美国Keytruda 市场规模、份额、趋势分析报告：按应用程式、付款人、分销管道和细分市场预测，2025 年至 2033 年

Keytruda在美国的市场规模及趋势

预计 2024 年美国Keytruda 市场规模为 178.7 亿美元，预计 2025 年至 2033 年期间复合年增长率为 -3.12%。

随着 2028 年专利到期即将到期，市场面临生物相似药竞争的挑战。儘管预计会出现下滑，但由于在既定适应症中的持续使用以及在新肿瘤类型中的持续临床评估，市场仍然活跃。

美国Keytruda产业正处于转折点，因其对多种癌症的疗效而成为癌症治疗的基石。 Keytruda由默克公司开发，可针对PD-1，以增强对肿瘤的免疫反应。其在肺癌、黑色素瘤和尿路上皮癌领域的核准巩固了其市场主导地位。然而，预计在预测期内Keytruda市场将出现下滑，反映出市场挑战日益加剧，包括2028年专利到期后生物相似药的竞争。癌症发生率持续上升，预计2024年美国将新增200万例癌症病例，但价格压力预计将抑制市场成长。

Keytruda 既可用于单药治疗，也可用于联合治疗，这仍然是支撑其市场地位的关键因素。新辅助治疗和辅助治疗适应症的扩大，例如三阴性乳癌，正在扩大目标患者群体。包括 KEYNOTE-689 在内的临床试验已显示存活率提高，这鼓励了该药物的推广。然而，治疗费用（每个週期可能超过数千美元）往往是患者难以获得治疗的障碍。为了解决这个问题，默克正在开发一种皮下注射剂型，并计划于 2025 年提交核准，旨在提高治疗的便利性并维持市场占有率。

此外，新的创新正在塑造Keytruda的临床应用。生物标记驱动的方法可以提高Keytruda在PD-L1表达肿瘤中的疗效，而对抗体药物复合体和查核点抑制剂等新型联合治疗的研究可以扩大Keytruda的适用范围。儘管拥有众多开发平臺，市场仍面临监管障碍、定价问题和生物相似药诉讼等挑战。默克正在探索新的应用，包括大肠癌，以应对这些风险。凭藉先进的医疗基础设施，美国仍然是北美最大的市场，但未来的成长将面临竞争和经济压力。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国Keytruda 市场变数、趋势与范围

• 市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 商业环境分析
  • 产业分析-波特五力分析
  • PESTLE分析
  • 管道分析
  • 专利到期分析
  • 定价分析

第四章美国Keytruda市场：应用业务分析

• 2024 年和 2033 年应用市场占有率
• 应用程式细分仪表板
• 市场规模、预测与趋势分析（按应用，2021-2033 年）
• 肺癌
• 乳癌
• 黑色素瘤
• 何杰金氏淋巴瘤
• 头颈癌
• 胃癌
• 尿路上皮癌
• 其他的

第五章美国Keytruda市场：付款人业务分析

• 2024 年及 2033 年付款人市场占有率
• 付款人细分仪表板
• 按付款人分類的市场规模、预测和趋势分析（2021-2033 年）
• 商业/个人
• 公共

第六章美国Keytruda市场：通路业务分析

• 2024年及2033年分销通路市场占有率
• 分销通路细分仪表板
• 按分销管道分類的市场规模、预测和趋势分析（2021-2033 年）
• 医院药房
• 专业药房

第七章美国Keytruda市场：竞争格局

• 参与者概览
• 企业市场分析
• 公司分类
• 战略地图
• 公司简介/上市公司

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, Grand View Research 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

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Application
  • 1.2.2. Payer
  • 1.2.3. Distribution Channel
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Keytruda Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
  • 3.3.3. Pipeline Analysis
  • 3.3.4. Patent Expiry Analysis
  • 3.3.5. Pricing Analysis

Chapter 4. U.S. Keytruda Market: Application Business Analysis

• 4.1. Application Market Share, 2024 & 2033
• 4.2. Application Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 4.4. Lung Cancer
  • 4.4.1. Lung Cancer Market, 2021 - 2033 (USD Million)
• 4.5. Breast Cancer
  • 4.5.1. Breast Cancer Market, 2021 - 2033 (USD Million)
• 4.6. Melanoma
  • 4.6.1. Melanoma Market, 2021 - 2033 (USD Million)
• 4.7. Hodgkin Lymphoma
  • 4.7.1. Hodgkin Lymphoma Market, 2021 - 2033 (USD Million)
• 4.8. Head and Neck Cancer
  • 4.8.1. Head and Neck Cancer Market, 2021 - 2033 (USD Million)
• 4.9. Gastric Cancer
  • 4.9.1. Gastric Cancer Market, 2021 - 2033 (USD Million)
• 4.10. Urothelial Cancer
  • 4.10.1. Urothelial Cancer Market, 2021 - 2033 (USD Million)
• 4.11. Other
  • 4.11.1. Other Market, 2021 - 2033 (USD Million)

Chapter 5. U.S. Keytruda Market: Payer Business Analysis

• 5.1. Payer Market Share, 2024 & 2033
• 5.2. Payer Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Payer, 2021 to 2033 (USD Million)
• 5.4. Commercial/Private
  • 5.4.1. Commercial/Private Market, 2021 - 2033 (USD Million)
• 5.5. Public
  • 5.5.1. Public Market, 2021 - 2033 (USD Million)

Chapter 6. U.S. Keytruda Market: Distribution Channel Business Analysis

• 6.1. Distribution Channel Market Share, 2024 & 2033
• 6.2. Distribution Channel Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2021 to 2033 (USD Million)
• 6.4. Hospital Pharmacy
  • 6.4.1. Hospital Pharmacy Market, 2021 - 2033 (USD Million)
• 6.5. Specialty Pharmacy
  • 6.5.1. Specialty Pharmacy Market, 2021 - 2033 (USD Million)

Chapter 7. U.S. Keytruda Market: Competitive Landscape

• 7.1. Participant Overview
• 7.2. Company Market Position Analysis
• 7.3. Company Categorization
• 7.4. Strategy Mapping
• 7.5. Company Profiles/Listing
  • 7.5.1. Merck & Co., Inc.
    • 7.5.1.1. Overview
    • 7.5.1.2. Financial Performance
    • 7.5.1.3. Product Benchmarking
    • 7.5.1.4. Strategic Initiatives

List of Tables

• Table 1. List of secondary sources
• Table 2. List of abbreviations
• Table 3. U.S. Keytruda market, by application, 2021 - 2033 (USD Million)
• Table 4. U.S. Keytruda market, by payer, 2021 - 2033 (USD Million)
• Table 5. U.S. Keytruda market, by distribution channel, 2021 - 2033 (USD Million)

List of Figures

• Fig. 1 Keytruda market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value-chain-based sizing & forecasting
• Fig. 7 Market formulation & validation
• Fig. 8 Market snapshot
• Fig. 9 Therapeutic approach and application outlook (USD Million)
• Fig. 10 Competitive landscape
• Fig. 11 Keytruda market dynamics
• Fig. 12 Keytruda market: Porter's five forces analysis
• Fig. 13 Keytruda market: PESTLE analysis
• Fig. 14 Application market, 2021 - 2033 (USD Million)
• Fig. 15 Lung Cancer market, 2021 - 2033 (USD Million)
• Fig. 16 Breast Cancer market, 2021 - 2033 (USD Million)
• Fig. 17 Melanoma market, 2021 - 2033 (USD Million)
• Fig. 18 Hodgkin Lymphoma market, 2021 - 2033 (USD Million)
• Fig. 19 Head and Neck Cancer market, 2021 - 2033 (USD Million)
• Fig. 20 Gastric Cancer market, 2021 - 2033 (USD Million)
• Fig. 21 Urothelial Cancer market, 2021 - 2033 (USD Million)
• Fig. 22 Other market, 2021 - 2033 (USD Million)
• Fig. 23 Payer market, 2021 - 2033 (USD Million)
• Fig. 24 Commercial/Private market, 2021 - 2033 (USD Million)
• Fig. 25 Public market, 2021 - 2033 (USD Million)
• Fig. 26 Distribution Channel market, 2021 - 2033 (USD Million)
• Fig. 27 Hospital Pharmacy market, 2021 - 2033 (USD Million)
• Fig. 28 Specialty Pharmacy market, 2021 - 2033 (USD Million)
• Fig. 29 Company market position analysis
• Fig. 30 Strategic framework