Global PD-L1 Biomarker Testing Market to Reach USD 1,690.8 Million by 2035 with a CAGR of 8.1%, Driven by Advances in Immunotherapy | FMI

The global PD-L1 biomarker testing market is on a strong growth trajectory, rising from USD 777.2 million in 2025 to USD 1,690.8 million by 2035, at a CAGR of 8.1% during the forecast period.

PD-L1 biomarker testing plays a crucial role in guiding immunotherapy treatments, helping identify patients who would benefit most from immune checkpoint inhibitors. By measuring PD-L1 protein levels in tumor tissues, this test enables a more targeted approach to cancer treatment.

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The increasing adoption of precision medicine and the development of advanced immunotherapies—such as pembrolizumab and nivolumab—are transforming cancer care. As the demand for personalized treatment strategies continues to rise, PD-L1 testing is set to witness significant growth in the coming years.

With ongoing advancements in immunotherapy and increased focus on tailored cancer treatments, the PD-L1 biomarker testing market is poised for substantial expansion, shaping the future of oncology diagnostics and patient care.

Key Cancer Types Driving Market Growth

1. Non-Small Cell Lung Cancer (NSCLC)

NSCLC remains one of the most common and deadly cancers worldwide. PD-L1 testing has become a standard diagnostic tool for NSCLC patients, as high PD-L1 expression is often linked to better responses to immunotherapy. With new drug approvals and ongoing clinical trials, the demand for PD-L1 testing is expected to rise significantly.

1. Melanoma

Melanoma, an aggressive form of skin cancer, has shown remarkable treatment advancements with immune checkpoint inhibitors. PD-L1 expression levels play a key role in treatment selection and patient prognosis, making biomarker testing an integral part of personalized melanoma therapy.

1. Renal Cell Carcinoma (RCC)

PD-L1 biomarker testing is gaining traction in renal cell carcinoma, particularly in combination therapies that involve immune checkpoint inhibitors. As research progresses, PD-L1 testing may become a standardized tool in RCC treatment planning, further driving market expansion.

1. Other Cancer Types

Beyond these major cancers, PD-L1 testing is also being explored in triple-negative breast cancer (TNBC), bladder cancer, head and neck squamous cell carcinoma (HNSCC), and gastroesophageal cancers. The increasing adoption of immunotherapies across diverse cancer types will fuel the market’s growth in the coming years.

Key Takeaways

• The United States is projected to witness a 7.8% Value CAGR from 2025 to 2035.
• Germany is expected to experience a 8.3% Value CAGR during the same period.
• Japan leads the growth trajectory with a 9.1% Value CAGR from 2025 to 2035.
• South Korea is forecasted to grow at a 7.4% Value CAGR over the next decade.
• The United Kingdom (UK) is anticipated to see a 9.3% Value CAGR, marking significant expansion.
• China is set to register a 8.8% Value CAGR between 2025 and 2035.

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Market Trends and Future Outlook (Through 2035)

1. Advancements in Testing Technologies

The PD-L1 testing landscape is evolving with next-generation technologies such as AI-powered pathology, multiplex biomarker analysis, and liquid biopsy techniques. These innovations are expected to enhance accuracy, speed, and accessibility of PD-L1 testing.

1. Regulatory Developments and Approvals

With regulatory agencies such as the FDA and EMA approving new companion diagnostics, the PD-L1 testing market is poised for accelerated growth. Standardization of testing methodologies will be crucial to ensuring consistent and reliable results.

1. Expanding Applications in Combination Therapies

PD-L1 testing is increasingly being used to identify candidates for combination therapies involving checkpoint inhibitors, targeted therapies, and chemotherapy. This expansion into combination treatments will further increase the demand for biomarker testing.

1. Growing Market Penetration in Emerging Regions

While North America and Europe currently dominate the PD-L1 testing market, Asia-Pacific and Latin America are witnessing rapid adoption of biomarker-based precision medicine. Expanding healthcare infrastructure and rising awareness about immunotherapy will contribute to market expansion in these regions.

Competitive Landscape

Companies in this market are employing diverse strategies to maintain their competitive edge. A key focus has been geographical expansion, particularly into emerging markets such as the United States and Asia Pacific, where healthcare infrastructure is rapidly advancing, and awareness is increasing.

Key Players of PD-L1 Biomarker Testing Industry

• F. Hoffmann-La Roche Ltd.
• Agilent Technologies, Inc.
• Merck & Co., Inc.
• Bristol-Myers Squibb
• Thermo Fisher Scientific
• Abcam plc.
• Abbott Laboratories
• NeoGenomics Laboratories, Inc.
• HalioDx
• Intas Pharmaceuticals
• Shuwen Biotech Co. Ltd.
• Leica Biosystems
• Bio-Rad Laboratories
• Genentech

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PD-L1 Biomarker Testing Industry Analysis of Key Segments

By Product Type:

In terms of product type, the industry is divided into PD-L1 22C3 Assay Kit, PD-L1 28-8 Assay Kit, PD-L1 SP142 Assay Kit, PD-L1 263 Assay Kit

By Test:

In terms of test, the industry is segregated into Non-Small Cell Lung Cancer (NSCLC), Melanoma, Renal Cell Carcinoma, Gastrointestinal tract Malignancy, Haematological Malignancies, Ovarian Cancer among Other.

By End User:

In terms of end user, the industry is divided into hospitals, diagnostic laboratories and cancer research institutes.

By Region:

Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle East and Africa (MEA) have been covered in the report.

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