Generic Semaglutide patent expiry opens over Rs 50,000 Crore opportunity for drugmakers: Report

The impending patent expiry of semaglutide drugs across India, emerging markets and select regulated markets such as Canada and Brazil is expected to unlock a revenue opportunity exceeding Rs 50 billion for generic drug manufacturers over the next 12-15 months, according to an industry update by Systematix Institutional Research.

The opportunity is likely to be shared among 10-15 Indian and global generic players. For FY27, incremental revenues are estimated at Rs 10-20 billion from India's branded formulations market, around Rs 45 billion from regulated markets like Canada and Brazil, and Rs 5-10 billion from emerging markets.

While regulated markets could see a sharp near-term upside, the opportunity there may moderate over time due to pricing pressure and competition, the report noted.

In India, the launch of generic semaglutide, expected in the first quarter of FY27, is projected to boost overall Indian Pharmaceutical Market (IPM) growth by 0.5-1%.

Prices are anticipated to be 30-50% lower than current levels initially, with the potential for deeper cuts of up to 70-75% over time. This is expected to significantly accelerate adoption of GLP-1 therapies among diabetics.

Market leadership within the GLP-1 segment is likely to remain concentrated among 5-10 players. At present, Alkem Laboratories, Dr. Reddy's Laboratories and Sun Pharma have secured regulatory approvals in India, while other players await clearance, the report noted.

Zydus Lifesciences is pursuing a differentiated injectable version, which could offer a competitive edge despite its relatively smaller diabetes franchise, it said.

In regulated markets, the combined semaglutide market in Canada and Brazil is estimated at nearly USD 2 billion annually. Assuming a 50% price erosion post-generic entry and 50% market share capture by generics, the addressable opportunity could be around USD 500 million.

However, analysts cautioned that success will depend heavily on timely regulatory approvals and competitive dynamics. Dr. Reddy's could emerge as the first Indian generic entrant in Canada, while Sun Pharma may enjoy a first-mover advantage in Brazil.

Emerging markets are expected to offer steadier, longer-term growth with comparatively lower regulatory risk. Companies such as Sun Pharma, Dr. Reddy's, Alkem, Biocon and OneSource Specialty Pharma are seen as better positioned to capitalise, aided by existing diabetes portfolios and partnerships.

Ancillary beneficiaries are also expected, including Shaily Engineering Plastics, a key global supplier of pen devices used in injectable therapies, which could see meaningful demand growth as generic launches scale up.