Global Immuno-Oncology Assays Market size is estimated to be valued at USD 5.55 Bn in 2025 and is expected to reach USD 11.82 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 11.4% from 2025 to 2032. The global immuno-oncology assays market is experiencing strong growth, driven by the rising incidence of cancer worldwide and the increasing use of targeted therapies for treatment. Immuno-oncology, an emerging area in cancer care, leverages the body’s immune system to identify and eliminate cancer cells. Factors such as encouraging clinical trial outcomes, deeper insights into tumor microenvironments and biomarkers, new product approvals, and a growing focus on precision medicine are expected to support the robust expansion of the immuno-oncology assays market throughout the forecast period.

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Global Immuno-Oncology Assays Market Key Takeaways

According to Coherent Market Insights (CMI), the global immuno-oncology assays market size is expected to more than double during the forecast period, increasing from USD 5.55 Bn in 2025 to USD 11.82 Bn by 2032.

Global demand for immuno-oncology assays is slated to rise at a CAGR of 11.4% during the forecast period.

Based on product, consumables segment is set to account for over two-thirds of the global immuno-oncology assays market share in 2025.

By indication, colorectal cancer category is anticipated to hold a prominent market share of 34.3% by 2025.

Research and development is the most lucrative application of immuno-oncology assays, capturing a market share of 54.3% in 2025.

North America, with a projected market share of 43.6% in 2025, is expected to maintain its dominance during the assessment period.

Asia Pacific immuno-oncology assays industry is poised to exhibit fastest growth over the forecast period.

Rising Prevalence of Cancer Fueling Market Growth

Coherent Market Insights’ latest immuno-oncology assays market analysis outlines major factors driving industry growth. Increasing incidence of cancer globally is one such prominent growth driver.

The global cancer burden continues to rise. According to the International Agency for Research on Cancer (IARC), annual new cancer cases are projected to exceed 35 million by 2050. This surge in cancer incidence is expected to drive demand for accurate, early, and personalized tools like immuno-oncology assays.

Immuno-oncology assays are being widely used to study interactions between the immune system and cancer cells. These assays play a crucial role in identifying predictive and prognostic biomarkers. As cancer cases continue to rise, so will the demand for immuno-oncology (IO) assays.

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High Cost of Assays Hampering Market Growth

The prospective immuno-oncology assays market outlook appears promising, owing to advances in cancer diagnostics and personalized medicine. However, high cost of immuno-oncology assays poses a barrier to widespread market expansion.

Immuno-oncology assays, especially next-generation sequencing (NGS)-based ones, are quite expensive. This limits their adoption in smaller hospitals, diagnostic laboratories, and research institutes, potentially dampening the overall immuno-oncology assays market demand.

Increasing Adoption of Immunotherapies Creating Lucrative Growth Opportunities

Rising awareness among patients and healthcare providers about the benefits and potential of immuno-oncology therapies is driving their wider acceptance. This trend is expected to open revenue opportunities for immuno-oncology assay companies during the forecast period.

Immunotherapies such as CAR T-cell therapies and checkpoint inhibitors are revolutionizing the cancer treatment landscape. However, these therapies require precise companion diagnostics to identify patients most likely to respond, thereby fueling immuno-oncology assay demand.

Impact of AI on the Immuno-Oncology Assays Market

Artificial Intelligence (AI) is reshaping the immuno‑oncology assay landscape. This advanced technology automates biomarker discovery, accelerates assay development, enhances diagnostic precision, and enables scalable digital pathology workflows.

AI‑powered models are uncovering new biomarkers or meta‑biomarkers beyond traditional methods. They have the potential to improve the prediction of how patients respond to immunotherapies.

Companies like Tempus AI and Illumina are embracing this trend by integrating AI. For example, Tempus recently expanded its immuno‑oncology portfolio with the launch of an AI‑enabled, multimodal Immune Profile Score (IPS) algorithmic test.

Emerging Immuno-Oncology Assays Market Trends

Growing shift towards personalized medicine is a prominent growth-shaping trend in the immuno-oncology assays market. These assays are essential for identifying and tailoring cancer immunotherapies to individual patient profiles. Thus, rising demand for targeted therapies will drive adoption of IO assays in clinical and research settings.

Pharmaceutical and biotechnology companies are increasingly utilizing immuno-oncology (IO) assays in clinical trials for patient stratification, biomarker discovery, and drug development. This growing adoption is significantly contributing to the expansion of the IO assays market.

Technological advancements in IO assay platforms are expected to boost the target market. Innovations in flow cytometry, next-generation sequencing (NGS), and multiplex assays are enhancing sensitivity, accuracy, and speed of immuno-oncology testing. Similarly, adoption of AI and bioinformatics tools is further expanding the application area of these assays.

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Analyst’s View

“The global immuno-oncology assays industry is poised for robust growth, driven by rising global cancer burden, increasing shift toward personalized medicine, widespread adoption of immunotherapies, and rapid advancements in biomarker discovery and high-throughput technologies,” said senior CMI analyst Abhijeet Kale.

Current Events and Their Impact on the Immuno-Oncology Assays Market

Event	Description and Impact
Rise of Neoantigen Vaccine Trials (Moderna & Merck)	Description: Moderna and Merck’s Phase 3 trials of personalized neoantigen vaccines for NSCLC and melanoma, launched in early 2025, require extensive immunogenicity profiling. Impact: This is driving demand for high-throughput, multiplexed immune profiling assays, particularly those that enable robust T-cell characterization, fostering growth in personalized immunoassay segments.
Artificial Intelligence Integration in Diagnostic Platforms	Description: Companies like Tempus AI are using machine learning and AI to enhance biomarker identification and predictive diagnostics, especially within oncology. Impact: Integration of AI enhances the analytical sensitivity and specificity of immuno-oncology assays, supporting premium pricing models and expanding clinical utility.
CAR-T Therapies Expand Beyond Hematologic Cancers (Ongoing 2025)	Description: As of 2025, CAR-T therapy trials targeting solid tumors, such as glioblastoma and pancreatic cancer, are showing early signs of efficacy, despite challenges in tumor penetration and TME resistance. Impact: This trend is driving demand for assays that profile tumor microenvironment and immune cell infiltration, supporting the development and monitoring of next-gen CAR-T therapies.

Competitor Insights

Key companies in the immuno-oncology assays market report:

– F. Hoffmann-La Roche Ltd

– Charles River Laboratories

– Thermo Fisher Scientific Inc.

– Illumina, Inc.

– Invivoscribe, Inc.

– Agilent Technologies, Inc.

– QIAGEN

– Bio-Rad Laboratories, Inc.

– Merck KGaA

– Sartorius AG

– Nexelis

– PerkinElmer Inc.

– Bruker Spatial Biology, Inc.

– Reaction Biology

– Axion BioSystems, Inc.

– Crown Bioscience

– BioTherapeutics LLC

– HTG Molecular Diagnostics, Inc.

Key Developments

In May 2025, Illumina officially expanded its clinical oncology portfolio, introducing enhanced tumor profiling and in vitro diagnostic (IVD) solutions. These include the TruSight Oncology (TSO) Comprehensive IVD test and the Pillar oncoReveal CDx panel. They aim to accelerate access to precision oncology and improve standards of care.

In July 2024, Tempus AI strengthened its immuno-oncology portfolio with the launch of AI-enabled, multimodal immune profile score (IPS) algorithmic tests. The IPS test has been made available for research use only (RUO). With this launch, Tempus is bringing next-generation algorithmic diagnostics to the immuno-oncology space.

In April 2024, Charles River Laboratories unveiled new advancements in immuno-oncology, in vitro assays at the AACR Annual Meeting. Apart from this, the company also presented technology-driven capabilities.

Detailed Segmentation

• By Product
  • Consumables
  • Software
• By Technology
  • Immunoassay
  • PCR
  • NGS
  • Fow Cytometry
  • Others
• By Indication
  • Colorectal Cancer
  • Lung Cancer
  • Melanoma
  • Bladder Cancer
  • Others
• By Application
  • Clinical Diagnostics
  • Research and Development
• By Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa

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