The global pharmaceutical industry faces over $500 billion in prescription drug sales at risk from patent expiries between 2026 and 2032. Industry exposure peaks at $158 billion in 2031, with 2028 seeing $99 billion at risk as Merck's Keytruda loses protection. Drugmakers are responding with aggressive dealmaking, led by Merck's $30.9 billion across six acquisitions and Eli Lilly's $27.2 billion in deals since early 2024.
Industry-wide patent cliff timeline
- ▪Norstella forecasting data provided by Evaluate projects that over $500 billion in worldwide prescription drug sales are at risk from generic competition between 2026 and 2032.
- ▪Evaluate projects the largest single-year patent cliff exposure between 2026 and 2032 will occur in 2031, with $158 billion in sales facing generic competition.
- ▪Evaluate forecasts that $99 billion in worldwide prescription drug sales will be at risk from patent expiration in 2028 alone, representing 6.5% of the global market.
Major drugmakers facing patent expiries
- ▪Johnson & Johnson faces patent expiration risk for Imbruvica and Darzalex in 2027 and 2028, while Sanofi's Praluent and Dupixent face competition in 2029 and 2030.
- ▪AbbVie faces roughly $50 billion in single-year sales exposure in 2032 as immunology drugs Rinvoq and Skyrizi approach patent expiry.
- ▪Evaluate notes that Novo Nordisk's Ozempic is expected to face generic competition before Eli Lilly's Mounjaro, which faces patent pressure in the mid-2030s.
- ▪AstraZeneca faces product patent expiries in the early 2030s for Imfinzi, Tagrisso, Calquence, Farxiga, and Saphnelo.
- ▪Merck & Co. faces patent expiry in 2028 for oncology blockbuster Keytruda, making Merck the most near-term exposed drugmaker in Evaluate's projection.
Revenue erosion and mitigation strategies
- ▪Drugmakers utilize portfolio lifecycle management and internal pipeline development alongside dealmaking to offset expected sales losses from post-patent competition.
- ▪Factors including patent expiry timing, market geography, generic competition timing, and lifecycle strategies dictate how rapidly post-patent revenue erodes for drugmakers.
- ▪To mitigate Keytruda's impending 2028 patent expiration, Merck & Co. secured FDA approval in September for a subcutaneous injectable version of Keytruda.
Recent acquisition spend by drugmakers
- ▪Merck & Co. announced $30.9 billion across six acquisitions since the start of 2024, the highest spend among patent-exposed drugmakers tracked by Evaluate.
- ▪Since the start of 2024, Johnson & Johnson announced $20.4 billion in acquisitions, Sanofi announced $16.1 billion, and AstraZeneca announced $6.8 billion in deals.
- ▪Since the start of 2024, Eli Lilly announced $27.2 billion across nine acquisitions, while AbbVie announced $22.3 billion in deal volume.
Debatable claims
- ▪Merck's subcutaneous Keytruda formulation serves to delay generic competition rather than improve care
- ▪Heavy pharma M&A spending to replace expiring blockbusters drives consolidation over discovery
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