India’s Biosimilars Boom: Growth Drivers and its Impact

With over 20% market share by volume of total pharmaceutical exports in the world and being the largest vaccine supplier in the world with more than 60% of all vaccines manufactured globally, the Indian pharmaceutical industry is one of the biggest in the world. In FY25, the Indian pharmaceutical industry was valued at Rs. 4,71,075 crore (US$ 55 billion) and is forecasted to reach Rs.1,13,450 crore (US$ 130 billion) by 2030.

Generic drugs along with active pharmaceutical ingredients (API) helped India gain recognition in the global pharmaceutical industry. In recent years biosimilars and biologics have become the front runners in the industry. India was the first to approve a biosimilar back in 2000 for the treatment of Hepatitis B, much before Europe and the US. Biologics and their potential in treating diseases such as certain types of cancer, autoimmune disorders, or rare genetic conditions have changed the face of healthcare around the world. India with its robust biotech and information technology sectors, has embraced this shift and is making significant improvements in developing and manufacturing biological medicines.

What are Biosimilars?

A Biosimilar is a medicine that is remarkably close in structure and functions to an existing biologic medicine. The original biologic medicine is a reference point and has already been approved for use in the US. Biosimilars are developed based on these reference points after the patents of the original drugs expire, leading to lower prices. This makes essential treatments more affordable and accessible to a wider range of patients.

Market overview

Over the past decade, the journey of Indian biotech industry has been transformational, making it a sunrise industry for the Indian economic sector. The Indian biotech industry includes 800 companies, records the second highest number of United States Food and Drug Administration (USFDA) approved plants and has seen remarkable growth, expanding from Rs. 85,650 crore (US$ 10 billion) in 2015 to Rs. 8,69,348 crore (US$ 101.5 billion) in 2024. Increasing Indian government expenditure, supportive policies, rising exports, and a skilled workforce are the major factors behind the growth of biotech industry.

Despite the economic uncertainties and post-covid slump in recent years, biotech companies have proved adaptability throughout the period. Biosimilar market in India was valued at approximately Rs. 437 crore (US$ 51 million) (as of May 2025) and is estimated to grow around Rs. 1,649 crore (US$ 192.5 million) by 2034 with a compounded annual growth rate (CAGR) of 14.2%.

Growth drivers

By 2020, many key biologic patents were expired which gave an opportunity for Indian pharmaceutical companies to develop biosimilars. As India being regarded as the global pharmacy of the world with its large supply of high quality yet affordable generic medicines, it quickly gained the same reputation in the biosimilar fields. With favourable labour laws, low production costs and lots of skilled workforce India became a formidable contender in the global biotech space. Some of the growth drivers include:

• Surging chronic & autoimmune disease loads

  India is grappling with increasing rates of cancer, diabetes, rheumatoid arthritis, cardiovascular and chronic kidney diseases. These conditions demand long-term, biologic-based treatments. With the disease burden climbing, biosimilars offer an affordable and scalable alternative compared to originator biologics

• Cost-effective manufacturing & skilled workforce

  Indian companies benefit from low production costs and ample technical talent. Manufacturing hubs and contract development/production organizations (CDMOs) have become highly competitive, attracting both domestic and global clients.

• Government policies & incentive programs

  Initiatives like the Biotechnology Industry Partnership Program and the Production Linked Incentive (PLI) scheme provide financial support, streamlined approvals, and a policy ecosystem encouraging biosimilar R&D and local production.

• Favourable regulatory pathways & global approvals

  India’s biosimilar guidelines are now well-aligned with international norms, enabling exports and approvals in regulated markets like the EU, UK, US—including recent FDA nods (e.g., Biocon’s bevacizumab biosimilar).

• Rising domestic healthcare spending and awareness

  With growing literacy, health insurance uptake, and disposable income, Indian patients are increasingly opting for biosimilars—driven by both affordability and accessibility.

Key market players

India boasts an impressive feat of having over 135 approved biosimilars in its domestic portfolio, a feat unrivalled by any other nation. The industry is characterized by a legion of pharmaceutical entities including Sun pharma, Biocon, Zydus Cadila, Reliance Life Sciences, Lupin Pharma, Intas Biologicals, Wockhardt, and others dominating the Indian pharmaceutical scene since decades.

Biocon is among the few companies globally to have received approvals for its biosimilars from major players like the US, Europe, Australia, and Japan. Biocon’s credibility as a serious competitor in the market was first set up with the Japanese approval for Insulin Glargine.

Recently, Biocon gained USFDA approval for Yesafili which is a significant milestone in ophthalmology treatment.

Opportunities

Biosimilars producers globally deal with several patent related issues, including patent litigation and the challenge of developing a biosimilar product before the product’s patent expires. This results in reduced production and causes delay in introducing the product to the market. This affects the profitability of companies and discourages them from investing in development of new biosimilars. In addition, the novelty of biologics and biosimilar development process makes it difficult for new companies to enter this space. To counter this, various regulatory changes and schemes have been introduced in the India biosimilar sphere.

The Indian government have launched various initiatives to foster and grow various biotechnical and pharmaceutical projects in India.

Biotechnology Industry Research Assistant Council (BIRAC) a not-for-profit organisation setup under department of biotechnologies offer funding assistance through various initiatives like:

• Biotechnology Ignition Grant (BIG)
• Sustainable Entrepreneurship and Enterprise development (SEED)
• Launching Entrepreneurial Driven Affordable products (LEAP)
• Intensifying the Impact of Industrial Innovation (i4)
• Promoting Academic Research Conversion to Enterprise (PACE)

These schemes help micro, small to medium enterprises (MSME) to refine their ideas, establish proof of concepts, pilot, patent and commercialize their products and technologies. As of June 30, 2024, the department for promotion of industry and internal trade (DPIIT) has recognized a total of 1,40,803 entities as startups of which 2,127 were set up in pharmaceutical sector.

Way forward

India has proven remarkable leadership in the biotech sphere leveraging its extensive pharmaceutical expertise and robust generic medical sector. Supported by government initiatives and a growing market, India’s biosimilar industry is equipped for continued growth and innovation. With emerging trends like gene-editing, precision medicine, bio manufacturing, synthetic biology, and the role of artificial intelligence in biotechnology, the potential for growth is immense. Indian manufacturers have already embarked on building world class manufacturing facilities and generating value through Contract development and manufacturing organization (CDMO). This would place India as a high quality and affordable biosimilar producers for the world. This growth trajectory is due to increasing domestic demand, bigger investments in biotech, and rapidly growing opportunities for exports to foreign markets. Going forward, the ability to develop treatments for chronic illnesses such as cancer, diabetes, depression, and various other cardiovascular diseases would be crucial. Between 2025 and 2032 over 39 high value biologic patent are due for expiry. This impending patent cliff also presents a significant opportunity for biosimilar companies worldwide. With Indian companies scaling up and investing heavily in research and development the future for Indian biosimilar market looks promising.