Download Sample
Add to CartPD-L1 Biomarker Testing Market
By Cancer Type;
NSCLC, Kidney Cancer, Melanoma, Head & Neck, Bladder Cancer and OthersBy Assay Kit Type;
PD-L1 22C3 IHC, PD-L1 28-8 IHC, PD-L1 SP263 and PD-L1 SP142By End Use;
Research & Development and DiagnosticsBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa and Latin America - Report Timeline (2021 - 2031).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 Period | 2025 - 2031 |
|---|---|
| Base Year | 2024 |
| CAGR (%) | 41.4 % |
| Market Size (2024) | USD 4,005.42 Million |
| Market Size (2031) | USD 45,268.29 Million |
| Market Concentration | Low |
| Report Pages | 318 |
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.
PD-L1 Biomarker Testing Market Recent Developments
-
In June 2020, Merck received the FDA approval for second application for KEYTRUDA (pembrolizumab), for the treatment of patients of all age groups suffering from metastatic tumour mutational burden-high (TMB-H).
-
In May 2020, Agilent Technologies' PD-L1 IHC 28-8 pharmDx was approved by the FDA for diagnosis of NSCLC.
PD-L1 Biomarker Testing Market Segment Analysis
In this report, the PD-L1 Biomarker Testing Market has been segmented by Cancer Type, Assay Kit Type, End Use and Geography.
PD-L1 Biomarker Testing Market, Segmentation by Cancer Type
The Cancer Type segmentation reflects how clinical demand clusters around tumor indications where PD-1/PD-L1 immunotherapies are standard-of-care or rapidly expanding. Stakeholders emphasize companion diagnostics alignment, real-world evidence integration, and regulatory approvals to drive test adoption across oncology pathways. Growth strategies include expanding test menus to adjacent indications, building pathology workflow efficiency, and enhancing sensitivity/specificity through assay optimization, while addressing challenges such as sample heterogeneity and interpretation consistency.
NSCLC
Non-Small Cell Lung Cancer (NSCLC) remains the anchor indication for PD-L1 testing, supported by broad therapy label requirements and well-defined testing algorithms. Vendors focus on pathologist training, automated image analysis, and robust quality control to sustain reliability across high-volume laboratories. Future outlook centers on combining PD-L1 with TMB, genomic alterations, and multi-omic panels to refine patient selection and improve treatment response prediction.
Kidney Cancer
In renal cell carcinoma, PD-L1 testing complements evolving IO-IO and IO-TKI regimens, where biomarker strategies are still being standardized across centers. Market expansion is driven by clinical trial maturation, hospital formulary adoption, and clearer guideline inclusion. Suppliers emphasize assay reproducibility and harmonized reporting to support urology–oncology care teams and streamline multidisciplinary decision-making.
Melanoma
Melanoma laboratories deploy PD-L1 testing as part of broader immuno-oncology workups, often alongside BRAF and other markers to optimize therapy choice. Growth depends on standardized scoring, integration with digital pathology, and streamlined tissue utilization given limited biopsy material. Vendors pursue education partnerships and validation studies to enhance confidence in PD-L1’s role within combination testing paradigms.
Head & Neck
Within head & neck cancers, test utilization is shaped by label indications and tumor microenvironment complexity, prompting laboratories to adopt validated clones and rigorous scoring cut-offs. Strategic priorities include turnaround time reduction, consistent staining performance across batch runs, and closer linkage to clinical pathways. The outlook favors labs that pair PD-L1 with complementary markers and decision support tools to guide therapy sequencing.
Bladder Cancer
In urothelial carcinoma, PD-L1 testing supports eligibility assessment for checkpoint inhibitors, particularly in specific treatment lines and patient subgroups. Adoption advances through pathology standardization, integration with neoadjuvant/adjuvant strategies, and payor recognition of test value. Suppliers differentiate on assay robustness, reagent stability, and interpretation software that improves reproducibility in challenging specimens.
Others
The Others category captures emerging tumor types where PD-L1 may inform trial enrollment or clinical practice in select settings. Market development relies on evidence generation, tumor board engagement, and real-world outcomes to clarify the biomarker’s predictive utility. Vendors position adaptable platforms and cross-indication service models to respond quickly as guidelines and therapy labels evolve.
PD-L1 Biomarker Testing Market, Segmentation by Assay Kit Type
The Assay Kit Type landscape is defined by clinically validated IHC clones that align with specific drug labels and scoring frameworks, making analytical performance and clinical concordance essential purchasing criteria. Laboratories evaluate ease of implementation, instrument compatibility, and workflow efficiency to manage high testing volumes. Partnerships emphasizing training, external quality assessment, and lifecycle support strengthen adoption and ensure consistent, guideline-compliant reporting.
PD-L1 22C3 IHC
The 22C3 assay is widely adopted for indications tied to its companion diagnostic role, driving strong utilization in centers prioritizing label-aligned testing. Strategy focuses on maintaining lot-to-lot consistency, robust staining protocols, and comprehensive interpretation training. Growth is supported by integration with digital image analysis and LIS connectivity that enhance throughput and reporting precision.
PD-L1 28-8 IHC
The 28-8 clone serves laboratories seeking validated alternatives with established clinical utility across selected tumor types. Procurement decisions emphasize inter-assay concordance, instrument support, and clear cut-off guidance. Vendors compete on technical support, documentation depth, and workflow adaptability to ensure reliable results in routine and referral testing.
PD-L1 SP263
SP263 adoption benefits from strong platform integration and performance data across multiple indications, supporting standardization in multi-site networks. Buyers value quality systems, automation-friendly protocols, and pathologist calibration resources. Forward strategies include expanding AI-assisted scoring and harmonization studies that bolster confidence in result comparability.
PD-L1 SP142
The SP142 assay remains relevant in settings where its immune-cell scoring framework is aligned to therapy guidance, though labs often balance it with alternative clones to optimize workflows. Success depends on tailored training, robust controls, and clear SOPs that address interpretation nuances. Vendors emphasize technical reproducibility and ongoing clinical education to sustain utilization.
PD-L1 Biomarker Testing Market, Segmentation by End Use
The End Use segmentation distinguishes between Research & Development and Diagnostics, reflecting different value drivers and procurement behaviors. R&D buyers prioritize assay flexibility, access to new protocols, and data-rich outputs for clinical research and method development. Diagnostic laboratories focus on regulatory compliance, turnaround time, and cost-effective scalability, with strong emphasis on quality assurance and interoperability with existing platforms.
Research & Development
In R&D, PD-L1 testing supports biomarker discovery, trial stratification, and translational studies that refine patient selection. Stakeholders value customizable workflows, robust documentation, and access to advanced analytics for exploratory endpoints. Partnerships with academic centers and biopharma sponsors expand use cases and create a pipeline for eventual diagnostic standardization.
Diagnostics
Within Diagnostics, laboratories require validated kits, consistent staining quality, and streamlined reporting that aligns to therapy labels and guidelines. Growth is enabled by investments in automation, pathologist training, and LIS integration that reduce variability across high-throughput settings. Future development points to AI-enabled scoring and combined biomarker panels that enhance clinical utility and operational efficiency.
PD-L1 Biomarker Testing Market, Segmentation by Geography
In this report, the PD-L1 Biomarker Testing Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
North America
North America demonstrates strong PD-L1 testing penetration driven by comprehensive guidelines, broad therapy access, and high laboratory automation. Growth strategies emphasize digital pathology, AI-assisted scoring, and integration with real-world evidence to support value-based oncology care. Vendors collaborate with reference labs and cancer networks to standardize performance and address variability across multi-site systems.
Europe
Europe balances centralized and decentralized testing models, with emphasis on quality assurance, external proficiency schemes, and cross-border harmonization. Procurement aligns to HTA considerations and national reimbursement policies, shaping kit adoption and platform choice. Forward focus includes inter-assay concordance, streamlined turnaround time, and expanded multi-omic panels within comprehensive cancer centers.
Asia Pacific
Asia Pacific is characterized by heterogeneous adoption, where leading markets invest in infrastructure upgrades, pathologist training, and regional guideline convergence. Partnerships with large hospital systems and government initiatives accelerate capacity building and improve access to companion diagnostics. Outlook points to rapid scaling via platform standardization and localized manufacturing that improves affordability and supply resiliency.
Middle East & Africa
Middle East & Africa is evolving with oncology centers expanding immunotherapy programs and strengthening laboratory capabilities. Priorities include workforce development, robust quality controls, and technology transfer to support sustainable operations. Strategic collaborations with regional hubs and international partners are expected to enhance access, reduce turnaround times, and broaden eligibility testing.
Latin America
Latin America shows steady progress as public and private providers incorporate companion diagnostics into oncology pathways. Market development focuses on reimbursement clarity, centralized testing models to ensure consistent quality, and supplier support for training and maintenance. The future outlook includes greater automation, digital reporting, and participation in multinational trials to strengthen evidence and access.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global PD-L1 Biomarker Testing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Immunotherapy Advancements
- Increasing Cancer Cases
-
Demand for Precision Medicine - The demand for precision medicine has propelled the growth of the global PD-L1 biomarker testing market. PD-L1 biomarker testing plays a crucial role in identifying patients who are likely to respond to immunotherapy treatments, particularly immune checkpoint inhibitors. These treatments have shown remarkable efficacy in various cancers, but not all patients benefit equally. PD-L1 biomarker testing helps oncologists tailor treatments to individual patients, maximizing therapeutic outcomes while minimizing adverse effects.
As cancer treatment evolves towards personalized approaches, the significance of PD-L1 biomarker testing continues to grow. With advancements in technology and increasing understanding of the tumor microenvironment, the scope and accuracy of PD-L1 testing are expanding. This has led to a surge in demand for testing services and related products from both healthcare providers and pharmaceutical companies. Additionally, regulatory approvals and guidelines supporting the use of PD-L1 testing in treatment decision-making further contribute to market growth.
The expanding applications of immunotherapy across various cancer types fuel the demand for PD-L1 biomarker testing. As research uncovers new biomarkers and therapeutic targets, the market is expected to witness continuous innovation and investment. Collaboration between academia, industry, and regulatory bodies also fosters the development and adoption of standardized testing protocols, enhancing the reliability and utility of PD-L1 biomarker testing in clinical practice. In essence, the global PD-L1 biomarker testing market is poised for sustained growth as precision medicine becomes increasingly integral to cancer care.
Restraints
- High Costs of Testing
- Limited Awareness and Access
-
Regulatory Challenges - The global PD-L1 biomarker testing market has seen significant growth in recent years due to its crucial role in guiding immunotherapy treatment decisions for cancer patients. However, this growth has not been without regulatory challenges. One major obstacle is the lack of standardized testing protocols across different laboratories and regions, leading to inconsistencies in results and interpretation. This lack of standardization not only affects the reliability of test results but also complicates the comparison of data between studies and hinders the development of universally accepted guidelines.
Another regulatory challenge facing the PD-L1 biomarker testing market is the evolving landscape of companion diagnostics regulation. Regulatory agencies such as the FDA in the United States and the EMA in Europe are continuously updating their guidelines for the approval and use of companion diagnostics alongside immunotherapy drugs. Keeping up with these evolving regulations and ensuring compliance can be daunting for companies developing PD-L1 tests, particularly smaller firms with limited resources.
The interpretation of PD-L1 expression levels as predictive biomarkers for immunotherapy response remains a subject of debate within the scientific and regulatory communities. While PD-L1 expression has been correlated with better responses to certain immunotherapies, its predictive value is not absolute, and other factors may influence treatment outcomes. Regulatory bodies are grappling with how to incorporate this uncertainty into approval processes and treatment guidelines, further complicating the regulatory landscape for PD-L1 testing.
Opportunities
- Growing Research Investments
- Emerging Markets Expansion
-
Technological Innovations - The global PD-L1 biomarker testing market has witnessed significant advancements driven by technological innovations in recent years. PD-L1 biomarker testing plays a crucial role in cancer diagnosis and treatment decisions, particularly in immunotherapy. Technological innovations have led to the development of more accurate and efficient testing methods, enhancing the reliability of results and improving patient outcomes. From traditional immunohistochemistry techniques to more sophisticated molecular assays, such as polymerase chain reaction (PCR) and next-generation sequencing (NGS), the landscape of PD-L1 testing has expanded, offering clinicians a wider range of options for assessing patient suitability for immunotherapy.
One notable technological innovation in PD-L1 testing is the advent of companion diagnostic assays tailored to specific immunotherapy drugs targeting the PD-1/PD-L1 pathway. These assays help identify patients who are most likely to benefit from treatment, optimizing therapy selection and reducing the risk of adverse reactions. Furthermore, the integration of artificial intelligence (AI) and machine learning algorithms has revolutionized PD-L1 testing by enabling automated image analysis and interpretation, streamlining the testing process, and reducing turnaround times. Such innovations not only improve the efficiency of PD-L1 testing but also contribute to precision medicine by enabling personalized treatment strategies based on individual patient profiles.
Continuous technological advancements are expected to further shape the landscape of PD-L1 biomarker testing, with innovations focused on enhancing test sensitivity, specificity, and scalability. Emerging technologies, including liquid biopsy assays capable of detecting PD-L1 expression in circulating tumor cells or cell-free DNA, hold promise for non-invasive and real-time monitoring of treatment response. Additionally, efforts to standardize PD-L1 testing protocols and establish harmonized guidelines are underway to ensure consistency and reproducibility across different testing platforms and laboratories, fostering confidence in test results and promoting widespread clinical adoption.
PD-L1 Biomarker Testing Market Competitive Landscape Analysis
PD-L1 Biomarker Testing Market is expanding rapidly as diagnostic companies adopt advanced strategies to support precision medicine and immuno-oncology. More than 48% of stakeholders emphasize assay standardization, accuracy, and clinical integration. Strong collaboration, strategic partnerships, and selective mergers are enhancing competitiveness, driving steady growth across laboratories and healthcare institutions.
Market Structure and Concentration
The market reflects moderate concentration, with nearly 53% of share dominated by established diagnostic firms and pharmaceutical alliances. Larger players implement integrated strategies in assay development and companion diagnostics, while smaller firms contribute niche innovation. This balance fosters sustainable growth and long-term expansion across oncology testing platforms.
Brand and Channel Strategies
Around 49% of companies focus on strengthening brand reputation by ensuring clinical reliability and regulatory approvals. Flexible channel strategies include hospital collaborations, diagnostic center partnerships, and digital platforms for test accessibility. Strong collaboration with pharma companies supports adoption, driving growth and reinforcing market credibility.
Innovation Drivers and Technological Advancements
Nearly 58% of firms are investing in technological advancements such as automated immunohistochemistry platforms, multiplex assays, and AI-driven pathology solutions. Innovation aligns with precision medicine strategies, improving diagnostic accuracy and treatment matching. Ongoing partnerships with research institutions are fueling growth and advancing biomarker-based expansion.
Regional Momentum and Expansion
North America leads with more than 55% of testing adoption, supported by oncology strategies and regulatory approvals. Europe emphasizes collaboration in clinical trials and biomarker validation, while Asia-Pacific demonstrates rapid expansion in oncology diagnostics. Regional partnerships between pharma and diagnostic firms are driving strong growth momentum globally.
Future Outlook
The future outlook for PD-L1 biomarker testing indicates robust growth, with nearly 62% of industry leaders prioritizing personalized therapy strategies and advanced diagnostics. Expanding collaboration, pharma-diagnostic partnerships, and continuous innovation will ensure long-term expansion, positioning PD-L1 testing as a cornerstone of precision oncology.
Key players in PD-L1 Biomarker Testing Market include :
- F. Hoffmann-La Roche Ltd.
- Agilent Technologies, Inc.
- Merck & Co., Inc.
- Bristol-Myers Squibb
- Thermo Fisher Scientific
- Abbott Laboratories
- Abcam plc.
- NeoGenomics Laboratories, Inc.
- HalioDx
- Leica Biosystems
- Shuwen Biotech Co. Ltd.
- Bio-Rad Laboratories
- Genentech
- Intas Pharmaceuticals
- QIAGEN
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Cancer Type
- Market Snapshot, By Assay Kit Type
- Market Snapshot, By End Use
- Market Snapshot, By Region
- PD-L1 Biomarker Testing Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Immunotherapy Advancements
- Increasing Cancer Cases
- Demand for Precision Medicine
- Restraints
- High Costs of Testing
- Limited Awareness and Access
- Regulatory Challenges
- Opportunities
- Growing Research Investments
- Emerging Markets Expansion
- Technological Innovations
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- PD-L1 Biomarker Testing Market, By Cancer Type, 2021 - 2031 (USD Million)
- NSCLC
- Kidney Cancer
- Melanoma
- Head & Neck
- Bladder Cancer
- Others
- PD-L1 Biomarker Testing Market, By Assay Kit Type, 2021 - 2031 (USD Million)
- PD-L1 22C3 IHC
- PD-L1 28-8 IHC
- PD-L1 SP263
- PD-L1 SP142
- PD-L1 Biomarker Testing Market, By End Use, 2021 - 2031 (USD Million)
- Research & Development
- Diagnostics
- PD-L1 Biomarker Testing Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- PD-L1 Biomarker Testing Market, By Cancer Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- F. Hoffmann-La Roche Ltd.
- Agilent Technologies, Inc.
- Merck & Co., Inc.
- Bristol-Myers Squibb
- Thermo Fisher Scientific
- Abbott Laboratories
- Abcam plc.
- NeoGenomics Laboratories, Inc.
- HalioDx
- Leica Biosystems
- Shuwen Biotech Co. Ltd.
- Bio-Rad Laboratories
- Genentech
- Intas Pharmaceuticals
- QIAGEN
- Company Profiles
- Analyst Views
- Future Outlook of the Market