Keytruda Market Boosted by Expanding Use in Early-Stage Cancer Patients

The global Keytruda market size was valued at USD 29.49 billion in 2024 and is projected to decline to USD 26.63 billion by 2030, registering a negative CAGR of –3.23% from 2025 to 2030. This downturn is primarily linked to the drug’s upcoming patent expiration, which is expected to invite strong biosimilar competition and drive downward pricing pressure.

Key Market Trends & Insights

  • North America leads the global Keytruda market with a 38.0% share in 2024.
  • The U.S. remains the dominant market within North America.
  • Lung cancer is the leading application segment, accounting for 27.4% of the global share in 2024.
  • By payer type, commercial/private insurance holds the majority share of 91.0% in 2024.
  • Hospital pharmacies form the largest distribution channel with 51.8% share in 2024.

Market Size & Forecast

  • 2024 Market Size: USD 29.49 Billion
  • 2030 Forecast Size: USD 26.63 Billion
  • CAGR (2025–2030): –3.23%
  • Largest Market in 2024: North America

Despite the projected decline, Keytruda has gained significant traction due to its broad and expanding use across multiple oncology indications. As one of the most successful immune checkpoint inhibitors worldwide, it has shown substantial efficacy in cancers such as non-small cell lung cancer, melanoma, and head & neck malignancies. The drug’s widespread adoption is supported by rising global cancer incidence, active clinical research, and ongoing development of combination therapies.

Keytruda’s market expansion has historically been driven by its multiple regulatory approvals, enabling its use in diverse treatment settings including monotherapy, combination therapy, first-line, and adjuvant applications. Emerging trials targeting new cancer types—such as triple-negative breast cancer, colorectal cancer, and hepatocellular carcinoma—continue to broaden its therapeutic potential. Biomarker-based patient selection methods, including PD-L1 expression and tumor mutational burden, further strengthen its position as a precision oncology therapy.

Company Insights

Merck & Co., Inc. remains the exclusive manufacturer of Keytruda and continues to dominate the global market. Its wide-ranging clinical successes and expanding indications make it the leading immunotherapy brand. However, as the patent approaches expiration, a significant market shift is anticipated with biosimilars expected to intensify competition.

Competitive Landscape & Emerging Players

  • Bristol-Myers Squibb – Opdivo (nivolumab): Key competitor with parallel approvals across lung, renal, and melanoma cancers.
  • Roche – Tecentriq (atezolizumab): Strong presence in lung and bladder cancer immunotherapy.
  • Regeneron/Sanofi – Libtayo (cemiplimab): Growing footprint in skin and lung cancer treatment.
  • Pfizer/Seagen: Strengthening oncology pipeline with innovative ADC combinations.
  • Upcoming Biosimilars: Companies such as Amgen, Samsung Bioepis, and Bio-Thera Solutions are actively developing biosimilars expected to reshape the market post-2028.

Order a free sample PDF of the Keytruda Market Intelligence Study, published by Grand View Research.

Key Companies in the Global Keytruda Market

  • Merck & Co., Inc.
  • Bristol-Myers Squibb Company
  • Hoffmann-La Roche Ltd.
  • Regeneron Pharmaceuticals, Inc. & Sanofi S.A.
  • Pfizer Inc. & Seagen Inc.
  • Amgen Inc.
  • Samsung Bioepis Co., Ltd.
  • Bio-Thera Solutions, Ltd.

Conclusion

The Keytruda market, despite its historical growth and strong clinical footprint, is entering a period of transition driven by patent expiration and emerging biosimilar competition. While adoption across multiple cancer types continues to highlight its therapeutic importance, pricing pressures and evolving competitive dynamics will shape the market’s future trajectory. Continued R&D, new indication approvals, and combination therapy advancements will determine how Keytruda maintains its relevance in the evolving immuno-oncology landscape.

Explore Horizon Databook – The world’s most expansive market intelligence platform developed by Grand View Research.

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