U.S. Keytruda Market Size, Share & Trends Analysis Report By Application (Lung Cancer, Breast Cancer, Melanoma, Hodgkin Lymphoma, Head & Neck Cancer, Gastric Cancer, Urothelial Cancer), By Payer, By Distribution Channel, And Segment Forecasts, 2025 - 2033

U.S. Keytruda Market Size & Trends

The U.S. keytruda market size was estimated at USD 17.87 billion in 2024 and is projected to decline at a CAGR of -3.12% from 2025 to 2033. The market faces challenges from the impending patent expiration in 2028, introducing biosimilar competition. Although the decline is expected, market activity remains supported by continued use in established indications and ongoing clinical evaluation in new tumor types.

The U.S. Keytruda industry, a cornerstone of oncology due to its efficacy in treating multiple cancers, is undergoing a transition. Keytruda, developed by Merck & Co., targets PD-1 to enhance immune responses against tumors. Its approvals for lung cancer, melanoma, and urothelial carcinoma have supported market dominance. However, a projected decline during the forecast period reflects growing challenges, particularly from biosimilar competition following its expected patent expiration in 2028. While the incidence of cancer continues to rise-estimated at 2 million new cases in the U.S. in 2024-pricing pressures are expected to limit market growth.

Keytruda’s use in both monotherapy and combination regimens continues to be a key factor supporting its market position. Expanding indications in the neoadjuvant and adjuvant settings, such as for triple-negative breast cancer, broadens the eligible patient population. Clinical trials, including KEYNOTE-689, have shown improved survival outcomes, boosting adoption. However, treatment costs that often exceed thousands of dollars per cycle create access barriers. To address this, Merck has developed a subcutaneous formulation, with regulatory submissions expected in 2025, aimed at increasing treatment convenience and preserving market share.

Additionally, emerging innovations are shaping Keytruda’s clinical use. Biomarker-driven approaches enhance its effectiveness in PD-L1-expressing tumors, and research into new combinations, such as with antibody-drug conjugates and checkpoint inhibitors, could broaden its reach. Despite this development pipeline, the market faces challenges from regulatory hurdles, pricing issues, and biosimilar litigation. Merck is exploring new applications, including colorectal cancer, to counter these risks. While the U.S. remains the top market in North America due to its advanced healthcare infrastructure, future growth will be influenced by competitive and economic pressures.

U.S. Keytruda Market Report Segmentation

This report forecasts revenue growth in the U.S. and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. Keytruda market report based on application, payer, and distribution channel:

Application Outlook (Revenue, USD Million, 2021 - 2033)

• Lung Cancer
• Breast Cancer
• Melanoma
• Hodgkin Lymphoma
• Head and Neck Cancer
• Gastric Cancer
• Urothelial Cancer
• Others

Payer Outlook (Revenue, USD Million, 2021 - 2033)

• Commercial/Private
• Public

Distribution Channel Outlook (Revenue, USD Million, 2021 - 2033)

• Hospital Pharmacy
• Speciality

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