The global pharmaceutical industry is bracing for a massive patent cliff by 2030, with multiple blockbuster drugs set to lose market exclusivity. According to GlobalData’s report, Blockbuster Drugs on Patent Cliffs, this looming wave of expirations will trigger intense biosimilar and generic competition, eroding prices—particularly in key therapy areas like oncology—and putting over $230 billion in U.S. market value at risk between 2025 and 2030.

Historical precedents such as the loss of exclusivity for Pfizer’s Lipitor and Merck’s Cozaar/Hyzaar have shown how quickly market dominance can diminish. Now, oncology blockbusters like Merck’s Keytruda and Johnson & Johnson’s Darzalex are slated to lose exclusivity by 2029, with Keytruda alone generating over $29 billion in 2024. Though these drugs may remain among the top 10 globally in 2030, significant revenue decline is expected.

Bristol Myers Squibb is likely to be among the hardest hit, with both Eliquis and Opdivo—major revenue contributors—set to go off-patent. GlobalData analyst George El-Helou notes that more than half of the top 15 pharma companies may struggle to absorb the impact, though some firms are leveraging promising pipeline drugs to cushion the blow.

To offset these losses, companies are urged to adopt multifaceted strategies including early lifecycle management, patent thickets, and targeted acquisitions of innovative biotech firms. Investing in R&D for therapies addressing unmet medical needs and developing differentiated delivery platforms are also critical.

Hannah Hans, Head of Pharma Strategic Intelligence at GlobalData, stresses the importance of integrating lifecycle and regulatory strategies early in development to maximise long-term value.

While the patent cliff presents serious risks, it also creates fresh opportunities—particularly for biotechs—to collaborate with big pharma on next-generation therapies and advanced formulations.