Immuno Oncology Assay Market

The expanding global geriatric population is emerging as a key driver of growth for the immuno-oncology (I-O) assay market. Older adults are at significantly higher risk of developing cancer due to age-related genetic mutations, immune system decline, and cumulative exposure to environmental risk factors. As a result, the demand for personalized, immune-based diagnostic solutions is rising in this demographic segment. Immuno-oncology assays, which help identify predictive biomarkers and assess immune response, are becoming essential tools in tailoring treatment strategies for elderly cancer patients—who often face unique clinical challenges due to comorbidities and reduced treatment tolerance. For instance, according to the World Data Atlas, the population aged 65 years and above in Argentina increased by 1.40%, rising from 12.1% in 2023 to 12.2% in 2024. Since a 1.10% growth in 2014, the population aged 65 and above has grown by 11.22% as of 2024. Moreover, according to Eurostat, the number of centenarians in the EU-27 is projected to reach nearly half a Billion by 2050. Women significantly outnumber men at older ages within the EU-27; in 2019, there were more than twice as many women aged 85 and over compared to men in the same age group. The median age is expected to rise by 4.5 years—from 43.7 in 2019 to 48.2 by 2050, reflecting the broader aging trend. While the total population of the EU-27 is projected to grow slightly from 446.8 Billion in early 2019 to a peak of 449.3 Billion between 2026 and 2029, it is expected to gradually decline to 441.9 Billion by 2050. These demographic shifts underscore the growing need for advanced cancer diagnostics capable of guiding immunotherapy decisions in aging populations, thereby creating substantial growth opportunities for the global immuno-oncology assay market.

The ongoing expansion of immunotherapy adoption, marked by more than 150 FDA immunotherapy approvals since 2011 and a sharp rise in new approvals in 2024, indicates that the Immuno-oncology Assay Market is poised for strong growth. This momentum is driving increased demand for precise biomarker analysis, immune profiling, and treatment-response assessment to support next-generation immunotherapies.

The rising global incidence of cancer has become a critical public health challenge, driven by a convergence of factors including increased life expectancy, urbanization, dietary changes, tobacco use, environmental pollution, and sedentary lifestyles. As cancer cases continue to rise, the complexity and heterogeneity of tumors necessitate advanced diagnostic tools that extend beyond conventional methods.

According to the Global Cancer Observatory, the estimated number of new cancer cases between 2022 and 2025, across both sexes and all cancer types, is as follows: Asia – 9,826,539; Europe – 4,471,422; Northern America – 2,850,879; Latin America and the Caribbean – 1,629,786; Africa – 1,301,241; and Oceania – 293,175.

Rapid technological advancements in immunohistochemistry (IHC) and biomarker development are creating lucrative growth opportunities in the global immuno-oncology assay market. For instance, in February 2020, Biocare Medical’s launched seven novel IVD IHC antibody markers for clinical diagnostics and research applications. This product expansion includes several cutting-edge immuno-oncology markers that are instrumental in accelerating early-stage cancer drug development and improving patient stratification for targeted therapies. Among these innovations is the redevelopment of the S100 protein antibody, which is widely used in the detection of Schwannomas, ependymomas, astrogliomas, and nearly all benign and malignant melanomas. Biocare’s enhanced version, S100, offers a significantly stronger and more robust staining signal, improving the sensitivity and accuracy of IHC applications. Such technological breakthroughs not only enhance diagnostic precision but also support the growing demand for personalized oncology solutions driving market expansion and attracting investment across diagnostics, biotech, and pharmaceutical sectors.

The surge in investment directed towards cancer research is a significant catalyst for the Immuno-Oncology Assay Market. Governments and private entities are increasingly allocating funds to explore innovative cancer therapies, particularly in immunotherapy. This financial support fosters the development of advanced immuno-oncology assays, which are essential for evaluating the efficacy of new treatments. As research initiatives expand, the demand for reliable and efficient assays is likely to grow, further propelling the market. The emphasis on collaborative research efforts among academic institutions, pharmaceutical companies, and biotechnology firms enhances the potential for breakthroughs in cancer treatment, thereby benefiting the Immuno-Oncology Assay Market.

The increasing demand for companion diagnostics is a pivotal driver for the Immuno-Oncology Assay Market. Companion diagnostics are essential for determining the suitability of specific therapies for individual patients, particularly in the context of immunotherapy. As healthcare providers strive to offer personalized treatment options, the need for reliable assays that can guide therapeutic decisions becomes paramount. The integration of companion diagnostics into clinical practice not only enhances patient outcomes but also drives the adoption of immuno-oncology assays. This trend is likely to result in a more tailored approach to cancer treatment, further solidifying the role of the Immuno-Oncology Assay Market in modern oncology.

Robust government and private sector funding for cancer research is significantly accelerating the growth of the global immuno-oncology (I-O) assay market. Large-scale investments by national health agencies and private foundations are fueling innovation in cancer diagnostics and personalized therapies. These funds support biomarker discovery, clinical trials, and the development of cutting-edge diagnostic platforms—including I-O assays—that enable precise patient stratification and therapy monitoring. For example, the Government of India has taken significant steps toward combating cancer and enhancing public health, allocating $1.20 billion (₹99,858.56 crore) to the Ministry of Health and Family Welfare in the recent budget. Of this, $1.15 billion (₹95,957.87 crore) is earmarked for the Department of Health and Family Welfare, and $47 million (₹3,900.69 crore) for the Department of Health Research. Among the notable initiatives is the plan to establish 200 Day Care Cancer Centres in district hospitals by 2025–26, significantly improving access to oncology services in underserved regions. To further support cancer care and the treatment of rare and chronic diseases, the government has introduced customs duty exemptions. A total of 36 life-saving drugs have been exempted from Basic Customs Duty (BCD), while six essential medicines now benefit from a concessional duty rate of 5%.

North America: increased prevalence of cancer

North America is the largest market for Immuno-oncology Assay services, holding approximately 42% of the global market share. The region's growth is driven by increased prevalence of cancer, combined with the increasing use of immunotherapies such as immune checkpoint inhibitors and CAR-T cell treatments, has resulted in a strong demand for better diagnostic solutions. According to National Institute of Health, in 2025, 2,041,910 new cancer cases and 618,120 cancer deaths are expected in the United States. Immuno-oncology assays are critical for finding biomarkers that drive individualized treatment, allowing clinicians to modify medicines based on unique patient profiles. The industry is also being boosted by an increasing emphasis on precision medicine, which stresses the use of biomarkers such as PD-L1, TMB, and MSI for more targeted and effective cancer treatments.

Europe : Emerging Cloud Market

Europe is witnessing a significant rise in the Immuno-oncology Assay market, accounting for approximately 30% of the global share. The region's growth is driven by a number of factors such as rising cancer rates, rapid advances in immunotherapy, and increased investments in customized medicine. According to the World Health Organization (WHO), cancer is still the second biggest cause of death in Europe, with more than 3.7 million new cases projected by 2025. The increase in cancer cases is creating a substantial demand for precise diagnostic tools, such as immuno-oncology assays.

Furthermore, the European Union's Horizon 2020 initiative has given more than USD 1.71 billion to cancer research, demonstrating the continent's commitment to improving cancer care and diagnostics. Immuno-oncology tests, which detect biomarkers such as PD-L1, Tumor Mutational Burden (TMB), and Microsatellite Instability (MSI), play an important role in directing the selection of immunotherapies such as immune checkpoint inhibitors and CAR-T cells.  The European Medicines Agency (EMA) has authorized many immuno-oncology medications and companion diagnostics, notably Merck's Keytruda (pembrolizumab) for a variety of cancer indications, increasing demand for biomarker-based testing.

Asia-Pacific: Rapidly Growing Cloud Sector

Asia-Pacific is rapidly emerging as a key player in the Immuno-oncology Assay market, holding around 20% of the global market share. The immuno-oncology assay market in Asia-Pacific (APAC) is expanding rapidly, owing to a combination of factors such as rising cancer rates, advances in immunotherapy, and considerable investments in healthcare infrastructure. For instance, according to the National Center for Disease Informatics and Research, lung, colorectal, and liver cancers are prevalent in nations such as China and India. For example, the cancer burden in India is expected to increase from 26.7 million disability-adjusted life years (DALYs) in 2021 to 29.8 million by 2025.

Middle East and Africa: Emerging Cloud Frontier

The Middle East and Africa region is gradually emerging in the Immuno-oncology Assay market, currently holding about 4% of the global share. The Middle East and Africa (MEA) market for immuno-oncology assays is expanding significantly due to rising cancer rates, improvements in immunotherapy, and improved healthcare facilities. The market for cancer immunotherapy is expected to increase significantly in the larger MEA area.  Rising cancer incidence, increased use of immunotherapy over traditional therapies, and improvements in medical technology are some of the reasons for this growth. Leading the way in the adoption of cutting-edge cancer treatments are nations like South Africa, Saudi Arabia, and the United Arab Emirates.

Key Players and Competitive Insights

Many global, regional, and local vendors characterize the Immuno-oncology Assay Market. The market is highly competitive, with all the players competing to gain market share. Intense competition, rapid advances in technology, frequent changes in government policies, and environmental regulations are key factors that confront market growth. The vendors compete based on cost, product quality, reliability, and government regulations. Vendors must provide cost-efficient, high-quality products to survive and succeed in an intensely competitive market.

The major players in the market include THERMO Fisher Scientific Inc, Qiagen, Merck KGAA, Sartorius Ag, F. Hoffmann-La Roche Ltd., Agilent Technologies Inc., ILLUMINA, INC,  Agilent Technologies Inc., Axion Biosystems, Inc, And Others. The Global Immuno-oncology Assay Market is a consolidated market due to increasing competition, acquisitions, mergers, and other strategic market developments and decisions to improve operational effectiveness.

Key Companies in the Immuno-oncology Assay Market market include

Many global, regional, and local vendors characterize the Immuno-oncology Assay Market. The market is highly competitive, with all the players competing to gain market share. Intense competition, rapid advances in technology, frequent changes in government policies, and environmental regulations are key factors that confront market growth. The vendors compete based on cost, product quality, reliability, and government regulations. Vendors must provide cost-efficient, high-quality products to survive and succeed in an intensely competitive market.

The major players in the market include THERMO Fisher Scientific Inc, Qiagen, Merck KGAA, Sartorius Ag, F. Hoffmann-La Roche Ltd., Agilent Technologies Inc., ILLUMINA, INC,  Agilent Technologies Inc., Axion Biosystems, Inc, And Others. The Global Immuno-oncology Assay Market is a consolidated market due to increasing competition, acquisitions, mergers, and other strategic market developments and decisions to improve operational effectiveness.

Key Companies in the Immuno-oncology Assay Market market include

Thermo Fisher Scientific Inc. – Thermo Fisher Scientific Inc. is a prominent U.S.-based provider of Immuno-oncology Assay products.

Estimated Market Presence: High (Global)

Thermo Fisher Scientific Inc. is a global leader in scientific services, operating through four primary segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Biopharma Services. The Life Sciences Solutions segment provides a wide range of reagents, instruments, and consumables for biological and medical research, drug and vaccine development, and disease diagnosis. It supports various markets, including pharmaceuticals, biotechnology, agriculture, clinical settings, healthcare, academia, and government, and is divided into Biosciences, Genetic Sciences, and BioProduction. In the Analytical Instruments segment, the company offers a diverse selection of instruments, consumables, software, and services used across pharmaceutical, biotechnology, academic, government, environmental, industrial, and clinical research fields.

F. Hoffmann-La Roche Ltd – one of the leading companies in the field of diagnostics and pharmaceuticals

The company develops and markets products for diagnosis and treatment of anemia, cancer, anticoagulation therapy, cardiovascular diseases, diabetes, central nervous system, chlamydia, dermatology, gonorrhea, gout, hepatitis B and C, hemostasis disorders, HIV/AIDS, HPV, infectious diseases, and autoimmune diseases. The company specializes in the field of molecular diagnostics and medicines for oncology, virology, inflammation, metabolism, central nervous system, clinical chemistry, immunology, urinalysis, blood screening, genetics, infectious diseases, and microbiology.  The firm operates in two major business segments, Pharmaceuticals and Diagnostics. The Pharmaceuticals segment offers a wide range of drugs for therapeutic areas, such as oncology, inflammation, neuroscience, infectious diseases, and ophthalmology. The segment is focussed on transforming scientific excellence into effective patient treatments.

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