Table of Content


i. Market Guides...........................................................................................................16
i. Situation Analysis & Impact of COVID-19 Pandemic ..................................................17
ii. Guide for Executives and Marketing Staff...................................................................20
iii. Guide for Investment Analysts and Management Consultants ...............................21
1. Introduction and Market Definition .......................................................................22
1.1 What are Immuno-Oncology Diagnostics? ..............................................................23
1.2 Immuno-oncology – the looming cure .....................................................................25
1.2.1 Immuno-oncology Diagnostics Takes a Leading Role.......................................27
1.3 Market Definition .........................................................................................................28
1.3.1 Market Size .............................................................................................................28 1.3.2 Currency.................................................................................................................28
1.3.3 Years .......................................................................................................................28
1.4 Methodology ...............................................................................................................29
1.4.1 Authors....................................................................................................................29
1.4.2 Sources ...................................................................................................................29
1.5 U.S. Medical Market and laboratory Testing - Perspective .....................................30
1.5.1 U.S. Medicare Expenditures for Laboratory Testing............................................31
2. Immunotherapy – Guide to Immune Technologies.............................................33
2.0 The Immune System.....................................................................................................34
2.0.1 Innate immune system ..........................................................................................35
2.0.1.1 Surface barriers ..............................................................................................36
2.0.1.2 Inflammation ..................................................................................................37
2.0.1.3 Complement system .....................................................................................37
2.0.1.4 Cellular barriers...............................................................................................38
2.0.1.5 Natural killer cells............................................................................................39
2.0.2 Adaptive immune system .....................................................................................40
2.0.2.1 Lymphocytes ..................................................................................................40
2.0.2.2 Killer T cells ......................................................................................................41
2.0.2.3 Helper T cells...................................................................................................43
2.0.2.4 Gamma delta T cells .....................................................................................44
2.0.2.5 B lymphocytes and antibodies.....................................................................44
2.0.3 Tumor immunology – the immune surveillance system .....................................46
2.1 Immuno Oncology Diagnostics..................................................................................48
2.1.1 Checkpoint Assays ................................................................................................48
2.1.1.1 Outlook for Checkpoint Assays ....................................................................53
2.1.2 Cytokine Assays .....................................................................................................54
2.1.2.1 Outlook for Cytokine Assays .........................................................................54
2.1.3 Genomic Germline................................................................................................55
2.1.3.1 Outlook for Genomic Germline....................................................................56
2.1.4 Genomic Tumour ...................................................................................................56
2.1.4.1 Outlook for Genomic Tumour .......................................................................59
2.1.5 Tumor Microenviroment ........................................................................................60
2.1.5.1 Outlook for Tumor Micro Environment .........................................................61
2.1.6 Others......................................................................................................................61
2.1.6.1 Outlook for Other Diagnostics ......................................................................61
3. Industry Overview ....................................................................................................62
3.1 Players in a Dynamic Market......................................................................................63
3.1.1 Academic Research Lab......................................................................................63
3.1.2 Diagnostic Test Developer ....................................................................................64
3.1.3 Genomic Instrumentation Supplier ......................................................................64
3.1.3.1 Cell Separation and Viewing Instrumentation Supplier .............................65
3.1.4 Pharmaceutical/Reagent Supplier ......................................................................65
3.1.5 Independent Testing Lab......................................................................................65
3.1.6 Public National/regional lab ................................................................................66
3.1.7 Hospital lab.............................................................................................................66
3.1.8 Physician Lab .........................................................................................................66
3.1.9 Audit Body..............................................................................................................67
3.1.10 Certification Body...............................................................................................67
4. Market Trends...........................................................................................................69
4.1 Factors Driving Growth................................................................................................70
4.1.1 Outcome potential ...............................................................................................70
4.1.2 Companion Diagnostics .......................................................................................71
4.1.3 Funding ...................................................................................................................71
4.1.4 Technology Environment ......................................................................................71
4.1.5 Target Solutions ......................................................................................................72
4.2 Factors Limiting Growth ..............................................................................................73
4.2.1 Complex Role of Diagnostics ...............................................................................73
4.2.2 Clinical Trials Role...................................................................................................74
4.2.3 Protocols .................................................................................................................74
4.3 Diagnostic Technology Development ......................................................................76
4.3.1 Combinations - Issues and Complexity ...............................................................76
4.3.2 Shifting Role of Diagnostics...................................................................................78
4.3.3 Multiplexing and Foundation One.......................................................................79
4.3.4 The Disruption Dynamic ........................................................................................80
4.3.5 The Race for Biomarkers .......................................................................................80
4.3.6 The Next Five Years................................................................................................81
5. Cancer Immunotherapy Recent Developments .................................................82
5.1 Recent Developments – Importance and How to Use This Section.......................83
5.1.1 Importance of These Developments ...................................................................83
5.1.2 How to Use This Section.........................................................................................83
ArcherDx partners with AstraZeneca for Immuno-Oncology .......................................83
Germline Results Guides Precision Therapy ....................................................................84
Agilent PD-L1 Assay Gets FDA Approval .........................................................................88
Bayer, OrigiMed Form Companion Diagnostic Development Alliance ......................89
Bio-Me to Develop Microbiome Biomarker Test for Cancer Immunotherapy.............89
SkylineDx, BioInvent Collaborate to Characterize Predictive Immunological Signatures ...........................................................................................................................90
Biocare Medical Launches 7 Novel IVD Antibodies ......................................................91
Oncocyte to Acquire Insight Genetics for $12M............................................................93
Novigenix and BioLizard to develop NGS Based Diagnostic Algorithm ......................94
Biodesix and Immodulon Collaborate for Pancreatic Cancer Treatment ..................95
Generex to Merge with NuGenerex Immuno-Oncology ..............................................96
Cellgen Diagnostics and Genomic Testing Cooperative Partner to Develop Companion Diagnostics for Cancer Therapies..............................................................98
Hematogenix Launches FDA Approved Immuno-oncology Test for Triple-Negative Breast Cancer ....................................................................................................................99
Icon Acquires MolecularMD...........................................................................................100
Guardant Health to Develop Companion Diagnostic Tests for AstraZeneca ..........101
Tumor Mutational Burden as Predictor of Immunotherapy Success..........................103
6. Profiles of Key Immunotherapy Companies ......................................................107
10X Genomics..................................................................................................................108
Abbott Laboratories ........................................................................................................109 Abcam..............................................................................................................................111
Adaptive Biotechnologies..............................................................................................113
Aethlon Medical..............................................................................................................114
Agena Bioscience ...........................................................................................................115
Angle plc..........................................................................................................................117
Apocell .............................................................................................................................118
ARUP Laboratories ...........................................................................................................119
Beckman Coulter.............................................................................................................121
Becton Dickinson .............................................................................................................122
Bioarray Genetics ............................................................................................................124 BioCartis............................................................................................................................125
Biocept .............................................................................................................................126
Biodesix Inc.......................................................................................................................128
BioFluidica ........................................................................................................................129 BioGenex..........................................................................................................................131 bioMérieux........................................................................................................................133
Bio-Rad .............................................................................................................................134
Bio-Techne........................................................................................................................135
Bristol-Myers Squibb .........................................................................................................137
Cancer Genetics.............................................................................................................139
Caris Molecular Diagnostics ...........................................................................................141
CellMax Life......................................................................................................................143
Charles River Laboratories..............................................................................................144
Chronix Biomedical .........................................................................................................146
Circulogene .....................................................................................................................147
Clearbridge BioMedics ...................................................................................................148
Clinical Genomics ...........................................................................................................150
Cynvenio ..........................................................................................................................151
Cytolumina Technologies Corp. ....................................................................................152
CytoTrack .........................................................................................................................153
Dako (Agilent)..................................................................................................................154
Diagnologix LLC...............................................................................................................156
Epic Sciences ...................................................................................................................157
Exosome Diagnostics.......................................................................................................158
Fluidigm Corp...................................................................................................................160
Fluxion Biosciences ..........................................................................................................162
Foundation Medicine......................................................................................................163
Freenome .........................................................................................................................164
Genomic Health ..............................................................................................................165
GenomOncology ............................................................................................................167
GRAIL ................................................................................................................................168
Guardant Health .............................................................................................................170 HalioDx..............................................................................................................................171
Horizon Discovery ............................................................................................................172 HTG
Molecular Diagnostics.............................................................................................174
iCellate .............................................................................................................................176
Illumina..............................................................................................................................177
Incell Dx ............................................................................................................................179 Inivata...............................................................................................................................180
Integrated Diagnostics....................................................................................................181
Invivoscribe ......................................................................................................................182
Leica Biosystems ..............................................................................................................184 Luminex.............................................................................................................................185
MDx Health.......................................................................................................................187
Merck & Co., Inc..............................................................................................................189
MIODx ...............................................................................................................................190
Molecular MD ..................................................................................................................191
MRM Proteomics Inc........................................................................................................192
Myriad Genetics/Myriad RBM ........................................................................................193
Nanostring ........................................................................................................................195 Natera...............................................................................................................................197
Neogenomics ..................................................................................................................199
New Oncology ................................................................................................................201 Oncocyte.........................................................................................................................202
Ortho Clinical Diagnostics ..............................................................................................203
Perkin Elmer ......................................................................................................................204
Personal Genome Diagnostics.......................................................................................206
Pfizer ..................................................................................................................................207 Promega...........................................................................................................................208
Protagen Diagnostics......................................................................................................210 Qiagen..............................................................................................................................211
Quanterix..........................................................................................................................213
Rarecells SAS ....................................................................................................................214
Roche Diagnostics...........................................................................................................216 Siemens.............................................................................................................................218
Silicon Biosystems.............................................................................................................219 SkylineDx...........................................................................................................................220
SRI International ...............................................................................................................221
Sysmex ..............................................................................................................................223
Thermo Fisher....................................................................................................................224
Trovagene ........................................................................................................................226
Vortex Biosciences...........................................................................................................227
7. The Global Market for Immuno-Oncology Diagnostics....................................228
7.1 Global Market Overview by Country ......................................................................229
7.1.1 Table – Global Market by Country.....................................................................229
7.1.2 Chart - Global Market by Country.....................................................................230
7.2 Global Market by Assay Type - Overview...............................................................231
7.2.1 Table – Global Market by Assay Type ...............................................................231
7.2.2 Chart – Global Market by Assay Type – Base/Final Year Comparison...........232
7.2.3 Chart – Global Market by Assay Type – Base Year ..........................................233
7.2.4 Chart – Global Market by Assay Type – End Year............................................234
7.2.5 Chart – Global Market by Assay Type – Share by Year ...................................235
7.2.6 Chart – Global Market by Assay Type – Segments Growth.............................236
8. Global Immuno-Oncology Diagnostic Markets – By Assay Type......................237
8.1 Checkpoint ................................................................................................................238
8.1.1 Table Checkpoint – by Country .........................................................................238
8.1.2 Chart - Checkpoint Growth................................................................................239
8.2 Cytokine .....................................................................................................................240
8.2.1 Table Cytokine – by Country ..............................................................................240
8.2.2 Chart - Cytokine Growth.....................................................................................241
8.3 Germline Genetic......................................................................................................242
8.3.1 Table Germline Genetic – by Country...............................................................242
8.3.2 Chart - Germline Genetic Growth .....................................................................243
8.4 Genetic Tumor ...........................................................................................................244
8.4.1 Table Genetic Tumor – by Country....................................................................244
8.4.2 Chart - Genetic Tumor Growth ..........................................................................245
8.5 Tumor Microenvironment..........................................................................................246
8.5.1 Table Tumor Microenvironment – by Country ..................................................246
8.5.2 Chart – Tumor Microenvironment Growth ........................................................247
8.6 Other...........................................................................................................................248
8.6.1 Table Other – by Country....................................................................................248
8.6.2 Chart - Other Growth ..........................................................................................249
9. Appendices............................................................................................................250
9.1 FDA Cancer Drug Approvals by Year......................................................................251
9.2 Clinical Trials Started 2010 to 2016 ...........................................................................252
9.3 Prevalence of Cancer Treatments ..........................................................................253

?Table of Tables
Table 1 List of Cancers by Mortality....................................................................................26 Table 2 Lab Spending 2014 to 2024....................................................................................32 Table 3 Overview of Innate and Adaptive Immunity ......................................................35 Table 4 FDA Approved Monoclonal Antibodies in Cancer treatment ...........................50 Table 5 FDA Approved Companion diagnostics in Cancer treatment..........................57 Table 6 Market Players by Type..........................................................................................63 Table 7 Five Factors Driving Growth ...................................................................................70 Table 8 Three Factors Limiting Growth................................................................................73 Table 9 - Global Market by Region...................................................................................229 Table 10 Global Market by Assay Type ............................................................................231 Table 11 Checkpoint by Country......................................................................................238 Table 12 Cytokine by Country..........................................................................................240 Table 13 Germline Genetic by Country ...........................................................................242 Table 14 Genetic Tumor by Country.................................................................................244 Table 15 Tumor Microenvironment by Country ...............................................................246 Table 16 Other by Country ................................................................................................248

Immuno-Oncology Diagnostics 2020 to 2024 Page | 14
Table of Figures
Figure 1 Cancer Death Rates – USA, CDC.........................................................................25 Figure 2 Clinical Lab Spending 2014 to 2024 .....................................................................31 Figure 3 Helper T Cell Roles..................................................................................................43 Figure 4 Antibody Diagram .................................................................................................45 Figure 5 Macrophages attack a Cancer Cell ...................................................................46 Figure 6 The Tumour Micro Environment.............................................................................60 Figure 7 Comparing IO Diagnostic and Traditional Testing..............................................78 Figure 8 Growth rates of IO DiagnosticTechnologies........................................................81 Figure 9 Global Market Density Chart .............................................................................230 Figure 10 Global Market by Assay Type - Base vs. Final..................................................232 Figure 11 Global Market by Assay Type Base Year .........................................................233 Figure 12 Global Market by Assay Type End Year...........................................................234 Figure 13 Assay Type Share by Year .................................................................................235 Figure 14 Assay Type Segments Growth...........................................................................236 Figure 15 Checkpoint Growth ...........................................................................................239 Figure 16 Cytokine Growth ................................................................................................241 Figure 17 Germline Genetic Growth ................................................................................243 Figure 18 Genetic Tumor Growth......................................................................................245 Figure 19 Tumor Microenvironment Growth ....................................................................247 Figure 20 Other Growth......................................................................................................249 Figure 21 FDA Cancer Drug Approvals by Year ..............................................................251 Figure 22 Clinical Trials for Immunotherapy by Year .......................................................252

Immuno-Oncology Diagnostics 2020 to 2024 Page | 15
Figure 23 Pie Chart of Prevalence of Cancer Treatments .............................................253