The India biosimilar market is witnessing significant momentum as the nation becomes a global hub for cost-effective biologic alternatives. With an increasing burden of chronic diseases such as cancer, diabetes, and autoimmune disorders, the demand for affordable biologic therapies has surged. In 2024, the market was valued at INR 4.37 billion and is projected to grow at an impressive CAGR of 14.20% during 2025–2034, reaching INR 16.49 billion by 2034.
The biosimilar industry’s growth is driven by supportive government policies, advances in biotechnology, and India’s growing biomanufacturing capabilities. The rise in healthcare expenditure, combined with a growing focus on expanding access to biologics, positions India as one of the fastest-growing biosimilar markets globally.
Overview of the India Biosimilar Market
Biosimilars are biological products highly similar to approved reference biologics, offering equivalent therapeutic efficacy and safety at lower costs. They play a vital role in enhancing treatment accessibility for life-threatening diseases such as oncology, autoimmune disorders, and blood-related conditions.
India has become one of the leading producers of biosimilars, supported by a robust biopharmaceutical ecosystem and affordable clinical trial capabilities. With more than 100 approved biosimilars already in the domestic market, India holds a unique position in the global biosimilar landscape.
Government initiatives like “Make in India”, favorable regulatory frameworks, and the National Biopharma Mission have propelled R&D efforts and encouraged domestic companies to scale production.
India Biosimilar Market Size and Share Analysis
The India biosimilar market has shown steady expansion, with strong performance across multiple product segments.
2024 Market Size: INR 4.37 billion
2034 Projected Size: INR 16.49 billion
CAGR (2025–2034): 14.20%
Monoclonal antibodies and recombinant hormones lead the market, driven by their extensive use in oncology and autoimmune therapy. Domestic manufacturers such as Biocon, Dr. Reddy’s Laboratories, and Intas Pharmaceuticals dominate the Indian landscape with a growing global footprint.
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Market Dynamics and Trends
Key Drivers
Rising Prevalence of Chronic Diseases: Increasing cases of cancer, rheumatoid arthritis, and diabetes are driving biosimilar adoption across India.
Government Support and Regulatory Reforms: Simplified approval processes and clinical trial guidelines have accelerated biosimilar development.
Cost Advantage and Accessibility: Biosimilars are priced significantly lower than originator biologics, making them an affordable option for patients.
Expanding Biomanufacturing Capacity: Indian pharmaceutical companies are investing heavily in biologics manufacturing infrastructure to meet both domestic and export demands.
Emerging Trends
Growing focus on biosimilar export opportunities in Europe, Asia-Pacific, and Latin America.
Increased collaboration between Indian firms and global biotech companies.
Rising adoption of digital platforms for clinical research and manufacturing quality control.
Surge in public-private partnerships to enhance biopharma innovation and training.
India Biosimilar Market Segmentation
By Product Class
Monoclonal Antibodies
Recombinant Hormones
Immunomodulators
Anti-Inflammatory Agents
Other Product Classes
Monoclonal antibodies hold the largest market share, primarily due to their therapeutic applications in oncology and autoimmune diseases. Recombinant hormones are also gaining traction with increased use in growth and fertility disorders.
By Manufacturing Type
In-House Manufacturing
Contract Manufacturing
In-house manufacturing dominates the Indian biosimilar market as major players invest in advanced production facilities to maintain cost efficiency and quality control. However, contract manufacturing organizations (CMOs) are gaining ground as smaller companies outsource production to reduce operational costs.
By Application
Blood Disorders
Growth Hormone Deficiency
Chronic and Autoimmune Disorders
Oncology
Other Applications
Oncology is the largest application segment in India’s biosimilar market, owing to the growing incidence of cancers such as breast, colorectal, and lung cancer. Biosimilars are increasingly used for chemotherapy support and targeted immunotherapy. Autoimmune disorders such as rheumatoid arthritis and psoriasis are also key growth areas due to rising awareness and diagnosis rates.
Market Growth and Opportunities
The India biosimilar market offers vast opportunities for both domestic and international players.
Key Opportunities
Export Expansion: Indian biosimilars are gaining regulatory approvals in emerging markets and developed economies, enhancing export revenues.
Collaborative R&D Models: Partnerships between biotech firms and academic institutions are fueling innovation and product development.
Biopharma Infrastructure Growth: The establishment of specialized biotech parks and manufacturing hubs is boosting production capabilities.
Patent Expirations: The expiry of several blockbuster biologic patents provides lucrative opportunities for biosimilar development.
Challenges in the India Biosimilar Market
Despite promising growth, the market faces several challenges:
Regulatory Complexity: Ensuring biosimilarity in efficacy and safety requires rigorous clinical testing and compliance.
Awareness Gap: Many physicians and patients remain unaware of biosimilar benefits and efficacy.
High Development Costs: Despite being more affordable than biologics, biosimilar R&D still involves significant investment.
Global Competition: Indian manufacturers face tough competition from global biosimilar producers in pricing and quality.
Addressing these challenges through education programs, R&D funding, and global quality alignment will be key to sustaining market growth.
Regional Insights
Biosimilar production and usage are expanding across India’s key regions, supported by biopharma clusters and government incentives.
South India: Leads the market with strong biotech infrastructure in Hyderabad, Bengaluru, and Chennai.
Western India: Home to major pharmaceutical manufacturing facilities in Gujarat and Maharashtra.
North India: Emerging as a key clinical research and development hub with growing investment inflows.
Competitive Landscape: Key Players in the India Biosimilar Market
The India biosimilar market is moderately consolidated, with a mix of domestic and multinational players actively expanding their portfolios. Leading companies 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
Indian companies like Biocon, Dr. Reddy’s, and Intas are global pioneers in biosimilar manufacturing, exporting products to regulated markets such as the EU and U.S. Their collaborations with international players have enhanced product accessibility and technological advancement.
Future Outlook
The future of the India biosimilar market looks highly promising. The combination of strong domestic demand, expanding R&D infrastructure, and global regulatory approvals will accelerate India’s emergence as a biosimilar innovation hub. Moreover, rising healthcare access, combined with digital and AI-driven clinical trials, will further streamline biosimilar development and distribution.
By 2034, India is expected to not only dominate the domestic market but also emerge as a global exporter of affordable, high-quality biosimilars, bridging the accessibility gap in biologic therapies.
Frequently Asked Questions (FAQs)
1. What is the current size of the India biosimilar market?
The India biosimilar market was valued at INR 4.37 billion in 2024 and is projected to reach INR 16.49 billion by 2034, growing at a CAGR of 14.20% during 2025–2034.
2. What factors are driving the growth of the India biosimilar market?
Key drivers include the rising prevalence of chronic diseases, favorable government regulations, and affordable manufacturing capabilities that position India as a biosimilar powerhouse.
3. Which product class dominates the India biosimilar market?
Monoclonal antibodies dominate due to their increasing applications in oncology and autoimmune disorders, followed by recombinant hormones.
4. How are Indian pharmaceutical companies contributing to global biosimilar growth?
Companies like Biocon, Dr. Reddy’s Laboratories, and Intas Pharmaceuticals are exporting biosimilars globally, expanding access to affordable biologic treatments.
5. What are the major challenges facing the biosimilar industry in India?
Key challenges include regulatory hurdles, awareness gaps, high R&D costs, and competition from international manufacturers.
