The global market for PD-L1 Biomarker Testing was estimated to be worth US$ 2815 million in 2024 and is forecast to a readjusted size of US$ 27020 million by 2031 with a CAGR of 38.7% during the forecast period 2025-2031.
PD-L1 Biomarker Testing measures the amount of PDL1 on cancer cells. PDL1 is a protein that helps keep immune cells from attacking nonharmful cells in the body. Normally, the immune system fights foreign substances like viruses and bacteria, and not your own healthy cells. Some cancer cells have high amounts of PDL1. This allows the cancer cells to "trick" the immune system, and avoid being attacked as foreign, harmful substances. Current PD-L1 testing is based on immunohistochemistry (IHC) methods. Immunohistochemistry (IHC) is the process whereby antibodies are used to detect proteins (antigens) in cells within a tissue section (for instance liver, pancreas or the heart). PD-L1 is a ligand that binds to PD-1 (programmed cell death-1), expressed on activated T cells, to evade anti-tumor responses. PD-L1 plays a role in inhibiting T cell activation and proliferation and has emerged as an important target in cancer treatment. PD-L1 protein detection by immunohistochemistry (IHC) testing is widely used as a predictive biomarker assay for anti-PD-1/PD-L1 therapies. PDL1 testing is used to find out if you have a cancer that may benefit from immunotherapy.
The PD-L1 biomarker testing market is being propelled by the rapid expansion of immune checkpoint inhibitor therapies, particularly those targeting the PD-1/PD-L1 axis, which have shown remarkable clinical success in treating various advanced cancers-spurring widespread demand for stratifying patients based on PD-L1 expression to optimize treatment outcomes. Additionally, the shift toward precision medicine has heightened the importance of molecular diagnostics. Clinicians and pharmaceutical developers are increasingly emphasizing personalized approaches, using PD-L1 testing to guide therapeutic decisions and enable companion diagnostics-especially as diagnostic technologies advance to include automated IHC systems, NGS platforms, and AI-enhanced analysis .
Despite these positive trends, the PD-L1 testing landscape faces significant obstacles due to a lack of standardization across protocols, assay clones, scoring systems, and cut-off thresholds. This inconsistency manifests in discordant results (with variability rates reported between 19-32% across different assays), undermining diagnostic reliability and complicating clinical decision-making. Moreover, high costs associated with advanced testing techniques (IHC, NGS) and uneven reimbursement frameworks create economic barriers, particularly in developing regions, impeding broad accessibility and exacerbating healthcare disparities.
The classification of PD-L1 Biomarker Testing includes PD-L1 (22C3), PD-L1 (28-8), PD-L1 (SP142), PD-L1 (SP263) and Other, and the revenue proportion of PD-L1 (22C3) in 2024 is about 21.68%. PD-L1 Biomarker Testing is widely used in Hospital and Diagnostic Laboratories. The most proportion of PD-L1 Biomarker Testing is Hospital, and the proportion in 2024 is about 52.7%.
This report aims to provide a comprehensive presentation of the global market for PD-L1 Biomarker Testing, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of PD-L1 Biomarker Testing by region & country, by Type, and by Application.
The PD-L1 Biomarker Testing market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding PD-L1 Biomarker Testing.
Market Segmentation
By Company
- Agilent Technologies
- Roche
- Merck
- Bristol-Myers Squibb
- AstraZeneca
- Ono Pharmaceutical
- Regeneron
- Innovent
- Hengrui Medicine
- Junshi Biosciences
Segment by Type
- PD-L1 (22C3)
- PD-L1(28-8)
- PD-L1 (SP142)
- PD-L1 (SP263)
- Other
Segment by Application
- Hospital
- Diagnostic Center
- Others
By Region
- North America
- Asia-Pacific
- China
- Japan
- South Korea
- Southeast Asia
- India
- Australia
- Rest of Asia-Pacific
- Europe
- Germany
- France
- U.K.
- Italy
- Netherlands
- Nordic Countries
- Rest of Europe
- Latin America
- Mexico
- Brazil
- Rest of Latin America
- Middle East & Africa
- Turkey
- Saudi Arabia
- UAE
- Rest of MEA
Chapter Outline
Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 2: Detailed analysis of PD-L1 Biomarker Testing company competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 5: Revenue of PD-L1 Biomarker Testing in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 6: Revenue of PD-L1 Biomarker Testing in country level. It provides sigmate data by Type, and by Application for each country/region.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.
Table of Contents
1 Market Overview
- 1.1 PD-L1 Biomarker Testing Product Introduction
- 1.2 Global PD-L1 Biomarker Testing Market Size Forecast (2020-2031)
- 1.3 PD-L1 Biomarker Testing Market Trends & Drivers
- 1.3.1 PD-L1 Biomarker Testing Industry Trends
- 1.3.2 PD-L1 Biomarker Testing Market Drivers & Opportunity
- 1.3.3 PD-L1 Biomarker Testing Market Challenges
- 1.3.4 PD-L1 Biomarker Testing Market Restraints
- 1.4 Assumptions and Limitations
- 1.5 Study Objectives
- 1.6 Years Considered
2 Competitive Analysis by Company
- 2.1 Global PD-L1 Biomarker Testing Players Revenue Ranking (2024)
- 2.2 Global PD-L1 Biomarker Testing Revenue by Company (2020-2025)
- 2.3 Key Companies PD-L1 Biomarker Testing Manufacturing Base Distribution and Headquarters
- 2.4 Key Companies PD-L1 Biomarker Testing Product Offered
- 2.5 Key Companies Time to Begin Mass Production of PD-L1 Biomarker Testing
- 2.6 PD-L1 Biomarker Testing Market Competitive Analysis
- 2.6.1 PD-L1 Biomarker Testing Market Concentration Rate (2020-2025)
- 2.6.2 Global 5 and 10 Largest Companies by PD-L1 Biomarker Testing Revenue in 2024
- 2.6.3 Global Top Companies by Company Type (Tier 1, Tier 2, and Tier 3) & (based on the Revenue in PD-L1 Biomarker Testing as of 2024)
- 2.7 Mergers & Acquisitions, Expansion
3 Segmentation by Type
- 3.1 Introduction by Type
- 3.1.1 PD-L1 (22C3)
- 3.1.2 PD-L1(28-8)
- 3.1.3 PD-L1 (SP142)
- 3.1.4 PD-L1 (SP263)
- 3.1.5 Other
- 3.2 Global PD-L1 Biomarker Testing Sales Value by Type
- 3.2.1 Global PD-L1 Biomarker Testing Sales Value by Type (2020 VS 2024 VS 2031)
- 3.2.2 Global PD-L1 Biomarker Testing Sales Value, by Type (2020-2031)
- 3.2.3 Global PD-L1 Biomarker Testing Sales Value, by Type (%) (2020-2031)
4 Segmentation by Application
- 4.1 Introduction by Application
- 4.1.1 Hospital
- 4.1.2 Diagnostic Center
- 4.1.3 Others
- 4.2 Global PD-L1 Biomarker Testing Sales Value by Application
- 4.2.1 Global PD-L1 Biomarker Testing Sales Value by Application (2020 VS 2024 VS 2031)
- 4.2.2 Global PD-L1 Biomarker Testing Sales Value, by Application (2020-2031)
- 4.2.3 Global PD-L1 Biomarker Testing Sales Value, by Application (%) (2020-2031)
5 Segmentation by Region
- 5.1 Global PD-L1 Biomarker Testing Sales Value by Region
- 5.1.1 Global PD-L1 Biomarker Testing Sales Value by Region: 2020 VS 2024 VS 2031
- 5.1.2 Global PD-L1 Biomarker Testing Sales Value by Region (2020-2025)
- 5.1.3 Global PD-L1 Biomarker Testing Sales Value by Region (2026-2031)
- 5.1.4 Global PD-L1 Biomarker Testing Sales Value by Region (%), (2020-2031)
- 5.2 North America
- 5.2.1 North America PD-L1 Biomarker Testing Sales Value, 2020-2031
- 5.2.2 North America PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
- 5.3 Europe
- 5.3.1 Europe PD-L1 Biomarker Testing Sales Value, 2020-2031
- 5.3.2 Europe PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
- 5.4 Asia Pacific
- 5.4.1 Asia Pacific PD-L1 Biomarker Testing Sales Value, 2020-2031
- 5.4.2 Asia Pacific PD-L1 Biomarker Testing Sales Value by Region (%), 2024 VS 2031
- 5.5 South America
- 5.5.1 South America PD-L1 Biomarker Testing Sales Value, 2020-2031
- 5.5.2 South America PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
- 5.6 Middle East & Africa
- 5.6.1 Middle East & Africa PD-L1 Biomarker Testing Sales Value, 2020-2031
- 5.6.2 Middle East & Africa PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
6 Segmentation by Key Countries/Regions
- 6.1 Key Countries/Regions PD-L1 Biomarker Testing Sales Value Growth Trends, 2020 VS 2024 VS 2031
- 6.2 Key Countries/Regions PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.3 United States
- 6.3.1 United States PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.3.2 United States PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.3.3 United States PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.4 Europe
- 6.4.1 Europe PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.4.2 Europe PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.4.3 Europe PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.5 China
- 6.5.1 China PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.5.2 China PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.5.3 China PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.6 Japan
- 6.6.1 Japan PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.6.2 Japan PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.6.3 Japan PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.7 South Korea
- 6.7.1 South Korea PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.7.2 South Korea PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.7.3 South Korea PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.8 Southeast Asia
- 6.8.1 Southeast Asia PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.8.2 Southeast Asia PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.8.3 Southeast Asia PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
- 6.9 India
- 6.9.1 India PD-L1 Biomarker Testing Sales Value, 2020-2031
- 6.9.2 India PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
- 6.9.3 India PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
7 Company Profiles
- 7.1 Agilent Technologies
- 7.1.1 Agilent Technologies Profile
- 7.1.2 Agilent Technologies Main Business
- 7.1.3 Agilent Technologies PD-L1 Biomarker Testing Products, Services and Solutions
- 7.1.4 Agilent Technologies PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.1.5 Agilent Technologies Recent Developments
- 7.2 Roche
- 7.2.1 Roche Profile
- 7.2.2 Roche Main Business
- 7.2.3 Roche PD-L1 Biomarker Testing Products, Services and Solutions
- 7.2.4 Roche PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.2.5 Roche Recent Developments
- 7.3 Merck
- 7.3.1 Merck Profile
- 7.3.2 Merck Main Business
- 7.3.3 Merck PD-L1 Biomarker Testing Products, Services and Solutions
- 7.3.4 Merck PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.3.5 Merck Recent Developments
- 7.4 Bristol-Myers Squibb
- 7.4.1 Bristol-Myers Squibb Profile
- 7.4.2 Bristol-Myers Squibb Main Business
- 7.4.3 Bristol-Myers Squibb PD-L1 Biomarker Testing Products, Services and Solutions
- 7.4.4 Bristol-Myers Squibb PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.4.5 Bristol-Myers Squibb Recent Developments
- 7.5 AstraZeneca
- 7.5.1 AstraZeneca Profile
- 7.5.2 AstraZeneca Main Business
- 7.5.3 AstraZeneca PD-L1 Biomarker Testing Products, Services and Solutions
- 7.5.4 AstraZeneca PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.5.5 AstraZeneca Recent Developments
- 7.6 Ono Pharmaceutical
- 7.6.1 Ono Pharmaceutical Profile
- 7.6.2 Ono Pharmaceutical Main Business
- 7.6.3 Ono Pharmaceutical PD-L1 Biomarker Testing Products, Services and Solutions
- 7.6.4 Ono Pharmaceutical PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.6.5 Ono Pharmaceutical Recent Developments
- 7.7 Regeneron
- 7.7.1 Regeneron Profile
- 7.7.2 Regeneron Main Business
- 7.7.3 Regeneron PD-L1 Biomarker Testing Products, Services and Solutions
- 7.7.4 Regeneron PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.7.5 Regeneron Recent Developments
- 7.8 Innovent
- 7.8.1 Innovent Profile
- 7.8.2 Innovent Main Business
- 7.8.3 Innovent PD-L1 Biomarker Testing Products, Services and Solutions
- 7.8.4 Innovent PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.8.5 Innovent Recent Developments
- 7.9 Hengrui Medicine
- 7.9.1 Hengrui Medicine Profile
- 7.9.2 Hengrui Medicine Main Business
- 7.9.3 Hengrui Medicine PD-L1 Biomarker Testing Products, Services and Solutions
- 7.9.4 Hengrui Medicine PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.9.5 Hengrui Medicine Recent Developments
- 7.10 Junshi Biosciences
- 7.10.1 Junshi Biosciences Profile
- 7.10.2 Junshi Biosciences Main Business
- 7.10.3 Junshi Biosciences PD-L1 Biomarker Testing Products, Services and Solutions
- 7.10.4 Junshi Biosciences PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
- 7.10.5 Junshi Biosciences Recent Developments
8 Industry Chain Analysis
- 8.1 PD-L1 Biomarker Testing Industrial Chain
- 8.2 PD-L1 Biomarker Testing Upstream Analysis
- 8.2.1 Key Raw Materials
- 8.2.2 Raw Materials Key Suppliers
- 8.2.3 Manufacturing Cost Structure
- 8.3 Midstream Analysis
- 8.4 Downstream Analysis (Customers Analysis)
- 8.5 Sales Model and Sales Channels
- 8.5.1 PD-L1 Biomarker Testing Sales Model
- 8.5.2 Sales Channel
- 8.5.3 PD-L1 Biomarker Testing Distributors
9 Research Findings and Conclusion
10 Appendix
- 10.1 Research Methodology
- 10.1.1 Methodology/Research Approach
- 10.1.1.1 Research Programs/Design
- 10.1.1.2 Market Size Estimation
- 10.1.1.3 Market Breakdown and Data Triangulation
- 10.1.2 Data Source
- 10.1.2.1 Secondary Sources
- 10.1.2.2 Primary Sources
- 10.2 Author Details
- 10.3 Disclaimer