Affordable Medicines – API
Grounded in Science,
Growing in Scale.
Our API business remains a core pillar of the Affordable Medicines platform, supported by scale, process chemistry expertise and a strong position in antiretroviral APIs.
We develop, manufacture and supply APIs across key therapeutic areas such as ARVs, cardiovascular and CNS, while gradually expanding the portfolio beyond its traditional base. The business is characterised by high-volume manufacturing, cost competitiveness and consistent supply to global markets, supported by integrated operations.
Market Context
The global API market continues to be supported by rising demand for affordable therapies, increasing chronic disease burden and sustained generic penetration across major healthcare systems. Recent estimates place the market at approximately USD270 billion in 2025, with the potential to exceed USD400 billion by the early 2030s, reflecting steady growth driven by generics and outsourcing demand.
Generics and biosimilars remain central to healthcare affordability. In the United States alone, generic and biosimilar medicines generated over USD450 billion in savings in 2024, highlighting the scale of value creation through cost-efficient manufacturing.
The ARV opportunity remains especially relevant, with over 31 million people globally accessing antiretroviral therapy, up from 7.7 million in 2010, underscoring the continued need for reliable API supply. At the same time, the market remains shaped by tender-led procurement, pricing pressure, regulatory timelines and evolving product mix across markets.
Our Strategic Response
Our strategy in APIs remains centred on reinforcing leadership in ARVs while steadily broadening the portfolio across other therapeutic areas and customer segments. Alongside this, we continue to focus on backward integration, process optimisation and closer alignment between capacity creation and demand visibility. The intent is not only to grow volumes, but also to improve the quality of growth by building a more balanced, efficient and resilient API platform over time.
FY 2025-26 Financial Highlights
The API business delivered a stronger performance in FY 2025-26, supported by healthy ARV demand, improved utilisation and better operating leverage. Growth during the year was aided by higher volumes, a more supportive product mix and improving traction across the broader portfolio.
FY 2025-26 Operational Highlights
- Maintained consistent deliveries despite global supply chain challenges
- Planned capacity availability for the business remained on track, supporting better delivery-readiness
- Higher CMO-linked volumes and revenue scale-up from new contracts contributed to stronger utilisation
- Production planning and manufacturing-readiness were more closely aligned with demand visibility
- Filing activity continued during the year, with 2 filings in FY 2025-26, taking cumulative DMF filings to 92
- Continued work on portfolio expansion and process efficiency supported the development of a broader and more effective API platform
Outlook
The outlook for the API business remains stable, supported by the structural demand for affordable medicines, our established position in ARVs and the gradual broadening of the portfolio. While near-term performance may continue to reflect procurement cycles and product mix dynamics, the underlying demand environment remains resilient.
Going forward, our focus will remain on improving utilisation and expanding the product portfolio. We will also strengthen our participation across developed and emerging markets, while driving closer integration between APIs and formulations. These efforts position the business for more consistent growth over the medium term.
Affordable Medicines – FDF
Grounded in Science,
Growing in Access.
Our Finished Drug Formulation (FDF) business extends the Affordable Medicines platform from APIs into formulations, enabling wider market access and deeper participation across value chains.
Present across therapeutic areas such as ARVs, cardiovascular, CNS and anti-infectives, the business is supported by integrated manufacturing, strong quality systems and a growing product portfolio. This provides a solid base to serve institutional and developed markets while expanding the role of formulations within the broader Affordable Medicines platform.
Market Context
The global generics market continues to expand, supported by rising healthcare access, patent expiries and sustained demand for affordable therapies. Recent estimates place the global generic pharmaceuticals market at USD454.7 billion in 2025, with the potential to reach USD770.0 billion by 2033, reflecting a CAGR of 6.5%. Oral formulations remain the most widely used delivery format within this market, underlining their importance as scalable and cost-effective therapies.
This relevance is especially visible in mature healthcare systems, where affordability and volume continue to define the category. In the United States, generic and biosimilar medicines accounted for 90% of prescriptions filled in 2024, while representing only 12% of prescription drug spending, highlighting the structural role of generic formulations in expanding access at lower cost.
Our Strategic Response
Our approach to formulations is centred on strengthening scale, improving portfolio depth and expanding participation across both global access and developed/emerging markets. The focus remains on deepening our position in ARV formulations while building a calibrated portfolio in select molecules.
We continue to leverage integration with our API business to support reliable supply, cost competitiveness and faster execution. Alongside this, the formulations platform is being strengthened through steady progress in product filings and approvals, expansion of oral solid dosage capacity and the addition of products under CMO to support better utilisation.
The KRKA joint venture remains an important part of this strategy, supporting the development of a formulations platform for regulated markets.
FY 2025-26 Financial Highlights
The FDF business delivered strong growth during FY 2025-26, with higher ARV volumes and strong offtake in select molecules within developed markets offsetting price pressure. The business also benefited from improving scale and better utilisation across the formulations platform.
FY 2025-26 Operational Highlights
- Continued growth in ARV formulations and developed-market supplies supported growth during the year
- Dedicated CMO oral dosage capacity in Vizag commenced operations during FY 2025-26
- An additional packaging line is being implemented, with the full commercial production line scheduled to commence from June 2026
- Filing activity in developed markets progressed further during the year, with 7 product dossiers filed and 6 approvals received during the year, taking cumulative product filings to 94
- Construction of the KRKA JV finished formulations facility progressed as planned, with Phase 1 expected to be completed by mid-2027. Laurus infused capital in KRKA Pharma India of ₹ 49 crore, while both partners together infused ₹ 100 crore to support ongoing facility construction
Outlook
The outlook for the FDF business remains positive, supported by stable demand in ARV formulations, continued traction in developed-market supplies, expanded footprint in emerging markets and the ramp-up of dedicated oral dosage capacity. While tender cycles, pricing dynamics and approval timelines may continue to influence near-term phasing, the business is building a stronger and more scalable formulations platform.
Going forward, the focus will remain on selective portfolio expansion, progress in filings and approvals, ramp-up of integrated CMO oral dosage capabilities and execution of the KRKA JV platform, supporting the next phase of growth.
CDMO – Small Molecules
Grounded in Chemistry,
Growing in Partnerships.
Our Small Molecules CDMO business supports global pharmaceutical innovators across development and manufacturing, with capabilities spanning early-stage programs to commercial supply.
Built on process chemistry expertise, integrated infrastructure and scale-up strength, the platform supports complex molecules across the development lifecycle. The business continues to strengthen its role as a long-term development and manufacturing partner to global pharmaceutical companies, supported by a growing pipeline and increasing participation in late-stage and commercial programs.
Market Context
The global small molecule CDMO market continues to expand, supported by rising outsourcing, development complexity and the need for specialised manufacturing partners. Recent estimates place the market at USD76.1 billion in 2025, with the potential to reach approximately USD145.5 billion by 2035, reflecting the growing need for partners that can support complex development pathways and commercial scale-up.
Small molecules also continue to dominate innovation pipelines. In 2025, the US FDA approved 46 novel drugs, of which 34 were new molecular entities, reinforcing the continued importance of small molecules in drug development. As pipelines become more complex and development timelines more compressed, innovator companies are increasingly looking for partners that can combine specialised chemistry capabilities, phase-appropriate development support and integrated pathways from early development to commercial supply.
Our Strategic Response
Our approach to small molecules CDMO is centred on deepening strategic partnerships, strengthening specialised capabilities and building scale in areas where complexity, reliability and speed of execution matter most. The focus remains on supporting customers across clinical and commercial phases through a combination of process chemistry expertise, integrated development and manufacturing infrastructure and flexible scale-up capabilities.
We continue to invest in differentiated technology platforms such as biocatalysis, flow chemistry, trickle-bed processing and peptides, while expanding development and manufacturing capacity to support a broader mix of programs over time. The platform is also supported by phase-appropriate quality systems across development and manufacturing, enabling fit-for-purpose execution at each stage of the product lifecycle while balancing speed, control and cost efficiency.
FY 2025-26 Financial Highlights
The small molecules CDMO business delivered strong growth during FY 2025-26, supported by late-stage pipeline progression, commercial supplies across multiple complex NCE APIs and a ramp-up in growth projects.
FY 2025-26 Operational Highlights
- Strong demand in complex small molecule offerings supported expansion of the project funnel, with a healthy mix of big and mid-sized pharma clients
- Expanding project pipeline, based on trust, capabilities, scale and delivery; the portfolio now comprises more than 125 active pipeline projects, including over 102 in human health and around 23 in animal health and crop science
- Several projects across scales were executed using flow chemistry and bio-catalysis technology
- Peptide manufacturing capability and capacity were further strengthened in line with future customer requirements
- Continued focus on new modalities with key partners and fully integrated projects
- Investment in large-scale commercial capacity expansion at Vizag continued through the year
Outlook
The outlook for the small molecules CDMO business remains positive, supported by a healthy project pipeline, continued demand for complex offerings and increasing traction in late-stage and commercial programs. Vendor diversification, rising chemistry complexity and the preference for strategic end-to-end partners continue to support the opportunity set.
Going forward, the focus will remain on deepening strategic customer relationships, advancing technology-led capabilities, expanding commercial capacity and maintaining strong quality and execution standards across the development-to-commercialisation cycle.
CDMO – Bio
Grounded in Biology,
Growing in Capability.
Our Bio CDMO business is built on large-scale microbial fermentation and downstream processing capabilities, supporting global customers across development and manufacturing of bio-based products, specialty ingredients and industrial biotechnology applications.
The platform is anchored in precision fermentation, enzymatic technologies and animal-origin-free (AOF) offerings, serving customers across life sciences, nutrition, personal care, industrial biotechnology and specialty applications. The business continues to build a diversified pipeline and deepen engagement with global customers, while expanding its capability base to support future opportunities in bio-manufacturing and next-generation therapies.
Market Context
The global industrial biotechnology market is expanding, supported by rising demand for sustainable manufacturing, bio-based ingredients and precision fermentation-derived products. Valued at approximately USD320 billion in 2025, it is projected to exceed USD600 billion by 2035.
Within this, precision fermentation is gaining strong momentum across specialty ingredients, enzymes, nutrition, personal care and functional bio-based products. Estimated at USD4.5 billion in 2025, the market is expected to grow at over 40% CAGR over the next decade.
Alongside this, the global industrial enzymes market, estimated at USD8–10 billion, continues to see strong demand. Together, these trends are creating opportunities for fermentation-focused CDMO partners with integrated scale-up, process development and manufacturing capabilities.
Our Strategic Response
Our approach to Bio CDMO is centred on building a robust and diversified pipeline, strengthening fermentation-led capabilities and deepening long-term customer partnerships. The focus remains on scaling the precision fermentation, AOF and enzymatic platform, while expanding capabilities to support evolving customer requirements for bio-based applications.
We continue to see increasing customer interest in dedicated manufacturing lines and longer-term partnerships, supported by the platform’s ability to integrate development and manufacturing. At the same time, investments are being directed towards expanding fermentation capacity, downstream processing infrastructure and strengthening capability in enzymatic technologies.
The platform is supported by phase-appropriate quality systems across development and manufacturing, enabling fit-for-purpose execution across industrial, food, nutrition, personal care and life science applications.
FY 2025-26 Financial Highlights
The Bio CDMO business delivered healthy growth during the year, supported by revenue diversification and continued pipeline progress with larger global accounts. Momentum was further strengthened by accelerated product development and launch activities, along with an improving mix of higher-value products and customers within CDMO.
FY 2025-26 Operational Highlights
- Focus remained on building a strong and diversified pipeline across customers, applications and fermentation platforms
- Customer interest in dedicated manufacturing lines and new innovative products continued during the year
- Discussions for longer-term manufacturing contracts progressed, improving visibility into FY 2026-27 and beyond
- Enzymatic and bio-catalysis platforms continued to gain traction across small molecule clinical and commercial API projects.
- Process development and scale-up capabilities continued to strengthen across precision fermentation programs
- The fermentation manufacturing site at Vizag progressed as planned, with operations expected to commence by the end of 2026
Outlook
The outlook for the Bio CDMO business remains constructive, supported by improving demand visibility, a strengthening pipeline and increasing customer engagement in long-term partnerships. Growing global interest in fermentation-led manufacturing and enzyme-based platforms is expected to support future growth.
Going forward, the focus will remain on building a diversified pipeline, scaling fermentation capacity, strengthening downstream processing capabilities, advancing enzymatic capabilities and progressing long-term customer engagements, supporting the next phase of growth in the Bio CDMO business.