The Immuno-Oncology Assays Market, estimated at USD 5.55 Bn in 2025, is expected to exhibit a CAGR of 11.4% and reach USD 11.82 Bn by 2032.
The market growth is fueled by rising demand for advanced biotechnology solutions that improve healthcare outcomes, along with increasing adoption in areas such as drug development, diagnostics, and personalized medicine. Innovations in genomics, cell and gene therapies, and biomanufacturing, supported by strong R&D investments, are enhancing treatment effectiveness, efficiency, and accessibility. Furthermore, favorable regulatory support, strategic collaborations, and the growing focus on precision medicine are accelerating market expansion and opening new opportunities for industry participants.
Market Dynamics:
The global immuno-oncology assays market is primarily driven by the increasing prevalence of cancer cases worldwide and growing adoption of immunotherapy for treatment. According to WHO, cancer accounted for nearly 10 million deaths in 2020 and is one of the leading causes of mortality globally. Moreover, the number of clinical trials evaluating various IO drug regimens and combination therapies has significantly increased over the past decade. This has prompted pharmaceutical companies and research institutes to widely incorporate immuno-oncology assays during drug development and clinical studies. The advent of biomarkers and companion diagnostics has also augmented the demand for these assays to predict treatment responses in patients.
Expanding Cancer Patient Pool is Driving Market Growth
One of the primary drivers fueling growth in the global immuno-oncology assays market is the expanding global cancer patient population. According to the World Health Organization, cancer incidences are rising year on year with over 18 million new cancer cases diagnosed globally in 2019. The economic burden of cancer treatment and care costs trillions of dollars annually worldwide. Immuno-oncology assays enable better screening, diagnosis and monitoring of cancer, helping improve patient outcomes. As cancer prevalence increases, the need for advanced tools like immuno-oncology assays is also rising significantly.
Growing Adoption of Personalized Medicine Approaches
Another key driver is the growing focus on personalized medicine approaches for cancer treatment. Immuno-oncology therapies are more effective when targeted to a patient's specific cancer biomarkers and genetics. Immuno-oncology assays help identify suitable therapies and monitor treatment response in a personalized manner. They play a vital role in the shift toward precision and personalized cancer care. With more oncologists adopting tailored treatment strategies, demand for companion diagnostic immuno-oncology assays is surging. This increasing integration of personalized diagnostics with immunotherapy regimens is a major growth factor.
Limited Healthcare Budgets Restrain Market Potential
Despite the drivers, limited healthcare budgets in some regions pose a challenge to market growth. Immuno-oncology assays are considerably more expensive than conventional in-vitro diagnostics. They also require significant infrastructure for companion diagnostic testing. In developing nations and underfunded healthcare systems, the high costs can hamper broader adoption of these assays. Reimbursement challenges also exist since immuno-oncology is a fairly new treatment paradigm. Overcoming financial obstacles, especially in price-sensitive markets, remains a key restraint area.
Lack of Skilled Professionals Hinders Market Adoption
Another restraint is the lack of sufficient numbers of trained oncologists, pathologists and laboratory technicians familiar with immuno-oncology assays. Unlike traditional diagnostics, these advanced assays require specialized expertise to perform, interpret results and integrate findings into treatment planning. The market is still in a growth stage with evolving testing paradigms. Healthcare systems globally face shortages when it comes to skilled manpower for immuno-oncology diagnostics. Limited knowledgeable resources restrict how quickly the market can expand in various geographies. Training initiatives and academic programs need strengthening to overcome this restraint.
Increasing Cancer Research Drives Assay Innovation
On the opportunities side, massive investments into cancer research globally are fueling innovation in immuno-oncology diagnostics. Academia and biotech/pharma firms are investing billions in understanding tumor immunology better and improving therapies. This extensive research requires advanced biomarker analysis and validation capabilities that immuno-oncology assays provide. The need for sophisticated molecular profiling and companion diagnostics in clinical trials and research studies offers ongoing opportunities for assay developers and vendors. Partnerships between industry and research ensure continuous product refinements and new offerings.
Emerging Markets Present Untapped Growth Potential
Finally, emerging economies across Asia Pacific, Latin America, Middle East and Africa present significant untapped market potential. While restraints exist today in terms of healthcare budgets and resources, these regions are expected to experience higher cancer burdens in future due to lifestyle changes, increasing life expectancy and other factors. As their diagnostic capabilities and access to novel therapies enhance over the coming decade, emerging markets will contribute substantially to global immuno-oncology assays demand. First-mover vendors stand to gain by investing in these under-penetrated but rapidly developing markets.
Link - https://www.coherentmarketinsights.com/market-insight/immuno-oncology-assays-market-2632
Key Development
- On January 30, 2024, Agilent Technologies Inc., a biotechnology company, announced that they they had entered into an agreement with Incyte, a pharmaceutical company, to support the development and commercialization of Incyte’s hematology and oncology portfolio.
- In November, 2023, Personalis, Inc., a leader in advanced genomics for precision oncology (Nasdaq: PSNL) and Tempus, a leader in artificial intelligence and precision medicine, announced a strategic collaboration to co-commercialize NeXT Personal Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer.
- In April 2023, TORL BioTherapeutics LLC, a biopharmaceutical company, announced a funding of USD 158 Mn to advance development of novel oncology biologics
- In October 2019, Agilent Technologies Inc., a biotechnology company, received approval for its PD-L1 IHC 22C3 pharmDx assay for use in China as a companion diagnostic to identify patients with locally advanced or metastatic non- small cell lung cancer. This is expected to further supplement the company’s growth in immunohistochemical-based diagnostics for cancer therapy.
Key Players: Charles River Laboratories, F. Hoffmann-La Roche Ltd, llumina, Inc., Agilent Technologies, Inc., Thermo Fisher Scientific Inc., Merck KGaA, Invivoscribe, Inc., QIAGEN, PerkinElmer Inc., Sartorius AG, Bio-Rad Laboratories, Inc., Bruker Spatial Biology, Inc., Nexelis, Reaction Biology, Crown Bioscience, HTG Molecular Diagnostics, Inc., Axion BioSystems, Inc, and BioTherapeutics LLC
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