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Informist, Tuesday, Oct. 6, 2026

 

HYDERABAD – India's biosimilar market is projected to reach $2.1 billion by 2030, growing at around 22% compounded annually and outpacing global market growth as a wave of biologic patent expiries creates a large opportunity for drugmakers, according to a report by Anand Rathi Investment Banking. The global biosimilar market is expected to reach $100 billion by 2030, growing 21% compounded annually from 2024, while the broader large-molecule market is projected to reach $900 billion. More than 40 biologics are expected to lose exclusivity by 2035, with the largest wave falling between 2028 and 2033, the report said.

 

The 2028–33 patent-expiry wave is expected to drive the next phase of growth, although biosimilar adoption is likely to build gradually. The report estimates global biosimilar sales could reach $64 billion by 2028 and expects the impact of the largest patent expiries to peak around 2033.

 

Around $99.9 billion of biologic sales is exposed to loss of exclusivity by 2033, led by Keytruda, the immune therapy drug used in cancer treatment, at $25 billion, the weight loss drug Ozempic at $13.9 billion, and Eliquis, used to treat pulmonary embolism, at $12 billion. The report expects the impact of the next major patent wave to build gradually, with the peak revenue opportunity around 2033 rather than immediately after expiry.

 

India's pharmaceutical market was valued at around $66 billion in 2024-25 (Apr-Mar), while its broader biopharma market, including biologics, biosimilars, vaccines, and cell and gene therapies, stood at $14.1 billion, Anand Rathi said. Indian companies can develop biosimilars at 50–65% of the US cost base, while the country benefits from manufacturing scale, regulatory experience, and a large talent pool. India supplies around 20% of global generic volumes and has the second-highest number of US Food and Drug Administration-approved manufacturing plants globally.

 

The country's biosimilar capabilities were largely led by companies such as Biocon Ltd., Zydus Lifesciences Ltd., Dr. Reddy's Laboratories Ltd., Lupin Ltd., Cipla Ltd., and Intas Pharmaceuticals Ltd. India also approved the world's first biosimilar for Hepatitis-B in 2000.

 

Policy support is expected to further strengthen the sector, with the Union Budget 2026-27 laying out the $1-billion Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation) initiative and the production-linked incentive scheme extended to biosimilar makers till FY28.

 

The report said three of the six recent global biosimilar-related deals identified by Anand Rathi were aimed at acquiring Indian capabilities, indicating that global companies are increasingly looking beyond India's cost advantage towards its development, manufacturing, and regulatory capabilities. Recent transactions, which include Fresenius Kabi's agreement with Dr. Reddy's for US rights to Rituximab, which is used to treat multiple sclerosis, Amneal Pharmaceuticals Inc.'s acquisition of Kashiv BioSciences Pvt. Ltd., STADA's partnership with Aurobindo Pharma Ltd. arm CuraTeQ Ltd., and Biocon's $3.3-billion acquisition of Viatris Inc.'s global biosimilars business, show India's growing importance in the sector, the report said.

 

Dr. Reddy's has also entered into co-development arrangements with Bio-Thera Solutions Ltd. and Alvotech SA, while Indian companies including OneSource Specialty Pharma Ltd. and Mankind Pharma Ltd. have pursued partnerships and in-licensing arrangements to expand their biosimilar portfolios.

 

Anand Rathi expects the biosimilar opportunity to build in phases. In the near term, policy support and capacity investments are likely to strengthen India's manufacturing base, while complex molecules such as semaglutide could demonstrate Indian companies' ability to develop products beyond conventional generics.

Over the longer term, the report expects regulatory approvals, global partnerships and GMP manufacturing capacity, rather than cost advantage alone, to determine which companies capture the opportunity. Pricing pressure from increasing competition and the rising cost of participating in multiple regulatory markets remain key risks, the report said.  End

 

US$1 = INR 96.42

 

Reported by Narayana Krishna

Edited by Shubhayan Bhattacharya

 

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