and supply chain diversification initiatives, including Chinaplusone strategies and evolving regulatory frameworks such as the BIOSECURE Act, reinforce the longterm case for outsourcing.
Our CRO Business
Syngene delivers its Research Services through flexible operating models that include shared resources and infrastructure as well as fully dedicated facilities, enabling customers to tailor engagement structures based on programme scale, duration and complexity. The Research Services portfolio comprises Discovery Services, Dedicated R&D Centers and Translational & Clinical Research, providing coverage across discovery, translational sciences and early clinical development.
Discovery Services span early stage research from target selection and screening through lead optimisation and candidate delivery across small molecules, biologics and emerging modalities. Clients may engage through individual functional services or integrated discovery programmes, supported by cross-functional coordination and programme management across stages of the discovery process. This flexible delivery model allows customers to prioritise speed, depth or integration depending on programme needs.
Dedicated R&D Centres are built on longterm strategic partnerships and provide fenced infrastructure and multidisciplinary scientific teams aligned with clients specific R&D strategies. These centres are designed to function as extensions of client organisations, offering continuity, predictability and deeper scientific integration while allowing access to Syngenes broader capabilities as programmes evolve. Translational & Clinical Research extends this continuum by supporting biomarker sciences, bioanalysis and global clinical trials, enabling closer integration between discovery and downstream development.
Strategically, Syngenes CRO business is focused on strengthening end-to- end discovery and translational capabilities across an expanding range of modalities, supported by continued investments in enabling technologies, automation and operational excellence. During FY26, this approach supported sustained client engagement across pilot and longterm programmes and reinforced Syngenes positioning as a strategic research partner rather than a transactional service provider.
Contract Development and Manufacturing Organization (CDMO)
CDMO Market
The global CDMO market (small + large molecules) was valued at USD ~130 billion in 2024 and is expected to grow at a ~8% CAGR to ~USD 190 billion by 2029. Strong technical and R&D infrastructure capabilities, availability of skilled scientific talent; quality manufacturing with strong track record of regulatory compliance are some of the key success factors for a CDMO.
The CDMO sector continues to be an attractive and fastevolving space. Two major industry forces are shaping this growth: Large pharmas continued pressure to accelerate development timelines and reduce cost, driving deeper reliance on CDMO partners.
The rapid emergence of new technologies and a growing pipeline of complex assets, which require specialized skills and infrastructure, are further favoring outsourcing models with CRDMOs that offer integrated services.
The reliance on CDMOs will further increase going forward as they continue to offer innovator pharmaceutical companies commercially feasible solutions for a range of drug development and manufacturing services, such as pharmaceutical formulation, analytical development, process optimization, and scale-up manufacturing.
Small Molecule CDMO Market
A typical small molecule CDMO offers services in clinical scale drug substance and drug product development, clinical scale manufacturing services and commercial scale development and manufacturing services. In the CDMO industry, small molecules currently dominate the industry, as they can target a wide range of diseases and disorders and remain a fundamental component of pharmaceutical markets. With increase in outsourcing and growing complexity and diversity of small molecules, Small Molecule CDMO industry was valued at USD ~105 billion in 2024 and is expected to grow at a ~7% CAGR to ~USD 146 billion by 2029.
Our Small Molecule CDMO Business
Syngene is an integrated, science driven and delivery focused provider of small molecule drug substance and drug product development and manufacturing services, with capabilities spanning the full small molecule lifecycle. The operating model reflects how customers increasingly engage with CDMO partners as continuity partners capable of advancing programmes seamlessly from discovery and early development through clinical and commercial supply.
Within its Small Molecule CDMO Development Services, Syngene provides comprehensive preclinical development, API and drug product development capabilities. Teams support clients from lead identification through clinical supplies of both drug substance and drug product, alongside regulatory support for submissions to the U.S. FDA and other global authorities. This integrated development capability enables smoother progression across stages and reduces execution risk associated with handoffs.
Syngene offers an integrated small molecule platform spanning process development, nGMP supplies and full cGMP clinical and commercial manufacturing. Across scales, the Company provides cGMP production from benchtop volumes to full commercial capacity, supporting GLP toxicology batches, clinical supplies, process scaleup, technology transfer, launch material and sustained commercial manufacturing. This end-to-end capability positions Syngene as a partner of choice for customers seeking scientific depth, regulatory reliability and globalquality manufacturing.
The strategic focus of the Small Molecule CDMO business is anchored in a "follow the molecule" approach, with continued emphasis on improving speed, quality and delivery reliability. During FY26, Syngene advanced this strategy through enhancements in early phase development and quality processes and by selectively expanding capabilities aligned with evolving modality requirements. The business continues to build differentiated capabilities across advanced chemistries and enabling technologies, supporting participation in increasingly complex development programmes while maintaining strong execution discipline.
Large Molecule CDMO Market
The large molecule CDMO market is characterized by higher scientific complexity and capital intensity, driven by the growth of biologics and advanced modalities. Large molecule development typically comprises drug substance development, including cellline development, process development and scaleup, and drug product development involving formulation and fillfinish activities.
The large molecule CDMO market was valued at USD ~24 billion in 2024 and is expected to grow at a ~13% CAGR to ~USD 44 billion by 2029. Growth is supported by a strong pipeline of biologics, increasing outsourcing by both large pharmaceutical companies and emerging biotech firms, and the need for specialised manufacturing infrastructure and expertise.
Our Large Molecule CDMO Business
Syngenes Large Molecule division operates as a fully integrated custom biomanufacturer, offering end-to-end development and manufacturing solutions for biologics across mammalian and microbial platforms. The business supports both clinical and commercial supply across a broad range of modalities, including monoclonal antibodies, bispecifics, antibody fragments, recombinant proteins, glycoproteins, mRNA, microbial products and Live Biotherapeutic Products, serving customers in human and animal health markets.
Syngenes biologics manufacturing facilities are designed to support multi product production campaigns using single use technology platforms, enabling flexibility across development stages and longterm commercial manufacturing programmes. This integrated platform, combined with experience in handling complex cellculturebased products, allows the Company to support customers through increasingly complex biologics development and manufacturing requirements.
The strategic direction of the Large Molecule business is focused on expanding technological breadth, strengthening integrated development to manufacturing capabilities and extending Syngenes global footprint. The Company continues to invest in emerging and complex modalities, including bioconjugation and antibody drug conjugates, alongside enhancements in upstream and downstream process development, in line with growing customer preference for integrated CRDMO partners.
During FY26, the Large Molecule business progressed meaningfully along this strategic path. The operationalization of Unit-3 in India and the acquisition of Syngenes first U.S. based biologics facility expanded manufacturing capacity and strengthened presence in key global markets. In parallel, investments in conjugation capabilities, upstream process innovation such as n1 perfusion, and enhanced protein production platforms supported the continued buildout of an integrated biologics development pipeline. The focus is now on scaling a sustainable portfolio of development programmes that can transition into longterm commercial manufacturing, while continuing to drive execution reliability and operational efficiency.
CRDMO (Syngene) - FY26 Highlights
During FY26, Syngene continued to strengthen its end-to-end research, development and manufacturing capabilities across Research Services and CDMO businesses, supported by targeted investments in infrastructure, technology and talent.
In Research Services, the Company expanded capabilities across emerging modalities including antibodydrug conjugates, peptides, oligonucleotides and biotherapeutics, alongside continued enhancement of core chemistry and biology platforms. Investments in automation, robotics and enabling technologies supported improvements in speed, scalability and scientific throughput. Within Translational & Clinical Research, Syngene initiated large, complex global clinical trials and established a Translational Science Unit integrating biobanking, biomarker sciences and translational model support, enabling closer integration between discovery and downstream development. During the year, the Company also secured its first global Phase III clinical trial and expanded its clinical trials footprint through strategic partnerships across multiple geographies.
Syngene further strengthened its longstanding strategic partnership with Bristol Myers Squibb, extending the collaboration through 2035 and broadening the scope of integrated services across discovery, translational sciences, pharmaceutical development, manufacturing, clinical trials and supporting digital and data services.
In Small Molecule CDMO, the Company accelerated early phase development and nGMP quality processes, resulting in improved turnaround times and faster delivery of development batches. Capability expansion focused on advanced chemistries and enabling technologies to support early evaluation of scalable routes. In line with its future focused modality strategy, Syngene initiated investments to establish a dedicated facility for the manufacture of cytotoxic molecules to address increasing demand for high potency drug substances. Green chemistry initiatives continued to play an important role in improving process sustainability and reducing waste.
In Large Molecule CDMO, FY26 marked significant milestones with the operationalisation and licensing of unit 3 in India and the acquisition of Syngenes first U.S. based biologics facility, expanding manufacturing capacity and strengthening the Companys global footprint. Progress continued integration of the U.S. site and buildout of Syngenes global biologics platform. During the year, the Company initiated the establishment of a dedicated nonclinical and clinical conjugation facility, strengthening capabilities in bioconjugation and antibodydrug conjugates, alongside advances in upstream process innovation and protein production platforms.
Across operations, Syngene further strengthened its regulatory and quality credentials, successfully completing multiple client and regulatory audits and inspections during the year, including U.S. FDA Good Clinical Practices inspections and favourable regulatory outcomes at its biologics facilities, reinforcing adherence to global quality and data integrity standards.
Syngenes sustainability leadership continued to receive global recognition, with the Company featuring among TIME magazine and Statistas Worlds Most Sustainable Companies and Worlds Best Companies in Sustainable Growth and earning inclusion in the S&P Global Sustainability Yearbook.
Across businesses, Syngene continued to strengthen scientific and operational teams through selective hiring in emerging modalities and critical capabilities, while streamlining documentation and execution workflows to support timely delivery and maintain high standards of regulatory compliance.
CRDMO (Syngene) - FY26 Financial Performance:
Syngene generated operating revenues of 37,387 million, contributing 22% of Biocons overall revenues during FY26. The Company delivered a steady and resilient financial performance in a challenging operating environment.
Revenue growth for the year was approximately 3% YoY, impacted by an inventory adjustment related to a single largemolecule biologics product within the Large Molecule CDMO business, while the underlying performance across Research Services and other CDMO activities remained steady. Operating EBITDA margin for the year stood at approximately 25%, reflecting the biologics impact and costs associated with new Biologics Unit-3 facility coming on stream.
Research Services accounted for approximately 65% of revenues during the year, with the balance 35% contributed by CDMO businesses.
Syngene maintained a strong balance sheet, generating cash flows of Rs.5,207 million (post capex and dividend), and closed the year with a net cash position of approximately Rs.18,003 million, underscoring financial strength and disciplined execution.
The consolidated financial performance of Syngene for FY26 is available in its Annual Report.
CRDMO (Syngene) - FY27 Outlook
FY26 closed with a muted topline growth of approximately 3% YoY, reflecting the impact of an inventory adjustment related to a single large molecule biologics product. Notwithstanding this impact, the underlying momentum of the business remains healthy and steady, supported by diversified operations across CRO and CDMO businesses.
The biologics inventory adjustment is expected to continue to influence performance in FY27 as well. As a result, FY27 is expected to be a transition year for Syngene. During this period, the Company is undertaking important leadership transitions and organizational alignment to position the business for its next phase of growth, particularly across CDMO, biologics and emerging technology enabled service offerings.
Syngene continues to invest in strengthening its capabilities beyond a traditional services model toward a more value added, technologyled partnership model. Investments in digital platforms and artificial intelligence are focused on improving speed, productivity, predictability and scalability across discovery, development and manufacturing workflows. These initiatives are expected to enhance operational efficiency while also supporting differentiated customer offerings over time.
Given the prevailing macroeconomic and geopolitical uncertainties, and the nearterm impact of the biologics inventory adjustment, the Company expects broadly flat performance in FY27, with operating EBITDA margins maintained in the mid 20% range through disciplined cost management and sharper execution. Performance is expected to be weighted towards the second half of the year, as new programs ramp up and business momentum improves.
Looking beyond FY27, Syngene believes it is well positioned for a return to stronger growth, supported by its diversified and integrated business model, expanding capabilities in emerging modalities, and a healthy pipeline of opportunities. FY27 is therefore viewed as a year of strategic reset and execution, laying the foundation for sustained growth in the years ahead.
Financial Performance - An Overview Consolidated Statement of Profit and Loss
The following table highlights key components of the statement of Profit and Loss for the fiscal years ended March 31,2026 (FY26) and March 31,2025 (FY25).
| All figures in Rs.Million | |||
Particulars |
FY 26 | FY 25 | Change |
| Total income | 172,695 | 164,699 | 5% |
| Expenses | |||
| Cost of goods sold | 61,171 | 55,754 | 10% |
| Employee benefit expense | 32,954 | 29,442 | 12% |
| Finance costs | 9,903 | 8,974 | 10% |
| Depreciation and amortisation expense | 19,567 | 16,870 | 16% |
| Research and development expenses, net of recovery partners | 9,821 | 8,585 | 14% |
| Other expenses | 30,771 | 27,173 | 13% |
| Total expenses | 164,187 | 146,798 | 12% |
| Share of profit/(loss) of joint venture and associate (net) | - | - | |
| Profit before tax and exceptional item | 8,508 | 17,901 | (52) % |
| Exceptional items, net | (4,029) | 965 | |
| Profit before tax | 4,479 | 18,866 | (76) % |
| Tax expense | 1,762 | 4,161 | (58) % |
| Tax on exceptional item | (971) | 212 | |
| Tax expense on adoption of new tax regime - exceptional | - | 199 | |
| Profit for the year | 3,688 | 14,294 | (74) % |
| Non-controlling interest | 2,388 | 3,928 | (39) % |
| Non-controlling interest on exceptional item | (2,556) | 233 | - |
| Profit attributable to shareholders of the Company | 3,856 | 10,133 | (62) % |
| Other comprehensive income attributable to shareholders | 19,137 | 3,563 | 437% |
| Total comprehensive income attributable to shareholders of the Company | 22,993 | 13,696 | 68% |
Total Income
During the year, Total Income grew 5% year-on-year, from Rs.164,699 million to Rs.172,695 million. Revenue from operations in Biosimilars, Generics and CRDMO was up 16%, 5% and 3% respectively.
Our Biosimilar revenues grew by 16% year-on-year to Rs.104,312 million. Revenue growth was supported by strong performance in advanced markets, mainly attributable to favourable pricing actions and strategic market prioritization, supplemented by new product launches.
Generics revenues grew 5% year-on-year to Rs.31,681 million. Adjusted for one-time, exclusivity sales of generic Lenalidomide in FY25, revenue from operations grew 17%, driven by new product launches, strengthening of US business footprint, and geographic expansion initiatives through direct-to-market and strategic partnership models.
The CRDMO Business grew 3% to 37,387 million, driven by its Discovery Services segment offset largely by significant reduction in demand from a major biologics client.
The Total Income composition for FY26 and FY25 is detailed below:
| FY26 | FY25 | |||
Particulars |
(Rs. million) | (%) | (Rs. million) | (%) |
| Biosimilars | 104,312 | 60% | 90,174 | 55% |
| Generics | 31,681 | 18% | 30,175 | 18% |
| CRDMO | 37,387 | 22% | 36,424 | 22% |
| Inter-segment | (4,110) | (2) % | (4,156) | (3) % |
| Revenue from operations | 169,270 | 98% | 152,617 | 93% |
| Other income | 3,425 | 2% | 12,082 | 7% |
| Total income | 172,695 | 100% | 164,699 | 100% |
Gross Margin
Gross Margin represents revenue from operations less cost of goods sold, expressed as a percentage of revenue from operations. Cost of goods sold includes cost of materials consumed, purchases of stock in trade, changes in inventories of finished goods, work in progress & stock in trade and power & fuel.
During FY26, material costs as a percentage of revenue from operations stood at 34%, resulting in a year-on-year decline in gross margin. The comparative performance was impacted by the absence of certain one-off benefits recorded in FY25, including income from Lenalidomide and the benefit arising from a change in inventory valuation policy that had favourably impacted margins in the previous year partly offset by improvement driven by market prioritisation initiatives that led to improved product and geographic mix.
Employees Benefit Expenses
Employee costs comprise of the following items:
• Salaries, wages, allowances, and bonuses
• Contributions to provident fund
• Contributions to gratuity
• Amortisation of employees stock compensation expenses
• Employee welfare expenses including employee insurance
• Certain consultancy services which are part of other expenses
Staff cost in FY26 increased from Rs.29,442 million to Rs.32,954 million driven by increments and new facility-related costs, offset by efficiencies.
Interest and Finance Charges
Finance costs increased to Rs.9,903 million in FY26 from Rs.8,974 million in FY25, primarily due to higher interest expense arising from lower capitalisation of interest, partly offset by early repayment of structured instruments and lower finance costs at the corporate level following refinancing and repayment of borrowings during the year.
Depreciation and Amortisation
During the fiscal, depreciation and amortisation expense increased by 16% to Rs.19,567 million from Rs.16,870 million in FY25, primarily due to depreciation on new facilities commissioned across businesses, and higher amortisation of intangible assets.
Research and Development Expenses
The net R&D expenditure for FY26 increased by 14% year-on-year, to Rs.9,821 million ( 8,585 million in FY25). Net R&D was at 8% of revenue, ex- Syngene. R&D spend increased due to clinical advancement of biosimilar development programs and addition of new molecules in development pipeline.
Other Expenses
Other expenses comprise power and fuel costs, professional fees, integration related costs, and other selling expenses such as freight outwards and general overheads.
Other expenses for FY26 increased by 13% year-on-year, to Rs.30,771 million ( 27,173 million in FY25) driven by increase in SG&A and forex loss.
Tax Expenses
The effective tax rate before exceptional item is at 21% in FY26, compared to 23% in FY25. The high ETR in the previous year reflected the impact of certain one-time items, including higher tax on entity profitability mix and Eris business one time gain.
Exceptional Items (net)
Exceptional items include the following:
a) Integration expenses amounted to 2,102 million, including the write-off of recoveries related to the Viatris transaction.
b) Impact of Rs.965 million arising from labor code implementation across three segments during the year.
c) Provision towards inventory, reflecting a prudent reassessment of inventory values.
d) Other exceptional expenses included a customer litigation settlement at Biocon Biologics, acceleration of vesting of ESOPs/ RSUs, integration-related costs, and write-off an IFQM investment.
e) These exceptional costs were partly offset by a derivative gain recognized on settlement with Viatris.
Collectively, these items are non-recurring in nature and do not reflect the underlying operating performance of the Group.
Other Comprehensive Income
Other comprehensive income for FY26 includes movements in fair value of equity instruments designated through OCI, exchange differences on translation of foreign operations, and the effective portion of gains and losses on cash flow hedges
Consolidated Balance Sheet
The following table highlights the Consolidated Balance Sheet as on March 31,2026 (FY26) and March 31,2025 (FY25):
| All Figures in Rs.Million | |||
ASSETS |
Mar-26 | Mar-25 | Change |
| Tangible assets | 140,855 | 128,099 | 12,756 |
| Goodwill and intangible assets | 293,871 | 276,618 | 17,253 |
| Inventories | 60,857 | 49,311 | 11,546 |
| Financial assets (other than cash and bank balances) | 75,273 | 66,176 | 9,097 |
| Cash and bank balances - A | 44,079 | 49,255 | (5,176) |
| Current and Deferred tax | 9,852 | 6,283 | 3,569 |
| Other assets | 11,719 | 12,231 | (512) |
| 636,506 | 587,973 | 48,533 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Share capital and other equity | 340,318 | 216,440 | 123,878 |
| Non-controlling interests | 25,897 | 60,685 | (34,788) |
| 366,215 | 277,124 | 89,090 | |
| Liabilities | |||
| Borrowings - B | 148,247 | 177,555 | (29,308) |
| Financial Liabilities | 92,193 | 109,847 | (17,654) |
| Income tax and deferred tax liabilities | 6,577 | 5,308 | 1,269 |
| Provisions and other liabilities | 23,274 | 18,138 | 5,136 |
| 270,291 | 310,848 | (40,557) | |
| Total | 636,506 | 587,973 | 48,533 |
| Net Debt C= (B-A)* | 104,168 | 128,300 | (24,132) |
* Net debt: Total Borrowings less cash and cash equivalents, bank balances, current investments in mutual funds, Inter-corporate deposits and other bank deposits net of interest accrued (Excluding ESOP Trust)
Tangible Assets
Tangible assets increased by 9%, driven by capacity additions in Biosimilars across Malaysia and India, expansion of the Generics peptides facility and the OSD facility in Cranbury, USA, and investments in Research Services facilities in Hyderabad, partly offset by depreciation during the year.
Goodwill and Intangible Assets
Goodwill and intangible assets increased by 6% during the year, driven by foreign currency translation impact from appreciation of the US Dollar against the Indian Rupee and capitalisation of borrowing costs, largely offset by amortisation.
Inventories
Inventories grew by 23% to Rs.60,857 million from Rs.49,311 million in FY25 largely reflecting higher inventory levels in the Biosimilars business, in line with scale-up of operations and business growth, partly offset by a marginal reduction in inventory levels in the Generics segment.
Financial Assets
Financial assets increased during the year, driven mainly by:
a) Fair value gains on equity investments, particularly in Bicara and Equillium, reflecting share price appreciation,
(b) Reclassification of a portion of investments to current assets, and
(c) Movements in other strategic energy investments.
Current and Deferred Tax Assets
Current and deferred tax assets increased during the year, primarily reflecting timing differences between accounting and tax treatment, higher advance tax and movements in deferred tax balances recognised during the year.
Cash and Bank Balances
Cash and bank balances include cash and cash equivalents, bank balances, inter corporate deposits with financial institutions, other bank deposits and current investments excluding cash balances of ESOP trust.
Other Assets
Other assets largely comprised balances with government authorities and capital advances, along with prepayments and advances to suppliers. The year-on-year movement primarily reflected utilisation and reclassification of advances during the year, with a reduction across the Businesses.
Share Capital and Other Equity
Share capital and other equity increase was primarily driven by issuance of shares through QIP tranches and preferential allotment, resulting in higher securities premium. This was further supported by profit for the year, movements in other comprehensive income, and an increase in ESOP reserve partly offset by dividend payments, charges relating to put options and equity components of structured instruments, and loss recognised on acquisition of additional stake in Biosimilars business during the year.
Non-controlling Interests
Non-controlling interest decreased primarily due to the acquisition of additional stake in Biosimilars business, partly offset by the share of profit, other comprehensive income and dividends attributable to non-controlling interests in subsidiaries.
Borrowings
Total Borrowings stood at Rs.148,247 million (March 31, 2025: Rs.177,555 million) as of March 31,2026. Net Debt stood at Rs.104,168 million (March 31, 2025: Rs.128,300 million)
Financial Liabilities
Financial liabilities decreased from Rs.109,847 million to Rs.92,193 million during the year, reflecting settlement and repayment of structured instruments, including put option obligations and CCDs, and settlement of derivative liabilities relating to the Viatris transaction
Provisions and Other Non-current Liabilities
Provisions and other non-current liabilities primarily include deferred revenue, deferred tax liability and provision for gratuity and compensated absences.
Key Financial Ratios
| Particulars | FY26 B | FY25 |
| Debtors days | 128 | 131 |
| Inventory days | 294 | 262 |
| Current ratio | 1.2 | 1.1 |
| Debt equity ratio | 0.4 | 0.6 |
| Operating profit margin (%) * | 22% | 27% |
| Net profit margin (%) * | 3% | 6% |
| Return on investmentA | 1.6% | 2.7% |
# Operating margin is defined as Profit before taxes, interest and depreciation
* Net Profit before exceptional item and tax thereon
A
Net Profit before exceptional income and tax thereon to average equityRisks, Threats, and Concerns
Enterprise Risk Management (ERM) represents a structured and integrated approach to the proactive identification, assessment, and management of risks that may impact the achievement of the organizations strategic and operational objectives. ERM does not seek to eliminate risk entirely, as risktaking is inherent to value creation and the pursuit of opportunities. Instead, the risk management framework is designed to ensure that risks are clearly understood, appropriately evaluated, and effectively addressed through a pragmatic, disciplined, and robust risk management process.
The ERM framework, overseen by the Risk Management Committee (RMC), ensures a structured evaluation of key business risks and supports timely, informed decision making. At the beginning of each year, an annual risk reporting plan—covering key business risks aligned with the Companys strategic objectives and organizational goals—is presented to the RMC for quarterly monitoring and reporting. This approach enables the Company to focus on addressing critical risks effectively, with appropriate oversight and guidance from the RMC.
The Risk Management Committee is supported by the Enterprise Risk Management (ERM) function through the following key activities:
• Identifying business, strategic, and operational risks considering the external factors.
• Risk assessment and prioritization and assisting risk owners in developing mitigation plans.
• Reviewing mitigation actions and discussing progress with functional heads, the Executive Committee, and the RMC.
• Implementing specific risk-related initiatives as recommended by the RMC.
• Conducting risk management training for key stakeholders to strengthen risk awareness and culture.
• Identifying top risk themes including financial risks, regulatory approvals, commercial risks, infotech & cybersecurity, ESG risks and compliance risks.
At Biocon, we follow a robust Risk Management framework that ensures business operations continue uninterrupted. The key objectives are:
• Better understand the Companys risk profile.
• Increased certainty and fewer surprises.
• Ensure that the Executive Leadership team can make informed business decisions based on risk assessment.
• Sound business opportunities are identified and pursued without exposing the business to an unacceptable level of risk.
• Contribute to safeguard Company value and interest of shareholders.
• Improve compliance with good corporate governance guidelines and practices as well as laws and regulations.
Our Risk Management Process:
Once a risk is identified, there are five different ways in which a risk can be handled - Treat, Terminate, Transfer, Take, Exploit. At Biocon, a responsive action plan is initiated for treating or managing the key risks identified and bringing them to a tolerable level. The risk management process at Biocon involves the following four steps:
Risk identification and assessment |
Risk prioritisation |
Risk mitigation |
Risk monitoring and reporting |
| • Risks are proactively identified from internal and external sources impacting business objectives | • Assess identified risks for impact, likelihood, and velocity to determine risk severity and readiness | • Risk response actions are defined to keep risks within acceptable levels | • Risk impact and likelihood are continuously monitored as conditions and controls evolve |
| • Multiple techniques (e.g., brainstorming, interviews) are applied to ensure comprehensive identification | • Rate each parameter on a fivepoint scale (1-5) | • Mitigation and contingency plans are developed by assigned Risk Owners | • Structured review forums/ cycles are in place for periodic risk tracking |
| • Compute overall risk rating as (Impact x Likelihood) + Velocity | • Response strategies (Treat, | • The risk environment, events, likelihood, and impact are reevaluated during regular reviews | |
| • Identified risks are mapped across all categories and appropriately classified | • Use risk ratings to prioritize risks and define response strategies | Tolerate, Transfer, Terminate, or Exploit) are applied based on risk drivers | |
| • Risks are clearly articulated using a cause-event-impact structure | • Risk owners, in collaboration with the Risk Team, perform the above assessment for each identified risks | • Risk and Response owners are assigned to each risk | • Risk dashboards are periodically shared with EC |
| • EC/ELT reviews the proposed responses | • Continuous improvements are underway to enhance the risk culture | ||
| • Actions, timelines, status, and review dates are tracked in the risk register |
The organizations risks are identified, assessed, and prioritized on a periodic basis. The risk monitoring and reporting process aims to provide assurance to the Management that risks have been adequately identified, assessed, prioritized based on its impact on business and the likelihood of occurrence, and mitigation strategies put in place and regularly monitored for their effectiveness. The Risk Management Committee reviews the key business risks along with the status of mitigation actions on a quarterly basis.
Our Risk Management Governance Structure:
Biocon Limiteds Board of Directors has direct oversight of the Companys overall risk management framework. The Board has formed a Risk Management Committee which reviews key existing and emerging risks, monitors the adequacy of mitigation strategies as well as the progress on implementing such strategies. The Risk Management Committee, which comprises of the Chairperson, Independent Directors and Managing Director and CEO meet once every quarter, and invites senior business leaders, who are essential to the discussions, to these meetings.
Risk Governance Structure
Board of Directors:
• Periodic oversight of the Companys overall risk profile.
• Evaluate the effectiveness of risk management systems.
Risk Management Committee :
• Advise the board on the effectiveness of the Risk Management Systems.
• Monitor and oversee the implementation of the Risk Management Policy, including evaluating the adequacy of Risk Management Systems.
• Review Risk Management Policy and associated frameworks, processes and practices.
Executive Committee/Executive Leadership Team:
• Monitor and review the implementation of risk management procedures as advised by RMC.
• Provide support and advise on the implementation of risk management and related matters across the business. Review existing risk management processes and documentation.
• Review the status of Key Risks and report the progress to the RMC.
Functional/Regional Heads :
• Report key risks and progress on response plans for their respective function to the Executive Committee.
• Identify new and emerging risks for the function/department/ region.
Global GRC Head :
• Oversee the risk strategy and advise the EC and RMC on existing and emerging risks.
Head of Risk Management/ERM Team :
• Assist the Risk Management Committee in fulfilling the risk management responsibilities.
• Collaborate with EC, ELT, Functional/Regional Heads in carrying out risk identification, assessment, prioritization, and mitigation activities. •
• Development of the Risk Reporting plan, consisting of key business risks that are critical to be monitored by the RMC.
• Provide support and consultancy role, including facilitation and advisory on the implementation of risk management and related matters across Departments and Corporate Functions.
• Monitor key risks on a quarterly basis (per the Risk Reporting Plan).
• Enhance the risk culture across the organization by providing training on the risk management process.
Collaboration: With time, the practice of risk management has shifted in a fundamental way. In the past, risks were managed in "silos". Over time, risk management framework recognized that risks, by their nature, are highly interconnected and interdependent. This evolved approach views all risks together, within a coordinated and strategic framework, which is integrated throughout the organization cutting across functions. To formalize and communicate its approach to risk management, the Company has put in place an enterprise-wide Risk Management Framework. This holistic approach provides the assurance that, to the best of its capabilities, the Company and all its business units identify, assess, and mitigate risks that could materially impact on its performance in achieving the stated objectives. Our Head of Risk Management and team work closely with all key functional heads who are the Risk and Mitigation plan owners.
Our integrated approach to risk management encompasses both business risks and ESG-related risks. This comprehensive view acknowledges the interconnected nature of risks across the Company, its stakeholders and the value chain.
Our risk universe covers the entire gamut of risk exposure categorized under Sectoral, Strategic, Information Technology, Catastrophic, ESG/ Sustainability, Geo-political, Regulatory and Statutory, and Executional/ Operational risks. From this risk library the key risks that matter are arrived at based on the high impact on business and the high likelihood of occurrence. For the key risks that matter, mitigation strategies are developed, implemented, and assessed on a periodic basis.
Key Business Risks and Opportunities:
Our established risk management framework addresses risks that are inherent to the pharma business and any others that may impact on our strategic goals. The following summary indicates some of our key risks and mitigation measures drawn from management reviews and deliberations with the Risk Management Committee:
Key Risks |
Business and Financial Impact |
Mitigation Approach |
| Risk Name: Financial Risk Risk Description: Meeting obligations of banks and | • Optimized capital structure and financial leverage. | • Successful fund raising enabled the settlement to PE Investors and bankers |
| PE Investors | • Compliance with investors and debt obligations. | • Minority shareholding in BBL was acquired, resulting it into 100% subsidiary of Biocon. |
| Category: Strategic | ||
| Risk Rating: Low (at a residual level) | ||
| Risk Name: Regulatory Approvals | ||
| Risk Description: Delay in regulatory approvals may impact launch of new products and life cycle management of existing products Category: Regulatory Risk Rating: Medium (at residual level) | • Timely launch of new products in key markets to meet patient needs faster | • Continued "Voluntary Action Indicated" (VAI) status for our manufacturing sites for in India and Malaysia |
| • Revenue generation | ||
| • Market share. | • With effective mitigations, new products were approved by the agencies (as disclosed to the media) | |
| Key Risks | Business and Financial Impact | Mitigation Approach |
| Risk Name: Commercial Risks Risk Description: Failure to meet the forecasted business growth plans in the markets where the Company is operating | • Adverse impact on the overall growth and business plans | • Before entering any new market, a comprehensive landscape analysis is performed covering competition and other market dynamics. |
| Category: Strategic Risk Rating: Medium (at residual level) | • Managing the timely launch of new products. | |
| • Partnership with local entities to ensure compliance with local requirements. | ||
| Risk Name: Infotech & Cybersecurity Risk Description: Inadequate defense mechanism to cyber-attacks. | • Data Loss/breach through employees/external parties, leading to reputational and financial impact. | • Building a strong cybersecurity resilient organization by establishing governance, defensive and monitoring capabilities. |
| Category: Technological Risk Rating: Medium (at residual level) | • Downtime leads to disruption of operations. | • Regular security testing, monitoring, and incident management processes are in place. |
| • Resilience measures include backups, disaster recovery planning, and cyber insurance coverage. | ||
| • Ongoing employee awareness and access management reduce human and insider risks. | ||
| Risk Name: Compliance Risks | • Financial penalties | • Established enterprisewide compliance framework with robust policies, governance committees, and board oversight. |
| Risk Description: Noncompliance with applicable laws like statutory compliance, data privacy laws etc. may result in regulatory penalties and reputational damage. | • Reputational impact | |
| • Centralized compliance management system with defined ownership, periodic reviews, and mandatory training for employees and partners. | ||
| Category: Regulatory | ||
| Risk Rating: Medium (at residual level) | ||
| • Strong thirdparty risk management including due diligence, sanctions screening, and standardized compliance clauses. | ||
| Risk Name: ESG Risks Risk Description: Key risks related to carbon emission, renewable energy, waste management, DEI, gender pay parity Category: Sustainability - ESG | • Reputational Impact if committed sustainability targets not achieved | • Commitment to reduce Scope 1 & 2 emissions through SBTialigned targets |
| • Increased use of renewable energy in manufacturing units | ||
| • Waste managed through certified vendors with regular audits to ensure compliance and effective disposal. | ||
| Risk Rating: Medium (at residual level) | ||
| • DE&I frameworks and initiatives are in place | ||
| • Period gender pay parity assessment planned. | ||
| Risk Name: Human capital | • Lack of skilled employees for operations | • Various initiatives like BLOOM career model (vertical and horizontal career growth path for employees), leadership development programs, encouraging job rotations taken, helped in talent attraction and retention. |
| Risk Description: Key risks related to talent attraction and retention, succession planning, compliances Category: Talent Risk Rating: Medium (at residual level) | • Drop in employee morale | |
| • Business Continuity | • Critical roles identification and development programs for succession being taken. | |
| • Compliances globally reviewed and actions taken accordingly. |
Key Opportunities
Access & Affordability, & Responsible Investments, Green Initiatives: Innovation led technologies to bring in efficiencies and cost savings, lessen environmental impact and enhance performance, and also increase accessibility and affordability to healthcare.
Implementing responsible pricing for innovative and generic medicines can improve affordability and healthcare cost efficiency, strengthening patient access, brand trust, and longterm profitability.
Digital Solutions: Digital solutions enable streamline operations by minimizing human error, increasing standardization, efficiency and transparency while ensuring data integrity. This approach can also result in cost savings, faster turnaround times and better decision-making capabilities, leading to improved competitiveness and profitability for the Company
Diversity and Inclusion: Efforts have been made to improve diversity in the workplace through interventions across recruitment at a functional level. We recognize the potential of a diverse and inclusive workforce in driving innovation, bringing fresh perspectives for long term value creation.
Community Engagement: Establishing engagement with local communities is vital for the Biocon Group to promote trust, stronger relationships with local communities, improved brand reputation and enhanced social responsibility. Through the Biocon Foundation, diversified social impact interventions, including employee volunteering activities, have been developed and implemented that drive engagement within communities that we operate in.
A keen eye to identify and understand Significant Emerging Risks and Opportunities is also placed from time to time. This enables the company to manage these risks and safeguard our business proactively.
Internal Controls
The Company has laid down guidelines, processes, and structures, which enable implementation of appropriate internal control systems commensurate with the business requirements, scale of operations and applicable statutes. Such internal financial controls encompass policies, processes and key activities or procedures adopted by the Company for ensuring the orderly and efficient conduct of business, including adherence to its policies, safeguarding of its assets, prevention and detection of fraud and errors, the accuracy and completeness of accounting records and the timely preparation of reliable financial information. These include controls in the nature of manual or automated (IT applications including the ERP applications wherein the transactions are approved and recorded).
The Company is staffed by experienced, qualified professionals who play an important role in designing, implementing, maintaining, and monitoring our internal control systems. Appropriate review and self-certification mechanisms have been put in place to ensure that such control systems are adequate and are operating effectively on an ongoing basis.
The internal audit team prepares annual audit plans based on risk assessment, which are approved by the Audit Committee of the Board. Audit execution is done in a co-sourcing model, partly in-house and partly by an Audit Firm. Such independent audits provide reasonable assurance of internal control effectiveness and benchmark on industry-wide best practices.
The Audit Committee, consisting of Independent Directors, reviews important issues raised by the internal and statutory auditors regularly and the status of rectification measures to ensure that risks are mitigated appropriately on a timely basis.
IIFL Customer Care Number
(Gold/NCD/NBFC/Insurance/NPS)
1860-267-3000 / 7039-050-000
IIFL Capital Services Support WhatsApp Number
+91 9892691696
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2026, IIFL Capital Services Ltd. All Rights Reserved
IIFL Capital Services Limited - Stock Broker SEBI Regn. No: INZ000164132 (Member ID - NSE: 10975 BSE: 179 MCX: 55995 NCDEX: 01249), DP SEBI Reg. No. IN-DP-185-2016, PMS SEBI Regn. No: INP000002213, IA SEBI Regn. No: INA000000623, Merchant Banker SEBI Regn. No. INM000010940, RA SEBI Regn. No: INH000000248, BSE Enlistment Number (RA): 5016, AMFI-Registered Mutual Fund Distributor & SIF Distributor
ARN NO : 47791 (Date of initial registration – 17/02/2007; Current validity of ARN – 08/02/2027), PFRDA Reg. No. PoP 20092018, IRDAI Corporate Agent (Composite) : CA1099
This Certificate Demonstrates That IIFL As An Organization Has Defined And Put In Place Best-Practice Information Security Processes.
