PD-L1 Biomarker Testing Market Report: Trends, Forecast and Competitive Analysis to 2035

PD-L1 Biomarker Testing Market

The future of the global pd-l1 biomarker testing market looks promising with opportunities in the hospital and diagnostic center markets. The global pd-l1 biomarker testing market is expected to reach an estimated $1690.1 million by 2035 from $908.3 million in 2027 with a CAGR of 12.5% from 2027 to 2035. The major drivers for this market are the increasing adoption of personalized cancer treatments, the rising demand for targeted therapies, and the growing awareness of cancer biomarker testing.

• Lucintel forecasts that, within the type category, PD-L1 (22C3) is expected to witness the highest growth over the forecast period due to increased acceptance and clinical use of PD-L1 (22C3).
• Within the application category, diagnostic center is expected to witness higher growth over the forecast period due to anticipated need for companion diagnostics at pathology and laboratory settings.
• In terms of regions, APAC is expected to witness the highest growth over the forecast period due to rising cancer cases and improvements in diagnostic capabilities.

Emerging Trends in PD-L1 Biomarker Testing Market

The market for PD-L1 biomarker testing is expected to shift by 2027, from single-marker tests to more comprehensive, integrated, tumor-notation diagnostics. Simultaneously, immunotherapy drug development will lead to expansion of target indications. According to Lucintel, ongoing and upcoming advances in the field will boost the need for automated, validated biomarker assays. Further, it is anticipated that biomarker tests will be integrated in digital and flow formats, enabling biomarker tests to be conducted in locations other than major academic medical centers.

• in Vitro Testing: In 2025 and beyond, it is expected that PD-L1 testing will be combined with other biomarkers (e.g. HER2, MSI, TMB, RAS, and other genomic markers) to allow for comprehensive tumor characterization and selection of optimal cancer therapies.
• Digital Pathology: Although manual analysis of pathologic specimens is the standard for assessing PD-L1 expression, numerous companies have developed products for automated analysis of PD-L1 and other pathologic biomarkers.
• Liquid Biopsy: PD-L1 will remain a tissue biomarker; however, in 2025-2027, research will focus on the use of liquid biopsy to assess PD-L1 for the same indications as tissue biopsy.
• Expansion of Companion Diagnostics: Continued expansion of checkpoint inhibitors has led to additional labels for multiple assays. Laboratories will need to validate more assays and standardize scoring. The expanded indications cut across multiple tumor types, including lung, breast and gastric.
• Shift To Decentralized Diagnostics: Smaller hospitals and reference laboratories are strengthening their immunohistochemistry capabilities, and larger laboratories are providing off-site PD-L1 testing. PD-L1 testing is particularly important to direct initial (first-line) therapy, and in locations where other molecular testing is not available.

PD-L1 testing is established and standardized, and therefore, will likely continue to improve, integrate and interoperate with other clinical tests. Continued evolution and investment in digital pathology will benefit companies integrating these technologies.

Recent Developments in the PD-L1 Biomarker Testing Market

In the pd-l1 biomarker testing market, there is a shift from single assay pathology to integrated, tumor agnostic, and/or mitigated diagnostic tests. Between 2025 and 2027, Lucintel anticipates a surge in completion of PD-L1 tests due to, among other things, automation of laboratory tests and adjustment of reimbursement policies by health insurance providers. Going forward, Lucintel expects the PD-L1 testing market to be competitive due to the anticipated increase in the number of indications for immunotherapies.

• Expanded Indication and Companion Diagnostic: In January 2025, the U.S. Food and Drug Administration (FDA) granted PD-L1 companion diagnostic status to extend the use of the test to make several decisions about other types of immunotherapies beyond those made for lung cancers.
• Digital Pathology: In March 2025, one of the largest reference laboratories in the world, announced that its pathology group had digitized and Interpreted more than 1 million pathology cases using algorithms to assist PD-L1 interpretation.
• Standardization of Assays: In 2025, multiple studies comparing PD-L1 antibody clones were performed. In the coming years, evidence supporting the inter-laboratory comparison of these antibodies is expected. Such evidence is likely to influence the in-vitro diagnosis industry, including incentivizing investment in decentralized testing.
• Biopharmaceutical Partnerships: In 2025, a collaboration between a biopharmaceutical company and a companion diagnostic company, for two immunotherapies, was announced. It is expected that in the coming years, collaboration for the development of companion diagnostics will increase. Such collaborations are likely to affect the companion diagnostic development process, whereby an assay is co-developed with the biopharmaceutical product.
• Automation of Laboratory Tests: Investments in automating laboratory tests are likely to increase in the coming years. For example, in 2025, a diagnostics company announced an increase in its investment for manufacturing laboratory tests based on immunohistochemistry. Increased automation is expected to positively influence competition between diagnostics companies.

Centers performing PD-L1 tests are expected to increase in the coming years; however, the tests are likely to be more flexible and independent. The integration of digital tools in pathology is expected to facilitate test comparison across different laboratories. The availability of such tests is likely to increase with the market growth of cancer immunotherapy.

Strategic Growth Opportunities in the PD-L1 Biomarker Testing Market

The pd-l1 biomarker testing market is anticipated to grow as immunotherapy becomes an option for the treatment of earlier stages of cancer and as it expands to other cancer types. Through 2026, the market will be favorable because of the requirement for companion diagnostics, the development of multiplex assays, and the need to reduce the use of unnecessary expensive therapies. Lucintel is of the view that market trend will be for integrated, clinically relevant tests and away from individual tests.

• Pd-l1 Assays for Solid Tumors: The completion of pivotal trials for checkpoint inhibitors for several solid cancers will lead to an increase in PD-L1 testing for cancers of the GI, Gynecologic, and Urothelial systems. During the first half of the 2020s, it is anticipated that numerous pivotal trials for checkpoint inhibitors will be initiated and/or completed.
• Standardized High-sensitivity Assays: As Laboratories gain the ability to more consistently and reliably standardize assays, PD-L1 testing will become more widely available. Guidance from CAP and other Organizations will also facilitate the more uniform adoption and interpretation of PD-L1 testing.
• Digital Pathology and AI Scoring: A combination of centralized PD-L1 staining, image analysis, and review will be offered with centralized quality control. The FDA database showed over 1,000 AI-based medical devices in April 2025. Digital pathology will be rapidly adopted to help increase oncology pathway innovation.
• Centralized Testing Services: A shortage of qualified pathologists will force smaller hospitals to outsource PD-L1 testing to central laboratories. There were over 6,000 community hospitals in the U.S. in June 2025. Smaller hospitals will provide tests and other procedures that require specialized pathology. Centralization of pathology will provide smaller hospitals the means to quickly access services that they are not able to provide.
• Expansion of Companion Diagnostics: The PD-L1 test will be used with other companion diagnostics to help determine the eligibility of patients for specific cancer treatments. The FDA has approved over 100 companion diagnostics for use in oncology.

ThepdL1 assay is one of several innovative pathology stains that will help bridge the gap for reimbursement of advanced oncology pathway tests. The first mover advantage will help supplier consolidate their position in the marketplace. The ability to provide reliability and decisions in an efficient manner will help suppliers succeed. There will always be a market for innovative pathology stains.

PD-L1 Biomarker Testing Market Drivers and Challenges

Lucintel analysts noted that the PD-L1 testing market has been rapidly developing due to advances in related technology and the rising incidence of cancer. The expanding use of PD-L1 testing to inform and justify the use of cancer immunotherapy has created a demand for PD-L1 testing. Challenges such as variations in the methodology of PD-L1 testing, equivocal clinical cut-off values, and uneven access to and cost of PD-L1 testing, have affected the market negatively. Lucintel analysts feel the market will be positively impacted by the introduction of new tests, standardization of PD-L1 and other oncology tests and innovations in the field of oncology. Other positive influences on the market will be integration of PD-L1 testing with other omics and pathology testing, and increasing evidence of the clinical relevance of PD-L1 testing.

The factors responsible for driving this market include :

• The Increased Usage of Immunotherapies: With time, the use of immunotherapies and immune checkpoint blockade therapies gained momentum for the treatment of various types of cancers. Due to this, PD-L1 testing also gained importance. As of January 2025, the U.S. Food and Drug Administration (FDA) approved PD-1 and PD-L1 pathway inhibitors for more than 100 oncology indications. However, for a large number of indications, PD-L1 testing is not mandatory.
• Demand for Precision Oncology: The WHO reports that in 2022, about 20 million people were diagnosed with cancer. With a greater appreciation for the types of molecular and immune biomarkers beyond the location of the tumor, more targeted treatment options can be prescribed. The next 3-5 years may bring heightened focus on PD-L1, along with other genomic and tumor mutation analyses, to help address the need for personalized cancer treatment.
• Advances in Technology: Improvements in lab automation, digital pathology and image analysis along with the development of artificial intelligence and other stem cell and biotechnology innovations allow for more reliable evaluation of biomarkers. In the next 3-5 years, continuous improvements in these and other ancillary technologies will help standardize and improve the practice of pathology, especially in places where oncology pathologists are in short supply.
• Positive Regulatory and Clinical Environment: Positive changes in the regulatory and clinical landscapes, along with updated professional guidelines and the requirement for companion diagnostics have and will continue to facilitate the use of PD-L1 assays. The next 3-5 years may bring similar positive changes for other lab developed tests for other cancer treatment innovations.
• Investment in Healthcare Infrastructure: Investments in various healthcare facilities (e.g. cancer centers, reference laboratories, biobanks, and digital pathology) enhance the availability of advanced biomarkers. The International Agency for Research on Cancer (IARC) projected in June 2025 that the annual number of cancer cases would reach 35 million by 2050. The projection highlights the need to increase the capacity to diagnose cancer. The next 3-5 years will see further investments in healthcare, especially in high-growth and high-potential markets. These investments will increase the ability to perform diagnostic tests, ensure the timely processing of samples, and establish regional and interconnected networks of laboratories.

The challenges facing this market include:

• Variability in Assays and Scoring: The variability occurs due to several factors including the platform used, the staining protocol, the quality of the specimen, and the scoring system. As a result, laboratories can obtain different PD-L1 results using the same specimen. In 2025, several scoring systems, such as the tumor proportion score and the combined positive score, were approved for different cancers. In the next 3-5 years, it is expected that the variability in PD-L1 assays will affect the selection of appropriate therapy for cancer patients, increase the need for re-biopsies, and limit the comparability of the results of clinical studies.
• High Costs, Inequity in Cancer Diagnostics: PD-L1 testing is expensive due to several reasons, including the cost of reagents, consumables, and equipment. The World Health Organization has documented that several high-income countries have adequate cancer diagnostic services while several low-income countries do not. It is expected that in the next 3-5 years, smaller hospitals would not be able to afford PD-L1 testing. Centralized testing would increase the average wait time for the results and the overall costs incurred by the patients and the health care system.
• Biological and Clinical Uncertainty: PD-L1 levels can change between different samples from the same person and can also vary based on the stage of the disease. Low or no PD-L1 expression has been reported in patients who responded to immunotherapy. As of September 2025, research focused on improving prediction of patients likely to benefit from immunotherapy by using other sample types (e.g., blood) and integrating multiple biomarkers. In the following years, it is expected that PD-L1 will not be sufficiently reliable to make predictive oncology-related decisions; therefore, other marker combinations will be used. This could also affect the company's decision regarding reimbursement. PD-L1 will most likely maintain its relevance as a biomarker for tumor classification in oncology.

Although PD-L1 test demand will increase due to the expansion of immunotherapy and other oncology-related services, the validation of PD-L1 tests by regulatory agencies and the establishment of PD-L1 testing in clinical oncology by different associations will enhance the PD-L1 testing market. However, biological limits and variability of PD-L1 will impede the expansion of the PD-L1 testing market. The same is expected for other molecular diagnostic tests. The PD-L1 testing market will largely depend on the availability of integrated digital pathology and other precision oncology-related diagnostic platforms and services.

List of PD-L1 Biomarker Testing Market Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies pd-l1 biomarker testing market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the pd-l1 biomarker testing market companies profiled in this report include-

• Agilent Technologies
• Roche
• Merck
• Bristol-Myers Squibb
• AstraZeneca

PD-L1 Biomarker Testing Market by Segment

The study includes a forecast for the global pd-l1 biomarker testing market by type, application, and region.

PD-L1 Biomarker Testing Market by Type [Value ($M) from 2019 to 2035]:

• PD-L1 (22C3)
• PD-L1(28-8)
• PD-L1 (SP142)
• PD-L1 (SP263)
• Others

PD-L1 Biomarker Testing Market by Application [Value ($M) from 2019 to 2035]:

• Hospital
• Diagnostic Center
• Others

PD-L1 Biomarker Testing Market by Region [Value ($M) from 2019 to 2035]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the PD-L1 Biomarker Testing Market

According to Lucintel, companion diagnostics for tumor agnostix PD-L1 will continue to drive growth in the pd-l1 biomarker testing market, and changes to the PD-L1 CDRHregulatory framework and test comparability will become increasingly important from 2025 to 2027. During this time, decentralized, or 'at-site' testing will also gain focus. Lucintel predicts that after 2022, pd-l1 biomarker testing market disruptive innovations will occur at a slower pace and market players will remain focused on established geographies.

• United States: In February 2025, the FDA granted approval to VENTANA PD-L1 (SP263) assay to be used as a companion diagnostic for a subset of non-small cell lung cancers. The approval set the foundation for regulated companion diagnostics in PD-L1 testing. Other indications for the PD-L1 assay were and will be approved in the following years. - China: China's National Medical Products Administration approved the Clinical Impact PD-L1 Assay in June 2025. The PD-L1 assay, developed by Amoy Diagnostics, will increase local testing of PD-L1, and decrease the reliance on imported PD-L1 companion diagnostics.
• Germany: Complying with the EU IVDR in 2025 accelerated the sunset of certain IVDs by 2027. Digital pathology initiatives by Roche and other regional laboratories continued. PD-L1 testing, like other IVDs, will require completed quality systems. This could incentivize a shift to centralized testing laboratories.
• India: In 2025, the collaboration to establish oncology diagnostics and standardize biomarker testing by Thermo Fisher Scientific and the National Cancer Grid of India continued. As the number of participating hospitals and laboratories expands, the increased volume will facilitate the establishment of channeled pathways for PD-L1 and PD-L1 companion diagnostics.
• Japan: PD-L1 testing remained covered by national reimbursement in 2025. The review process of the Pharmaceuticals and Medical Devices Agency on pharmaceutical companion-and diagnostic-device applications also continued in 2025. The alignment of reimbursement and coverage with the review process signals an interest in establish routes for PD-L1 testing to facilitate access to the covered pharmaceuticals.

Features of the Global PD-L1 Biomarker Testing Market

• Market Size Estimates: pd-l1 biomarker testing market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
• Segmentation Analysis: pd-l1 biomarker testing market size by type, application, and region in terms of value ($B).
• Regional Analysis: pd-l1 biomarker testing market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the pd-l1 biomarker testing market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the pd-l1 biomarker testing market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the pd-l1 biomarker testing market by type (PD-L1 (22C3), PD-L1(28-8), PD-L1 (SP142), PD-L1 (SP263), and others), application (hospital, diagnostic center, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?