Table of Content

Table of Contents
i. Molecular Dx Oncology Market - Strategic Situation Analysis with Impact of the COVID Pandemic................................................................................................................................16
ii. Guide for Executives, Marketing, Sales and Business Development Staff .....................19 iii. Guide for Management Consultants and Investment Advisors ....................................20 1. Introduction and Market Definition ...................................................................................21
1.1 What is Molecular Diagnostics............................................................................................... 22 1.2 The Diagnostics Revolution.................................................................................................. 22 1.3 Market Definition .................................................................................................................... 24
1.3.1 Revenue Market Size........................................................................................................ 24 1.4 Methodology .......................................................................................................................... 25 1.4.1 Authors .............................................................................................................................. 25 1.4.2 Sources.............................................................................................................................. 25 1.5 U.S. Medical Market and laboratory Testing - Perspective ................................................. 26 1.5.1 U.S. Medicare Expenditures for Laboratory Testing ....................................................... 26
2. Market Overview ................................................................................................................28
2.1 Market Participants ................................................................................................................ 29 2.1.1 Academic Research Lab ................................................................................................ 30 2.1.2 Diagnostic Test Developer............................................................................................... 30 2.1.3 Genomic Instrumentation Supplier ................................................................................. 30 2.1.4 Pharmaceutical/Reagent Supplier ................................................................................. 31 2.1.5 Independent Testing Lab................................................................................................. 31 2.1.6 Public National/regional lab ........................................................................................... 31 2.1.7 Hospital lab ....................................................................................................................... 32 2.1.8 Physician Lab .................................................................................................................... 32 2.1.9 Audit Body ........................................................................................................................ 32
2.1.10 Certification Body........................................................................................................... 33 2.2 Market Segments.................................................................................................................... 34 2.2.1 Traditional Market Segmentation.................................................................................... 34 2.2.2 Laboratory Focus and Segmentation............................................................................. 35 2.3 Industry Structure .................................................................................................................... 37 2.3.1 Hospital Testing Share ...................................................................................................... 37 2.3.2 Economies of Scale.......................................................................................................... 37 2.3.3 Physician Office Lab’s...................................................................................................... 39 2.3.4 Physician’s and POCT ...................................................................................................... 39
3. Market Trends......................................................................................................................40
3.1 Factors Driving Growth........................................................................................................... 41 3.1.1 New Diagnostics Create New Markets........................................................................... 41 3.1.2 New Roles for Diagnostics................................................................................................ 42 3.1.3 Longevity and Outcomes................................................................................................ 42 3.1.3 Expanding the Pharmaceutical Toolbox........................................................................ 43 3.1.4 Regulatory Retreat ........................................................................................................... 43 3.2 Factors Limiting Growth.......................................................................................................... 44 3.2.1 Falling Prices...................................................................................................................... 44 3.2.2 Lower Costs....................................................................................................................... 45 3.2.3 COVID Pandemic............................................................................................................. 45 3.2.4 Wellness has a Downside................................................................................................. 45 3.3 Instrumentation and Automation.......................................................................................... 46 3.3.1 Instruments Key to Market Share..................................................................................... 46 3.3.2 Bioinformatics Plays a Role .............................................................................................. 46 3.4 Diagnostic Technology Development.................................................................................. 47 3.4.1 Next Generation Sequencing ......................................................................................... 48 3.4.2 Shifting Role of Diagnostics.............................................................................................. 50 3.4.3 Multiplexing and Foundation One.................................................................................. 51

3.4.4 Pharmacogenomics Technology ................................................................................... 51 3.4.5 Whole Genome Sequencing .......................................................................................... 52 3.4.6 Gene Editing and Gene Therapy.................................................................................... 52
4. Molecular Diagnostics Recent Developments.................................................................54 Recent Developments – Importance and How to Use This Section......................................... 55 Importance of These Developments ....................................................................................... 55 How to Use This Section ............................................................................................................ 55 Biocartis Collaborating With GeneproDx, Endpoint Health on Tests for Idylla Platform ......... 55 Wales to Routinely Screen Cancer Patients With Yourgene Elucigene Test............................ 56 Metastatic Cancer Markers Identified in Clinical WGS Study................................................... 57 Stitch Bio Bets on CRISPR Tech..................................................................................................... 59 Bayer, LifeLabs Launch Free NTRK Genetic Testing Program.................................................... 63 Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Dx............ 64 Progress, Challenges in Liquid Biopsy Reimbursement.............................................................. 65 Israeli Startup Curesponse Raises $6M ........................................................................................ 68 Coronavirus Pandemic Bites into European Cancer Research................................................ 69 Veracyte's Prosigna IDs Patients Likely to Benefit from Aggressive Chemotherapy ............... 71 Combining CRISPR and Nanopore Sequencing ....................................................................... 72 Liquid Biopsy Detects Cancer Early via Cell Clusters................................................................. 74 Roche, Illumina unveil 15-year cancer diagnostic tie-up ......................................................... 77 Saga, Servier Sign Liquid Biopsy Services Deal........................................................................... 78 Home urine test could revolutionize diagnosis of prostate cancer.......................................... 78 Cancer Gene Tests Cost-Effective for Breast Cancer Patients................................................. 79 Personal Genome Diagnostics Gets CE Mark for Elio Tissue Assay........................................... 81 OncoCyte to Buy Cancer Testing Company Razor Genomics................................................ 81 Blood Test May Eliminate Need for Exploratory Surgery............................................................ 83 NGS Cancer Panel Receives New York State Conditional Approval ...................................... 84 Biocartis Inks Cancer CDx Deal With Bristol-Myers Squibb ........................................................ 84

5. Profiles of Key MDx Companies.........................................................................................86
10x Genomics, Inc........................................................................................................................ 87 Abbott Diagnostics....................................................................................................................... 88 AccuraGen Inc............................................................................................................................. 89 Adaptive Biotechnologies ........................................................................................................... 90 Aethlon Medical........................................................................................................................... 91 Agena Bioscience, Inc................................................................................................................. 92 Agilent ........................................................................................................................................... 94 Anchor Dx ..................................................................................................................................... 96 ANGLE plc ..................................................................................................................................... 97 ApoCell, Inc. ................................................................................................................................. 98 ArcherDx, Inc. ............................................................................................................................... 99 ARUP Laboratories...................................................................................................................... 100 Asuragen..................................................................................................................................... 102 AVIVA Biosciences ..................................................................................................................... 103 Baylor Miraca Genetics Laboratories ....................................................................................... 104 Beckman Coulter, Inc. ............................................................................................................... 105 BGI Genomics Co. Ltd ............................................................................................................... 107 Bioarray Genetics ....................................................................................................................... 109 Biocartis ....................................................................................................................................... 110 Biocept, Inc................................................................................................................................. 111 Biodesix Inc. ................................................................................................................................ 112 BioFluidica ................................................................................................................................... 113 BioGenex..................................................................................................................................... 114 Biolidics Ltd.................................................................................................................................. 116 bioMérieux Diagnostics.............................................................................................................. 117 Bioneer Corporation................................................................................................................... 118 Bio-Rad Laboratories, Inc........................................................................................................... 120

Bio-Reference Laboratories ....................................................................................................... 122 Bio-Techne .................................................................................................................................. 123 Bioview ........................................................................................................................................ 124 Bolidics......................................................................................................................................... 125 Boreal Genomics........................................................................................................................ 126 Bristol-Myers Squibb .................................................................................................................... 127 Cancer Genetics........................................................................................................................ 128 Caris Molecular Diagnostics ...................................................................................................... 129 CellMax Life................................................................................................................................. 130 Cepheid (now Danaher) ........................................................................................................... 131 Charles River Laboratories ......................................................................................................... 132 Chronix Biomedical .................................................................................................................... 133 Circulogene................................................................................................................................ 134 Clinical Genomics ...................................................................................................................... 135 Cynvenio..................................................................................................................................... 136 Cytolumina Technologies Corp. ............................................................................................... 137 CytoTrack.................................................................................................................................... 138 Datar Cancer Genetics Limited................................................................................................ 139 Diagnologix LLC.......................................................................................................................... 140 Diasorin S.p.A. ............................................................................................................................. 141 Enzo Life Sciences, Inc. .............................................................................................................. 142 Epic Sciences.............................................................................................................................. 143 Epigenomics AG......................................................................................................................... 144 Eurofins Scientific ........................................................................................................................ 145 Exosome Diagnostics.................................................................................................................. 147 Exosome Sciences...................................................................................................................... 148 Fabric Genomics ........................................................................................................................ 149 Fluidigm Corp ............................................................................................................................. 150

Fluxion Biosciences ..................................................................................................................... 151 Foundation Medicine................................................................................................................. 152 Freenome.................................................................................................................................... 153 FUJIFILM Wako Diagnostics ........................................................................................................ 154 GeneFirst Ltd. .............................................................................................................................. 155 Genetron Health (Beijing) Co., Ltd............................................................................................ 156 Genomic Health......................................................................................................................... 157 GenomOncology....................................................................................................................... 158 GILUPI Nanomedizin ................................................................................................................... 159 Grail, Inc. ..................................................................................................................................... 160 Guardant Health ........................................................................................................................ 161 HalioDx ........................................................................................................................................ 162 HansaBiomed ............................................................................................................................. 163 HeiScreen.................................................................................................................................... 164 Helomics...................................................................................................................................... 165 Horizon Discovery ....................................................................................................................... 166 HTG Molecular Diagnostics........................................................................................................ 167 iCellate ........................................................................................................................................ 168 Illumina ........................................................................................................................................ 169 Incell Dx....................................................................................................................................... 170 Inivata.......................................................................................................................................... 171 Integrated Diagnostics............................................................................................................... 172 Invivogen .................................................................................................................................... 173 Invivoscribe ................................................................................................................................. 174 Janssen Diagnostics ................................................................................................................... 175 MDNA Life SCIENCES, Inc........................................................................................................... 176 MDx Health ................................................................................................................................. 177 Menarini Silicon Biosystems ........................................................................................................ 178

Millipore Sigma............................................................................................................................ 179 Miltenyi Biotec............................................................................................................................. 180 MIODx.......................................................................................................................................... 181 miR Scientific............................................................................................................................... 182 Molecular MD ............................................................................................................................. 183 MyCartis ...................................................................................................................................... 184 Myriad Genetics/Myriad RBM ................................................................................................... 185 NantHealth, Inc. ......................................................................................................................... 186 Natera ......................................................................................................................................... 187 NeoGenomics ............................................................................................................................ 188 New Oncology ........................................................................................................................... 189 Novogene Bioinformatics Technology Co., Ltd. ...................................................................... 190 Oncocyte.................................................................................................................................... 192 OncoDNA.................................................................................................................................... 193 Ortho Clinical Diagnostics ......................................................................................................... 194 Oxford Nanopore Technologies................................................................................................ 195 Panagene ................................................................................................................................... 197 Perkin Elmer ................................................................................................................................. 198 Personal Genome Diagnostics.................................................................................................. 199 Personalis..................................................................................................................................... 200 Precipio ....................................................................................................................................... 201 PrecisionMed .............................................................................................................................. 202 Promega ..................................................................................................................................... 203 Qiagen Gmbh ............................................................................................................................ 205 Rarecells SAS............................................................................................................................... 207 RareCyte ..................................................................................................................................... 208 Roche Molecular Diagnostics ................................................................................................... 210 Screencell ................................................................................................................................... 212

Sense Biodetection. ................................................................................................................... 213 Serametrix ................................................................................................................................... 214 Siemens Healthineers ................................................................................................................. 215 Silicon Biosystems........................................................................................................................ 217 simfo GmbH ................................................................................................................................ 218 Singulomics ................................................................................................................................. 220 SkylineDx...................................................................................................................................... 221 Stratos Genomics ....................................................................................................................... 222 Sysmex Inostics............................................................................................................................ 223 Tempus Labs, Inc. ....................................................................................................................... 224 Thermo Fisher Scientific Inc. ....................................................................................................... 225 Thrive Earlier Detection .............................................................................................................. 227 Todos Medical ............................................................................................................................ 228 Trovagene................................................................................................................................... 229 Volition......................................................................................................................................... 230 Vortex Biosciences ..................................................................................................................... 231
6. The Global Market for MDx Cancer ...............................................................................232
6.1 MDx Cancer – Global Market Overview by Country ........................................................ 233 6.1.1 Table – Global Market by Country................................................................................ 233 6.1.2 Chart - Global Market by Country................................................................................ 234
7. Global MDx Cancer Markets – By Type of Cancer........................................................235
7.1 Global Market by Cancer Type - Overview ....................................................................... 236 7.1.1 Table – Global Market by Cancer Type ....................................................................... 236 7.1.2 Chart – Global Market by Cancer Type – Base/Final Comparison ............................ 237 7.1.3 Chart – Global Market by Cancer Type – Base Year .................................................. 238 7.1.4 Chart – Global Market by Cancer Type –Final Year.................................................... 239 7.1.5 Chart – Global Market by Cancer Type – Share by Year ........................................... 240 7.1.6 Chart – Global Market by Cancer Type – Segment Growth ...................................... 241
7.2 MDx Breast Cancer .............................................................................................................. 242 7.2.1 Table Breast Cancer Testing – by Country ................................................................... 242 7.2.2 Chart - Breast Cancer Testing Growth.......................................................................... 243
7.3 MDx Colorectal Cancer....................................................................................................... 244 7.3.1 Table Colorectal Cancer Testing – by Country............................................................ 244 7.3.2 Chart - Colorectal Cancer Testing Growth.................................................................. 245
7.4 MDx Cervical Cancer .......................................................................................................... 246 7.4.1 Table Cervical Cancer Testing – by Country ............................................................... 246 7.4.2 Chart - Cervical Cancer Testing Growth...................................................................... 247
7.5 MDx Lung Cancer ................................................................................................................ 248 7.5.1 Table Lung Cancer Testing – by Country ..................................................................... 248 7.5.2 Chart - Lung Cancer Testing Growth............................................................................ 249
7.6 MDx Prostate......................................................................................................................... 250 7.2.1 Table Prostate Testing – by Country.............................................................................. 250 7.6.2 Chart - Prostate Testing Growth .................................................................................... 251
7.7 MDx Melanoma Cancer ...................................................................................................... 252 7.7.1 Table Melanoma Cancer Testing – by Country........................................................... 252 7.7.2 Chart - Melanoma Cancer Testing Growth ................................................................. 253
7.8 MDx Blood ............................................................................................................................. 254 7.8.1 Table Blood Testing – by Country.................................................................................. 254 7.8.2 Chart - Blood Testing Growth ........................................................................................ 255
7.9 MDx Companion Dx Development .................................................................................... 256 7.9.1 Table Companion Dx Development – by Country...................................................... 256 7.9.2 Chart - Companion Dx Development Growth ............................................................ 257
7.10 MDx Other Cancer ............................................................................................................. 258 7.10.1 Table Other Cancer Testing – by Country.................................................................. 258 7.10.2 Chart - Other Cancer Testing Growth ........................................................................ 259
8. Cancer Treatment and Trials ..........................................................................................260 

8.1 FDA Cancer Drug Approvals by Year ................................................................................. 261 8.2 Clinical Trials Started 2010 to 2016....................................................................................... 262 8.3 Prevalence of Cancer Treatments – 2015 .......................................................................... 263
Appendices ..........................................................................................................................264
I. United States Medicare System: January 2020 Clinical Laboratory Fees Schedule .......... 264 II. FDA Approved Human Genetic Tests ................................................................................... 325 III. FDA Approved Microbial Tests .............................................................................................. 328 III. FDA Approved Pharmacogenomics Tests ........................................................................... 337

 

Table of Tables
Table 1 Lab Spending 2014 to 2024 ............................................................................................... 27 Table 2 Market Players by Type ...................................................................................................... 29 Table 3 Clinical Laboratory Departments and Segments ............................................................ 34 Table 4 Laboratory Management Focus – Different Approaches .............................................. 35 Table 5 Key Segmentation Variables Going Forward................................................................... 36 Table 6 Five Factors Driving Growth............................................................................................... 41 Table 7 Four Factors Limiting Growth ............................................................................................. 44 Table 8 Key Diagnostic Laboratory Technology Trends ............................................................... 47 Table 9 Next Generation Sequencing Technologies – Speed and Cost .................................... 48 Table 10 - Global MDx Cancer Market by Region...................................................................... 233 Table 11 Global Market by Cancer Type .................................................................................... 236 Table 12 MDx Breast Cancer by Country ................................................................................... 242 Table 13 MDx Colorectal Cancer by Country............................................................................. 244 Table 14 Cervical Cancer Testing by Country ............................................................................ 246 Table 15 Lung Cancer Testing by Country .................................................................................. 248 Table 16 Prostate Testing by Country........................................................................................... 250 Table 17 Melanoma Cancer Testing by Country ........................................................................ 252 Table 18 MDx Blood by Country ................................................................................................... 254 Table 19 MDx Companion Dx Development by Country .......................................................... 256 Table 20 MDx Other Cancer Testing by Country ........................................................................ 258 Table 21 2020 Clinical Lab Fee Schedule .................................................................................... 264
Table of Figures


Molecular Diagnostics for Cancer 2021 to 2025 Page | 15
Figure 1 Clinical Lab Spending 2014 to 2024................................................................................. 26 Figure 2 Growth in Aging Population ............................................................................................. 42 Figure 3 Death Rates from Cancer - USA....................................................................................... 43 Figure 4 Comparing MDx Diagnostic and Traditional Testing...................................................... 50 Figure 5 Global Market Shares Base Year.................................................................................... 234 Figure 6 MDx Market by Cancer - Base vs. Final ......................................................................... 237 Figure 7 Cancer Market Base Year .............................................................................................. 238 Figure 8 Cancer Market Final Year............................................................................................... 239 Figure 9 MDx Cancer Share by Year ............................................................................................ 240 Figure 10 MDx Cancer Segment Growth Rates .......................................................................... 241 Figure 11 Breast Cancer Testing Growth...................................................................................... 243 Figure 12 Colorectal Cancer Testing Growth.............................................................................. 245 Figure 13 Cervical Cancer Testing Growth.................................................................................. 247 Figure 14 Lung Cancer Testing Growth........................................................................................ 249 Figure 15 Prostate Testing Growth ................................................................................................ 251 Figure 16 Melanoma Cancer Testing Growth ............................................................................. 253 Figure 17 Blood Testing Growth .................................................................................................... 255 Figure 18 Companion Dx Development Growth ........................................................................ 257 Figure 19 Other Cancer Testing Growth ...................................................................................... 259 Figure 20 FDA Cancer Drug Approvals by Year.......................................................................... 261 Figure 21 Clinical Trials for Immunotherapy by Year ................................................................... 262 Figure 22 Pie Chart of Prevalence of Cancer Treatments ......................................................... 263