Immuno Oncology Assays Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Colorectal Cancer, Lung Cancer, Melanoma Cancer, Bladder Cancer, Others), By Technology (Immunoassays, Polymerase chain reaction (PCR), Next-generation sequencing (NGS), Flow Cytometry), By Region and Competition, 2021-2031F

Market Overview

The Global Immuno Oncology Assays Market will grow from USD 5.47 Billion in 2025 to USD 8.21 Billion by 2031 at a 7.01% CAGR. Immuno oncology assays are specialized analytical platforms designed to evaluate the interaction between tumor cells and the immune system to facilitate the development of immunotherapies and patient stratification. The market is primarily driven by the escalating global burden of cancer and the concurrent shift toward precision medicine which necessitates robust biomarkers for treatment selection. According to the American Cancer Society, in 2024, it was projected that 2,001,140 new cancer cases would be diagnosed in the United States. This rising incidence underscores the critical need for advanced diagnostic tools to guide therapeutic intervention and improve clinical outcomes.

Despite the strong growth trajectory, the market faces a substantial impediment regarding the high financial investment required for assay development and validation. The significant costs associated with specialized reagents and complex analytical platforms restrict accessibility for smaller research institutions and healthcare facilities with limited budgets. This economic barrier limits the widespread adoption of these essential diagnostic technologies and may slow the pace of market expansion in cost-sensitive regions.

Key Market Drivers

The surge in research and development investment for immunotherapy serves as a primary catalyst for the market, as pharmaceutical companies aggressively pursue novel therapeutic modalities such as antibody-drug conjugates and bispecific antibodies. This financial commitment directly fuels the demand for specialized immuno-oncology assays, which are indispensable for target validation, mechanism-of-action studies, and clinical trial monitoring. The intensification of these efforts is evident in the expenditure of major industry players who are prioritizing oncology pipelines to address unmet medical needs. For instance, according to Merck & Co., Inc., February 2024, in the 'Fourth-Quarter and Full-Year 2023 Financial Results', the company's research and development expenses rose to $30.5 billion for the full year 2023, reflecting a strategic intensification of their pipeline development including oncology assets. Such massive capital infusion ensures a continuous requirement for high-complexity assays to screen and characterize expanding libraries of immunotherapeutic candidates.

Concurrently, the increasing adoption of companion diagnostics (CDx) is reshaping the market landscape by establishing a critical link between assay results and therapeutic decision-making. As precision oncology becomes the standard of care, regulatory frameworks are evolving to mandate the co-development of diagnostic tests with new drugs to ensure patient eligibility and maximize treatment efficacy. This trend forces diagnostic manufacturers to innovate rapidly, integrating biomarkers like PD-L1 and MSI status into robust clinical platforms. According to the U.S. Food and Drug Administration (FDA), March 2024, in the 'Oncology Regulatory Review 2023', the agency authorized 15 new companion diagnostic indications for oncology devices in 2023. This regulatory momentum highlights the essential role of assays in modern treatment paradigms. Furthermore, the sector's 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.

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Key Market Challenges

The high financial investment required for the development and validation of immuno oncology assays constitutes a significant barrier to market expansion. Developing these specialized diagnostic platforms involves substantial research and development expenditure, which inevitably translates into 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.

The financial strain on the global healthcare ecosystem exacerbates this challenge, compelling 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.

Key Market Trends

The Integration of AI-Enabled Assay Analytics is fundamentally reshaping the Global Immuno Oncology Assays Market by enhancing 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.

Simultaneously, 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.

Segmental Insights

The Colorectal Cancer segment represents the fastest-growing category within the Global Immuno Oncology Assays Market, driven by the rising prevalence of this malignancy and the critical need for targeted therapeutic selection. This expansion is significantly accelerated by regulatory frameworks, including guidelines from the US FDA, which advocate for screening tumors for biomarkers such as microsatellite instability. These diagnostic tests are essential for identifying patients eligible for specific immune checkpoint inhibitors, thereby fueling the demand for assays that ensure clinical decisions are based on accurate genomic profiles.

Regional Insights

North America maintains a dominant position in the global immuno-oncology assays market due to substantial investments in pharmaceutical research and the widespread adoption of precision medicine. The presence of established biotechnology firms and research institutions within the region accelerates the development of novel diagnostic tools. Additionally, the United States Food and Drug Administration fosters market stability through clear guidelines for approving companion diagnostics and immunotherapy protocols. This combination of strong regulatory support, extensive clinical trial activity, and high healthcare spending on cancer diagnostics solidifies the region's status as the principal market for immuno-oncology solutions.

Recent Developments

• In August 2024, Illumina, Inc. announced that the U.S. Food and Drug Administration approved its TruSight Oncology Comprehensive test along with two companion diagnostic indications. This development in the Global Immuno Oncology Assays Market involved a test capable of interrogating over 500 genes to profile solid tumors and identify immuno-oncology biomarkers. The distributable in vitro diagnostic kit was designed to enable comprehensive genomic profiling, facilitating the identification of patients eligible for targeted therapies. This approval allows laboratories to perform testing locally, thereby supporting broader access to precision oncology and assisting clinicians in matching patients with appropriate treatments based on specific genomic alterations.
• In March 2024, Thermo Fisher Scientific Inc. and Bayer AG established a collaboration to develop next-generation sequencing-based companion diagnostic assays. This initiative in the Global Immuno Oncology Assays Market focused on identifying patients suitable for precision cancer therapies. The partnership involved co-developing assays on the Ion Torrent Genexus Dx System to enable decentralized testing with rapid results. The collaboration aimed to improve patient access to personalized treatments by supporting the identification of specific genomic markers. This effort highlighted the companies' shared objective to advance genomic testing and ensure patients receive targeted interventions based on their unique tumor profiles.
• In February 2024, Standard BioTools Inc. announced a collaboration with Navignostics AG to develop clinical research applications using the Hyperion XTi Imaging System. This partnership, relevant to the Global Immuno Oncology Assays Market, focused on utilizing spatial single-cell proteomics to characterize tumors and generate biological insights. The companies aimed to automate and standardize imaging mass cytometry workflows to support drug development and precision medicine strategies. By combining their technologies, the collaboration intended to provide data that informs treatment decisions and accelerates the identification of optimal therapies for cancer patients in clinical research settings.
• In January 2024, Agilent Technologies Inc. announced a partnership with Incyte to develop companion diagnostics for hematology and oncology programs. This collaboration within the Global Immuno Oncology Assays Market aimed to create tests that support the commercialization of targeted therapeutics. The agreement leveraged the companies' combined expertise to advance diagnostic solutions through clinical trials and regulatory processes in the United States and Europe. By focusing on the identification of biomarkers, the partnership intended to select patients most likely to benefit from specific treatments, thereby reinforcing the role of precision medicine in managing complex cancer indications.

Key Market Players

• 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, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE