India Biosimilars Market Assessment, By Product Class, By Indication By Distribution Channel, By Region, Opportunities and Forecast, FY2019-FY2033F

India biosimilars market is projected to witness a CAGR of 19.89% during the forecast period FY2026-FY2033, growing from USD 1.51 billion in FY2025 to USD 6.44 billion in FY2033. The Indian biosimilars market is being propelled by the rising incidence of chronic and autoimmune diseases, coupled with increasing demand for affordable biologic therapies. Government support through favorable regulatory pathways and incentive schemes is encouraging domestic manufacturing and R&D. Additionally, strategic investments and global collaborations are strengthening India's position as a global biosimilar production and export hub.

For example, in April 2025, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, announced that the U.S. Food and Drug Administration had granted approval for Jobevne(TM) (bevacizumab-nwgd), a biosimilar version of Bevacizumab intended for intravenous administration. JOBEVNE is a recombinant humanized monoclonal antibody utilized in the treatment of various cancer types and is a biosimilar to the original product Avastin(R) (bevacizumab).

Growing Burden of Chronic and Autoimmune Diseases in India

India is witnessing a steep rise in the prevalence of chronic diseases such as cancer, chronic kidney disease, and cardiovascular ailments, along with infections requiring frequent hospitalizations. These conditions often demand long-term administration of medications, IV fluids, and blood transfusions, significantly increasing the demand for biosimilars. Conditions such as cancer, rheumatoid arthritis, diabetes, and inflammatory bowel disease are becoming more prevalent due to lifestyle changes, aging population, and genetic factors. Biosimilars provide a cost-effective alternative to biologics, improving accessibility for the Indian population, especially within the public healthcare system. With the rising financial burden of chronic illnesses, biosimilars offer sustainable treatment pathways for both patients and healthcare providers. This trend is prompting Indian pharmaceutical companies to invest heavily in biosimilar R&D and manufacturing. This broad healthcare push, combined with higher patient volumes and increasing disease burden, is driving consistent growth in the demand for biosimilars across India. The burden of noncommunicable diseases (NCDs) has overtaken that of infectious diseases in India. An estimated 5.8 million Indians lose their lives to NCDs annually, and one in four Indians are at danger of passing away before turning 70. The World Health Organization (WHO) estimates that NCDs cause nine million deaths a year in Southeast Asia, or 62% of all deaths. The high rate of premature fatalities, or deaths that happen before the age of 70, associated with NCDs is a serious concern.

Supportive Government Regulations and Policies for Biosimilar Development

The Indian government's favorable regulatory framework is a critical enabler of biosimilar market growth. India was among the first countries to implement specific guidelines for biosimilars (2012, updated in 2016), ensuring a streamlined pathway for clinical trials, approvals, and commercialization. The regulatory clarity and cost advantages attract both domestic and international pharmaceutical players to invest in the Indian biosimilar space. Moreover, initiatives such as the 'Pharma Vision 2020' and production-linked incentives (PLI) schemes encourage indigenous manufacturing and R&D in biosimilars. These frameworks foster innovation and improve affordability for the local population, enhancing market penetration and competition. In December 2024, the Department of Pharmaceuticals (DoP) announced an extension of its PLI scheme to include biosimilar manufacturers under its funding umbrella, offering financial incentives to boost domestic capabilities and global competitiveness.

Increasing Investments and Collaborations in Indian Biosimilar Landscape

India's biosimilar market is rapidly expanding due to rising domestic and foreign investments, joint ventures, and strategic collaborations. Global companies are partnering with Indian manufacturers to capitalize on cost-efficient production, skilled workforce, and a strong distribution network. These collaborations foster technology transfer, accelerate clinical development, and improve product availability. Local players are also scaling up manufacturing facilities and enhancing their biologics portfolios. Moreover, biosimilars developed in India are increasingly being approved and marketed in international markets, establishing India as a global hub for biosimilar production. CuraTeq Biologics, a division of Aurobindo Pharma, intends to introduce a minimum of 10 biosimilar products by the year 2031, as stated by the company's chief executive. 'Achieving the launch of four products, which will enter the commercial phase in the July quarter, marks a significant milestone for us during this six-year journey,' remarked Satakarni Makkapati, CEO of biologics, vaccines, and peptides at Aurobindo Pharma, in an exclusive interview with ET NOW at the company's facility located near Hyderabad. 'Curateq and Aurobindo are set to release at least 10 products into the market by 2031.'

Future Market Scenario (FY2026 - FY2033F)

The India biosimilars market is poised for robust growth over the coming years, driven by a confluence of rising chronic disease prevalence, increased healthcare spending, and supportive regulatory policies. As demand for cost-effective biologic therapies grows, biosimilars are expected to play a pivotal role in enhancing treatment accessibility, especially for oncology and autoimmune diseases. Domestic pharmaceutical firms are expanding manufacturing capacities and pursuing global regulatory approvals, reinforcing India's role as a major biosimilar hub. Additionally, international collaborations, government-backed incentives, and the evolving biologics pipeline will continue to fuel innovation. With improving awareness and affordability, biosimilars are set to become a mainstream component of India's therapeutic landscape, especially in public healthcare settings.

Key Players Landscape and Outlook

Key players in the biosimilars industry utilize strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing big-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For instance, the pharmaceutical company USV, in collaboration with the biotechnology firm Biogenomics, introduced INSUQUICK, the first biosimilar Insulin Aspart in India, aimed at enhancing accessibility for individuals with diabetes. InsuQuick is a product of the 'Make in India' initiative, developed and produced utilizing entirely domestic technology, and has completed a comprehensive clinical program to meet international quality standards.