According to this study, the global PD-L1 Biomarker Testing market size will reach US$ 28130 million by 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%.
The “PD-L1 Biomarker Testing Industry Forecast” looks at past sales and reviews total world PD-L1 Biomarker Testing sales in 2024, providing a comprehensive analysis by region and market sector of projected PD-L1 Biomarker Testing sales for 2025 through 2031. With PD-L1 Biomarker Testing sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world PD-L1 Biomarker Testing industry.
This Insight Report provides a comprehensive analysis of the global PD-L1 Biomarker Testing landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on PD-L1 Biomarker Testing portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global PD-L1 Biomarker Testing market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for PD-L1 Biomarker Testing and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global PD-L1 Biomarker Testing.
This report presents a comprehensive overview, market shares, and growth opportunities of PD-L1 Biomarker Testing market by product type, application, key players and key regions and countries.
Segmentation by Type:
PD-L1 (22C3)
PD-L1(28-8)
PD-L1 (SP142)
PD-L1 (SP263)
Other
Segmentation by Application:
Hospital
Diagnostic Center
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Agilent Technologies
Roche
Merck
Bristol-Myers Squibb
AstraZeneca
Ono Pharmaceutical
Regeneron
Innovent
Hengrui Medicine
Junshi Biosciences
Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.
1 Scope of the Report
1.1 Market Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 Market Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 Market Estimation Caveats
2 Executive Summary
2.1 World Market Overview
2.1.1 Global PD-L1 Biomarker Testing Market Size (2020-2031)
2.1.2 PD-L1 Biomarker Testing Market Size CAGR by Region (2020 VS 2024 VS 2031)
2.1.3 World Current & Future Analysis for PD-L1 Biomarker Testing by Country/Region (2020, 2024 & 2031)
2.2 PD-L1 Biomarker Testing Segment by Type
2.2.1 PD-L1 (22C3)
2.2.2 PD-L1(28-8)
2.2.3 PD-L1 (SP142)
2.2.4 PD-L1 (SP263)
2.2.5 Other
2.3 PD-L1 Biomarker Testing Market Size by Type
2.3.1 PD-L1 Biomarker Testing Market Size CAGR by Type (2020 VS 2024 VS 2031)
2.3.2 Global PD-L1 Biomarker Testing Market Size Market Share by Type (2020-2025)
2.4 PD-L1 Biomarker Testing Segment by Application
2.4.1 Hospital
2.4.2 Diagnostic Center
2.4.3 Others
2.5 PD-L1 Biomarker Testing Market Size by Application
2.5.1 PD-L1 Biomarker Testing Market Size CAGR by Application (2020 VS 2024 VS 2031)
2.5.2 Global PD-L1 Biomarker Testing Market Size Market Share by Application (2020-2025)
3 PD-L1 Biomarker Testing Market Size by Player
3.1 PD-L1 Biomarker Testing Market Size Market Share by Player
3.1.1 Global PD-L1 Biomarker Testing Revenue by Player (2020-2025)
3.1.2 Global PD-L1 Biomarker Testing Revenue Market Share by Player (2020-2025)
3.2 Global PD-L1 Biomarker Testing Key Players Head office and Products Offered
3.3 Market Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 PD-L1 Biomarker Testing by Region
4.1 PD-L1 Biomarker Testing Market Size by Region (2020-2025)
4.2 Global PD-L1 Biomarker Testing Annual Revenue by Country/Region (2020-2025)
4.3 Americas PD-L1 Biomarker Testing Market Size Growth (2020-2025)
4.4 APAC PD-L1 Biomarker Testing Market Size Growth (2020-2025)
4.5 Europe PD-L1 Biomarker Testing Market Size Growth (2020-2025)
4.6 Middle East & Africa PD-L1 Biomarker Testing Market Size Growth (2020-2025)
5 Americas
5.1 Americas PD-L1 Biomarker Testing Market Size by Country (2020-2025)
5.2 Americas PD-L1 Biomarker Testing Market Size by Type (2020-2025)
5.3 Americas PD-L1 Biomarker Testing Market Size by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC PD-L1 Biomarker Testing Market Size by Region (2020-2025)
6.2 APAC PD-L1 Biomarker Testing Market Size by Type (2020-2025)
6.3 APAC PD-L1 Biomarker Testing Market Size by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe PD-L1 Biomarker Testing Market Size by Country (2020-2025)
7.2 Europe PD-L1 Biomarker Testing Market Size by Type (2020-2025)
7.3 Europe PD-L1 Biomarker Testing Market Size by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa PD-L1 Biomarker Testing by Region (2020-2025)
8.2 Middle East & Africa PD-L1 Biomarker Testing Market Size by Type (2020-2025)
8.3 Middle East & Africa PD-L1 Biomarker Testing Market Size by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 Market Drivers, Challenges and Trends
9.1 Market Drivers & Growth Opportunities
9.2 Market Challenges & Risks
9.3 Industry Trends
10 Global PD-L1 Biomarker Testing Market Forecast
10.1 Global PD-L1 Biomarker Testing Forecast by Region (2026-2031)
10.1.1 Global PD-L1 Biomarker Testing Forecast by Region (2026-2031)
10.1.2 Americas PD-L1 Biomarker Testing Forecast
10.1.3 APAC PD-L1 Biomarker Testing Forecast
10.1.4 Europe PD-L1 Biomarker Testing Forecast
10.1.5 Middle East & Africa PD-L1 Biomarker Testing Forecast
10.2 Americas PD-L1 Biomarker Testing Forecast by Country (2026-2031)
10.2.1 United States Market PD-L1 Biomarker Testing Forecast
10.2.2 Canada Market PD-L1 Biomarker Testing Forecast
10.2.3 Mexico Market PD-L1 Biomarker Testing Forecast
10.2.4 Brazil Market PD-L1 Biomarker Testing Forecast
10.3 APAC PD-L1 Biomarker Testing Forecast by Region (2026-2031)
10.3.1 China PD-L1 Biomarker Testing Market Forecast
10.3.2 Japan Market PD-L1 Biomarker Testing Forecast
10.3.3 Korea Market PD-L1 Biomarker Testing Forecast
10.3.4 Southeast Asia Market PD-L1 Biomarker Testing Forecast
10.3.5 India Market PD-L1 Biomarker Testing Forecast
10.3.6 Australia Market PD-L1 Biomarker Testing Forecast
10.4 Europe PD-L1 Biomarker Testing Forecast by Country (2026-2031)
10.4.1 Germany Market PD-L1 Biomarker Testing Forecast
10.4.2 France Market PD-L1 Biomarker Testing Forecast
10.4.3 UK Market PD-L1 Biomarker Testing Forecast
10.4.4 Italy Market PD-L1 Biomarker Testing Forecast
10.4.5 Russia Market PD-L1 Biomarker Testing Forecast
10.5 Middle East & Africa PD-L1 Biomarker Testing Forecast by Region (2026-2031)
10.5.1 Egypt Market PD-L1 Biomarker Testing Forecast
10.5.2 South Africa Market PD-L1 Biomarker Testing Forecast
10.5.3 Israel Market PD-L1 Biomarker Testing Forecast
10.5.4 Turkey Market PD-L1 Biomarker Testing Forecast
10.6 Global PD-L1 Biomarker Testing Forecast by Type (2026-2031)
10.7 Global PD-L1 Biomarker Testing Forecast by Application (2026-2031)
10.7.1 GCC Countries Market PD-L1 Biomarker Testing Forecast
11 Key Players Analysis
11.1 Agilent Technologies
11.1.1 Agilent Technologies Company Information
11.1.2 Agilent Technologies PD-L1 Biomarker Testing Product Offered
11.1.3 Agilent Technologies PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.1.4 Agilent Technologies Main Business Overview
11.1.5 Agilent Technologies Latest Developments
11.2 Roche
11.2.1 Roche Company Information
11.2.2 Roche PD-L1 Biomarker Testing Product Offered
11.2.3 Roche PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.2.4 Roche Main Business Overview
11.2.5 Roche Latest Developments
11.3 Merck
11.3.1 Merck Company Information
11.3.2 Merck PD-L1 Biomarker Testing Product Offered
11.3.3 Merck PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.3.4 Merck Main Business Overview
11.3.5 Merck Latest Developments
11.4 Bristol-Myers Squibb
11.4.1 Bristol-Myers Squibb Company Information
11.4.2 Bristol-Myers Squibb PD-L1 Biomarker Testing Product Offered
11.4.3 Bristol-Myers Squibb PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.4.4 Bristol-Myers Squibb Main Business Overview
11.4.5 Bristol-Myers Squibb Latest Developments
11.5 AstraZeneca
11.5.1 AstraZeneca Company Information
11.5.2 AstraZeneca PD-L1 Biomarker Testing Product Offered
11.5.3 AstraZeneca PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.5.4 AstraZeneca Main Business Overview
11.5.5 AstraZeneca Latest Developments
11.6 Ono Pharmaceutical
11.6.1 Ono Pharmaceutical Company Information
11.6.2 Ono Pharmaceutical PD-L1 Biomarker Testing Product Offered
11.6.3 Ono Pharmaceutical PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.6.4 Ono Pharmaceutical Main Business Overview
11.6.5 Ono Pharmaceutical Latest Developments
11.7 Regeneron
11.7.1 Regeneron Company Information
11.7.2 Regeneron PD-L1 Biomarker Testing Product Offered
11.7.3 Regeneron PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.7.4 Regeneron Main Business Overview
11.7.5 Regeneron Latest Developments
11.8 Innovent
11.8.1 Innovent Company Information
11.8.2 Innovent PD-L1 Biomarker Testing Product Offered
11.8.3 Innovent PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.8.4 Innovent Main Business Overview
11.8.5 Innovent Latest Developments
11.9 Hengrui Medicine
11.9.1 Hengrui Medicine Company Information
11.9.2 Hengrui Medicine PD-L1 Biomarker Testing Product Offered
11.9.3 Hengrui Medicine PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.9.4 Hengrui Medicine Main Business Overview
11.9.5 Hengrui Medicine Latest Developments
11.10 Junshi Biosciences
11.10.1 Junshi Biosciences Company Information
11.10.2 Junshi Biosciences PD-L1 Biomarker Testing Product Offered
11.10.3 Junshi Biosciences PD-L1 Biomarker Testing Revenue, Gross Margin and Market Share (2020-2025)
11.10.4 Junshi Biosciences Main Business Overview
11.10.5 Junshi Biosciences Latest Developments
12 Research Findings and Conclusion
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*If Applicable.
