The global immuno-oncology biomarkers market was valued at USD 5.42 billion in 2025. The market is estimated at USD 6.01 billion in 2026 and is projected to reach USD 16.38 billion by 2036, at a CAGR of 10.5% during the forecast period 2026-2036. This report provides a detailed assessment of the market, covering biomarker science and scoring systems, companion diagnostic approvals, regulation and reimbursement, the immunotherapy pipeline, pricing, and the supplier landscape.
The market covers products and services that measure tumor and blood biomarkers to help clinicians select patients for cancer immunotherapy, choose among regimens, and track whether treatment is working. This includes PD-L1 and mismatch repair (MMR) immunohistochemistry (IHC) assays, next-generation sequencing (NGS) tests for tumor mutational burden (TMB) and microsatellite instability (MSI), PCR-based MSI assays, immune gene expression signatures, multiplex and spatial tissue assays, circulating tumor DNA (ctDNA) monitoring tests, and AI scoring software. Biomarkers used only for targeted therapy selection, cancer screening tests, and general pathology products with no immuno-oncology use are excluded.
Agilent's PD-L1 IHC 22C3 pharmDx gained FDA approval in February 2026 as a companion test for KEYTRUDA (pembrolizumab) in ovarian, fallopian tube, and primary peritoneal carcinoma, the first immuno-oncology approval in that disease, and the FDA then added esophageal and gastroesophageal junction cancers in March 2026, giving the assay eight approved KEYTRUDA indications. Natera, maker of the Signatera tumor-informed ctDNA test, reported second-quarter 2026 revenue of USD 752.8 million, up 37.7%, on roughly 296,700 oncology tests, and Medicare has issued a draft local coverage determination supporting Signatera for immunotherapy response monitoring.
Current biomarkers predict benefit imperfectly, since some PD-L1-negative patients respond to immunotherapy, many PD-L1-positive patients do not, and TMB cutoffs perform unevenly across tumors, so some regimens are approved without a biomarker requirement. Laboratories must also handle several PD-L1 clones, platforms, cutoffs, and scoring methods, which adds workload and creates variation between sites. Scarce tissue in advanced disease, long turnaround for broad panels, and the costly utility studies needed to win reimbursement for gene signatures, spatial markers, and ctDNA monitoring are further challenges.
Novel immunotherapies offer a significant opportunity, since bispecific antibodies, cell therapies, cancer vaccines, and LAG-3 and TIGIT inhibitors will each need biomarkers to find likely responders, favoring diagnostic firms that partner with drug developers early. Spatial assays that measure dozens of proteins in one tissue section, AI scoring of PD-L1 and tumor-infiltrating lymphocytes, and wider immunotherapy access in Asia-Pacific are other openings. Key trends include the consolidation of IHC onto automated stainers, combined reporting of PD-L1 with genomic TMB and MSI results, and the routine use of ctDNA monitoring during immunotherapy.
By offering, the immuno-oncology biomarkers market is segmented into assays & kits, testing services, instruments, and software & digital pathology solutions. Assays & kits are expected to account for the largest share in 2026, as PD-L1 and MMR IHC kits are used in pathology laboratories worldwide, companion diagnostic labels make specific kits a testing requirement, and reagents are consumed for every patient. Software & digital pathology solutions are expected to grow at the highest CAGR, supported by digital pathology adoption, AI tools that score PD-L1 and immune cells, and the need to reduce differences between pathologists. Testing services should also grow strongly as reference laboratories add profiling and ctDNA work.
By biomarker type, the immuno-oncology biomarkers market is segmented into PD-L1, tumor mutational burden (TMB), MSI & mismatch repair deficiency, ctDNA-based response monitoring biomarkers, gene expression signatures, tumor-infiltrating lymphocytes (TILs) & immune cell profiling, and other biomarkers. PD-L1 is expected to hold the largest share in 2026, as it is a companion or complementary diagnostic for several checkpoint inhibitors across many tumor types. ctDNA-based response monitoring biomarkers are expected to grow at the highest CAGR, driven by evidence that ctDNA changes reveal response before imaging, draft Medicare coverage for Signatera, and rising oncology test volumes at Natera. MSI & mismatch repair deficiency testing should also grow strongly, helped by tumor-agnostic labels and checkpoint inhibitor use in dMMR colorectal and endometrial tumors.
By technology, the immuno-oncology biomarkers market is segmented into immunohistochemistry (IHC), next-generation sequencing (NGS), PCR, multiplex immunofluorescence & spatial profiling, and other technologies. Immunohistochemistry is expected to account for the largest share in 2026, as PD-L1 and MMR staining is part of routine pathology work, the method is inexpensive, and it fits existing workflows and stainers. Next-generation sequencing is expected to register the highest CAGR, as genomic profiling that reports TMB and MSI becomes standard in advanced cancers, blood-based profiling helps patients with too little tissue, and NGS-based ctDNA monitoring is expanding. Spatial profiling is small today but should expand as spatial signatures are clinically validated.
By cancer type, the immuno-oncology biomarkers market is segmented into non-small cell lung cancer (NSCLC), melanoma, gastrointestinal cancers, breast cancer, head & neck cancer, genitourinary cancers, gynecologic cancers, and other cancers. Non-small cell lung cancer is expected to account for the largest share in 2026, reflecting high lung cancer incidence, checkpoint inhibitor use across treatment lines, and the established role of PD-L1 testing in choosing therapy. Gynecologic cancers are expected to grow at the highest CAGR, supported by immunotherapy in dMMR endometrial and PD-L1-positive cervical cancer and the February 2026 approval that brought the first immuno-oncology indication to ovarian cancer. Gastrointestinal cancers add demand through new esophageal indications and colorectal MSI testing.
By application, the immuno-oncology biomarkers market is segmented into companion and complementary diagnostics, treatment response monitoring, prognostic testing, and drug discovery & clinical development. Companion and complementary diagnostics are expected to account for the largest share in 2026, as most testing decides whether a patient qualifies for checkpoint inhibitor therapy, new indications usually come with a linked test, and testing is repeated for every eligible patient. Treatment response monitoring is expected to grow at the highest CAGR, driven by ctDNA monitoring during immunotherapy, the difficulty of reading scans during pseudoprogression, and emerging Medicare coverage. Drug discovery & clinical development should grow strongly as drug developers fund biomarker work for new immunotherapies.
By end user, the immuno-oncology biomarkers market is segmented into hospitals & pathology laboratories, reference laboratories, pharmaceutical & biotechnology companies, and academic & research institutes. Hospitals & pathology laboratories are expected to account for the largest share in 2026, as PD-L1 and MMR IHC are run routinely in hospital pathology departments, where tissue is processed and stainers are installed. Reference laboratories are expected to grow at the highest CAGR, supported by the expansion of genomic profiling and ctDNA services at specialized laboratories and the shift toward multi-biomarker panels. Drug developers remain key buyers through companion diagnostic co-development and trial testing.
North America is set to hold the largest share of the immuno-oncology biomarkers market in 2026, supported by broad checkpoint inhibitor use, a large number of FDA-approved companion diagnostics, high uptake of genomic profiling and ctDNA testing, established reimbursement, and home-based suppliers such as Agilent, Foundation Medicine, Caris Life Sciences, Guardant Health, Natera, and NeoGenomics. Canada adds demand through provincial cancer agencies and expanding biomarker testing. Europe holds a significant share, backed by high cancer incidence, broad immunotherapy access, and strong hospital pathology networks, and the EU In Vitro Diagnostic Regulation favors CE-IVD assays from established makers; the leading national markets are Germany, the U.K., France, Italy, Spain, and the Netherlands.
Asia-Pacific is projected to post the highest CAGR through 2036, owing to the high burden of lung, gastric, esophageal, and liver cancers, more approvals and reimbursement for domestic and imported checkpoint inhibitors, and growing NGS capacity. China is expected to hold the largest share in the region, helped by many local immunotherapies and a large genomics industry, while Japan, where national insurance covers genomic profiling for eligible patients, South Korea, India, and Australia are set for strong growth. Latin America, led by Brazil and Mexico, and the Middle East & Africa, led by Saudi Arabia, the UAE, and Israel, hold smaller shares.
The immuno-oncology biomarkers market is moderately consolidated, as a small group of tissue diagnostics firms dominates PD-L1 and MMR staining while genomic profiling providers, ctDNA specialists, NGS suppliers, and digital pathology firms compete in other parts of the testing workflow. Competition centers on companion labels and drug developer partnerships, assay accuracy and automation, biomarker range, speed, and reimbursement. Leaders are adding labels, automating assays, and building ctDNA and AI pathology offerings. Notable developments include the 2026 FDA approvals for PD-L1 IHC 22C3 pharmDx in ovarian and esophageal cancers and its June 2026 approval on the automated Dako Omnis platform for four more tumor types.
Key companies profiled in the report include Agilent Technologies, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Foundation Medicine, Inc. (U.S.), Thermo Fisher Scientific Inc. (U.S.), Illumina, Inc. (U.S.), QIAGEN N.V. (Netherlands), Guardant Health, Inc. (U.S.), Natera, Inc. (U.S.), Caris Life Sciences, Inc. (U.S.), and NeoGenomics, Inc. (U.S.).
The market covers products and services that measure tumor and blood biomarkers to help clinicians select patients for cancer immunotherapy, choose among regimens, and track whether treatment is working. This includes PD-L1 and mismatch repair (MMR) immunohistochemistry (IHC) assays, next-generation sequencing (NGS) tests for tumor mutational burden (TMB) and microsatellite instability (MSI), PCR-based MSI assays, immune gene expression signatures, multiplex and spatial tissue assays, circulating tumor DNA (ctDNA) monitoring tests, and AI scoring software. Biomarkers used only for targeted therapy selection, cancer screening tests, and general pathology products with no immuno-oncology use are excluded.
Agilent's PD-L1 IHC 22C3 pharmDx gained FDA approval in February 2026 as a companion test for KEYTRUDA (pembrolizumab) in ovarian, fallopian tube, and primary peritoneal carcinoma, the first immuno-oncology approval in that disease, and the FDA then added esophageal and gastroesophageal junction cancers in March 2026, giving the assay eight approved KEYTRUDA indications. Natera, maker of the Signatera tumor-informed ctDNA test, reported second-quarter 2026 revenue of USD 752.8 million, up 37.7%, on roughly 296,700 oncology tests, and Medicare has issued a draft local coverage determination supporting Signatera for immunotherapy response monitoring.
Market Dynamics
Demand in the immuno-oncology biomarkers market rises with every new checkpoint inhibitor indication, because each approval creates a defined group of patients who must be tested before treatment. Use in adjuvant and neoadjuvant settings keeps widening the tested population. Companion labels turn this into recurring volume; Roche's VENTANA PD-L1 (SP263) assay is approved in lung cancer with four immunotherapy drugs, and FoundationOne CDx identifies TMB-high and MSI-high solid tumors. Genomic profiling adds volume by reporting TMB and MSI with targeted therapy markers in one test, while ctDNA testing shows response or resistance earlier than imaging.Current biomarkers predict benefit imperfectly, since some PD-L1-negative patients respond to immunotherapy, many PD-L1-positive patients do not, and TMB cutoffs perform unevenly across tumors, so some regimens are approved without a biomarker requirement. Laboratories must also handle several PD-L1 clones, platforms, cutoffs, and scoring methods, which adds workload and creates variation between sites. Scarce tissue in advanced disease, long turnaround for broad panels, and the costly utility studies needed to win reimbursement for gene signatures, spatial markers, and ctDNA monitoring are further challenges.
Novel immunotherapies offer a significant opportunity, since bispecific antibodies, cell therapies, cancer vaccines, and LAG-3 and TIGIT inhibitors will each need biomarkers to find likely responders, favoring diagnostic firms that partner with drug developers early. Spatial assays that measure dozens of proteins in one tissue section, AI scoring of PD-L1 and tumor-infiltrating lymphocytes, and wider immunotherapy access in Asia-Pacific are other openings. Key trends include the consolidation of IHC onto automated stainers, combined reporting of PD-L1 with genomic TMB and MSI results, and the routine use of ctDNA monitoring during immunotherapy.
Segment Analysis
The report analyzes the market by offering, biomarker type, technology, cancer type, application, end user, and geography, helping stakeholders identify the most attractive areas for product development, partnering, and investment.By offering, the immuno-oncology biomarkers market is segmented into assays & kits, testing services, instruments, and software & digital pathology solutions. Assays & kits are expected to account for the largest share in 2026, as PD-L1 and MMR IHC kits are used in pathology laboratories worldwide, companion diagnostic labels make specific kits a testing requirement, and reagents are consumed for every patient. Software & digital pathology solutions are expected to grow at the highest CAGR, supported by digital pathology adoption, AI tools that score PD-L1 and immune cells, and the need to reduce differences between pathologists. Testing services should also grow strongly as reference laboratories add profiling and ctDNA work.
By biomarker type, the immuno-oncology biomarkers market is segmented into PD-L1, tumor mutational burden (TMB), MSI & mismatch repair deficiency, ctDNA-based response monitoring biomarkers, gene expression signatures, tumor-infiltrating lymphocytes (TILs) & immune cell profiling, and other biomarkers. PD-L1 is expected to hold the largest share in 2026, as it is a companion or complementary diagnostic for several checkpoint inhibitors across many tumor types. ctDNA-based response monitoring biomarkers are expected to grow at the highest CAGR, driven by evidence that ctDNA changes reveal response before imaging, draft Medicare coverage for Signatera, and rising oncology test volumes at Natera. MSI & mismatch repair deficiency testing should also grow strongly, helped by tumor-agnostic labels and checkpoint inhibitor use in dMMR colorectal and endometrial tumors.
By technology, the immuno-oncology biomarkers market is segmented into immunohistochemistry (IHC), next-generation sequencing (NGS), PCR, multiplex immunofluorescence & spatial profiling, and other technologies. Immunohistochemistry is expected to account for the largest share in 2026, as PD-L1 and MMR staining is part of routine pathology work, the method is inexpensive, and it fits existing workflows and stainers. Next-generation sequencing is expected to register the highest CAGR, as genomic profiling that reports TMB and MSI becomes standard in advanced cancers, blood-based profiling helps patients with too little tissue, and NGS-based ctDNA monitoring is expanding. Spatial profiling is small today but should expand as spatial signatures are clinically validated.
By cancer type, the immuno-oncology biomarkers market is segmented into non-small cell lung cancer (NSCLC), melanoma, gastrointestinal cancers, breast cancer, head & neck cancer, genitourinary cancers, gynecologic cancers, and other cancers. Non-small cell lung cancer is expected to account for the largest share in 2026, reflecting high lung cancer incidence, checkpoint inhibitor use across treatment lines, and the established role of PD-L1 testing in choosing therapy. Gynecologic cancers are expected to grow at the highest CAGR, supported by immunotherapy in dMMR endometrial and PD-L1-positive cervical cancer and the February 2026 approval that brought the first immuno-oncology indication to ovarian cancer. Gastrointestinal cancers add demand through new esophageal indications and colorectal MSI testing.
By application, the immuno-oncology biomarkers market is segmented into companion and complementary diagnostics, treatment response monitoring, prognostic testing, and drug discovery & clinical development. Companion and complementary diagnostics are expected to account for the largest share in 2026, as most testing decides whether a patient qualifies for checkpoint inhibitor therapy, new indications usually come with a linked test, and testing is repeated for every eligible patient. Treatment response monitoring is expected to grow at the highest CAGR, driven by ctDNA monitoring during immunotherapy, the difficulty of reading scans during pseudoprogression, and emerging Medicare coverage. Drug discovery & clinical development should grow strongly as drug developers fund biomarker work for new immunotherapies.
By end user, the immuno-oncology biomarkers market is segmented into hospitals & pathology laboratories, reference laboratories, pharmaceutical & biotechnology companies, and academic & research institutes. Hospitals & pathology laboratories are expected to account for the largest share in 2026, as PD-L1 and MMR IHC are run routinely in hospital pathology departments, where tissue is processed and stainers are installed. Reference laboratories are expected to grow at the highest CAGR, supported by the expansion of genomic profiling and ctDNA services at specialized laboratories and the shift toward multi-biomarker panels. Drug developers remain key buyers through companion diagnostic co-development and trial testing.
Regional Analysis
The report covers North America, Asia-Pacific, Europe, Latin America, and the Middle East & Africa, spanning 18 countries and four rest-of-region groups. The regional analysis of the immuno-oncology biomarkers market considers checkpoint inhibitor use, reimbursement, companion diagnostic rules, NGS capacity, and cancer incidence.North America is set to hold the largest share of the immuno-oncology biomarkers market in 2026, supported by broad checkpoint inhibitor use, a large number of FDA-approved companion diagnostics, high uptake of genomic profiling and ctDNA testing, established reimbursement, and home-based suppliers such as Agilent, Foundation Medicine, Caris Life Sciences, Guardant Health, Natera, and NeoGenomics. Canada adds demand through provincial cancer agencies and expanding biomarker testing. Europe holds a significant share, backed by high cancer incidence, broad immunotherapy access, and strong hospital pathology networks, and the EU In Vitro Diagnostic Regulation favors CE-IVD assays from established makers; the leading national markets are Germany, the U.K., France, Italy, Spain, and the Netherlands.
Asia-Pacific is projected to post the highest CAGR through 2036, owing to the high burden of lung, gastric, esophageal, and liver cancers, more approvals and reimbursement for domestic and imported checkpoint inhibitors, and growing NGS capacity. China is expected to hold the largest share in the region, helped by many local immunotherapies and a large genomics industry, while Japan, where national insurance covers genomic profiling for eligible patients, South Korea, India, and Australia are set for strong growth. Latin America, led by Brazil and Mexico, and the Middle East & Africa, led by Saudi Arabia, the UAE, and Israel, hold smaller shares.
Competitive Landscape
The report provides a detailed review of the competitive landscape, covering key growth strategies, competitive benchmarking, the competitive dashboard, and market share/rank analysis by key player for 2025, together with company profiles covering business and financial overviews, portfolios, developments, and SWOT analyses.The immuno-oncology biomarkers market is moderately consolidated, as a small group of tissue diagnostics firms dominates PD-L1 and MMR staining while genomic profiling providers, ctDNA specialists, NGS suppliers, and digital pathology firms compete in other parts of the testing workflow. Competition centers on companion labels and drug developer partnerships, assay accuracy and automation, biomarker range, speed, and reimbursement. Leaders are adding labels, automating assays, and building ctDNA and AI pathology offerings. Notable developments include the 2026 FDA approvals for PD-L1 IHC 22C3 pharmDx in ovarian and esophageal cancers and its June 2026 approval on the automated Dako Omnis platform for four more tumor types.
Key companies profiled in the report include Agilent Technologies, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Foundation Medicine, Inc. (U.S.), Thermo Fisher Scientific Inc. (U.S.), Illumina, Inc. (U.S.), QIAGEN N.V. (Netherlands), Guardant Health, Inc. (U.S.), Natera, Inc. (U.S.), Caris Life Sciences, Inc. (U.S.), and NeoGenomics, Inc. (U.S.).
How This Report Helps
- Provides reliable market size estimates and long-term forecasts for the global immuno-oncology biomarkers market.
- Explains how new checkpoint inhibitor indications, companion diagnostic approvals, genomic profiling, and ctDNA monitoring are driving testing demand.
- Assesses how limited predictive accuracy, scoring variability, and reimbursement hurdles affect growth.
- Identifies high-growth opportunities across offering, biomarker type, technology, cancer type, application, end user, and region.
- Tracks spatial biomarkers, AI-enabled digital pathology, and biomarkers for novel immunotherapies.
- Benchmarks leading companies by companion diagnostic approvals, test menus, automation, and partnerships.
- Supports product planning, partnering, and market entry decisions for diagnostic companies, laboratories, and investors.
Key Questions Answered
- How big is the global immuno-oncology biomarkers market today, and how will it grow through 2036?
- How are new checkpoint inhibitor indications and companion diagnostic approvals shaping testing demand?
- What are the main drivers, restraints, opportunities, challenges, and trends shaping the market?
- How are assay variability, multiple PD-L1 scoring systems, and tissue limits affecting laboratories?
- Which offering, biomarker type, technology, cancer type, application, and end user segments will grow the fastest?
- How quickly will ctDNA-based response monitoring become part of routine immunotherapy care?
- Which regions and countries offer the most attractive business opportunities?
- Who are the leading companies in the market, and what strategies are they using?
Table of Contents
1. Introduction
2. Research Methodology
4. Market Overview
5. Immuno-Oncology Biomarkers Market, by Offering
6. Immuno-Oncology Biomarkers Market, by Biomarker Type
7. Immuno-Oncology Biomarkers Market, by Technology
8. Immuno-Oncology Biomarkers Market, by Cancer Type
9. Immuno-Oncology Biomarkers Market, by Application
10. Immuno-Oncology Biomarkers Market, by End User
11. Immuno-Oncology Biomarkers Market, by Geography
12. Competitive Landscape
13. Company Profiles
14. Appendix
LIST OF TABLES
LIST OF FIGURES
Companies Mentioned
- Agilent Technologies, Inc.
- F. Hoffmann-La Roche Ltd
- Foundation Medicine, Inc.
- Thermo Fisher Scientific Inc.
- Illumina, Inc.
- QIAGEN N.V.
- Guardant Health, Inc.
- Natera, Inc.
- Caris Life Sciences, Inc.
- NeoGenomics, Inc.
