Global Economy1
The global economy demonstrated resilience in 2026 amid rising trade tensions and geopolitical uncertainties, with GDP growth steady at 3.2%. This performance was supported by front-loaded trade momentum, sustained investments in Artificial Intelligence (AI), semiconductors and digital infrastructure, along with continued fiscal support across major economies.
Advanced economies expanded by 1.9%, led by the United States at 2.1%, while Europe recorded growth of 1.4% in a challenging trade environment. Emerging and developing economies outpaced advanced markets with growth of 4.4%, supported by China at 5.0%. However, several smaller economies continued to face pressures from elevated debt levels and currency volatility.
While policy measures and technological progress provided a foundation for stability, escalating tensions in West Asia pose risks to energy supply chains, with potential implications for oil prices, logistics costs and broader industrial activity.
Outlook
The global economy is expected to moderate in the near term, with growth projected at 3.1% in 2026 before improving marginally to 3.2% in 2027. The moderation reflects the impact of trade-related uncertainties, softer consumption trends across major economies and cautious investment activity amid evolving geopolitical conditions. Global headline inflation is projected to increase to 4.4% in 2026 before easing to 3.7% in 2027, reflecting the potential impact of geopolitical developments on energy markets, transportation costs and supply chains.
Escalating geopolitical tensions and regional conflicts have also increased risks to global trade and logistics networks. Congestion at key ports, extended transit timelines and operational uncertainty across supply chains have affected the movement of goods in several regions. In addition, freight rates across both ocean and air transportation have increased significantly, while constraints in container and tank availability have added further pressure on global logistics infrastructure. Supply disruptions and challenges across major shipping routes may continue to impact supply chains and increase costs in the near term. These developments underscore the growing importance of supply-chain diversification, strategic sourcing and operational resilience for businesses globally.
Over the longer term, greater emphasis on bilateral trade partnerships, supply-chain reconfiguration and continued investments in technology are expected to support economic resilience. Advancements in Artificial Intelligence (AI), automation and digitalisation are likely to enhance productivity and drive efficiency across industries. While the medium-term outlook remains constructive, sustained growth will depend on the stability of global trade routes, improved investment momentum and the ability of economies to navigate geopolitical and macroeconomic challenges effectively.
Key Highlights
Increasing prevalence of chronic diseases and ageing populations. continue to support long-term pharmaceutical demand.
Growing investments in biologics, specialty therapies and precision medicine are accelerating industry innovation.
Rising pharmaceutical R&D expenditure is expanding development pipelines and outsourcing opportunities.
Adoption of AI, advanced analytics and digital technologies is improving drug discovery and development efficiency.
Greater focus on healthcare accessibility and treatment outcomes continues to support market expansion.
The global pharmaceutical industry is undergoing a structural transformation, supported by an ageing population, increasing disease burden, rising healthcare expenditure and continuous scientific innovation. Advancements in biologics, cell and gene therapies, precision medicines and digital technologies are reshaping the global healthcare landscape, while increasing focus on accessibility and treatment outcomes continues to support industry growth. Against this backdrop, the global pharmaceutical market is projected to expand from USD 1,524 billion in 2024 to USD 2,076 billion by 2029, growing at a CAGR of 6.4%, according to Frost & Sullivan.
These drivers collectively underpin a structurally strong and innovation-led growth trajectory for the global pharmaceutical industry
Innovation is Increasingly Driving Pharmaceutical Growth
The pharmaceutical industry is witnessing a gradual shift from volume-led growth towards innovation-led growth. Innovator drugs, comprising New Chemical Entities (NCEs) and New Biological Entities (NBEs), are expected to increase their share of global pharmaceutical revenues from 51.3% in 2024 to 53.9% by 2029.
The innovator drug market is projected to grow from USD 783 billion in 2024 to USD 1,119 billion by 2029, representing a CAGR of 5.2%, compared with 6.4% for the overall pharmaceutical market during the same period.
The growing contribution of innovator therapies reflects increasing investments in differentiated medicines, precision therapies and advanced treatment platforms aimed at addressing unmet medical needs.
Emerging Biotech Companies are Accelerating Innovation
A significant proportion of pharmaceutical innovation is increasingly originating from emerging biotechnology and small pharmaceutical companies. These organisations are playing a critical role in advancing novel therapies across oncology, immunology, rare diseases and precision medicine.
The market share of small pharmaceutical and biotechnology companies is expected to increase from 23.7% in 2024 to 26.1% by 2029. Correspondingly, revenues from this segment are projected to grow at a CAGR of 8.5% between 2024 and 2029, significantly higher than the growth rate of large pharmaceutical companies.
The growing prominence of biotech innovators reflects the industrys increasing focus on specialised research, breakthrough therapies and scientific differentiation, creating a dynamic ecosystem for pharmaceutical innovation.
Biologics and Advanced Modalities are Reshaping Drug Development
Biologics have emerged as one of the fastest-growing segments of the pharmaceutical industry, driven by their superior efficacy, targeted action and increasing application across oncology, autoimmune disorders and rare diseases.
Between 2018 and 2024, the share of New Biological Entity (NBE) approvals increased from 29% to 44% of total FDA approvals, highlighting the growing importance of large-molecule therapies alongside traditional small molecules.
Reflecting this trend, the biologics market expanded from USD 373 billion in 2019 to USD 519 billion in 2024 and is expected to reach USD 794 billion by 2029, growing at a CAGR of 8.9%, significantly faster than small molecules.
More than 100 biologic drugs achieved blockbuster status in 2024, with the top ten biologics generating nearly USD 132 billion in annual sales.
Factors Contributing to the Growth of Biologics (Large Molecules)
* Growing R&D investments in biological therapies driving the share of the Biologics drug pipeline volume to 49.8% in 2024 with a growth of 13.0% from 2019 to 2024. |
* Expanding access and availability to new markets and a broader patient population through sponsorships and company programs. |
* Regulatory support and fast-track approvals for new biologics (large molecules). |
* Acceptance of experimental therapies (e.g. combination immunotherapies). |
* Emergence of value-based care reimbursement models driving faster adoption of expensive therapies. |
* Biologics (large molecules) offer targeted action, precision and efficacy with fewer side effects. |
* Highly effective in complex therapeutic areas such as oncology and autoimmune diseases. |
* Technology advancements in bi-specific and multi-specific antibodies, innovations in MRNA and in CGT are creating higher curative potential of biologics (large molecules). |
* Introduction of novel action mechanisms, offering promising solutions for previously untreatable and rare diseases. |
* Investments in global bio-manufacturing infrastructure, including modular facilities and single-use technologies, are supporting the scalability and accessibility of biologics (large molecules), contributing to market growth. |
* Improvements in discovery and manufacturing technologies (enhancing production efficiency, scalability and reducing costs) such as CRISPR, high-throughput screening and single-use bioreactors, are accelerating the development and production of biologics (large molecules), improving accessibility. |
Global Pharma R&D2
The pharmaceutical R&D value chain has four stages: discovery, followed by development (pre-clinical and clinical Phase 1, 2 and 3) and finally, approval of the new drug.
Phase |
Stages |
Description |
Drug Discovery |
Constitutes the processes from target identification to target validation to lead generation and lead optimisation. During this stage thousands of compounds are narrowed down to a few hundred with promising potential. | |
Preclinical Development |
Exhaustive laboratory and animal experimentation of the preclinical drug candidates for safety and therapeutic effect to determine whether a compound is suitable for human testing. The process may take several years and the data generated during this stage is a critical part of the dossier for regulatory bodies to receive clinical trials approvals. | |
Development |
Clinical Trials |
Promising drug candidates are presented to regulatory authorities for permission to conduct human clinical trials via Investigational New Drug Applications. Once approved, these drug candidates are referred to as Investigational New Drugs (IND). INDs proceed to clinical trials, which are studies in humans to determine the safety, efficacy and suitable drug dosage of potential drug candidates. |
Drug Substance Development |
Covers early stage and late-stage process development and optimisation. Small quantities of drug substance are manufactured under non-GMP conditions for toxicology evaluation and under GMP conditions for initial clinical studies. Depending on the outcome of these studies, larger quantities of drug substance are manufactured for late-stage clinical programmes. | |
Clinical Supplies/ Drug Product Development |
Covers early stage and late-stage formulation development and manufacture. As the molecule moves further along the development cycle, the formulation becomes increasingly nuanced in line with the data being generated through the trials. | |
Commercial Manufacturing |
Large-scale commercial production of approved Drug Product with the highest level of quality. Companies must adhere to FDA or all other relevant regulations for manufacturing. |
Global pharmaceutical R&D continues to evolve, driven by increasing investments in innovation, growing complexity of drug development and rapid advances in technology. Worldwide R&D spending is projected to increase from USD 289 billion in 2024 to USD 343 billion by 2030, reflecting the industrys continued commitment to strengthening development pipelines and advancing next-generation therapies. As research programmes become increasingly specialised and capital-intensive, pharmaceutical companies are placing greater emphasis on collaboration, digital transformation and external innovation partnerships.
Key Themes Shaping Pharmaceutical R&D Outsourcing is Becoming a Strategic Imperative
The growing complexity of drug development, rising R&D expenditure and increasing focus on speed-to-market are accelerating outsourcing across the pharmaceutical value chain.
Biotech companies and pharmaceutical innovators are increasingly partnering with specialised Contract Research, Development and Manufacturing Organisations (CRDMOs) to support discovery, development and commercial manufacturing activities. This trend is particularly pronounced in complex modalities such as biologics, peptides, oligonucleotides, antibody-drug conjugates and other next-generation therapies.
As innovation intensity increases and development timelines become more demanding, integrated CRDMOs are emerging as critical enablers of pharmaceutical innovation, supporting customers through the entire product lifecycle from early-stage discovery to commercial-scale manufacturing.
Industry Outlook
The long-term outlook for the global pharmaceutical industry remains robust, supported by expanding healthcare demand, increasing biologics adoption, rising innovation intensity and growing R&D investments. The continued shift towards advanced therapies, coupled with increasing outsourcing across the pharmaceutical value chain, is expected to create significant opportunities for specialised CRDMO partners with integrated discovery, development and manufacturing capabilities.
Indian Economy3
India remains one of the fastest-growing major economies globally, with real GDP estimated to expand by approximately 7.6% in FY 2026, up from 7.1% in FY 2025. Growth is supported by strong rural consumption, steady agricultural, industrial performance and robust services activity. Government initiatives such as Production Linked Incentive (PLI) schemes and sustained infrastructure spending have further strengthened economic momentum.
Inflation remains contained, with CPI at 3.40%4 on the revised 2024 base, supporting real purchasing power and consumption across urban and rural markets. India is further strengthening its integration into global value chains through trade engagements with the United States and the European Union, alongside efforts to diversify crude sourcing to enhance energy security amid ongoing geopolitical uncertainties.
Outlook
India is expected to remain the fastest-growing major economy, with Real GDP growth for FY 2027 is projected to be 6.9%5, supported by continued government capital expenditure and a recovery in private consumption. Real Private Final Consumption Expenditure is projected to grow by around 7.0% in FY 2026, indicating improving demand conditions.
Ongoing structural reforms, including GST rationalisation, new trade agreements and measures to improve the ease of doing business, are expected to support long-term growth prospects. With inflation anticipated to remain moderate, the Reserve Bank of India (RBI) is likely to maintain a supportive policy stance, facilitating investment activity and credit expansion despite an uncertain global backdrop.
Source: Economic Survey 2025-26
Indias pharmaceutical industry has emerged as a global leader, ranking third in terms of volume and among the leading markets by value. It is widely recognised for its role in supplying affordable medicines, accounting for nearly one-fifth of global generic drug volumes. The country also plays a significant role in vaccine production.
The sector has demonstrated consistent expansion in recent years, supported by robust domestic demand and export growth. With turnover exceeding I4 lakh crore and expanding at over 10% annually, the industry continues to scale steadily. Indias pharmaceutical market, currently valued at approximately USD 5060 billion, is projected to reach USD 130 billion by 2030, driven by sustained domestic demand and strong export performance. Additionally, India exports medicines to over 200 countries, reinforcing its position as a key pillar of global healthcare supply chains. Indian pharmaceutical companies also possess extensive experience in working with global regulatory agencies such as the USFDA and EMA, supported by Indias distinction of having the highest number of USFDA-approved manufacturing facilities outside
Key Highlights
India remains one of the worlds largest suppliers of affordable generic medicines and vaccines.
Strong regulatory capabilities and manufacturing expertise continue to enhance Indias global competitiveness.
Expanding healthcare access, rising incomes and increasing healthcare expenditure are supporting domestic demand.
Government initiatives and infrastructure investments continue to strengthen the pharmaceutical ecosystem.
India is increasingly emerging as a preferred partner for global pharmaceutical and biotechnology companies.
United States. This strong regulatory track record enables Indian companies to operate at global quality standards, leverage transferable compliance expertise and increasingly position themselves as preferred partners for multinational pharmaceutical and biotechnology companies.
Government Initiatives:
Production Linked Incentive (PLI) Scheme for Pharmaceuticals: Incentivises domestic manufacturing of high-value products, including biopharmaceuticals, complex generics and patented medicines.
Production Linked Incentive Scheme for Bulk Drugs (APIs/ KSMs/DIs): Focuses on reducing import dependence by strengthening domestic manufacturing of critical raw materials and active pharmaceuticals.
Promotion of Research and Innovation in Pharma MedTech
(PRIP): Backed by an outlay of I5,000 crore to boost research, innovation and collaboration across industry and academia.
K1 Lakh Crore Research, Development and Innovation (RDI) Scheme: Announced to provide long-term financing support for research, innovation and deep-tech development across strategic sectors, including pharmaceuticals, biotechnology and healthcare innovation.
Biotechnology Industry Research Assistance Council
(BIRAC): Supports biotechnology innovation, startup incubation and translational research, with the Government proposing a I2,000 crore allocation to strengthen the biotechnology ecosystem. Bulk to develop
Drug Parks Scheme: Aims integrated infrastructure to improve manufacturing efficiency and cost competitiveness.
Strengthening of Pharmaceutical Industry Scheme: Supports quality enhancement, regulatory compliance and global competitiveness.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): Expands access to affordable generic medicines through dedicated distribution networks.
Outlook
The outlook for the Indian pharmaceutical industry remains favourable, driven by a gradual transition towards a value-driven growth model.
Increasing emphasis on complex generics, biosimilars and speciality products is expected to grow at 911% annually in the near term, supported by strong domestic demand, export expansion and stable operating performance.
Policy support aimed at enhancing self-reliance, encouraging research and reducing dependence on imports continues to reinforce the industrys long-term prospects. At the same time, emerging opportunities in biologics, advanced manufacturing and diversified export markets are expected to support Indias progression towards higher value segments within the global pharmaceutical landscape.
CRDMO Industry
Global CRDMO Industry8
Key Highlights
Pharmaceutical and biotechnology companies continue to increase outsourcing to optimise costs and accelerate development timelines.
Growing demand for peptides, oligonucleotides, ADCs, biologics and other advanced modalities is driving specialised CRDMO requirements.
Increasing complexity of drug development programmes is strengthening demand for integrated service providers.
Supply-chain diversification initiatives are creating opportunities for established CRDMO partners globally.
Long-term partnerships and strategic outsourcing models continue to gain traction across the industry.
The Contract Research, Development and Manufacturing Organisation (CRDMO) industry has evolved into a critical enabler of pharmaceutical innovation, supporting companies across the drug development lifecycle from discovery through commercial manufacturing. Increasing R&D complexity, growing adoption of advanced therapeutic modalities and the need for greater speed-to-market are encouraging pharmaceutical and biotechnology companies to expand outsourcing partnerships and adopt asset-light operating models.
A key structural shift underway is the transition from fragmented outsourcing arrangements to integrated service delivery models, where CRDMOs act as strategic partners across multiple stages of the pharmaceutical value chain. These integrated partnerships enable pharmaceutical companies to improve development efficiency, optimise costs, accelerate commercialisation and access specialised capabilities without significant capital investment.
Industry Structure and Operating Model
The CRDMO industry operates across an increasingly integrated pharmaceutical value chain encompassing discovery, pre-clinical research, clinical development, process development and commercial manufacturing.
At the early stages, CRDMOs support target identification, lead optimisation, assay development and molecule screening. This is followed by pre-clinical and clinical development services, including pharmacokinetic and toxicology studies, clinical trial support, formulation development and process optimisation. In later stages, CRDMOs provide commercial-scale manufacturing, regulatory support, supply-chain management and lifecycle management services.
Source: Frost & Sullivan
Traditionally segmented into Contract Research Organisations (CROs) and Contract Development and Manufacturing Organisations (CDMOs), the industry is increasingly evolving toward a unified CRDMO model that offers end-to-end solutions across the pharmaceutical development lifecycle.
Global CRDMO Market Continues to Expand
The increasing reliance on outsourcing, coupled with rising pharmaceutical innovation and growing development complexity, continues to support strong growth across the global CRDMO industry.
The global CRDMO market was valued at USD 213 billion in 2024 and is projected to reach USD 330.0 billion by 2029, reflecting a CAGR of 9.1% during the forecast period. Between 2019 and 2024, the industry expanded from USD 136 billion to USD 213 billion, registering a CAGR of 9.4%.
Geographically, North America and Europe continue to dominate the market, while Asia-Pacific is emerging as the fastest-growing region, supported by cost competitiveness, talent availability and ongoing supply-chain diversification initiatives. Within Asia-Pacific, India and China continue to strengthen their position as key outsourcing destinations, with India increasingly transitioning toward value-based and integrated service partnerships.
Advanced Modalities are Driving the Next Phase of Growth
One of the most significant trends shaping the CRDMO industry is the growing demand for advanced therapeutic modalities, including biologics, peptides, oligonucleotides, antibody-drug conjugates (ADCs), cell and gene therapies and GLP-1-based treatments.
The global biologics CRDMO market was valued at USD 48 billion in 2024 and is expected to reach USD 86 billion by 2029, growing at a CAGR of 12.5%. Biologics are projected to account for 26.1% of the global CRDMO market by 2029.
In comparison, the small-molecule CRDMO market accounted for 77.5% of the industry in 2024 and is expected to grow at a CAGR of 8.1% between 2024 and 2029, reaching USD 244 billion by 2029.
The rapid adoption of GLP-1 therapies, including semaglutide-based products for diabetes and obesity management, is further accelerating investments in peptide development and specialised manufacturing infrastructure globally.
Demand is Increasing Across the Pharmaceutical Value Chain
The expansion of outsourcing is occurring across all stages of pharmaceutical development, from discovery and pre-clinical services through development and commercial manufacturing.
In 2024, development and commercial manufacturing together accounted for approximately 60.4% of the global CRDMO market. These segments are expected to continue expanding as pharmaceutical companies increasingly seek integrated outsourcing solutions.
The development segment is projected to grow from USD 38 billion in 2024 to USD 60 billion by 2029, representing a CAGR of 9.5%. Commercial manufacturing, the largest segment within the industry, is expected to increase from USD 91 billion to USD 130 billion during the same period, growing at a CAGR of 7.5%.
Among all functions, clinical services are expected to remain the fastest-growing segment, expanding at a CAGR of 15.7% between 2019 and 2024 and 11.1% between 2024 and 2029.
Outlook
The global CRDMO industry is expected to witness sustained long-term growth, supported by structural outsourcing trends, increasing complexity of drug development and the expansion of the global biotech ecosystem. The shift toward integrated service models and strategic partnerships is likely to further strengthen the role of CRDMOs as essential partners in the pharmaceutical value chain.
In the medium to long term, growth will be driven by rising demand for biologics, specialty therapies and advanced modalities, alongside increasing adoption of digital technologies across R&D and manufacturing. While regulatory requirements, capital intensity and talent constraints remain key challenges, the industry is well-positioned to benefit from continued innovation, supply chain realignment and evolving pharmaceutical business models.
Indian CRDMO Industry
Key Highlights
India remains one of the fastest-growing CRDMO markets globally, supported by strong outsourcing demand and innovation-led pharmaceutical development.
The Indian CRDMO market is projected to grow from USD 8 billion in 2024 to USD 15 billion by 2029.
Industry growth is expected to outpace the global CRDMO market, strengthening Indias market share opportunity.
Regulatory developments and global supply-chain diversification initiatives continue to support Indias attractiveness as a CRDMO destination.
Strong capabilities across CRO and CDMO services position India to capture a larger share of global pharmaceutical outsourcing.
India has emerged as one of the most attractive destinations for pharmaceutical outsourcing, supported by a strong scientific talent pool, cost competitiveness, regulatory expertise and expanding capabilities across research, development and manufacturing services. Increasing global demand for integrated outsourcing solutions, coupled with supply-chain diversification initiatives, is strengthening Indias position within the global pharmaceutical value chain.
Robust Market Growth Underpinned by Outsourcing Trends
The Indian CRDMO industry is among the fastest-growing globally, having grown at a CAGR of 13.2% between 2019 and 2024. The market is projected to expand from USD 8 billion in 2024 to USD 15 billion by 2029, reflecting a CAGR of 13.4%, significantly higher than the projected global CRDMO industry growth rate of 9.1%. In addition, evolving geopolitical dynamics and regulatory developments, including the implementation of the US BIOSECURE Act, are expected to accelerate outsourcing opportunities and support Indias increasing share of the global CRDMO market.
Expanding Opportunities Across Therapeutic Modalities
Small molecules continue to dominate the Indian CRDMO industry. The segment represented more than 92% of the industry in 2024. However, biologics are gaining importance due to significantly higher growth rates. The biologics (large molecules) segment in India grew rapidly between 2019 and 2024 at a CAGR of 23.2% to reach USD 1 billion in 2024 and is estimated to grow at 15.5% CAGR from 2024 to 2029.
Increasing Demand Across the Pharmaceutical Value Chain
Within the value chain, development and commercial manufacturing contributed 76.8% of the Indian CRDMO market in 2024. These segments are expected to grow at CAGRs of 14.9% and 12.8%, respectively, between 2024 and 2029.
Growth is supported by improving technical capabilities among Indian companies. Global pharmaceutical companies increasingly outsource manufacturing activities to Indian service providers. Indian CRDMOs are also expanding integrated offerings across multiple therapeutic segments, including biologics.
Demographic Advantage:
*Young working-age population to support research and manufacturing activities: India is a relatively young country with 66% of the population below 35 years of age as of 2022.9 According to the World Bank, Indias working-age population is also rising from 65% in 2012 to 68% in 2023.10
*Skilled English-speaking workforce capable of delivering high-tech global needs: India produces an average of 24,000 post-doctoral graduates annually and has a strong base of STEM graduates, crucial for science-intensive drug discovery work. India has a bigger pool of STEM graduates than the US and UK.
*Large disease burdened population and patient pool to participate in clinical trials: With 2 billion of population (as of 2024), India offers a significant patient pool for clinical trials. As one of the leading nations for lifestyle diseases, including Diabetes (90 million cases in 2024) and Hypertension (310 million+ cases in 2024), as well as chronic conditions such as Cancer (2 million new cases in 2024), India offers a diverse treatment patient group which has not received any treatment for a particular condition and with a wide-ranging gene pool.
Infrastructure Advantage:
*Strong Development and Manufacturing base: The Indian facilities have a lower percentage of OAI (Official Action Indicated) flags compared to China. Indian companies also have deep experience working with the FDA and the European Medicines Agency (EMA) and are fully equipped to work at scale and in line with global standards. Notably, India is the worlds largest provider of generic drugs with approximately 60% share of global vaccine supply (as of 2024)11. India has the second-highest number of catalogued sites as per the FDA, next to the US and saw an increase of 16% between 2019 and 2023.
Favourable Policy Advantage:
*Governments FDI Policy: Supportive FDI policies have significantly benefited Indias pharmaceutical sector. The sector ranked eighth for FDI in 2024. Under the automatic approval route, up to 100% FDI is permitted in greenfield projects. Up to 74% FDI is permitted in brownfield projects.
*Robust Intellectual Property (IP) Protection: Indias strengthened intellectual property framework has increased confidence in pharmaceutical outsourcing. The transition towards complete product patent protection has reduced patent infringement concerns. Supportive IP regulations position India as an attractive hub for pharmaceutical innovation and manufacturing. India ranked sixth globally in patents applications12.
*Financial Incentives for Pharma Manufacturing and R&D:
The pharmaceutical sector benefits significantly from strong fiscal and policy support. India offers a 100% tax deduction on eligible R&D expenditure. Government initiatives such as Biotechnology Industry Research Assistance Council (BIRAC), Bio-NEST and Biotech Science Clusters support pharmaceutical R&D and biotech startups. The Production-Linked Incentive (PLI) scheme supports domestic pharmaceutical manufacturing. Bulk drug parks also reduce operational costs through shared API infrastructure. These initiatives are strengthening Indias manufacturing competitiveness and attracting foreign investments into the CRDMO sector.
*Policy Reforms Enhancing Transparency and Efficiency: India has implemented several regulatory reforms aligned with global standards. Key reforms include the 2019 New Drugs and Clinical Trial Rules, the 2017 National Ethical Guidelines for Human Research and the SUGAM online submission portal. These initiatives have streamlined clinical trial approvals and improved process transparency. Faster approval timelines and enhanced participant protection are supporting a more predictable clinical trial environment in India.
Cost Advantage:
India continues to offer significant cost advantages compared with Western markets. Drug development and manufacturing costs in India are approximately 30% to 40% lower than in the US or Europe13. These advantages make India an attractive outsourcing destination for pharmaceutical companies seeking operational efficiency without compromising quality.
Transition of Growth from China to other emerging markets, particularly India
Chinas advantages in the CDMO market are gradually declining. This transition is shifting outsourcing demand towards emerging markets, particularly India. Global biopharmaceutical companies are increasingly diversifying supply chains to reduce geographic concentration risks.
Impact of the BIOSECURE Act: The US BIOSECURE Act may restrict US-based companies from using biotechnology equipment or services from select Chinese firms. This development could significantly reduce demand for Chinese CDMO services, particularly from the US market.
The legislation is prompting global pharmaceutical companies to evaluate alternative outsourcing destinations. India is emerging as a preferred market due to its cost advantages, technical capabilities, regulatory track record and expanding manufacturing infrastructure.
Indian CRDMO Industry Opportunities and Challenges
Outlook
The Indian CRDMO industry is poised for strong and sustained growth, driven by increasing global outsourcing, rising complexity of drug development and Indias evolving capabilities in high-value, innovation-led services. With the industry expected to grow at a double-digit CAGR and double in size over the next five years, India is well-positioned to emerge as a preferred global partner for integrated research, development and manufacturing services.
The next phase of growth will be defined by the industrys ability to move further up the value chain, particularly in biologics, advanced modalities and early-stage research services, while leveraging digital technologies to enhance efficiency and innovation. Strengthening regulatory compliance, expanding specialised infrastructure and developing high-end scientific talent will be critical to sustaining this momentum.
Overall, the Indian CRDMO sector is transitioning from a cost-driven outsourcing hub to a strategic innovation partner, reinforcing its role as a key contributor to global pharmaceutical R&D and manufacturing ecosystems.
Company Overview
Anthem Biosciences Limited is an integrated Contract Research, Development and Manufacturing Organisation (CRDMO) with capabilities spanning the entire pharmaceutical value chain, from early-stage discovery to commercial-scale manufacturing. Established in 2006, the Company has developed a global footprint, serving leading pharmaceutical and biotechnology companies across regulated markets.
The Company operates through two primary segments, CRDMO Services and Speciality Ingredients, enabling it to cater to both innovator-led pharmaceutical development and science-based nutrition and bio-based applications. Its expertise spans small molecules, biologics, peptides, oligonucleotides and high-potency compounds, supported by advanced technology platforms and regulatory-compliant infrastructure. With state-of-the-art manufacturing facilities, a strong emphasis on innovation, process excellence and backward integration has enabled Anthem to establish long-standing client relationships and deliver scalable solutions across multiple stages of the product lifecycle.
Guided by its FY 2026 theme, "People. Performance. Progress. Transforming Tomorrow with Expertise," the Company continued to strengthen its scientific capabilities, operational scale and growth platforms during the year.
PEOPLE
Anthems success has been built on a strong culture of scientific excellence, entrepreneurship and long-term employee engagement. Having operated as a privately held enterprise for nearly two decades, the Company has nurtured a stable and experienced talent base, with several employees associated with the organisation since its formative years.
Following its successful public listing, Anthem recognised the contribution of its employees through a broad-based ESOP programme, enabling meaningful wealth creation and reinforcing a culture of shared success. As of March 31, 2026, the Company employed approximately 2,300 professionals, including scientists, researchers and technical experts across discovery, development and manufacturing functions.
PROGRESS
Over the past few years, Anthem has continued to expand its scientific, technological and manufacturing capabilities to address evolving customer requirements and emerging therapeutic opportunities.
The Company expanded custom synthesis capacity from 270 KL to approximately 425 KL and increased fermentation capacity from 80 KL to approximately 180 KL (including NeoAnthem - Unit III) across its facilities. During the year, Anthem further strengthened capabilities across advanced modalities including peptides, oligonucleotides, ADCs, RNA-based technologies and high-potency APIs. Ongoing investments across Unit II and NeoAnthem continued to enhance manufacturing scale and flexibility. In addition, the Company commenced development of Unit IV, its largest infrastructure and capacity expansion project to date, which is expected to significantly strengthen future manufacturing capabilities and support long-term growth requirements.
The Company also continued to invest in advanced and sustainable technology platforms including flow chemistry, biocatalysis, fermentation and process automation. These technologies support greener manufacturing practices, improved resource efficiency and reduced waste generation, while enabling customers to accelerate development timelines, simplify scale-up and improve cost efficiency.
Supported by a differentiated presence across both small and large molecules, deep scientific expertise, advanced technology platforms and longstanding customer relationships, Anthem remains well positioned to capitalise on the growing demand for integrated CRDMO services globally.
The following timeline highlights the evolution of the Companys modalities, technology platforms and manufacturing capabilities over the years.
Anthem: An Integrated Contract Research, Development & Manufacturing Company
The Public Markets Debut
The successful listing of Anthem Biosciences Limited on the BSE and NSE in July 2025 marked a significant milestone in the Companys evolution from a privately held enterprise into a publicly listed organisation. The I3,395 crore Initial Public Offering, comprising a 100% Offer for Sale, was 67x times oversubscribed, reflecting strong investor confidence in Anthems integrated CRDMO platform, scientific capabilities and long-term growth potential. The listing represents the culmination of nearly two decades of disciplined growth, innovation and capability building, while also creating an opportunity for long-serving employees to participate in the value created over the Companys journey. As Anthem enters its next phase of growth, the listing strengthens its governance framework, enhances stakeholder trust and provides a stronger platform for future expansion and value creation.
Business Segments
Segment-wise Revenue Split
CRDMO Services
The CRDMO segment offers integrated solutions across the drug development lifecycle, encompassing discovery, development and commercial manufacturing. The Company provides a comprehensive suite of services, including medicinal chemistry, process development, preclinical research and GMP-compliant manufacturing for both small molecules and biologics.
Over the last few years, Anthem has expanded its capabilities across advanced modalities such as peptides, oligonucleotides, high-potency
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APIs, antibody-drug conjugates (ADCs), fermentation and flow chemistry, while strengthening integrated chemistry and biology platforms. The Company has also undertaken capacity expansion and technology enhancement initiatives across its manufacturing facilities, including custom synthesis, peptide manufacturing and fermentation infrastructure, supported by process automation and advanced analytical systems. The Company continues to strengthen its CRDMO platform through ongoing investments in capacity expansion, technology infrastructure and advanced manufacturing capabilities across multiple modalities. Recent investments in manufacturing infrastructure, including expansion initiatives at Unit IV and other facilities, are aimed at supporting increasing customer requirements, enhancing scalability and enabling faster commercialisation timelines for global innovator and biotech clients.
Anthem possesses advanced GMP-compliant manufacturing infrastructure with capabilities spanning milligram, kilogram, multi- kilogram and multi-ton scale synthesis across both chemistry and biology platforms. Its integrated and technology-driven operating model enables seamless transition of molecules from early research to commercialisation, helping customers accelerate development timelines, reduce technology transfer complexities and improve speed-to-market. The timeline below highlights key milestones achieved by the Company over the years.
Speciality Ingredients
The Speciality Ingredients segment focuses on the development and manufacture of science-based products catering to pharmaceuticals, nutraceuticals and industrial applications. The portfolio comprises fermentation-based products, probiotics, enzymes, peptides, biosimilars, nutritional actives and vitamin analogues, addressing a diverse set of end-use requirements.
Over the last few years, the Company has strengthened its fermentation, biotransformation and biologics capabilities through capacity expansion and technology enhancement initiatives across its manufacturing infrastructure. Supported by process optimisation, scalable fermentation platforms and integrated development capabilities, the segment enables cost-efficient and sustainable production of specialised ingredients and next-generation products.
The segment provides a relatively stable and diversified revenue base, supported by increasing demand for probiotics, biosimilars and specialised nutrition products across domestic and international markets.
Manufacturing and Infrastructure
Anthem has established a scalable manufacturing network supported by cGMP-compliant infrastructure, advanced technology platforms, digital integration and a strong emphasis on automation and efficiency. The Companys strategically located facilities in Bengaluru are designed to support the entire value chain from development to commercial-scale manufacturing.
Facility Network and cGMP Infrastructure
The Company operates three manufacturing units, with a fourth greenfield facility under development. Unit I and Unit II facilities comply with global regulatory standards, including USFDA, ANVISA, PMDA and TGA. Unit III is recently commissioned, and is inspection ready for USFDA and other regulatory bodies. The infrastructure supports a wide range of modalities such as small molecules, biologics, peptides, oligonucleotides and high-potency compounds.
Unit I Bommasandra
Commissioned in 2007, Unit I serves as the Companys core research and development and small-scale GMP manufacturing facility. The facility houses chemistry laboratories, peptide synthesis infrastructure, high-potent compound laboratories and oligonucleotide capabilities, supported by over 100 fume hoods and associated scientific infrastructure. Unit I has custom synthesis capacity of 24 KL and fermentation capacity of 2 KL. The facility is approved by multiple global regulatory authorities including USFDA, ANVISA and PMDA.
Unit II Harohalli
Commissioned in 2016, Unit II is a highly automated cGMP-compliant manufacturing facility designed for parallel production of multiple products across custom synthesis and fermentation operations. The facility currently has custom synthesis capacity of 376 KL and fermentation capacity of 140 KL and includes large-scale manufacturing suites for wet and dry processing, enzyme production and biologics-related operations. Unit II also houses GMP-scale flow chemistry capabilities and advanced manufacturing infrastructure supporting commercial-scale operations. The facility has received approvals from regulatory authorities including USFDA, ANVISA and TGA.
Unit III NeoAnthem
Unit III, operated under NeoAnthem Lifesciences Private Limited, is a greenfield manufacturing facility commissioned in phases during 2025 and 2026. Spread across 8 acres at Harohalli, the facility has custom synthesis capacity of 25 KL and fermentation capacity of 40 KL (yet to be commissioned). The facility houses dedicated infrastructure for chemistry development laboratories, pilot and kilo laboratories, peptide manufacturing, high-potent manufacturing, probiotics and enzymes manufacturing, along with planned biosimilar drug substance and sterile drug product capabilities. Unit III also strengthens the Companys presence across advanced modalities including peptides, high-potent APIs and biologics manufacturing.
Unit IV Upcoming Expansion
The Company is also developing a new 30-acre greenfield facility at Harohalli (Unit IV), which is expected to further strengthen capabilities across custom synthesis, fermentation and biologics manufacturing. The upcoming facility is being designed to support large-scale commercial manufacturing, advanced modalities and future customer requirements, while enhancing manufacturing flexibility, scalability and long-term growth capacity.
Capacity and Utilisation Trends
Anthem has built significant manufacturing capacity across its facilities, enabling scalability and operational flexibility.
Custom Synthesis Capacity-
Unit I: 24 KL (operating at ~75% utilisation)
Unit II: 376 KL (core 300 KL capacity ~75% utilised; recent addition of ~76 KL yet to ramp up) Unit III: 25 KL (newly commissioned facility, strong growth headroom)
Fermentation Capacity-Unit I: 2 KL
Unit II: ~140 KL (~50% utilisation) Unit III: ~40 KL (yet to be commissioned)
Overall utilisation remains balanced, with mature assets operating efficiently and newer facilities providing significant growth headroom.
Expansion Roadmap
Anthem adopts a proactive and strategically aligned capacity expansion approach, guided by pipeline visibility and long-term demand dynamics.
Unit II expansion: The Company has recently completed expansion, increasing custom synthesis capacity to 376 KL, with additional blocks commissioned in FY 2026.
Unit III (NeoAnthem): Commissioned in a phased manner, the facility offers substantial scope for further brownfield expansion through pre-built modular shells, enabling rapid capacity augmentation with minimal operational disruptions.
Unit IV (Greenfield):
*Planned investment of approximately I12,000 million (Phase I), with 365 KL Custom Synthesis and 100 KL Fermentation capacity being added, as well as a Food and Nutraceutical facility
*Development currently underway on a 30-acre site
*Focus areas include small molecules, peptides, fermentation/ biologics and high-potent capabilities
The Companys expansion strategy is forward-looking, with capacity being created ahead of demand to support late-stage development and commercial-scale opportunities.
Technology Upgrades and Automation
Anthem has made continuous investments in advanced technologies and digital infrastructure to enhance operational efficiency, quality and scalability.
Advanced Chemistry Platforms: Deployment of flow chemistry, biocatalysis, electrochemistry and metal-mediated synthesis to drive process optimisation and support green chemistry initiatives.
Biologics and Fermentation Technologies: Established capabilities across microbial and mammalian systems, including high-density fermentation, biotransformation and downstream processing.
High-Potency and Advanced Modalities: Dedicated containment facilities (OEB 5 compliant) for the safe handling of high-potency compounds, including ADCs and oncology APIs.
Automation and Digital Integration: Fully integrated IT systems across all facilities, supported by virtualised infrastructure, advanced data analytics, automated manufacturing systems and integrated
Distributed Control Systems (DCS) that connect API manufacturing, fermentation, biologics, utilities and continuous manufacturing operations. The integrated digital ecosystem enables real-time process monitoring, automation, data-driven decision-making, enhanced operational efficiency and end-to-end traceability across the manufacturing value chain.
Flexible Manufacturing Systems: Infrastructure designed for rapid reconfiguration, facilitating efficient handling of high-value, low-volume products and multi-product operations.
Collectively, these capabilities provide a strong competitive advantage, enabling Anthem to execute complex, multi-modality projects at scale while maintaining stringent quality standards and regulatory compliance.
Financial Performance
Consolidated Profit and Loss Statement
Particulars (K Mn) |
FY 2026 | FY 2025 |
| Revenue from Operations | 21,243 | 18,446 |
| CRDMO | 17,727 | 15,061 |
| Speciality Ingredients | 3,516 | 3,385 |
| Other Income | 1,558 | 857 |
| Total Revenues | 22,801 | 19,303 |
| Cost of materials consumed and changes in inventories | 8,123 | 7,439 |
| Employee benefits expense | 2,827 | 2,605 |
| Other expenses | 1,955 | 1,693 |
| EBITDA | 9,896 | 7,566 |
| EBITDA Margins | 43.4% | 39.2% |
| Finance cost | 69 | 103 |
| Depreciation and amortisation expense | 1,341 | 894 |
| PBT before exceptional items | 8,486 | 6,569 |
| Exceptional Items* | 244 | - |
| PBT after exceptional items | 8,242 | 6,569 |
| Total tax expense | 2,324 | 2,056 |
| Profit after tax | 5,918 | 4,513 |
*On November 21 2025 the Government of India notified four new Labour Codes: the Code on Wages, 2019 the Industrial Relations Code, 2020 the Code on Social Security, 2020 and the Occupational Safety, Health and Working Conditions Code, 2020 consolidating 29 existing labour laws The Ministry of Labour Employment has published draft Central Rules and FAQs, in this regard the Company has assessed and made a provision, as an Exceptional Item consistent with the guidance provided by the Institute of Chartered Accountants of India, in the financial results for the year ended 31 March 2026. In case of any further clarification from the Government on other aspects of the Labour Codes, the Company will evaluate and account for differential impact, if any, in subsequent periods.
Financial Performance Highlights
The Companys financial performance during FY 202526 was supported by strong growth across its business segments and continued operating efficiency:
Revenue Growth: Revenue from operations increased by 15.2% to I21,243 million in FY 2026 from I18,446 million in FY 2025, driven primarily by growth in the CRDMO business.
CRDMO Momentum: Revenue from the CRDMO segment grew by 17.7% to I17,727 million and contributed 83.4% of total revenue, supported by robust customer demand, increasing commercialisation of key molecules and continued expansion of customer programmes across the CRDMO value chain.
Profitability Improvement: Despite geopolitical uncertainties and supply chain disruptions during the year, EBITDA increased by 30.8% to I9,896 million, significantly outpacing revenue growth, supported by operating leverage, process optimisation and a favourable product mix.
Margin Expansion: EBITDA margin expanded by 420 basis points to 43.4% in FY 2026 from 39.2% in FY 2025, reflecting improved operating efficiency, process optimisation initiatives and increased backward integration of key intermediates, which contributed to stronger gross margins and enhanced cost competitiveness.
Strong Earnings Growth: Profit after tax increased by 31.1% to I5,918 million compared with I4,513 million in FY 2025, driven by higher profitability and improved business scale.
Risks, Concerns and Mitigation Strategy
The Company has aligned its risk management framework with critical business processes to ensure that operations are conducted efficiently and in line with strategic objectives. Risks are identified, assessed and monitored through structured discussions with business and functional heads. Mitigation measures are implemented within defined timelines and progress is periodically reviewed by the management and the Board.
1. Regulatory and Quality Compliances
The Company continues to maintain high quality standards across its R&D and manufacturing operations, which remain critical to its growth and operational performance. Anthem has implemented cGMP-compliant systems and processes across all manufacturing facilities, which are regularly audited by customers and inspected by regulatory authorities including the USFDA, TGA (Australia), ANVISA (Brazil) and PMDA (Japan).
As part of its ongoing digital transformation and quality enhancement initiatives, the Company continues to strengthen its integrated quality management systems through platforms such as Veeva Vault Quality and SAP S/4HANA for process management, compliance monitoring and material management.
A) Veeva Vault Quality
The Company continues to utilise Veeva Vault Quality as an integrated cloud-based platform for managing quality documentation, training, quality processes and audit readiness across operations. The platform supports data integrity, compliance monitoring and process standardisation across business functions.
The following modules continue to be implemented across operations:
i. Veeva Vault Quality Docs: Supports document lifecycle management including drafting, review, approval, training and archival of quality-related documents while ensuring compliance with 21 CFR Part 11 requirements and electronic record management standards.
ii. Veeva Vault Training: Enables role-based qualification and training management through configurable learner roles, curricula, assignments and compliance tracking systems.
iii. Veeva QMS: Supports monitoring of manufacturing and quality practices to ensure compliance with applicable cGMP standards and regulatory requirements.
B) SAP S/4HANA
All day-to-day operations and regulated transactions continue to be managed through SAP S/4HANA. The Companys quality department, comprising over 650 employees, oversees implementation of pharmaceutical quality systems and process controls across operations.
The integrated SAP and Veeva systems support monitoring of processes across R&D, procurement, manufacturing, packaging and delivery. Vendor qualification and assessment procedures are undertaken through risk-based quality evaluation processes considering regulatory accreditations, supply consistency and operational capabilities. Incoming raw materials are tested and released by the Quality Control department in accordance with approved specifications.
The Company has also established QC testing facilities supporting analytical services including release testing, method development, validation and stability studies.
Further, the following controls remain in place to maintain data integrity:
i. Individual user IDs and password controls ii. Audit trail-enabled analytical instruments iii. Validated and calibrated instruments and software iv. Role-based access controls and user group restrictions v. Periodic data backup systems vi. Secure server-based data storage
vii. Real-time standalone software backup systems
The facilities at Unit I and Unit II continue to operate under ISO 9001:2015 certified quality management systems.
2. Patent Compliance
The Company continues to maintain a policy of complying with intellectual property rights and avoiding patent infringement. Anthem regularly reviews process development activities involving active ingredients and maintains monitoring mechanisms to validate non-infringement of developed processes.
3. People and Culture
The Company considers employees as an integral part of its operations and continues to focus on building a skilled, engaged and future-ready workforce through structured learning, leadership development and employee engagement initiatives. The Company maintains employee-friendly policies, a safe and inclusive work environment and performance-driven systems that support operational excellence and long-term growth.
As of March 31, 2026, the Company had 2,282 employees and 1,020 contract labour personnel, all of whom were based in India. The following table sets out the number of employees by function for the years indicated:
Function |
FY 2026 | FY 2025 |
| Executive Directors | 3 | 3 |
| Sales and Business Development | 25 | 27 |
| Manufacturing | 543 | 485 |
| Quality (Quality Assurance and Quality Control) | 654 | 569 |
| R&D | 633 | 592 |
| Regulatory and Operations | 205 | 177 |
| Support | ||
| Sales, Purchase and Logistics | 39 | 37 |
| Environmental, Health and Safety | 94 | 87 |
| Finance, HR, Legal, IT and Admin | 86 | 85 |
Total |
2,282 | 2,062 |
Additionally, the Company employed 1,020 contract labour personnel as at March 31, 2026. The Company had employed 909 contract labour personnel as at March 31, 2025.
The table below sets forth the educational qualification profile of employees as of the dates indicated:
Educational Qualification |
FY 2026 | FY 2025 |
| PhD Degree | 32 | 35 |
| Masters Degree | 1,285 | 1,147 |
| Graduate Degree | 686 | 621 |
| Undergraduate Degree | 279 | 259 |
Total |
2,282 | 2,062 |
Learning and Development
TheCompanycontinuestoinvestinstructuredlearninganddevelopment programmes aimed at enhancing technical expertise, leadership capabilities and operational effectiveness across functions. Employees are provided with role-specific technical training, onboarding programmes, cross-functional exposure and leadership development initiatives aligned with evolving business and scientific requirements.
The Company also promotes a culture of continuous learning through performance management systems, knowledge-sharing initiatives and skill enhancement programmes that support career progression and organisational growth.
The training programmes conducted for employees include:
Internal trainings: Covering areas such as emergency response systems, fire and industrial safety, process safety, chemical handling, confined space safety, laboratory practices, first aid and operational compliance requirements.
External trainings: Covering technical and behavioural programmes including HAZOP studies, industrial hygiene, environmental health and safety, quality systems, workplace conduct, leadership development, electrical safety, occupational health and emergency preparedness initiatives.
The Company continues to align its talent strategy with business objectives through workforce planning, internal leadership development and performance-driven systems. The Company also promotes diversity, equity and inclusion through fair recruitment practices, equal opportunity policies and employee engagement initiatives aimed at building a collaborative and inclusive workplace culture.
Further, the Company recognises and rewards employee contributions through structured performance appraisal systems, merit-based growth opportunities, recognition programmes and leadership-driven appreciation initiatives that reinforce a high-performance culture.
Going forward, the Company intends to continue investing in technical capability building, leadership development, upskilling initiatives and future-ready workforce programmes aligned with expanding manufacturing capacities, advanced technology platforms and evolving CRDMO requirements.
5. Commercial and Financial Risk
Given the export-oriented nature of operations, the Company remains exposed to risks relating to market conditions, regulatory changes, customer credit, foreign exchange fluctuations, liquidity and contractual obligations. The Company continuously reviews internal systems and operational processes to identify, monitor and mitigate such risks.
6. Insurance
The Companys fixed assets, inventories and products continue to be adequately insured against operational and business risks including fire, transit, public liability, employee-related risks and directors and officers liability.
7. Environment, Health and Safety Environment
The Company remains committed to implementing robust environmental management practices across its operations and continues to integrate sustainability principles into its manufacturing, research and infrastructure development activities. The Company has aligned its climate strategy with near-term Science Based Targets initiative (SBTi) commitments focused on reducing Scope 1 and Scope 2 greenhouse gas emissions in line with global climate goals.
To support its sustainability objectives, the Company continues to increase the use of renewable energy across operations through wind and solar power sourcing arrangements, on-site solar installations and long-term renewable energy procurement initiatives. Renewable energy continues to account for a significant proportion of the Companys total energy consumption. The following diagram illustrates the breakdown of energy sources for the years indicated:
Particulars |
FY 2026 | FY 2025 |
| Renewable Energy | 60.80 | 47.30 |
| Consumption (Million kWh) | ||
| Electricity Grid Consumption (Million kWh) | 3.30 | 5.59 |
| Renewable Energy Contribution (%) | 94.86% | 89.43% |
The Company continues to implement multiple initiatives aimed at reducing greenhouse gas emissions and improving energy efficiency, including adoption of energy-efficient equipment, process optimisation systems, smart HVAC systems, natural gas utilisation and renewable energy integration across facilities. The Company also continues to strengthen green chemistry practices to reduce solvent consumption, hazardous waste generation and environmental impact.
The following table sets forth a breakdown of GHG emissions intensity for the periods indicated:
Particulars |
FY 2026 | FY 2025 |
| Scope 1 Emissions (tCO2e) | 17,260 | 16,922 |
| Scope 2 Emissions (tCO2e) | 2,339 | 4,067 |
| Biogenic Emissions (tCO2e) | 1,889 | 879 |
| Total Emissions (tCO2e) | 21,488 | 21,868 |
| Revenues (I million) | 21,243 | 18,446 |
| GHG Emission Intensity | 0.94 | 1.19 |
| (Scope 1 + Scope 2, tCO2e per Rs million) |
The Company continues to undertake multiple resource efficiency and waste management initiatives aimed at minimising environmental impact and strengthening circularity practices across operations. Key initiatives include:
The Company also continues to strengthen environmentally responsible manufacturing practices through process optimisation, green chemistry principles, waste minimisation systems, renewable integration and digital monitoring frameworks aligned with regulatory requirements and sustainability commitments.
Health and Safety
The Company remains committed to maintaining high standards of occupational health and safety across all operations through an integrated Environment, Health and Safety (EHS) framework aligned with recognised standards including ISO 14001, ISO 45001 and OHSAS requirements. The Company continues to promote a strong safety culture focused on risk prevention, employee wellbeing and operational safety.
The Company undertakes structured hazard identification, risk assessment and process safety evaluation exercises across manufacturing and operational environments. Risk mitigation measures are implemented through HAZOP studies, Hazard Identification and Risk Assessment (HIRA) procedures, safety audits, preventive maintenance systems and hierarchy-based control measures.
High-risk activities across operations are governed through a structured Work Permit System supported by field-level risk assessments, process safety summaries and defined operating protocols. The Company also conducts Pre-Start-Up Safety Reviews (PSSR), Process Hazard Analysis (PHA) and periodic safety evaluations to further strengthen safety management systems and operational controls.
Employees undergo regular safety and compliance training programmes focused on hazard recognition, emergency preparedness, risk prevention, use of personal protective equipment (PPE) and workplace safety procedures. Emergency preparedness is managed through a comprehensive On-site Emergency Plan supported by mock drills, fire drills and designated emergency response teams including incident controllers, first aiders and safety squads.
The Company also continues to support employee health and wellbeing through annual medical check-ups, occupational health centre facilities, respirator fit-test programmes and external first-aid training initiatives aimed at strengthening workplace health standards and emergency response preparedness.
Further, the Company continues to strengthen manufacturing safety infrastructure through automation systems, distributed control systems, fire hydrant and sprinkler systems, dust control systems, scrubbers, interlock-enabled solvent handling systems and process containment measures designed to reduce operational risks and enhance workplace safety across facilities.
Social
As a company driven by social responsibility, the Company remains committed to enhancing the welfare of employees, communities and society at large. The Company continues to focus on providing equal employment opportunities, promoting diversity and inclusion and supporting employee wellbeing through a safe, equitable and collaborative work environment.
The Company continues to undertake gender diversity initiatives aimed at increasing participation of women employees across functions and leadership levels. The table below sets forth the number of women employees as a percentage of total employees as at the dates indicated:
Particulars |
FY 2026 | FY 2025 |
| Number of Women Employees | 373 | 342 |
| Women Employees as % of Total Workforce | 16.35% | 16.59% |
| Total Number of Employees | 2,282 | 2,062 |
The Company continues to conduct various learning, leadership and employee development programmes focused on communication skills, project management, ESG awareness, reporting, technical capability building and professional development. The Company also continues to support employee wellbeing through annual medical examinations, wellness programmes, vaccination drives and employee engagement initiatives.
Further, the Company continues to recognise and reward employee contributions through performance-linked incentive structures, recognition programmes and long-term reward initiatives aimed at promoting employee engagement and retention.
The Company continues to implement Corporate Social Responsibility (CSR) initiatives focused on education, healthcare, environmental sustainability, women empowerment, livelihood enhancement and community development. The CSR Committee continues to oversee implementation and monitoring of CSR activities in line with the Companys CSR policy and applicable regulatory requirements.
The table below sets forth key CSR focus areas and activities undertaken by the Company:
Focus Area |
Key Activities |
Education, Skill Building and Livelihood Enhancement |
Development of school infrastructure, support for rural childcare centres, education initiatives for differently abled individuals and programmes supporting equitable access to education. |
Healthcare, Nutrition and Sanitation |
Community healthcare initiatives, mid- day meal programmes, safe drinking water projects and sanitation-related initiatives across local communities. |
Gender Equality and Women Empowerment |
Women empowerment programmes, support for homes and hostels for women and initiatives aimed at reducing socio-economic inequalities. |
Environment and Conservation |
Ecological conservation initiatives and programmes supporting environmental sustainability and biodiversity preservation. |
Technology, Research and Community Development |
Support for scientific research, educational laboratories, innovation-led initiatives and contributions towards community development programmes. |
Governance
The Company remains committed to maintaining high standards of corporate governance, ethics and regulatory compliance across its operations. The Board of Directors continues to oversee governance practices relating to compliance management, internal controls, risk management, cybersecurity, sustainability and stakeholder engagement.
The Company has established policies and governance frameworks covering areas such as Code of Conduct, Anti-Bribery and Anti-Corruption, Prevention of Sexual Harassment (POSH), Human Rights, Conflict of Interest, Whistle-blower mechanisms and Anti-Money Laundering practices. These frameworks support ethical business conduct, accountability and transparent governance practices across the organisation.
The Company also continues to strengthen governance processes through digital compliance systems, internal audits, risk monitoring frameworks and structured policy review mechanisms to support regulatory compliance and long-term sustainable growth.
. Information Technology
The Company utilises a wide range of information technology systems and digital platforms across its research, development and manufacturing operations, with all internal units and divisions securely connected through an integrated digital infrastructure. The Company continues to strengthen its digital transformation framework through enterprise-wide systems integration, automation technologies, cloud-based quality platforms and advanced cybersecurity infrastructure.
Enterprise Resource Planning (ERP): The Company utilises SAP S/4HANA as its core enterprise platform for finance, accounting, procurement, supply chain, production planning and inventory management. The platform enables seamless integration across business functions, enhances operational efficiency and supports real-time data visibility and decision-making.
Quality Management Systems (QMS), Document Management Systems (DMS) and Learning Management Systems (LMS): The Company has implemented Veeva Vault Quality as an integrated cloud-based platform across research, manufacturing and subsidiary operations. The platform includes modules such as QualityDocs, QMS, Training and Station Manager for managing quality documentation, compliance workflows, training administration and audit readiness. The system supports standardised quality processes, enhanced traceability and real-time visibility for regulators, customers and internal stakeholders.
Laboratory and Quality Control Systems: The Company has deployed specialised QC systems supporting scientific data management, analytical workflows, stability studies and batch release processes. The Company is also progressing towards implementation of a next-generation Laboratory Information Management System (LIMS), which is expected to further strengthen sample tracking, laboratory workflow automation, analytical data management and regulatory compliance capabilities.
Building Management Systems (BMS): The Company utilises BMS infrastructure across manufacturing facilities for monitoring, managing and reporting utility-related data and environmental conditions. The BMS supports predictive maintenance, utility monitoring, energy optimisation and environmental control across cleanrooms and storage facilities, while enabling real-time monitoring and alerts for critical operating parameters.
Distributed Control Systems (DCS): The Company has implemented integrated DCS platforms across API manufacturing, fermentation, biologics operations, utilities and continuous manufacturing systems. The DCS infrastructure supports automation, process integration, scalable monitoring and real-time data collection across operations, while enabling process optimisation, improved manufacturing consistency and regulatory compliance.
Control Process Automation Systems: Automated process control systems are deployed across manufacturing operations for real-time monitoring and control of critical process parameters including temperature, pressure, pH and flow rates. These systems support manufacturing precision, process consistency, operational efficiency and reduced manual intervention.
Cloud-based Quality and Digital Infrastructure: The Companys digital infrastructure is supported through centralised in-house data centres with virtualised applications, systems and endpoints, enabling secure connectivity, scalability and seamless integration across facilities and functions. The integrated digital ecosystem facilitates efficient data exchange, traceability and execution of complex multi-site operations.
To ensure cybersecurity, data integrity and regulatory compliance, the Company has implemented a multi-layered cybersecurity framework comprising firewalls, intrusion detection and prevention systems, endpoint protection platforms, role-based access controls, audit trails and a centralised Security Operations Centre (SOC) for real-time monitoring and incident response. The Companys systems and processes are aligned with ALCOA+ principles, 21 CFR Part 11, cGMP and GxP requirements to ensure reliability, traceability and integrity of digital records.
The Company regularly reviews and upgrades its information technology systems and automation infrastructure to improve operational efficiency, support evolving business requirements and strengthen digital capabilities across research, manufacturing and quality operations. The Company also continues to invest in advanced analytics, laboratory automation, AI-enabled systems and smart manufacturing technologies to support future operational scalability and growth.
Outlook
Anthem is well positioned to capitalise on sustained global demand for outsourcing across the pharmaceutical value chain sustained by the Companys differentiated position as an integrated CRDMO player. Increasing complexity in drug development, alongside an expanding pipeline across stages, is expected to drive continued momentum in the CRDMO segment, particularly in high-value areas such as biologics, peptides and advanced therapies.
The Company stands to benefit from long-term structural tailwinds, including supply chain diversification, increasing strategic engagement with global pharmaceutical companies and a gradually improving funding environment for biotechnology firms. A growing portfolio of commercialised molecules, coupled with a robust development pipeline, provides strong medium-term revenue visibility, not with standing inherent variability in project-based revenues.
The Company is also witnessing increasing opportunities in high-growth therapeutic segments such as GLP-1s and peptide-based therapies, including Semaglutide, supported by rising global demand and increasing focus on cost-effective manufacturing solutions. Anthems integrated development and manufacturing capabilities, process expertise and scalable infrastructure position it favourably to participate in these emerging opportunities.
In the Speciality Ingredients segment, growth is expected to be driven by expansion in probiotics, fermentation-based products, biosimilars and peptide-based offerings, reinforced by increasing emphasis on import substitution and global market expansion.
Ongoing capacity additions, including new manufacturing facilities, combined with a focus on backward integration and operational efficiencies, are expected to support sustained growth while preserving a strong margin profile over the medium term.
Internal Control Systems
The Company has an adequate system of internal controls commensurate with the nature, size and complexity of its manufacturing, finance and marketing operations, including controls over financial reporting. Appropriate review and control mechanisms are in place for ensuring the internal control systems are operating effectively. The internal control system is supported by qualified personnel and a continuous programme of internal audit.
Cautionary Statement
The Management Discussion and Analysis (MDA) section may include forward-looking statements regarding prospects. These statements entail various known and unknown risks and uncertainties, which could result in material differences between actual results and the forward-looking statements. The estimates andfigurespresentedinthereportarebasedoncertainassumptions made by the Company, considering both internal and external information currently available. However, these assumptions are subject to change over time due to shifting underlying factors, potentially leading to adjustments in the estimates. It is important to note that forward-looking statements reflect the Companys current intentions, beliefs, or expectations only as of the date of their issuance. The Company is not obligated to revise or update any forward-looking statements in response to new information, future events, or other factors.
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