The North America Immuno Oncology Assays Market is experiencing significant expansion, driven by technological advances, increased R&D investments, and growing prevalence of cancer. The market was valued at USD 1,320 Million in 2025 and is forecasted to reach USD 5,930 Million by 2035 at a CAGR of 15.8% from 2024 to 2035. This growth is supported by widening clinical applications, favorable regulatory landscapes, and heightened collaboration among key players.
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Market Growth Drivers
Increasing prevalence of cancer in North America is driving the demand for advanced immuno-oncology assays. According to the American Cancer Society, there are around 2 million new cancer cases annually in the region, creating ongoing need for effective diagnostics and personalized treatment. Thermo Fisher Scientific has responded by expanding its Oncomine portfolio, making immune profiling more accessible to laboratories, and supporting oncology physicians in selecting tailored therapies.
Rising investments in immuno-oncology research and development are fueling assay innovation and adoption. Leading biopharmaceutical companies such as Bristol-Myers Squibb are partnering with diagnostics developers to enhance assay sensitivity and specificity. Their collaboration with Illumina to advance biomarker discovery and companion diagnostics exemplifies the trend toward integrating robust molecular testing in immunotherapy clinical trials and commercial care.
Market Trends
Adoption of multiplex immunoassays for simultaneous detection of multiple biomarkers is reshaping the market landscape. Multiplex platforms from companies like Bio-Rad Laboratories enable comprehensive immune profiling, reduce sample requirements, and accelerate clinical decision-making. This trend is increasingly important as personalized oncology becomes the standard of care in North America.
Integration of artificial intelligence and machine learning in assay data analysis is enhancing the predictive power and precision of immuno-oncology assays. F. Hoffmann-La Roche Ltd. has launched AI-powered solutions for analyzing immunohistochemistry results, thus optimizing biomarker interpretation and improving outcome prediction for patients undergoing immunotherapy.
Market Opportunity
Expansion into companion diagnostics for novel immunotherapies represents a significant growth opportunity. Companies such as Agilent Technologies are building partnerships with pharmaceutical firms to develop FDA-approved companion assays for next-generation immune checkpoint inhibitors.
Development of liquid biopsy-based immuno-oncology assays offers minimally invasive alternatives for tumor monitoring. Guardant Health is leveraging circulating tumor DNA technologies to support real-time therapy decisions and longitudinal management of cancer patients.
North America Immuno Oncology Assays Market Revenue (USD Million), 2020-2035
The market revenue chart shows a strong upward trajectory for the North America Immuno Oncology Assays Market from 2020 to 2035. The market's value was approximately USD 410 million in 2020 and witnessed consistent growth each year, reaching USD 1,320 million in 2025, and is projected to soar to USD 5,930 million by 2035. This impressive compound annual growth rate of 15.8% reflects the increasing reliance on immuno-oncology assays for cancer diagnostics, driven by technological innovations, expanding applications, and supportive healthcare policies. The slope steepens after 2027, indicating acceleration in adoption with the introduction of novel assays and AI-driven solutions in the region.
North America Immuno Oncology Assays Market by Region Share (%) - 2025
The 2025 pie chart for market share by region indicates that the United States is the dominant player, accounting for 74% of the North America Immuno Oncology Assays Market. Canada follows with 18%, and Mexico holds 6%. The remainder is split between the rest of Central America (1%) and the Caribbean (1%). The substantial share held by the US is due to robust healthcare infrastructure, substantial R&D investments, and a high cancer incidence rate. Canada benefits from strong government support and growing biotech industry activity, while Mexico and other regions are seeing gradual improvements in adoption and access to advanced cancer diagnostics.
Recent Developments (Last 6 Months)
In March 2024, Thermo Fisher Scientific introduced its latest upgrade to the Oncomine Precision Assays, featuring expanded immune profiling and more automated workflows. This enhancement enables laboratories to accelerate turnaround times for oncology patients and provides clinicians with richer, actionable insights for immunotherapy selection.
In April 2024, Guardant Health announced a strategic collaboration with Merck to develop a liquid biopsy companion diagnostic for a new class of immune checkpoint inhibitors. This partnership seeks to advance the detection of relevant biomarkers in blood samples, expanding access to personalized immuno-oncology therapies across North America.
In February 2024, Bio-Rad Laboratories launched a line of multiplex immunoassays targeting novel immune checkpoints, providing researchers with tools to evaluate emerging immunotherapy mechanisms. This product series is designed to support both research and clinical applications, reinforcing Bio-Rad’s leadership in immuno-oncology assay innovation.
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