Semaglutide Patent Expiry to Unlock Rs 50,000 Cr Generic Drug Opportunity
Generic Semaglutide to Create Rs 50,000 Cr Market

A major shift is on the horizon for the global pharmaceutical industry and diabetes care. The impending expiration of patents for semaglutide drugs, widely used for diabetes and weight management, is set to unlock a colossal revenue opportunity exceeding Rs 50 billion for generic drug manufacturers. This windfall is expected to materialize over the next 12 to 15 months, according to a detailed industry update by Systematix Institutional Research.

A Multi-Billion Dollar Opportunity Across Markets

This substantial financial opportunity is projected to be shared among approximately 10 to 15 Indian and global generic pharmaceutical players. The revenue streams are segmented across different markets. For the financial year 2027 (FY27), analysts estimate incremental revenues of Rs 10 to 20 billion from India's own branded formulations market. Regulated markets such as Canada and Brazil are expected to contribute a significant Rs 45 billion, while other emerging markets could add another Rs 5 to 10 billion.

The report notes that while regulated markets may experience a sharp, near-term surge, this upside could moderate over time due to intense competition and subsequent pricing pressure. In contrast, emerging markets are anticipated to offer steadier, long-term growth with relatively lower regulatory hurdles.

Impact on the Indian Pharmaceutical Market and Patients

The launch of generic semaglutide in India, currently projected for the first quarter of FY27, is a landmark event. It is forecast to boost the overall growth of the Indian Pharmaceutical Market (IPM) by 0.5% to 1%. Most importantly, it promises to revolutionize treatment accessibility for millions of diabetics.

Prices for the therapy are expected to drop dramatically, starting at 30% to 50% lower than current branded levels. Over time, this price erosion could deepen to cuts of up to 70% to 75%. Such a significant reduction in cost is predicted to massively accelerate the adoption of GLP-1 therapies across the country, making advanced diabetes management more affordable.

Within India's GLP-1 segment, market leadership is likely to remain with a focused group of 5 to 10 players. Currently, companies like Alkem Laboratories, Dr. Reddy's Laboratories, and Sun Pharma have already secured regulatory approvals. Others are awaiting clearance. Notably, Zydus Lifesciences is developing a differentiated injectable version, which could provide a competitive advantage despite its smaller presence in the diabetes segment.

Global Dynamics and Key Players

The combined semaglutide market in the two key regulated markets of Canada and Brazil is estimated at nearly USD 2 billion annually. The analysis assumes a scenario with 50% price erosion after generic entry and generics capturing 50% market share, creating an addressable opportunity of roughly USD 500 million. Success, however, hinges on timely regulatory approvals and navigating competitive landscapes. Dr. Reddy's is positioned to potentially be the first Indian generic entrant in Canada, while Sun Pharma may secure a first-mover advantage in Brazil.

For the emerging markets, companies with strong existing diabetes portfolios and partnerships are seen as best positioned. This includes firms like Sun Pharma, Dr. Reddy's, Alkem, Biocon, and OneSource Specialty Pharma.

The ripple effects of this generic wave will extend beyond drug manufacturers. Ancillary businesses, such as Shaily Engineering Plastics—a key global supplier of pen devices for injectable therapies—are also poised to benefit from meaningful demand growth as production of generic versions scales up worldwide.