Immuno Oncology Assays Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Immuno Oncology Assays Market is projected to expand from USD 5.47 Billion in 2025 to USD 8.21 Billion by 2031, registering a compound annual growth rate (CAGR) of 7.01%. These assays serve as specialized analytical platforms designed to assess the interactions between tumor cells and the immune system, thereby aiding in the development of immunotherapies and patient stratification. The market is driven primarily by the increasing global cancer burden and a simultaneous shift toward precision medicine, which demands reliable biomarkers for treatment selection. As reported by the American Cancer Society, it was projected that 2,001,140 new cancer cases would be diagnosed in the United States in 2024, a statistic that underscores the urgent need for advanced diagnostic tools to guide therapeutic interventions and enhance clinical outcomes.

Despite this positive growth trajectory, the market encounters a significant hurdle regarding the high financial investment necessary for assay development and validation. The substantial costs linked to specialized reagents and complex analytical platforms restrict access for smaller research institutions and healthcare facilities with constrained budgets. This economic barrier impedes the widespread adoption of these essential diagnostic technologies and may decelerate the pace of market expansion in regions that are sensitive to costs.

Market Drivers

Increased investment in research and development for immunotherapy acts as a major catalyst for the market, with pharmaceutical companies aggressively pursuing novel therapeutic modalities such as antibody-drug conjugates and bispecific antibodies. This financial dedication fuels the demand for specialized immuno-oncology assays, which are essential for target validation, mechanism-of-action studies, and clinical trial monitoring.

The scale of these efforts is evident in the expenditure of major industry players prioritizing oncology pipelines; for instance, Merck & Co., Inc. reported in its 'Fourth-Quarter and Full-Year 2023 Financial Results' in February 2024 that R&D expenses reached $30.5 billion for the full year, reflecting a strategic intensification of their pipeline development, including oncology assets. Such massive capital infusion ensures a continuous need for high-complexity assays to screen and characterize expanding libraries of immunotherapeutic candidates.

Simultaneously, the rising adoption of companion diagnostics (CDx) is transforming the market landscape by establishing a vital link between assay results and therapeutic decision-making. As precision oncology becomes the standard of care, regulatory frameworks are evolving to require the co-development of diagnostic tests with new drugs to ensure patient eligibility and maximize treatment efficacy.

This trend compels diagnostic manufacturers to innovate rapidly, integrating biomarkers like PD-L1 and MSI status into robust clinical platforms. Highlighting this regulatory momentum, the U.S. Food and Drug Administration (FDA) noted in its 'Oncology Regulatory Review 2023' in March 2024 that the agency authorized 15 new companion diagnostic indications for oncology devices in 2023. Furthermore, commercial vitality is reflected in the performance of key market leaders; according to Roche, in 2024, the company's Diagnostics Division achieved a 7% growth in base business sales for the 2023 fiscal year, driven largely by sustained demand for immunodiagnostic solutions.

Market Challenges

The substantial financial investment required for the development and validation of immuno-oncology assays presents a significant barrier to market expansion. Creating these specialized diagnostic platforms involves considerable research and development expenditure, which inevitably leads to high pricing for end-users. Consequently, smaller research institutions, community hospitals, and healthcare facilities with limited budgets are often unable to acquire these advanced analytical tools and the necessary specialized reagents. This economic disparity restricts adoption primarily to well-funded academic centers and major pharmaceutical companies, thereby stifling broader market penetration and slowing the overall volume of testing in decentralized settings.

This challenge is further exacerbated by the financial strain on the global healthcare ecosystem, which compels decision-makers to strictly prioritize cost containment over the acquisition of expensive technologies. This intense economic pressure limits the funds available for diagnostic innovation. According to the American Association for Cancer Research (AACR), in its 2024 Cancer Progress Report, the cumulative economic burden of cancer globally is projected to reach $25.2 trillion between 2020 and 2050. Such profound financial liabilities force healthcare providers to limit capital expenditure, directly hampering the growth of the immuno-oncology assays market in cost-sensitive regions.

Market Trends

The integration of AI-enabled assay analytics is fundamentally reshaping the Global Immuno Oncology Assays Market by improving the accuracy and throughput of biomarker interpretation. These advanced algorithms allow for the automated, quantitative scoring of complex tissue markers, addressing the variability inherent in manual pathology and facilitating the precise characterization of the tumor microenvironment. The accelerating adoption of these digital tools is reflected in the financial performance of key innovators in the sector. According to Korea Biomedical Review, February 2025, in the article 'Lunit achieves record revenue growth driven by global expansion, innovation', Lunit reported a 116% year-over-year revenue increase to approximately $37.2 million in 2024, fueled by the expanded deployment of its AI-powered diagnostic suites across global medical institutions.

Concurrently, the emergence of liquid biopsy-based immuno-oncology assays is driving market expansion by enabling non-invasive, longitudinal monitoring of treatment response. These assays overcome the limitations of tissue availability by detecting circulating tumor DNA, providing critical insights into minimal residual disease and helping clinicians rapidly adjust immunotherapeutic strategies. This shift towards blood-based testing is generating significant commercial momentum as test volumes surge. According to Guardant Health, February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company achieved total revenue of $739 million for the fiscal year 2024, marking a 31% increase from the prior year, primarily driven by a 20% growth in clinical oncology test volume.

Key Players Profiled in the Immuno Oncology Assays Market

• Agilent Technologies, Inc.
• BIO-RAD LABORATORIES, INC.
• Charles River Laboratories, Inc.
• F. Hoffmann-La Roche Ltd.
• Illumina, Inc.
• NanoString Technologies, Inc.
• PerkinElmer Inc.
• QIAGEN N.V.
• Sartorius AG
• THERMO FISHER SCIENTIFIC, INC.

Report Scope

In this report, the Global Immuno Oncology Assays Market has been segmented into the following categories:

Immuno Oncology Assays Market, by Indication:

• Colorectal Cancer
• Lung Cancer
• Melanoma Cancer
• Bladder Cancer
• Others

Immuno Oncology Assays Market, by Technology:

• Immunoassays
• Polymerase chain reaction (PCR)
• Next-generation sequencing (NGS)
• Flow Cytometry

Immuno Oncology Assays Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Immuno Oncology Assays Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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