For the diagnosis and detection of many malignant disorders, immuno oncology assays are employed. DNA/RNA, blood, tumors, and cells are the samples used for the detection. Different assays are used to identify the circulating free DNA, cells, and proteins in the blood. The market for immuno oncology assays is expanding due to rising immunotherapy clinical trials, targeted therapy use, and consumer desire for tailored medication.

The market worth of immuno oncology assays in 2021 was USD 3.84 billion, and it will be worth USD 11.74 billion by 2030, growing at an 11.87% CAGR during the forecast period.

The market will grow faster as a result of the creation of new revolutionary therapeutics and continued innovation and research in the field of oncology. Nevertheless, the market is growing because of the rising occurrence of different cancer types. One of the key market-driving elements is the widespread use of targeted therapy.

Market Dynamics


The prevalence of cancer is rising quickly, which is expected to increase demand for efficient detection techniques like immunoassay. Chronic and infectious diseases like the COVID-19 outbreak are responsible for the growth of the immuno oncology assays market. SARS-CoV2 (COVID-19), Hepatitis B and C, HIV, Dengue, Malaria, tuberculosis, and other infectious diseases are rising. In 2020, there will be 19.3 million new instances of cancer and more than 10.0 million cancer deaths, according to GLOBOCAN 2020 from the International Agency for Research on Cancer.


Due to the significant drug attrition rate in clinical diagnostics, manufacturers face severe financial difficulties. Companies must complete Phase III clinical trials using well-validated biomarker tests to obtain regulatory approval for in vitro diagnostics (IVD). According to CenterWatch research, only 6% of clinical studies are finished on time, while 80% of trials are postponed by at least one month. These delays raise study costs and sales costs, which could result in daily losses ranging from $600,000 to $8 million.


There is significant development potential due to the lack of regulatory barriers, the enhanced healthcare infrastructure, the growing patient population, and the rising healthcare costs. The Asia Pacific region has more flexible and business-friendly regulatory policies than developed nations. Leading businesses in the immuno oncology assays market have also decided to concentrate their efforts in growing regions due to increased competition in developed regions.

Market Segmentation 

By Product, due to the utilization of numerous types of kits, reagents, and devices for the assays, the Consumables and Accessories category held the largest market. However, it is anticipated that the software category will grow at the fastest rate.

By Technology, the Monoclonal Antibodies segment ruled the entire market. Monoclonal antibodies effectively identify and treat a subset of cancerous cells while ignoring healthy cells. Due to their low toxicity and side effects, cancer patients highly desire monoclonal antibodies. Recent research in Frontiers in Medicine indicates that most licensed mAbs are utilized in oncology and immunology, with only a small number being used to treat infectious disorders. 

By indication, Due to the high prevalence of lung malignancies worldwide, the lung cancer category commands the largest market share for immuno oncology tests. Lower respiratory infections are the third-leading cause of early death and will stay that way through the year 2040, according to Global Burden of Disease (2017).

By end-user, Due to an increase in hospital admissions connected to cancer treatment, the hospital segment commands most of the share. Additionally, people opt to receive treatment for different types of cancer at an increasing number of public and private facilities worldwide. The expanding use of advanced medical technologies and the penetration of hospitals around the globe will probably fuel the segment’s growth.

Regional Insights

Due to increased government financing and a greater emphasis on creating novel medications and biomarkers in this area, North America holds the biggest market share. Per the Global Burden of Disease Study, infectious diseases only account for 4.2% of all disability-adjusted life years lost in countries like the United States with established market economies, whereas neoplastic and chronic diseases account for 81%.

Due to the growing number immuno-oncology assay launches, increased acceptance of targeted therapy, rising incidence of cancer, and growing population in this area, the Asia Pacific will have the fastest growing market.

Key Players 

  • Sartorius Ag
  • Thermo Fisher Scientific, Inc.
  • Bio-Rad Laboratories, Inc.
  • Perkinelmer, Inc.
  • Nanostring Technologies, Inc.
  • Agilent Technologies, Inc
  • F. Hoffmann-La Roche Ltd.
  • Charles River Laboratories, Inc
  • Qiagen N.V.
  • Illumina, inc. 

The market worth of immuno oncology assays in 2021 was USD 3.84 billion, and it will be worth USD 11.74 billion by 2030, growing at an 11.87% CAGR during the forecast period. The market is expanding due to rising cancer rates, cancer immunotherapy clinical trials, increased targeted therapy use, and companion diagnostics’s growing significance in drug development.