Immuno-Oncology Assays Market Analysis & Forecast: 2025-2032

Immuno-Oncology Assays Market Analysis & Forecast: 2025-2032

Global Immuno-Oncology Assays Market size is estimated to be valued at USD 5.55 Bn in 2025 and is expected to reach USD 11.82 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 11.4% from 2025 to 2032.

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Key Takeaways

• By Product, the Consumables segment is projected to dominate the Immuno-Oncology Assays Market with a 66.4% share in 2025. This is primarily driven by the rising incidence of colorectal cancer, especially in Asia, where the disease burden is highest.
• By Indication, the Colorectal Cancer segment is anticipated to lead with 34.3% of Immuno-Oncology Assays Market share in 2025, fueled by increasing global incidences.
• By Application, the Research and Development segment is expected to capture a commanding 54.3% share in 2025, as focus intensifies on translational research and immunotherapeutic innovation.
• Regionally, North America is projected to lead the global market with a 43.6% share in 2025, supported by high cancer prevalence, robust R&D funding, and widespread adoption of precision medicine.

Market Overview

The global immuno-oncology assays market trend is witnessing a high growth due to rising incidences of cancer globally and increasing adoption of targeted therapies for cancer treatment. Immuno-oncology is an evolving field in oncology that harnesses the power of the immune system to detect and destroy cancer cells. With promising clinical trial results, improved understanding of tumor microenvironment and biomarkers, new product approvals, and growing emphasis on precision medicine, the global immuno-oncology assays market is estimated to witness a healthy growth during the forecast period.

Current Events and Its Impact

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Pricing Analysis of Immuno-Oncology Assays

• Pricing for Immuno-Oncology (IO) assays differs significantly by assay type, geography, technology, and the end-user's profile. PD-L1/PD-1 assays such as Roche’s VENTANA SP142 and Agilent’s 22C3/28-8 pharmDx are priced between USD 100 to 350 per test. The cost of TMB assays, such as FoundationOne CDx, and TruSight Oncology 500, is between USD 2,500 to 6,000. Multiplex IHC and IF assays Akoya and NanoString are priced between USD 150 to 1,200 per test with the instruments costing above USD 200,000.
• Flow cytometry assays BD FACSymphony are priced USD 300-600 per run while the instrument has a price over USD 150,000. Chemokine and cytokine assays such as Bio-Plex and Luminex are priced at USD 250-1,100 while Quantikine ELISAs charge USD 400-600 per 96 tests. NGS-based immune profiling like ImmunoSEQ and AmpliSeq is priced between USD 500 to 1,500 per sample.
• The regional pricing differences stem from distribution, reimbursement, and regulatory factors. More developed regions tend to have steeper pricing while emerging areas benefit from a 10--20% discount. Industrial volume purchasers like pharma companies and diagnostic labs receive 20-35% discounts, leaving smaller laboratories at list prices. Prices are expected to drop with technological advancements coupled with wider reimbursement, though high-complexity assays will remain premium priced.

End-User Feedback on Immuno-Oncology Assay Adoption

• IVF Clinics

Even though these users are not core customers, IVF clinics sometimes use immuno-oncology assays as a part of their research activities. These assays aid in studying the immune system’s behavior, providing information that may be useful for reproductive treatments and reproductive immunology.

• Biotechnology and Pharmaceutical Firms

This first group is the most advanced in their use of immuno-oncology assays. Extensive efforts are being made by companies to incorporate these assays into the processes of drug development and more refined techniques in immunotherapy and precision medicine. Their application ranges from preliminary investigations to clinical trials, underscoring the strategic significance of these assays in therapeutic innovation.

• Academic and Research Institutions

University and research institutions play a very important role in advancing immuno-oncology technologies. They are working towards the validation of the assays and the identification of new biomarkers to advance diagnostics as well as rational clinical pathways supported by evidence.

• Biobanks

Biobanks perform a fundamental task for the development of an assay by submitting well-characterized biological specimens. Their participation guarantees reliability of the assay from the scientific research and clinical research viewpoint concerning immuno-oncological studies.

Role of AI in the Immuno-Oncology Assays Market

• Predictive biomarker recognition, assay development, and precision oncology eligibility are enhanced through the implementation of AI in immuno-oncology assays.
• Through expansive genomic and clinical datasets, Tempus Labs processes massive datasets to provide tailored therapies to patients by matching them based on their tumor immunobiology and treatment response patterns.
• Enhanced accuracy and consistency in the detection of immune biomarkers is achieved through the use of AI in pathology software by PathAI, which lowers inter-observer variability and manual error proficiently.
• Using multicenter clinical, genomic, and imaging data, privacy-preserving federated learning AI models by Owkin enable institutions to securely collaborate on predicting immunotherapy outcomes and analyzing the data.
• Assay development, diagnostic turnaround time, clinical decision-making, and treatment efficacy are all improved through the application of AI.
• The integration of these technologies aids in the scaling and standardization of diagnostics in immuno-oncology, which improves results and care for patients while lowering costs associated with healthcare expenditures.

Market Concentration and Competitive Landscape

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Rising Burden of Cancer Globally

Rise in burden of cancer across the globe is expected to augment growth of the global immuno-oncology assays market over the forecast period. Immuno-oncology (IO) is a class of treatment designed to boost the body's natural immune defense against cancer. For instance, in March 2023, according to the data published by the Centers for Disease Control and Prevention, it was estimated that a total of 32,320 new ovarian cancer cases will be diagnosed globally in the year 2023.

Moreover, according to the World Health Organization (WHO), cancer was a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths. The most common cancers were breast, lung, prostate, and colon and rectum cancer. This in turn is expected to increase demand for immuno-oncology assays around the world.

Increasing Awareness Programs

Increasing inorganic activities, such as awareness programs, is expected to drive the market growth over the forecast period. For instance, in June, 2022, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) announced a new model aimed at improving cancer care for Medicare patients and lowering health care costs.

Market Opportunity – Increasing Collaborations Among Key Market Players

Increasing adoption of inorganic growth strategies such collaborations by the key market players is expected to drive the market growth over the forecast period. For instance, in May, 2021, the University of California, San Francisco (UCSF) in collaboration with the San Francisco Veteran Affairs (VA) Health Care System, the Prostate Cancer Foundation, launched the Drew Foundation Precision Oncology Center of Excellence, providing precision medicine treatments to veterans facing prostate cancer.

Segmental Insights

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Immuno-Oncology Assays Market Insights, By Product

 Product segment is sub-segmented into consumables, software. The consumables segment is estimated to hold 66.4% of the market share in 2025, owing to the increasing incidences of colorectal cancer.

According to International Agency for Research on Cancer, March 2022, in 2020, almost 2 million cases were diagnosed, for example, alcohol consumption was responsible for more than 160 000 new cases of colorectal cancer in 2020. It is the second most common cause of cancer death, leading to almost 1 million deaths per year.

Immuno-Oncology Assays Market Insights, By Indication

 Indication segment is sub-segmented into colorectal cancer, lung cancer, melanoma, bladder cancer, others. The colorectal cancer segment is estimated to hold 34.3% of the market share in 2025 owing to the increasing incidences of colorectal cancer.

The burden of colorectal cancer is the highest in Asia, where more than half of all cases and deaths are recorded. China alone accounts for more than half a million new cases and more than 280 000 deaths per year. Japan records the second highest number of deaths from colorectal cancer, almost 60 000 per year.

Immuno-Oncology Assays Market Insights, By Application

Application segment is sub-segmented into clinical diagnostics, and research and development. The research and development segment is estimated to hold 54.3% of the market share in 2025 due to the extensive translational research activities in this field. Pharmaceutical and biotech companies heavily rely on various immunoassay platforms to study immune mechanisms, discover and validate immune-related biomarkers, and conduct preclinical safety and efficacy testing of immunotherapies.

National cancer institutes and academic medical centers too employ immuno-oncology assays while investigating tumor immunobiology, immunomonitoring, and novel treatment strategies. The need to deepen understanding of complex immune-tumor interactions, identify predictive and prognostic biomarkers along with responding patient subsets is driving the demand for customized research applications of these assays.

Additionally, they aid evaluation of immune effects during nonclinical and early clinical phases of drug development. With ongoing efforts to harness immunity against cancer, the R&D application segment will likely maintain its lead position in the coming years backed by significant investments in immuno-oncology innovations.

Regional Insights                      

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North America Immuno-Oncology Assays Market Analysis and Trends

North America is projected to dominate the global Immuno-Oncology Assays Market, accounting for 43.6% of the market share in 2025. This dominance is driven by the increasing incidence of cancer and the rising elderly population in the U.S. In 2024, the American Cancer Society (ACS) estimated that nearly 1.9 million new cancer cases would be diagnosed in the U.S., along with over 600,000 cancer-related deaths.

With growing government initiatives, advancements in cancer research, and strong healthcare infrastructure, the adoption of immuno-oncology assays in the region is accelerating, especially for the diagnosis and treatment of solid tumors and hematologic cancers.

Asia Pacific Immuno-Oncology Assays Market Analysis and Trends

Asia Pacific is expected to experience robust growth in the global Immuno-Oncology Assays Market by 2025, driven by the region’s increasing cancer incidence and a rapidly aging population. India, for instance, is anticipated to see a 12.5% rise in cancer cases within the next five years, with projections indicating that 1.5 million people will be affected by cancer by 2025.

The Indian Council of Medical Research (ICMR) reported in 2024 that cancer cases in the country have been on the rise due to changing lifestyle factors, which is expected to result in higher demand for immuno-oncology assays as part of the nation’s healthcare strategy.

Immuno-Oncology Assays Market Dominating Countries

United States Immuno-Oncology Assays Market Analysis and Trends

The U.S. continues to lead the Immuno-Oncology Assays Market in North America, contributing significantly to global market share. Recent advancements in immunotherapy and cancer diagnostics have further driven the need for more sophisticated diagnostic tools. In 2024, major healthcare providers and research institutions in the U.S. have ramped up investments in immuno-oncology research.

As the U.S. government implements increased funding for cancer research through the National Cancer Institute (NCI), the integration of advanced immuno-oncology assays into routine clinical practice is gaining momentum.

India Immuno-Oncology Assays Market Analysis and Trends

India is emerging as a significant market in the Asia Pacific region, with the expected increase in cancer cases driving the demand for immuno-oncology assays. The Indian Council of Medical Research (ICMR) forecasted a sharp rise in cancer prevalence by 2025, which is prompting the government to implement nationwide cancer awareness and screening programs.

With a focus on boosting diagnostic accuracy and early cancer detection, India’s healthcare infrastructure is increasingly incorporating immuno-oncology assays, especially in urban centers with improving access to cutting-edge medical technologies.

Market Report Scope

Immuno-Oncology Assays Market Report Coverage

Analyst Viewpoint:

• The global immuno-oncology assays market is poised to grow substantially in the coming years. The market growth is driven by the rising prevalence of cancer worldwide and growing adoption of immuno-oncology drugs and therapies for treatment.
• Increased R&D investments by pharmaceutical companies to develop novel immuno-oncology biomarkers and companion diagnostics will further propel the demand. Advancements in immunoassay technologies for detection of circulatory tumor DNA and growing application of next-generation sequencing in liquid biopsy also create new opportunities.
• However, complexity of immuno-oncology assays and challenges associated with developing robust and reproducible results could hinder the market growth to an extent. Strict regulatory framework around the development and commercialization of these assays also acts as a restraint.
• Among regions, North America dominates the global immuno-oncology assays market currently due to presence of sophisticated healthcare infrastructure and rising healthcare expenditure. Asia Pacific is anticipated to be the fastest-growing regional market owing to expansion of healthcare facilities, increasing affordability, and rising cancer burden in developing nations.

Immuno-Oncology Assays Market Key Developments

• In January 2025, Agilent Technologies Inc. announced an extended collaboration with Incyte to accelerate the development and commercialization of Incyte’s hematology and oncology portfolio. The partnership focuses on integrating advanced assay technologies to support precision diagnostics and targeted therapies.
• In March 2025, Personalis, Inc. and Tempus expanded their strategic collaboration to advance the clinical deployment of NeXT Personal Dx, a liquid biopsy test for the detection of molecular residual disease (MRD). The partnership now includes joint data integration and commercialization efforts across multiple cancer centers in the U.S., further supporting the adoption of genomic-driven cancer monitoring.
• In April 2025, TORL BioTherapeutics secured additional funding to initiate Phase I trials for its lead oncology biologic candidates. The new investment aims to accelerate clinical development timelines and support regulatory submissions for first-in-class immuno-oncology therapies.
• In May 2025, The Institute of Cancer Research, London, and NeoPhore announced early positive results from their ongoing preclinical collaboration. Their joint research demonstrated promising tumor response data using NeoPhore’s mismatch repair-targeting inhibitors, with plans to initiate translational studies later in the year.

Market Segmentation

• Product Insights (Revenue, USD Bn, 2020 - 2032)
• Consumables
• Software
•  Technology Insights (Revenue, USD Bn, 2020 - 2032)
• Immunoassay
• PCR
• NGS
• Fow Cytometry
• Others
•  Indication Insights (Revenue, USD Bn, 2020 - 2032)
• Colorectal Cancer
• Lung Cancer
• Melanoma
• Bladder Cancer
• Others
•  Application Insights (Revenue, USD Bn, 2020 - 2032)
• Clinical Diagnostics
• Research and Development
• Regional Insights (Revenue, USD Bn, 2020 - 2032)
• North America
• U.S.
• Canada
• Latin America
• Brazil
• Argentina
• Mexico
• Rest of Latin America
• Europe
• Germany
• U.K.
• Spain
• France
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East
• GCC Countries
• Israel
• Rest of Middle East
• Africa
• South Africa
• North Africa
• Central Africa
• Key Players Insights
• Charles River Laboratories
• F. Hoffmann-La Roche Ltd
• llumina, Inc.
• Agilent Technologies, Inc.
• Thermo Fisher Scientific Inc.
• Merck KGaA
• Invivoscribe, Inc.
• QIAGEN 
• PerkinElmer Inc. 
• Sartorius AG
• Bio-Rad Laboratories, Inc.
• Bruker Spatial Biology, Inc.
• Nexelis
• Reaction Biology
• Crown Bioscience
• HTG Molecular Diagnostics, Inc.
• Axion BioSystems, Inc
• BioTherapeutics LLC

Sources

Primary Research Interviews

• CEO/Managing Directors of Immuno-Oncology Assay Companies
• Research Scientists/Investigators Specializing in Immune-Oncology
• Marketing and Sales Executives from Leading Assay Providers
• Industry Consultants and Key Opinion Leaders in Immunotherapy Assays
• Others

Databases

• ClinicalTrials.gov
• ScienceDirect
• Scopus
• Others

Magazines

• BioPharm International
• Genetic Engineering & Biotechnology News (GEN)
• Drug Discovery & Development Magazine
• PharmaVOICE
• Others

Journals

• Journal for ImmunoTherapy of Cancer
• Cancer Immunology Research
• Journal of Translational Medicine
• Others

Newspapers

• The Pharma Letter
• FierceBiotech
• BioWorld Today
• PharmaTimes
• Others

Associations

• American Association for Cancer Research (AACR)
• Society for Immunotherapy of Cancer (SITC)
• European Society for Medical Oncology (ESMO)
• American Society of Clinical Oncology (ASCO)
• Others

Public Domain Sources

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• National Cancer Institute (NCI)
• European Medicines Agency (EMA)
• Others

Proprietary Elements

• CMI Data Analytics Tool
• Proprietary CMI Existing Repository of Information for Last 8 Years

*Definition: Immuno-oncology is emerging as a novel approach to cancer treatment through the stimulation of the body's own immune system. It is a formidable weapon against cancer as it has the ability to harness the body's natural defenses against infection. It is one of the most promising areas of research in the world of anti-cancer therapeutics.