美國Keytruda 市場規模、佔有率、趨勢分析報告：按應用程式、付款人、分銷管道和細分市場預測，2025 年至 2033 年

Keytruda在美國的市場規模及趨勢

預計 2024 年美國Keytruda 市場規模為 178.7 億美元，預計 2025 年至 2033 年期間複合年成長率為 -3.12%。

隨著 2028 年專利到期即將到期，市場面臨生物相似藥競爭的挑戰。儘管預計會出現下滑，但由於在既定適應症中的持續使用以及在新腫瘤類型中的持續臨床評估，市場仍然活躍。

美國Keytruda產業正處於轉折點，因其對多種癌症的療效而成為癌症治療的基石。 Keytruda由默克公司開發，可針對PD-1，以增強對腫瘤的免疫反應。其在肺癌、黑色素瘤和尿路上皮癌領域的核准鞏固了其市場主導地位。然而，預計在預測期內Keytruda市場將出現下滑，反映出市場挑戰日益加劇，包括2028年專利到期後生物相似藥的競爭。癌症發生率持續上升，預計2024年美國將新增200萬例癌症病例，但價格壓力預計將抑制市場成長。

Keytruda 既可用於單藥治療，也可用於聯合治療，這仍然是支撐其市場地位的關鍵因素。新輔助治療和輔助治療適應症的擴大，例如三陰性乳癌，正在擴大目標患者群體。包括 KEYNOTE-689 在內的臨床試驗已顯示存活率提高，這鼓勵了該藥物的推廣。然而，治療費用（每個週期可能超過數千美元）往往是患者難以獲得治療的障礙。為了解決這個問題，默克正在開發一種皮下注射劑型，並計劃於 2025 年提交核准，旨在提高治療的便利性並維持市場佔有率。

此外，新的創新正在塑造Keytruda的臨床應用。生物標記驅動的方法可以提高Keytruda在PD-L1表達腫瘤中的療效，而對抗體藥物複合體和查核點抑制劑等新型聯合治療的研究可以擴大Keytruda的適用範圍。儘管擁有眾多開發平臺，市場仍面臨監管障礙、定價問題和生物相似藥訴訟等挑戰。默克正在探索新的應用，包括大腸癌，以應對這些風險。憑藉先進的醫療基礎設施，美國仍然是北美最大的市場，但未來的成長將面臨競爭和經濟壓力。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國Keytruda 市場變數、趨勢與範圍

• 市場展望
• 市場動態
  • 市場促進因素分析
  • 市場限制因素分析
• 商業環境分析
  • 產業分析-波特五力分析
  • PESTLE分析
  • 管道分析
  • 專利到期分析
  • 定價分析

第4章美國Keytruda市場：應用業務分析

• 2024 年和 2033 年應用市場佔有率
• 應用程式細分儀表板
• 市場規模、預測與趨勢分析（按應用，2021-2033 年）
• 肺癌
• 乳癌
• 黑色素瘤
• 何傑金氏淋巴瘤
• 頭頸癌
• 胃癌
• 尿路上皮癌
• 其他

第5章美國Keytruda市場：付款人業務分析

• 2024 年及 2033 年付款人市場佔有率
• 付款人細分儀表板
• 按付款人分類的市場規模、預測和趨勢分析（2021-2033 年）
• 商業/個人
• 公共

第6章美國Keytruda市場：通路業務分析

• 2024年及2033年分銷通路市場佔有率
• 分銷通路細分儀表板
• 按分銷管道分類的市場規模、預測和趨勢分析（2021-2033 年）
• 醫院藥房
• 專業藥房

第7章美國Keytruda市場：競爭格局

• 參與者概覽
• 企業市場分析
• 公司分類
• 戰略地圖
• 公司簡介/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