Press release
India Biosimilar Market to Hit INR 16.49 Bn by 2034, CAGR 14.2%
The India biosimilar market has been witnessing rapid expansion due to the rising burden of chronic diseases, increasing demand for affordable biologics, and growing acceptance of biosimilar therapies among physicians and patients. In 2024, the market was valued at INR 4.37 billion, and it is projected to grow at a CAGR of 14.20% between 2025 and 2034, reaching INR 16.49 billion by 2034.
The surge is primarily fueled by India's strong manufacturing capabilities, government initiatives to promote biologics, and the expiration of several blockbuster biologic patents that open the door for biosimilar entry. Moreover, the cost-effectiveness of biosimilars compared to branded biologics is making them increasingly attractive in India's healthcare ecosystem.
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India Biosimilar Market Trends and Opportunities
Rising Demand for Cost-Effective Biologics
Biologics have transformed the treatment of cancers, autoimmune diseases, and hormonal disorders, but their high prices restrict patient access. Biosimilars, being lower-cost alternatives, are bridging this gap in India.
Patent Expiry of Blockbuster Drugs
The expiration of patents for drugs like Humira, Avastin, and Herceptin has created opportunities for Indian pharmaceutical firms to launch biosimilars and capture market share.
Government and Regulatory Support
India's regulatory framework is evolving to streamline biosimilar approvals while ensuring safety and efficacy. The Drugs Controller General of India (DCGI) and other authorities are actively promoting local production.
Investments and Collaborations
Indian firms are collaborating with global pharmaceutical leaders to strengthen biosimilar R&D and manufacturing capabilities. Partnerships and contract manufacturing agreements are boosting the supply chain.
India Biosimilar Market Segmentation
By Product Class
Monoclonal Antibodies (mAbs): The fastest-growing category, widely used in oncology and autoimmune disorders.
Recombinant Hormones: Includes insulin, growth hormones, and erythropoietin, critical for diabetes and endocrine disorders.
Immunomodulators: Growing adoption in chronic inflammatory conditions.
Anti-Inflammatory Agents: Rising prevalence of rheumatoid arthritis and related conditions is driving demand.
Other Product Classes: Covers a broad range of biosimilar therapies for various indications.
By Manufacturing Type
In-House Manufacturing: Preferred by large Indian pharma companies like Biocon and Dr. Reddy's due to cost and control benefits.
Contract Manufacturing: Gaining traction among smaller firms to reduce capital investment and speed up market entry.
By Application
Blood Disorders: Includes biosimilars for hemophilia, anemia, and related conditions.
Growth Hormonal Deficiency: Strong demand due to pediatric and adult growth-related disorders.
Chronic and Autoimmune Disorders: A rapidly growing segment due to rising cases of rheumatoid arthritis, psoriasis, and lupus.
Oncology: The largest and most lucrative application, driven by the increasing cancer burden in India.
Other Applications: Covers neurological, metabolic, and rare diseases.
Competitive Landscape of the India Biosimilar Market
India has become a global hub for biosimilar development, with companies expanding both domestic and international footprints.
Key Players
Biocon Limited: India's leading biosimilar company, exporting to the US and Europe.
Dr. Reddy's Laboratories: Strong portfolio in oncology and autoimmune therapies.
Intas Pharmaceuticals: Expanding presence in monoclonal antibodies and contract manufacturing.
Pfizer Inc. and Eli Lilly: Collaborating with Indian partners to strengthen market access.
Novartis AG and Celltrion Healthcare: Global leaders with a strong focus on Indian distribution.
Samsung Bioepis, Amgen Inc., and Coherus Biosciences: Increasing investments in partnerships with Indian pharma.
The competitive landscape is expected to intensify as patent expiries open more opportunities for biosimilar launches.
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Regional Outlook of the India Biosimilar Market
North India
Strong growth driven by the presence of pharma manufacturing hubs, research institutions, and high patient population.
South India
A hub for biotech innovation with companies like Biocon and Dr. Reddy's headquartered in the region. Bengaluru and Hyderabad lead in R&D and clinical trials.
Western India
Pune and Mumbai act as central nodes for pharma exports and collaborations.
Eastern India
Emerging market with potential for expansion as healthcare infrastructure improves.
Challenges in the India Biosimilar Market
Regulatory Hurdles: Despite progress, biosimilar approvals in India remain complex.
Physician and Patient Awareness: Limited understanding of biosimilars compared to generics.
Price Pressures: While biosimilars are cheaper than biologics, intense competition squeezes profit margins.
R&D Costs: Developing biosimilars requires significant investment in clinical trials and manufacturing.
Future Outlook of the India Biosimilar Market
The India biosimilar market is poised for strong growth, backed by rising healthcare demand, affordability concerns, and India's proven capabilities in large-scale pharmaceutical production. Between 2025 and 2034, oncology and autoimmune biosimilars will dominate the market, while collaborations with global companies will further boost innovation.
The future will also see greater penetration into rural India, expansion of online pharmacy distribution, and increased adoption of contract manufacturing for exports.
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