The pharmaceutical industry is set to face a significant patent cliff over the coming years as several blockbuster drugs lose market exclusivity, increasing exposure to biosimilar and generic competition. This wave is expected to create substantial revenue and pricing pressures across the industry, according to GlobalData, a leading intelligence and productivity platform.
GlobalData’s latest report, “The State of the Biopharmaceutical Industry 2026,” reveals that there will be a sharp decline in the proportion of global drug sales protected by patents by 2030, with only 4% of sales retaining exclusivity, compared to 12% in 2022 and 6% in 2024. Many of the drugs approaching patent expiry are biologics and small molecules with multiple indications, leaving them particularly vulnerable to biosimilar and generic erosion.
Oncology is expected to be one of the most impacted therapy areas, with leading drugs such as Merck’s Keytruda and Johnson & Johnson’s Darzalex/Faspro set to lose US exclusivity by 2029. Although these products are forecast to remain among the top-selling drugs by 2030, their revenues are expected to decline as competition intensifies.
George El-Helou, Strategic Intelligence Analyst at GlobalData, comments: “More than half of the top 15 pharma companies are expected to face significant challenges as the industry approaches the patent cliff. The scale of revenue at risk means companies must increasingly rely on the strength of their pipelines and next-generation assets to offset losses and remain competitive.”
To mitigate the impact of lost exclusivity, pharmaceutical companies are increasingly focusing on lifecycle management strategies, including formulation improvements, label expansions, and next-generation therapies.
El-Helou concludes: “As the patent cliff approaches, companies that successfully deploy early portfolio planning and lifecycle management strategies will be better positioned to protect revenues and sustain long-term growth.”