Nearly $300 billion worth of blockbuster biologic drugs are set to lose patent protection by 2030, giving India a rare opportunity to move up the global pharma value chain, said a report from NITI Aayog which calls for a strategic shift from conventional generics to biologics, biosimilars and AI-driven drug discovery.
The report predicts that the global biosimilars market will grow at a 17% compound annual growth rate (CAGR), far outpacing the 2% growth expected in traditional generics, while noting that 40% of medicines sold globally will be biologics by 2035. The policy think-tank has also estimated that even capturing 1% of the global biosimilar market – currently valued at $73-76 billion – could generate annual revenues of around Rs 6,400 crore for India by 2030.
To capitalise on this opportunity, NITI Aayog has suggested a dedicated BioPharmaNext mission to position India as a global hub for affordable biologics, biosimilars, monoclonal antibodies, vaccines and cell and gene therapies by 2035. It has argued that India’s pharma industry must evolve beyond its long-standing dependence on generic medicines and transition towards innovation-led biopharmaceutical manufacturing.
“BioPharmaNext should build on the Rs 10,000 crore Biopharma SHAKTI outlay and the network of 3 new National Institutes of Pharmaceutical Education and Research (NIPER) to drive this commercial ambition with institutional depth,” the report stated.
Harnessing AI
Further, it recommends deploying AI across the pharma value chain and creating an exclusive regulatory sandbox for biologics, gene therapies and AI-designed drugs. By deploying AI-driven drug discovery, large-scale genomics, BioDigital Twins and automated Design-Build-Test-Learn (DBTL) engines, the report estimated that the drug development time can be curtailed by 60-80% in addition to the reduction in research costs by 20-30%.
Additionally, NITI Aayog has flagged concerns around regulatory approvals as the average time to obtain such approvals take around 900 days in India compared to about 500 days in peer countries. To remove some of the structural bottlenecks, the report suggests setting up of five integrated bio-innovation clusters with shared GMP (good manufacturing practices) facilities, and high-performance computing centres to support AI-enabled drug development.
Scaling Beyond Pharma
Beyond pharma, the roadmap has laid out an ambitious vision for India’s bioeconomy, projecting it to expand from $195.3 billion in 2025 to $691 billion by 2035, contributing 5-6% of GDP. The BioPharma segment alone is projected to grow from $129.4 billion in 2030 to $228 billion by 2035, and further to $857 billion by 2047, driven by precision medicines, monoclonal antibodies, biosimilars, mRNA therapies, CAR-T therapies and fermentation-based APIs.
To support the bio-economy growth, NITI Aayog has also proposed a Rs 50,000-crore BioEconomy growth fund for 2026-35 to bridge the gap between lab research and commercial-scale manufacturing. “A central proposal is the creation of a Rs 50,000-crore BioEconomy Growth Fund to close India’s most dangerous gap – the “valley of death” between proof-of-concept and manufacturing at scale,” it said.
