Table of Content

Table of Contents
1 Molecular Dx Oncology Market - Strategic Situation Analysis with Impact of the COVID
Pandemic............................................19
2 Guide for Executives, Marketing, Sales and Busines Development Staf .......2
3 Guide for Management Consultants and Investment Advisors............23
4 Introduction and Market Definiton ............................24
4.1 What is Molecular Diagnostics................................ 25
4.2 The Diagnostics Revolution.................................. 25
4.3 Market Definiton....................................... 27
4.3.1 Revenue Market Size................................... 27
4.4 Methodology......................................... 28
4.4.1 Authors .......................................... 28
4.4.2 Sources.......................................... 28
4.5 U.S. Medical Market and laboratory Testing - Perspective................ 29
4.5.1 U.S. Medicare Expenditures for Laboratory Testing .................. 29
5 Market Overview......................................31
5.1 Market Participants...................................... 32
5.1.1 Academic Research Lab ................................ 3
5.1.2 Diagnostic Test Developer............................... 3
5.1.3 Genomic Instrumentation Supplier ........................... 3
5.1.4 Cel Separation and Viewing Instrumentation Supplier................ 34
5.1.5 Pharmaceutical/Reagent Supplier........................... 34
5.1.6 Independent Testing Lab................................ 34
5.1.7 Public National/regional ab .............................. 34
5.1.8 Hospital ab ........................................ 35
5.1.9 Physician Lab....................................... 35
5.1.10 Audit Bodies....................................... 35
5.1.1 Certifcation Body.................................... 36
5.2 Market Segments....................................... 37
5.2.1 Traditonal Market Segmentation............................ 37
5.2.2 Laboratory Focus and Segmentation......................... 38
5.3 Industry Structure....................................... 40
5.3.1 Hospital Testing Share .................................. 40
5.3.2 Economies of Scale................................... 40
5.3.3 Physician Ofice Lab’s.................................. 42
5.3.4 Physician’s and POCT .................................. 42
6 Market Trends ........................................43
6.1 Factors Driving Growth .................................... 4
6.1.1 New Diagnostics Create New Markets......................... 4
6.1.2 New Roles for Diagnostics................................ 45
6.1.3 Longevity and Outcomes................................ 45
6.1.4 Expanding the Pharmaceutical Toolbox........................ 46
6.1.5 Regulatory Retreat.................................... 46
6.2 Factors Limitng Growth .................................... 47
6.2.1 Faling Prices....................................... 47
6.2.2 Lower Costs........................................ 48
6.2.3 COVID Pandemic.................................... 48
6.2.4 Welnes has a Downside................................ 48
6.3 Instrumentation and Automation .............................. 49
6.3.1 Instruments Key to Market Share............................ 49
6.3.2 Bioinformatics Plays a Role ............................... 49
6.4 Diagnostic Technology Development ........................... 50
6.4.1 Next Generation Sequencing ............................. 51
6.4.2 Shifting Role of Diagnostics............................... 53
6.4.3 Multiplexing and Foundation One........................... 54
6.4.4 Pharmacogenomics Technology ........................... 54
6.4.5 Whole Genome Sequencing .............................. 5
6.4.6 Gene Editng and Gene Therapy............................ 5
7 Molecular Diagnostics Recent Developments .....................57
7.1 Recent Developments – Importance and How to Use This Section ........... 58
7.1.1 Importance of These Developments.......................... 58
7.1.2 How to Use This Section................................. 58
7.2 Nucleix to Invest in Early-Stage Lung Cancer Dx...................... 58
7.3 Invitae to Acquire Genosity for $20M........................... 60
7.4 Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test ......... 61
7.5 Agilent Technologies to Acquire Liquid Biopsy Firm Resolution Bioscience ....... 62
7.6 Natera Revenues Grow 35 Percent............................. 63
7.7 AnchorDx Closes $40M Financing Round .......................... 63
7.8 Exact Sciences Strategy for End-to-End Cancer Testing ................. 64
7.9 Genomics England: Whole Genome Sequencing for Cancer Patients to Launch ... 67
7.10 Singlera Genomics Closes $150M Funding for Cancer Screening ........... 70
7.1 Biocartis GeneproDx, Endpoint Health Colaborate on Tests for Idyla Platform ... 71
7.12 Wales to Routinely Screen Cancer Patients With Yourgene Elucigene Test ..... 72
7.13 Metastatic Cancer Markers Identifed in Clinical WGS Study.............. 72
7.14 Stich Bio Bets on CRISPR Tech .............................. 75
7.15 Bayer, LifeLabs Launch Free NTRK Genetic Testing Program .............. 79
7.16 Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Dx 79
7.17 Progres, Chalenges in Liquid Biopsy Reimbursement................. 80
7.18 Israeli Startup Curesponse Raises $6M.......................... 84
7.19 Coronavirus Pandemic Bites into European Cancer Research ............ 84
7.20 Veracyte's Prosigna IDs Patients Likely to Benefit from Aggresive Chemotherapy. 87
7.21 Combining CRISPR and Nanopore Sequencing .................... 88
7.2 Liquid Biopsy Detects Cancer Early via Cel Clusters.................. 90
7.23 Roche, Ilumina unveil 15-year cancer diagnostic tie-up................ 92
7.24 Saga, Servier Sign Liquid Biopsy Services Deal...................... 93
7.25 Home urine test could revolutionize diagnosis of prostate cancer .......... 94
7.26 Cancer Gene Tests Cost-Efective for Breast Cancer Patients............. 95
7.27 Personal Genome Diagnostics Gets CE Mark for Elio Tisue Asay........... 96
7.28 OncoCyte to Buy Cancer Testing Company Razor Genomics............. 97
7.29 Blood Test May Eliminate Need for Exploratory Surgery................. 98
7.30 NGS Cancer Panel Receives New York State Conditonal Approval ......... 9
7.31 Biocartis Inks Cancer CDx Deal With Bristol-Myers Squibb............... 10
8 Profiles of Key MDx Companies .............................102
8.1 10x Genomics, Inc...................................... 103
8.2 Abbot Diagnostics ..................................... 104
8.3 AccuraGen Inc........................................ 105
8.4 Adaptive Biotechnologies.................................. 106
8.5 Aethlon Medical ....................................... 107
8.6 Agena Bioscience, Inc.................................... 108
8.7 Agilent............................................. 10
8.8 Anchor Dx .......................................... 12
8.9 ANGLE plc.......................................... 13
8.10 ApoCel, Inc........................................ 14
8.1 ArcherDx, Inc........................................ 15
8.12 ARUP Laboratories..................................... 16
8.13 Asuragen.......................................... 18
8.14 AVIVA Biosciences .................................... 19
8.15 Baylor Miraca Genetics Laboratories.......................... 120
8.16 Beckman Coulter, Inc................................... 121
8.17 BGI Genomics Co. Ltd .................................. 123
8.18 Bioaray Genetics..................................... 125
8.19 Biocartis.......................................... 126
8.20 Biocept, Inc......................................... 127
8.21 Biodesix Inc......................................... 128
8.2 BioFluidica......................................... 129
8.23 BioGenex ......................................... 130
8.24 Biolidics Ltd......................................... 132
8.25 bioMérieux Diagnostics.................................. 13
8.26 Bioneer Corporation ................................... 134
8.27 Bio-Rad Laboratories, Inc................................ 136
8.28 Bio-Reference Laboratories............................... 138
8.29 Bio-Techne......................................... 139
8.30 Bioview ........................................... 140
8.31 Bolidics ........................................... 141
8.32 Boreal Genomics..................................... 142
8.3 Bristol-Myers Squibb.................................... 143
8.34 Cancer Genetics..................................... 14
8.35 Caris Molecular Diagnostics............................... 145
8.36 CelMax Life ........................................ 146
8.37 Cepheid (now Danaher)................................. 147
8.38 Charles River Laboratories................................ 148
8.39 Chronix Biomedical.................................... 149
8.40 Circulogene........................................ 150
8.41 Clinical Genomics..................................... 151
8.42 Cynvenio.......................................... 152
8.43 Cytolumina Technologies Corp............................. 153
8.4 CytoTrack......................................... 154
8.45 Datar Cancer Genetics Limited............................. 155
8.46 Diagnologix LC...................................... 156
8.47 Diasorin S.p.A........................................ 157
8.48 Enzo Life Sciences, Inc................................... 158
8.49 Epic Sciences....................................... 159
8.50 Epigenomics AG...................................... 160
8.51 Eurofins Scientifc ..................................... 161
8.52 Exosome Diagnostics ................................... 163
8.53 Exosome Sciences..................................... 164
8.54 Fabric Genomics..................................... 165
8.5 Fluidigm Corp ....................................... 166
8.56 Fluxion Biosciences.................................... 167
8.57 Foundation Medicine ................................... 168
8.58 Freenome......................................... 169
8.59 FUJIFILM Wako Diagnostics................................ 170
8.60 GeneFirst Ltd........................................ 171
8.61 Genetron Health (Beijng) Co., Ltd............................ 172
8.62 Genomic Health...................................... 173
8.63 GenomOncology..................................... 174
8.64 GILUPI Nanomedizin.................................... 175
8.65 Grail, Inc.......................................... 176
8.6 Guardant Health..................................... 17
8.67 HalioDx ........................................... 178
8.68 HansaBiomed ....................................... 179
8.69 HeiScreen......................................... 180
8.70 Helomics.......................................... 181
8.71 Horizon Discovery ..................................... 182
8.72 HTG Molecular Diagnostics ............................... 183
8.73 iCelate........................................... 184
8.74 Ilumina........................................... 185
8.75 Incel Dx.......................................... 186
8.76 Inivata ........................................... 187
8.7 Integrated Diagnostics .................................. 18
8.78 Invivogen ......................................... 189
8.79 Invivoscribe........................................ 190
8.80 Jansen Diagnostics.................................... 191
8.81 MDNA Life SCIENCES, Inc................................. 192
8.82 MDx Health ........................................ 193
8.83 Menarini Silcon Biosystems................................ 194
8.84 Milipore Sigma ...................................... 195
8.85 Miltenyi Biotec ....................................... 196
8.86 MIODx........................................... 197
8.87 miR Scientifc........................................ 198
8.8 Molecular MD....................................... 19
8.89 MyCartis .......................................... 200
8.90 Myriad Genetics/Myriad RBM .............................. 201
8.91 NantHealth, Inc...................................... 202
8.92 Natera........................................... 203
8.93 NeoGenomics ....................................... 204
8.94 New Oncology ...................................... 205
8.95 Novogene Bioinformatics Technology Co., Ltd..................... 206
8.96 Oncocyte......................................... 208
8.97 OncoDNA ......................................... 209
8.98 Ortho Clinical Diagnostics ................................ 210
8.9 Oxford Nanopore Technologies ............................. 211
8.10 Panagene......................................... 213
8.101 Perkin Elmer........................................ 214
8.102 Personal Genome Diagnostics.............................. 215
8.103 Personalis.......................................... 216
8.104 Precipio .......................................... 217
8.105 PrecisionMed....................................... 218
8.106 Promega .......................................... 219
8.107 Qiagen Gmbh....................................... 21
8.108 Rarecels SAS........................................ 23
8.109 RareCyte.......................................... 24
8.10 Roche Molecular Diagnostics .............................. 26
8.11 Screencel ......................................... 28
8.12 Sense Biodetection.................................... 29
8.13 Serametrix ......................................... 230
8.14 Siemens Healthineers................................... 231
8.15 Silcon Biosystems..................................... 23
8.16 simfo GmbH........................................ 234
8.17 Singlera Genomics Inc................................... 235
8.18 Singulomics........................................ 236
8.19 SkylineDx .......................................... 237
8.120 Stratos Genomics ..................................... 238
8.121 Sysmex Inostics....................................... 239
8.12 Tempus Labs, Inc...................................... 240
8.123 Thermo Fisher Scientifc Inc................................ 241
8.124 Thrive Earlier Detection .................................. 243
8.125 Todos Medical ....................................... 24
8.126 Trovagene......................................... 245
8.127 Voliton ........................................... 246
8.128 Vortex Biosciences .................................... 247
9 The Global Market for MDx Cancer ...........................248
9.1 MDx Cancer – Global Market Overview by Country................... 249
9.1.1 Table – Global Market by Country.......................... 249
9.1.2 Chart - Global Market by Country.......................... 250
9.2 Global Market by Cancer Type - Overview........................ 251
9.2.1 Table – Global Market by Cancer Type ....................... 251
9.2.2 Chart – Global Market by Cancer Type – Base/Final Comparison........ 252
9.2.3 Chart – Global Market by Cancer Type – Base Year ................ 253
9.2.4 Chart – Global Market by Cancer Type –Final Year................. 254
9.2.5 Chart – Global Market by Cancer Type – Share by Year .............. 25
9.2.6 Chart – Global Market by Cancer Type – Segment Growth............ 256
9.3 Global Market by Product Type - Overview ........................ 257
9.3.1 Table – Global Market by Product Type....................... 257
9.3.2 Chart – Global Market by Product Type – Base/Final Comparison ........ 258
9.3.3 Chart – Global Market by Product Type – Base Year................ 259
9.3.4 Chart – Global Market by Product Type –Final Year ................ 260
9.3.5 Chart – Global Market by Product Type – Share by Year.............. 261
9.3.6 Chart – Global Market by Product Type – Segment Growth............ 262
9.4 Global Market by Place - Overview............................ 263
9.4.1 Table – Global Market by Place............................ 263
9.4.2 Chart – Global Market by Place – Base/Final Comparison ............. 264
9.4.3 Chart – Global Market by Place – Base Year.................... 265
9.4.4 Chart – Global Market by Place –Final Year..................... 26
9.4.5 Chart – Global Market by Place – Share by Year.................. 267
9.4.6 Chart – Global Market by Place – Segment Growth ................ 268
10 Global Market by Cancer Type...........................269
10.1 MDx Breast Cancer .................................... 270
10.1.1 Table Breast Cancer Testing – by Country ...................... 270
10.1.2 Chart - Breast Cancer Testing Growth........................ 271
10.2 MDx Colorectal Cancer ................................. 272
10.2.1 Table Colorectal Cancer Testing – by Country................... 272
10.2.2 Chart - Colorectal Cancer Testing Growth..................... 273
10.3 MDx Cervical Cancer ................................... 274
10.3.1 Table Cervical Cancer Testing – by Country .................... 274
10.3.2 Chart - Cervical Cancer Testing Growth....................... 275
10.4 MDx Lung Cancer ..................................... 276
10.4.1 Table Lung Cancer Testing – by Country ....................... 276
10.4.2 Chart - Lung Cancer Testing Growth......................... 27
10.5 MDx Prostate........................................ 278
10.5.1 Table Prostate Testing – by Country.......................... 278
10.5.2 Chart - Prostate Testing Growth ............................ 279
10.6 MDx Melanoma Cancer................................. 280
10.6.1 Table Melanoma Cancer Testing – by Country................... 280
10.6.2 Chart - Melanoma Cancer Testing Growth ..................... 281
10.7 MDx Blood......................................... 282
10.7.1 Table Blood Testing – by Country........................... 282
10.7.2 Chart - Blood Testing Growth ............................. 283
10.8 MDx Companion Dx Development........................... 284
10.8.1 Table Companion Dx Development – by Country................. 284
10.8.2 Chart - Companion Dx Development Growth ................... 285
10.9 MDx Other Cancer.................................... 286
10.9.1 Table Other Cancer Testing – by Country...................... 286
10.9.2 Chart - Other Cancer Testing Growth ........................ 287
1 Global Market by Product Type ...........................28
1.1 MDx Instruments ...................................... 289
1.1.1 Table Instruments – by Country ............................ 289
1.1.2 Chart - Instruments Growth.............................. 290
1.2 MDx Reagents ....................................... 291
1.2.1 Table Reagents – by Country ............................. 291
1.2.2 Chart - Reagents Growth ............................... 292
1.3 MDx Software and Services............................... 293
1.3.1 Table Software and Services – by Country...................... 293
1.3.2 Chart - Software and Services Growth........................ 294
12 Global Market by Place ...............................295
12.1 MDx Clinical Laboratory ................................. 296
12.1.1 Table Clinical Laboratory – by Country ........................ 296
12.1.2 Chart - Clinical Laboratory Growth .......................... 297
12.2 MDx Pharmaceutical................................... 298
12.2.1 Table Pharmaceutical – by Country......................... 298
12.2.2 Chart - Pharmaceutical Growth ........................... 29
12.3 MDx Research ....................................... 29
12.3.1 Table Research – by Country ............................. 30
12.3.2 Chart - Research Growth............................... 301
13 Cancer Treatment and Trials.............................302
13.1 FDA Cancer Drug Approvals by Year.......................... 303
13.2 Clinical Trials Started 2010 to 2016 ............................ 304
13.3 Prevalence of Cancer Treatments – 2015........................ 305
14 Appendices......................................306
14.1 United States Medicare System: January 2021 Clinical Laboratory Fees Schedule. 306
14.2 FDA Approved Human Genetic Tests.......................... 367
14.3 FDA Approved Microbial Tests.............................. 371
14.4 FDA Approved Pharmacogenomics Tests....................... 380
 


Table of Tables
Table 1 Lab Spending 2014 to 2024 ................................. 30
Table 2 Market Players by Type................................... 32
Table 3 Clinical Laboratory Departments and Segments..................... 37
Table 4 Laboratory Management Focus – Diferent Approaches ................ 38
Table 5 Key Segmentation Variables Going Forward....................... 39
Table 6 Five Factors Driving Growth................................. 44
Table 7 Four Factors Limitng Growth ................................ 47
Table 8 Key Diagnostic Laboratory Technology Trends ...................... 50
Table 9 Next Generation Sequencing Technologies – Speed and Cost ............. 51
Table 10 - Global MDx Cancer Market by Region........................ 249
Table 1 Global Market by Cancer Type ............................. 251
Table 12 Global Market by Product Type............................. 257
Table 13 Global Market by Place.................................. 263
Table 14 MDx Breast Cancer by Country ............................. 270
Table 15 MDx Colorectal Cancer by Country........................... 272
Table 16 Cervical Cancer Testing by Country .......................... 274
Table 17 Lung Cancer Testing by Country ............................ 276
Table 18 Prostate Testing by Country............................... 278
Table 19 Melanoma Cancer Testing by Country ......................... 280
Table 20 MDx Blood by Country .................................. 282
Table 21 MDx Companion Dx Development by Country .................... 284
Table 2 MDx Other Cancer Testing by Country ......................... 286
Table 23 MDx Instruments by Country............................... 289
Table 24 MDx Reagents by Country................................ 291
Table 25 Software and Services by Country............................ 293
Table 26 MDx Clinical Laboratory by Country.......................... 296
Table 27 MDx Pharmaceutical by Country ............................ 298
Table 28 Research by Country ................................... 300
Table 29 2021 Clinical Lab Fee Schedule ............................. 306
Table of Figures
Figure 1 Clinical Lab Spending 2014 to 2024............................ 29
Figure 2 Growth in Aging Population ................................ 45
Figure 3 Death Rates from Cancer - USA.............................. 46
Figure 4 Comparing MDx Diagnostic and Traditonal Testing................... 53
Figure 5 Global Market Shares Base Year............................. 250
Figure 6 MDx Market by Cancer - Base vs. Final ......................... 252
Figure 7 Cancer Market Base Year ................................ 253
Figure 8 Cancer Market Final Year................................. 254
Figure 9 MDx Cancer Share by Year................................ 255
Figure 10 MDx Cancer Segment Growth Rates .......................... 256
Figure 1 MDx Market by Product - Base vs. Final......................... 258
Figure 12 Product Market Base Year................................ 259
Figure 13 Product Market Final Year ................................ 260
Figure 14 MDx Product Share by Year ............................... 261
Figure 15 MDx Product Segment Growth Rates.......................... 262
Figure 16 MDx Market by Place - Base vs. Final.......................... 264
Figure 17 Place Market Base Year................................. 265
Figure 18 Place Market Final Year ................................. 266
Figure 19 MDx Place Share by Year ................................ 267
Figure 20 MDx Place Segment Growth Rates ........................... 268
Figure 21 Breast Cancer Testing Growth.............................. 271
Figure 2 Colorectal Cancer Testing Growth........................... 273
Figure 23 Cervical Cancer Testing Growth............................ 275
Figure 24 Lung Cancer Testing Growth.............................. 277
Figure 25 Prostate Testing Growth ................................. 279
Figure 26 Melanoma Cancer Testing Growth ........................... 281
Figure 27 Blood Testing Growth ................................... 283
Figure 28 Companion Dx Development Growth ......................... 285
Figure 29 Other Cancer Testing Growth .............................. 287
Figure 30 Instruments Growth .................................... 290
Figure 31 Reagents Growth ..................................... 292
Figure 32 Software and Services Growth............................. 294
Figure 3 Clinical Laboratory Growth ............................... 297
Figure 34 Pharmaceutical Growth ................................. 299
Figure 35 Research Growth..................................... 301
Figure 36 FDA Cancer Drug Approvals by Year.......................... 303
Figure 37 Clinical Trials for Immunotherapy by Year ....................... 304
Figure 38 Pie Chart of Prevalence of Cancer Treatments .................... 305