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    Immuno Oncology Assay Market

    ID: MRFR/HC/41291-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Immuno-Oncology Assay Market Research Report By Assay Type (Immune Cell Profiling Assays, Cytokine Release Assays, Tumor Mutation Burden Assays, Biomarker Discovery Assays), By Technology (Enzyme-Linked Immunosorbent Assay, Flow Cytometry, PCR-based Techniques, Next Generation Sequencing), By Application (Cancer Diagnosis, Therapeutic Monitoring, Patient Stratification, Clinical Trials), By End Use (Hospitals, Clinical Laboratories, Research Institutions, Pharmaceutical Companies) and By Regional (North America, Europe, South America, Asia P...

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    Immuno Oncology Assay Market Summary

    The Global Immuno-Oncology Assay Market is projected to grow from 29.4 USD Billion in 2024 to 50 USD Billion by 2035.

    Key Market Trends & Highlights

    Immuno-Oncology Assay Key Trends and Highlights

    • The market is expected to expand at a compound annual growth rate of 4.95 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 50 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 29.4 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of immuno-oncology assays due to increasing cancer prevalence is a major market driver.

    Market Size & Forecast

    2024 Market Size 29.4 (USD Billion)
    2035 Market Size 50 (USD Billion)
    CAGR (2025-2035) 4.95%

    Major Players

    Amgen, Merck, Pfizer, Bristol Myers Squibb, PerkinElmer, Agilent Technologies, AbbVie, Qiagen, Thermo Fisher Scientific, Novartis, Illumina, Sanofi, Roche, Eli Lilly, GSK

    Immuno Oncology Assay Market Trends

    The Global Immuno-Oncology Assay Market is experiencing significant growth driven by several key factors. The rise in cancer prevalence worldwide and the increasing demand for personalized medicine are primary market drivers. Advances in technology and research have led to the development of new assays that enhance the ability to tailor treatments to individual patients.

    Furthermore, the growing focus on early cancer detection and the increasing investment in research and development by pharmaceutical companies are also contributing to market expansion. These factors are creating a robust landscape for growth in immuno-oncology assays.

    Opportunities within this market are becoming more pronounced, especially with the increasing adoption of companion diagnostics. As more therapies are developed, the need for effective assays to identify suitable patient populations will grow. Additionally, collaboration between biotech firms and pharmaceutical companies is likely to yield innovative solutions that can improve outcomes for cancer patients.

    Expanding regulatory approvals for immuno-oncology products also present avenues for market participants to enhance their product offerings and reach broader patient populations. Companies that can harness these opportunities may position themselves as leaders in this evolving space.

    In recent times, trends such as the integration of artificial intelligence in assay development and an emphasis on biomarker research have emerged. This integration is streamlining the process of assay identification and validation, enabling quicker turnaround times for results.

    There is also a growing movement towards the standardization of assays to ensure consistency across different platforms and laboratories. As the market continues to mature, a focus on improving patient outcomes while minimizing costs will be paramount. Overall, the Global Immuno-Oncology Assay Market is poised for dynamic growth driven by innovation, collaboration and a commitment to enhancing cancer care.

    The ongoing evolution of immuno-oncology assays is poised to enhance personalized treatment strategies, thereby potentially improving patient outcomes in cancer therapy.

    National Cancer Institute

    Immuno Oncology Assay Market Drivers

    Rising Cancer Incidence

    The increasing prevalence of cancer globally is a primary driver for the Global Immuno-Oncology Assay Market Industry. As cancer cases continue to rise, the demand for effective diagnostic and therapeutic solutions intensifies. In 2024, the market is projected to reach 29.4 USD Billion, reflecting a growing recognition of immuno-oncology assays as vital tools in cancer management. This trend is expected to persist, with the market anticipated to expand significantly by 2035, potentially reaching 50 USD Billion. The need for innovative assays that can accurately identify and characterize tumors is paramount in addressing this global health challenge.

    Market Growth Projections

    The Global Immuno-Oncology Assay Market Industry is projected to experience robust growth over the coming years. By 2024, the market is expected to reach 29.4 USD Billion, with a forecasted compound annual growth rate of 4.95% from 2025 to 2035. This growth is indicative of the increasing reliance on immuno-oncology assays for cancer diagnosis and treatment. As more healthcare providers recognize the value of these assays in improving patient outcomes, the market is likely to expand significantly. The anticipated market size of 50 USD Billion by 2035 reflects the ongoing evolution and integration of immuno-oncology assays into standard clinical practice.

    Technological Advancements

    Technological innovations in assay development are propelling the Global Immuno-Oncology Assay Market Industry forward. Advances in high-throughput screening, next-generation sequencing, and bioinformatics are enhancing the precision and efficiency of immuno-oncology assays. These technologies enable researchers to better understand tumor microenvironments and immune responses, leading to more personalized treatment approaches. As a result, the market is likely to witness a compound annual growth rate of 4.95% from 2025 to 2035. The integration of artificial intelligence and machine learning in assay design further indicates a transformative shift in how immuno-oncology assays are developed and utilized.

    Regulatory Support and Approvals

    Regulatory bodies are increasingly recognizing the importance of immuno-oncology assays, which is fostering growth in the Global Immuno-Oncology Assay Market Industry. Streamlined approval processes and supportive regulatory frameworks are encouraging the development and commercialization of innovative assays. For instance, expedited pathways for breakthrough therapies and companion diagnostics are being established, allowing for quicker access to essential tools in cancer treatment. This regulatory support not only enhances market confidence but also accelerates the introduction of novel assays that can significantly impact patient outcomes. As a result, the market is poised for continued expansion as new products gain approval.

    Growing Investment in Research and Development

    Increased investment in research and development (R&D) within the field of immuno-oncology is a significant driver of the Global Immuno-Oncology Assay Market Industry. Governments and private entities are allocating substantial funds to explore novel therapeutic targets and improve existing assays. This trend is evidenced by various initiatives aimed at fostering innovation in cancer treatment. The financial commitment to R&D not only enhances the development of new assays but also supports clinical trials that validate their efficacy. As the market evolves, the influx of funding is expected to facilitate breakthroughs that could reshape the landscape of cancer diagnostics and treatment.

    Patient Awareness and Demand for Personalized Medicine

    There is a growing awareness among patients regarding the benefits of personalized medicine, which is driving demand for immuno-oncology assays in the Global Immuno-Oncology Assay Market Industry. Patients are increasingly seeking tailored treatment options that align with their specific cancer profiles. This shift in patient expectations is prompting healthcare providers to adopt immuno-oncology assays that can guide treatment decisions based on individual tumor characteristics. As the market evolves, this trend is likely to contribute to the overall growth trajectory, with projections indicating a market size of 50 USD Billion by 2035. The emphasis on personalized approaches underscores the importance of innovative assay development.

    Market Segment Insights

    Immuno-Oncology Assay Market Assay Type Insights

    The Global Immuno-Oncology Assay Market is witnessing substantial growth driven by its diverse assay type offerings such as Immune Cell Profiling Assays, Cytokine Release Assays, Tumor Mutation Burden Assays, and Biomarker Discovery Assays. In 2024, the overall market is expected to be valued significantly, reflecting a robust landscape for immuno-oncology research and testing, particularly with the rising demand for personalized medicine.

    Among these assay types, Immune Cell Profiling Assays hold a major position with a valuation of 7.0 USD Billion, which is projected to rise to 12.0 USD Billion by 2035. This growth can be attributed to their critical role in understanding and assessing the immune system's response to cancer therapies, allowing for more targeted and effective treatment options.

    Cytokine Release Assays also play a significant part in this space, with an expected value of 6.5 USD Billion in 2024, increasing to 11.0 USD Billion by 2035. These assays are vital for evaluating immune responses, especially in the context of immunotherapy, thereby enhancing our comprehension of the underlying mechanisms of action in cancer treatment.

    The Tumor Mutation Burden Assays are poised for noteworthy expansion with a valuation of 8.0 USD Billion in 2024, projected to reach 13.0 USD Billion by 2035. This assay’s importance lies in its ability to quantify the number of mutations within the cancer genome, providing critical insights into tumor behavior and treatment responsiveness, as well as enabling stratified patient management.

    Biomarker Discovery Assays contribute significantly as well, with a current valuation of 7.9 USD Billion expected to grow to 14.0 USD Billion by 2035, indicating a robust growth trajectory. These assays are essential for identifying new biomarkers that can predict patient responses to therapies, guiding clinicians toward more precise therapeutic strategies.

    Overall, the segmentation within the Global Immuno-Oncology Assay Market showcases a rich tapestry of assay types, each playing a pivotal role in advancing our understanding and treatment of cancers through innovative testing methods. The trend towards personalized medicine and the increasing prevalence of cancer worldwide are expected to dominate the landscape, driving market growth as healthcare systems increasingly adopt these advanced assay technologies for better patient outcomes.

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Immuno-Oncology Assay Market Technology Insights

    This market encompasses various technology-driven approaches, including Enzyme-Linked Immunosorbent Assay, Flow Cytometry, PCR-based Techniques, and Next Generation Sequencing, which are essential for understanding and treating cancer effectively. The Enzyme-Linked Immunosorbent Assay technology is pivotal for its high-throughput screening capabilities, while Flow Cytometry dominates in cell analysis and provides detailed insights into the tumor microenvironment. PCR-based Techniques are increasingly significant due to their precision in detecting genetic alterations, and Next Generation Sequencing offers comprehensive genomic profiling, thus enabling personalized medicine strategies in immuno-oncology.

    These technologies together form a crucial foundation in the Global Immuno-Oncology Assay Market, as their advancements drive efficiency and accuracy in cancer diagnostics and research, reflecting the evolving landscape of cancer treatment methodologies. The integration of these technologies indicates a focused approach toward improving patient outcomes and unlocking new therapeutic avenues.

    Immuno-Oncology Assay Market Application Insights

    The Global Immuno-Oncology Assay Market is expected to see robust growth in its Application segment, particularly as the demand for advanced diagnostic and therapeutic solutions rises. Within the Application market, Cancer Diagnosis plays a crucial role in enabling early intervention through enhanced biomarker identification, contributing significantly to the overall market revenue. Therapeutic Monitoring is equally important, as it helps in assessing treatment efficacy and adjusting therapies accordingly.

    Patient Stratification is pivotal for personalizing treatment plans, ensuring that patients receive the most suitable therapies, while Clinical Trials leverage these assays for efficient drug development and validation processes. The growth drivers in this segment include rising cancer prevalence, increased healthcare expenditure, and advancements in laboratory technologies. However, challenges such as regulatory hurdles and the high cost of assays can impact growth trajectories. Overall, the segment reflects a promising landscape with ample opportunities as healthcare systems continue to prioritize innovative diagnostic and therapeutic strategies in fighting cancer.

    Immuno-Oncology Assay Market End Use Insights

    The segmentation within the End Use sector includes Hospitals, Clinical Laboratories, Research Institutions, and Pharmaceutical Companies, all playing critical roles. Hospitals serve as primary hubs for patient treatment and diagnosis, making them a major component of this market. Clinical Laboratories are essential for conducting assays that support clinical decisions and are vital for both routine and complex testing.

    Research Institutions are increasingly important as they drive innovation in immuno-oncology through extensive studies and clinical trials, facilitating the development of new therapeutic approaches. Meanwhile, Pharmaceutical Companies hold a significant position by integrating assay technologies into drug development processes, underscoring their importance in bringing new treatments to market. The overall growth of the market is fueled by a combination of increasing cancer prevalence, technological advancements, and a growing emphasis on effective therapeutic strategies. As these factors continue to evolve, the Global Immuno-Oncology Assay Market is poised for steady progress in the years ahead.

    Get more detailed insights about Immuno Oncology Assay Market

    Regional Insights

    The Global Immuno-Oncology Assay Market exhibits significant regional diversity, with North America leading the landscape, projected to reach a valuation of 15.0 USD Billion in 2024 and 25.0 USD Billion by 2035, underscoring its majority holding within the market. Following this, Europe demonstrates a substantial presence, with values of 7.5 USD Billion in 2024 and an expected rise to 12.0 USD Billion by 2035, highlighting its significant contribution and advanced research initiatives in this field.

    In contrast, the APAC region shows a promising growth trajectory with a valuation of 4.0 USD Billion in 2024, projected to double by 2035 to 8.0 USD Billion, emphasizing its increasing investment in immuno-oncology solutions. South America, with a value of 2.0 USD Billion in 2024 to 3.5 USD Billion by 2035, remains a developing market, presenting opportunities for expansion and collaboration.

    Lastly, the MEA segment, valued at 1.9 USD Billion in 2024, experiences challenges for growth as its valuation indicates a decline to 1.5 USD Billion by 2035. Overall, these insights into the Global Immuno-Oncology Assay Market segmentation reveal the dynamic interplay of regional strengths and potential as the industry evolves.

    Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

    Key Players and Competitive Insights

    The Global Immuno-Oncology Assay Market has become increasingly crucial in the landscape of cancer treatment, serving as a vital component in understanding tumor behavior and patient-specific responses to immunotherapies. A range of players are involved in this market, which facilitates competition among established pharmaceutical companies, biotechnology firms, and diagnostic service providers.

    These competitive insights reflect an ecosystem where innovation drives growth, and technology advancements bolster the development of various assays that are essential for determining the efficacy of immuno-oncology therapies. As the demand for personalized medicine rises, organizations that can harness advanced analytics, genomic profiling, and biomarker discovery will likely emerge as leaders in this fast-evolving market, showcasing a dynamic interplay of competitive strategies aimed at securing market share and addressing unmet clinical needs in oncology.

    Amgen has carved out a significant space for itself in the Global Immuno-Oncology Assay Market by leveraging its extensive research capabilities and solid understanding of molecular pathways associated with immune responses in tumors. The company's strong portfolio of innovative therapies is complemented by its commitment to advancing companion diagnostics, which are essential for the tailored use of immunotherapies in clinical practice.

    With robust financial backing and a history of strategic partnerships, Amgen can invest heavily in research and development, propelling forward its capabilities in assay development. This positions the company favorably within the market as the ability to provide precise and actionable insights via advanced assays becomes more critical. Furthermore, Amgen's emphasis on regulatory compliance and securing necessary approvals for their assays anchors their strength, enhancing their market presence and trustworthiness in the field.

    Merck is another vital player in the Global Immuno-Oncology Assay Market, recognized for its substantial contributions to drug development and diagnostics. The company has successfully built strong relationships within healthcare ecosystems that facilitate access to cutting-edge technologies in immuno-oncology. Merck's focus on integrating diagnostics with therapeutic options enables personalized treatment approaches, highlighting its dual expertise in developing effective immunotherapies and corresponding assays.

    The firm's investment in clinical trials, combined with a robust pipeline of innovative immuno-oncology products, further consolidates its standing as a formidable competitor in this space. Merck's strong emphasis on scientific research and collaboration with academic institutions enhances its potential to stay ahead of trends while addressing the evolving needs and challenges in the landscape of cancer treatment through improved assays.

    Key Companies in the Immuno Oncology Assay Market market include

    Industry Developments

    • Q2 2024: Personalis Launches NeXT Personal Dx, a Tumor-Informed, Ultra-Sensitive MRD Assay for Solid Tumors Personalis announced the launch of NeXT Personal Dx, a tumor-informed, ultra-sensitive minimal residual disease (MRD) assay for solid tumors, expanding its immuno-oncology assay portfolio.
    • Q2 2024: Guardant Health Announces FDA Approval of Guardant360 CDx as a Companion Diagnostic for KRAZATI in Non-Small Cell Lung Cancer Guardant Health received FDA approval for its Guardant360 CDx liquid biopsy assay as a companion diagnostic for KRAZATI, supporting immuno-oncology treatment decisions in non-small cell lung cancer.
    • Q2 2024: NeoGenomics Launches RaDaR Assay for MRD Detection in Solid Tumors NeoGenomics announced the commercial launch of its RaDaR assay, designed for minimal residual disease detection in solid tumors, enhancing its immuno-oncology assay offerings.
    • Q2 2024: Bio-Techne and Regeneron Announce Strategic Partnership to Develop Companion Diagnostics for Immuno-Oncology Therapies Bio-Techne and Regeneron Pharmaceuticals entered a strategic partnership to co-develop companion diagnostics supporting Regeneron's immuno-oncology pipeline.
    • Q3 2024: Roche launches new immuno-oncology assay to support clinical trials Roche launched a new immuno-oncology assay aimed at supporting pharmaceutical clinical trials, expanding its diagnostics portfolio for cancer immunotherapy.
    • Q3 2024: Agilent Technologies Receives FDA Approval for PD-L1 IHC 22C3 pharmDx as a Companion Diagnostic in Cervical Cancer Agilent Technologies received FDA approval for its PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic for immunotherapy in cervical cancer.
    • Q3 2024: Caris Life Sciences Announces Opening of New Liquid Biopsy Laboratory to Expand Immuno-Oncology Testing Caris Life Sciences opened a new liquid biopsy laboratory to expand its immuno-oncology assay capabilities, supporting advanced cancer diagnostics.
    • Q4 2024: Illumina and Merck Expand Partnership to Develop Next-Generation Sequencing-Based Companion Diagnostics for Immuno-Oncology Illumina and Merck expanded their partnership to develop next-generation sequencing-based companion diagnostics for immuno-oncology therapies.
    • Q4 2024: Thermo Fisher Scientific Launches Oncomine Immune Response Assay for Research Use Thermo Fisher Scientific launched the Oncomine Immune Response Assay, designed to profile immune-related gene expression in cancer research.
    • Q1 2025: Grail Announces New Partnership with AstraZeneca to Develop Blood-Based Immuno-Oncology Assays Grail and AstraZeneca announced a partnership to co-develop blood-based immuno-oncology assays for early cancer detection and therapy selection.
    • Q1 2025: Natera Receives CE Mark for Signatera MRD Assay in Colorectal Cancer Natera received CE Mark approval for its Signatera minimal residual disease (MRD) assay for use in colorectal cancer, supporting immuno-oncology clinical applications in Europe.
    • Q2 2025: Foundation Medicine Announces FDA Approval of FoundationOne CDx as a Companion Diagnostic for New Immunotherapy Foundation Medicine received FDA approval for its FoundationOne CDx assay as a companion diagnostic for a newly approved immunotherapy, expanding its role in precision oncology.

    Future Outlook

    Immuno Oncology Assay Market Future Outlook

    The Immuno-Oncology Assay Market is projected to grow at a 4.95% CAGR from 2024 to 2035, driven by advancements in biomarker discovery, increasing cancer prevalence, and enhanced therapeutic strategies.

    New opportunities lie in:

    • Develop novel assays for personalized immunotherapy treatments.
    • Invest in AI-driven data analytics for improved assay performance.
    • Expand partnerships with biotech firms for innovative assay development.

    By 2035, the Immuno-Oncology Assay Market is expected to achieve substantial growth, reflecting its critical role in cancer treatment.

    Market Segmentation

    Immuno-Oncology Assay Market End Use Outlook

    • Hospitals
    • Clinical Laboratories
    • Research Institutions
    • Pharmaceutical Companies

    Immuno-Oncology Assay Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Immuno-Oncology Assay Market Assay Type Outlook

    • Immune Cell Profiling Assays
    • Cytokine Release Assays
    • Tumor Mutation Burden Assays
    • Biomarker Discovery Assays

    Immuno-Oncology Assay Market Technology Outlook

    • Enzyme-Linked Immunosorbent Assay
    • Flow Cytometry
    • PCR-based Techniques
    • Next Generation Sequencing

    Immuno-Oncology Assay Market Application Outlook

    • Cancer Diagnosis
    • Therapeutic Monitoring
    • Patient Stratification
    • Clinical Trials

    Report Scope

    Scope:
    Attribute/Metric Source: Details
    MARKET SIZE 2023 28.01(USD Billion)
    MARKET SIZE 2024 29.4(USD Billion)
    MARKET SIZE 2035 50.0(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 4.94% (2025 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    MARKET FORECAST PERIOD 2025 - 2035
    HISTORICAL DATA 2019 - 2023
    MARKET FORECAST UNITS USD Billion
    KEY COMPANIES PROFILED Amgen, Merck, Pfizer, Bristol Myers Squibb, PerkinElmer, Agilent Technologies, AbbVie, Qiagen, Thermo Fisher Scientific, Novartis, Illumina, Sanofi, Roche, Eli Lilly, GSK
    SEGMENTS COVERED Assay Type, Technology, Application, End Use, Regional
    KEY MARKET OPPORTUNITIES Emerging biomarkers for personalized therapy, Increased funding for cancer research, Rising demand for combination therapies, Adoption of companion diagnostics, Growing focus on early detection.
    KEY MARKET DYNAMICS rising cancer prevalence, increasing R&D investments, advancements in assay technologies, growing personalized medicine adoption, regulatory approvals and compliance
    COUNTRIES COVERED North America, Europe, APAC, South America, MEA

    FAQs

    What is the expected market size of the Global Immuno-Oncology Assay Market in 2024?

    The Global Immuno-Oncology Assay Market is expected to be valued at 29.4 USD Billion in 2024.

    What will the market size reach by 2035 for the Global Immuno-Oncology Assay Market?

    By 2035, the Global Immuno-Oncology Assay Market is projected to reach a value of 50.0 USD Billion.

    What is the expected compound annual growth rate (CAGR) for the Global Immuno-Oncology Assay Market from 2025 to 2035?

    The market is anticipated to grow at a CAGR of 4.94% from 2025 to 2035.

    Which region holds the largest market share for the Global Immuno-Oncology Assay Market?

    North America is expected to hold the largest market share, valued at 15.0 USD Billion in 2024.

    How much is the European market for Global Immuno-Oncology Assays valued at in 2024?

    The European market for Global Immuno-Oncology Assays is anticipated to be valued at 7.5 USD Billion in 2024.

    What is the market size for the Immune Cell Profiling Assays segment in 2024?

    Immune Cell Profiling Assays are projected to be valued at 7.0 USD Billion in 2024.

    Who are the major players in the Global Immuno-Oncology Assay Market?

    Key players include Amgen, Merck, Pfizer, and Bristol Myers Squibb among others.

    What is the expected market value of Tumor Mutation Burden Assays in 2024?

    The Tumor Mutation Burden Assays segment is expected to be valued at 8.0 USD Billion in 2024.

    What will the market value for Cytokine Release Assays be in 2035?

    In 2035, the Cytokine Release Assays segment is expected to reach a value of 11.0 USD Billion.

    What are the anticipated revenues for the North American Immuno-Oncology Assay Market by 2035?

    The North American Immuno-Oncology Assay Market is anticipated to grow to 25.0 USD Billion by 2035.

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