Market Forecasts for Immuno-Oncology Diagnostics. Including Executive/Consultant Guides and Customized Forecasting/Analysis. 2025 to 2029. Including Impact of Aritificial Intelligence

PUBLISHED: April 14, 2025

PAGES: 472 Pages

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Diagnostics, companion diagnostics, is driving the success of Immuno-oncology Therapeutics. An entire new segment of the diagnostics industry is being created. And its not a small segment either. It promises to grow dramatically. Histology, genomics and liquid biopsy are converging. A complicated network of pharmaceutical companies, diagnostic companies and instrumentation suppliers are jockeying for position in a new approach to conquering cancer. The approach seems to be working and showing great promise.

A revolution in cancer therapy is underway. New therapy based on using the body's natural immune defenses is having unprecedented success. But diagnostics, especially biomarkers are desperately needed to help select the right therapy.

The technology is moving faster than the market. The impact on the health care industry is enormous. Tumor Mutational Burden? Checkpoint Inhibitors? Cytokines? Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size in this new expanded and comprehensive report.

1. Market Guides

1.1. Situation Analysis
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
3.2. 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

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