Table of Content

Table of Contents
i. Liquid Biopsy Market - Strategic Situation Analysis & Impact of COVID-19.......21
i. Guide for Executives, Marketing, Sales and Busines Development Staf .......23
i. Guide for Management Consultants and Investment Advisors .............25
1. Introduction and Market Definiton.............................26
1.1 What is Liquid Biopsy? ..................................... 27
1.2 The Sequencing Revolution.................................. 28
1.3 Market Definiton ........................................ 30
1.3.1 Revenue Market Size.................................... 30
1.4 Methodology .......................................... 31
1.4.1 Authors ........................................... 31
1.4.2 Sources........................................... 32
1.5 A Spending Perspective on Liquid Biopsy .......................... 3
1.5.1 An Historical Look at Clinical Testing........................... 34
2. Market Overview .......................................36
2.1 Players in a Dynamic Market.................................. 37
2.1.1 Academic Research Lab ................................. 38
2.1.2 Diagnostic Test Developer................................. 38
2.1.3 Genomic Instrumentation Supplier ............................ 38
2.1.3.1 Cel Separation and Viewing Instrumentation Supplier .............. 3
2.1.4 Pharmaceutical/Reagent Supplier............................ 39
2.1.5 Independent Testing Lab.................................. 39
2.1.6 Public National/regional ab ............................... 40
2.1.7 Hospital ab ......................................... 40
2.1.8 Physician Lab........................................ 40
2.1.9 Audit Body ......................................... 41
2.1.10 Certifcation Body..................................... 41
2.2 Using Biopsies .......................................... 43
2.2.1 Cancer ........................................... 43
2.2.2 Precancerous conditons.................................. 4
2.2.3 Inflammatory conditons.................................. 4
2.3 Biopsy Sites ........................................... 45
2.4 The Situation Today – Biopsy Analysis............................. 47
2.5 Evidence of Cancer - Liquid Biopsy Technology ....................... 48
2.5.1 The Big Picture on Liquid Biopsy Technology ....................... 48
2.5.2 The Role of CTCs...................................... 50
2.5.2.1 Types of CTCs..................................... 51
2.5.2.2 CelSearch Detection- Ultimate Sensitvity ..................... 52
2.5.2.3 Epic Sciences Detection- Imaging Takes the Lead................ 53
2.5.2.4 Maintrac Detection – The Microscope....................... 53
2.5.2.5 Other Methods .................................... 5
2.5.3 ctDNA – Going Mainstream? ............................... 56
2.5.4 Exosomes and Micro Vesicles – New Kid on the Block................. 57
2.5.5 The Multiple Play...................................... 60
2.6 Cancer Treatment Protocol Under Siege ........................... 62
2.6.1 Isues to Liquid Biopsy Adoption – Double Diagnostics................. 62
2.6.2 The Cancer Screening Market Opportunity....................... 63
2.6.2.1 GRAIL – What Is It?................................... 64
2.6.3 Cancer Management vs. Diagnosis........................... 65
2.6.3.1 The Role of Risk Asesment ............................. 65
2.6.3.2 Managing Therapy.................................. 6
2.6.3.3 Monitoring Disease – What Is It?........................... 6
2.6.4 Phases of Adoption – Looking into The Future ...................... 67
2.6.5 The Promise of Liquid Biopsy ................................ 68
2.7 Structure of Industry Plays a Part ............................... 70
2.7.1 Hospital Testing Share ................................... 70
2.7.2 Economies of Scale..................................... 70
2.7.2.1 Hospital vs. Central Lab ............................... 71
2.7.3 Physician Ofice Lab’s................................... 72
2.7.4 Physician’s and POCT ................................... 72
3. Market Trends.........................................74
3.1 Factors Driving Growth..................................... 75
3.1.1 Non Invasive Game Changer ............................... 75
3.1.2 Lower Cost ......................................... 76
3.1.3 Greater Accuracy..................................... 76
3.1.4 Wide Range of Potential Uses ............................... 76
3.1.5 Aging Population...................................... 76
3.2 Factors Limitng Growth..................................... 78
3.2.1 Lower prices......................................... 78
3.2.2 Lack of Standards...................................... 79
3.2.3 Protocol Resistance..................................... 79
3.2.4 Inital Adoption Cost.................................... 79
3.2.5 COVID-19 .......................................... 79
3.3 Instrumentation and Automation............................... 81
3.3.1 Instruments Key to Market Share............................. 81
3.3.2 Bioinformatics Plays a Role ................................ 81
3.4 Diagnostic Technology Development............................ 82
3.4.1 Next Generation Sequencing Fuels a Revolution.................... 83
3.4.2 Impact of NGS on pricing................................. 84
3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment.................. 84
3.4.4 CGES Testing, A Brave New World............................ 85
3.4.5 Biochips/Giant magneto resistance based asay.................... 85
4. Liquid Biopsy Recent Developments............................87
4.1 Recent Developments – Importance and How to Use This Section............ 8
4.1.1 Importance of These Developments........................... 8
4.1.2 How to Use This Section................................... 8
Agilent Enters Liquid Biopsy Market with Resolution Biosciences Acquisiton ......... 8
Bio-Techne to Acquire Asuragen for up to $320M ........................ 92
Personalis Broadens Liquid Biopsy Ofering ............................ 93
Exact Sciences to Ofer End-to-End Cancer Testing With Ashion Acquisiton ......... 96
Delfi Diagnostics Plans Multi-Cancer Screening Test....................... 99
Menarini's CelSearch Shows Potential to Predict Breast Cancer Prognosis, Treatment
Response.............................................. 10
Liquid Biopsy NGS Panels - Diverse Test Claims......................... 102
CMS Colon Cancer Screening Memo Bodes Wel for Asays................. 108
Natera Liquid Biopsy Test Coverage to Expand ........................ 10
Freenome Closes Financing to Support Early Cancer Detection Trial ............ 11
C$2.6M Liquid Biopsy Initative .................................. 12
NeoGenomics, Inivata Partner for Lung Cancer Liquid Biopsy ................ 14
Liquid Biopsy Shows Promise as Screen for Cancers ...................... 15
Inivata launches RaDaR™ for the detection of residual disease and recurence..... 15
Liquid Biopsy Asay Detects 50+ Types of Cancer....................... 16
Liquid Biopsy Study Confirms Concordance with Tisue Biopsy................ 19
Guardant Health Liquid Biopsy Expands Medicare Coverage ................ 121
Aethlon Medical Lands Grant for Exosome Isolation Device ................. 12
Biolidics to Develop Liquid Biopsy Breast Cancer Test..................... 123
Liquid Biopsy Equal to Tisue to Indicate Immunotherapy Response............. 123
Exact Sciences buys Genomic Health.............................. 125
Multi-Gene Liquid Biopsy Breast Cancer Panel......................... 127
Bio-Techne receives FDA breakthrough device for prostate cancer liquid biopsy..... 128
Thrive to Develop Earlier Detection of Multiple Cancer Types ................ 129
Guardant Health Liquid Biopsy Test to be Covered by EviCore................ 131
Liquid biopsy combines Ilumina’s ‘ultradeep’ sequencing with Grail’s machine learning. 132
Biocept Partnership Ofering for Liquid Biopsy Adds Several Key Services.......... 134
Natera Commercializes Tumor Whole Exome Sequencing from Plasma .......... 134
Sienna Buys Liquid Biopsy & Exosome Isolation Technology .................. 136
Inivata Completes £39.8M Series B Funding Round....................... 137
Bio-Rad Clinical ddPCR Test, Diagnostic System Get FDA Clearance............ 138
CelMax, Medigen Biotech Partner in Colorectal Cancer Clinical Trials ........... 139
5. Profiles of Key Players ....................................140
Abbot Diagnostics........................................ 141
AccuraGen Inc........................................... 143
Acuamark Diagnostics...................................... 14
Admera Health, LC........................................ 145
Agena Bioscience, Inc....................................... 147
Agilent ............................................... 149
Amoy Diagnostics Co., Ltd.................................... 151
Anchor Dx ............................................. 152
ANGLE plc............................................. 153
ApoCel, Inc............................................ 15
ArcherDx, Inc............................................ 156
Asuragen.............................................. 157
AVIVA Biosciences ........................................ 159
Baylor Miraca Genetics Laboratories .............................. 160
Beckman Coulter, Inc....................................... 161
Becton, Dickinson and Company................................ 163
BGI Genomics Co. Ltd ...................................... 165
Bioaray Genetics......................................... 167
Biocartis............................................... 168
Biocept, Inc............................................. 169
Biodesix Inc............................................. 170
BioFluidica............................................. 171
bioMérieux Diagnostics...................................... 172
Bioneer Corporation........................................ 174
Bio-Rad Laboratories, Inc..................................... 176
Bio-Techne ............................................. 178
Bioview ............................................... 180
Bolidics............................................... 182
Boreal Genomics......................................... 183
Caris Molecular Diagnostics ................................... 184
CelMax Life............................................. 185
Cepheid (now Danaher)..................................... 186
Chronix Biomedical ........................................ 18
Circulogene............................................ 189
Clinical Genomics......................................... 190
Cynvenio.............................................. 191
Cytolumina Technologies Corp................................. 192
CytoTrack.............................................. 193
Datar Cancer Genetics Limited................................. 194
Diagenode Diagnostics...................................... 195
Diagnologix LC.......................................... 196
Enzo Life Sciences, Inc....................................... 197
Epic Sciences........................................... 199
Epigenomics AG.......................................... 20
Eurofins Scientifc ......................................... 201
Exosome Diagnostics....................................... 204
Exosome Sciences......................................... 206
Fluidigm Corp ........................................... 207
Fluxion Biosciences........................................ 209
Foundation Medicine....................................... 210
Freenome.............................................. 21
GeneFirst Ltd............................................ 212
Genetron Health (Beijng) Co., Ltd................................ 213
Genomic Health.......................................... 214
GILUPI Nanomedizin........................................ 216
Grail, Inc............................................... 217
Guardant Health ......................................... 219
HansaBiomed ........................................... 20
HeiScreen.............................................. 21
Helomics.............................................. 23
Horizon Discovery ......................................... 25
iCelate............................................... 27
Ilumina ............................................... 28
Incel Dx............................................... 230
Inivata................................................ 231
Integrated Diagnostics...................................... 232
Jansen Diagnostics ........................................ 233
MDNA Life SCIENCES, Inc..................................... 234
MDx Health ............................................. 235
Menarini Silcon Biosystems.................................... 237
Milipore Sigma........................................... 238
Miltenyi Biotec........................................... 239
miR Scientifc............................................ 240
Molecular MD ........................................... 241
Myriad Genetics/Myriad RBM .................................. 242
NantHealth, Inc.......................................... 24
Natera ............................................... 246
NeoGenomics ........................................... 248
New Oncology .......................................... 250
Novogene Bioinformatics Technology Co., Ltd......................... 251
Oncocyte.............................................. 253
OncoDNA.............................................. 254
Oxford Nanopore Technologies................................. 25
Perkin Elmer............................................. 257
Personal Genome Diagnostics.................................. 259
PrecisionMed ........................................... 260
Promega .............................................. 261
Qiagen Gmbh ........................................... 263
Quidel................................................ 265
Rarecels SAS............................................ 267
RareCyte.............................................. 269
Resolution Biosciences, Inc.................................... 270
Roche Molecular Diagnostics .................................. 271
Screencel ............................................. 273
Siemens Healthineers ....................................... 274
simfo GmbH ............................................ 276
Singlera Genomics Inc....................................... 27
SRI nternational.......................................... 278
Sysmex Inostics........................................... 280
Tempus Labs, Inc.......................................... 281
Thermo Fisher Scientifc Inc.................................... 282
Thrive Earlier Detection ...................................... 284
Trovagene............................................. 285
Voliton............................................... 286
6. The Global Market for Liquid Biopsy Diagnostics ....................287
6.1 Global Market Overview by Country............................ 28
6.1.1 Table – Global Market by Country............................ 28
6.1.2 Chart - Global Market by Country............................ 289
6.2 Global Market by Cancer - Overview ............................ 290
6.2.1 Table – Global Market by Cancer ............................ 290
6.2.2 Chart – Global Market by Cancer – Base/Final Year Comparison .......... 291
6.2.3 Chart – Global Market by Cancer – Base Year .................... 292
6.2.4 Chart – Global Market by Cancer – End Year..................... 293
6.2.5 Chart – Global Market by Cancer – Share by Year .................. 294
6.2.6 Chart – Global Market by Cancer – Segments Growth................ 295
6.3 Global Market by Usage - Overview ............................ 296
6.3.1 Table – Global Market by Usage............................. 296
6.3.2 Chart – Global Market by Usage – Base/Final Year Comparison .......... 297
6.3.3 Chart – Global Market by Usage – Base Year..................... 298
6.3.4 Chart – Global Market by Usage – End Year ...................... 29
6.3.5 Chart – Global Market by Usage – Share by Year................... 30
6.3.6 Chart – Global Market by Usage – Segments Growth ................. 301
7. Global Liquid Biopsy Diagnostic Markets – By Cancer .................302
7.1 Breast.............................................. 303
7.1.1 Table Breast – by Country................................ 303
7.1.2 Table Breast – by Country, Price and Volume ..................... 304
7.1.3 Chart - Breast Growth ................................... 306
7.2 Colorectal ........................................... 307
7.2.1 Table Colorectal – by Country .............................. 307
7.2.2 Table Colorectal – by Country, Price and Volume................... 308
7.2.3 Chart - Colorectal Growth................................ 310
7.3 Cervical ............................................. 31
7.3.1 Table Cervical – by Country............................... 31
7.3.2 Table Cervical – by Country, Price and Volume .................... 312
7.3.3 Chart - Cervical Growth ................................. 314
7.4 Lung............................................... 315
7.4.1 Table Lung – by Country................................. 315
7.4.2 Table Lung – by Country, Price and Volume ...................... 316
7.4.3 Chart - Lung Growth ................................... 318
7.5 Prostate ............................................. 319
7.5.1 Table Prostate – by Country ............................... 319
7.5.2 Table Prostate – by Country, Price and Volume.................... 320
7.5.3 Chart – Prostate Growth ................................. 32
7.6 Other.............................................. 323
7.6.1 Table Other – by Country ................................ 323
7.1.2 Table Other – by Country, Price and Volume..................... 324
7.6.2 Chart - Other Growth................................... 325
8. Global Liquid Biopsy Diagnostic Markets – by Usage..................327
8.1 Screening ........................................... 327
8.1.1 Table Screening – by Country .............................. 327
8.1.2 Chart - Screening Growth................................ 328
8.2 Diagnostic ........................................... 30
8.2.1 Table Diagnostic – by Country .............................. 30
8.2.2 Chart - Diagnostic Growth................................ 31
8.3 Therapy............................................. 32
8.3.1 Table Therapy – by Country............................... 32
8.3.2 Chart - Therapy Growth.................................. 33
8.4 Monitor ............................................. 34
8.4.1 Table Monitor – by Country ............................... 34
8.4.2 Chart - Monitor Growth.................................. 35
Appendices ..........................................36
I. United States Medicare System: 2021 Clinical Laboratory Fees Schedule ......... 36

Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2024 ($Bilion) .... 35
Table 2 Market Players by Type ................................... 37
Table 3 Biopsy Sites.......................................... 45
Table 4 Advantages of Liquid Biopsy in Screening Market .................... 64
Table 5 Outlook - Phases of Liquid Biopsy Adoption by Year................... 67
Table 6 Five Factors Driving Growth................................. 75
Table 7 Factors Limitng Growth ................................... 78
Table 8 Key Diagnostic Laboratory Technology Trends ...................... 82
Table 9 Next Generation Sequencing Technologies – Speed and Cost ............. 83
Table 10 - Global Market by Region ................................ 28
Table 11 Global Market by Cancer ................................ 290
Table 12 Global Market by Usage................................. 296
Table 13 Breast by Country ..................................... 303
Table 14 Breast by Country Price and Volume .......................... 304
Table 15 Colorectal by Country .................................. 307
Table 16 Colorectal by Country Price and Volume........................ 308
Table 17 Cervical by Country .................................... 310
Table 18 Cervical by Country Price and Volume ......................... 312
Table 19 Lung by Country ...................................... 315
Table 20 Lung by Country Price and Volume ........................... 316
Table 21 Prostate by Country .................................... 319
Table 22 Prostate by Country Price and Volume......................... 320
Table 23 Other by Country..................................... 323
Table 24 Other by Country Price and Volume.......................... 324
Table 25 Screening by Country .................................. 328
Table 26 Diagnostic by Country .................................. 330
Table 27 Therapy by Country.................................... 332
Table 28 Monitor by Country .................................... 334
Table 29 2021 Clinical Lab Fee Schedule ............................. 336

Table of Figures
Figure 1 Medicare Clinical Lab Expenditures 2014 to 2024 ($Milion)............... 34
Figure 2 Comparison of Liquid Biopsy Clases........................... 49
Figure 3 Characteristics of Diferent Vesicle Types ......................... 60
Figure 4 Percentage of World Population Over 65......................... 77
Figure 5 Global Market Regional Share Chart .......................... 289
Figure 6 Global Market by Cancer - Base vs. Final ........................ 291
Figure 7 Global Market by Cancer Base Year .......................... 292
Figure 8 Global Market by Cancer End Year ........................... 293
Figure 9 Cancer Share by Year ................................... 294
Figure 10 Cancer Segments Growth................................ 295
Figure 1 Global Market by Usage - Base vs. Final........................ 297
Figure 12 Global Market by Usage Base Year........................... 298
Figure 13 Global Market by Usage End Year ........................... 299
Figure 14 Usage Share by Year................................... 300
Figure 15 Usage Segments Growth................................ 301
Figure 16 Breast Growth ....................................... 306
Figure 17 Colorectal Diagnostics Growth............................. 310
Figure 18 Cervical Growth ..................................... 314
Figure 19 Lung Growth ....................................... 318
Figure 20 Prostate Growth...................................... 322
Figure 21 Other Growth....................................... 326
Figure 2 Screening Growth .................................... 329
Figure 23 Diagnostic Growth .................................... 331
Figure 24 Therapy Growth...................................... 333
Figure 25 Monitor Growth...................................... 335