키트루다(Keytruda) 시장 : 시장 규모, 점유율, 동향 분석 보고서 - 용도별, 지불자별, 유통 채널별, 지역별, 부문 예측(2025-2030년)

Keytruda Market Growth & Trends:

The global Keytruda market size is anticipated to reach USD 26.63 billion by 2030 and is projected to decline at a CAGR of -3.23% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market is experiencing a slight decline in the growth trajectory. However, the market is moving ahead due to its effectiveness in combination therapies, enhancing outcomes when used alongside chemotherapy, targeted agents, and other immunotherapies. Ongoing clinical trials are evaluating its efficacy in additional cancer indications, particularly in biomarker-driven treatment approaches. The drug's ability to extend progression-free survival in challenging cancers such as triple-negative breast cancer, lung cancer, and urothelial carcinoma further strengthens its market presence. Additionally, regulatory bodies are increasingly recognizing the value of Keytruda in early-stage cancers, fueling its adoption in neoadjuvant and adjuvant settings.

Despite its strong market foothold, Keytruda faces challenges, primarily due to its upcoming patent expiration in 2028. The introduction of biosimilar competition is expected to create pricing pressures and reduce market exclusivity. To counter this, Merck is actively working on lifecycle management strategies, including the development of a subcutaneous (SC) formulation that offers a more convenient alternative to the intravenous (IV) version. Recent Phase 3 trials have confirmed that SC Keytruda maintains comparable efficacy and safety, potentially extending its commercial viability.

The competitive landscape is also evolving, with rival PD-1/PD-L1 inhibitors, such as Opdivo and Tecentriq, vying for market share. Additionally, next-generation immunotherapies and novel treatment modalities pose potential threats to Keytruda's dominance. However, Merck's ongoing investments in research and development, coupled with strategic collaborations, are expected to sustain Keytruda's relevance in the oncology space. The company's continued efforts to expand indications, explore new combination regimens, and enhance patient accessibility through innovative drug formulations will be crucial in maintaining its leadership in the immuno-oncology market.

One of the biggest challenges Keytruda faces is its impending patent expiration in 2028, which will open the market to biosimilar competition. As a result, several pharmaceutical companies are actively developing biosimilar versions, which could significantly impact Merck's revenue from Keytruda. With the loss of exclusivity, pricing pressures and reimbursement challenges are expected to intensify, particularly in cost-sensitive markets. Additionally, regulatory hurdles and litigation over biosimilar approvals could create market uncertainties. To mitigate these risks, Merck is focusing on life cycle management strategies, including the development of new formulations and expanded indications to sustain demand even after biosimilar entry.

At the same time, opportunities remain strong for Keytruda, particularly in combination therapies and earlier treatment lines. The shift toward personalized medicine and biomarker-driven oncology treatments presents a significant growth avenue, as Keytruda continues to demonstrate efficacy in patients with specific genetic and molecular markers. Clinical trials exploring Keytruda in combination with novel agents, such as antibody-drug conjugates and next-generation immune checkpoint inhibitors, could further enhance its therapeutic potential. Moreover, approvals in neoadjuvant and adjuvant settings are expected to increase treatment durations and expand the eligible patient pool, ensuring continued demand.

Another key opportunity for Merck lies in the development of the subcutaneous (SC) formulation of Keytruda, which aims to improve patient convenience and access. If approved, this version could offer an alternative for patients who face barriers to IV administration, such as limited access to infusion centers. The SC formulation could also help extend Keytruda's market exclusivity by offering a differentiated product that may delay the impact of biosimilars. Additionally, emerging oncology markets in Asia-Pacific and Latin America present expansion opportunities, as rising cancer prevalence and improving healthcare infrastructure drive demand for advanced immunotherapies. With strategic investments in new indications, combination regimens, and innovative drug delivery methods, Merck is positioning Keytruda to maintain its strong presence in the global immuno-oncology market, despite the challenges ahead.

Keytruda Market Report Highlights:

• Based on application, lung cancer dominated the Keytruda market in 2024 with the largest revenue share of 27.4%, due to its widespread adoption as a first-line treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Meanwhile, breast cancer is projected to grow at the fastest CAGR over the forecast period, driven by Keytruda's increasing use in triple-negative breast cancer (TNBC) and ongoing clinical trials exploring its efficacy in other breast cancer subtypes.
• Based on payer, the commercial/private insurance segment held the largest share of 91.0% in 2024, owing to strong reimbursement support for immuno-oncology therapies in developed markets. However, the public insurance segment is expected to see steady growth as government healthcare programs and national reimbursement policies expand access to costly cancer treatments.
• Based on distribution channel, hospital pharmacies emerged as the dominant segment with a share of 51.8% in 2024, accounting for the highest revenue share due to the need for controlled administration and specialist supervision in oncology treatment centers. Meanwhile, specialty pharmacies are projected to witness the fastest CAGR over the forecast period, driven by the growing shift towards outpatient immunotherapy administration and potential approval of the subcutaneous Keytruda formulation, which could improve accessibility outside traditional hospital settings.
• In February 2025, the U.S. Food and Drug Administration (FDA) granted Priority Review to Merck's supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) in combination with standard care as a perioperative treatment for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This decision is based on the Phase 3 KEYNOTE-689 trial, which demonstrated a statistically significant improvement in event-free survival (EFS) and major pathological response (mPR) for patients receiving the Keytruda regimen compared to standard treatment alone. The FDA has set a target action date of June 23, 2025, for this application.

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, 2024 & 2030
• 4.2. Application Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 4.4. Lung Cancer
  • 4.4.1. Lung Cancer Market, 2018 - 2030 (USD Million)
• 4.5. Breast Cancer
  • 4.5.1. Breast Cancer Market, 2018 - 2030 (USD Million)
• 4.6. Hodgkin Lymphoma
  • 4.6.1. Hodgkin Lymphoma Market, 2018 - 2030 (USD Million)
• 4.7. Head and Neck Cancer
  • 4.7.1. Head and Neck Cancer Market, 2018 - 2030 (USD Million)
• 4.8. Gastric Cancer
  • 4.8.1. Gastric Cancer Market, 2018 - 2030 (USD Million)
• 4.9. Urothelial Cancer
  • 4.9.1. Urothelial Cancer Market, 2018 - 2030 (USD Million)
• 4.10. Others
  • 4.10.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. Keytruda Market: Payer Business Analysis

• 5.1. Payer Market Share, 2024 & 2030
• 5.2. Payer Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Payer, 2018 to 2030 (USD Million)
• 5.4. Commercial/Private
  • 5.4.1. Commercial/Private Market, 2018 - 2030 (USD Million)
• 5.5. Public
  • 5.5.1. Public Market, 2018 - 2030 (USD Million)

Chapter 6. Keytruda Market: Distribution Channel Business Analysis

• 6.1. Distribution Channel Market Share, 2024 & 2030
• 6.2. Distribution Channel Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2018 to 2030 (USD Million)
• 6.4. Hospital Pharmacy
  • 6.4.1. Hospital Pharmacy Market, 2018 - 2030 (USD Million)
• 6.5. Specialty Pharmacy
  • 6.5.1. Specialty Pharmacy Market, 2018 - 2030 (USD Million)

Chapter 7. Keytruda Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts Trend Analysis, 2018 to 2030
• 7.4. North America
  • 7.4.1. North America Keytruda Market Estimates And Forecasts, By Country, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Keytruda Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Keytruda Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Keytruda Market Estimates and Forecasts, 2018 - 2030 (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. Japan Keytruda Market Estimates and Forecasts, 2018 - 2030 (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. China Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Keytruda Market Estimates and Forecasts, 2017 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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