PD-1 및 PD-L1 억제제 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the PD-1 and PD-L1 inhibitors market size is projected to be USD 62.12 billion in 2025, USD 74.16 billion in 2026, and reach USD 142.04 billion by 2031, growing at a CAGR of 13.88% from 2026 to 2031.

This report is Segmented by Type of Inhibitors (PD-1 Inhibitors and PD-L1 Inhibitors), Application (Non-Small Cell Lung Cancer, and More), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global PD-1 And PD-L1 Inhibitors Market Trends and Insights

Favorable Regulatory Pathways for Immuno-Oncology Agents

In November 2024, Arcus Biosciences achieved accelerated approval for its drug combination, domvanalimab + zimberelimab, targeting PD-L1-high metastatic NSCLC. This approval is contingent on the company demonstrating survival benefits through Phase III trials by 2027. Similarly, China's conditional approval framework accelerates the approval process for domestic biologics, such as tislelizumab, while requiring post-marketing real-world evidence (RWE) submissions. These expedited pathways reduce early-stage capital risks but also increase exposure to potential withdrawal if critical endpoints are not met. For instance, pembrolizumab's indication for triple-negative breast cancer was rescinded in March 2024 due to unmet endpoints.

Growing Acceptance of Combination Immunotherapies

Dual checkpoint blockade, IO-chemotherapy, and IO-TKI pairings are increasingly replacing monotherapy in cases of low PD-L1 expression or immunologically "cold" tumor microenvironments. The combination of nivolumab and ipilimumab has demonstrated a median overall survival (OS) of 55.7 months in intermediate- or poor-risk renal cell carcinoma (RCC), contributing 18% to Opdivo's 2024 revenue. In the United States, pembrolizumab with chemotherapy accounts for 62% of first-line metastatic non-small cell lung cancer (NSCLC) treatments, driven by its durable 5-year survival benefits. Atezolizumab combined with bevacizumab leads the market for unresectable hepatocellular carcinoma (HCC) and has achieved reimbursement in 47 countries. While triplet regimens are advancing into late-stage trials, challenges such as high-grade toxicities (grades 3-4).

Imminent Loss of Exclusivity for Leading Checkpoint Inhibitors

Nivolumab's core antibody patent expired in July 2026, and pembrolizumab's patent expires in June 2028, with a pediatric extension to December 2028. Eight biosimilar sponsors are in Phase III, but the FDA's 2024 extrapolation guidance may delay multi-indication launches by up to 18 months. Net U.S. price erosion is projected at 25-30% over the two years post-entry, slightly below the adalimumab experience.

Other drivers and restraints analyzed in the detailed report include:

1. Advancements in Predictive Biomarkers and Diagnostics
2. Expanding Clinical Application Across Multiple Tumor Types
3. Stringent Health Technology Assessments on Cost Effectiveness

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

PD-1 agents represented 80.92% of 2025 revenue, reflecting pembrolizumab's leadership across 20 indications and nivolumab's entrenchment in melanoma and RCC. The PD-1 and PD-L1 inhibitor market is projected to grow from USD 60.0 billion in 2026 to USD 108.1 billion by 2031, at a 12.7% CAGR. PD-L1 inhibitors are set to outpace overall expansion, rising 15.43% annually as durvalumab consolidates its role in unresectable stage III NSCLC, and atezolizumab-bevacizumab secures reimbursement for hepatocellular carcinoma in 47 nations.

Durvalumab achieved USD 3.2 billion in global sales in 2024 under the PACIFIC paradigm and faces no direct rivals before the 2032 patent expiry. Atezolizumab captured 48% of first-line HCC starts by mid-2025, lifting its share inside the PD-1 and PD-L1 inhibitors market. Subcutaneous formulations offer further upside: Phase III Tecentriq SC aims for a five-minute injection that could shift infusions to outpatient clinics or even home care.

Complete Report Scope:

• By Type Of Inhibitors
  • PD-1 Inhibitors
  • PD-L1 Inhibitors
• By Application
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Kidney Cancer
  • Hodgkin Lymphoma
  • Other Cancers
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 43.21% of 2025 revenue, driven by Medicare reimbursement and a dense clinical-trial infrastructure. The Inflation Reduction Act will negotiate pembrolizumab prices for 2027, potentially trimming U.S. sales growth to mid-single digits. Canada secured nationwide public reimbursement with an average 35% rebate, while Mexico added pembrolizumab for PD-L1 >= 50% NSCLC but faces supply gaps in smaller states.

Europe placed second at 28% share. Germany and France granted "considerable" or "important" benefit ratings, translating into 15-28% premiums relative to comparators, whereas the U.K. demands deep confidential discounts. Italy's managed-entry contracts and Spain's shorter reimbursement lags facilitate penetration beyond tertiary centers.

Asia-Pacific is projected to add 14.65% CAGR through 2031, propelled by China's domestic quartet-tislelizumab, sintilimab, toripalimab, and serplulimab-priced at 40-60% discounts and now reimbursed nationwide. Japan broadened subsidy ceilings to cut patient co-pays by one-third, boosting initiation among seniors. India green-lit Phase III studies for a local pembrolizumab biosimilar that could arrive by 2027 at 60% lower cost, extending reach into public hospitals.

The Middle East & Africa, plus South America, jointly represent 6% share. The UAE listed pembrolizumab nationally in 2024, and South Africa signed a tech-transfer license with Merck for local manufacture at 70% lower prices. Brazil's ANVISA approved new labels but SUS reimbursement remains pending, limiting access to privately insured patients.

1. Akeso Inc.
2. Amgen
3. Arcus Biosciences
4. AstraZeneca
5. BeiGene Ltd.
6. Bristol-Myers Squibb
7. Coherus BioSciences
8. Daiichi Sankyo Co., Ltd.
9. Eli Lilly and Company
10. Roche
11. GlaxoSmithKline
12. Henlius Biotech
13. Hengrui Medicine
14. Innovent Biologics
15. Leap Therapeutics
16. Merck
17. Novartis
18. Pfizer
19. Regeneron Pharmaceuticals
20. Sanofi
21. Shanghai Junshi Biosciences
22. Zai Lab Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expanding Clinical Application across Multiple Tumor Types
  • 4.2.2 Favorable Regulatory Pathways for Immuno-Oncology Agents
  • 4.2.3 Growing Acceptance of Combination Immunotherapies
  • 4.2.4 Advancements in Predictive Biomarkers and Diagnostics
  • 4.2.5 Increasing Oncology Healthcare Expenditures Worldwide
  • 4.2.6 Rising Partnerships and Licensing Deals in Immuno-Oncology
• 4.3 Market Restraints
  • 4.3.1 High Development and Manufacturing Costs of Monoclonal Antibodies
  • 4.3.2 Imminent Loss of Exclusivity for Leading Checkpoint Inhibitors
  • 4.3.3 Stringent Health Technology Assessments on Cost Effectiveness
  • 4.3.4 Intensifying Competition from Novel Checkpoint Modalities
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power Of Suppliers
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Threat Of New Entrants
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type Of Inhibitors
  • 5.1.1 PD-1 Inhibitors
  • 5.1.2 PD-L1 Inhibitors
• 5.2 By Application
  • 5.2.1 Non-Small Cell Lung Cancer
  • 5.2.2 Melanoma
  • 5.2.3 Kidney Cancer
  • 5.2.4 Hodgkin Lymphoma
  • 5.2.5 Other Cancers
• 5.3 By Distribution Channel
  • 5.3.1 Hospital Pharmacies
  • 5.3.2 Retail Pharmacies
  • 5.3.3 Online Pharmacies
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 Akeso Inc.
  • 6.3.2 Amgen Inc.
  • 6.3.3 Arcus Biosciences
  • 6.3.4 AstraZeneca PLC
  • 6.3.5 BeiGene Ltd.
  • 6.3.6 Bristol-Myers Squibb
  • 6.3.7 Coherus BioSciences
  • 6.3.8 Daiichi Sankyo Co., Ltd.
  • 6.3.9 Eli Lilly And Co.
  • 6.3.10 F. Hoffmann-La Roche AG
  • 6.3.11 GSK Plc
  • 6.3.12 Henlius Biotech
  • 6.3.13 Hengrui Medicine
  • 6.3.14 Innovent Biologics
  • 6.3.15 Leap Therapeutics
  • 6.3.16 Merck & Co.
  • 6.3.17 Novartis AG
  • 6.3.18 Pfizer Inc.
  • 6.3.19 Regeneron Pharmaceuticals Inc.
  • 6.3.20 Sanofi SA
  • 6.3.21 Shanghai Junshi Biosciences
  • 6.3.22 Zai Lab Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment