“Has Liquid Biopsy crossed the chasm ?”
“LIQUID BIOPSY MARKETS BY CANCER, USAGE, BIOMARKER, PLACE, & PRODUCT WITH PRICE AND VOLUME OUTLOOK. INCLUDING EXECUTIVE AND CONSULTANT GUIDES AND CUSTOMIZED FORECASTING AND ANALYSIS 2024-2028"
Howe Sound Research Published August 2024 – 585 pages
The Screening, Diagnostic, Therapy Selection, Minimal Residual Disease and Screening Market Potential are all explored in this report. We look at Price and Volume Outlooks by type of cancer. This report provides detailed analysis.
Circulating Tumor Cells? Cell Free DNA? Exosomes? Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size.
A revolution in cancer diagnostics is occurring using in vitro blood testing to identify cancer DNA. The technology has created the possibility of widespread cancer screening tests.
The technology is moving faster than the market. New technology that definitively identifies disease conditions from blood samples is poised to replace expensive invasive surgical biopsy procedures. What Growth Phase is the market in? The impact on the health care industry is enormous. The report forecasts the market size looking out 5 years. In addition, the report looks at potential market sizes by country, by cancer and by the four types of usage: screening, diagnosis, therapy selection and recurrence monitoring.
Use independent research that makes you the expert. Get our research team working for you by ordering this comprehensive report. Your credit card order sends the report to your inbox instantly. Check all your licensing options but don’t worry, your order is available as a credit if you wish to upgrade to more information.
The report includes detailed breakouts for 15 Countries and 4 Regions along with breakouts for Lung, Breast, Colorectal, Prostate, Cervical, and Other Cancers as well as breakouts by Screening/Early Detection, Diagnostic, Therapy Monitoring and Recurrence Monitoring.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
1 Market Guides …………………………………………………………………………………………………… 27
1.1 Liquid Biopsy Market – Strategic Situation Analysis ……………………………………………….. 28
1.2 Guide for Executives, Marketing, Sales, and Business Development Staff ……………… 30
1.3 Guide for Management Consultants and Investment Advisors …………………………….. 32
2 Introduction and Market Definition …………………………………………………………………….. 33
2.1 What is Liquid Biopsy? ………………………………………………………………………………………… 34
2.2 The Sequencing Revolution ………………………………………………………………………………… 35
2.3 Market Definition ……………………………………………………………………………………………….. 37
2.3.1 Revenue Market Size ………………………………………………………………………………………. 37
2.4 Methodology …………………………………………………………………………………………………….. 39
2.4.1 Methodology …………………………………………………………………………………………………. 39
2.4.2 Sources ………………………………………………………………………………………………………….. 39
2.4.3 Authors ………………………………………………………………………………………………………….. 39
2.5 Perspective: Healthcare and the IVD Industry …………………………………………………….. 41
2.5.1 Global Healthcare Spending ………………………………………………………………………….. 41
2.5.2 Spending on Diagnostics ………………………………………………………………………………… 43
2.5.3 Important Role of Insurance for Diagnostics …………………………………………………….. 44
3 Market Overview ……………………………………………………………………………………………….. 45
3.1 Players in a Dynamic Market ………………………………………………………………………………. 46
3.1.1 Academic Research Lab ……………………………………………………………………………….. 47
3.1.2 Diagnostic Test Developer ………………………………………………………………………………. 48
3.1.3 Instrumentation Supplier …………………………………………………………………………………. 48
3.1.4 Chemical/Reagent Supplier ……………………………………………………………………………. 48
3.1.5 Pathology Supplier …………………………………………………………………………………………. 49
3.1.6 Independent Clinical Laboratory ……………………………………………………………………. 49
3.1.7 Public National/regional Laboratory ……………………………………………………………….. 49
3.1.8 Hospital Laboratory ………………………………………………………………………………………… 50
3.1.9 Physicians Office Lab (POLS) …………………………………………………………………………… 50
3.1.10 Audit Body ………………………………………………………………………………………………….. 51
3.1.11 Certification Body ……………………………………………………………………………………….. 51
3.2 Using Biopsies …………………………………………………………………………………………………….. 53
3.2.1 Cancer ………………………………………………………………………………………………………….. 53
3.2.2 Precancerous conditions ………………………………………………………………………………… 54
3.2.3 Inflammatory conditions …………………………………………………………………………………. 54
3.3 Biopsy Sites ………………………………………………………………………………………………………… 55
3.4 The Situation Today – Biopsy Analysis ………………………………………………………………….. 57
3.5 Evidence of Cancer – Liquid Biopsy Technology ………………………………………………….. 58
3.5.1 The Big Picture on Liquid Biopsy Technology ……………………………………………………. 58
3.5.2 The Role of CTCs …………………………………………………………………………………………….. 61
3.5.3 Application of CTCs ……………………………………………………………………………………….. 62
3.5.4 CellSearch Detection- Ultimate Sensitivity ……………………………………………………….. 63
3.5.5 Epic Sciences Detection- Imaging Takes the Lead …………………………………………… 64
3.5.6 Maintrac Detection – The Microscope …………………………………………………………….. 65
3.5.7 Other Methods ………………………………………………………………………………………………. 67
3.5.8 ctDNA Role ……………………………………………………………………………………………………. 68
3.5.9 ctDNA Applications ………………………………………………………………………………………… 69
3.5.10 Exosomes and Micro Vesicles – New Kid on the Block …………………………………… 71
3.5.11 The Multiple Play …………………………………………………………………………………………. 74
3.6 Cancer Treatment Protocol Under Siege …………………………………………………………….. 76
3.6.1 Issues to Liquid Biopsy Adoption – Double Diagnostics ……………………………………… 77
3.6.2 The Cancer Screening Market Opportunity ……………………………………………………… 78
3.6.2.1 GRAIL – What Is It? …………………………………………………………………………………… 79
3.6.3 Cancer Management vs. Diagnosis ………………………………………………………………… 80
3.6.3.1 The Role of Risk Assessment ……………………………………………………………………… 80
3.6.3.2 Managing Therapy ………………………………………………………………………………….. 81
3.6.3.3 Monitoring Disease – What Is It? ……………………………………………………………….. 81
3.6.4 Phases of Adoption – Looking into The Future ………………………………………………….. 82
3.6.5 The Promise of Liquid Biopsy ……………………………………………………………………………. 83
3.7 Structure of Industry Plays a Part …………………………………………………………………………. 85
3.7.1 Hospital Testing Share …………………………………………………………………………………….. 85
3.7.2 Economies of Scale ………………………………………………………………………………………… 85
3.7.2.1 Hospital vs. Central Lab ……………………………………………………………………………. 86
3.7.3 Physician Office Lab’s …………………………………………………………………………………….. 87
3.7.4 Physician’s and POCT …………………………………………………………………………………….. 87
4 Market Trends ……………………………………………………………………………………………………. 89
4.1 Factors Driving Growth ………………………………………………………………………………………. 90
4.1.1 Non-Invasive Game Changer …………………………………………………………………………. 90
4.1.2 Lower Cost …………………………………………………………………………………………………….. 91
4.1.3 Greater Accuracy ………………………………………………………………………………………….. 91
4.1.4 Wide Range of Potential Uses …………………………………………………………………………. 91
4.1.5 Aging Population……………………………………………………………………………………………. 92
4.2 Factors Limiting Growth ……………………………………………………………………………………… 95
4.2.1 Lower prices …………………………………………………………………………………………………… 95
4.2.2 Lack of Standards ………………………………………………………………………………………….. 96
4.2.3 Protocol Resistance ………………………………………………………………………………………… 96
4.2.4 Initial Adoption Cost ……………………………………………………………………………………….. 96
4.2.5 Conclusion …………………………………………………………………………………………………….. 96
4.3 Instrumentation and Automation ……………………………………………………………………….. 97
4.3.1 Instruments Key to Market Share ……………………………………………………………………… 97
4.3.2 Bioinformatics Plays a Role ……………………………………………………………………………… 97
4.4 Diagnostic Technology Development ………………………………………………………………… 98
4.4.1 Next Generation Sequencing Fuels a Revolution ……………………………………………… 99
4.4.2 Impact of NGS on pricing ……………………………………………………………………………… 100
4.4.3 Pharmacogenomics Blurs Diagnosis and Treatment ……………………………………….. 100
4.4.4 CGES Testing, A Brave New World …………………………………………………………………. 101
4.4.5 Biochips/Giant magneto resistance based assay …………………………………………… 101
5 Liquid Biopsy Recent Developments …………………………………………………………………. 103
5.1 Recent Developments – Importance and How to Use This Section …………………….. 104
5.1.1 Importance of These Developments ……………………………………………………………… 104
5.1.2 How to Use This Section …………………………………………………………………………………. 104
5.2 Delfi Dx Liquid Biopsy Technology Shows Promise ………………………………………………. 104
5.3 Thermo Fisher Scientific, Bayer to Develop NGS-Based CDx ……………………………….. 105
5.4 Grail Details TBE Method for Cancer Monitoring ………………………………………………… 107
5.5 Naveris HPV Liquid Biopsy Test Gets Medicare Coverage …………………………………… 110
5.6 Personalis NeXT Personal Dx Early-Access Program ……………………………………………. 114
5.7 Liquid Biopsy Shortens Time to Treatment ………………………………………………………….. 114
5.8 Guardant Health MRD Test Garners Coverage ………………………………………………….. 115
5.9 IMBdx, AstraZeneca Expand Prostate Cancer Liquid Biopsy Partnership ……………… 115
5.10 FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic …….. 116
5.11 Epic Sciences Raises $24M for Breast Cancer Liquid Biopsy Test …………………………. 117
5.12 GenoMe Diagnostics Preparing DPCR-Based Ovarian Cancer Test ……………………. 118
5.13 Sophia Genetics to Commercialize Liquid Biopsy Test ………………………………………… 121
5.14 Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx ……………….. 122
5.15 Liquid Biopsy Startup Haystack Oncology Raises $56M ………………………………………. 123
5.16 Hedera Dx to Launch Liquid Biopsy Streamlined Platform ………………………………….. 124
5.17 PamGene Expanding Liquid Biopsy Assays………………………………………………………… 126
5.18 Liquid Biopsy Firm Hedera Dx Raises €14M …………………………………………………………. 129
5.19 MDxHealth Plans One-Stop Shop for Prostate Cancer Dx …………………………………… 129
5.20 Precision Oncology Dx Access Varies Widely in Europe ……………………………………… 132
5.21 Extracellular Vesicles Show Promise as Early-Stage Cancer Diagnostic ……………….. 136
5.22 Predicine Receives CE Mark for Blood and Urine Liquid Biopsy …………………………… 139
5.23 BillionToOne Launches First Liquid Biopsy Products …………………………………………….. 140
5.24 Dxcover Advances Multicancer Detection Platform ………………………………………….. 140
5.25 CorePath Laboratories, Cizzle Biotechnology Partner on Lung Cancer Blood Test . 143
5.26 Illumina Sues Guardant Health Over Patents……………………………………………………… 143
5.27 Invitae to Expand Cancer Testing Portfolio ………………………………………………………… 146
5.28 Cancer Centre, Inivata Partner on Clinical Liquid Biopsy Studies ………………………… 150
5.29 IVBH Bio Takes Aim at With Liquid Biopsy Incubator ……………………………………………. 151
5.30 Molecular Health, Eone-Diagnomics Ink Liquid Biopsy Partnership ……………………… 154
5.31 Delfi Diagnostics Looks To Fragmentation-Based Liquid Biopsy Tech …………………… 154
5.32 BillionToOne Adapting Fetal Dx Tech for Liquid Biopsy ……………………………………….. 157
5.33 EDGC to Expand Liquid Biopsy Space With Cell-Free DNA Platform ……………………. 160
5.34 Liquid Biopsy Startup BioCaptiva Raises £1M in Seed Funding …………………………….. 163
5.35 Agilent Enters Liquid Biopsy Market with Resolution Biosciences Acquisition ………… 164
5.36 Bio-Techne to Acquire Asuragen for up to $320M ……………………………………………… 168
5.37 Personalis Broadens Liquid Biopsy Offering ………………………………………………………… 169
5.38 Exact Sciences to Offer End-to-End Cancer Testing With Ashion Acquisition ……….. 171
5.39 Delfi Diagnostics Plans Multi-Cancer Screening Test …………………………………………… 174
5.40 Menarini’s CellSearch Shows Potential to Predict Breast Cancer Prognosis, Treatment
Response ……………………………………………………………………………………………………………………. 175
5.41 Liquid Biopsy NGS Panels – Diverse Test Claims …………………………………………………… 178
5.42 CMS Colon Cancer Screening Memo Bodes Well for Assays ………………………………. 184
5.43 Natera Liquid Biopsy Test Coverage to Expand …………………………………………………. 186
5.44 Freenome Closes Financing to Support Early Cancer Detection Trial ………………….. 187
5.45 C$2.6M Liquid Biopsy Initiative ………………………………………………………………………….. 188
5.46 NeoGenomics, Inivata Partner for Lung Cancer Liquid Biopsy ……………………………. 189
5.47 Liquid Biopsy Shows Promise as Screen for Cancers …………………………………………… 190
5.48 Inivata launches RaDaRTM for the detection of residual disease and recurrence … 191
5.49 Liquid Biopsy Assay Detects 50+ Types of Cancer ………………………………………………. 192
5.50 Liquid Biopsy Study Confirms Concordance with Tissue Biopsy ……………………………. 194
6 Profiles of Key Players ……………………………………………………………………………………….. 197
6.1 Admera Health, LLC …………………………………………………………………………………………. 198
6.2 Abbott Laboratories …………………………………………………………………………………………. 199
6.3 AccuraGen Inc. ………………………………………………………………………………………………. 201
6.4 Acuamark Diagnostics……………………………………………………………………………………… 202
6.5 Agilent …………………………………………………………………………………………………………….. 203
6.6 Amoy Diagnostics Co., Ltd. ………………………………………………………………………………. 205
6.7 Anchor Dx ……………………………………………………………………………………………………….. 206
6.8 ANGLE plc ……………………………………………………………………………………………………….. 208
6.9 Applied DNA Sciences……………………………………………………………………………………… 209
6.10 ARUP Laboratories ……………………………………………………………………………………………. 211
6.11 AVIVA Systems Biology ……………………………………………………………………………………… 213
6.12 Baylor Miraca Genetics Laboratories ………………………………………………………………… 214
6.13 Beckman Coulter Diagnostics (Danaher) ………………………………………………………….. 215
6.14 Becton, Dickinson and Company …………………………………………………………………….. 216
6.15 Berkley Lights ……………………………………………………………………………………………………. 218
6.16 BGI Genomics Co. Ltd ……………………………………………………………………………………… 219
6.17 BillionToOne …………………………………………………………………………………………………….. 221
6.18 Bioarray Genetics …………………………………………………………………………………………….. 223
6.19 Biocartis …………………………………………………………………………………………………………… 224
6.20 Biocept, Inc. …………………………………………………………………………………………………….. 225
6.21 Biodesix Inc. …………………………………………………………………………………………………….. 226
6.22 BioFluidica ……………………………………………………………………………………………………….. 228
6.23 Biolidics Ltd ………………………………………………………………………………………………………. 229
6.24 bioMérieux Diagnostics …………………………………………………………………………………….. 230
6.25 Bioneer Corporation ………………………………………………………………………………………… 233
6.26 Bio-Rad Laboratories, Inc………………………………………………………………………………….. 235
6.27 Bio-Techne ………………………………………………………………………………………………………. 237
6.28 Bioview ……………………………………………………………………………………………………………. 239
6.29 Burning Rock ……………………………………………………………………………………………………. 240
6.30 Cardiff Oncology …………………………………………………………………………………………….. 242
6.31 CareDx ……………………………………………………………………………………………………………. 243
6.32 Caris Molecular Diagnostics ……………………………………………………………………………… 245
6.33 CellCarta ………………………………………………………………………………………………………… 246
6.34 CellMax Life …………………………………………………………………………………………………….. 247
6.35 Cepheid (Danaher) …………………………………………………………………………………………. 248
6.36 Circulogene …………………………………………………………………………………………………….. 250
6.37 Cizzle Biotech ………………………………………………………………………………………………….. 251
6.38 Clearbridge Biomedics …………………………………………………………………………………….. 252
6.39 Clinical Genomics ……………………………………………………………………………………………. 253
6.40 Cytolumina Technologies Corp. ……………………………………………………………………….. 254
6.41 Datar Cancer Genetics Limited ………………………………………………………………………… 255
6.42 Diagnologix LLC……………………………………………………………………………………………….. 256
6.43 Dxcover …………………………………………………………………………………………………………… 257
6.44 Element Biosciences ………………………………………………………………………………………… 258
6.45 Enzo Biochem ………………………………………………………………………………………………….. 260
6.46 Epic Sciences …………………………………………………………………………………………………… 262
6.47 Epigenomics AG………………………………………………………………………………………………. 263
6.48 Eurofins Scientific ……………………………………………………………………………………………… 264
6.49 Exact Sciences ………………………………………………………………………………………………… 265
6.50 Fluxion Biosciences (Cell Microsystems) …………………………………………………………….. 266
6.51 Freenome ………………………………………………………………………………………………………… 267
6.52 Fyr Diagnostics …………………………………………………………………………………………………. 268
6.53 GeneFirst Ltd. …………………………………………………………………………………………………… 270
6.54 Genetron Holdings …………………………………………………………………………………………… 271
6.55 GILUPI Nanomedizin …………………………………………………………………………………………. 272
6.56 Guardant Health ……………………………………………………………………………………………… 273
6.57 HansaBiomed ………………………………………………………………………………………………….. 275
6.58 Haystack Oncology (Quest Dx) ………………………………………………………………………… 276
6.59 iCellate ……………………………………………………………………………………………………………. 277
6.60 ICON PLC ………………………………………………………………………………………………………… 278
6.61 Illumina ……………………………………………………………………………………………………………. 279
6.62 Incell Dx …………………………………………………………………………………………………………… 280
6.63 Inivata …………………………………………………………………………………………………………….. 281
6.64 INOVIQ ……………………………………………………………………………………………………………. 282
6.65 Invitae Corporation ………………………………………………………………………………………….. 283
6.66 J&J Innovative Medicine ………………………………………………………………………………….. 284
6.67 Lucence Health ……………………………………………………………………………………………….. 285
6.68 Lunglife AI Inc ………………………………………………………………………………………………….. 286
6.69 MDNA Life SCIENCES, Inc. …………………………………………………………………………………. 287
6.70 MDx Health ……………………………………………………………………………………………………… 288
6.71 Menarini Silicon Biosystems ……………………………………………………………………………….. 289
6.72 Mesa Laboratories, Inc. ……………………………………………………………………………………. 290
6.73 Millipore Sigma ………………………………………………………………………………………………… 292
6.74 Miltenyi Biotec …………………………………………………………………………………………………. 293
6.75 miR Scientific ……………………………………………………………………………………………………. 294
6.76 Myriad Genetics ………………………………………………………………………………………………. 296
6.77 Nanostring ……………………………………………………………………………………………………….. 298
6.78 NantHealth, Inc. ………………………………………………………………………………………………. 300
6.79 Natera …………………………………………………………………………………………………………….. 302
6.80 NeoGenomics …………………………………………………………………………………………………. 304
6.81 Novogene ……………………………………………………………………………………………………….. 306
6.82 On-Chip Biotechnologies …………………………………………………………………………………. 307
6.83 Oncocyte………………………………………………………………………………………………………… 308
6.84 OncoDNA ……………………………………………………………………………………………………….. 309
6.85 Oncimmune …………………………………………………………………………………………………….. 310
6.86 Oxford Nanopore Technologies ……………………………………………………………………….. 311
6.87 PamGene ……………………………………………………………………………………………………….. 313
6.88 Panagene ……………………………………………………………………………………………………….. 314
6.89 Personalis…………………………………………………………………………………………………………. 315
6.90 PGDx (Labcorp) ………………………………………………………………………………………………. 316
6.91 PrecisionMed …………………………………………………………………………………………………… 317
6.92 Predicine …………………………………………………………………………………………………………. 318
6.93 Predictive Oncology ………………………………………………………………………………………… 319
6.94 Prenetics ………………………………………………………………………………………………………….. 321
6.95 Promega …………………………………………………………………………………………………………. 322
6.96 Qiagen ……………………………………………………………………………………………………………. 324
6.97 Rarecells SAS ……………………………………………………………………………………………………. 326
6.98 RareCyte …………………………………………………………………………………………………………. 327
6.99 Revvity …………………………………………………………………………………………………………….. 328
6.100 Roche Diagnostics ……………………………………………………………………………………….. 330
6.101 Saga Diagnostics ………………………………………………………………………………………….. 332
6.102 Screencell ……………………………………………………………………………………………………. 333
6.103 Siemens Healthineers ……………………………………………………………………………………. 334
6.104 simfo GmbH …………………………………………………………………………………………………. 336
6.105 Singlera Genomics Inc. …………………………………………………………………………………. 337
6.106 Singular Genomics ……………………………………………………………………………………….. 338
6.107 Standard BioTools …………………………………………………………………………………………. 340
6.108 Stilla Technologies ………………………………………………………………………………………… 342
6.109 Superfluid Dx ………………………………………………………………………………………………… 343
6.110 Sysmex Inostics ……………………………………………………………………………………………… 345
6.111 Tempus Labs, Inc. …………………………………………………………………………………………. 346
6.112 Thermo Fisher Scientific …………………………………………………………………………………. 347
6.113 Todos Medical ……………………………………………………………………………………………… 349
6.114 Ultima Genomics ………………………………………………………………………………………….. 350
6.115 Veracyte ……………………………………………………………………………………………………… 351
6.116 VolitionRX …………………………………………………………………………………………………….. 352
6.117 Vortex Biosciences ……………………………………………………………………………………….. 353
7 The Global Market for Liquid Biopsy Diagnostics ………………………………………………… 354
7.1 Global Market Overview by Country ………………………………………………………………… 355
7.1.1 Table – Global Market by Country …………………………………………………………………. 355
7.1.2 Chart – Global Market by Country …………………………………………………………………. 356
7.2 Global Market by Cancer – Overview ……………………………………………………………….. 357
7.2.1 Table – Global Market by Cancer …………………………………………………………………. 357
7.2.2 Chart – Global Market by Cancer – Base/Final Year Comparison …………………… 358
7.2.3 Chart – Global Market by Cancer – Base Year ………………………………………………. 359
7.2.4 Chart – Global Market by Cancer – End Year ………………………………………………… 360
7.2.5 Chart – Global Market by Cancer – Share by Year ………………………………………… 361
7.2.6 Chart – Global Market by Cancer – Segments Growth …………………………………… 362
7.3 Global Market by Usage – Overview …………………………………………………………………. 363
7.3.1 Table – Global Market by Usage ……………………………………………………………………. 363
7.3.2 Chart – Global Market by Usage – Base/Final Year Comparison …………………….. 364
7.3.3 Chart – Global Market by Usage – Base Year …………………………………………………. 365
7.3.4 Chart – Global Market by Usage – End Year ………………………………………………….. 366
7.3.5 Chart – Global Market by Usage – Share by Year …………………………………………… 367
7.3.6 Chart – Global Market by Usage – Segments Growth …………………………………….. 368
7.4 Global Market by Place – Overview ………………………………………………………………….. 369
7.4.1 Table – Global Market by Place …………………………………………………………………….. 369
7.4.2 Chart – Global Market by Place – Base/Final Year Comparison ……………………… 370
7.4.3 Chart – Global Market by Place – Base Year………………………………………………….. 371
7.4.4 Chart – Global Market by Place – End Year …………………………………………………… 372
7.4.5 Chart – Global Market by Place – Share by Year ……………………………………………. 373
7.4.6 Chart – Global Market by Place – Segments Growth ……………………………………… 374
7.5 Global Market by Marker – Overview ………………………………………………………………… 375
7.5.1 Table – Global Market by Marker ………………………………………………………………….. 375
7.5.2 Chart – Global Market by Marker – Base/Final Year Comparison ……………………. 376
7.5.3 Chart – Global Market by Marker – Base Year ……………………………………………….. 377
7.5.4 Chart – Global Market by Marker – End Year …………………………………………………. 378
7.5.5 Chart – Global Market by Marker – Share by Year ………………………………………….. 379
7.5.6 Chart – Global Market by Marker – Segments Growth ……………………………………. 380
7.6 Global Market by Product – Overview ………………………………………………………………. 381
7.6.1 Table – Global Market by Product …………………………………………………………………. 381
7.6.2 Chart – Global Market by Product – Base/Final Year Comparison …………………… 382
7.6.3 Chart – Global Market by Product – Base Year ………………………………………………. 383
7.6.4 Chart – Global Market by Product – End Year ……………………………………………….. 384
7.6.5 Chart – Global Market by Product – Share by Year ………………………………………… 385
7.6.6 Chart – Global Market by Product – Segments Growth ………………………………….. 386
8 Global Liquid Biopsy Diagnostic Markets – By Cancer ………………………………………… 387
8.1 Breast ………………………………………………………………………………………………………………. 388
8.1.1 Table Breast – by Country ……………………………………………………………………………… 388
8.1.2 Table Breast – by Country, Price…………………………………………………………………….. 389
8.1.3 Table Breast – by Country Volume …………………………………………………………………. 390
8.1.4 Chart – Breast Growth …………………………………………………………………………………… 391
8.2 Colorectal ……………………………………………………………………………………………………….. 392
8.2.1 Table Colorectal – by Country ………………………………………………………………………. 392
8.2.2 Table Colorectal – by Country, Price ……………………………………………………………… 393
8.2.3 Table Colorectal – by Country, Volume …………………………………………………………. 394
8.2.4 Chart – Colorectal Growth…………………………………………………………………………….. 395
8.3 Cervical …………………………………………………………………………………………………………… 396
8.3.1 Table Cervical – by Country ………………………………………………………………………….. 396
8.3.2 Table Cervical – by Country, Price …………………………………………………………………. 397
8.3.3 Table Cervical – by Country, Volume …………………………………………………………….. 398
8.3.4 Chart – Cervical Growth ……………………………………………………………………………….. 399
8.4 Lung ………………………………………………………………………………………………………………… 399
8.4.1 Table Lung – by Country ……………………………………………………………………………….. 400
8.4.2 Table Lung – by Country, Price ………………………………………………………………………. 401
8.4.3 Table Lung – by Country, Volume ………………………………………………………………….. 402
8.4.4 Chart – Lung Growth …………………………………………………………………………………….. 403
8.5 Prostate …………………………………………………………………………………………………………… 404
8.5.1 Table Prostate – by Country ………………………………………………………………………….. 404
8.5.2 Table Prostate – by Country, Price …………………………………………………………………. 405
8.5.3 Table Prostate – by Country, Volume …………………………………………………………….. 406
8.5.4 Chart – Prostate Growth ……………………………………………………………………………….. 407
8.6 Other ………………………………………………………………………………………………………………. 408
8.6.1 Table Other – by Country ……………………………………………………………………………… 408
8.6.2 Table Other – by Country, Price …………………………………………………………………….. 409
8.6.3 Table Other – by Country, Volume ………………………………………………………………… 410
8.6.4 Chart – Other Growth ……………………………………………………………………………………. 411
9 Global Liquid Biopsy Diagnostic Markets – by Usage ………………………………………….. 412
9.1 Screening ………………………………………………………………………………………………………… 413
9.1.1 Table Screening – by Country ……………………………………………………………………….. 413
9.2 Chart – Screening Growth ………………………………………………………………………………… 414
9.3 Diagnostic ……………………………………………………………………………………………………….. 415
9.3.1 Table Diagnostic – by Country ………………………………………………………………………. 415
9.3.2 Chart – Diagnostic Growth…………………………………………………………………………….. 416
9.4 Therapy …………………………………………………………………………………………………………… 417
9.4.1 Table Therapy – by Country …………………………………………………………………………… 417
9.4.2 Chart – Therapy Growth ………………………………………………………………………………… 418
9.5 Monitor ……………………………………………………………………………………………………………. 419
9.5.1 Table Monitor – by Country …………………………………………………………………………… 419
9.5.2 Chart – Monitor Growth …………………………………………………………………………………. 420
10 Global Liquid Biopsy Diagnostic Markets – by Place ……………………………………… 421
10.1 Hospital Lab …………………………………………………………………………………………………….. 422
10.1.1 Table Hospital Lab – by Country ………………………………………………………………… 422
10.1.2 Chart – Hospital Lab Growth ………………………………………………………………………. 423
10.2 Lab Service ……………………………………………………………………………………………………… 424
10.2.1 Table Lab Service – by Country ………………………………………………………………….. 424
10.2.2 Chart – Lab Service Growth ……………………………………………………………………….. 425
10.3 Lab Outpatient ………………………………………………………………………………………………… 426
10.3.1 Table Lab Outpatient – by Country ……………………………………………………………. 426
10.3.2 Chart – Lab Outpatient Growth ………………………………………………………………….. 427
10.4 Other Lab ………………………………………………………………………………………………………… 428
10.4.1 Table Other Lab – by Country ……………………………………………………………………. 428
10.4.2 Chart – Other Lab Growth ………………………………………………………………………….. 429
11 Global Liquid Biopsy Diagnostic Markets – by Marker ……………………………………. 430
11.1 Circulating Tumor Cell ………………………………………………………………………………………. 431
11.1.1 Table Circulating Tumor Cell – by Country ………………………………………………….. 431
11.1.2 Chart – Circulating Tumor Cell Growth ……………………………………………………….. 432
11.2 Cell Free DNA ………………………………………………………………………………………………….. 433
11.2.1 Table Cell Free DNA – by Country ………………………………………………………………. 433
11.2.2 Chart – Cell Free DNA Growth ……………………………………………………………………. 434
11.3 Vesicle …………………………………………………………………………………………………………….. 435
11.3.1 Table Vesicle – by Country ………………………………………………………………………… 435
11.3.2 Chart – Vesicle Growth ………………………………………………………………………………. 436
11.4 Other Marker …………………………………………………………………………………………………… 437
11.4.1 Table Other Marker – by Country ……………………………………………………………….. 437
11.4.2 Chart – Other Marker Growth …………………………………………………………………….. 438
12 Global Liquid Biopsy Diagnostic Markets – by Product …………………………………… 439
12.1 Kits …………………………………………………………………………………………………………………… 440
12.1.1 Table Kits – by Country ………………………………………………………………………………. 440
12.1.2 Chart – Kits Growth ……………………………………………………………………………………. 441
12.2 Instruments ………………………………………………………………………………………………………. 442
12.2.1 Table Instruments – by Country ………………………………………………………………….. 442
12.2.2 Chart – Instruments Growth ………………………………………………………………………… 443
12.3 Service …………………………………………………………………………………………………………….. 444
12.3.1 Table Service – by Country ………………………………………………………………………… 444
12.3.2 Chart – Service Growth ……………………………………………………………………………… 445
13 Appendices ………………………………………………………………………………………………… 446
13.1 Growth of Approved IVD Test Menu …………………………………………………………………. 447
13.2 Growth of Approved Average IVD Test Fee ………………………………………………………. 448
13.3 The Most Used IVD Assays …………………………………………………………………………………. 449
13.4 The Highest Grossing Assays ……………………………………………………………………………… 454
13.5 Laboratory Fees Schedule ………………………………………………………………………………… 461
Table of Tables
Table 1 Market Players by Type ………………………………………………………………………………………… 47
Table 2 Biopsy Sites ………………………………………………………………………………………………………….. 55
Table 3 LB Clinical Applications by Entity ………………………………………………………………………….. 76
Table 4 Advantages of Liquid Biopsy in Screening Market …………………………………………………. 79
Table 5 Outlook – Phases of Liquid Biopsy Adoption by Year ………………………………………………. 82
Table 6 Five Factors Driving Growth ………………………………………………………………………………….. 90
Table 7 Factors Limiting Growth ……………………………………………………………………………………….. 95
Table 8 Key Diagnostic Laboratory Technology Trends ……………………………………………………… 98
Table 9 Next Generation Sequencing Technologies – Speed and Cost ……………………………… 99
Table 10 – Global Market by Region ……………………………………………………………………………….. 355
Table 11 Global Market by Cancer ………………………………………………………………………………… 357
Table 12 Global Market by Usage …………………………………………………………………………………… 363
Table 13 Global Market by Place ……………………………………………………………………………………. 369
Table 14 Global Market by Marker ………………………………………………………………………………….. 375
Table 15 Global Market by Product ………………………………………………………………………………… 381
Table 16 Breast by Country …………………………………………………………………………………………….. 388
Table 17 Breast by Country Price …………………………………………………………………………………….. 389
Table 18 Breast by Country Volume ………………………………………………………………………………… 390
Table 19 Colorectal by Country …………………………………………………………………………………….. 392
Table 20 Colorectal by Country Price ……………………………………………………………………………… 393
Table 21 Colorectal by Country Volume …………………………………………………………………………. 394
Table 22 Cervical by Country …………………………………………………………………………………………. 396
Table 23 Cervical by Country Price …………………………………………………………………………………. 397
Table 24 Cervical by Country Volume …………………………………………………………………………….. 398
Table 25 Lung by Country ………………………………………………………………………………………………. 400
Table 26 Lung by Country Price ………………………………………………………………………………………. 401
Table 27 Lung by Country Volume ………………………………………………………………………………….. 402
Table 28 Prostate by Country …………………………………………………………………………………………. 404
Table 29 Prostate by Country Price …………………………………………………………………………………. 405
Table 30 Prostate by Country Volume …………………………………………………………………………….. 406
Table 31 Other by Country ……………………………………………………………………………………………… 408
Table 32 Other by Country Price …………………………………………………………………………………….. 409
Table 33 Other by Country Volume ………………………………………………………………………………… 410
Table 34 Screening by Country ……………………………………………………………………………………… 413
Table 35 Diagnostic by Country ……………………………………………………………………………………… 415
Table 36 Therapy by Country …………………………………………………………………………………………. 417
Table 37 Monitor by Country …………………………………………………………………………………………. 419
Table 38 Hospital Lab by Country ………………………………………………………………………………….. 422
Table 39 Lab Service by Country …………………………………………………………………………………….. 424
Table 40 Lab Outpatient by Country ……………………………………………………………………………… 426
Table 41 Other Lab by Country ……………………………………………………………………………………… 428
Table 42 Circulating Tumor Cell by Country ……………………………………………………………………. 431
Table 43 Cell Free DNA by Country …………………………………………………………………………………. 433
Table 44 Vesicle by Country ………………………………………………………………………………………….. 435
Table 45 Other Marker by Country …………………………………………………………………………………. 437
Table 46 Kits by Country ………………………………………………………………………………………………… 440
Table 47 Instruments by Country …………………………………………………………………………………….. 442
Table 48 Service by Country ………………………………………………………………………………………….. 444
Table 49 The Most Common Assays ……………………………………………………………………………….. 449
Table 50 Largest Revenue Assays ……………………………………………………………………………………. 454
Table 51 Clinical Lab Fee Schedule ………………………………………………………………………………… 461
Table of Figures
Figure 1 Global Healthcare Spending Picture ………………………………………………………………….. 42
Figure 2 The Global Lab Test Pie ……………………………………………………………………………………….. 43
Figure 3 The Road to Diagnostics ……………………………………………………………………………………… 46
Figure 4 Comparison of Liquid vs Tissue Biopsy …………………………………………………………………… 58
Figure 5 Entities Analyzed in liquid Biopsy ………………………………………………………………………….. 60
Figure 6 Characteristics of Different Vesicle Types …………………………………………………………….. 74
Figure 7 The Changing Age of World Population ………………………………………………………………. 93
Figure 8 Health Care Consumption by Age ………………………………………………………………………. 94
Figure 9 Cancer Incidence – Age at Diagnosis ………………………………………………………………….. 94
Figure 10 Global Market Regional Share Chart ………………………………………………………………. 356
Figure 11 Global Market by Cancer – Base vs. Final …………………………………………………………. 358
Figure 12 Global Market by Cancer Base Year ……………………………………………………………….. 359
Figure 13 Global Market by Cancer End Year …………………………………………………………………. 360
Figure 14 Cancer Share by Year …………………………………………………………………………………….. 361
Figure 15 Cancer Segments Growth ……………………………………………………………………………….. 362
Figure 16 Global Market by Usage – Base vs. Final……………………………………………………………. 364
Figure 17 Global Market by Usage Base Year ………………………………………………………………….. 365
Figure 18 Global Market by Usage End Year …………………………………………………………………… 366
Figure 19 Usage Share by Year ……………………………………………………………………………………….. 367
Figure 20 Usage Segments Growth …………………………………………………………………………………. 368
Figure 21 Global Market by Place – Base vs. Final…………………………………………………………….. 370
Figure 22 Global Market by Place Base Year …………………………………………………………………… 371
Figure 23 Global Market by Place End Year ……………………………………………………………………. 372
Figure 24 Place Share by Year ………………………………………………………………………………………… 373
Figure 25 Place Segments Growth ………………………………………………………………………………….. 374
Figure 26 Global Market by Marker – Base vs. Final ………………………………………………………….. 376
Figure 27 Global Market by Marker Base Year …………………………………………………………………. 377
Figure 28 Global Market by Marker End Year ………………………………………………………………….. 378
Figure 29 Marker Share by Year ………………………………………………………………………………………. 379
Figure 30 Marker Segments Growth ………………………………………………………………………………… 380
Figure 31 Global Market by Product – Base vs. Final …………………………………………………………. 382
Figure 32 Global Market by Product Base Year ……………………………………………………………….. 383
Figure 33 Global Market by Product End Year …………………………………………………………………. 384
Figure 34 Product Share by Year …………………………………………………………………………………….. 385
Figure 35 Product Segments Growth ………………………………………………………………………………. 386
Figure 36 Breast Growth …………………………………………………………………………………………………. 391
Figure 37 Colorectal Diagnostics Growth ………………………………………………………………………… 395
Figure 38 Cervical Growth ……………………………………………………………………………………………… 399
Figure 39 Lung Growth …………………………………………………………………………………………………… 403
Figure 40 Prostate Growth ………………………………………………………………………………………………. 407
Figure 41 Other Growth ………………………………………………………………………………………………….. 411
Figure 42 Screening Growth …………………………………………………………………………………………… 414
Figure 43 Diagnostic Growth ………………………………………………………………………………………….. 416
Figure 44 Therapy Growth ………………………………………………………………………………………………. 418
Figure 45 Monitor Growth ……………………………………………………………………………………………….. 420
Figure 46 Hospital Lab Growth ………………………………………………………………………………………… 423
Figure 47 Lab Service Growth …………………………………………………………………………………………. 425
Figure 48 Lab Outpatient Growth …………………………………………………………………………………… 427
Figure 49 Other Lab Growth …………………………………………………………………………………………… 429
Figure 50 Circulating Tumor Cell Growth …………………………………………………………………………. 432
Figure 51 Cell Free DNA Growth ……………………………………………………………………………………… 434
Figure 52 Vesicle Growth ……………………………………………………………………………………………….. 436
Figure 53 Other Marker Growth ………………………………………………………………………………………. 438
Figure 54 Kits Growth ……………………………………………………………………………………………………… 441
Figure 55 Instruments Growth …………………………………………………………………………………………. 443
Figure 56 Service Growth ……………………………………………………………………………………………….. 445
Figure 57 IVD Test Menu Growth …………………………………………………………………………………….. 447
Figure 58 IVD Test Average Fees – A Ten Year View …………………………………………………………. 448
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