PUBLISHER: Howe Sound Research | PRODUCT CODE: 2024185
PUBLISHER: Howe Sound Research | PRODUCT CODE: 2024185
Immuno-Oncology Diagnostics. Market Forecasts for Immuno-Oncology Diagnostics by Assay Type, Technology, Client, and Country. With Executive/Consultant Guides. 2026 to 2030 (4th Edition)
Market Overview:
Market Size 2025: USD $6.22B Market Size 2030: USD $11.1B CAGR: 12.3%
Immuno-oncology (IO) diagnostics are in vitro diagnostic tests used to identify biomarkers that predict patient response to immunotherapies. These therapies stimulate or restore the immune system's ability to recognize and destroy cancer cells and have become one of the most important advances in oncology over the past decade. As immunotherapies increasingly become standard treatment options across multiple tumor types, diagnostic tests that guide patient selection have become critical components of clinical decision-making.
The IO diagnostics market has developed in parallel with the rapid expansion of immunotherapy drug classes, including immune checkpoint inhibitors, CAR-T cell therapies, bispecific antibodies, and therapeutic cancer vaccines. Unlike traditional targeted therapies that focus on specific genetic mutations, immunotherapies rely on complex interactions between tumors and the immune system. As a result, IO diagnostics often require evaluation of multiple biological parameters including protein expression, immune cell infiltration, tumor mutational burden, and gene expression signatures.
The global immuno-oncology therapeutics market has demonstrated substantial growth, exceeding approximately USD 200 billion in recent years and projected to continue expanding as additional checkpoint inhibitors, cell therapies, and combination therapies are introduced. This growth is driving demand for predictive biomarker testing capable of identifying patients most likely to benefit from immune-based treatments.
Role of Biomarkers in Immuno-Oncology
Biomarkers play a central role in guiding immunotherapy treatment decisions. One of the most widely used biomarkers is PD-L1 expression, which is commonly assessed using immunohistochemistry (IHC) assays. PD-L1 testing is used to determine eligibility for checkpoint inhibitor therapies targeting PD-1 or PD-L1 pathways in cancers such as non-small cell lung cancer, melanoma, bladder cancer, and head and neck cancer.
Other important biomarkers include tumor mutational burden (TMB), microsatellite instability (MSI), mismatch repair deficiency (dMMR), and gene expression profiles that characterize immune system activity within the tumor microenvironment. High tumor mutational burden or MSI-high status may indicate increased likelihood of response to immune checkpoint inhibitors due to greater neoantigen presentation.
Emerging biomarkers include immune gene signatures, tumor-infiltrating lymphocyte (TIL) density measurements, and circulating biomarkers detected through liquid biopsy technologies. These approaches aim to improve predictive accuracy beyond single biomarker testing.
Technologies Used in IO Diagnostics
The IO diagnostics market incorporates a range of molecular and immunological testing technologies. Immunohistochemistry remains one of the most widely used methods due to its ability to detect protein expression patterns within tissue samples. IHC assays are commonly used to measure PD-L1 expression and other immune-related markers.
Next-generation sequencing (NGS) technologies enable comprehensive genomic profiling, allowing simultaneous detection of multiple biomarkers including TMB, MSI, and gene expression signatures. NGS panels can support both companion diagnostics and broader tumor profiling approaches.
Polymerase chain reaction (PCR) technologies continue to play an important role in detecting specific genetic alterations and microsatellite instability. Digital pathology and image analysis technologies are increasingly used to quantify immune cell infiltration and biomarker expression patterns.
Liquid biopsy technologies represent an emerging segment of the IO diagnostics market. These tests analyze circulating tumor DNA or other biomarkers in blood samples, enabling less invasive monitoring of disease progression and treatment response.
Market Drivers
Several factors are driving growth in the immuno-oncology diagnostics market. One of the most significant drivers is the continued expansion of immunotherapy drug pipelines. Pharmaceutical companies are investing heavily in checkpoint inhibitors, cell therapies, and combination immunotherapies that require biomarker testing to guide patient selection.
Increasing adoption of precision medicine approaches is also supporting demand for IO diagnostics. Clinicians are increasingly using biomarker information to tailor treatment decisions based on individual patient characteristics.
Advances in genomic sequencing technologies and bioinformatics tools have improved the sensitivity and specificity of biomarker detection, supporting broader clinical adoption.
The growing use of combination therapies is also increasing the need for more complex biomarker testing strategies capable of evaluating multiple immune pathways simultaneously.
Market Segmentation
The IO diagnostics market can be segmented by technology platform, cancer type, end user, and geographic region.
By technology, immunohistochemistry remains widely used, while next-generation sequencing represents one of the fastest-growing segments due to its ability to evaluate multiple biomarkers simultaneously.
By cancer type, lung cancer represents one of the largest segments due to widespread use of checkpoint inhibitors in non-small cell lung cancer. Other important segments include melanoma, bladder cancer, breast cancer, colorectal cancer, and head and neck cancer.
End users include hospital laboratories, reference laboratories, academic research centers, and pharmaceutical companies conducting clinical trials.
North America represents the largest geographic market due to advanced healthcare infrastructure and high adoption of immunotherapy treatments. Europe and Asia-Pacific are also experiencing increasing demand for IO diagnostic testing.
Competitive Landscape
The immuno-oncology diagnostics market includes large in vitro diagnostics companies, molecular diagnostics firms, and specialized biotechnology companies focused on biomarker discovery.
Many diagnostic developers partner with pharmaceutical companies to co-develop companion diagnostic tests aligned with specific immunotherapy drugs. Strategic collaborations are common due to the need for coordinated clinical validation and regulatory approval.
Companies are increasingly focused on developing multiplex testing platforms capable of supporting multiple biomarker types across therapeutic indications.
Data analytics and bioinformatics capabilities are becoming important competitive differentiators as biomarker interpretation becomes more complex.
Future Outlook
The immuno-oncology diagnostics market is expected to continue expanding as immunotherapies become standard treatments across additional cancer types and earlier lines of therapy.
Emerging technologies such as spatial biology, multiplex imaging, and artificial intelligence-based biomarker analysis may improve predictive accuracy and support development of more personalized treatment strategies.
Liquid biopsy technologies may expand testing volumes by enabling non-invasive monitoring of treatment response.
Overall, IO diagnostics are expected to remain a critical component of precision oncology, supporting more effective patient selection and improved clinical outcomes as immunotherapy continues to evolve.
Table of Contents
1 Market Guides
- 1.1 Situation Analysis
- 1.1.1 Strategic Importance of Biomarkers in Immuno-Oncology
- 1.1.2 Scientific Complexity and Biomarker Validation Challenges
- 1.1.3 Regulatory Complexity and Co-development Risk
- 1.1.4 Technology Evolution and Platform Competition
- 1.1.5 Reimbursement and Economic Value Considerations
- 1.1.6 Dependence on Immunotherapy Drug Pipelines
- 1.1.7 Competitive Landscape and Industry Structure
- 1.1.8 Outlook and Strategic Implications
- 1.2 Guide for Executives and Marketing Staff
- 1.3 Guide for Investment Analysts and Management Consultants
- 1.4 Impact of Artificial Intelligence
2 Introduction and Market Definition
- 2.1 What are Immuno-Oncology Diagnostics?
- 2.2 Immuno-oncology - the looming cure
- 2.2.1 Immuno-oncology Diagnostics Takes a Leading Role
- 2.3 Market Definition
- 2.3.1 Market Size
- 2.3.2 Currency
- 2.3.3 Years
- 2.4 Methodology
- 2.4.1 Methodology
- 2.4.2 Sources
- 2.4.3 Authors
- 2.5 Perspective: Healthcare and the IVD Industry
- 2.5.1 Global Healthcare Spending
- 2.5.2 Spending on Diagnostics
- 2.5.3 Important Role of Insurance for Diagnostics
3 Immunotherapy - Guide to Immune Technologies
- 3.1 The Immune System
- 3.1.1 Innate immune system
- 3.1.1.1 Surface barriers
- 3.1.1.2 Inflammation
- 3.1.1.3 Complement system
- 3.1.1.4 Cellular barriers
- 3.1.1.5 Natural killer cells
- 3.1.2 Adaptive immune system
- 3.1.2.1 Lymphocytes
- 3.1.2.2 Killer T cells
- 3.1.2.3 Helper T cells
- 3.1.2.4 Gamma delta T cells
- 3.1.2.5 B lymphocytes and antibodies
- 3.1.3 Tumor immunology - the immune surveillance system
- 3.1.1 Innate immune system
- 3.2 Immuno Oncology Diagnostics
- 3.2.1 Checkpoint Assays
- 3.2.1.1 Outlook for Checkpoint Assays
- 3.2.2 Cytokine Assays
- 3.2.2.1 Outlook for Cytokine Assays
- 3.2.3 Genomic Germline
- 3.2.3.1 Outlook for Genomic Germline
- 3.2.4 Genomic Tumour
- 3.2.4.1 Outlook for Genomic Tumour
- 3.2.5 Tumor Microenviroment
- 3.2.5.1 Outlook for Tumor Microenvironment
- 3.2.6 Others
- 3.2.6.1 Outlook for Other Diagnostics
- 3.2.1 Checkpoint Assays
4 Industry Overview
- 4.1 Players in a Dynamic Market
- 4.1.1 Academic Research Lab
- 4.1.2 Diagnostic Test Developer
- 4.1.3 Instrumentation Supplier
- 4.1.4 Chemical/Reagent Supplier
- 4.1.5 Pathology Supplier
- 4.1.6 Independent Clinical Laboratory
- 4.1.7 Public National/regional Laboratory
- 4.1.8 Hospital Laboratory
- 4.1.9 Physicians Office Lab (POLS)
- 4.1.10 Audit Body
- 4.1.11 Certification Body
5 Market Trends
- 5.1 Factors Driving Growth
- 5.1.1 Outcome potential
- 5.1.2 Companion Diagnostics
- 5.1.3 Funding
- 5.1.4 Technology Environment
- 5.1.5 Target Solutions
- 5.2 Factors Limiting Growth
- 5.2.1 Complex Role of Diagnostics
- 5.2.2 Clinical Trials Role
- 5.2.3 Protocols
- 5.3 Diagnostic Technology Development
- 5.3.1 Combinations - Issues and Complexity
- 5.3.2 Shifting Role of Diagnostics
- 5.3.3 Multiplexing and Foundation One
- 5.3.4 The Disruption Dynamic
- 5.3.5 The Race for Biomarkers
- 5.3.6 The Next Five Years
6 Cancer Immuno-Oncology Diagnostics Recent Developments
- 6.1 Recent Developments - Importance and How to Use This Section
- 6.1.1 Importance of These Developments
- 6.1.2 How to Use This Section
- 6.2 Personalis Outlook Positive
- 6.3 Agilent Technologies Expands Certification for PD-L1 CDx
- 6.4 Foundation Medicine, Sumitomo Pharma to Develop CDx
- 6.5 Erisyon to Develop Diagnostic for Immuno-Oncology
- 6.6 Caris Life Sciences Expands CDx
- 6.7 FDA approves Illumina cancer biomarker test
- 6.8 Tempus Expands Immuno-Oncology Portfolio with AI
- 6.9 Foundation Medicine, Repare to Partner on CDx for Lunresertib
- 6.10 Thermo Fisher and Bayer to Develop CDx for Cancer Therapies
- 6.11 ClearNote Health Expands Into Immunotherapy Monitoring
- 6.12 Foundation Medicine to Collaborate on CDx for Lung Cancer
- 6.13 Qiagen and Myriad Genetics Partner to Develop Cancer CDx
- 6.14 Lung Cancer Data Heralds Shift for Hummingbird Dx
- 6.15 PamGene Awarded Euro 7.5M for Immunotherapy Test
- 6.16 Freenome Acquires Oncimmune
- 6.17 Guardant Health Gets Coverage for Liquid Biopsy Treatment Response Test
- 6.18 BostonGene to Develop Sarcoma-Specific Liquid Biopsy
- 6.19 Exact Sciences OncoExTra Therapy Selection Test
- 6.20 Integrated DNA Technologies Buys NGS Research Assays
- 6.21 Navignostics Using Single-Cell Spatial Proteomics
- 6.22 New Reference Samples for NGS-Based Cancer Tests
- 6.23 Spatial Proteomics Panel for Immuno-Oncology
- 6.24 dMMR, MSI Assays for Immunotherapy Patient Selection
- 6.25 OncoHost Expands Prophet Platform Research
- 6.26 Protein-Based Liquid Biopsy Panel Assesses TME
7 Profiles of Key Immuno-oncology Companies
- 7.1 10x Genomics, Inc.
- 7.2 Abbott Laboratories
- 7.3 AccuraGen Inc.
- 7.4 Adaptive Biotechnologies
- 7.5 Aethlon Medical
- 7.6 Agilent
- 7.7 Anchor Dx
- 7.8 ANGLE plc
- 7.9 ARUP Laboratories
- 7.10 AVIVA Systems Biology
- 7.11 Baylor Miraca Genetics Laboratories
- 7.12 Beckman Coulter Diagnostics (Danaher)
- 7.13 Becton, Dickinson and Company
- 7.14 Berkley Lights
- 7.15 BGI Genomics Co. Ltd
- 7.16 Bioarray Genetics
- 7.17 Biocartis
- 7.18 Biocept, Inc.
- 7.19 Biodesix Inc.
- 7.20 BioFluidica
- 7.21 BioGenex
- 7.22 BioIVT
- 7.23 Biolidics Ltd
- 7.24 bioMerieux Diagnostics
- 7.25 Bioneer Corporation
- 7.26 Bio-Rad Laboratories, Inc.
- 7.27 Bio-Reference Laboratories
- 7.28 Bio-Techne
- 7.29 Bioview
- 7.30 Bristol-Myers Squibb
- 7.31 Burning Rock
- 7.32 Cardiff Oncology
- 7.33 Caris Molecular Diagnostics
- 7.34 Castle Biosciences, Inc.
- 7.35 CellCarta
- 7.36 CellMax Life
- 7.37 Cepheid (Danaher)
- 7.38 Charles River Laboratories
- 7.39 Circulogene
- 7.40 Cizzle Biotech
- 7.41 Clearbridge Biomedics
- 7.42 Clinical Genomics
- 7.43 Cytolumina Technologies Corp.
- 7.44 Datar Cancer Genetics Limited
- 7.45 Diagnologix LLC
- 7.46 Diasorin S.p.A.
- 7.47 Dxcover
- 7.48 Element Biosciences
- 7.49 Enzo Biochem
- 7.50 Epic Sciences
- 7.51 Epigenomics AG
- 7.52 Eurofins Scientific
- 7.53 Fabric Genomics
- 7.54 Fluxion Biosciences (Cell Microsystems)
- 7.55 Freenome
- 7.56 FUJIFILM Wako Diagnostics
- 7.57 Fujirebio
- 7.58 Fyr Diagnostics
- 7.59 GeneFirst Ltd.
- 7.60 Genetron Holdings
- 7.61 GenomOncology
- 7.62 GILUPI Nanomedizin
- 7.63 Guardant Health
- 7.64 HansaBiomed
- 7.65 HTG Molecular Diagnostics
- 7.66 iCellate
- 7.67 ICON PLC
- 7.68 Illumina
- 7.69 Incell Dx
- 7.70 Inivata
- 7.71 INOVIQ
- 7.72 Invitae Corporation
- 7.73 Invivogen
- 7.74 Invivoscribe
- 7.75 J&J Innovative Medicine
- 7.76 KEW
- 7.77 Lucence Health
- 7.78 Lunglife AI Inc
- 7.79 MDNA Life SCIENCES, Inc.
- 7.80 MDx Health
- 7.81 Menarini Silicon Biosystems
- 7.82 Mesa Laboratories, Inc.
- 7.83 Millipore Sigma
- 7.84 Miltenyi Biotec
- 7.85 miR Scientific
- 7.86 Myriad Genetics
- 7.87 Nanostring
- 7.88 NantHealth, Inc.
- 7.89 Natera
- 7.90 NeoGenomics
- 7.91 NGeneBio
- 7.92 Novogene
- 7.93 Oncimmune
- 7.94 Oncocyte
- 7.95 OncoDNA
- 7.96 Oncohost
- 7.97 Oxford Nanopore Technologies
- 7.98 PamGene
- 7.99 Panagene
- 7.100 Personalis
- 7.101 PGDx (Labcorp)
- 7.102 Precipio
- 7.103 PrecisionMed
- 7.104 Predicine
- 7.105 Predictive Oncology
- 7.106 Prenetics
- 7.107 Promega
- 7.108 Qiagen
- 7.109 QuidelOrtho
- 7.110 Rarecells SAS
- 7.111 RareCyte
- 7.112 Recursion Pharma
- 7.113 Revvity
- 7.114 Roche Diagnostics
- 7.115 Screencell
- 7.116 Sherlock Biosciences
- 7.117 Siemens Healthineers
- 7.118 simfo GmbH
- 7.119 Singlera Genomics Inc.
- 7.120 Singular Genomics
- 7.121 Singulomics
- 7.122 SkylineDx
- 7.123 Standard BioTools
- 7.124 Stilla Technologies
- 7.125 Sysmex Inostics
- 7.126 Tempus Labs, Inc.
- 7.127 Thermo Fisher Scientific
- 7.128 Todos Medical
- 7.129 Ultima Genomics
- 7.130 Veracyte
- 7.131 VolitionRX
- 7.132 Vortex Biosciences
8 The Global Market for Immuno-Oncology Diagnostics
- 8.1 Global Market Overview by Country
- 8.1.1 Table - Global Market by Country
- 8.1.2 Chart - Global Market by Country
- 8.2 Global Market by Assay Type - Overview
- 8.2.1 Table - Global Market by Assay Type
- 8.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
- 8.2.3 Chart - Global Market by Assay Type - Base Year
- 8.2.4 Chart - Global Market by Assay Type - End Year
- 8.2.5 Chart - Global Market by Assay Type - Share by Year
- 8.2.6 Chart - Global Market by Assay Type - Segments Growth
- 8.3 Global Market by Technology - Overview
- 8.3.1 Table - Global Market by Technology
- 8.3.2 Chart - Global Market by Technology - Base/Final Year Comparison
- 8.3.3 Chart - Global Market by Technology - Base Year
- 8.3.4 Chart - Global Market by Technology - End Year
- 8.3.5 Chart - Global Market by Technology - Share by Year
- 8.3.6 Chart - Global Market by Technology - Segments Growth
- 8.4 Global Market by Customer - Overview
- 8.4.1 Table - Global Market by Customer
- 8.4.2 Chart - Global Market by Customer - Base/Final Year Comparison
- 8.4.3 Chart - Global Market by Customer - Base Year
- 8.4.4 Chart - Global Market by Customer - End Year
- 8.4.5 Chart - Global Market by Customer - Share by Year
- 8.4.6 Chart - Global Market by Customer - Segments Growth
9 Global Immuno-Oncology Diagnostic Markets - By Application
- 9.1 Checkpoint
- 9.1.1 Table Checkpoint - by Country
- 9.1.2 Chart - Checkpoint Growth
- 9.2 Cytokine
- 9.2.1 Table Cytokine - by Country
- 9.2.2 Chart - Cytokine Growth
- 9.3 Germline Genetic
- 9.3.1 Table Germline Genetic - by Country
- 9.3.2 Chart - Germline Genetic Growth
- 9.4 Genetic Tumor
- 9.4.1 Table Genetic Tumor - by Country
- 9.4.2 Chart - Genetic Tumor Growth
- 9.5 Tumor Microenvironment
- 9.5.1 Table Tumor Microenvironment - by Country
- 9.5.2 Chart - Tumor Microenvironment Growth
- 9.6 Other
- 9.6.1 Table Other - by Country
- 9.6.2 Chart - Other Growth
10 Global Immuno-Oncology Diagnostic Markets - By Technology
- 10.1 NGS
- 10.1.1 Table NGS - by Country
- 10.1.2 Chart - NGS Growth
- 10.2 PCR
- 10.2.1 Table PCR - by Country
- 10.2.2 Chart - PCR Growth
- 10.3 Fish/IHC
- 10.3.1 Table Fish/IHC - by Country
- 10.3.2 Chart - Fish/IHC Growth
- 10.4 Chem/IA
- 10.4.1 Table Chem/IA - by Country
- 10.4.2 Chart - Chem/IA Growth
- 10.5 Other Technology
- 10.5.1 Table Other Technology - by Country
- 10.5.2 Chart - Other Technology Growth
11 Global Immuno-Oncology Diagnostic Markets - By Customer
- 11.1 Pharma
- 11.1.1 Table Pharma - by Country
- 11.1.2 Chart - Pharma Growth
- 11.2 Clinic
- 11.2.1 Table Clinic - by Country
- 11.2.2 Chart - Clinic Growth
- 11.3 Other Customer Genetic
- 11.3.1 Table Other Customer - by Country
- 11.3.2 Chart - Other Customer Growth
12 Appendices
- 12.1 Prevalence of Cancer Treatments
- 12.2 Growth of Approved IVD Test Menu
- 12.3 Growth of Approved Average IVD Test Fee
- 12.4 The Most Used IVD Assays
- 12.5 The Highest Grossing Assays
- 12.6 Laboratory Fees Schedule
Table of Tables
- Table 1 List of Cancers by Mortality
- Table 2 Overview of Innate and Adaptive Immunity
- Table 3 FDA Approved Monoclonal Antibodies in Cancer treatment
- Table 4 FDA Approved Companion diagnostics in Cancer treatment
- Table 5 Market Players by Type
- Table 6 Five Factors Driving Growth
- Table 7 Three Factors Limiting Growth
- Table 8 - Global Market by Region
- Table 9 Global Market by Assay Type
- Table 10 Global Market by Technology
- Table 11 Global Market by Customer
- Table 12 Checkpoint by Country
- Table 13 Cytokine by Country
- Table 14 Germline Genetic by Country
- Table 15 Genetic Tumor by Country
- Table 16 Tumor Microenvironment by Country
- Table 17 Other by Country
- Table 18 NGS by Country
- Table 19 PCR by Country
- Table 20 Fish/IHC by Country
- Table 21 Chem/IA by Country
- Table 22 Other Technology by Country
- Table 23 Pharma by Country
- Table 24 Clinic by Country
- Table 25 Other Customer by Country
- Table 26 The Most Common Assays
- Table 27 Largest Revenue Assays
- Table 28 Clinical Lab Fee Schedule
Table of Figures
- Figure 1 Cancer Death Rates - USA, CDC
- Figure 2 Global healthcare Spending
- Figure 3 The Lab Test Pie
- Figure 4 Helper T Cell Roles
- Figure 5 Antibody Diagram
- Figure 6 Macrophages attack a Cancer Cell
- Figure 7 The Tumour Micro Environment
- Figure 8 The Road to Diagnostics
- Figure 9 Comparing IO Diagnostic and Traditional Testing
- Figure 10 Growth rates of IO DiagnosticTechnologies
- Figure 11 Global Market Density Chart
- Figure 12 Global Market by Assay Type - Base vs. Final
- Figure 13 Global Market by Assay Type Base Year
- Figure 14 Global Market by Assay Type End Year
- Figure 15 Assay Type Share by Year
- Figure 16 Assay Type Segments Growth
- Figure 17 Global Market by Technology - Base vs. Final
- Figure 18 Global Market by Technology Base Year
- Figure 19 Global Market by Technology End Year
- Figure 20 Technology Share by Year
- Figure 21 Technology Segments Growth
- Figure 22 Global Market by Customer - Base vs. Final
- Figure 23 Global Market by Customer Base Year
- Figure 24 Global Market by Customer End Year
- Figure 25 Customer Share by Year
- Figure 26 Customer Segments Growth
- Figure 27 Checkpoint Growth
- Figure 28 Cytokine Growth
- Figure 29 Germline Genetic Growth
- Figure 30 Genetic Tumor Growth
- Figure 31 Tumor Microenvironment Growth
- Figure 32 Other Growth
- Figure 33 NGS Growth
- Figure 34 PCR Growth
- Figure 35 Fish/IHC Growth
- Figure 36 Chem/IA Growth
- Figure 37 Other Technology Growth
- Figure 38 Pharma Growth
- Figure 39 Clinic Growth
- Figure 40 Other Customer Growth
- Figure 41 Prevalence of Cancer Treatments
- Figure 42 IVD Test Menu Growth
- Figure 43 IVD Test Average Fees - A Ten Year View
