The biopharmaceutical industry is confronting its most significant loss-of-exclusivity cycle in history, with estimates of revenue at risk ranging from $230 billion to $300 billion in the U.S. by 2030, and global projections reaching $400 billion. This represents roughly one-sixth of the industry's annual global output. Key drugs like Merck & Co.'s Keytruda, Bristol Myers Squibb's Eliquis and Opdivo, and Novo Nordisk's Ozempic are among those nearing patent expiration.
Companies like Bristol Myers Squibb face substantial challenges, with a projected $38 billion growth gap as Eliquis and Opdivo, which account for over half of its earnings, lose exclusivity. Merck & Co. and Pfizer are also looking at gaps of $23 billion and $21 billion, respectively. Merck's Keytruda, the world's best-selling drug, is expected to peak at $32 billion in sales in 2026 before biosimilar competition sets in, representing more than half of the company's sales.
To navigate this cliff, pharmaceutical companies are employing various strategies. These include dealmaking to acquire new drug pipelines, delaying patent expirations, and developing new drugs. AbbVie, for instance, successfully reduced its reliance on Humira from 39% of revenues in 2022 to an expected 9% in 2025 by creating "patent thickets" and using M&A to bolster its pipeline with drugs like Rinvoq and Skyrizi. Johnson & Johnson has also delayed biosimilar competition for its drug Stelara, which still generated over $6 billion in sales in 2025 despite a drop from $10 billion in 2024.
While some companies, such as Eli Lilly and Novo Nordisk, are well-positioned due to strong earnings from GLP-1 weight-loss drugs and limited patent exposure, others are making strategic moves. Merck is developing Keytruda Qlex, an easier-to-administer alternative, projected to bring in $7 billion in sales by early 2032. Sanofi expects Dupixent, its top-selling product, to reach approximately $28.79 billion in annual sales by 2030 and plans a vigorous defense of its patents extending to 2045, despite its primary U.S. compound patent expiring in March 2031.