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

1. U.S. Keytruda market projected to decline at a CAGR of 3.12%. 2. Patent expiration in 2028 introduces biosimilar competition. 3. Keytruda's efficacy continues but faces pricing pressures. 4. New formulations and indications aim to boost adoption. 5. Regulatory hurdles and pricing challenges could limit growth.

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FAQ

Why Bearish?

The projected decline in market size and increasing competition poses risks to MRK's revenue. Historical data shows that patent expirations often lead to significant drops in pharmaceutical revenues.

How important is it?

The article discusses Keytruda's market position and challenges, directly affecting MRK's valuation.

Why Long Term?

With the patent expiration expected in 2028, the long-term financial outlook for MRK could be adversely affected.

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Dublin, July 25, 2025 (GLOBE NEWSWIRE) -- The "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" report has been added to ResearchAndMarkets.com's offering.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. Why should you buy this report? Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.Competitive Landscape: Explore the market presence of key players worldwide.Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions. Companies Featured Merck & Co., Inc. U.S. Keytruda Market Report SegmentationApplication Outlook (Revenue, USD Million, 2021 - 2033) Lung CancerBreast CancerMelanomaHodgkin LymphomaHead and Neck CancerGastric CancerUrothelial CancerOthers Payer Outlook (Revenue, USD Million, 2021 - 2033) Commercial/PrivatePublic Distribution Channel Outlook (Revenue, USD Million, 2021 - 2033) Hospital PharmacySpeciality For more information about this report visit https://www.researchandmarkets.com/r/5hkpwf About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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