U.S. Keytruda Market Research Report 2025 | Merck's Keytruda Faces Challenges as Patent Expiry Approaches in 2028 - Forecast to 2033

Core Insights - The U.S. Keytruda market is projected to decline from an estimated size of USD 17.87 billion in 2024 at a CAGR of 3.12% from 2025 to 2033 due to challenges such as patent expiration and biosimilar competition [1][2] - Keytruda, developed by Merck & Co., is a significant player in oncology, particularly for lung cancer, melanoma, and urothelial carcinoma, but faces pricing pressures despite rising cancer incidence [2][3] - Merck is addressing access barriers through a new subcutaneous formulation expected in 2025, which aims to enhance treatment convenience and maintain market share [3][4] Market Dynamics - The market is supported by Keytruda's use in both monotherapy and combination regimens, with expanding indications in neoadjuvant and adjuvant settings [3] - Clinical trials, such as KEYNOTE-689, have demonstrated improved survival outcomes, contributing to increased adoption [3] - The incidence of cancer in the U.S. is estimated at 2 million new cases in 2024, indicating a growing patient population despite market challenges [2] Competitive Landscape - The market faces competition from emerging biosimilars following Keytruda's expected patent expiration in 2028, which could impact market dynamics [1][2] - Innovations such as biomarker-driven approaches and new combination therapies are being explored to enhance Keytruda's effectiveness [4] - Merck is also investigating new applications for Keytruda, including colorectal cancer, to mitigate risks associated with market competition [4] Future Outlook - The U.S. remains the leading market for Keytruda due to its advanced healthcare infrastructure, but future growth will be influenced by competitive and economic pressures [4] - Ongoing clinical evaluations and the introduction of new formulations are expected to play a crucial role in sustaining market activity despite anticipated declines [1][3]