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.
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.
Table of Contents
1. Market Guides
1.1. Situation Analysis
1.2. Guide for Executives and Marketing Staff
1.3. Guide for Investment Analysts and Management Consultants
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. Integrated DNA Technologies Buys NGS Research Assays
6.3. Navignostics Using Single-Cell Spatial Proteomics
6.4. New Reference Samples for NGS-Based Cancer Tests
6.5. Spatial Proteomics Panel for Immuno-Oncology
6.6. dMMR, MSI Assays for Immunotherapy Patient Selection
6.7. OncoHost Expands Prophet Platform Research
6.8. Protein-Based Liquid Biopsy Panel Assesses TME
6.9. Oncimmune Announces Sixfold Revenue Increase
6.10. Mayo Clinic, Personalis Ink Collaboration
6.11. Lucence Liquid Biopsy Test Tracks Immune Treatment ctDNA Changes
6.12. Qiagen, OncXerna Close Companion Dx Development Deal
6.13. Natera Test to Guide Therapy for Bladder Cancer
6.14. Veracyte Halio Acquisition to Boost Immuno-oncology Activity
6.15. Freenome Eyes New Dx Possibilities
6.16. Oncocyte Data has Potential as Immunotherapy Response Predictor
6.17. OncoDNA use HalioDx to Expand into North America
6.18. Adaptive Biotechnologies, Q2 Solutions Agreement for ImmunoSeq Assay
6.19. Qiagen Expands Immuno-Oncology Portfolio
6.20. Immune Profiling System Redirected to Fight COVID-19
6.21. IncellDx Awarded PD-L1 Detection Patent
6.22. FDA Approves CDx for Trastuzumab
6.23. Promega Nabs CE Mark for Microsatellite Instability IVD
6.24. ArcherDx partners with AstraZeneca for Immuno-Oncology
6.25. Germline Results Guides Precision Therapy
6.26. Agilent PD-L1 Assay Gets FDA Approval
6.27. Bayer, OrigiMed Form Companion Diagnostic Development Alliance
6.28. Bio-Me to Develop Microbiome Biomarker Test for Cancer Immunotherapy136
6.29. SkylineDx, BioInvent Collaborate to Characterize Predictive Immunological Signatures
6.30. Biocare Medical Launches 7 Novel IVD Antibodies
7. Profiles of Key Immuno-oncology Companies
7.1. 10x Genomics, Inc.
7.2. Abbott Laboratories
7.3. AccuraGen Inc.
7.4. Aethlon Medical
7.5. Agilent/Dako
7.6. Anchor Dx
7.7. ANGLE plc
7.8. AVIVA Systems Biology
7.9. Baylor Miraca Genetics Laboratories
7.10. Becton, Dickinson and Company
7.11. Berkley Lights
7.12. BGI Genomics Co. Ltd
7.13. Bioarray Genetics
7.14. Biocartis
7.15. Biocept, Inc.
7.16. Biodesix Inc.
7.17. BioFluidica
7.18. BioGenex
7.19. BioIVT
7.20. Biolidics Ltd
7.21. bioMérieux Diagnostics
7.22. Bioneer Corporation
7.23. Bio-Rad Laboratories, Inc.
7.24. Bio-Reference Laboratories
7.25. Bio-Techne
7.26. Bioview
7.27. Bolidics
7.28. Boreal Genomics
7.29. Bristol-Myers Squibb
7.30. Burning Rock
7.31. Cardiff Oncology
7.32. Caris Molecular Diagnostics
7.33. Castle Biosciences, Inc.
7.34. CellCarta
7.35. CellMax Life
7.36. Cepheid (Danaher)
7.37. Charles River Laboratories
7.38. Circulogene
7.39. Cizzle Biotech
7.40. Clinical Genomics
7.41. Cytolumina Technologies Corp.
7.42. Datar Cancer Genetics Limited
7.43. Diagnologix LLC
7.44. Diasorin S.p.A.
7.45. Dxcover
7.46. Element Biosciences
7.47. Enzo Biochem
7.48. Epic Sciences
7.49. Epigenomics AG
7.50. Eurofins Scientific
7.51. Fabric Genomics
7.52. Fluxion Biosciences
7.53. Freenome
7.54. FUJIFILM Wako Diagnostics
7.55. Fyr Diagnostics
7.56. GeneFirst Ltd.
7.57. Genetron Holdings
7.58. GenomOncology
7.59. GILUPI Nanomedizin
7.60. Guardant Health
7.61. HansaBiomed
7.62. HeiScreen
7.63. Helomics
7.64. HTG Molecular Diagnostics
7.65. iCellate
7.66. ICON PLC
7.67. Illumina
7.68. Incell Dx
7.69. Inivata
7.70. INOVIQ
7.71. Integrated Diagnostics
7.72. Invitae Corporation
7.73. Invivogen
7.74. Invivoscribe
7.75. Janssen Diagnostics
7.76. Lunglife AI Inc
7.77. MDNA Life SCIENCES, Inc.
7.78. MDx Health
7.79. Menarini Silicon Biosystems
7.80. Mesa Laboratories, Inc.
7.81. Millipore Sigma
7.82. Miltenyi Biotec
7.83. miR Scientific
7.84. Myriad Genetics/Myriad RBM
7.85. NantHealth, Inc.
7.86. Natera
7.87. NeoGenomics
7.88. NGeneBio
7.89. Novogene Bioinformatics Technology Co., Ltd.
7.90. Oncocyte
7.91. OncoDNA
7.92. Ortho Clinical Diagnostics
7.93. Oxford Nanopore Technologies
7.94. PamGene
7.95. Panagene
7.96. Perkin Elmer
7.97. Personal Genome Diagnostics
7.98. Personalis
7.99. Precipio
7.100. Precision Medicine Group
7.101. PrecisionMed
7.102. Predicine
7.103. Promega
7.104. Qiagen
7.105. Rarecells SAS
7.106. RareCyte
7.107. Roche Molecular Diagnostics
7.108. Screencell
7.109. Sense Biodetection
7.110. Siemens Healthineers
7.111. simfo GmbH
7.112. Singlera Genomics Inc.
7.113. Singular Genomics
7.114. Singulomics
7.115. SkylineDx
7.116. Standard BioTools
7.117. Stilla Technologies
7.118. Sysmex Inostics
7.119. Tempus Labs, Inc.
7.120. Thermo Fisher Scientific Inc.
7.121. Todos Medical
7.122. Ultima Genomics
7.123. Veracyte
7.124. Volition
7.125. 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. Growth of Approved IVD Test Menu
12.2. Prevalence of Cancer Treatments
12.3. United States Medicare System: Clinical Laboratory Fees Schedule
12.4. The Most Used IVD Assays
12.5. The Highest Grossing Assays
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 Customers by Country
Table 26: 2022 Clinical Lab Fee Schedule
Table 27: The Most Common Assays
Table 28: Largest Revenue Assays
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: IVD Test Menu Growth 2011-2022
Figure 42: Prevalence of Cancer Treatments
Samples
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Companies Mentioned
- 10x Genomics, Inc.
- Abbott Laboratories
- AccuraGen Inc.
- Aethlon Medical
- Agilent/Dako
- Anchor Dx
- ANGLE plc
- AVIVA Systems Biology
- Baylor Miraca Genetics Laboratories
- Becton, Dickinson and Company
- Berkley Lights
- BGI Genomics Co. Ltd
- Bioarray Genetics
- Biocartis
- Biocept, Inc.
- Biodesix Inc.
- BioFluidica
- BioGenex
- BioIVT
- Biolidics Ltd
- bioMérieux Diagnostics
- Bioneer Corporation
- Bio-Rad Laboratories, Inc.
- Bio-Reference Laboratories
- Bio-Techne
- Bioview
- Bolidics
- Boreal Genomics
- Bristol-Myers Squibb
- Burning Rock
- Cardiff Oncology
- Caris Molecular Diagnostics
- Castle Biosciences, Inc.
- CellCarta
- CellMax Life
- Cepheid (Danaher)
- Charles River Laboratories
- Circulogene
- Cizzle Biotech
- Clinical Genomics
- Cytolumina Technologies Corp.
- Datar Cancer Genetics Limited
- Diagnologix LLC
- Diasorin S.p.A.
- Dxcover
- Element Biosciences
- Enzo Biochem
- Epic Sciences
- Epigenomics AG
- Eurofins Scientific
- Fabric Genomics
- Fluxion Biosciences
- Freenome
- FUJIFILM Wako Diagnostics
- Fyr Diagnostics
- GeneFirst Ltd.
- Genetron Holdings
- GenomOncology
- GILUPI Nanomedizin
- Guardant Health
- HansaBiomed
- HeiScreen
- Helomics
- HTG Molecular Diagnostics
- iCellate
- ICON PLC
- Illumina
- Incell Dx
- Inivata
- INOVIQ
- Integrated Diagnostics
- Invitae Corporation
- Invivogen
- Invivoscribe
- Janssen Diagnostics
- Lunglife AI Inc
- MDNA Life SCIENCES, Inc.
- MDx Health
- Menarini Silicon Biosystems
- Mesa Laboratories, Inc.
- Millipore Sigma
- Miltenyi Biotec
- miR Scientific
- Myriad Genetics/Myriad RBM
- NantHealth, Inc.
- Natera
- NeoGenomics
- NGeneBio
- Novogene Bioinformatics Technology Co., Ltd.
- Oncocyte
- OncoDNA
- Ortho Clinical Diagnostics
- Oxford Nanopore Technologies
- PamGene
- Panagene
- Perkin Elmer
- Personal Genome Diagnostics
- Personalis
- Precipio
- Precision Medicine Group
- PrecisionMed
- Predicine
- Promega
- Qiagen
- Rarecells SAS
- RareCyte
- Roche Molecular Diagnostics
- Screencell
- Sense Biodetection
- Siemens Healthineers
- simfo GmbH
- Singlera Genomics Inc.
- Singular Genomics
- Singulomics
- SkylineDx
- Standard BioTools
- Stilla Technologies
- Sysmex Inostics
- Tempus Labs, Inc.
- Thermo Fisher Scientific Inc.
- Todos Medical
- Ultima Genomics
- Veracyte
- Volition
- Vortex Biosciences
