PD-L1 Biomarker Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global PD-L1 Biomarker Testing Market is projected to expand from USD 771.02 Million in 2025 to USD 1.21 billion by 2031, reflecting a compound annual growth rate of 7.92%. This diagnostic sector focuses on quantifying Programmed Death-Ligand 1 protein expression on tumor cells, a vital step in determining patient suitability for immune checkpoint inhibitor therapies. Market growth is largely fueled by the rising global prevalence of non-small cell lung cancer alongside an increase in regulatory approvals for companion diagnostics, which necessitate specific testing protocols before treatment can commence.

Despite this upward trajectory, market progress is hindered by the substantial financial requirements for deploying advanced diagnostic assays across various healthcare infrastructures. Financial limitations and varied reimbursement structures frequently curb widespread usage, specifically in resource-constrained environments where laboratory facilities are still maturing. Data from the International Association for the Study of Lung Cancer in 2024 indicates that cost remains the leading obstacle to optimal biomarker testing, noted by 27% of respondents globally; this economic challenge causes fluctuations in testing rates, potentially slowing market penetration and obstructing the equitable implementation of precision oncology.

Market Drivers

The escalating global incidence of Non-Small Cell Lung Cancer (NSCLC) acts as a major engine for the PD-L1 biomarker testing market by significantly enlarging the patient population requiring diagnosis. As malignancy rates rise, there is a proportional increase in the demand for diagnostic procedures necessary to verify eligibility for immune checkpoint inhibitor treatments, particularly in leading healthcare markets where enhanced screening efforts are identifying previously undiagnosed cases. The American Lung Association's 'State of Lung Cancer 2024' report from November 2024 projected nearly 235,000 new lung cancer diagnoses in the United States for that year, highlighting the critical need for scalable, routine biomarker testing infrastructure to manage the increasing disease burden.

Additionally, the growing clinical reliance on PD-1 and PD-L1 immune checkpoint inhibitors is accelerating market expansion by solidifying the relationship between therapeutic prescriptions and diagnostic requirements. Because these high-value immunotherapies frequently depend on companion diagnostics to select likely responders, the commercial success of these drugs drives the parallel use of PD-L1 assays. For instance, Merck & Co., Inc. reported in their October 2024 earnings release that global sales of Keytruda rose 17% to $7.4 billion year-over-year, illustrating the heavy integration of these regimens into standard care; furthermore, the International Association for the Study of Lung Cancer noted in September 2024 that 67% of global survey respondents indicated most patients in their nations now receive biomarker testing, reflecting a substantial increase in adoption.

Market Challenges

The expansion of the Global PD-L1 Biomarker Testing Market faces significant obstacles due to the high expense of implementing advanced diagnostic assays and the absence of uniform reimbursement frameworks. While clinical guidelines increasingly require these tests, the heavy financial outlay needed for instrumentation and consumables restricts their adoption, especially within smaller laboratories and public healthcare networks. Consequently, when reimbursement rates do not adequately offset operational costs, healthcare providers are often discouraged from conducting these critical diagnostics, which directly lowers testing volumes and impedes revenue generation for market participants.

This economic divide creates a marked disparity in market penetration between developed nations and developing regions. According to 2024 data from the International Association for the Study of Lung Cancer, only 18.6% of respondents in low- and middle-income countries reported having healthcare system support for biomarker testing, suggesting that the market is limited more by financial infrastructure deficiencies than by a lack of clinical necessity. As a result, the inability to secure sufficient funding and insurance coverage excludes a large segment of the global patient population from testing access, thereby hindering the equitable distribution of precision medicine.

Market Trends

The incorporation of Artificial Intelligence (AI) into diagnostic workflows is transforming the sector by automating PD-L1 scoring to resolve the persistent issue of inter-observer variability found in manual pathology. By standardizing the interpretation of Tumor Proportion Score (TPS) and Combined Positive Score (CPS), algorithms improve the accuracy of patient selection for immunotherapy and detect eligible candidates who might otherwise be overlooked by conventional visual methods. Highlighting this capability, Lunit announced in a May 2025 press release regarding ASCO 2025 that their AI-powered analyzer identified higher PD-L1 expression in 231 non-small cell lung cancer patients who had been previously classified as negative by pathologists, demonstrating the technology's potential to significantly widen the treatable patient pool.

Simultaneously, the market is undergoing a strategic broadening of testing applications to include novel solid tumor indications beyond lung cancer, propelled by evolving regulatory standards and new approvals for companion diagnostics. Manufacturers are actively pursuing certifications for gastrointestinal and gynecological malignancies to match expanding immunotherapy labels, ensuring biomarker testing becomes a standard requirement across a wider range of oncology fields. This trend was reinforced in April 2025, as reported by FirstWord Pharma, when Agilent Technologies secured European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic for gastric or gastroesophageal junction adenocarcinoma, officially extending the assay's regulatory clearance to support treatment eligibility in this high-mortality cancer.

Key Players Profiled in the PD-L1 Biomarker Testing Market

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

Report Scope

In this report, the Global PD-L1 Biomarker Testing Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global PD-L1 Biomarker Testing Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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