India's $1.2B BioPharmaNext bid targets $300B patent cliff by 2030

India laid out plans Thursday for BioPharmaNext, a government mission to turn the country into a global hub for advanced biologic medicines by 2035. The NITI Aayog report backing the initiative estimates biologic drugs worth $300 billion will lose patent protection by 2030, opening a window for Indian companies to capture a slice of the biosimilar market.

The mission runs on the ₹10,000-crore Biopharma SHAKTI programme announced in the Union Budget 2026-27. It will focus on gene therapies, cell therapies, monoclonal antibodies, and AI-designed drugs. Four government bodies will lead the effort: the Department of Biotechnology, the Department of Pharmaceuticals, the Ministry of Health, and the drug regulator CDSCO.

For Indian pharma companies with biosimilar pipelines, the patent cliff represents a material revenue opportunity. The report says capturing just 1% of the global biosimilar market, expected to hit $73–$76 billion by 2030, could generate about ₹6,400 crore a year. Dr. Reddy's Laboratories and Sun Pharmaceutical Industries, both of which have biosimilar programs for oncology and autoimmune diseases, stand to benefit if the mission delivers on its timelines.

The same report flags several hurdles that could slow the payoff. Regulatory approvals in India currently take around 900 days, nearly double the 500-day benchmark in competing countries. Clinical trial infrastructure is limited. There is a shortage of researchers trained in biotechnology and computational biology. High-performance computing capacity for AI-based drug discovery is also insufficient, the report notes.