Global Immuno Oncology Assays Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Consumables and SoftwareBy Technology;
Immunoassay, PCR, NGS, Flow Cytometry, and OthersBy Indication;
Colorectal Cancer, Lung Cancer, Melanoma, Bladder Cancer, and OthersBy Application;
Clinical Diagnostics and ResearchBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Immuno Oncology Assays Market Overview
Immuno Oncology Assays Market (USD Million)
In the year 2024, the Immuno Oncology Assays Market was valued at USD 5,860.31 million. The size of this market is expected to increase to USD 11,132.55 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 9.6%.
Global Immuno Oncology Assays Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 9.6 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 9.6 % |
Market Size (2024) | USD 5,860.31 Million |
Market Size (2031) | USD 11,132.55 Million |
Market Concentration | Medium |
Report Pages | 387 |
Major Players
- Merck & Co., Inc.
- Thermo Fisher Scientific Inc.
- F. Hoffmann-La Roche Ltd.
- Agilent Technologies, Inc.
- Abbott Laboratories
- Illumina, Inc.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Immuno Oncology Assays Market
Fragmented - Highly competitive market without dominant players
Increasing Preference for Personalized Cancer Treatments
The immuno oncology assays is accelerating as personalized cancer therapies gain traction in modern oncology. These assays enable tailored treatment strategies by identifying patient-specific biomarkers, which guide immunotherapy decisions. With more than 40% of oncologists now integrating biomarker testing into clinical workflows, the market is witnessing significant momentum.
Innovation in Assay Technologies Enhancing Market Appeal
Advancements in assay technology—such as next-generation sequencing and multiplex platforms—have greatly enhanced the precision and efficiency of immuno oncology diagnostics. About 35% of new assays now feature AI-powered analytics, offering faster and more reliable insights into immune responses. These technological strides are pushing the boundaries of both clinical practice and research.
Broader Utilization in Clinical and Drug Development Environments
Usage of immuno oncology assays is expanding across clinical settings and pharmaceutical R&D. These assays are essential for evaluating treatment efficacy and accelerating drug development timelines. Currently, around 50% of active immunotherapy trials rely on these tools for biomarker validation, demonstrating their integral role in advancing therapeutic pipelines.
Supportive Regulations and Coverage Fueling Growth
The market is further supported by streamlined regulatory approvals and improving reimbursement landscapes. Regulatory authorities are prioritizing the approval of companion diagnostics, while roughly 30% of insurance providers now offer coverage for biomarker-based immunotherapy tests. These developments are reducing barriers to adoption and fostering market confidence.
Wider Application Across Multiple Cancer Types
Immuno oncology assays, once limited in use, are now being applied to a broad spectrum of cancers—including lung, gastrointestinal, and melanoma. Today, over 45% of cancer patients undergoing immunotherapy receive biomarker testing, underscoring the growing importance of these assays in treatment planning and outcome optimization.
Immuno Oncology Assays Market Recent Developments
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In January 2025, Agilent Technologies Inc. expanded its collaboration with Incyte to advance the development and commercialization of Incyte’s hematology and oncology portfolio. The partnership emphasizes integrating advanced assay technologies to support precision diagnostics and targeted therapies.
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In May 2025, The Institute of Cancer Research, London, and NeoPhore reported early positive results from their ongoing preclinical collaboration. Their research showed promising tumor response using mismatch repair-targeting inhibitors, with translational studies planned for later in the year.
Immuno Oncology Assays Market Segment Analysis
In this report, the Immuno Oncology Assays Market has been segmented by Product, Technology, Indication, Application and Geography.
Immuno Oncology Assays Market, Segmentation by Product
The Immuno Oncology Assays Market has been segmented by Product into Consumables and Software.
Consumables
Consumables dominate the Immuno Oncology Assays Market, representing around 70% of the market share. These products include reagents, test kits, and other essential materials required for conducting immuno-oncology assays. The increasing demand for personalized medicine and the growing number of cancer patients worldwide contribute to the expansion of this segment. As immuno-oncology therapies gain traction, the need for consumables in diagnostic and therapeutic procedures continues to rise.
Software
Software used in immuno-oncology assays makes up the remaining 30% of the market. This category includes software solutions that assist in data analysis, processing, and management of assay results. With the increasing complexity of immuno-oncology treatments, software solutions are becoming critical for researchers and healthcare providers to manage large datasets and derive actionable insights for patient care. The growing integration of artificial intelligence (AI) and machine learning (ML) in oncology research also propels the demand for advanced software tools in the market.
Immuno Oncology Assays Market, Segmentation by Technology
The Immuno Oncology Assays Market has been segmented by Technology into Immunoassay, PCR, NGS, Flow Cytometry and Others.
Immunoassay
Immunoassay technology holds a significant share of the Immuno Oncology Assays Market, accounting for approximately 40% of the market. Immunoassays are widely used for detecting cancer biomarkers and assessing immune responses. The versatility and high sensitivity of immunoassay-based tests, such as enzyme-linked immunosorbent assays (ELISA), make them a popular choice in both clinical and research settings. The increasing focus on personalized oncology treatments continues to drive the growth of immunoassay technologies in the market.
PCR (Polymerase Chain Reaction)
Polymerase Chain Reaction (PCR) technology makes up about 25% of the market. PCR is extensively used in immuno-oncology assays for detecting specific genetic mutations, gene expression profiling, and identifying cancer-related biomarkers. As the demand for more precise molecular diagnostic techniques increases, PCR’s role in immuno-oncology applications continues to grow, particularly in identifying potential therapeutic targets for personalized treatment plans.
NGS (Next-Generation Sequencing)
Next-Generation Sequencing (NGS) is one of the fastest-growing segments in the Immuno Oncology Assays Market, accounting for nearly 20% of the market share. NGS enables comprehensive genetic profiling of tumors, allowing for in-depth analysis of mutations and alterations at the genomic level. As immuno-oncology therapies become increasingly personalized, the demand for NGS to identify suitable biomarkers and therapeutic targets has surged.
Flow Cytometry
Flow Cytometry holds about 10% of the Immuno Oncology Assays Market share. This technology is widely used for immunophenotyping and analyzing immune cell populations in blood and tissue samples. Flow cytometry plays a crucial role in assessing the effectiveness of immunotherapies by measuring immune cell responses. The rising adoption of cell-based immunotherapies, such as CAR T-cell therapy, is contributing to the growth of this technology in immuno-oncology assays.
Others
The "Others" segment, accounting for the remaining 5% of the market, includes various emerging technologies used in immuno-oncology assays. These may include mass spectrometry, microarray technology, and others that offer specialized capabilities in the analysis of cancer biomarkers, immune response, and genetic alterations. As research into immuno-oncology continues to evolve, new technologies are expected to contribute to the overall growth of this market segment.
Immuno Oncology Assays Market, Segmentation by Indication
The Immuno Oncology Assays Market has been segmented by Indication into Colorectal Cancer, Lung Cancer, Melanoma, Bladder Cancer and Others.
Colorectal Cancer
Colorectal cancer accounts for approximately 30% of the Global Immuno Oncology Assays Market. The prevalence of colorectal cancer is rising globally, with early detection playing a crucial role in improving treatment outcomes. Immuno-oncology assays help identify relevant biomarkers and potential therapeutic targets for personalized treatment plans. The growing adoption of immunotherapies targeting colorectal cancer has significantly contributed to the expansion of this segment in the market.
Lung Cancer
Lung cancer represents around 25% of the market share. Due to its high incidence and mortality rates, lung cancer is a key area of focus for immuno-oncology assays. These assays assist in identifying cancer biomarkers, tracking the response to immunotherapy, and determining prognosis. The increasing availability of immunotherapies tailored for lung cancer is driving the demand for assays, further boosting the segment's growth.
Melanoma
Melanoma is a significant driver of the Immuno Oncology Assays Market, holding about 20% of the market share. As one of the most aggressive forms of skin cancer, melanoma's early detection and precise treatment are crucial. Immuno-oncology assays have proven effective in identifying biomarkers and assessing the response to immune checkpoint inhibitors. The rise in melanoma cases and the growing number of immunotherapies available are driving demand for assays in this segment.
Bladder Cancer
Bladder cancer accounts for approximately 15% of the market. Immuno-oncology assays are increasingly being used to identify bladder cancer biomarkers, monitor treatment responses, and assess immunotherapy efficacy. With the development of novel immunotherapies for bladder cancer, including immune checkpoint inhibitors, the demand for assays to guide treatment decisions has surged.
Others
The "Others" segment, which comprises the remaining 10%, includes cancers such as breast cancer, prostate cancer, and esophageal cancer. These cancers are seeing growing application of immuno-oncology assays to identify biomarkers, determine therapy responses, and guide clinical decisions. As new immunotherapies and diagnostic techniques emerge, the segment is expected to expand further.
Immuno Oncology Assays Market, Segmentation by Application
The Immuno Oncology Assays Market has been segmented by Application into Clinical Diagnostics and Research.
Clinical Diagnostics
The Clinical Diagnostics segment holds a significant share of around 65%. This segment plays a critical role in detecting cancer and monitoring the efficacy of immunotherapies. The demand for clinical diagnostics is driven by the rising need for accurate and early diagnosis of cancers, which can help in developing personalized treatment strategies. As immuno-oncology therapies advance, clinical diagnostics are becoming increasingly essential in patient management and therapeutic decision-making.
Research
The Research segment represents approximately 35% of the Global Immuno Oncology Assays Market. This sub-segment focuses on the development and exploration of new immunotherapies and diagnostic technologies. As research institutions and pharmaceutical companies work on discovering new biomarkers and therapeutic targets, the demand for immuno-oncology assays in research applications continues to grow. The segment is expected to expand as more innovative therapies and diagnostic tools are developed and integrated into clinical practices.
Immuno Oncology Assays Market, Segmentation by Geography
In this report, the Immuno Oncology Assays Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
Immuno Oncology Assays Market Share (%), by Geographical Region, 2024
As of the previous year, the Immuno Oncology Assays Market exhibited varying market shares across different geographical regions, reflecting regional differences in healthcare infrastructure, prevalence of cancer types, and adoption of advanced diagnostic technologies. The region's leadership was further supported by extensive regulatory approvals for immuno-oncology assays and the presence of key market players actively involved in developing and commercializing innovative diagnostic solutions.
North America
North America holds a significant share of the Immuno Oncology Assays Market, accounting for approximately 40%. The region benefits from a highly developed healthcare infrastructure, significant investments in cancer research, and a high adoption rate of advanced diagnostic technologies. The increasing prevalence of cancer, along with the rising demand for immunotherapies, has further fueled the growth of immuno-oncology assays in the region.
Europe
Europe contributes around 30% to the Global Immuno Oncology Assays Market. The market growth in Europe is driven by the increasing focus on personalized medicine and the rising demand for effective cancer diagnostics. The adoption of advanced diagnostic platforms and government initiatives aimed at improving healthcare infrastructure have positively impacted market growth in the region.
Asia Pacific
Asia Pacific accounts for roughly 20% of the Global Immuno Oncology Assays Market. The market in this region is growing due to the increasing cancer prevalence, improving healthcare infrastructure, and rising disposable income in emerging economies like China and India. Additionally, increasing investments in cancer research and biotechnology further support the growth of this segment.
Middle East and Africa
The Middle East and Africa (MEA) region represents approximately 5% of the Global Immuno Oncology Assays Market. The market growth in this region is driven by an increasing awareness of cancer diagnostics and treatment, alongside improving healthcare infrastructure. However, challenges such as economic instability and limited access to advanced medical technologies in some regions may impact market expansion.
Latin America
Latin America accounts for around 5% of the Global Immuno Oncology Assays Market. The demand for immuno-oncology assays in this region is being driven by rising cancer incidence, along with the improving healthcare infrastructure and increased focus on medical advancements. While the market is growing, challenges related to access to healthcare in some countries may hinder faster adoption.
Immuno Oncology Assays Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Immuno Oncology Assays Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
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Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Rising demand for autoimmune disease treatments
- Increasing adoption in therapeutic apheresis procedures
- Technological advances in column efficiency
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Growing prevalence of chronic inflammatory disorders - The rising incidence of chronic inflammatory disorders is emerging as a major catalyst for the growth of the immuno oncology assays market. Prolonged inflammation is now widely recognized for its role in cancer development, as it can disrupt normal immune function and create an environment that fosters tumor formation. This persistent inflammatory state often leads to genetic mutations, immune suppression, and abnormal tissue repair, all of which contribute to cancer progression. Importantly, such conditions result in the increased expression of immune-related biomarkers, which are essential for identifying early oncogenic changes.
As the prevalence of these inflammatory conditions continues to grow, so does the demand for advanced diagnostic solutions capable of detecting and monitoring relevant biomarkers. Immuno oncology assays are at the forefront of this need, offering precision in identifying immune responses associated with both inflammation and malignancy. Healthcare professionals are increasingly relying on these assays for early cancer detection, treatment planning, and therapeutic monitoring in patients with chronic inflammation. This trend is driving significant market expansion, supported by the need for accurate, reliable, and clinically validated testing platforms that can link inflammation with cancer risk.
Restraints
- High cost of immunoadsorption procedures
- Limited awareness in developing healthcare systems
- Stringent regulatory requirements for product approval
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Inconsistent reimbursement across treatment markets - Inconsistent reimbursement policies across global healthcare systems pose a significant challenge to the expansion of the immuno oncology assays market. While these assays are becoming critical tools in the diagnosis and monitoring of cancer, their high cost and lack of uniform coverage hinder widespread adoption. In many regions, especially in low- and middle-income countries, these diagnostic tests are not fully reimbursed by insurance providers or public health programs. They are often viewed as non-essential or investigational tools, limiting access for patients and discouraging healthcare facilities from incorporating them into routine clinical practice.
The absence of a standardized global reimbursement framework not only impacts the affordability and availability of these assays but also slows down their integration into mainstream healthcare. Countries with strong healthcare funding and consistent reimbursement structures are seeing higher adoption rates, while others are lagging behind due to financial and policy-related constraints. This imbalance affects the overall market potential and restricts the delivery of personalized cancer care on a broader scale. Eliminating these disparities is essential to support equal access to advanced diagnostics and fully leverage the benefits of immuno oncology innovations.
Opportunities
- Expansion into emerging healthcare markets
- Development of disease-specific adsorption columns
- Strategic collaborations with biotech firms
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Rising focus on personalized treatment solutions - The growing emphasis on personalized treatment strategies in oncology is unlocking new growth opportunities for the immuno oncology assays market. As cancer care increasingly moves toward precision medicine, healthcare providers are prioritizing diagnostic tools that can tailor therapies to an individual’s unique immune response and tumor profile. Immuno oncology assays are vital in this shift, enabling the identification of specific biomarkers that help determine the most effective and targeted treatment options. This personalized approach improves treatment outcomes while minimizing side effects, aligning with the broader goal of enhancing patient care.
The integration of genomic, proteomic, and immunologic data into clinical decision-making is accelerating the adoption of advanced assay technologies. Research institutions, pharmaceutical companies, and diagnostics developers are increasingly investing in tools that support individualized therapeutic planning. Immuno oncology assays stand at the center of this transformation by delivering comprehensive insights into the interactions between cancer cells and the immune system. This rising demand is driving innovation in companion diagnostics, adaptive therapy solutions, and next-generation testing platforms, all of which are helping expand the market and redefine how cancer is managed at a personalized level.
Immuno Oncology Assays Market Competitive Landscape Analysis
Key players in Immuno Oncology Assays Market include,
- F. Hoffmann-La Roche Ltd,
- Illumina, 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.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Technology
- Market Snapshot, By Indication
- Market Snapshot, By Application
- Market Snapshot, By Region
- Immuno Oncology Assays Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
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Rising demand for autoimmune disease treatments
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Increasing adoption in therapeutic apheresis procedures
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Technological advances in column efficiency
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Growing prevalence of chronic inflammatory disorders
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- Restraints
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High cost of immunoadsorption procedures
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Limited awareness in developing healthcare systems
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Stringent regulatory requirements for product approval
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Inconsistent reimbursement across treatment markets
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- Opportunities
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Expansion into emerging healthcare markets
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Development of disease-specific adsorption columns
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Strategic collaborations with biotech firms
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Rising focus on personalized treatment solutions
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- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Immuno Oncology Assays Market, By Product, 2021 - 2031 (USD Million)
- Consumables
- Software
- Immuno Oncology Assays Market, By Technology, 2021 - 2031 (USD Million)
- Immunoassay
- PCR
- NGS
- Flow Cytometry
- Others
- Immuno Oncology Assays Market, By Indication, 2021 - 2031 (USD Million)
- Colorectal Cancer
- Lung Cancer
- Melanoma
- Bladder Cancer
- Others
- Immuno Oncology Assays Market, By Application, 2021 - 2031 (USD Million)
- Clinical Diagnostics
- Research
- Immuno Oncology Assays Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN(Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Immuno Oncology Assays Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- F. Hoffmann-La Roche Ltd,
- Illumina, 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.
- Company Profiles
- Analyst Views
- Future Outlook of the Market