“The steps come at a time when India is expected to double its biologics and biosimilar markets to a projected $30–35 billion by 2030 from the current $14–16 billion,” said Sheetal Sapale, vice-president (commercial) at Pharmarack.
Measures such as the Rs 10,000 crore Biopharma Shakti initiative, she said, are expected to boost domestic production of biologics and biosimilars and reduce import dependence.
“Most biologics available in India are monoclonal antibodies, used for oncology, autoimmune diseases and cardiology-related therapies. These molecules are very popular as they have a selective mode of action which targets the root cause of the disease,” Sapale said.
An increase in research and development (R&D), supported by Budget measures such as Biopharma Shakti, is expected to bring the cost of biologics down by a considerable margin.
Giving the example of the bone health drug denosumab, Sapale said the molecule was initially introduced in India as Prolia by US-based Amgen in partnership with Dr Reddy’s at around Rs 35,000.
“With a lot of biosimilars coming into the market, the price for denosumab-based drugs has gone down to Rs 8,000, thereby increasing access to these drugs for the masses who require them,” she added.
The mission also aims at strengthening India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), with dedicated scientific review cadres and specialist expertise to speed up approvals and align with global standards.
With a significant part of the Budget’s pharma push focusing on building research and clinical infrastructure, Sapale said the move supports not only manufacturing but also innovation and early-stage drug development, which historically has lagged in bench-to-market transitions in India.
Analysts indicate that the government is aiming to underwrite the entire biopharma value chain, with at least 30 major patent expiries over the next eight years unlocking entry opportunities for biosimilars.
“This will complement the increasing demand for such therapies due to the rising burden of chronic diseases and preference for oncology treatments,” Sapale said.
She added that beyond strategic funding, the Budget also touches on a couple of direct market boosters.
These include customs duty exemptions on 17 cancer and rare disease drugs and a focus on easier regulatory pathways through a strengthened CDSCO, which could improve timelines and reduce compliance costs.
“These steps could translate into lower prices for end consumers and improved profitability for players focusing on complex therapeutics,” Sapale said.
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