Product Code: GVR-4-68040-539-2
Keytruda Market Summary
The global Keytruda market size was estimated at USD 31.38 billion in 2025 and is projected to reach USD 24.95 billion by 2033, declining at a CAGR of -3.80% from 2026 to 2033. The market outlook for Keytruda (pembrolizumab) is expected to soften after its patent expiry due to rising biosimilar competition and pricing pressures.
Despite the impending challenges, Keytruda continues to strengthen its global presence, including in South America and the Gulf Cooperation Council (GCC), supported by its broad adoption across numerous cancer indications. In both regions, the increasing prevalence of cancer, growing investment in oncology infrastructure, and wider access to advanced immunotherapies are driving uptake. As a leading immune checkpoint inhibitor, Keytruda has demonstrated strong efficacy in non-small cell lung cancer, melanoma, head and neck cancers, and several other malignancies, leading to a consistent expansion of regulatory approvals worldwide. Its market resilience is further supported by a growing volume of clinical trials, particularly those evaluating combination therapies, as well as sustained global investment in immuno-oncology research.
Keytruda's expansion across international markets, including developing regions such as South America, where healthcare modernization is accelerating, and the GCC, where governments are prioritizing premium cancer care, has been driven largely by its increasing number of approved indications. These approvals, covering conditions such as non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, and urothelial carcinoma, have substantially broadened its eligible patient base. Its demonstrated effectiveness in monotherapy and combination regimens supports use in first-line, advanced, and adjuvant settings across diverse healthcare environments. Continued clinical research exploring new uses in colorectal cancer, triple-negative breast cancer, and hepatocellular carcinoma provides further growth potential. The drug's incorporation into biomarker-driven strategies, including PD-L1 expression and tumor mutational burden, enhances targeted patient selection and solidifies its position within precision oncology across mature and emerging markets.
Combination therapy remains a pivotal driver of Keytruda's industry performance, especially in regions such as South America and the GCC, where oncologists are increasingly adopting modern, multimodal treatment approaches. Its synergy with chemotherapy, targeted agents, and other immunotherapies has shown strong clinical results in aggressive and late-stage cancers. Strategic partnerships aimed at advancing combination trials continue to reinforce Keytruda's competitive advantage. As more of these regimens gain regulatory approval and real-world acceptance, they extend the drug's lifecycle and help mitigate the impact of future biosimilar competition. This focus on combination approaches ensures Keytruda remains clinically relevant and commercially resilient across diverse global markets.
Keytruda's rising use in earlier treatment lines is another major catalyst, with similar trends emerging across South America and the GCC, where healthcare systems are increasingly adopting immunotherapy for early-stage disease management. Originally reserved for metastatic settings, Keytruda now carries approvals for first-line, neoadjuvant, and adjuvant use, helping reduce recurrence risk and improve survival outcomes. Approvals for early-stage non-small cell lung cancer, triple-negative breast cancer, and melanoma have significantly expanded its patient population across both developed and developing markets. As oncologists worldwide shift toward the earlier integration of immunotherapy, demand for Keytruda continues to grow, strengthening its market position ahead of the anticipated competitive pressures following patent expiry.
Global Keytruda Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels 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 global Keytruda market report based on application, payer, distribution channel, and region:
- 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
- Specialty Pharmacy
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Thailand
- Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
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. 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. Patent Expiry Analysis
- 3.3.4. Pricing and Reimbursement Scenario
- 3.3.5. M&A and Deals
- 3.3.6. Impact of Generics/Biosimilars
Chapter 4. Keytruda Market: Application Business Analysis
- 4.1. Application Market Share, 2025 & 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. Others
- 4.11.1. Others Market, 2021 - 2033 (USD Million)
Chapter 5. Keytruda Market: Payer Business Analysis
- 5.1. Payer Market Share, 2025 & 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. Keytruda Market: Distribution Channel Business Analysis
- 6.1. Distribution Channel Market Share, 2025 & 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. Keytruda Market: Regional Estimates & Trend Analysis
- 7.1. Regional Market Share Analysis, 2025 & 2033
- 7.2. Regional Market Dashboard
- 7.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
- 7.4. North America
- 7.4.1. North America Keytruda Market Estimates and Forecasts, By Country, 2021 - 2033 (USD Million)
- 7.4.2. U.S.
- 7.4.2.1. Key Country Dynamics
- 7.4.2.2. Target Disease Prevalence
- 7.4.2.3. Regulatory Framework
- 7.4.2.4. Reimbursement Framework
- 7.4.2.5. U.S. Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.3. Canada
- 7.4.3.1. Key Country Dynamics
- 7.4.3.2. Target Disease Prevalence
- 7.4.3.3. Regulatory Framework
- 7.4.3.4. Reimbursement Framework
- 7.4.3.5. Canada Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.4. Mexico
- 7.4.4.1. Key Country Dynamics
- 7.4.4.2. Target Disease Prevalence
- 7.4.4.3. Regulatory Framework
- 7.4.4.4. Reimbursement Framework
- 7.4.4.5. Mexico Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5. Europe
- 7.5.1. Europe Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.2. UK
- 7.5.2.1. Key Country Dynamics
- 7.5.2.2. Target Disease Prevalence
- 7.5.2.3. Regulatory Framework
- 7.5.2.4. Reimbursement Framework
- 7.5.2.5. UK Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.3. Germany
- 7.5.3.1. Key Country Dynamics
- 7.5.3.2. Target Disease Prevalence
- 7.5.3.3. Regulatory Framework
- 7.5.3.4. Reimbursement Framework
- 7.5.3.5. Germany Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.4. France
- 7.5.4.1. Key Country Dynamics
- 7.5.4.2. Target Disease Prevalence
- 7.5.4.3. Regulatory Framework
- 7.5.4.4. Reimbursement Framework
- 7.5.4.5. France Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.5. Italy
- 7.5.5.1. Key Country Dynamics
- 7.5.5.2. Target Disease Prevalence
- 7.5.5.3. Regulatory Framework
- 7.5.5.4. Reimbursement Framework
- 7.5.5.5. Italy Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.6. Spain
- 7.5.6.1. Key Country Dynamics
- 7.5.6.2. Target Disease Prevalence
- 7.5.6.3. Regulatory Framework
- 7.5.6.4. Reimbursement Framework
- 7.5.6.5. Spain Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.7. Denmark
- 7.5.7.1. Key Country Dynamics
- 7.5.7.2. Target Disease Prevalence
- 7.5.7.3. Regulatory Framework
- 7.5.7.4. Reimbursement Framework
- 7.5.7.5. Denmark Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.8. Sweden
- 7.5.8.1. Key Country Dynamics
- 7.5.8.2. Target Disease Prevalence
- 7.5.8.3. Regulatory Framework
- 7.5.8.4. Reimbursement Framework
- 7.5.8.5. Sweden Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.9. Norway
- 7.5.9.1. Key Country Dynamics
- 7.5.9.2. Target Disease Prevalence
- 7.5.9.3. Regulatory Framework
- 7.5.9.4. Reimbursement Framework
- 7.5.9.5. Norway Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6. Asia Pacific
- 7.6.1. Asia Pacific Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.2. Japan
- 7.6.2.1. Key Country Dynamics
- 7.6.2.2. Target Disease Prevalence
- 7.6.2.3. Regulatory Framework
- 7.6.2.4. Reimbursement Framework
- 7.6.2.5. Japan Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.3. China
- 7.6.3.1. Key Country Dynamics
- 7.6.3.2. Target Disease Prevalence
- 7.6.3.3. Regulatory Framework
- 7.6.3.4. Reimbursement Framework
- 7.6.3.5. China Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.4. India
- 7.6.4.1. Key Country Dynamics
- 7.6.4.2. Target Disease Prevalence
- 7.6.4.3. Regulatory Framework
- 7.6.4.4. Reimbursement Framework
- 7.6.4.5. India Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.5. Australia
- 7.6.5.1. Key Country Dynamics
- 7.6.5.2. Target Disease Prevalence
- 7.6.5.3. Regulatory Framework
- 7.6.5.4. Reimbursement Framework
- 7.6.5.5. Australia Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.6. South Korea
- 7.6.6.1. Key Country Dynamics
- 7.6.6.2. Target Disease Prevalence
- 7.6.6.3. Regulatory Framework
- 7.6.6.4. Reimbursement Framework
- 7.6.6.5. South Korea Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.6.7. Thailand
- 7.6.7.1. Key Country Dynamics
- 7.6.7.2. Target Disease Prevalence
- 7.6.7.3. Regulatory Framework
- 7.6.7.4. Reimbursement Framework
- 7.6.7.5. Thailand Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.7. Latin America
- 7.7.1. Latin America Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.7.2. Brazil
- 7.7.2.1. Key Country Dynamics
- 7.7.2.2. Target Disease Prevalence
- 7.7.2.3. Regulatory Framework
- 7.7.2.4. Reimbursement Framework
- 7.7.2.5. Brazil Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.7.3. Argentina
- 7.7.3.1. Key Country Dynamics
- 7.7.3.2. Target Disease Prevalence
- 7.7.3.3. Regulatory Framework
- 7.7.3.4. Reimbursement Framework
- 7.7.3.5. Argentina Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8. Middle East and Africa
- 7.8.1. Middle East and Africa Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8.2. South Africa
- 7.8.2.1. Key Country Dynamics
- 7.8.2.2. Target Disease Prevalence
- 7.8.2.3. Regulatory Framework
- 7.8.2.4. Reimbursement Framework
- 7.8.2.5. South Africa Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8.3. Saudi Arabia
- 7.8.3.1. Key Country Dynamics
- 7.8.3.2. Target Disease Prevalence
- 7.8.3.3. Regulatory Framework
- 7.8.3.4. Reimbursement Framework
- 7.8.3.5. Saudi Arabia Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8.4. UAE
- 7.8.4.1. Key Country Dynamics
- 7.8.4.2. Target Disease Prevalence
- 7.8.4.3. Regulatory Framework
- 7.8.4.4. Reimbursement Framework
- 7.8.4.5. UAE Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.8.5. Kuwait
- 7.8.5.1. Key Country Dynamics
- 7.8.5.2. Target Disease Prevalence
- 7.8.5.3. Regulatory Framework
- 7.8.5.4. Reimbursement Framework
- 7.8.5.5. Kuwait Keytruda Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
- 8.1. Participant Overview
- 8.2. Company Market Position Analysis
- 8.3. Company Categorization
- 8.4. Strategy Mapping
- 8.5. Company Profiles/Listing
- 8.5.1. Merck & Co., Inc.
- 8.5.1.1. Overview
- 8.5.1.2. Financial Performance
- 8.5.1.3. Product Benchmarking
- 8.5.1.4. Strategic Initiatives
- 8.5.2. Bristol-Myers Squibb Company
- 8.5.2.1. Overview
- 8.5.2.2. Financial Performance
- 8.5.2.3. Product Benchmarking
- 8.5.2.4. Strategic Initiatives
- 8.5.3. F. Hoffmann-La Roche Ltd.
- 8.5.3.1. Overview
- 8.5.3.2. Financial Performance
- 8.5.3.3. Product Benchmarking
- 8.5.3.4. Strategic Initiatives
- 8.5.4. Regeneron Pharmaceuticals, Inc. & Sanofi S.A.
- 8.5.4.1. Overview
- 8.5.4.2. Financial Performance
- 8.5.4.3. Product Benchmarking
- 8.5.4.4. Strategic Initiatives
- 8.5.5. Pfizer Inc. & Seagen Inc.
- 8.5.5.1. Overview
- 8.5.5.2. Financial Performance
- 8.5.5.3. Product Benchmarking
- 8.5.5.4. Strategic Initiatives
- 8.5.6. Amgen Inc.
- 8.5.6.1. Overview
- 8.5.6.2. Financial Performance
- 8.5.6.3. Product Benchmarking
- 8.5.6.4. Strategic Initiatives
- 8.5.7. Samsung Bioepis Co., Ltd.
- 8.5.7.1. Overview
- 8.5.7.2. Financial Performance
- 8.5.7.3. Product Benchmarking
- 8.5.7.4. Strategic Initiatives
- 8.5.8. Bio-Thera Solutions, Ltd.
- 8.5.8.1. Overview
- 8.5.8.2. Financial Performance
- 8.5.8.3. Product Benchmarking
- 8.5.8.4. Strategic Initiatives