Table of Content

Table of Contents
1 Market Guides.......................................20
1.1 Companion Diagnostic Market - Strategic Situation Analysis............... 21
1.2 Guide for Executives, Marketing, Sales and Busines Development Staf ........ 24
1.3 Guide for Management Consultants and Investment Advisors.............. 26
2 Introduction and Market Definiton ............................27
2.1 What are Companion Diagnostics?............................. 28
2.2 The Personalized Medicine Revolution........................... 31
2.3 Market Definiton....................................... 33
2.3.1 Revenue Market Size................................... 33
2.4 Methodology......................................... 34
2.4.1 Authors .......................................... 34
2.4.2 Sources.......................................... 35
2.5 A Spending Perspective on Clinical Laboratory Testing.................. 36
2.5.1 U.S. Medicare Expenditures for Laboratory Testing .................. 36
3 Market Overview......................................38
3.1 Players in a Dynamic Market................................. 39
3.1.1 Academic Research Lab ................................ 40
3.1.2 Diagnostic Test Developer............................... 40
3.1.3 Instrumentation Supplier ................................ 40
3.1.4 Distributor and Reagent Supplier ............................ 41
3.1.5 Independent Testing Lab................................ 41
3.1.6 Public National/regional ab .............................. 42
3.1.7 Hospital ab ........................................ 42
3.1.8 Physician Ofice Labs.................................. 43
3.1.9 Audit Body ........................................ 43
3.1.10 Certifcation Body.................................... 43
3.2 Personalized Medicine and Companion Diagnostics ................... 45
3.2.1 Basics........................................... 45
3.2.2 Method.......................................... 46
3.2.3 Disease risk asesment................................. 46
3.2.4 Applications....................................... 46
3.2.5 Diagnosis and intervention ............................... 47
3.2.5.1 Companion Diagnostics .............................. 48
3.2.6 Drug development and usage ............................. 48
3.2.7 Respiratory proteomics................................. 49
3.2.8 Cancer genomics .................................... 50
3.2.9 Population screening.................................. 51
3.2.10 Chalenges........................................ 51
3.2.1 Regulatory oversight ................................... 51
3.2.12 Intelectual property rights............................... 52
3.2.13 Reimbursement policies................................. 52
3.2.14 Patient privacy and confidentiality .......................... 52
3.3 Chromosomes, Genes and Epigenetics .......................... 54
3.3.1 Chromosomes ...................................... 54
3.3.2 Genes........................................... 56
3.3.3 Epigenetics ........................................ 59
3.4 Cancer Genes......................................... 60
3.4.1 Germline vs Somatic ................................... 62
3.4.2 Changing Clinical Role................................. 64
3.5 Structure of Industry Plays a Part............................... 65
3.5.1 New Pharmaceutical Funding Market ......................... 65
3.5.2 Economies of Scale................................... 65
3.5.2.1 Hospital vs. Central Lab.............................. 66
3.5.3 Physician Ofice Labs.................................. 67
3.5.4 Physicians and POCT................................... 67
4 Market Trends ........................................69
4.1 Factors Driving Growth .................................... 70
4.1.1 Level of Care....................................... 70
4.1.2 Immuno-oncology.................................... 71
4.1.3 Liabilty........................................... 71
4.1.4 Aging Population..................................... 71
4.2 Factors Limitng Growth .................................... 73
4.2.1 State of knowledge.................................... 73
4.2.2 Genetic Blizard...................................... 74
4.2.3 Protocol Resistance.................................... 74
4.2.4 Regulation and coverage................................ 74
4.3 Instrumentation and Automation .............................. 75
4.3.1 Instruments Key to Market Share............................ 75
4.3.2 Bioinformatics Plays a Role ............................... 75
4.4 Diagnostic Technology Development ........................... 76
4.4.1 Next Generation Sequencing Fuels a Revolution................... 77
4.4.2 Single Cel Genomics Changes the Picture. ..................... 78
4.4.3 Pharmacogenomics Blurs Diagnosis and Treatment.................. 79
4.4.4 CGES Testing, A Brave New World. ........................... 79
4.4.5 Biochips/Giant magneto resistance based asay................... 80
5 Companion Diagnostics Recent Developments....................81
5.1 Recent Developments – Importance and How to Use This Section ........... 82
5.1.1 Importance of These Developments.......................... 82
5.1.2 How to Use This Section................................. 82
5.2 HTG Molecular Diagnostics 2020 Revenues Fal 56 Percent ................ 82
5.3 Oncocyte Details Expansions Plans............................. 83
5.4 Agilent Acquires Resolution Biosciences.......................... 87
5.5 Qiagen, Inovio Expand CDx Partnership.......................... 89
5.6 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Aliance ............... 90
5.7 NeoGenomics to Grow Through CDx Agreements, Acquisitons............. 91
5.8 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction ..... 96
5.9 Biocartis Colaborating with Endpoint Health on CDx Tests for Idyla Platform ..... 100
5.10 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies .. 101
5.1 Promega to Develop MSI Asay as CDx......................... 107
5.12 HTG Molecular Q2 Revenues Drop 6 Percent..................... 107
5.13 Guardant Health to Develop CDx for Jansen..................... 109
5.14 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx ........... 110
5.15 FDA Approval for FoundationOne®CDx ........................ 110
5.16 FDA finalizes CDx Guidance............................... 111
5.17 QIAGEN Launches CDx Therascreen BRAF Test.................... 133
5.18 Myriad Genetics Seeks Approval for Companion Diagnostic............. 114
5.19 ARUP Labs Seek PMA for Hemophila Gene Therapy CDx............... 115
5.20 QIAGEN Builds on Global Colaboration with Amgen ................. 115
5.21 Foundation Medicine nabs 19th companion Dx.................... 116
5.2 Maze Therapeutics Uses CRISPR for Precision Medicine Companion Diagnostics . 117
5.23 Myriad Wins Japanese Approval for BRACAnalysis.................. 119
5.24 Fujitsu Improves Eficiency in Cancer Genomic Medicine .............. 121
5.25 Thermo Fisher's automated sequencer to ofer same-day, pan-cancer test results 123
5.26 Takeda, Prometheus Enter IBD Drug-Companion Diagnostic Partnership ...... 124
5.27 Thermo Fisher, Eli Lily Ink CDx Colaboration in NSCLC, Thyroid Cancer ....... 125
5.28 Roche VENTANA PD-L1 (SP142) Asay approved as companion diagnostic .... 127
5.29 Universal Genetic Testing for Al Breast Cancer Patients ............... 128
5.30 Exact Sciences buys Genomic Health ......................... 128
5.31 Biodesix Highlights Pipeline and Companion Diagnostic Development....... 131
6 Profiles of Key Players...................................133
6.1 10x Genomics, Inc...................................... 134
6.2 Abbot Diagnostics ..................................... 135
6.3 AccuraGen Inc........................................ 137
6.4 Adaptive Biotechnologies.................................. 138
6.5 Aethlon Medical ....................................... 139
6.6 Agena Bioscience, Inc.................................... 140
6.7 Agilent............................................. 142
6.8 Anchor Dx .......................................... 144
6.9 ANGLE plc.......................................... 145
6.10 ApoCel, Inc........................................ 146
6.11 ArcherDx, Inc........................................ 147
6.12 ARUP Laboratories..................................... 148
6.13 Asuragen.......................................... 150
6.14 AVIVA Biosciences .................................... 152
6.15 Baylor Miraca Genetics Laboratories.......................... 153
6.16 Beckman Coulter Diagnostics.............................. 154
6.17 Becton, Dickinson and Company ............................ 155
6.18 BGI Genomics Co. Ltd .................................. 157
6.19 Bioaray Genetics..................................... 158
6.20 Biocartis.......................................... 159
6.21 Biocept, Inc......................................... 160
6.22 Biodesix Inc......................................... 161
6.23 BioFluidica......................................... 162
6.24 BioGenex ......................................... 163
6.25 BioIVT ............................................ 165
6.26 Biolidics Ltd......................................... 166
6.27 bioMérieux Diagnostics.................................. 167
6.28 Bioneer Corporation ................................... 170
6.29 Bio-Rad Laboratories, Inc................................ 172
6.30 Bio-Reference Laboratories............................... 174
6.31 Bio-Techne......................................... 175
6.32 Bioview ........................................... 17
6.3 Bolidics ........................................... 178
6.34 Boreal Genomics..................................... 179
6.35 Bristol-Myers Squibb.................................... 180
6.36 Cancer Genetics..................................... 182
6.37 Caris Molecular Diagnostics............................... 184
6.38 Castle Biosciences, Inc.................................. 185
6.39 CelMax Life ........................................ 186
6.40 Cepheid (now Danaher)................................. 187
6.41 Charles River Laboratories................................ 188
6.42 Chronix Biomedical.................................... 189
6.43 Circulogene........................................ 190
6.4 Clinical Genomics..................................... 191
6.45 Cynvenio.......................................... 192
6.46 Cytolumina Technologies Corp............................. 193
6.47 CytoTrack......................................... 194
6.48 Datar Cancer Genetics Limited............................. 195
6.49 Diagnologix LC...................................... 196
6.50 Diasorin S.p.A........................................ 197
6.51 Enzo Life Sciences, Inc................................... 198
6.52 Epic Sciences....................................... 200
6.53 Epigenomics AG...................................... 201
6.54 Eurofins Scientifc ..................................... 202
6.55 Exosome Diagnostics ................................... 204
6.56 Exosome Sciences..................................... 205
6.57 Fabric Genomics..................................... 206
6.58 Fluidigm Corp ....................................... 207
6.59 Fluxion Biosciences.................................... 208
6.60 Foundation Medicine ................................... 209
6.61 Freenome......................................... 210
6.62 GeneFirst Ltd........................................ 212
6.63 Genetron Health (Beijng) Co., Ltd............................ 213
6.64 Genomic Health...................................... 214
6.65 GenomOncology..................................... 215
6.66 GILUPI Nanomedizin.................................... 216
6.67 Grail, Inc.......................................... 217
6.68 Guardant Health..................................... 218
6.69 HalioDx ........................................... 219
6.70 HansaBiomed ....................................... 220
6.71 HeiScreen......................................... 221
6.72 Helomics.......................................... 222
6.73 Horizon Discovery ..................................... 223
6.74 HTG Molecular Diagnostics ............................... 225
6.75 iCelate........................................... 226
6.76 Ilumina........................................... 227
6.77 Incel Dx.......................................... 228
6.78 Inivata ........................................... 229
6.79 Integrated Diagnostics .................................. 230
6.80 Invivogen ......................................... 233
6.81 Invivoscribe........................................ 234
6.82 Jansen Diagnostics.................................... 235
6.83 MDNA Life SCIENCES, Inc................................. 236
6.84 MDx Health ........................................ 237
6.85 Menarini Silcon Biosystems................................ 238
6.86 Milipore Sigma ...................................... 239
6.87 Miltenyi Biotec ....................................... 240
6.8 MIODx........................................... 241
6.89 miR Scientifc........................................ 242
6.90 Molecular MD....................................... 243
6.91 MyCartis .......................................... 244
6.92 Myriad Genetics/Myriad RBM .............................. 245
6.93 NantHealth, Inc...................................... 246
6.94 Natera........................................... 247
6.95 NeoGenomics ....................................... 248
6.96 New Oncology ...................................... 249
6.97 Novogene Bioinformatics Technology Co., Ltd..................... 250
6.98 Oncocyte......................................... 252
6.99 OncoDNA ......................................... 253
6.10 Ortho Clinical Diagnostics ................................ 254
6.101 Oxford Nanopore Technologies ............................. 255
6.102 Panagene......................................... 256
6.103 Perkin Elmer........................................ 257
6.104 Personal Genome Diagnostics.............................. 259
6.105 Personalis.......................................... 260
6.106 Precipio .......................................... 261
6.107 PrecisionMed....................................... 262
6.108 Promega .......................................... 263
6.109 Qiagen Gmbh....................................... 265
6.10 Rarecels SAS........................................ 267
6.11 RareCyte.......................................... 268
6.12 Roche Molecular Diagnostics .............................. 269
6.13 Screencel ......................................... 271
6.14 Sense Biodetection.................................... 272
6.15 Serametrix ......................................... 273
6.16 Siemens Healthineers................................... 274
6.17 Silcon Biosystems..................................... 277
6.18 simfo GmbH........................................ 278
6.19 Singlera Genomics Inc................................... 279
6.120 Singulomics........................................ 280
6.121 SkylineDx .......................................... 282
6.12 Stratos Genomics ..................................... 283
6.123 Sysmex Inostics....................................... 284
6.124 Tempus Labs, Inc...................................... 285
6.125 Thermo Fisher Scientifc Inc................................ 286
6.126 Thrive Earlier Detection .................................. 288
6.127 Todos Medical ....................................... 289
6.128 Trovagene......................................... 290
6.129 Voliton ........................................... 291
6.130 Vortex Biosciences .................................... 292
7 The Global Market for Companion Diagnostics....................293
7.1 Global Market Overview by Country ........................... 294
7.1.1 Table – Global Market by Country.......................... 294
7.1.2 Chart - Global Market by Country.......................... 295
7.2 Global Market by Application - Overview......................... 296
7.2.1 Table – Global Market by Application ........................ 296
7.2.2 Chart – Global Market by Application – Base/Final Year Comparison ...... 297
7.2.3 Chart – Global Market by Application – Base Year ................. 298
7.2.4 Chart – Global Market by Application – Final Year................. 29
7.2.5 Chart – Global Market by Application – Share by Year............... 30
7.3 Global Market Funding Source - Overview ........................ 301
7.3.1 Table – Global Market by Funding Source...................... 301
7.3.2 Chart – Global Market Funding Source – Base/Final Year Comparison ...... 302
7.3.3 Chart – Global Market Funding Source – Base Year ................ 303
7.3.4 Chart – Global Market Funding Source – Final Year................. 304
7.3.5 Chart – Global Market Funding Source – Share by Year .............. 305
8 Global Companion Diagnostic Markets – By Application...............306
8.1 Oncology........................................... 307
8.1.1 Table Oncology – by Country ............................. 307
8.1.2 Chart - Oncology Growth............................... 308
8.2 Neurology .......................................... 309
8.2.1 Table Neurology – by Country............................. 309
8.2.2 Chart - Neurology Growth............................... 310
8.3 Cardiology.......................................... 311
8.3.1 Table Cardiology – by Country ............................ 311
8.3.2 Chart - Cardiology Growth.............................. 312
8.4 Other Application ...................................... 313
8.4.1 Table Other Application – by Country........................ 313
8.4.2 Chart - Other Application Growth.......................... 314
9 Global Companion Diagnostic Markets – Funding Source ..............315
9.1 Global Market Pharmaceutical.............................. 316
9.1.1 Table Pharmaceutical – by Country......................... 316
9.1.2 Chart - Pharmaceutical Growth ........................... 317
9.2 Global Market Venture................................... 318
9.2.1 Table Venture – by Country.............................. 318
9.2.2 Chart - Venture Growth................................ 319
9.3 Global Market Clinical.................................... 320
9.3.1 Table Clinical – by Country.............................. 320
9.3.2 Chart - Clinical Growth ................................ 321
9.4 Global Market Other Funding............................... 322
9.4.1 Table Other Funding – by Country.......................... 322
9.4.2 Chart - Other Funding Growth ............................ 323
10 Appendices......................................324
10.1 United States Medicare System: January 2021 Clinical Laboratory Fees Schedule . 325
8.2 Neurology .......................................... 309
8.2.1 Table Neurology – by Country............................. 309
8.2.2 Chart - Neurology Growth............................... 310
8.3 Cardiology.......................................... 31
8.3.1 Table Cardiology – by Country ............................ 31
8.3.2 Chart - Cardiology Growth.............................. 312
8.4 Other Application ...................................... 313
8.4.1 Table Other Application – by Country........................ 313
8.4.2 Chart - Other Application Growth.......................... 314
9 Global Companion Diagnostic Markets – Funding Source ..............315
9.1 Global Market Pharmaceutical.............................. 316
9.1.1 Table Pharmaceutical – by Country......................... 316
9.1.2 Chart - Pharmaceutical Growth ........................... 317
9.2 Global Market Venture................................... 318
9.2.1 Table Venture – by Country.............................. 318
9.2.2 Chart - Venture Growth................................ 319
9.3 Global Market Clinical.................................... 320
9.3.1 Table Clinical – by Country.............................. 320
9.3.2 Chart - Clinical Growth ................................ 321
9.4 Global Market Other Funding............................... 32
9.4.1 Table Other Funding – by Country.......................... 32
9.4.2 Chart - Other Funding Growth ............................ 323
10 Appendices......................................324
10.1 United States Medicare System: January 2021 Clinical Laboratory Fees Schedule . 325

 

Table of Tables
Table 1 Lab Spending 2014 to 2024 ................................. 37
Table 2 Market Players by Type ................................... 39
Table 3 The Base Pairs......................................... 57
Table 4 Five Factors Driving Growth................................. 70
Table 5 Four Factors Limitng Growth ................................ 73
Table 6 Key Diagnostic Laboratory Technology Trends ...................... 76
Table 7 Next Generation Sequencing Technologies – Speed and Cost ............. 77
Table 8 Global Companion Diagnostic Market by Region................... 294
Table 9 Global Market by Application .............................. 296
Table 10 Global Market by Funding Source............................ 301
Table 1 Oncology by Country ................................... 307
Table 12 Neurology by Country.................................. 309
Table 13 Cardiology by Country .................................. 311
Table 14 Other Application by Country.............................. 313
Table 15 Pharmaceutical by Country............................... 316
Table 16 Venture by Country.................................... 318
Table 17 Clinical by Country.................................... 320
Table 18 Other Funding by Country................................ 322
Table 19 2021 Clinical Laboratory Fee Schedule......................... 325
Table 20 Pharmacogenomic Biomarkers ............................. 428

Table of Figures
Figure 1 FDA Approved Companion Diagnostics......................... 30
Figure 2 Clinical Lab Spending 2014 to 2024............................ 37
Figure 3 DNA Strands and Chromosomes ............................. 54
Figure 4 Karyogram of Human Chromosomes........................... 55
Figure 5 Size of Various Genomes .................................. 58
Figure 6 Germline vs Somatic Mutations.............................. 62
Figure 7 Comparing Genomic Diagnostic and Traditonal Testing ................ 64
Figure 8 Percentage of World Population Over 65......................... 71
Figure 9 Base Year Country Market Share Chart ......................... 295
Figure 10 CDx Market by Application - Base vs. Final Year................... 297
Figure 1 CDx Market by Application Base Year ......................... 298
Figure 12 CDx Market by Application Final Year......................... 299
Figure 13 Application Type Share by Year............................. 300
Figure 14 Funding Source – Base vs. Final Year .......................... 302
Figure 15 Funding Source Market Base Year........................... 303
Figure 16 Funding Source Market Final Year ........................... 304
Figure 17 Funding Source Share by Year ............................. 305
Figure 18 Oncology Growth .................................... 308
Figure 19 Neurology Growth.................................... 310
Figure 20 Cardiology Growth .................................... 312
Figure 21 Other Application Growth................................ 314
Figure 2 Pharmaceutical Growth ................................. 317
Figure 23 Venture Growth...................................... 319
Figure 24 Clinical Growth...................................... 321
Figure 25 Other Funding Growth .................................. 323