India’s pharmaceutical industry is gearing up to tap into a significant opportunity, as the U.S. prepares to lose exclusivity on small-molecule drugs worth $63.7 billion between 2025 and 2029. According to a report by Antique Stock Broking, this represents a 65% increase over the previous five-year period.
$180 Billion LoE Opportunity by 2035
The report highlights that the broader Loss of Exclusivity (LoE) window across the U.S. and EU markets will reach $180 billion by 2035. This massive shift is set to fuel a surge in generic drug launches, creating fertile ground for growth—especially as Indian players expand their U.S. operations and leverage their expertise in complex generics.
Emerging Players and Complex Generics Gain Edge
Indian companies like Alembic Pharmaceuticals and Shilpa Medicare, which have smaller U.S. footprints, are well-positioned to gain share, particularly in the complex generics space. Larger players like Cipla and Lupin, who invested early in injectables and respiratory therapies, also stand to benefit as demand for differentiated, high-barrier products rises.
Indian Firms Step In as Global Giants Retreat
With global giants such as Teva, Viatris, and Sandoz scaling back operations and closing dozens of manufacturing sites since 2018, Indian drugmakers are stepping in to fill the supply gap. This shift is taking place alongside a growing strategic focus within the industry.
ANDA Filings Reflect Quality-over-Quantity Strategy
While the opportunity is vast, Indian drugmakers are approaching it with greater strategic discipline. U.S. Abbreviated New Drug Application (ANDA) filings have dropped 25% year-on-year, with FY25 expected to close at around 550 filings, down from 740 in FY24 and 857 in FY22. This signals a shift from volume-based growth toward portfolio quality, regulatory compliance, and margin sustainability.
India’s Export Strength and Regulatory Progress
“India’s pharma exports have grown from $15 billion in 2013–14 to nearly $28 billion in a decade,” said Nilaya Varma, Group CEO and Co-founder of Primus Partners. He emphasized that with over 750 USFDA-approved plants and growing strength in complex generics and biosimilars, India is poised to lead the next wave of affordable, high-quality medicines. He also noted that achieving the full potential of the $180 billion LoE opportunity will require sustained compliance and robust quality systems. Encouragingly, regulatory headwinds are easing. The share of USFDA inspections resulting in Official Action Indicated (OAI) for Indian firms has declined from 19% in 2013 to just 9% in 2023.
Cipla, Lupin, and Sun Pharma Lead the Charge
Cipla is actively de-risking its U.S. operations through multi-site manufacturing and digital quality systems. With 284 ANDA and NDA filings—175 approved and 73 under review—Cipla is intensifying its focus on commercialisation-ready products, including PEPFAR-approved generics. It is betting heavily on respiratory and injectable therapies to drive U.S. growth.
Lupin, meanwhile, is preparing to finalise its U.S. launch strategy for Etanercept, its blockbuster autoimmune biologic, closer to the drug’s 2029 patent expiry.
Business-standard.com reports that Sun Pharma, despite a cautious FY26 outlook amid global uncertainty, is aggressively expanding in oncology. The company expects its recent acquisition of UNLOXCYT (cosibelimab) to bolster U.S. revenue. Although it has factored Keytruda’s patent expiry into the deal, Sun remains confident that UNLOXCYT—targeting only one of Keytruda’s indications—will strongly contribute to its U.S. specialty portfolio. At the same time, Sun is advancing its immunotherapy pipeline through a global licensing deal with Philogen.
