Immuno Oncology Assays Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Global Immuno-Oncology Assays Market Report is Segmented by Product (Reagents & Antibodies, Instruments, and More), Technology (Immunoassay, PCR, and More), Assay Type (CDx, Ldts, RUO), Indication (Lung, Colorectal, Melanoma, Breast, Other Cancers), Sample Type (Tissue, Liquid Biopsy), and Geography (North America, Europe, Asia-Pacific, MEA, South America). The Market Forecasts are Provided in Terms of Value (USD).

Immuno Oncology Assays Market Size and Share

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Immuno Oncology Assays Market Analysis by Mordor Intelligence

The immuno Oncology assays market stands at USD 6.05 billion in 2025 and is forecast to reach USD 10.69 billion by 2030, reflecting a healthy 12.11% CAGR. Rising global cancer incidence, steady regulatory support for companion diagnostics, and accelerating adoption of spatial biology platforms combine to spur demand for sophisticated immune profiling tests. Growing pharma–diagnostic partnerships shorten validation timelines and expand test menus, while artificial intelligence (AI) integration strengthens assay accuracy and throughput. North America maintains leadership through favorable reimbursement, but Asia-Pacific records the fastest uptake as healthcare infrastructure matures and clinical trial activity rises. Competitive strategies increasingly hinge on multi-omics integration and real-world evidence generation, positioning agile technology providers to capture sizeable share in community oncology settings.

Key Report Takeaways

  • By product, Reagents & Antibodies led with 40.12% of immuno-oncology assays market share in 2024; Software & Analytics is projected to grow at a 12.67% CAGR through 2030.
  • By technology, Next-Generation Sequencing held 37.67% revenue share of the immuno-oncology assays market in 2024, while Multiplex Spatial Profiling is set to expand at a 12.71% CAGR to 2030.
  • By assay type, Laboratory-Developed Tests accounted for 51.23% share of the immuno-oncology assays market size in 2024; Companion Diagnostics show the highest forecast CAGR at 12.69% through 2030.
  • By indication, Lung Cancer commanded 32.12% of immuno-oncology assays market size in 2024, whereas Breast Cancer is anticipated to grow at a 12.91% CAGR between 2025 and 2030.
  • By sample type, Tissue Biopsy retained 53.12% share of the global immuno-oncology assays market in 2024; Liquid Biopsy is expected to post a 12.74% CAGR to 2030.
  • By geography, North America captured 42.34% of the immuno-oncology assays market in 2024; Asia-Pacific represents the fastest-growing region with a 12.86% CAGR to 2030.

Segment Analysis

By Product: Reagents Dominate, Software Accelerates

Reagents & Antibodies captured 40.12% of the immuno-oncology assays market in 2024, evidencing the consumable-heavy nature of immune testing workflows. Hospital and reference laboratories turn to validated antibody panels to meet SITC-endorsed biomarker requirements. Instruments enjoy steady demand as labs upgrade to imaging-mass-cytometry platforms capable of 40-plus marker detection.

Software & Analytics, projected to post a 12.67% CAGR through 2030, benefits from AI modules that automate cell-phenotype mapping and cloud-based data sharing. The Garvan Institute’s AAnet and similar solutions lower analysis times, creating new revenue streams for digital pathology vendors. This software upsurge diversifies revenue composition within the immuno-oncology assays market.

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Note: Segment shares of all individual segments available upon report purchase

By Technology: NGS Leads, Spatial Profiling Transforms

Next-Generation Sequencing retained 37.67% share of the immuno-oncology assays market in 2024, remaining indispensable for broad mutational scans. High-depth panel sequencing supports tumour mutational burden calculation, directly guiding checkpoint inhibitor use.

Multiplex Spatial Profiling, forecast to grow at 12.71% CAGR, permits single-cell resolution mapping of protein and RNA markers within intact tissues. Illumina’s whole-transcriptome spatial platform highlights this shift toward context-rich analytics. Immunoassay, PCR, and flow cytometry modalities maintain complementary roles for targeted or high-throughput applications, collectively sustaining technology diversity inside the immuno-oncology assays market.

By Assay Type: LDTs Dominate, CDx Gains Momentum

Laboratory-Developed Tests held 51.23% of immuno-oncology assays market share in 2024, reflecting academic centers’ need for flexible assay design. Custom panels support exploratory research on neo-antigens and immune evasion pathways.

Regulatory acceleration in companion diagnostics fuels a 12.69% CAGR for CDx through 2030. FDA clearance of the VENTANA MET (SP44) assay and similar tests formalises biomarker criteria for therapy eligibility, driving clinical demand. Research-Use-Only panels continue to seed discovery pipelines, indirectly bolstering long-term market vitality.

By Indication: Lung Cancer Leads, Breast Cancer Accelerates

Lung Cancer generated 32.12% of immuno-oncology assays market size in 2024 thanks to established guidelines mandating PD-L1, KRAS, and EGFR profiling. High global incidence rates sustain testing volumes.

Breast Cancer is poised for a 12.91% CAGR as HER2-low, HER2-ultra-low, and immune biomarkers expand clinical decision trees. FDA approval of fam-trastuzumab deruxtecan-nxki, paired with the Ventana PATHWAY anti-HER-2 assay, underscores broader biomarker adoption. Growth across colorectal, melanoma, and other tumour types rounds out indication-level opportunity in the immuno-oncology assays market.

Immuno Oncology Assays Market: Market Share by Indication
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Note: Segment shares of all individual segments available upon report purchase

By Sample Type: Tissue Rules, Liquid Biopsy Transforms

Tissue Biopsy accounted for 53.12% share of the immuno-oncology assays market in 2024, supported by well-established protocols and rich histopathology context. Comprehensive tissue profiling remains the clinical gold standard for staging and therapeutic planning.

Liquid Biopsy’s forecast 12.74% CAGR reflects advances in circulating tumour DNA, exosome, and methylation assays. Guardant360 Tissue’s launch, analysing 1,100-plus DNA and RNA genes with 40% less material, exemplifies efficiency gains. Non-invasive monitoring augments, rather than replaces, tissue testing, reinforcing multimodal sampling across the immuno-oncology assays market.

Geography Analysis

North America generated 42.34% of 2024 global revenue through favourable reimbursement, early AI adoption, and dense networks of comprehensive cancer centres. Medicare’s evolving coverage for NGS diagnostics still poses short-term reimbursement uncertainty, but strong private-payer frameworks keep overall growth intact.

Europe maintains balanced progress as health technology assessments verify clinical benefit before wide rollout. EMA’s approval of agents such as tislelizumab shows regional commitment to immunotherapeutic expansion[1]European Medicines Agency, “Tevimbra (tislelizumab) Authorization,” ema.europa.eu. Although multiple national approval layers can delay diagnostics launches, streamlined EU IVDR-compliant pathways promise to shorten time-to-market after 2026.

Asia-Pacific leads growth at a 12.86% CAGR as China deploys national cancer screening programs and Japan subsidises genomic testing. Emerging precision-medicine hubs in India and South Korea further stimulate demand. Simplified regulatory fast-tracks for innovative devices improve access, giving international suppliers a sizeable addressable base in the immuno-oncology assays market.

Middle East & Africa witnesses incremental uptake as Gulf states invest in oncology centres of excellence and procure multiplex platforms. South America records steady progress, led by Brazil’s public-private oncology partnerships and Argentina’s inclusion of genomic testing in national guidelines. Varying reimbursement coverage still restricts volume but long-term incidence trends underpin latent demand.

Immuno Oncology Assays Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The immuno-oncology assays market is moderately consolidated. Thermo Fisher Scientific’s USD 3.1 billion acquisition of Olink integrates high-throughput proteomics with existing NGS kits, reinforcing end-to-end service capability[2]Financial Times, “Thermo Fisher Moves into Proteomics with Olink Deal,” ft.com. Veracyte’s USD 95 million purchase of C2i Genomics extends into minimal residual disease monitoring.

Technology differentiation centres on AI-enabled multiplex imaging and data integration. Owkin’s TLS Detect achieves 97% sensitivity in detecting tertiary lymphoid structures, positioning the firm as a reference for spatial AI analytics[3]Owkin, “TLS Detect: AI Biomarker for Immunotherapy,” owkin.com. Guardant Health’s partnership with ConcertAI merges expansive electronic medical records with molecular data, advancing real-world evidence and payer acceptance.

White-space innovation targets decentralised workflows. Companies such as Mursla Bio focus on extracellular vesicle-based assays tailored for organ-specific signatures, complementing central lab services. Mid-size players leverage ISO-accredited manufacturing and regional distribution to serve hospitals adopting comprehensive immune panels. As clinical utility broadens, market success will favour firms that deliver integrated, regulator-ready, and clinician-friendly solutions.

Immuno Oncology Assays Industry Leaders

  1. Agilent Technologies, Inc

  2. Thermo Fisher Scientific

  3. Illumina, Inc.

  4. PerkinElmer, Inc.

  5. Crown Bioscience

  6. *Disclaimer: Major Players sorted in no particular order
Immuno Oncology Assays Market Concentration
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Recent Industry Developments

  • July 2025: FDA granted accelerated approval to sunvozertinib (Zegfrovy) for metastatic NSCLC with EGFR exon 20 insertions; Oncomine Dx Express Test approved as companion diagnostic.
  • May 2025: Roche obtained FDA approval for VENTANA MET (SP44) RxDx assay as first companion diagnostic for MET protein in non-squamous NSCLC.
  • April 2025: Ventana TROP2 (EPR20043) RxDx assay received breakthrough device designation for datopotamab deruxtecan selection in NSCLC.
  • April 2025: Guardant Health launched Guardant360 Tissue multiomic profiling test analysing 742 DNA and 367 RNA genes while using fewer slides.

Table of Contents for Immuno Oncology Assays Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Sustained rise in Global Cancer Incidence
    • 4.2.2 Expanding Adoption of Immune-checkpoint Inhibitors
    • 4.2.3 Regulatory Approvals of Companion Dx Assays (PD-1/PD-L1, TMB)
    • 4.2.4 Pharma-Dx Co-development Partnerships Accelerating Test Menus
    • 4.2.5 AI-driven Multiplex Spatial Profiling Boosting Biomarker Discovery
    • 4.2.6 Decentralised Liquid-biopsy Testing in Community Oncology
  • 4.3 Market Restraints
    • 4.3.1 High Assay Costs & Complex Reimbursement Pathways
    • 4.3.2 Stringent Multi-jurisdiction Regulatory Validation Demands
    • 4.3.3 Scarcity of Well-annotated Matched Tumour/normal Biobanks
    • 4.3.4 Lack of Global Standardisation in Multiplex Assay Protocols
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces Analysis
    • 4.7.1 Bargaining Power of Suppliers
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Threat of New Entrants
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value-USD)

  • 5.1 By Product
    • 5.1.1 Reagents & Antibodies
    • 5.1.2 Instruments
    • 5.1.3 Software & Analytics
    • 5.1.4 Consumables & Accessories
  • 5.2 By Technology
    • 5.2.1 Immunoassay (ELISA, CLIA)
    • 5.2.2 Polymerase Chain Reaction (PCR/qPCR/ddPCR)
    • 5.2.3 Next-Generation Sequencing (NGS)
    • 5.2.4 Flow Cytometry
    • 5.2.5 Multiplex Spatial Profiling (mIF, IMC, DSP)
  • 5.3 By Assay Type
    • 5.3.1 Companion Diagnostic (CDx) Assays
    • 5.3.2 Laboratory-Developed Tests (LDTs)
    • 5.3.3 Research-Use-Only (RUO) Panels
  • 5.4 By Indication
    • 5.4.1 Lung Cancer
    • 5.4.2 Colorectal Cancer
    • 5.4.3 Melanoma
    • 5.4.4 Breast Cancer
    • 5.4.5 Other Cancers
  • 5.5 By Sample Type
    • 5.5.1 Tissue Biopsy
    • 5.5.2 Liquid Biopsy (Blood, Plasma, cfDNA)
  • 5.6 Geography
    • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
    • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
    • 5.6.3 Asia-pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-pacific
    • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
    • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Products & Services, and Recent Developments)}
    • 6.3.1 Agilent Technologies
    • 6.3.2 Thermo Fisher Scientific
    • 6.3.3 Illumina
    • 6.3.4 PerkinElmer
    • 6.3.5 Roche
    • 6.3.6 Merck KGaA
    • 6.3.7 HTG Molecular Diagnostics
    • 6.3.8 Crown Bioscience
    • 6.3.9 InSphero
    • 6.3.10 Qiagen
    • 6.3.11 Bio-Rad Laboratories
    • 6.3.12 NanoString Technologies
    • 6.3.13 ArcherDx (Invitae)
    • 6.3.14 Adaptive Biotechnologies
    • 6.3.15 Sysmex
    • 6.3.16 Oxford Nanopore Tech.
    • 6.3.17 Guardant Health
    • 6.3.18 NeoGenomics
    • 6.3.19 Foundation Medicine
    • 6.3.20 Danaher (Leica-Cytiva)

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-Need Assessment
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Global Immuno Oncology Assays Market Report Scope

As per the scope of the report, Immuno oncology assays is a next-generation sequencing application that delivers real-time automated measurements of immune and tumor cell dynamics. With the help of this assay, people can analyze biological processes driving the immune response against cancer. It helps continuously examine and analyze key events from proliferation and activation to migration and immune cell killing without disturbing the existing body cells. The Immuno Oncology Assays Market is segmented by product (reagents and antibodies, instruments, software and consumables, and accessories), technology (immunoassay, PCR, NGS, Flow Cytometry, and other technologies), indication (lung cancer, colorectal cancer, Melanoma, and other cancers) and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the value in (USD million) for the above segments.

By Product Reagents & Antibodies
Instruments
Software & Analytics
Consumables & Accessories
By Technology Immunoassay (ELISA, CLIA)
Polymerase Chain Reaction (PCR/qPCR/ddPCR)
Next-Generation Sequencing (NGS)
Flow Cytometry
Multiplex Spatial Profiling (mIF, IMC, DSP)
By Assay Type Companion Diagnostic (CDx) Assays
Laboratory-Developed Tests (LDTs)
Research-Use-Only (RUO) Panels
By Indication Lung Cancer
Colorectal Cancer
Melanoma
Breast Cancer
Other Cancers
By Sample Type Tissue Biopsy
Liquid Biopsy (Blood, Plasma, cfDNA)
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-pacific China
Japan
India
Australia
South Korea
Rest of Asia-pacific
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
South America Brazil
Argentina
Rest of South America
By Product
Reagents & Antibodies
Instruments
Software & Analytics
Consumables & Accessories
By Technology
Immunoassay (ELISA, CLIA)
Polymerase Chain Reaction (PCR/qPCR/ddPCR)
Next-Generation Sequencing (NGS)
Flow Cytometry
Multiplex Spatial Profiling (mIF, IMC, DSP)
By Assay Type
Companion Diagnostic (CDx) Assays
Laboratory-Developed Tests (LDTs)
Research-Use-Only (RUO) Panels
By Indication
Lung Cancer
Colorectal Cancer
Melanoma
Breast Cancer
Other Cancers
By Sample Type
Tissue Biopsy
Liquid Biopsy (Blood, Plasma, cfDNA)
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-pacific China
Japan
India
Australia
South Korea
Rest of Asia-pacific
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the projected value of the immuno-oncology assays market by 2030?

The market is forecast to reach USD 10.69 billion by 2030, advancing at a 12.11% CAGR.

Which product category contributes the most revenue today?

Reagents & Antibodies lead with 40.12% of global revenue, reflecting the consumable-intensive nature of immune profiling workflows.

What technology segment is growing the fastest?

Multiplex spatial profiling is expanding at a 12.71% CAGR as laboratories adopt single-cell, context-rich analysis platforms.

Why are companion diagnostics gaining momentum?

Recent FDA approvals for assays targeting MET, KRAS G12C, and TROP2 validate multi-parameter testing and are pushing the companion diagnostic segment toward a 12.69% CAGR.

How significant is liquid biopsy to future growth?

Liquid biopsy tests, used for non-invasive monitoring of circulating tumor DNA, are expected to grow at a 12.74% CAGR and complement tissue-based assays.

Which region offers the highest growth potential?

Asia-Pacific is projected to post a 12.86% CAGR through 2030, driven by rising cancer incidence, expanding screening programs, and streamlined regulatory pathways.

Page last updated on: July 7, 2025

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