Immuno Oncology Assays Market Size, Share, and Industry Analysis By Product (Instruments and Consumables), By Technology (Immunoassay, Polymerase Chain reaction (PCR), Next-generation sequencing (NGS), Flow Cytometry, and Others), By Cancer Type (Colorectal Cancer, Lung Cancer, Melanoma, and Others), By End User (Hospitals & Clinics, Academic and Research Institutes, and Others), and Regional Forecast, 2026-2034

The global immuno oncology assays market size was valued at USD 6.08 billion in 2025. The market is projected to grow from USD 6.89 billion in 2026 to USD 16.85 billion by 2034, exhibiting a CAGR of 11.8% during the forecast period.

Immuno oncology assays are lab tests used for tumor profiling and the immune microenvironment to support clinical-trial stratification, immunotherapy discovery, and companion diagnostics in a few cases. The market growth is attributed to the increasing demand for checkpoint inhibitors and combination regimens, which require tighter patient selection and response monitoring, particularly in high-burden cancers such as lung cancer, where PD-L1 and broad genomic profiling are routinely considered.

Furthermore, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Illumina, Inc., and Agilent Technologies, Inc. accounted for the highest market share, driven by innovations and strategic initiatives.

IMMUNO ONCOLOGY ASSAYS MARKET TRENDS

Broader NGS Panels Incorporating Immunotherapy Signatures to Emerge as a Key Trend

Currently, there has been a significant shift toward NGS workflows that combine DNA variants, fusions, and immunotherapy-relevant signatures, such as TMB/MSI, HRD, and immune gene expression, in fewer tests. This enables tissue conservation and reduces operational complexity.

In response, key players are launching new NGS assays, including TMB/MSI for translational or clinical research.

• For instance, in April 2023, Agilent Technologies Inc. launched the SureSelect Cancer CGP Assay, a next-generation sequencing panel covering 679 genes for somatic variant profiling in solid tumors.

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MARKET DYNAMICS

MARKET DRIVERS

Expansion of Precision Immunotherapy Biomarker Adoption to Fuel the Market Growth

In recent years, there has been an increasing development of clinical trials and routine oncology care that increasingly rely on biomarker-defined decisions, resulting in higher volumes of validated assays (PD-L1, TMB/MSI, RNA signatures) and faster turnaround times.

Moreover, the companion diagnostic momentum is evident in approvals and label expansions. This is expected to encourage labs and biopharma companies to invest in standardized workflows, boosting immuno oncology assays market growth.

• For instance, in October 2022, F. Hoffmann-La Roche Ltd’s VENTANA PD-L1 (SP263) Assay received FDA approval as a companion diagnostic for Tecentriq (atezolizumab) in non-small cell lung cancer (NSCLC) patients with PD-L1 expression on ≥1% of tumor cells.

MARKET RESTRAINTS

Pre-analytical Variability and Rigorous Validation Regulations to Restrict Market Growth

Immuno oncology assays are highly sensitive to specimen handling, such as the fixation time, tissue age, tumor heterogeneity, decalcification, and assay-specific scoring or threshold definitions. This is creating a lack of consistency across labs and technologies, which is complicating clinical interpretation and limiting payor or physician confidence in borderline results.

Moreover, the need for proficiency testing, rigorous validation, and standardized analytics is expected to slow down the adoption of newer multiplex and multi-omic assays. This is especially when transitioning from research use to clinical-grade use. Such a scenario is expected to hinder the market growth in the upcoming years.

MARKET OPPORTUNITIES

Spatial & Multi-Omic Immune Profiling in Translational and CDx Pipelines to Create Significant Growth Opportunities

In recent years, spatial biology has been advancing immuno-oncology biomarker work beyond “single-marker” readouts into contextual immune mapping, creating significant opportunities for premium assays in drug discovery, translational research, and Companion Diagnostics (CDx) development.

As a result, major players are entering partnerships to drive the development of multiplex tissue assays for biopharma applications, thereby further expanding their commercial availability in the market.

• For instance, in January 2023, Agilent Technologies and Akoya Biosciences announced a partnership to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis in clinical research.

MARKET CHALLENGES

Data Interpretation and Limited Training to Challenge Market Expansion

Although immune oncology assays are analytically strong, multi-omic and spatial assays add bioinformatics overhead, interpretive complexity, and integration challenges to pathology workflows.

Moreover, scaling high-plex assays requires training, quality assurance (QA), and repeatability across sites, particularly for global trials where cross-site harmonization is mandatory. This is expected to hinder product adoption and challenge market growth.

Segmentation Analysis

By Product

High Adoption of Consumables in NGS Profiling to Drive the Segment Growth

Based on product, the market is segmented into instrument and consumables.

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The consumables segment accounted for the largest global immuno oncology assays market share in 2025. The growth is attributed to the high adoption of antibodies, staining kits, slides, extraction kits, library prep, and more for multiplex IHC/IF, spatial assays, and NGS-based profiling. This is influencing key players to increase their offerings.

In addition, the instrument segment is projected to grow at a CAGR of 11.3% over the forecast period.

By Technology

Increasing Adoption of NGS in Translational Research to Drive the Segment’s Growth

By technology, the market is segmented into immunoassay, polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), and others.

The Next-Generation Sequencing (NGS) segment accounted for the largest market share in 2025. NGS consolidates multiple immunotherapy-relevant markers into a single workflow, which is increasing its adoption for translational research. The segment is estimated to hold a share of 28.1% in 2026.

Additionally, the immunoassay segment is anticipated to grow at a CAGR of 12.0% over the forecast period.

By Indication

High Incidence of Lung Cancer to Boost the Segment’s Growth

By indication, the market is classified into lung cancer, breast cancer, colorectal cancer, prostate cancer, melanoma, and others.

The lung cancer segment accounted for a major market share in 2025. The growth is attributed to the increasing incidence of lung cancer, which has high immunotherapy use and strong reliance on PD-L1 and broader tumor profiling to guide treatment selection. Moreover, the segment is projected to hold a share of 33.4% in 2026.

• For instance, according to the World Cancer Research Fund, there were 2,480,675 new cases of lung cancer in 2022 globally.

Additionally, the breast cancer segment is expected to grow at a CAGR of 11.4% during the forecast period.

By End-user

Increasing Number of Pharmaceutical & Biotechnology Companies to Propel the Segment Growth

On the basis of end-user, the market is classified into pharmaceutical & biotechnology companies, contract research organizations (CROs), academic & research institutes, and others.

In 2025, the pharmaceutical & biotechnology companies segment dominated the market by end-user. In past years, there has been a surge in pharmaceutical and biotechnology companies, which has increased the number of immuno oncology trials and driven the utilization of assays. This is expected to fuel the growth of the segment, which is set to hold a share of 38.8% in 2026.

• For instance, according to the Organization for Economic Co-operation and Development (OECD), the global number of active biotechnology firms rose from 2,840 in 2021 to 3,040 in 2022.

In addition, the academic & research institutes segment is projected to grow at a CAGR of 11.7% during the forecast period.

Immuno Oncology Assays Market Regional Outlook

Based on geography, the market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America accounted for the largest share of revenues in 2024, valued at USD 2.81 billion, and also dominated the market in 2025 with a value of USD 3.25 billion. The growth is primarily driven by the strong adoption of immunotherapies, the presence of leading assay developers and pharmaceutical companies, and a high penetration of biomarker testing.

• For instance, in August 2025, Cross River Therapy stated that there are over 5,000 pharmaceutical companies in the U.S.

U.S. Immuno Oncology Assays Market

In 2026, the U.S. market is projected to reach USD 3.42 billion, accounting for approximately 49.7% of global revenues.

Europe    

Europe is projected to record a growth rate of 11.0% over the forecast period, the second highest globally. The regional market is poised to reach a value of USD 1.79 billion by 2026. The growth is attributed to the strong presence of academic & research institutes and CROs in the region.

U.K. Immuno Oncology Assays Market

The U.K. market is expected to reach USD 0.36 billion by 2026, representing approximately 5.2% of global revenue.

Germany Immuno Oncology Assays Market

The Germany market is projected to reach approximately USD 0.38 billion by 2026, accounting for around 5.5% of global revenue.

Asia Pacific

By 2026, the Asia Pacific immuno oncology assays market is expected to reach USD 1.13 billion, making it the third-largest market globally. The regional growth is attributed to the large cancer patient pool in China and India. This is anticipated to fuel the research initiatives for cancer research involving the usage of immuno oncology assays.

Japan Immuno Oncology Assays Market

Japan is expected to generate approximately USD 0.28 billion in revenue by 2026, representing nearly 4.1% of the global market.

China Immuno Oncology Assays Market

China’s immuno oncology assays market is projected to reach around USD 0.46 billion by 2026, accounting for approximately 6.6% of global revenue.

India Immuno Oncology Assays Market

India’s immuno-oncology assays market is expected to generate approximately USD 0.11 billion by 2026, representing around 1.6% of global revenue.

Latin America and Middle East & Africa

Both Latin America and the Middle East & Africa markets are expected to experience moderate growth, with the Latin American market projected to reach approximately USD 0.18 billion by 2026. The growth is primarily driven by increasing government initiatives for cancer research, which is expected to boost the adoption of assays.

GCC Immuno Oncology Assays Market

By 2026, the GCC market is projected to reach approximately USD 0.07 billion, representing nearly 1.0% of global revenue.

COMPETITIVE LANDSCAPE

Key Industry Players

Diversified Product Offerings to Strengthen the Market Position of Prominent Players

In 2025, Thermo Fisher Scientific Inc. and F. Hoffmann-La Roche Ltd held the major global immuno oncology assays market share. This share is attributed to strong biopharma partnerships and global commercial reach.

Moreover, other major players, including Illumina, Inc., and Agilent Technologies, Inc., are expanding aggressively into multiplex and spatial immuno-oncology assays, which are expected to drive the company’s market share.

LIST OF KEY IMMUNO ONCOLOGY ASSAYS COMPANIES PROFILED

• Thermo Fisher Scientific Inc. (U.S.)
• Hoffmann-La Roche Ltd (Switzerland)
• Illumina, Inc.(U.S.)
• Agilent Technologies, Inc. (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• Danaher (U.S.)
• Merck KGaA (Germany)
• QIAGEN (Netherlands)
• Revvity (U.S.)
• 10x Genomics (U.S.)

KEY INDUSTRY DEVELOPMENTS

• July 2025: Thermo Fisher Scientific Inc. introduced the Oncomine Comprehensive Assay Plus, a next-generation sequencing assay, for the Ion Torrent Genexus System.
• June 2025: QIAGEN and GENCURIX announced a partnership to develop oncology IVD assays for the QIAcuityDx digital PCR platform, marking the launch of QIAGEN's QIAcuityDx Partnering Program.
• March 2024: Foundation Medicine announced the details of its presentation at the 2024 American Association for Cancer Research (AACR) Annual Meeting.
• April 2023: Agilent Technologies, Inc. launched the SureSelect Cancer CGP Assay on April 13, 2023, featuring a 679-gene NGS panel for comprehensive somatic variant profiling across solid tumors.
• December 2022: NanoString Technologies began the commercial shipments of its CosMx Spatial Molecular Imager (SMI) and AtoMx Spatial Informatics Platform (SIP), enabling high-plex imaging of over 1,000 RNA and 64 protein analytes at single-cell resolution in FFPE tissues.

REPORT COVERAGE

The report offers a comprehensive analysis of all market segments, outlining the key drivers, trends, opportunities, restraints, and challenges. It further examines technological advancements, prevalence of cancer, major industry developments, company market share dynamics, and the detailed profiles of leading market players.

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