Immuno Oncology Assays Market Size, Share, Growth, and Industry Analysis, By Type (Immunoassay, Flow Cytometry, PCR, and Next Generation Sequencing), By Application (Research, and Clinical Diagnostics), and Regional Forecast to 2035

IMMUNO ONCOLOGY ASSAYS MARKET OVERVIEW

The global Immuno Oncology Assays market size was USD 6.71 billion in 2026 and is projected to touch USD 17.29 billion in 2035, exhibiting a CAGR of 10.9% during the forecast period.

The immuno-oncology assays market is experiencing tremendous growth because of the rising concentration in customized cancer therapy and the immune system-based treatment. Specialized tests are referred to as immuno-oncology assays that are used to measure the immune response to cancer cells that can be used in the development and monitoring of immunotherapies. The assays offer important information on tumor microenvironment, biomarker prescription, and therapeutic effectiveness. The current market is expanding owing to increasing investment in research of cancer and the development of technologies in assays. The market is also enhanced by the increasing need for specific and accurate cancer treatment remedies all over the world.

GLOBAL CRISES IMPACTING IMMUNO ONCOLOGY ASSAYS MARKET

COVID-19 IMPACT

Immuno Oncology Assays Industry Had a Negative Effect Due to disrupting research and clinical trials during COVID-19 Pandemic

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The immuno-oncology assays market had a significant decrease in the COVID-19 pandemic with the interference of the laboratory work and the delay of clinical trials going on. Numerous healthcare institutions placed COVID-19 testing and treatment as a priority so that less attention was given to cancer research and immuno-oncology assays. Interruptions in the supply chain also influenced the supply of essential reagents and assay kits, further dragging down the market activities. Also, the limits on the number of visits to patients and collecting the samples impeded the generation of data on immunotherapy in time. All in all, the pandemic led to the temporary slowdown of the market and the postponement of the introduction of new technologies in assays.

LATEST TREND

Market growth is driven by AI, multiplex profiling, and non-invasive assays

One of the main tendencies of the immuno-oncology assays market today is the increased use of artificial intelligence-enabled analytics in assay development and interpretation, which is enhancing the speed and accuracy of immune profiling. A preference is also shifting strongly towards multiplex spatial profiling, which enables detection of multiple biomarkers on intact tissue at once to map the tumor microenvironment with greater accuracy. Further on, non-invasive monitoring of the immune responses becomes a possibility with the increase of liquid biopsy-based assays. The other trend is augmented cooperation between diagnostics and pharmaceutical companies to jointly develop companion diagnostics in immunotherapies. Among them, the analytics trend based on AI is the most prominent, as it greatly improves throughput and predictive power both in research and clinical use.

IMMUNO ONCOLOGY ASSAYS MARKET SEGMENTATION

BY TYPE

Based on Type, the global market can be categorized into Immunoassay, Flow Cytometry, PCR, and Next Generation Sequencing

Immunoassay: Immunoassays serve a wide range of applications in the immuno-oncology assays market to either identify and measure certain proteins, antibodies, or antigens in regard to cancer immune responses. They are very sensitive and specific, hence useful in identifying biomarkers and monitoring therapy. Such assays are not that expensive and can be used in high-throughput screening. Immunoassays are being implemented because of increasing needs in immune profiling both in research and clinical samples.

Flow Cytometry: Flow cytometry provides the ability to comprehensively study a population of immune cells by measuring a number of parameters at one go on a single-cell level. Evaluation of immune responses, tumor-infiltrating lymphocytes, and immunotherapy efficacy is crucially dependent on it. Improved data analysis and faster speeds as well as accuracy with the help of technology. Its demand is growing in the market due to growing applications in personalized medicine and immunotherapy research and development.

PCR: Polymerase chain reaction tests are employed to exploit the detection and quantification of nucleic acids to aid in the identification of the patterns of gene expression and immune-associated mutation in cancer. PCR has high sensitivity, is rapid, and can be done at extremely low levels of sample volumes. It is commonly used in research and clinical diagnostics of immuno-oncology research. Increased attention to genetic profiling and targeted therapies is creating PCR uptake in the market.

Next Generation Sequencing: Next Generation Sequencing: Next-generation sequencing provides an opportunity to carry out thorough genomic profiling, which will allow the simultaneous study of multiple genes and mutations that are the subject of immuno-oncology. It assists in the detection of biomarkers, the interpretation of tumor heterogeneity, and the delivery of individual immunotherapy approaches. NGS technologies have been made cheaper, faster, and more incorporated into clinical practice. There is a general increase in the use of NGS-based assays, which is driven by the growing focus of precision medicine.

BY APPLICATION

Based on application, the global market can be categorized into Research, and Clinical Diagnostics

Research: Immuno-oncology tests are widely applied in research to investigate the mechanisms of interaction between the immune system and cancer cells. They assist in detecting new biomarkers, determining immunotherapy efficacy, and learning tumor microenvironments. Sophisticated tests, including multiplex and spatial profiling, are supplementing the richness and accuracy of the research results. The rising industrial trend toward individualized and specific cancer treatments is resulting in the increased use of these assays in labs.

Clinical Diagnostics: Immuno-oncology assays in clinical diagnostics are used in clinical diagnostics to inform treatment decision-making, assess therapy response, and forecast patient outcome. They allow accuracy in the profiling of immune response, which helps physicians in choosing suitable immunotherapies. The combination of high throughput and next-generation sequencing measurement is enhancing the speed and accuracy in diagnosis. Immuno-oncology assays are being used in the clinics due to the growing demand to treat the individual cancer with precision and companion diagnostics.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.            

DRIVING FACTOR

Market growth is driven by rising immunotherapy applications and immune profiling

The immuno-oncology assays market is one of the major drivers driven by increased application of immunotherapies in the treatment of cancer. These tests are critical towards assessing the immune response in patients and patient therapeutic effectiveness. With the increasing number of immunotherapy drugs coming to the medical landscape, there is an increase in the need to have fine and accurate immune profiling instruments. It is a developing trend that is driving investment in new high-end assay technologies and their use throughout research and clinical laboratories.

Market growth is driven by advanced technologies and improved assay capabilities

There have been increased advancements in technology that have been massively accelerating the immuno-oncology assays market. The immune responses could be analyzed more accurately and quickly and in larger volumes with the help of next-generation sequencing, multiplex assays, and artificial intelligence-enabled platforms. These developments allow more effective identification of biomarkers and custom design of treatment. Consequently, advanced assay functions are spurring the development of the market and enabling the wider application of immuno-oncology diagnostics.

RESTRAINING FACTOR

Market growth is limited by high costs and specialized technology requirements

Immuno-oncology assays have high costs, which is a major limitation to the market. On the one hand, complex technologies require a lot of money, as they demand costly tools, such as next-generation sequencing; on the other, multiplex profiling systems demand specialized professionals. Such expenses restrict the access of the small research labs and other health institutions within the developing areas. In turn, the financial load retards the broad usage and the general development of the market.

OPPORTUNITY

Market growth is driven by personalized therapies and precision medicine applications

The increased focus on individual therapies for cancer is an immense market opportunity for the Immuno Oncology Assays Market Growth. The extension of the application of companion diagnostics makes it possible to engage in personalized immunotherapy depending on the specifics of patients. The enhancement of precision medicine and biomarker-based research increases the market growth. This situation will promote the use of sophisticated testing in the clinical and research environments.

CHALLENGE

Market growth is hindered by complex data interpretation and assay variability

The immuno-oncology assays market is confronted with a major issue in the form of the complexity of the interpretation of the data on immune reaction. Heterogeneity in patients and the microenvironment of tumors complicates the achievement of consistent and reliable results. Also, harmonization of assay procedures in all labs is a significant hurdle. All these hamper reproducibility and delay adoption of assays in routine practice.

IMMUNO ONCOLOGY ASSAYS MARKET REGIONAL INSIGHTS

• NORTH AMERICA

North America drives market growth due to advanced healthcare infrastructure investments

The immuno-oncology assays market is dominated by North America because of the developed healthcare infrastructure, the great utilization of immunotherapies, and the allocation of money into cancer research studies. The technological innovation and market growth are caused by the existence of major pharmaceutical and diagnostic firms. Intense investment in research and development aids the expansion of sophisticated assay platforms. The United States is one of the most influential countries in North America, with the United States Immuno Oncology Assays Market presenting many advantages of clinical trials and precision medicine ventures. An increase in awareness and government sponsorship adds more strength to the market leadership of the region.

• EUROPE

Europe boosts market growth through R&D, clinical trials, and funding

The high rate of research and development undertaken by Europe and the established healthcare facilities confirms that Europe plays a significant role in the immuno-oncology assays market. The area is rich in immunotherapy clinical trials, which stimulate the need to develop sophisticated assays. Market development is further enhanced by government support and funding for cancer research. Moreover, the availability of major biotechnology and pharmaceutical firms also promotes innovation and uptake of immuno-oncology assays in Europe.

• ASIA

Asia drives market growth through healthcare investment, awareness, and clinical trials

The Asian region is becoming a major source of the immuno-oncology assays market with the growing investments in healthcare structures and research on cancer. There is the increasing awareness of immunotherapy and increasing cancer prevalence to stimulate the demand for improved assay technologies. The market growth is also being supported by the increased clinical trial operations and partnership with international pharmaceutical companies. Also, the desirable factors are the cost benefits and the high number of patients in Asia, which is particularly where the use of immuno-oncology assays can be easily adopted.

KEY INDUSTRY PLAYERS

Key industry players drive market growth through innovation, partnerships, and expansion

The immuno-oncology assays market is also being strongly influenced by the key industry players who adopt continuous innovation and strategic alliances as well as the expansion of product lines. Firms are doing research and development to introduce new high-tech assay technology, including multiplex profiling, next-generation sequencing, and machine-learning-based platforms. Cooperation with pharmaceutical companies on companion diagnostics and clinical trials is increasing its reach and acceptance into the market. In addition, their presence is increasing based on aggressive marketing campaigns and international distribution chains fueling their growth and increasing the overall integration of the immuno-oncology tests in research and clinical practice.

LIST OF TOP IMMUNO ONCOLOGY ASSAYS COMPANIES

• Thermo Fisher Scientific (USA)
• Roche Diagnostics (Switzerland)
• Agilent Technologies (USA)
• Illumina (USA)

KEY INDUSTRY DEVELOPMENT

July 2025: Illumina Inc. launched an enhanced version of its immuno-oncology tumor profiling assay, TruSight Oncology 500 v2, featuring faster turnaround times, lower tissue sample requirements, and built-in biomarker detection. This development enables more precise evaluation of patient immune responses and supports personalized cancer therapies.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

This research report examines the segmentation of the market by using both quantitative and qualitative methods to provide a thorough analysis that also evaluates the influence of strategic and financial perspectives on the market. Additionally, the report's regional assessments consider the dominant supply and demand forces that impact market growth. The competitive landscape is detailed meticulously, including shares of significant market competitors. The report incorporates unconventional research techniques, methodologies and key strategies tailored for the anticipated frame of time. Overall, it offers valuable and comprehensive insights into the market dynamics professionally and understandably.