PD-L1 Biomarker Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Cancer Type (NSCLC, Kidney Cancer, Melanoma, Head and Neck, Bladder Cancer, Others), By Assay Kit Type (PD-L1 22C3 IHC, PD-L1 28-8 IHC, PD-L1 SP263, PD-L1 SP142), By End Use (Research and Development, Diagnostics), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 771.02 Million
CAGR (2026-2031)	7.92%
Fastest Growing Segment	Research and Development
Largest Market	North America
Market Size (2031)	USD 1218.08 Million

Market Overview

The Global PD-L1 Biomarker Testing Market will grow from USD 771.02 Million in 2025 to USD 1218.08 Million by 2031 at a 7.92% CAGR. PD-L1 biomarker testing constitutes a diagnostic procedure designed to quantify Programmed Death-Ligand 1 protein expression on tumor cells, serving as a critical determinant for patient eligibility regarding immune checkpoint inhibitor therapies. The market is primarily propelled by the escalating global incidence of non-small cell lung cancer and the concurrent expansion of regulatory approvals for companion diagnostics, which mandate specific testing protocols prior to treatment administration.

However, market expansion is impeded by the significant financial burden associated with implementing advanced diagnostic assays across diverse healthcare systems. Financial constraints and inconsistent reimbursement models often restrict widespread adoption, particularly in resource-limited settings where laboratory infrastructure is developing. According to the International Association for the Study of Lung Cancer, in 2024, cost remained the primary barrier to optimal biomarker testing, cited by 27% of global respondents. This economic hurdle creates variability in testing rates, potentially stalling market reach and hindering the equitable delivery of precision oncology.

Key Market Drivers

The surging global prevalence of Non-Small Cell Lung Cancer (NSCLC) functions as a primary catalyst for the PD-L1 biomarker testing market, fundamentally expanding the target patient population. As the incidence of malignancies increases, the volume of diagnostic procedures required to determine eligibility for immune checkpoint inhibitor therapies scales proportionally. This demand is particularly acute in major healthcare markets where screening initiatives are intensifying to capture undiagnosed cases. According to the American Lung Association, November 2024, in the 'State of Lung Cancer 2024' report, close to 235,000 individuals in the United States were projected to be diagnosed with lung cancer in 2024, a statistic that underscores the immense necessity for scalable and routine biomarker testing infrastructure to accommodate the growing burden of disease.

Furthermore, the increasing clinical adoption of PD-1 and PD-L1 immune checkpoint inhibitors is directly accelerating market growth by cementing the link between therapeutic prescription and diagnostic prerequisites. Since these high-value immunotherapies often rely on companion diagnostics to identify potential responders, the commercial success of the drugs drives the concurrent utilization of PD-L1 assays. According to Merck & Co., Inc., October 2024, in the 'Third-Quarter 2024 Earnings' report, worldwide sales of the anti-PD-1 therapy Keytruda grew 17% to $7.4 billion compared to the prior year, reflecting the heavy reliance on these regimens in standard care. This therapeutic uptake is driving higher diagnostic compliance; according to the International Association for the Study of Lung Cancer, September 2024, in the '2024 Global Survey on Biomarker Testing', 67% of global respondents reported that the majority of patients in their country now undergo biomarker testing, marking a significant rise in adoption.

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Key Market Challenges

The high cost of implementing advanced diagnostic assays and the lack of consistent reimbursement models serve as a formidable barrier to the expansion of the Global PD-L1 Biomarker Testing Market. Although clinical guidelines increasingly mandate these tests, the substantial financial burden associated with acquiring necessary instrumentation and consumables limits adoption, particularly in smaller laboratories and public healthcare systems. When reimbursement rates fail to cover the operational costs of testing, healthcare providers are disincentivized from offering these essential diagnostics, directly reducing the volume of tests administered and stalling revenue growth for market stakeholders.

This economic disconnect creates a severe disparity in market penetration between developed and developing regions. According to the International Association for the Study of Lung Cancer, in 2024, only 18.6% of respondents from low- and middle-income countries reported having healthcare system support for biomarker testing. This statistic highlights that in many parts of the world, the market is effectively capped by a lack of financial infrastructure rather than a lack of clinical demand. Consequently, the inability to secure adequate funding and coverage prevents a significant portion of the global patient population from undergoing testing, thereby hampering the equitable delivery of precision medicine.

Key Market Trends

The integration of Artificial Intelligence (AI) for automated PD-L1 scoring is fundamentally reshaping diagnostic workflows by addressing the critical challenge of inter-observer variability in manual pathology. Algorithms are increasingly deployed to standardize Tumor Proportion Score (TPS) and Combined Positive Score (CPS) interpretation, thereby enhancing the precision of patient selection for immunotherapy and identifying eligible candidates who might be misclassified by traditional visual assessment. This technological shift is proving essential for uncovering "hidden" responders in complex tissue samples where human quantification may lack sensitivity. According to Lunit, May 2025, in the 'Lunit Highlights AI's Role in Advancing Precision Oncology at ASCO 2025 with 12 Studies' press release, a validation study involving non-small cell lung cancer samples revealed that their AI-powered analyzer detected higher PD-L1 expression in 231 patients who had been initially classified as negative (TPS <1%) by pathologists, demonstrating the technology's capacity to significantly expand the treatable patient population.

Concurrently, the market is witnessing a strategic expansion of testing applications into novel solid tumor indications beyond lung cancer, driven by evolving regulatory frameworks and new companion diagnostic approvals. Manufacturers are aggressively securing certifications for gastrointestinal and gynecological malignancies to align with widening immunotherapy labels, ensuring that biomarker testing becomes a prerequisite across a broader spectrum of oncology. This trend is exemplified by recent regulatory milestones in Europe that mandate rigorous compliance for these expanded indications. According to FirstWord Pharma, April 2025, in the article 'Agilent wins EU nod for Keytruda companion test in gastric cancer', Agilent Technologies received European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic for gastric or gastroesophageal junction adenocarcinoma, formally extending the assay's regulatory clearance to support therapeutic eligibility in this high-mortality cancer type.

Segmental Insights

The Research and Development segment represents the fastest growing category in the Global PD-L1 Biomarker Testing Market due to an intensified focus on immunotherapy clinical trials. Pharmaceutical companies are investing significantly in biomarker validation to meet the rigorous approval standards set by regulatory bodies like the US Food and Drug Administration. This necessity to demonstrate therapeutic efficacy through precise patient selection compels researchers to incorporate PD-L1 testing early in drug development pipelines. Additionally, the continuous exploration of new cancer indications for immune checkpoint inhibitors ensures a sustained increase in testing volume within this sector.

Regional Insights

North America commands the leading position in the global PD-L1 biomarker testing market, driven by the widespread integration of precision oncology into standard medical practice. This regional dominance is supported by a favorable regulatory environment, where the U.S. Food and Drug Administration (FDA) actively grants approval for companion diagnostic tests required for specific immunotherapy prescriptions. These regulatory milestones ensure that biomarker testing becomes a routine step in patient care pathways. Furthermore, the strong presence of major pharmaceutical and diagnostic companies in the United States facilitates broad access to these essential testing services, reinforcing the market leadership of North America.

Recent Developments

• In December 2024, Agilent Technologies Inc. announced that it received a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for its PD-L1 IHC 28-8 pharmDx assay. This certification allows the assay to be used in the European Union for nine cancer indications, including non-small cell lung cancer (NSCLC), muscle-invasive urothelial carcinoma, and gastric adenocarcinoma. The PD-L1 IHC 28-8 pharmDx test is a critical tool for identifying patients who may benefit from PD-1 targeted immunotherapies, such as nivolumab, and the new certification ensures its continued availability and compliance with the latest European regulatory standards for diagnostic medical devices.
• In December 2024, Bristol Myers Squibb received approval from the U.S. Food and Drug Administration (FDA) for a subcutaneous formulation of nivolumab, marketed as Opdivo Qvantig, for all previously approved adult solid tumor indications. This new product launch is significant for the PD-L1 testing market as the drug's label includes indications for non-small cell lung cancer, gastric cancer, and esophageal squamous cell carcinoma, where PD-L1 biomarker expression levels are often required to determine patient eligibility. The availability of a more convenient administration method is expected to support the continued demand for associated PD-L1 companion diagnostic testing in clinical practice.
• In September 2024, Lunit announced a strategic partnership with Roche to integrate its artificial intelligence-powered PD-L1 analysis tool, Lunit SCOPE PD-L1, into Roche’s navify Digital Pathology platform. This collaboration aims to enhance the accuracy and consistency of PD-L1 tumor proportion score (TPS) assessment, which is a key biomarker for selecting patients for immunotherapy. By incorporating Lunit’s AI algorithms into Roche’s widely used digital pathology ecosystem, the companies intend to address the challenges of inter-observer variability among pathologists and improve the workflow for biomarker testing in non-small cell lung cancer and other solid tumors.
• In May 2024, PathAI unveiled a new artificial intelligence-powered product, PathExplore IOP (Immuno-Oncology Profiling), ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting. This new tool was designed to provide spatial resolution and characterization of the tumor microenvironment, including the quantification of tumor-infiltrating lymphocytes, from routine pathology samples. While distinct from traditional PD-L1 staining, the launch of this platform represents a technological advancement in the broader immuno-oncology biomarker market, offering researchers complementary insights to PD-L1 status for stratifying patient responses to checkpoint inhibitor therapies in cancers such as non-small cell lung cancer.

Key Market Players

• AstraZeneca PLC
• Merck Group
• F. Hoffmann-La Roche Ltd.
• Abcam
• Agilent technologies
• NeoGenomics Laboratories, Inc.
• ACROBiosystems
• PerkinElmer Inc.
• Guardant Health
• Quanterix

By Cancer Type	By Assay Kit Type	By End Use	By Region
NSCLC Kidney Cancer Melanoma Head and Neck Bladder Cancer Others	PD-L1 22C3 IHC PD-L1 28-8 IHC PD-L1 SP263 PD-L1 SP142	Research and Development Diagnostics	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global PD-L1 Biomarker Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• PD-L1 Biomarker Testing Market, By Cancer Type:

• NSCLC
• Kidney Cancer
• Melanoma
• Head and Neck
• Bladder Cancer
• Others

• PD-L1 Biomarker Testing Market, By Assay Kit Type:

• PD-L1 22C3 IHC
• PD-L1 28-8 IHC
• PD-L1 SP263
• PD-L1 SP142

• PD-L1 Biomarker Testing Market, By End Use:

• Research and Development
• Diagnostics

• PD-L1 Biomarker Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE