The India biosimilar market is emerging as a key player in the global pharmaceutical landscape, thanks to increasing disease burden, a maturing regulatory environment, and advancements in biologics manufacturing. According to Expert Market Research, the India biosimilar market was valued at INR 4.37 billion in 2024, and is projected to grow at a CAGR of 14.20% during the forecast period of 2025–2034. By 2034, the market is expected to reach a value of INR 16.49 billion.
India Biosimilar Market Size
Biosimilars—biological products highly similar to approved reference biologics—offer a cost-effective alternative for treating complex and chronic diseases such as cancer, autoimmune disorders, and diabetes. India, with its strong base of biotechnology companies and growing healthcare demand, is rapidly advancing in biosimilar development and manufacturing.
A combination of high domestic demand, lower production costs, and government incentives has positioned India as both a large consumer and exporter of biosimilars. This growth is also propelled by the increasing adoption of Pharmaceutical Cleanroom Technology, ensuring adherence to global regulatory standards for biologic manufacturing.
India Biosimilar Market Share
India's biosimilar market is dominated by domestic pharmaceutical giants such as Biocon Limited and Dr. Reddy’s Laboratories, with Intas Pharmaceuticals also holding a substantial share. These companies have developed extensive biosimilar portfolios targeting therapeutic areas like oncology, endocrinology, and immunology.
In terms of manufacturing type, in-house manufacturing holds the majority market share due to vertical integration and quality control, though contract manufacturing organizations (CMOs) are increasingly gaining traction among smaller biotech firms seeking to reduce operational costs.
From a product class perspective, monoclonal antibodies lead the market, followed by recombinant hormones and immunomodulators, reflecting the rising demand for cancer and autoimmune disorder treatments.
India Biosimilar Market Growth & Trends
Key trends and growth drivers shaping the India biosimilar market include:
Rising Prevalence of Chronic Diseases: Conditions like diabetes, rheumatoid arthritis, and cancers are on the rise in India, boosting demand for affordable treatment options like biosimilars.
Patent Expiries of Biologics: The expiry of patents for blockbuster biologic drugs globally has opened doors for Indian pharmaceutical companies to enter the market with competitive biosimilar versions.
Supportive Government Policies: Initiatives such as ‘Make in India’ and Startup India are providing funding and regulatory support for local biopharma players.
Expansion in Global Markets: Indian companies are also eyeing the U.S., Europe, and Southeast Asian markets, especially with increasing FDA and EMA approvals for biosimilars.
Improved Pharmaceutical Cleanroom Infrastructure: The adoption of advanced cleanroom technologies is enhancing sterility and compliance, which are critical in biologics production.
India Biosimilar Market Case Studies & News
Biocon Biologics, a subsidiary of Biocon Ltd., entered into a strategic alliance with Serum Institute of India to strengthen its vaccine and biosimilar portfolio.
Dr. Reddy’s Laboratories launched biosimilars of Pegfilgrastim and Rituximab in select markets, reinforcing its oncology portfolio.
Intas Pharmaceuticals expanded its biosimilar offerings by investing in R&D and high-containment cleanroom manufacturing facilities, compliant with international GMP standards.
For a comprehensive understanding of biosimilar development and its role in modern pharmacology, readers may refer to Biosimilar on Wikipedia.
India Biosimilar Market Analysis
India’s biosimilar industry operates under the Biosimilar Guidelines established by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT). These guidelines, updated in 2016, brought Indian regulations closer to global standards set by the FDA and EMA.
Price sensitivity remains a key challenge in the Indian market, requiring companies to balance innovation, efficacy, and affordability. At the same time, clinical trials and pharmacovigilance are increasingly critical for market approval and trust-building.
Regulatory bottlenecks still exist, particularly for newer entrants lacking infrastructure or international experience. However, government incentives and collaborations with academic institutions are working to close the skill and innovation gap.
India Biosimilar Market Segmentation
By Product Class:
Monoclonal Antibodies
Recombinant Hormones
Immunomodulators
Anti-Inflammatory Agents
Others
By Manufacturing Type:
In-House Manufacturing
Contract Manufacturing
By Applications:
Blood Disorders
Growth Hormonal Deficiency
Chronic and Autoimmune Disorders
Oncology
Other Applications
This segmentation reflects the diversity of India’s biosimilar pipeline, addressing diseases with significant public health burdens and unmet treatment needs.
India Biosimilar Market Key Players
Key players in the India biosimilar market include:
Pfizer Inc.
Eli Lilly and Company
Celltrion Healthcare
Viatris Inc. (Mylan)
Novartis AG
Samsung Bioepis Co. Ltd.
Stada Arzneimittel AG
Teva Pharmaceutical Industries Ltd.
Intas Pharmaceutical Ltd.
LG Life Sciences Inc.
Biocon Limited
Amgen Inc.
Dr. Reddy's Laboratories
Coherus Biosciences Inc.
Biocad
These companies are investing heavily in biosimilar R&D, global clinical trials, and pharmaceutical cleanroom upgrades to meet regulatory expectations and patient demand.
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