Global PD-L1 Biomarker Testing Market Research Report 2025(Status and Outlook)

Report Overview

PD-L1 biomarker testing is a diagnostic tool used to measure the expression levels of programmed death-ligand 1 (PD-L1) in tumor cells, aiding in the identification of patients who may benefit from immune checkpoint inhibitors, particularly in cancers such as non-small cell lung cancer (NSCLC), melanoma, and bladder cancer. The test is critical for personalized immunotherapy, as PD-L1 expression is a predictive biomarker for response to drugs like pembrolizumab and atezolizumab. The market for PD-L1 biomarker testing has grown significantly due to the rising incidence of cancer, advancements in precision medicine, and increasing adoption of companion diagnostics. Key drivers include the expanding use of immunotherapy, regulatory approvals for PD-L1-based therapies, and the development of standardized assays by companies such as Roche, Agilent, and Dako. However, challenges such as assay variability, interpretation discrepancies, and reimbursement issues may hinder market growth. The competitive landscape features diagnostic firms, pharmaceutical companies, and research institutions collaborating to enhance test accuracy and accessibility. Emerging economies are witnessing increased demand due to improving healthcare infrastructure and awareness, while North America and Europe dominate the market due to established diagnostic frameworks and high immunotherapy adoption rates. Technological innovations, such as AI-powered image analysis and next-generation sequencing, are expected to further refine PD-L1 testing efficiency and reliability.

The global PD-L1 Biomarker Testing market size was estimated at USD 2230.51 million in 2024, exhibiting a CAGR of 12.34% during the forecast period.

This report provides a deep insight into the global PD-L1 Biomarker Testing market covering all its essential aspects. This ranges from a macro overview of the market to micro details of the market size, competitive landscape, development trend, niche market, key market drivers and challenges, SWOT analysis, value chain analysis, etc.

The analysis helps the reader to shape the competition within the industries and strategies for the competitive environment to enhance the potential profit. Furthermore, it provides a simple framework for evaluating and accessing the position of the business organization. The report structure also focuses on the competitive landscape of the Global PD-L1 Biomarker Testing Market, this report introduces in detail the market share, market performance, product situation, operation situation, etc. of the main players, which helps the readers in the industry to identify the main competitors and deeply understand the competition pattern of the market.

In a word, this report is a must-read for industry players, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the PD-L1 Biomarker Testing market in any manner.

Global PD-L1 Biomarker Testing Market: Market Segmentation Analysis

The research report includes specific segments by region (country), manufacturers, Type, and Application. Market segmentation creates subsets of a market based on product type, end-user or application, Geographic, and other factors. By understanding the market segments, the decision-maker can leverage this targeting in the product, sales, and marketing strategies. Market segments can power your product development cycles by informing how you create product offerings for different segments.

Key Company

Agilent Technologies

Roche

Merck

Bristol-Myers Squibb

AstraZeneca

Ono Pharmaceutical

Regeneron

Innovent

Hengrui Medicine

Junshi Biosciences

Market Segmentation (by Type)

PD-L1 (22C3)

PD-L1(28-8)

PD-L1 (SP142)

PD-L1 (SP263)

Other

Market Segmentation (by Application)

Hospital

Diagnostic Center

Others

Geographic Segmentation

North America (USA, Canada, Mexico)

Europe (Germany, UK, France, Russia, Italy, Rest of Europe)

Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)

South America (Brazil, Argentina, Columbia, Rest of South America)

The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

Key Benefits of This Market Research:

Industry drivers, restraints, and opportunities covered in the study

Neutral perspective on the market performance

Recent industry trends and developments

Competitive landscape & strategies of key players

Potential & niche segments and regions exhibiting promising growth covered

Historical, current, and projected market size, in terms of value

In-depth analysis of the PD-L1 Biomarker Testing Market

Overview of the regional outlook of the PD-L1 Biomarker Testing Market:

Chapter Outline

Chapter 1 mainly introduces the statistical scope of the report, market division standards, and market research methods.

Chapter 2 is an executive summary of different market segments (by region, product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the PD-L1 Biomarker Testing Market and its likely evolution in the short to mid-term, and long term.

Chapter 3 makes a detailed analysis of the market's competitive landscape of the market and provides the market share, capacity, output, price, latest development plan, merger, and acquisition information of the main manufacturers in the market.

Chapter 4 is the analysis of the whole market industrial chain, including the upstream and downstream of the industry, as well as Porter's five forces analysis.

Chapter 5 introduces the 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 6 provides the analysis of various market segments according to product types, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.

Chapter 7 provides the analysis of various market segments according to 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 8 provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world.

Chapter 9 shares the main producing countries of PD-L1 Biomarker Testing, their output value, profit level, regional supply, production capacity layout, etc. from the supply side.

Chapter 10 introduces the basic situation of the main companies in the market in detail, including product sales revenue, sales volume, price, gross profit margin, market share, product introduction, recent development, etc.

Chapter 11 provides a quantitative analysis of the market size and development potential of each region in the next five years.

Chapter 12 provides a quantitative analysis of the market size and development potential of each market segment in the next five years.

Chapter 13 is the main points and conclusions of the report.

Key Reasons to Buy this Report:

Access to date statistics compiled by our researchers. These provide you with historical and forecast data, which is analyzed to tell you why your market is set to change

This enables you to anticipate market changes to remain ahead of your competitors

You will be able to copy data from the Excel spreadsheet straight into your marketing plans, business presentations, or other strategic documents

The concise analysis, clear graph, and table format will enable you to pinpoint the information you require quickly

Provision of market value data for each segment and sub-segment

Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market

Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region

Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled

Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players

The current as well as the future market outlook of the industry concerning recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions

Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis

Provides insight into the market through Value Chain

Market dynamics scenario, along with growth opportunities of the market in the years to come


1 Research Methodology and Statistical Scope
1.1 Market Definition and Statistical Scope of PD-L1 Biomarker Testing
1.2 Key Market Segments
1.2.1 PD-L1 Biomarker Testing Segment by Type
1.2.2 PD-L1 Biomarker Testing Segment by Application
1.3 Methodology & Sources of Information
1.3.1 Research Methodology
1.3.2 Research Process
1.3.3 Market Breakdown and Data Triangulation
1.3.4 Base Year
1.3.5 Report Assumptions & Caveats
2 PD-L1 Biomarker Testing Market Overview
2.1 Global Market Overview
2.2 Market Segment Executive Summary
2.3 Global Market Size by Region
3 PD-L1 Biomarker Testing Market Competitive Landscape
3.1 Company Assessment Quadrant
3.2 Global PD-L1 Biomarker Testing Product Life Cycle
3.3 Global PD-L1 Biomarker Testing Revenue Market Share by Company (2020-2025)
3.4 PD-L1 Biomarker Testing Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
3.5 PD-L1 Biomarker Testing Company Headquarters, Area Served, Product Type
3.6 PD-L1 Biomarker Testing Market Competitive Situation and Trends
3.6.1 PD-L1 Biomarker Testing Market Concentration Rate
3.6.2 Global 5 and 10 Largest PD-L1 Biomarker Testing Players Market Share by Revenue
3.6.3 Mergers & Acquisitions, Expansion
4 PD-L1 Biomarker Testing Value Chain Analysis
4.1 PD-L1 Biomarker Testing Value Chain Analysis
4.2 Midstream Market Analysis
4.3 Downstream Customer Analysis
5 The Development and Dynamics of PD-L1 Biomarker Testing Market
5.1 Key Development Trends
5.2 Driving Factors
5.3 Market Challenges
5.4 Industry News
5.4.1 New Product Developments
5.4.2 Mergers & Acquisitions
5.4.3 Expansions
5.4.4 Collaboration/Supply Contracts
5.5 PEST Analysis
5.5.1 Industry Policies Analysis
5.5.2 Economic Environment Analysis
5.5.3 Social Environment Analysis
5.5.4 Technological Environment Analysis
5.6 Global PD-L1 Biomarker Testing Market Porter's Five Forces Analysis
6 PD-L1 Biomarker Testing Market Segmentation by Type
6.1 Evaluation Matrix of Segment Market Development Potential (Type)
6.2 Global PD-L1 Biomarker Testing Market Size Market Share by Type (2020-2025)
6.3 Global PD-L1 Biomarker Testing Market Size Growth Rate by Type (2021-2025)
7 PD-L1 Biomarker Testing Market Segmentation by Application
7.1 Evaluation Matrix of Segment Market Development Potential (Application)
7.2 Global PD-L1 Biomarker Testing Market Size (M USD) by Application (2020-2025)
7.3 Global PD-L1 Biomarker Testing Sales Growth Rate by Application (2020-2025)
8 PD-L1 Biomarker Testing Market Segmentation by Region
8.1 Global PD-L1 Biomarker Testing Market Size by Region
8.1.1 Global PD-L1 Biomarker Testing Market Size by Region
8.1.2 Global PD-L1 Biomarker Testing Market Size Market Share by Region
8.2 North America
8.2.1 North America PD-L1 Biomarker Testing Market Size by Country
8.2.2 U.S.
8.2.3 Canada
8.2.4 Mexico
8.3 Europe
8.3.1 Europe PD-L1 Biomarker Testing Market Size by Country
8.3.2 Germany
8.3.3 France
8.3.4 U.K.
8.3.5 Italy
8.3.6 Spain
8.4 Asia Pacific
8.4.1 Asia Pacific PD-L1 Biomarker Testing Market Size by Region
8.4.2 China
8.4.3 Japan
8.4.4 South Korea
8.4.5 India
8.4.6 Southeast Asia
8.5 South America
8.5.1 South America PD-L1 Biomarker Testing Market Size by Country
8.5.2 Brazil
8.5.3 Argentina
8.5.4 Columbia
8.6 Middle East and Africa
8.6.1 Middle East and Africa PD-L1 Biomarker Testing Market Size by Region
8.6.2 Saudi Arabia
8.6.3 UAE
8.6.4 Egypt
8.6.5 Nigeria
8.6.6 South Africa
9 Key Companies Profile
9.1 Agilent Technologies
9.1.1 Agilent Technologies Basic Information
9.1.2 Agilent Technologies PD-L1 Biomarker Testing Product Overview
9.1.3 Agilent Technologies PD-L1 Biomarker Testing Product Market Performance
9.1.4 Agilent Technologies SWOT Analysis
9.1.5 Agilent Technologies Business Overview
9.1.6 Agilent Technologies Recent Developments
9.2 Roche
9.2.1 Roche Basic Information
9.2.2 Roche PD-L1 Biomarker Testing Product Overview
9.2.3 Roche PD-L1 Biomarker Testing Product Market Performance
9.2.4 Roche SWOT Analysis
9.2.5 Roche Business Overview
9.2.6 Roche Recent Developments
9.3 Merck
9.3.1 Merck Basic Information
9.3.2 Merck PD-L1 Biomarker Testing Product Overview
9.3.3 Merck PD-L1 Biomarker Testing Product Market Performance
9.3.4 Merck SWOT Analysis
9.3.5 Merck Business Overview
9.3.6 Merck Recent Developments
9.4 Bristol-Myers Squibb
9.4.1 Bristol-Myers Squibb Basic Information
9.4.2 Bristol-Myers Squibb PD-L1 Biomarker Testing Product Overview
9.4.3 Bristol-Myers Squibb PD-L1 Biomarker Testing Product Market Performance
9.4.4 Bristol-Myers Squibb Business Overview
9.4.5 Bristol-Myers Squibb Recent Developments
9.5 AstraZeneca
9.5.1 AstraZeneca Basic Information
9.5.2 AstraZeneca PD-L1 Biomarker Testing Product Overview
9.5.3 AstraZeneca PD-L1 Biomarker Testing Product Market Performance
9.5.4 AstraZeneca Business Overview
9.5.5 AstraZeneca Recent Developments
9.6 Ono Pharmaceutical
9.6.1 Ono Pharmaceutical Basic Information
9.6.2 Ono Pharmaceutical PD-L1 Biomarker Testing Product Overview
9.6.3 Ono Pharmaceutical PD-L1 Biomarker Testing Product Market Performance
9.6.4 Ono Pharmaceutical Business Overview
9.6.5 Ono Pharmaceutical Recent Developments
9.7 Regeneron
9.7.1 Regeneron Basic Information
9.7.2 Regeneron PD-L1 Biomarker Testing Product Overview
9.7.3 Regeneron PD-L1 Biomarker Testing Product Market Performance
9.7.4 Regeneron Business Overview
9.7.5 Regeneron Recent Developments
9.8 Innovent
9.8.1 Innovent Basic Information
9.8.2 Innovent PD-L1 Biomarker Testing Product Overview
9.8.3 Innovent PD-L1 Biomarker Testing Product Market Performance
9.8.4 Innovent Business Overview
9.8.5 Innovent Recent Developments
9.9 Hengrui Medicine
9.9.1 Hengrui Medicine Basic Information
9.9.2 Hengrui Medicine PD-L1 Biomarker Testing Product Overview
9.9.3 Hengrui Medicine PD-L1 Biomarker Testing Product Market Performance
9.9.4 Hengrui Medicine Business Overview
9.9.5 Hengrui Medicine Recent Developments
9.10 Junshi Biosciences
9.10.1 Junshi Biosciences Basic Information
9.10.2 Junshi Biosciences PD-L1 Biomarker Testing Product Overview
9.10.3 Junshi Biosciences PD-L1 Biomarker Testing Product Market Performance
9.10.4 Junshi Biosciences Business Overview
9.10.5 Junshi Biosciences Recent Developments
10 PD-L1 Biomarker Testing Market Forecast by Region
10.1 Global PD-L1 Biomarker Testing Market Size Forecast
10.2 Global PD-L1 Biomarker Testing Market Forecast by Region
10.2.1 North America Market Size Forecast by Country
10.2.2 Europe PD-L1 Biomarker Testing Market Size Forecast by Country
10.2.3 Asia Pacific PD-L1 Biomarker Testing Market Size Forecast by Region
10.2.4 South America PD-L1 Biomarker Testing Market Size Forecast by Country
10.2.5 Middle East and Africa Forecasted Sales of PD-L1 Biomarker Testing by Country
11 Forecast Market by Type and by Application (2026-2033)
11.1 Global PD-L1 Biomarker Testing Market Forecast by Type (2026-2033)
11.2 Global PD-L1 Biomarker Testing Market Forecast by Application (2026-2033)
12 Conclusion and Key Findings

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