Alkem Laboratories Ltd Management Discussions

<dhhead>Management, Discussion & Analysis Report</dhhead>

GLOBAL PHARMACEUTICAL INDUSTRY

The global pharmaceutical industry is undergoing rapid expansion, driven by advancements in drug discovery, a rising burden of chronic diseases, and the strengthening of healthcare infrastructure across regions. Persistent conditions such as cardiovascular diseases, diabetes, and cancer remain the leading causes of death globally, accounting for nearly 71% of annual mortalities and significantly fueling demand for pharmaceuticals.

Breakthroughs in biotechnology, including gene therapy and RNA-based treatments, are reshaping therapeutic approaches and creating new growth opportunities. The industry also benefits from strong governmental and institutional support. For instance, the U.S. National Institutes of Health (NIH) allocated over US$ 45 billion in 2023 to medical research, accelerating innovation in drugs and vaccines.

Source: https://www.globenewswire.com/news-release/2025/02/07/3022874/0/en/Pharmaceutical-Market-Size-Expected-to-Reach-USD-3-033-21-Bnby-2034. html

The global pharmaceutical market, valued at approximately US$ 1,772.65 billion in 2025, is projected to reach US$ 3,033.21 billion by 2034, registering a CAGR of 6.15%. Key growth drivers include the rising incidence of chronic diseases, innovation in drug development, an ageing global population, increasing access to healthcare in emerging markets, the growing adoption of generic medicines, and patent expirations of branded drugs.

Regionally, North America continues to lead the global pharmaceutical landscape, underpinned by advanced research capabilities, significant R&D investments, and a concentration of top pharmaceutical companies. The U.S., in particular, remains a hub for cutting-edge healthcare innovations and is seeing growing demand due to its ageing population.

Asia-Pacific is emerging as the fastest-growing region, propelled by increased healthcare spending, favourable policy initiatives, and growing public awareness of health and wellness. Government-led programs, such as Japan’s Healthcare Vision 2030, China’s Healthy China 2030 and India’s National Health Mission, are expanding access to medical services. Enhanced investment in R&D and personalised medicine is further stimulating growth across the region.

Following a temporary decline in 2022, driven by inflationary pressures and rising interest rates that dampened over-the-counter (OTC) product demand, the global pharmaceutical market experienced a recovery in 2023 as economic conditions began to stabilise. Expanded public health budgets and wider reimbursement coverage have continued to underpin industry growth (global patient use of medicines rose roughly 14% over the past five years. Offsetting these tailwinds are intensified cost_containment policies: recent reforms to drug pricing in major markets (the US, EU and UK) are expected to constrain revenue growth and squeeze industry margins.

Looking ahead, IQVIA projects that overall medicine usage has essentially plateaued and will grow only modestly through the late 2020s. Volume increases will be heavily concentrated in emerging markets. For example, China’s medicine volumes are forecast to rise about 8% by 2029, while many developed regions see minimal per_capita growth. Innovation remains a principal growth driver: oncology and immunology are the fastest_expanding segments, fueled by new biologic and precision therapies. In particular, next_generation modalities (including advanced biologics, gene- and RNA-based treatments) are rapidly scaling up, enhancing outcomes in complex disease areas such as cancer, autoimmune disorders and rare genetic conditions.

Expedited regulatory approvals, a shift toward patient-centric care models, and advances in drug delivery systems are further bolstering the industry. Strategic R&D investments and collaborations are accelerating product innovation, ensuring competitiveness. The rising adoption of modern therapeutics and innovative healthcare solutions remains a cornerstone of long-term market expansion.

Source:

IQVIA Institute – Global Use of Medicines, June 2025

Global medicine spending and growth by product type

		ORIGINAL BRANDS	NON-ORIGINAL BRANDS	UNBRANDED GENERICS	OTHER	TOTAL
Spending 2023	Global	1,184.3	235.3	166.5	163.7	1,749.8
US$ Bn	Developed	1,091.6	120.6	124.6	84.7	1,421.5
	10 Developed	964.0	70.3	107.0	52.6	1,194.5
	Other Developed	127.0	50.3	17.6	32.1	227.0
	Pharmerging Lower-income countries	88.4	106.3	41.1	76.5	312.2
		4.4	4.4	0.8	2.5	16.1
Constant dollar	Global	3.9%	4.3%	4.8%	5.4%	4.6%
CAGR 2019–2023	Developed	9.4%	5.0%	3.9%	5.0%	8.2%
	10 Developed	9.6%	3.7%	3.8%	3.6%	8.2%
	Other developed	8.1%	7.7%	3.3%	8.3%	7.8%
	Pharmerging	8.4%	9.1%	6.8%	6.0%	6.0%
	Lower-income	-0.8%	1.5%	3.3%	2.1%	1.0%
	countries
Spending 2028	Global	$1,685–$1,715	$270–$300	$170–$200	$180–$210	$2,355–$2,385
US$ Bn	Developed	$1,555–$1,585	$135–$155	$120–$150	$95–$115	$1,945–$1,975
	10 Developed	$1,370–$1,400	$75–$95	$105–$125	$58–$62	$1,635–$1,665
	Other developed	$185–$195	$60–$70	$15–$25	$35–$45	$310–$325
	Pharmerging	$115–$135	$120–$140	$40–$60	$80–$100	$375–$405
	Lower-income countries	$3–$7	$8–$12	$0.7–$1.1	$2.5–$3.5	$18–$22
Constant dollar	Global	6–9%	3.5–6.5%	4–5.5%	2–5%	5.5–8%
CAGR 2024–2028	Developed	6–9%	3–5%	3.5–5.5%	2–5%	5.5–8%
	10 Developed	6–9%	1.5–4.5%	3.5–5.5%	0.5–3.5%	5.5–8%
	Other developed	5–8%	4.5–7.5%	2.5–5.5%	4.5–7.5%	5.5–8%
	Pharmerging	7–10%	2.5–5.5%	5.5–6.5%	2.5–5.5%	3.5–6.5%
	Lower-income countries	4–7%	1–4%	0–3%	1.5–4.5%	2–5%

DEVELOPED AND PHARMERGING MARKETS

The global outlook for spending growth across healthcare and pharmaceuticals from 2019 to 2029 paints a complex yet revealing picture. While the global CAGR stands at a steady 5-8%, reaching a total market size of approximately $2365-2395 billion in constant US dollars by 2029, regional disparities reflect diverse economic, demographic, and policy-driven dynamics shaping the next wave of market evolution.

North America, representing the largest market share, is expected to grow steadily between 6–9%, reaching $1,200– 1,230 billion. The trend suggests maturity, with marginal year-on-year shifts. Drivers include consistent innovation, biologics adoption, and policy reforms aimed at reducing out-of-pocket costs. However, pricing pressures and payer driven constraints could moderate long-term growth.

Western Europe follows a similar trajectory with expected growth of 4.5–7.5% and spending between $390–420 billion. The region continues to balance innovation with strong health technology assessments (HTAs), centralized pricing controls, and aging populations, contributing to cautious yet stable spending increases.

Asia-Pacific, excluding China and Japan, shows promising growth of 5–8%, driven by increasing healthcare access, urbanization, insurance expansion, and greater generic and biosimilar adoption. Expected to reach $120–125 billion, the region holds significant long-term potential despite short term regulatory uncertainties.

Japan, however, presents a concerning picture with negative to marginal growth (-0.5% to 2.5%) and spending capping at $72-74 billion. This flat trajectory is shaped by population decline, ongoing deflationary pricing policies, and government efforts to curtail healthcare costs amid an aging society.

Africa and the Middle East project a modest yet optimistic 5–8% growth, reaching $68–72 billion. The region’s improving healthcare infrastructure, foreign investments, and population growth present long-term opportunities, albeit with existing challenges of affordability and access.

Among emerging markets, Latin America is expected to witness strong growth of 6-9%, totaling $126–130 billion. Despite economic volatility, the region benefits from improved access to care, digital transformation, and public private healthcare collaborations.

Eastern Europe mirrors this trend with 7–10% CAGR and market potential of $133-137 billion, indicating recovery from geopolitical disruptions and increasing pharmaceutical investments.

India also emerges as a high-growth market with 6.5–9.5% CAGR, though from a smaller base of $40–44 billion. The country’s focus on expanding universal health coverage, digital health infrastructure, and public schemes such as Ayushman Bharat is expected to fuel this rise. India also continues to be a global generics powerhouse, driving exports alongside domestic access.

China, despite its dominant global footprint, is forecast to grow at a more tempered 1-4%, reaching $175-205 billion. The deceleration is largely due to government-led price controls, volume-based procurement, and local production policies aiming to control costs and boost self-reliance.

Overall Outlook: The decade ahead is defined by a dual-speed reality—mature markets experiencing stabilization, and emerging economies propelling growth through infrastructure development and healthcare democratization. While global growth remains positive, the nuances lie in policy, access, innovation, and economic resilience. Strategically, stakeholders will need to navigate this evolving landscape by investing in local partnerships, digital health, and value-based care models. The balance between innovation and affordability will be the central theme driving the future of global healthcare spending.

KEY MARKETS

UNITED STATES PHARMACEUTICAL MARKET

The United States remains the largest pharmaceutical market globally, with net medicine spending reaching US$ 487 billion in 2024, marking an 11.4% increase from US$ 437 billion in 2023. 31 high-impact products primarily drove this surge, each contributing over US$ 500 million in annual growth. Notably, increased utilisation of clinically significant therapies is driving overall spending, despite net pricing remaining essentially flat.

Source:

IQVIA Institute, Apr 2025.

Notes:

The IQVIA Institute has analyzed company reported net revenues for a sample of companies and products and projected a total market estimate (see Methodology section). Individual product net sales have been analyzed to segment growth products with remaining growth based on the total market estimates. Measures total value of spending on medicines, including generics, branded products, biologics, small-molecules, and retail and non-retail channels.

Net spending reflects company recognized revenue after off-invoice discounts, rebates and price concessions are applied. Estimates of COVID-19 vaccine and therapeutic spending are based on company financials, including reversals due to returns.

Looking ahead, total net spending is expected to rise by US$ 116 billion between 2024 and 2029, fueled by expanded access, increased medicine usage, and adoption of innovations. However, this growth will be partially offset by pricing pressures, loss of exclusivity, and evolving legislative measures.

Over the next five years:

• Spending is projected to grow at a 5–8% CAGR on a list price basis, and

• 3–6% CAGR on a net basis, factoring in discounts and rebates.

The Use of Medicines in the U.S. 2025: Usage and Spending Trends, and Outlook to 2029

Source:

IQVIA Institute, Global Use of Medicines outlook through 2029

Notes: Spending is based on IQVIA reported values from wholesale transactions measured at list (WAC) prices and excludes discounts and rebates that reduce net revenue received by manufacturers. Net spending reflects company-recognised revenue after both invoice and off-invoice discounts, rebates and price concessions are applied. Includes all medicines in both pharmacy and institutional settings. Includes COVID-19 vaccines and therapeutics from company-reported values.

Report: The Use of Medicines in the U.S. 2025; Usage and Spending Trends and Outlook to 2029, April 2025.

Innovation will remain a central driver of growth, with an estimated 50–55 new product launches annually, particularly in oncology, speciality care, orphan drugs, and chronic conditions such as diabetes, obesity, and neurological disorders.

India continues to play a pivotal role in supplying affordable medicines, meeting approximately 40% of the U.S. generic drug demand, thereby creating significant opportunities for Indian pharmaceutical companies to expand their footprint through innovation and capitalising on patent expirations. From October 2023 to September 2024, the U.S. FDA approved 694 Abbreviated New Drug Applications (ANDAs) and granted tentative approval to 162 additional applications, underscoring continued momentum in the generics segment.

The U.S. pharmaceutical market remains one of the most competitive and tightly regulated among developed economies. It features complex pricing dynamics and reimbursement mechanisms, alongside stringent regulatory oversight by bodies such as the U.S. FDA. Despite these challenges, Indian pharmaceutical companies are well-positioned to strengthen their presence in the U.S. market. Their deep domain expertise, cost-efficient manufacturing capabilities, and extensive experience in navigating regulatory pathways have enabled them to compete successfully, particularly in the generics segment. As demand for affordable, high-quality medicines continues to grow in the U.S., Indian firms are expected to play an increasingly vital role in driving accessibility and innovation.

Source:

Understanding the Use of Medicines in the U.S. 2025 - IQVIA

INDIAN PHARMACEUTICAL MARKET

India is the world’s third-largest pharmaceutical industry by volume and fourteenth by value. It stands as the largest global supplier of generic medicines and vaccines. In FY2025, the Indian pharmaceutical sector was valued at _2.25 lakh crore, registering a robust 8.4% year-on-year growth, primarily driven by price increases across key therapies. Notably, the market experienced disruption in March 2025 due to the patent expiry of the diabetes drug empagliflozin. Furthermore, post March 2026, when the launch of the anti-obesity drug semaglutide is due, the market is expected to witness a significant impact.

Source: https://www.ibef.org/news/booster-shot-as-india-s-pharma-market-grew-8-4-in-fy25-pharmarack

India’s Pharma Exports: Top 10 Markets

Rank Country	FY2024 (US$ Mn)	YoY Growth	Share (%)
1 USA	8,728.6	15.7%	31.4%
2 UK	784.3	21.1%	2.8%
3 South Africa	718.5	9.4%	2.6%
4 Netherlands	699.2	17.6%	2.5%
5 France	667.5	17.1%	2.4%
6 Brazil	655.6	2.0%	2.4%
7 Belgium	574.4	-19.7%	2.1%
8 Germany	567.4	-8.5%	2.0%
9 Russia	518.5	-9.6%	1.9%
10 Nigeria	508.1	-1.5%	1.8%

Source:

Pharmexcil 20^th Annual Report

The Indian pharmaceutical industry is broadly segmented into formulations and bulk drugs. Formulations are nearly evenly split between domestic and export markets. India’s export portfolio is dominated by low-value generics, accounting for approximately 3.5% of global drug exports. These exports span more than 200 countries and territories, including stringent regulatory markets such as the United States, the United Kingdom, the European Union, and Canada. With the second-highest number of US FDA-compliant manufacturing facilities outside the US, India has emerged as a reliable global manufacturing hub, backed by world-class infrastructure, skilled talent, and a strong academic and research ecosystem.

Indian Pharma Market (IPM) - Key Therapy Areas (FY2025)

Therapy Area	Sales (_ Cr)	Contribution (in %)	YoY Growth (in %)
Cardiac	26,603	13.5	11.9
Gastrointestinal	22,161	11.3	9.6
Anti-infectives	20,638	10.5	4.8
Anti-diabetic	18,719	9.5	8.5
VMN*	15,795	8.0	7.8
Respiratory	16,426	8.4	3.2
Pain/Analgesics	15,642	8.0	7.0
Neuro/CNS	12,217	6.2	8.6
Dermatology	14,120	7.2	9.3
Gynecology	8,895	4.5	3.3

Source:

IQVIA March 2025 SSA Data *Vitamins/Minerals/Nutrients

Despite its strength, the Indian pharmaceutical sector continues to rely heavily on imports for key inputs such as active pharmaceutical ingredients (APIs) and key starting materials (KSMs). However, the Production-Linked Incentive (PLI) scheme and domestic capacity expansion are enabling backwards integration, improving supply chain resilience, softening of some of the KSM’s/API’s, and reducing external dependency.

India’s competitive manufacturing cost structure has allowed its pharmaceutical companies to achieve global parity in margins, even as they move up the value chain. Increasingly, Indian firms are gaining regulatory approvals for complex generics, biosimilars, and injectables (high-margin segments that enhance global positioning).

Regulatory compliance continues to improve. In 2023, the US FDA conducted 225 inspections at Indian manufacturing sites, resulting in 18 Official Action Indicated (OAI) and 117 Voluntary Action Indicated (VAI) outcomes. In 2024, despite increased scrutiny, inspections declined to 206, with OAIs falling to 14 and VAIs to 115. This trend underscores India’s growing alignment with international quality standards.

Source:

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024 Health News - Business Standard

India manufactures around 60,000 generic brands across 60 therapeutic categories, contributing nearly 20% to the global supply. Trade generics, an essential component of domestic access, were valued at approximately _24,000 crore in 2023. With improved distribution networks and affordability, this segment is expected to grow at a 15–18% CAGR and reach ~_68,000 crore by 2030.

Source:

Changing Dynamics of Indian Pharma Supply Chain 2024 by Pharmarak

A notable shift is also underway from a generics-driven model to one focused on innovation and value-added products. Investments in R&D, especially in biologics and precision medicine, are rising. Indian firms are also engaging in strategic collaborations with global biotech companies and expanding contract research operations, further strengthening their innovation capabilities.

Policy Support and Growth Drivers

The Union Budget 2025–26 highlighted several reforms to boost the sector:

Establishment of 200 district-level day-care cancer centres

Concessional duties and exemptions on essential medicines

Expansion of medical education and research fellowships

Broadband connectivity for all Primary Health Centres (PHCs) to promote telemedicine

Focus on medical tourism and "Heal in India" campaigns

Increased FDI limits in health insurance and nutritional support programs The Indian pharmaceutical sector stands at an inflection point. Its future growth will be driven by the rising burden of non-communicable diseases, an ageing population, increasing health awareness, and the growing consumerisation of healthcare. However, to maintain global leadership, India must accelerate R&D investments, modernise its regulatory framework, and embrace innovation. Technologies such as artificial intelligence, machine learning, and precision medicine are expected to transform drug discovery, development, and delivery.

Biosimilars and Biologics

Biologics represent one of the fastest-growing segments in global pharmaceuticals, driven by their targeted therapeutic benefits in oncology, autoimmune disorders, and chronic diseases. Biosimilars, highly similar, cost-effective alternatives to approved biologic drugs, are gaining rapid traction as patents on blockbuster biologics expire.

Globally, the biosimilars market is projected to reach US$ 75 billion by 2030, from US$ 21 billion in 2024, growing at a CAGR of ~20%. Much of this growth is expected to come from oncology and autoimmune segments, where biologics dominate and payers are actively encouraging biosimilar substitution to reduce healthcare costs. Biosimilars are anticipated to generate cumulative global savings of ~US$ 285 billion by 2030.

India has emerged as a significant player in the global biosimilars space, leveraging its scientific talent pool, strong manufacturing base, and cost competitiveness. The domestic biosimilars market, currently valued at approximately _5,300 crore, is growing at a compounded annual growth rate (CAGR) of 25–28%. This momentum is fueled by increasing diagnosis and treatment rates, the adoption of biosimilars in hospitals, and heightened affordability through price parity efforts.

Indian pharmaceutical companies are actively expanding their biosimilars portfolios, targeting high-value molecules such as adalimumab, trastuzumab, bevacizumab, pegfilgrastim, and insulin analogues. As regulatory clarity improves and commercial pathways become more defined in developed markets, Indian firms are securing approvals in highly regulated regions, including the US, EU, and Japan.

The Indian government has taken strategic steps to promote domestic biologics manufacturing through schemes such as the Biopharmaceutical Mission under BIRAC and support for the establishment of biotechnology parks and incubation centres. The Department of Biotechnology and CDSCO have also issued detailed regulatory guidelines for the development, testing, and approval of biosimilars, improving the confidence of both industry and healthcare providers.

Key challenges remain, including the complexity of biologics manufacturing, long development cycles, and the need for extensive pharmacovigilance data. However, leading Indian companies are investing in high-end R&D infrastructure, global clinical trials, and strategic alliances with multinational firms to overcome these barriers.

The transition from volume-driven generics to science-driven biologics represents a transformative opportunity. Indian firms that can scale up biologics manufacturing while ensuring regulatory compliance and cost efficiency are well-positioned to become global biosimilar powerhouses over the next decade.

Medical Devices

The global MedTech industry has entered a phase of accelerated evolution, driven by rapid technological innovation, demographic changes, and growing healthcare awareness. As of 2023, the global medical devices market is valued at approximately US$ 700 billion and is projected to exceed US$ 850 billion by 2027, growing at a CAGR of 6%. Among the key categories, orthopaedic implants form one of the most established and high-value segments, currently estimated at around US$ 46 billion globally. A rising prevalence of osteoarthritis, sports-related injuries, and age-associated musculoskeletal disorders is propelling the growth in this segment.

Indias MedTech sector is gaining strong momentum, catalysed by supportive policy frameworks, evolving healthcare demand, and increasing investment in domestic manufacturing. Valued at US$ 11 billion in 2022, the Indian MedTech market is expected to grow to US$ 40–50 billion by 2032, at a CAGR of over 14%. This growth is being powered by:

Expanding insurance coverage: The overall health insurance penetration in India has doubled from 25% to 51%, led by public initiatives such as the Pradhan Mantri Jan Arogya Yojana (PM-JAY) and other state-led schemes. The recent expansion of AB PM-JAY, which now includes universal coverage for senior citizens aged 70 and above, further strengthens healthcare access. Private health insurance is also witnessing a robust 23% CAGR over the past decade.

Rising healthcare expenditure: Per capita healthcare spending has grown significantly, supported by increased public and private sector investment in healthcare infrastructure.

Improved affordability and access: India’s growing middle class, rising per capita disposable income (US$ 2,900 in FY2024, up 8% YoY), and demographic advantage (median age of 29.8 years in 2024) are creating sustained demand for quality and affordable medical devices. Accelerating urbanisation and digital health integration are further enabling market penetration.

Focus on Orthopaedics

Within the broader MedTech domain, orthopaedics is emerging as a high-potential segment in India. Estimated at approximately _4,000 crore, the Indian orthopaedic market is poised for sustained double-digit growth. Key growth drivers include an ageing population, increasing life expectancy, higher diagnosis rates of musculoskeletal conditions, and expanding access to tertiary care.

Joint replacement, particularly knee, hip, and shoulder implants, constitutes the largest category, accounting for nearly 65% of the overall orthopaedic market. Price caps introduced by the National Pharmaceutical Pricing Authority (NPPA) for knee implants have significantly widened affordability, unlocking access for a more price-sensitive patient population. In parallel, the government’s focus on import substitution and ‘Make in India’ is creating a favourable ecosystem for domestic manufacturers.

Despite these positive developments, a large portion of India’s orthopaedic implant market remains import-dependent, underscoring the need for indigenous, high-quality, and cost-effective alternatives. Alkem MedTech Pvt. Ltd.’s entry into this space is strategically positioned to address this need by offering world-class orthopaedic solutions designed for Indian clinical needs and price sensitivities. Through advanced R&D, clinician partnerships, and robust manufacturing capabilities, the Company aims to strengthen India’s self-reliance in critical MedTech categories.

Source:

IBEF Industry report, LEK report on Indian MedTech market and Internal Market Intelligence

Company Overview

With over five decades of experience, Alkem Laboratories Limited ("Alkem" or "the Company") stands as a prominent Indian-origin global pharmaceutical company with expertise spanning across generics, speciality, pharmaceuticals, biosimilars, and the medical devices sector. For more than 20 years, Alkem has consistently ranked among the top 10 pharmaceutical companies in India, cementing its position as a trusted healthcare provider across acute and chronic therapies.

Innovation remains central to Alkem’s growth philosophy. The Company has pioneered several technologically advanced and cost-effective pharmaceutical solutions across its integrated value chain, from product development to manufacturing and distribution. Alkem operates in over 40 countries, with the United States being its largest export market. Its expansive commercial infrastructure includes:

Alkem’s strong brand equity is underpinned by a seasoned management team, robust manufacturing capabilities, a deep commitment to quality, and a culture rooted in integrity and resilience. The Company is actively investing in over 10 high-growth platforms, such as injectables and biosimilars, and three emerging technology platforms: mRNA, viral vectors, and antibody-drug conjugates (ADCs).

Strategic Acquisitions

In FY2025, Alkem undertook two strategic acquisitions to strengthen its presence in high-growth segments:

Adroit Biomed: A derma-cosmetological healthcare company with a focus on dermatology, acquired for an enterprise value of _140 crore.

Bombay Ortho: A domestic manufacturer and supplier of orthopaedic implants (hip and knee), acquired for an enterprise value of _147 crore.

These acquisitions are aligned with Alkem’s strategy to diversify into fast-growing, innovation-led segments while enhancing its product portfolio.

Global Manufacturing and R&D Capabilities

Alkem operates 18 world-class manufacturing facilities, 17 in India and 1 in the United States, all regularly audited and approved by global regulatory bodies including the US FDA, WHO, MHRA (UK), TGA (Australia), ANVISA (Brazil), and SAHPRA (South Africa).

The Company has:

Filed 185 ANDAs and 2 NDAs with the US FDA

Received approvals for 156 ANDAs (including 13 tentative approvals) and 2 NDAs

Registered 1,100+ products across various international markets The Company’s innovation engine is powered by three advanced R&D centres staffed by 500+ scientists focused on differentiated, first-to-market products. Enzene Biosciences, its biotechnology subsidiary, continues to experience robust growth, with seven biosimilars launched in the domestic market and a strong pipeline under development.

Domestic Market Leadership

In India, Alkem holds leadership positions in several acute therapy areas, including:

Anti-infectives

Gastrointestinal

Pain management

Vitamins, Minerals and Nutrients (VMN)

The Indian domestic business remains Alkem’s significant revenue contributor, reflecting the Company’s strong fundamentals and leadership position in the Indian Pharmaceutical Market (IPM). This performance underlines Alkem’s resilience and its sustained growth outlook across key therapeutic categories.

Business Segment	Revenue (_ million)	Contribution to Total Revenue (%)	YoY Growth (%)
Domestic Business	_89,837	70.2%	6.5%
US Business	_24,818	19.4%	-10.4%
Other International	_13,392	10.5%	8.7%
Markets

Several of Alkem’s flagship brands—Clavam, Pan, Pan-D, and Taxim-O—rank among the top 50 pharmaceutical brands in India, demonstrating long-standing brand equity and physician trust. The Company has retained its leadership in the anti-infective segment for over 15 years and is also a major player in the trade generics space.

In line with its growth vision, Alkem is actively expanding into chronic therapy areas such as Neuro/CNS, Neurology, Diabetes, and Dermatology, which increasingly contribute to the revenue mix.

Revenue by Key Markets (FY2025)

Financial Overview

Alkem Laboratories delivered a strong financial performance in FY2025, marked by good revenue growth, improved margins, and enhanced profitability. Despite a challenging macro environment and pricing pressures in key geographies, the Company leveraged operational efficiencies, a favourable product mix, and strategic market expansion to drive value.

Particulars	FY2025	FY2024	YoY Change	Comments
Revenue from Operations	_1,29,645	_1,26,676	2.3%	Domestic business grew 6.5%.
				US business de-grew 10.4%.
				Other international markets grew 8.7%.
Gross Profit	_82,003	_77,300	6.1%	Margin improvement is driven by favourable product mix and declining API prices.
Gross Profit Margin	63.3%	61.0%	—
EBITDA	_25,122	_22,455	11.9%	Boosted by gross margin gains and
				optimisation of other expenses.
EBITDA Margin	19.4%	17.7%	—
PBT (Before Exceptional Item)	_25,270	_21,446	17.8%	Primarily driven by higher EBITDA and high other income due to increased cash generation.
Exceptional Item	-	_1,215	—
PBT (After Exceptional Item)	_25,270	_20,231	24.9%
PBT Margin	19.5%	16.0%	—
PAT (After Minority Interest)	_21,655	_17,958	20.6%
PAT Margin	16.7%	14.2%	—

Domestic Business

Alkem continued to reinforce its position as a leading pharmaceutical player in the Indian Pharmaceutical Market (IPM) in FY2025, delivering resilient secondary sales of _8,058 crore (IQVIA MAT SSA March 2025), registering a YoY growth of 6.8%. While this growth was marginally below the overall IPM growth rate of 7.7%, it must be viewed in the context of Alkem’s leadership in therapeutic segments that witnessed relatively modest market expansion, particularly anti-infectives, which grew at 2.5% during the year.

According to IQVIA (SSA) data, for FY2025, the Company registered a volume growth of 2.1% vs. IPM’s volume growth of 1.2%, outperforming IPM by 90 bps.

Key Highlights:

8,984 crore

revenue from domestic business

6.5%

YoY growth

17 brands*

in the IPM Top _

70.2 %

contribution to total revenue

Ranked 05 overall*

in the Indian Pharmaceutical Market

#1

in anti-infectives in India for over >? consecutive years

Despite slower growth in a few core categories, Alkem retained its strong position among the top five companies in the IPM, with a market share of 4.1%. In segments where the Company has historically been dominant, it continued to rank among the top three players:

#1 in Anti-infectives (leader for over 15 years)

#2 in Vitamins/Minerals/Nutrients (VMN)

#3 in Gastrointestinal therapies

#3 in Pain and Analgesics

Alkem is also the third most prescribed pharmaceutical company in India across all therapy areas and medical specialities, underscoring the breadth and trust of its brand portfolio.

Power Brands Driving Growth

The Company’s long-standing strategy of building market-leading brands across therapy areas continues to yield dividends. In FY2025:

18 brands crossed _100 crore in annual sales

These brands contributed 52% of total domestic revenue

Collectively, they grew at 9.16% YoY, outpacing the IPM average

Notable brand performances include:

PAN: Entered the top five brands in the IPM, growing 14.5% YoY PAN-D: Rose from rank 12 to rank 09, with 17.1% YoY growth Clavam: Maintained rank 11, growing 4%, despite headwinds in the anti-infectives segment

These successes highlight the deep confidence prescribers places in Alkem’s products, built on a legacy of scientific credibility, consistent quality, and patient-focused outcomes. The performance is also a testament to Alkem’s field force of over 12,500+ marketing professionals, who drive engagement through evidence-based promotion and enduring physician relationships.

PERFORMANCE OF NEW PRODUCT LAUNCHES

BRAND	MOLECULE	RANK MAT MARCH 2025
ALNESOL OD	NEPAFENAC	6(+4)
ALSITA-E	EMPAGLIFLOZIN+SITAGLIPTIN	4
BUPROJOY	BUPROPION+DEXTROMETHORPHAN	5
EMPANORM	EMPAGLIFLOZIN	7(+2)
EMPANORM L	EMPAGLIFLOZIN+LINAGLIPTIN	10(+1)
ENDOGOLIX	ELAGOLIX	7
GLYCOQUIC F	FORMOTEROL+GLYCOPYRRONIUM	7(+1)
HEMFER-MAX	CYANOCOBALAMIN+ERGOCALCIFEROL+FOLIC ACID+IRON	3
	FERRIC+MORINGA OLEIFERA
IPRASURE LS	IPRATROPIUM BROMIDE+LEVOSALBUTAMOL	6
KOJIGLO	ARBUTIN+KOJIC ACID+OCTINOXATE+PINUS PINASTER	10
MASTMAX	OLOPATADINE	4
POLMAKEM-P	PARACETAMOL+POLMACOXIB	2
PULMOSMART G	BUDESONIDE+FORMOTEROL+GLYCOPYRRONIUM	8
XONE ES	CEFTRIAXONE+EDETIC ACID+SULBACTAM	3

Source:

IQVIA March 2025 SSA Data

Alkem’s performance in key therapeutic segments

Therapy Area	Market Rank	Market share (%)	Company growth (% YoY)	Industry growth (% YoY)
Anti-Infectives	1	13.2	2.5	4.8
Gastro Intestinal	3	7.7	ALIGN=RIGHT>11.4	9.6
Pain / Analgesics	3	5.2	5.0	7.0
Vitamins / Minerals / Nutrients	2	6.1	12.7	7.8
Anti Diabetic	14	2.2	9.7	8.5
Neuro / CNS	7	2.4	11.4	8.6
Gynaecology	8	3.7	6.8	3.3
Respiratory	16	1.5	4.9	3.2
Derma	20	1.4	8.8	9.3
Cardiac	27	0.7	1.0	11.9

Performance of Alkem’s Top 10 Brands

Brand	Molecule	Rank in molecule category	Brand sales _ crore in FY2025	Market share (in %)
PAN	Pantaprazole	1	639.9	39.3
PAN-D	Domperidone+Pantoprazole	1	581.5	36.8
CLAVAM	Amoxicillin+Clavulanic Acid	2	578.0	16.3
TAXIM-O	Cefixime	2	317.1	24.9
A TO Z NS	Ascorbic	2	296.2	14.4
	Acid+Copper+Manganese+Nicotinamide+Pantothenic
	Acid+Pyridoxine+Retinol+Riboflavin+Vitamin E+Zinc
XONE	Ceftriaxone	2	233.3	16.1
UPRISE-D3	Colecalciferol	1	219.4	22.1
PIPZO	Piperacillin+Tazobactam	1	194.9	29.4
TAXIM	Cefotaxime	1	167.6	82.0
GEMCAL	Calcitriol+Calcium & Combination	1	164.0	19.9

Source:

IQVIA March 2025 SSA Data

In addition to its leadership in acute therapies, the Company has strategically expanded its presence in chronic therapy areas such as anti-diabetes, neurology/CNS, dermatology, and inhaled chronic respiratory therapies. In few of these therapies, Alkem has not only outpaced market growth but has also gained notable market share.

The Company continues to be consistently ranked among the top five in terms of sales contribution from new product launches, underlining its strong capabilities in lifecycle management and timely market entry. Notably, Alkem has achieved market leadership in at least two blockbuster diabetes drugs following their patent expiries, reaffirming its agility and scientific acumen in capitalising on high-value opportunities.

Backed by an unwavering commitment to R&D, operational excellence, a strategically optimised supply chain, and a deeply experienced management team, Alkem is well-positioned to harness emerging opportunities and sustain its growth trajectory in the Indian Pharmaceutical Market.

Outlook for Domestic Business

The Indian pharmaceutical market (IPM) has continued on a steady growth trajectory, although volume growth has moderated to around 1-2%. Price-led growth and new product introductions remain the primary levers for outperforming the broader market. Chronic therapies continue to outpace acute segments, highlighting a structural shift in disease burden and healthcare priorities.

Looking ahead, several key industry trends are expected to shape Alkem’s domestic strategy:

1. Patent Expiry Opportunities

The IPM is on the cusp of major high-value patent expiries. Of particular strategic relevance are:

Semaglutide, expected to lose patent protection in March 2026. Alkem is well-positioned for first wave of launch upon patent expiry.

Nivolumab, the first immune-oncology biologic, has a patent expiry in May 2026. The Company is preparing for a timely biosimilar launch.

Alkem is actively evaluating launch strategies across multiple therapeutic areas, balancing speed to market, cost of development, and expected market dynamics.

2. CDMO-Led ‘Day One’ Launches and Market Crowding

There is a growing trend of CDMOs leading post-patent launches, including conducting bioequivalence and clinical studies. These products are then offered semi-exclusively or non-exclusively to marketing companies. While this model enhances cost-efficiency, it is also driving intense competition, with multiple players entering markets with similar products under various branding strategies. Alkem remains cautious and strategic in its participation, evaluating competitive intensity, pricing pressure, manufacturing cost, and quality considerations before deciding to partner or develop in-house.

3. Inorganic Growth and Licensing Activity

While co-marketing innovative, patented blockbusters with leading multinational corporations has been a well-established strategy in the Indian Pharmaceutical Market (IPM) for over 15 years, there is now a clear shift toward inorganic growth through licensing arrangements. Indian pharmaceutical companies are increasingly pursuing licensing opportunities to accelerate their pipeline expansion, particularly in complex generics, speciality molecules, and biologics.

This trend is gaining momentum across both small molecules and biopharmaceuticals, as companies seek to gain early-mover advantages in high-value therapeutic areas. Beyond traditional partnerships with global MNCs, Indian players are also engaging with emerging biologic innovators in markets such as China, tapping into novel product development and differentiated assets.

In alignment with this industry shift, the company keeps evaluating licensing opportunities with several partners with several potential partners to bring differentiated products to the Indian market.

4. Trade Generic Market Dynamics

The trade generic segment, now exceeding _25,000 Cr and growing at 14–15% CAGR, continues to be a key focus area. Alkem, already a market leader in this space, is strengthening its chronic portfolio to drive future growth. However, the segment is becoming increasingly competitive, with new entrants and aggressive expansions by large companies. The Company remains committed to reinforcing its leadership through quality, affordability, and reach.

5. Compliance, Regulation, and Quality

Regulatory rigour has increased, with the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) now in force and the revised Schedule M raising GMP standards. Alkem has implemented robust internal controls and training to ensure full compliance. The Company’s exposure to state-licensed Fixed Dose Combinations (FDCs) under scrutiny is minimal. While price control under DPCO continues to expand, much of Alkem’s portfolio is already included, limiting incremental impact. To further strengthen product integrity and patient trust, the Company is introducing anti-counterfeit packaging technologies such as holograms and security strips, especially on high-volume brands.

6. Diversification through MedTech

As Indian pharmaceutical companies increasingly diversify beyond formulations, Alkem has taken strategic steps by forming a wholly-owned subsidiary, Alkem MedTech Pvt. Ltd., focused on orthopaedic implants and musculoskeletal medical devices. This includes:

A technology transfer partnership with US-based Exactech for joint replacement implants.

Acquiring Bombay Ortho, a domestic orthopaedic implant manufacturer, enabling backward integration and manufacturing self-reliance under the Make-in-India initiative.

Strategic Vision Forward

Alkem remains focused on:

Filling portfolio gaps through new launches, in-licensing, and acquisitions.

Enhancing field force productivity and deepening prescriber engagement.

Optimising operations across manufacturing, distribution, and IT systems.

Safeguarding and extending leadership in core and emerging therapies.

Despite heightened regulatory expectations and increasing competition, Alkem sees tremendous opportunity in the domestic market. With its legacy brands, expansive reach, high-performing teams, and resilient supply chain, the Company is confident of maintaining its competitive edge and outpacing market growth over the medium to long term.

US Business

The US business continues to be a strategic growth pillar for the Company, contributing significantly to overall revenues. In FY2025, the Company generated _24,818 million in revenue from the US market, marking a 10.4% year-on-year decrease. This de-growth was primarily driven by pricing pressure in existing portfolio and absence of meaningful launches.

Key Highlights:

24,818 million

revenue from the US business

19.4%

share of total Company revenue

10.4%

YoY de-growth

185 cumulative

ANDAs filed

156 cumulative

ANDAs approved, including tentative approvals

Of these:

143 final

ANDA approvals

13

tentative approvals

2 NDAs filed,

both approved

The Company continued to expand its US product portfolio through robust regulatory activity. As of 31 March, 2025, a total of 185 Abbreviated New Drug Applications (ANDAs) had been filed, reflecting consistent pipeline progression. The Company also filed 2 New Drug Applications (NDAs), both of which received approval.

These approvals provide a strong base for future launches and help enhance the Company’s presence in key therapeutic segments within the US generics market. The business remains focused on optimising its cost structures, strengthening supply reliability, and enhancing product mix to navigate the pricing pressures that continue to characterise the US generics space.

Alkem’s ANDA filings and approval (chart)

Year	Total filed (cumulative) *	Total approved (cumulative)*#
2013-14	49	15
2014-15	63	19
2015-16	77	31
2016-17	91	39
2017-18	108	50
2018-19	127	70
2019-20	144	89
2020-21	152	110
2021-22	163	123
2022-23	175	134
2023-24	178	147
2024-25	187	158

Update on USFDA Inspections

In FY2025, the Company underwent the following USFDA inspections across its manufacturing facilities:

March 2025 – Taloja R&D: The USFDA conducted a Bioresearch Monitoring (BIMO) inspection at the Company’s Bioequivalence Center. The inspection was concluded with no issuance of Form 483.

June 2024 – Baddi Facility: The USFDA completed the inspection at the manufacturing facility in Baddi by issuing an Establishment Inspection Report (EIR) and classifying it as Voluntary Action Indicated (VAI). The establishment was examined by the USFDA on 27 March, 2024.

*includes NDA #includes tentative approvals

Quality remains a top priority for Alkem, and the Company adheres strictly to all applicable regulatory standards, including current Good Manufacturing Practices (cGMP). Alkem continues to invest in its people, processes, and technology to meet the evolving regulatory requirements, ensuring compliance and positioning itself for continued growth and operational excellence.

Facility	Capability	Inspection Date	Regulatory Status
Baddi (India)	Formulations	Mar-24	EIR Received in June 2024
Daman (India)	Formulations	Aug-19	EIR Received in Oct 2019
Taloja R&D (India)	Bioequivalence Centre	Mar-25	No observation
Ankleshwar (India)	API	Apr-23	EIR Received in July 2023
Mandva (India)	API	Dec-23	EIR Received in Mar 2024
California (USA)	API	Aug-18	EIR Received in Oct 2018

Note: USFDA conducted a virtual inspection at our manufacturing facilities in Daman from 5 to 7 October, 2020.

Outlook for the US Business

The US pharmaceutical market is one of the key revenue contributors for Alkem, owing to its significant size and purchasing power. However, there is a paradigm shift across US healthcare industry in recent times impacting mainstay US healthcare program, FDA layoffs, Inflation Reduction Act, Reciprocal tariffs shaping trade alliances, Drug pricing tied to MFN across foreign countries, conflicts and rising tensions in Ukraine, Middle East & India. Additionally, the generic drug sector is experiencing heightened competition due to the entry of new players, pricing pressures, and margin reductions in retail generic segments. Advent of Blockbuster GLP-1 drug classes to shape the industry and underlying investment in future. Gen-AI driving holistic impact across the pharma value chain.

Despite these challenges, opportunities remain in niche areas such as complex generics. Alkem is actively exploring avenues beyond traditional oral therapies, focusing on expanding into complex orals and injectables, particularly Complex Gx injectables, peptides via Organic pathway which are considered to be niche areas.

Alkem is also exploring ways to untap potential via inorganic pathways like strategic partnerships via in-licensing, co-development, CDMO models capitalizing on near term launches opportunities for blockbuster potential at the same time diversifying risk exposures for high cost development drugs.

Alkem’s technologically advanced R&D facilities, including an in-house CRO unit, alongside formulation R&D at Taloja and API R&D at Mandva, are key to addressing the global market’s evolving needs. The Company remains committed continuous innovation, product development, and maintaining high standards of quality to ensure it stays ahead the curve in the international pharmaceutical landscape.

In the U.S., Alkem has built a solid reputation, securing the #1 position in 8 of its top 20 molecules and ranking within the top 5 for the rest. Its strong presence is driven by a focused portfolio across key therapeutic areas like diabetes, heart health, iron deficiency, central nervous system (CNS) disorders, and pain management, reflecting its commitment to improving patient care across a wide range of health needs.

Source :

IQVIA MAT April 2025

Outlook for Other International Market Business

The Company continues to strive to expand reach in the existing 40 international markets, apart from India and the US. Its key markets include LatAm, Australia, Europe (UK, Germany) and RoW markets (Philippines, Kazakhstan, South Africa, East Africa, etc.).

In FY2025, the Company’s revenues from the Other International Markets business grew by 8.7% YoY to _13,392 million, with healthy growth in key markets such as Australia and Europe.

The Company is actively expanding its footprint in newer international markets, recognizing them as vital drivers of long-term growth. Simultaneously, it is strengthening its presence in existing geographies by deepening market penetration and enhancing customer access.

As part of a comprehensive strategic refresh for our Non-US markets, we undertook a structured exercise to assess both internal capabilities and external opportunities. The objective was to recalibrate our growth strategy in alignment with evolving market dynamics and future business needs.

Strategic Focus Areas

1. Market Opportunity Assessment

Identification of untapped potential in our existing geographies Exploration of new market entry opportunities with strategic relevance

2. Capability Baseline & Development

Assessment of current capabilities across commercial, regulatory, and operational dimensions Initiatives launched to build future-ready capabilities that support scale and adaptability

Key Strategic Initiatives Underway

Dossier Extensions - Tailored to specific regulatory and market demands in respective geographies to maximize portfolio reach

Therapy Area Expansion - Targeted entry into new therapeutic segments in select high-opportunity markets to enhance market depth.

Profitability-Driven Cost Initiatives - Implementation of cost optimization measures to improve margin performance and operating leverage

In-Licensing & Strategic Partnerships - Ongoing evaluation of in-licensing opportunities and collaborative partnerships to unlock incremental growth and innovation access.

Enzene Biosciences

Enzene Biosciences Limited, a subsidiary of Alkem Laboratories, operates across the entire biosimilars value chain, encompassing research, development, and manufacturing. Enzene leverages its technological expertise and commitment to innovation to provide accessible and affordable biopharmaceutical solutions. Its comprehensive capabilities span R&D, analytics, and Good Manufacturing Practice (GMP) manufacturing, empowering the Company to deliver high-quality solutions that address the ever-evolving challenges in the biotech industry.

Enzene specialises in the development and production of biosimilars, novel biologics, synthetic peptides, and phytopharmaceuticals. The Company offers a wide range of Contract Development and Manufacturing Organisation (CDMO) services, catering to both domestic and international markets. With its fully integrated capabilities, Enzene provides a "clone to vial" solution, covering the entire process from cell line development to upstream and downstream processes, advanced analytical and bioanalytical characterisation, and drug product development.

Enzene has successfully built its biologics CDMO business, using both traditional manufacturing processes and its novel EnzeneX™ platform. This innovative platform enables Enzene to offer integrated services and disruptive technologies that have attracted significant interest across global markets. The Company’s diverse portfolio serves clients in both human health and animal health, strengthening its market position and expanding its reach.

To support the growing demand for CDMO services and the expanding product pipeline, Enzene has enhanced its manufacturing capabilities, including the expansion of its bioreactor capacity at the Chakan plant. Enzene has also become one of the first movers globally to develop a patented end-to-end continuous manufacturing platform for biologics. This continuous manufacturing process allows raw materials (media and feed) to be fed into the system continuously, with products being harvested and continuously extracted, resulting in a steady-state process that operates 24/7. This technology offers several benefits, including:

Lower capital expenditure (Capex) due to smaller plant outlays

Higher output ratios, leading to reduced costs

Environmental sustainability, contributing to a smaller carbon footprint

The comparison between EnzeneX™ and traditional fed-batch manufacturing is outlined below:

Feature	Continuous Manufacturing (EnzeneX™)	Fed-Batch Manufacturing (Traditional Process)
Input/output	Continuous input/output	Intermittent feed, batch output
Output Ratio	High	Moderate
Capex Investment	Low	High
Carbon Footprint	Low	High
Complexity	More complex setup and control, limited replication ability	Simpler and easier to replicate

Enzene’s state-of-the-art manufacturing facility in India is equipped with advanced technology for monoclonal antibodies (mAb) and therapeutic protein manufacturing, as well as single-use technology for drug substance manufacturing and a fill and finish line for drug product manufacturing. This facility is capable of higher production at a lower cost compared to traditional biologics manufacturing facilities, facilitating rapid movement of pre-clinical assets to later-stage development or commercialisation. The facility has undergone audits by multiple customers and regulatory bodies, confirming its adherence to global standards.

In addition, Enzene’s clinical manufacturing facility in New Jersey, USA, began its first clinical batch production in March 2025, marking a significant milestone in its expansion strategy. The facility is set to commence full-scale commercial operations by mid-FY2026, further strengthening Enzenes ability to serve US-based clients with localised needs.

Key Highlights of FY2025

Robust growth across both India-based products and CDMO services.

In the last three years, Enzene launched seven biosimilar products in India, expanding its commercial footprint. Efforts to add additional domestic customers contributed to revenue growth.

Cost leadership strategies have improved access to lifesaving medications for patients in India.

Pertuzumab completed clinical trials for HER2-positive metastatic breast cancer, with a launch planned for FY2026, enhancing Enzene’s oncology-focused biosimilars portfolio.

Ongoing focus on the development of early-stage products to expand the existing portfolio and drive future growth.

The regulatory dossier for Denosumab has been submitted for EMA approval.

Enzene’s manufacturing facilities in India received European Medicines Agency (EMA) certification, further validating the Company’s commitment to international quality standards.

The clinical manufacturing facility in New Jersey partially commenced its first clinical batch production, with full-scale commercial operations slated for FY2026.

Enzene has entered into partnerships for commercial rights to global markets for its pipeline products. These licensing agreements provide development-based milestone payments and align with Enzene’s strategy of maximising product value through global partnerships.

As of 31 March, 2025, Enzene’s total R&D headcount stood at 191.

MedTech

In line with Alkems strategic vision to diversify into high-growth, future-oriented sectors, Alkem MedTech Pvt. Ltd. (Alkem MedTech) was established during the year as a wholly owned subsidiary to mark the Company’s entry into the dynamic and rapidly evolving medical devices industry. Within its inaugural year, MedTech has successfully laid the groundwork for a scalable, innovation-driven business, with a strong emphasis on clinically validated, precision-engineered orthopaedic joint solutions, tailored to serve both the Indian market and RoW markets.

MedTech’s philosophy is centred on patient-centricity and surgeon-friendly design, with a sharp focus on meeting global regulatory standards such as ISO 13485 and EU MDR. In a significant step toward strengthening its operational capabilities, Alkem MedTech acquired a manufacturing facility in Rajkot, Gujarat. This state-of-the-art facility, purpose-built for knee and hip joint implants, offers immediate manufacturing capabilities and forms the backbone of MedTech’s long-term strategy around quality, scalability, and cost efficiency. Designed with modular scalability in mind, the facility currently can meet projected demand for the next 2–3 years, with plans underway to triple production capacity over the next 12 months to respond to market expansion and customer needs.

MedTech also entered into a technology transfer and licensing agreement with a US-based orthopaedic company, gaining commercial and manufacturing rights for their knee and hip implant portfolio in India, along with trademark rights for the Indian market. This partnership gives MedTech access to clinically proven, globally recognised products, accelerating its go-to-market strategy.

Further, MedTech has embarked on a digital transformation journey with a focus on evolving its manufacturing operations through SAP integration across core functions. This initiative will enable real-time data insights, predictive maintenance, and data-driven decision-making. Investments in advanced automation, robotic systems, precision CNC machinery, and lean manufacturing principles underscore MedTech’s commitment to quality, efficiency, and regulatory compliance.

Looking beyond operations, MedTech is building a robust clinical collaboration roadmap, partnering with leading multi-speciality hospitals in India to conduct Real-World Evidence (RWE) and Post-Market Surveillance (PMS) studies. These initiatives will support evidence generation and clinical validation of MedTech’s products. Simultaneously, the company is actively evaluating inorganic growth opportunities to broaden its capabilities in adjacent med-tech segments.

Medtech - Key Milestones Achieved in FY2025

Infrastructure Development

Completed a technology transfer agreement with a leading US-based orthopaedic company, securing rights to manufacture and market their knee and hip implant portfolio in India.

Acquired a world-class manufacturing facility in Rajkot equipped with cleanrooms, CNC machines, robotic grinding and polishing units, laying the foundation for domestic manufacturing excellence.

Gained access to a robust product pipeline for global rollout of both knee and hip implants.

Regulatory Compliance and Certification

Obtained MD-17 test license for the import of knee and hip implants.

Completed ISO 13485 Stage I audit, reinforcing alignment with international quality systems and regulatory benchmarks.

Talent Acquisition and Organisation Building

Built a cross-functional leadership team with deep expertise across regulatory affairs, quality assurance, business development, strategy, commercial operations, and manufacturing.

Indigenous Innovation and Development

Initiated development of indigenous instrumentation for knee and hip implants.

This strategic step supports the ‘Make in India’ initiative, aiming to reduce import dependency and strengthen domestic capabilities.

With foundational blocks now firmly in place across infrastructure, regulatory readiness, talent, and product development, MedTech is well-positioned to transition from a development-phase entity to a full-scale market participant in the current fiscal year. The Company’s mission is to emerge as a globally credible Indian-origin manufacturer of orthopaedic solutions, delivering high-quality, accessible care to patients and empowering healthcare professionals. MedTech is committed to contributing meaningfully to the vision of ‘Atmanirbhar Bharat’ in the field of medical technology.

Research and Development (R&D)

Alkem’s R&D capabilities form the cornerstone of its strategy to deliver high-quality, differentiated, and globally competitive healthcare solutions. The Company’s investments in advanced R&D infrastructure, scientific talent, and strategic collaborations continue to strengthen its innovation pipeline and regulatory readiness for global markets.

Clinical Research and Global Regulatory Compliance

Alkem’s state-of-the-art clinical research facility is licensed to conduct not only bioequivalence (BE) and bioavailability (BA) studies, but also first-in-human and early-phase (Phase I) clinical trials. This advanced facility has been successfully inspected by leading global regulatory authorities, including the USFDA, UK MHRA, EMA, ANVISA, NPRA (Malaysia), and CDSCO (India). In March 2025, the facility cleared a USFDA Bioresearch Monitoring (BIMO) inspection without any Form 483 observations, affirming Alkem’s commitment to data integrity, patient safety, and global regulatory compliance.

The Company has a strong track record of conducting scientifically robust clinical trials across all phases (Phase I to Phase IV) and a wide range of therapeutic areas—including infectious diseases, oncology, endocrinology, neurology, cardiology, haematology, rheumatology, ophthalmology, and gastroenterology. The clinical research team brings deep expertise in executing trials involving both small molecules and large molecules, including stem cell-based therapies, supporting regulatory submissions across India, the US, the EU, and other global markets.

All clinical development is conducted in adherence to ICH-GCP and other internationally accepted ethical and regulatory frameworks. Alkem maintains a clear focus on addressing unmet medical needs and generating high-quality, evidence-based data for the development of safe, effective, and accessible therapies.

Innovation Through Strategic Collaborations

Alkem actively fosters innovation through strategic R&D partnerships with premier national and international academic and research institutions. Globally, the Company collaborates with esteemed organisations such as:

Harvard University

Johns Hopkins University

National Institutes of Health (NIH), USA

Biosergen, Sweden

In India, Alkem partners with top-tier institutes, including:

IIT Bombay

IIT Kanpur

Tata Memorial Hospital

These collaborations are designed to leverage complementary scientific and technical expertise, accelerate the development of complex generics, biotechnology products, and novel therapeutics, and advance Alkem’s regulatory filings in emerging and regulated markets.

*Includes a dossier for each strength ** filing is SKU-wise #Includes 13 tentative approvals.

Quality Assurance

Alkem’s unwavering commitment to quality is anchored in a robust, technology-enabled Quality Management System (QMS) designed to comply with and exceed global regulatory standards. The QMS is continuously updated to align with the latest regulatory guidance from agencies across the US, EU, India, Australia, UK, and other key international markets, ensuring consistent product quality, safety, and efficacy.

Markets	Filled	Approved
US (ANDA)	185	156#
US (NDA)	2	2
Australia	83	77
Europe	54	37
UK	44	34
Chile*	227	224
China**	10	2
South Africa*	196	144
Kazakhstan*	33	33
Philippines*	28	28
Brazil	2	2
Mexico	48	16

Focus on Novel Drug Development and IP Strength

Beyond external collaborations, Alkem continues to drive internal innovation, particularly through the development of 505(b)(2) products across various therapeutic domains. Several of these programs have successfully entered Phase I and Phase II clinical development, reflecting the Company’s capability to create differentiated product profiles with enhanced patient outcomes.

Alkem’s innovation efforts are further strengthened by a robust and expanding intellectual property (IP) portfolio, which protects its proprietary technologies and ensures long-term value creation from novel R&D assets.

Pharmacovigilance and Patient Safety

Alkem operates a well-integrated pharmacovigilance (PV) system, ensuring ongoing safety monitoring of its products throughout clinical development and post-marketing phases. The PV system is aligned with international best practices and continuously evaluates the benefit-risk profiles of marketed drugs. Alkem remains committed to transparency and regulatory responsibility in communicating safety information with healthcare professionals, regulators, and patients.

Product filings in key international markets (as on 31 March, 2025)

Quality by Design (QbD) and Culture of Excellence

The principles of Quality by Design (QbD) are deeply embedded across Alkem’s research, development, manufacturing, and quality control operations. This proactive approach ensures high-quality, consistent products by integrating quality into every stage of the product lifecycle. Teams across the organisation work in unison to uphold a culture of excellence, constantly aiming to meet and surpass global standards.

Alkem also fosters a quality-conscious and inclusive organisational culture, driving continuous improvement and operational sustainability. Through regular process evaluations, the Company works to streamline, simplify, and future-proof its product supply chains.

Digitalisation of Quality Systems

Alkem is advancing its quality assurance framework through the digital transformation of data systems across its manufacturing facilities. The implementation of advanced data management tools ensures:

Enhanced traceability

Improved accuracy and real-time monitoring

Reduced human error

Greater audit readiness

Higher operational efficiency

These digital initiatives support compliance with high regulatory expectations while laying the foundation for predictive quality control and intelligent decision-making.

Regulatory Compliance and Global Standards

Alkem’s manufacturing facilities comply with a broad spectrum of international Good Manufacturing Practices (GMP), including but not limited to:

Schedule M (India)

21 CFR (United States)

Eudralex Volumes (European Union)

WHO-GMP (World Health Organisation)

Orange Book (UK MHRA)

TGA GMP guidance (Australia)

The QMS framework ensures that all developed, manufactured, and distributed products adhere to the legal and quality requirements of target markets, strengthening Alkem’s position as a trusted global supplier.

Ethics, Integrity, and Supply Chain Assurance

Alkem enforces a stringent Code of Conduct applicable to all stakeholders—employees, vendors, and partners. This code ensures that all activities are carried out with the highest levels of integrity, transparency, and ethical responsibility, further reinforcing product and process quality.

The Company also maintains a mature and resilient supply chain, supported by trained professionals and quality systems that enable end-to-end compliance, traceability, and efficiency. Continuous training, both internal and external, ensures that employees remain aligned with global quality benchmarks.

Information Technology

In FY2025, Alkem’s Information Technology (IT) function played a pivotal role in enabling enterprise-wide transformation, advancing both operational efficiency and digital innovation. IT has evolved from a support role to a core strategic enabler, accelerating the Company’s journey toward enhanced agility, data-driven decisions, and future-ready operations.

Enterprise Systems Modernisation

HR Digital Transformation: Alkem successfully implemented a fully integrated ‘Hire to Retire’ digital HR ecosystem, combining SAP SuccessFactors and TurboHire. This initiative streamlined talent acquisition, employee lifecycle management, and performance tracking, enhancing workforce experience and organisational productivity.

Expense & Travel Management: The deployment of RxTravelEase simplified travel and reimbursement processes for the field force, improving turnaround times and operational visibility.

ERP Upgrade: A significant milestone was the upgrade of SAP ERP to HANA 2023, modernising Alkem’s core digital infrastructure and preparing the groundwork for a global rollout across international subsidiaries.

Data & Collaboration Platforms

Cloud-Based Data Warehousing: A robust data warehousing platform was launched on the cloud, enabling unified, real-time dashboards and analytics for field operations. Plans are underway to extend this to manufacturing, supply chain, and other functions, creating a connected, insight-driven enterprise.

Workplace Productivity: The rollout of Microsoft O365 tools—including Teams, Outlook, and SharePoint, fostered seamless collaboration across functions and geographies. Additionally, the introduction of FreshService IT Helpdesk enhanced user support and reduced resolution times.

CRM Enhancement: An upgraded CRM system provided a more intuitive and responsive interface, empowering the field force with faster access to customer insights and engagement tools.

Strategic Enablers

Global Capability Centre (GCC): Alkem established a Global Capability Centre to centralise enterprise operations and provide shared service support to group companies, improving scalability and process standardisation.

Smart Manufacturing: Digital initiatives in manufacturing focused on automation, compliance, and efficiency, leveraging innovative systems to enhance plant performance and reduce variability.

AI in R&D: Alkem initiated pilots using AI-assisted technologies to streamline R&D documentation and accelerate regulatory submissions, setting the stage for next-generation research capabilities.

Cybersecurity & Risk Management

Throughout the year, cybersecurity remained a top priority. Alkem invested in strengthening threat detection, endpoint protection, and risk mitigation frameworks, ensuring robust information security and regulatory compliance in an increasingly digital landscape.

Risk Management

Alkem has established a robust Enterprise Risk Management (ERM) framework to proactively identify, assess, and mitigate risks associated with its diversified operations across geographies. This framework enables informed decision-making and helps preserve long-term value for stakeholders.

A dedicated Risk Management Committee, constituted by the Board of Directors, provides strategic oversight and governance of risk management activities. This Committee ensures that key business, financial, operational, strategic, regulatory, and cyber-related risks are systematically identified and mitigated through structured response plans.

The ERM function collaborates closely with business and functional leaders to embed a risk-aware culture across the organisation. Internal and external developments are continuously monitored to detect emerging threats, ensuring that Alkem remains resilient and responsive in a dynamic business environment.

Key elements of Alkem’s risk management approach include:

Regular risk assessments and reviews

Integration of risk considerations into strategic planning and operations

Real-time monitoring of key risk indicators (KRIs)

Periodic reporting to the Risk Management Committee and the Board

The table below summarises key risk categories along with corresponding mitigation strategies:

Internal Control System

Alkem has established a robust global internal control framework tailored to the scale and complexity of its operations. This framework encompasses financial, operational, and regulatory controls, fostering a culture grounded in ethics, integrity, and accountability. Its primary objectives include safeguarding assets, ensuring operational efficiency, preventing fraud, minimising errors, and maintaining compliance with all applicable regulatory requirements.

To uphold and continuously strengthen these controls, the Company has engaged a leading Big Four audit firm. In parallel, an independent Global Internal Audit function, reporting directly to the Audit Committee, conducts risk-based audits to assess the adequacy and effectiveness of the control environment across business functions. The Audit Committee reviews the annual audit plan, monitors key audit findings, and evaluates the performance of the internal audit team to ensure continuous improvement.

In recognition of the evolving regulatory landscape and the growing importance of data protection, Alkem has significantly invested in advanced information systems to mitigate cybersecurity risks. The Company also conducts regular training and awareness programs to ensure strict adherence to laws, regulations, and industry standards. Feedback from both internal and external audits, along with industry benchmarks, is used to refine and strengthen the internal control environment on an ongoing basis.

Human Resources

At Alkem, people are at the heart of long-term value creation. The Company firmly believes that empowered employees, a resilient organisational culture, and a strong social conscience are critical enablers of sustainable success. During FY2025, Alkem reinforced these pillars through targeted initiatives focused on business expansion, digital transformation, and inclusive employee engagement.

Efforts were directed towards aligning individual and team objectives with the Company’s strategic vision, fostering a high-performance culture built on transparency, trust, and innovation. Alkem also continued to invest in skill development, leadership training, and diversity programs to enhance employee capabilities and strengthen its talent pipeline.

These initiatives have collectively contributed to higher employee satisfaction, improved collaboration, and greater alignment between people and purpose, laying a strong foundation for future growth and organisational resilience.

Strategic HR Contributions to Growth

Alkem’s Human Resources function continues to play a pivotal role in enabling business growth by aligning talent strategies with evolving strategic priorities. In FY2025, HR actively supported commercial expansion by facilitating critical hiring across high-potential therapy areas such as gastroenterology and cardiology. These efforts enhanced the Company’s market reach and deepened customer engagement in priority segments.

To further strengthen its market position, HR collaborated with business leaders to:

Expand the acute portfolio into previously untapped territories.

Establish a dedicated division to grow the injectable portfolio.

Reinforce institutional and government tender businesses in response to changing healthcare dynamics.

Additionally, HR was instrumental in the realignment of the vitamins and minerals portfolio by optimising field resources and enhancing market penetration across the prescription, OTX, and OTC segments. The team also played a foundational role in setting up the core team of Alkem’s newly launched MedTech business.

Digital Transformation in Human Resources

As Alkem’s operations scale globally, digital transformation has become a key enabler of operational agility and employee experience. In partnership with the IT function, HR introduced technology-driven platforms to streamline core processes. This included the deployment of TurboHire for recruitment automation and SAP SuccessFactors for managing the full employee lifecycle.

These platforms simplify workflows, reduce manual interventions, and offer a more seamless and engaging experience for employees. Multiple modules have already been successfully rolled out, with ongoing efforts to integrate them across global operations, thereby laying the foundation for a digital-first HR ecosystem.

Building Future-Ready Capabilities: Global Capability Centre (GCC)

The launch of Alkem’s Global Capability Centre (GCC) marks a strategic step towards future-ready operations. Designed to be a central hub for enterprise-wide efficiency, innovation, and scalability, the GCC will:

Drive analytics-based decision-making,

Foster operational agility, and

Support global business expansion.

Together with the ongoing digital transformation in HR, the GCC is expected to elevate Alkem’s competitiveness in a rapidly evolving healthcare environment.

Enhancing Employee Engagement, Capability, and Inclusion

Alkem remains deeply committed to fostering a culture of transparency, capability-building, and inclusivity. Open communication is facilitated through regular CEO-led town halls and cross-level leadership interactions, fostering alignment with the Company’s long-term vision and strategy.

In FY2025, several initiatives were undertaken to strengthen employee engagement:

Capability-building programs and outbound team-building activities were conducted across teams and functions.

The SHinE program continued to support the professional development of women executives.

The Corporate Chanakya Business Simulation Challenge, a dynamic two-day workshop, enabled 80 employees to assume CXO roles and gain hands-on experience in strategic decision-making, sharpening leadership, problem-solving, and teamwork skills.

A standout diversity initiative was launched at the Sikkim manufacturing facility (Unit V), where an all-female team now manages end-to-end operations of the liquid manufacturing line. This effort not only advanced gender inclusion but also led to improved production output, reduced rejection rates, and enhanced process discipline, reinforcing the value of diverse, empowered teams.

Cautionary Statement

This document contains certain statements that are or may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and regulations. These statements include, but are not limited to, projections, estimates, expectations, plans, objectives, and assumptions regarding the Company’s future performance, business strategies, operational initiatives, and industry conditions.

Such forward-looking statements are based on current assumptions, anticipated developments, and other factors that are subject to known and unknown risks, uncertainties, and other factors beyond the Company’s control. These may cause actual results, performance, or achievements to differ materially from those expressed or implied in the statements.

Key factors that could affect performance include, but are not limited to: global and domestic macroeconomic conditions, regulatory changes, evolving competitive landscapes, technological advancements, successful execution of business strategies and growth plans, R&D outcomes, changes in customer and supplier dynamics, and developments in the pharmaceutical and MedTech industries.

The Company undertakes no obligation to update, revise, or amend any forward-looking statements to reflect events or circumstances arising after the date of this report, except as required under applicable law.