COVER STORY
growth, solidifying its position as a global leader in the development and production of cost-effective biologic alternatives. Valued at approximately USD 550 million, the Indian biosimilars market is projected to grow at a compound annual growth rate( CAGR) of around 20 %, with expectations to cross USD 1 billion by 2027. This surge is being fueled by rising domestic demand, expanding exports, and increased acceptance of biosimilars in regulated markets.
India is home to more than 100 biosimilars approved for use, significantly more than many other countries. Key players such as Biocon Biologics, Dr. Reddy’ s Laboratories, Intas Pharmaceuticals, Zydus Lifesciences, and Cipla are at the forefront, contributing not only to the Indian market but also to global supply chains. In 2024, Biocon Biologics continues to expand its reach, especially after acquiring the biosimilars business of Viatris, strengthening its footprint in the US and Europe. Dr. Reddy’ s has also made significant headway with its oncology and immunology biosimilars in emerging and developed markets.
The regulatory ecosystem has matured, with the Central Drugs Standard Control Organization( CDSCO) aligning closer with international standards. The recent adoption of revised guidelines for biosimilar approvals, harmonized with the World Health Organization and EMA frameworks, has provided greater clarity and accelerated market entry for new products. Furthermore, the Indian government’ s Production Linked Incentive( PLI) scheme and investments under the National Biotechnology Development Strategy are incentivizing local production
and innovation.
Export growth remains a highlight in 2024, with Indian biosimilars gaining strong traction in Latin America, Southeast Asia, and Africa, and making steady inroads into the highly regulated US and EU markets. According to industry estimates, biosimilars account for nearly 10 % of India’ s total biopharma exports, a figure expected to grow rapidly in the coming years.
Overcoming Challenges
While the opportunities are immense, Indian pharmaceutical firms also face several challenges. The regulatory landscape for biosimilars is far more stringent than that for traditional smallmolecule generics. Agencies such as the U. S. Food and Drug Administration( FDA) and the European Medicines Agency( EMA) require extensive comparative studies to ensure biosimilars are as safe and effective as the original biologic drugs. This makes the approval process longer and costlier. Additionally, market dynamics pose a challenge. Unlike generic drugs, which rapidly gain market share once patents expire, biosimilars face resistance from both physicians and patients who may be hesitant to switch from well-established biologic therapies. Overcoming this hurdle will require aggressive marketing, physician education, and regulatory support.
Unlike small-molecule generics, biosimilars require extensive clinical trials to demonstrate similarity in efficacy and safety. The development cost of a biosimilar can range between $ 100-250 million, significantly higher than traditional
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BioVoiceNews | April 2025