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

Report Overview

Programmed death-ligand 1 (PD-L1) biomarker testing is a diagnostic method used to detect the expression of PD-L1 proteins on tumor cells or immune cells, primarily to identify patients who may benefit from immune checkpoint inhibitor therapies, such as anti-PD-1/PD-L1 drugs. This testing plays a crucial role in personalized oncology, as PD-L1 expression levels help predict treatment responsiveness in cancers like non-small cell lung cancer (NSCLC), melanoma, and bladder cancer. The test is typically performed via immunohistochemistry (IHC) on tumor tissue samples, with various FDA-approved companion diagnostic assays available, each with distinct scoring criteria. The growing adoption of immunotherapy has driven demand for PD-L1 testing, though challenges such as assay variability, tissue heterogeneity, and evolving clinical guidelines influence its standardization and clinical utility. The market is further shaped by advancements in multiplexed biomarker panels and next-generation sequencing, which aim to improve predictive accuracy beyond PD-L1 alone.

The global PD L1 Biomarker Testing market size was estimated at USD 3960.98 million in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 39.09% 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

PD-

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
2.1.1 Global Pd L1 Biomarker Testing Market Size (M Usd) Estimates And Forecasts (2020-2033)
2.1.2 Global Pd L1 Biomarker Testing Sales Estimates And Forecasts (2020-2033)
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 Sales By Manufacturers (2020-2025)
3.4 Global Pd L1 Biomarker Testing Revenue Market Share By Manufacturers (2020-2025)
3.5 Pd L1 Biomarker Testing Market Share By Company Type (Tier 1, Tier 2, And Tier 3)
3.6 Global Pd L1 Biomarker Testing Average Price By Manufacturers (2020-2025)
3.7 Manufacturers’ Manufacturing Sites, Areas Served, And Product Types
3.8 Pd L1 Biomarker Testing Market Competitive Situation And Trends
3.8.1 Pd L1 Biomarker Testing Market Concentration Rate
3.8.2 Global 5 And 10 Largest Pd L1 Biomarker Testing Players Market Share By Revenue
3.8.3 Mergers & Acquisitions, Expansion
4 Pd L1 Biomarker Testing Industry Chain Analysis
4.1 Pd L1 Biomarker Testing Industry Chain Analysis
4.2 Market Overview Of Key Raw Materials
4.3 Midstream Market Analysis
4.4 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
5.6.1 Global Trade Frictions
5.6.2 U.S. Tariff Policy – April 2025
5.6.3 Global Trade Frictions And Their Impacts To Pd L1 Biomarker Testing Market
5.7 Esg Ratings Of Leading Companies
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 Sales Market Share By Type (2020-2025)
6.3 Global Pd L1 Biomarker Testing Market Size Market Share By Type (2020-2025)
6.4 Global Pd L1 Biomarker Testing Price By Type (2020-2025)
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 Sales By Application (2020-2025)
7.3 Global Pd L1 Biomarker Testing Market Size (M Usd) By Application (2020-2025)
7.4 Global Pd L1 Biomarker Testing Sales Growth Rate By Application (2020-2025)
8 Pd L1 Biomarker Testing Market Sales By Region
8.1 Global Pd L1 Biomarker Testing Sales By Region
8.1.1 Global Pd L1 Biomarker Testing Sales By Region
8.1.2 Global Pd L1 Biomarker Testing Sales Market Share By Region
8.2 Global Pd L1 Biomarker Testing Market Size By Region
8.2.1 Global Pd L1 Biomarker Testing Market Size By Region
8.2.2 Global Pd L1 Biomarker Testing Market Size Market Share By Region
8.3 North America
8.3.1 North America Pd L1 Biomarker Testing Sales By Country
8.3.2 North America Pd L1 Biomarker Testing Market Size By Country
8.3.3 U.S. Market Overview
8.3.4 Canada Market Overview
8.3.5 Mexico Market Overview
8.4 Europe
8.4.1 Europe Pd L1 Biomarker Testing Sales By Country
8.4.2 Europe Pd L1 Biomarker Testing Market Size By Country
8.4.3 Germany Market Overview
8.4.4 France Market Overview
8.4.5 U.K. Market Overview
8.4.6 Italy Market Overview
8.4.7 Spain Market Overview
8.5 Asia Pacific
8.5.1 Asia Pacific Pd L1 Biomarker Testing Sales By Region
8.5.2 Asia Pacific Pd L1 Biomarker Testing Market Size By Region
8.5.3 China Market Overview
8.5.4 Japan Market Overview
8.5.5 South Korea Market Overview
8.5.6 India Market Overview
8.5.7 Southeast Asia Market Overview
8.6 South America
8.6.1 South America Pd L1 Biomarker Testing Sales By Country
8.6.2 South America Pd L1 Biomarker Testing Market Size By Country
8.6.3 Brazil Market Overview
8.6.4 Argentina Market Overview
8.6.5 Columbia Market Overview
8.7 Middle East And Africa
8.7.1 Middle East And Africa Pd L1 Biomarker Testing Sales By Region
8.7.2 Middle East And Africa Pd L1 Biomarker Testing Market Size By Region
8.7.3 Saudi Arabia Market Overview
8.7.4 Uae Market Overview
8.7.5 Egypt Market Overview
8.7.6 Nigeria Market Overview
8.7.7 South Africa Market Overview
9 Pd L1 Biomarker Testing Market Production By Region
9.1 Global Production Of Pd L1 Biomarker Testing By Region(2020-2025)
9.2 Global Pd L1 Biomarker Testing Revenue Market Share By Region (2020-2025)
9.3 Global Pd L1 Biomarker Testing Production, Revenue, Price And Gross Margin (2020-2025)
9.4 North America Pd L1 Biomarker Testing Production
9.4.1 North America Pd L1 Biomarker Testing Production Growth Rate (2020-2025)
9.4.2 North America Pd L1 Biomarker Testing Production, Revenue, Price And Gross Margin (2020-2025)
9.5 Europe Pd L1 Biomarker Testing Production
9.5.1 Europe Pd L1 Biomarker Testing Production Growth Rate (2020-2025)
9.5.2 Europe Pd L1 Biomarker Testing Production, Revenue, Price And Gross Margin (2020-2025)
9.6 Japan Pd L1 Biomarker Testing Production (2020-2025)
9.6.1 Japan Pd L1 Biomarker Testing Production Growth Rate (2020-2025)
9.6.2 Japan Pd L1 Biomarker Testing Production, Revenue, Price And Gross Margin (2020-2025)
9.7 China Pd L1 Biomarker Testing Production (2020-2025)
9.7.1 China Pd L1 Biomarker Testing Production Growth Rate (2020-2025)
9.7.2 China Pd L1 Biomarker Testing Production, Revenue, Price And Gross Margin (2020-2025)
10 Key Companies Profile
10.1 Agilent Technologies
10.1.1 Agilent Technologies Basic Information
10.1.2 Agilent Technologies Pd L1 Biomarker Testing Product Overview
10.1.3 Agilent Technologies Pd L1 Biomarker Testing Product Market Performance
10.1.4 Agilent Technologies Business Overview
10.1.5 Agilent Technologies Swot Analysis
10.1.6 Agilent Technologies Recent Developments
10.2 Roche
10.2.1 Roche Basic Information
10.2.2 Roche Pd L1 Biomarker Testing Product Overview
10.2.3 Roche Pd L1 Biomarker Testing Product Market Performance
10.2.4 Roche Business Overview
10.2.5 Roche Swot Analysis
10.2.6 Roche Recent Developments
10.3 Merck
10.3.1 Merck Basic Information
10.3.2 Merck Pd L1 Biomarker Testing Product Overview
10.3.3 Merck Pd L1 Biomarker Testing Product Market Performance
10.3.4 Merck Business Overview
10.3.5 Merck Swot Analysis
10.3.6 Merck Recent Developments
10.4 Bristol-myers Squibb
10.4.1 Bristol-myers Squibb Basic Information
10.4.2 Bristol-myers Squibb Pd L1 Biomarker Testing Product Overview
10.4.3 Bristol-myers Squibb Pd L1 Biomarker Testing Product Market Performance
10.4.4 Bristol-myers Squibb Business Overview
10.4.5 Bristol-myers Squibb Recent Developments
10.5 Astrazeneca
10.5.1 Astrazeneca Basic Information
10.5.2 Astrazeneca Pd L1 Biomarker Testing Product Overview
10.5.3 Astrazeneca Pd L1 Biomarker Testing Product Market Performance
10.5.4 Astrazeneca Business Overview
10.5.5 Astrazeneca Recent Developments
10.6 Ono Pharmaceutical
10.6.1 Ono Pharmaceutical Basic Information
10.6.2 Ono Pharmaceutical Pd L1 Biomarker Testing Product Overview
10.6.3 Ono Pharmaceutical Pd L1 Biomarker Testing Product Market Performance
10.6.4 Ono Pharmaceutical Business Overview
10.6.5 Ono Pharmaceutical Recent Developments
10.7 Regeneron
10.7.1 Regeneron Basic Information
10.7.2 Regeneron Pd L1 Biomarker Testing Product Overview
10.7.3 Regeneron Pd L1 Biomarker Testing Product Market Performance
10.7.4 Regeneron Business Overview
10.7.5 Regeneron Recent Developments
10.8 Innovent
10.8.1 Innovent Basic Information
10.8.2 Innovent Pd L1 Biomarker Testing Product Overview
10.8.3 Innovent Pd L1 Biomarker Testing Product Market Performance
10.8.4 Innovent Business Overview
10.8.5 Innovent Recent Developments
10.9 Hengrui Medicine
10.9.1 Hengrui Medicine Basic Information
10.9.2 Hengrui Medicine Pd L1 Biomarker Testing Product Overview
10.9.3 Hengrui Medicine Pd L1 Biomarker Testing Product Market Performance
10.9.4 Hengrui Medicine Business Overview
10.9.5 Hengrui Medicine Recent Developments
10.10 Junshi Biosciences
10.10.1 Junshi Biosciences Basic Information
10.10.2 Junshi Biosciences Pd L1 Biomarker Testing Product Overview
10.10.3 Junshi Biosciences Pd L1 Biomarker Testing Product Market Performance
10.10.4 Junshi Biosciences Business Overview
10.10.5 Junshi Biosciences Recent Developments
11 Pd L1 Biomarker Testing Market Forecast By Region
11.1 Global Pd L1 Biomarker Testing Market Size Forecast
11.2 Global Pd L1 Biomarker Testing Market Forecast By Region
11.2.1 North America Market Size Forecast By Country
11.2.2 Europe Pd L1 Biomarker Testing Market Size Forecast By Country
11.2.3 Asia Pacific Pd L1 Biomarker Testing Market Size Forecast By Region
11.2.4 South America Pd L1 Biomarker Testing Market Size Forecast By Country
11.2.5 Middle East And Africa Forecasted Sales Of Pd L1 Biomarker Testing By Country
12 Forecast Market By Type And By Application (2026-2033)
12.1 Global Pd L1 Biomarker Testing Market Forecast By Type (2026-2033)
12.1.1 Global Forecasted Sales Of Pd L1 Biomarker Testing By Type (2026-2033)
12.1.2 Global Pd L1 Biomarker Testing Market Size Forecast By Type (2026-2033)
12.1.3 Global Forecasted Price Of Pd L1 Biomarker Testing By Type (2026-2033)
12.2 Global Pd L1 Biomarker Testing Market Forecast By Application (2026-2033)
12.2.1 Global Pd L1 Biomarker Testing Sales (K Units) Forecast By Application
12.2.2 Global Pd L1 Biomarker Testing Market Size (M Usd) Forecast By Application (2026-2033)
13 Conclusion And Key Findings

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