PD-L1 Biomarker Testing Market

By Product;

PD L1 22C3 Assay Kit, PD L1 28 8 Assay Kit, PD L1 SP142 Assay Kit, and PD L1 SP263 Assay Kit

By Indication;

Gastrointestinal Tract Malignancies, Hematological Malignancies, Melanoma, Non Small Cell Lung Cancer (NSCLC), Ovarian Cancer, and Renal Cell Carcinoma

By End User;

Diagnostic Laboratories, Hospitals, and Specialty Clinics

By Geography;

North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031).
Report ID: Rn867542482 Published Date: June, 2025 Updated Date: July, 2025

PD-L1 Biomarker Testing Market Overview

PD-L1 Biomarker Testing Market (USD Million)

PD-L1 Biomarker Testing Market was valued at USD 4,005.42 million in the year 2024. The size of this market is expected to increase to USD 45,268.29 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 41.4%.


PD-L1 Biomarker Testing Market

*Market size in USD million

CAGR 41.4 %


Study Period2025 - 2031
Base Year2024
CAGR (%)41.4 %
Market Size (2024)USD 4,005.42 Million
Market Size (2031)USD 45,268.29 Million
Market ConcentrationLow
Report Pages318
4,005.42
2024
45,268.29
2031

Major Players

  • Roche Diagnostics
  • Merck & Co., Inc.
  • Bristol Myers Squibb
  • Dako (Agilent Technologies)
  • Abbott Laboratories
  • Thermo Fisher Scientific
  • Bio-Rad Laboratories
  • Qiagen
  • NanoString Technologies
  • Ventana Medical Systems

Market Concentration

Consolidated - Market dominated by 1 - 5 major players

PD-L1 Biomarker Testing Market

Fragmented - Highly competitive market without dominant players


The PD-L1 Biomarker Testing Market is gaining significant attention due to the increasing demand for personalized cancer treatment strategies. With over 60% of immunotherapy treatment plans now relying on biomarker-based diagnostics, PD-L1 testing has become a cornerstone in determining therapeutic response. This demand has created substantial opportunities for laboratories and diagnostic developers focusing on precision medicine.

Technological Advancements in Diagnostic Tools
Advancements in companion diagnostic technologies and automated immunohistochemistry platforms are significantly improving the accuracy and speed of PD-L1 testing. Over 55% of laboratories are transitioning toward high-throughput platforms to enhance efficiency. These innovations are fostering expansion, enabling companies to develop more reliable and reproducible results for critical decision-making in oncology care.

Emerging Opportunities in Cancer Immunotherapy
The surge in immunotherapy approvals is directly influencing the trajectory of the PD-L1 Biomarker Testing Market. With nearly 65% of immuno-oncology drugs requiring PD-L1 status as a criterion, testing services are witnessing strong growth potential. Diagnostic firms are adopting aggressive strategies to increase service reach and support oncologists in selecting the most effective treatment protocols.

Future Outlook and Expansion Prospects
The future of the market shows clear potential for long-term expansion, especially with over 70% of cancer care centers integrating PD-L1 testing as a routine diagnostic approach. Innovations in AI-powered analysis and next-generation pathology tools are expected to improve clinical efficiency and interpretation. The market’s future outlook remains positive as the healthcare sector continues to prioritize targeted therapies supported by robust biomarker testing infrastructure.

  1. Introduction
    1. Research Objectives and Assumptions
    2. Research Methodology
    3. Abbreviations
  2. Market Definition & Study Scope
  3. Executive Summary
    1. Market Snapshot, By Product
    2. Market Snapshot, By Indication
    3. Market Snapshot, By End-user
    4. Market Snapshot, By Region
  4. PD-L1 Biomarker Testing Market Dynamics
    1. Drivers, Restraints and Opportunities
      1. Drivers
        1. Immunotherapy Advancements
        2. Increasing Cancer Cases
        3. Demand for Precision Medicine
      2. Restraints
        1. High Costs of Testing
        2. Limited Awareness and Access
        3. Regulatory Challenges
      3. Opportunities
        1. Growing Research Investments
        2. Emerging Markets Expansion
        3. Technological Innovations
    2. PEST Analysis
      1. Political Analysis
      2. Economic Analysis
      3. Social Analysis
      4. Technological Analysis
    3. Porter's Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of Substitutes
      4. Threat of New Entrants
      5. Competitive Rivalry
  5. Market Segmentation
    1. PD-L1 Biomarker Testing Market, By Product, 2021 - 2031 (USD Million)
      1. PD-L1 22C3 Assay Kit
      2. PD-L1 28-8 Assay Kit
      3. PD-L1 SP142 Assay Kit
      4. PD-L1 SP263 Assay Kit
    2. PD-L1 Biomarker Testing Market, By Indication, 2021 - 2031 (USD Million)
      1. Non-small Cell Lung Cancer (NSCLC)
      2. Melanoma
      3. Renal Cell Carcinoma
      4. Gastrointestinal Tract Malignancies
      5. Ovarian Cancer
      6. Hematological Malignancies
    3. PD-L1 Biomarker Testing Market, By End-user, 2021 - 2031 (USD Million)
      1. Hospitals
      2. Diagnostic Laboratories
      3. Specialty Clinics
    4. PD-L1 Biomarker Testing Market, By Geography, 2021 - 2031 (USD Million)
      1. North America
        1. United States
        2. Canada
      2. Europe
        1. Germany
        2. United Kingdom
        3. France
        4. Italy
        5. Spain
        6. Nordic
        7. Benelux
        8. Rest of Europe
      3. Asia Pacific
        1. Japan
        2. China
        3. India
        4. Australia & New Zealand
        5. South Korea
        6. ASEAN (Association of South East Asian Countries)
        7. Rest of Asia Pacific
      4. Middle East & Africa
        1. GCC
        2. Israel
        3. South Africa
        4. Rest of Middle East & Africa
      5. Latin America
        1. Brazil
        2. Mexico
        3. Argentina
        4. Rest of Latin America
  6. Competitive Landscape
    1. Company Profiles
      1. Roche Diagnostics
      2. Merck & Co., Inc.
      3. Bristol Myers Squibb
      4. Dako (Agilent Technologies)
      5. Abbott Laboratories
      6. Thermo Fisher Scientific
      7. Bio-Rad Laboratories
      8. Qiagen
      9. NanoString Technologies
      10. Ventana Medical Systems
  7. Analyst Views
  8. Future Outlook of the Market