THE FUTURE OF DIAGNOSTICS BY APPLICATION, TECHNOLOGY AND FUNDING. WITH EXECUTIVE AND CONSULTANT GUIDES 2024-2028
Howe Sound Research Published June 2024 – 546 pages
Companion Diagnostics are changing the diagnostics industry. Whole new markets are emerging. Diagnostic and Therapeutic partnerships. Find out the latest outlook for this important market.
Will Companion Diagnostics become the norm?
Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost picture is changing.
“Companion Diagnostic Markets, the Future of Diagnostics” provides data that analysts and planners can use. Hundreds of pages of information. Get specific growth and market sizes for your area of interest. Assistance in using the information is normally provided without additional charges.
The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country or specific area in the world is available to purchasers of the report.
Your report is provided on a 12-month subscription basis from the date you receive your first report. You will receive 2 or more updated versions of the complete report during the 12 months. At least one of these updates will provide forecasts based on next year’s data.
1 Market Guides …………………………………………………………………………………………………… 23
1.1 Strategic Situation Analysis …………………………………………………………………………………. 24
1.2 Guide for Executives, Marketing, Sales and Business Development Staff ………………. 26
1.3 Guide for Management Consultants and Investment Advisors …………………………….. 28
2 Introduction and Market Definition …………………………………………………………………….. 29
2.1 What are Companion Diagnostics? ……………………………………………………………………. 30
2.2 The Personalized Medicine Revolution ………………………………………………………………… 42
2.3 Market Definition ……………………………………………………………………………………………….. 44
2.3.1 Revenue Market Size. ……………………………………………………………………………………… 44
2.4 Methodology …………………………………………………………………………………………………….. 46
2.4.1 Methodology …………………………………………………………………………………………………. 46
2.4.2 Sources ………………………………………………………………………………………………………….. 46
2.4.3 Authors ………………………………………………………………………………………………………….. 46
2.5 Perspective: Healthcare and the IVD Industry …………………………………………………….. 48
2.5.1 Global Healthcare Spending ………………………………………………………………………….. 48
2.5.2 Spending on Diagnostics ………………………………………………………………………………… 49
2.5.3 Important Role of Insurance for Diagnostics …………………………………………………….. 51
3 Market Overview ……………………………………………………………………………………………….. 52
3.1 Players in a Dynamic Market ………………………………………………………………………………. 53
3.1.1 Academic Research Lab ……………………………………………………………………………….. 54
3.1.2 Diagnostic Test Developer ………………………………………………………………………………. 54
3.1.3 Instrumentation Supplier …………………………………………………………………………………. 55
3.1.4 Chemical/Reagent Supplier ……………………………………………………………………………. 55
3.1.5 Pathology Supplier …………………………………………………………………………………………. 55
3.1.6 Independent Clinical Laboratory ……………………………………………………………………. 56
3.1.7 Public National/regional Laboratory ……………………………………………………………….. 56
3.1.8 Hospital Laboratory ………………………………………………………………………………………… 57
3.1.9 Physicians Office Lab (POLS) …………………………………………………………………………… 57
3.1.10 Audit Body ………………………………………………………………………………………………….. 58
3.1.11 Certification Body ……………………………………………………………………………………….. 58
3.2 Personalized Medicine and Companion Diagnostics …………………………………………… 60
3.2.1 Basics …………………………………………………………………………………………………………….. 60
3.2.2 Method………………………………………………………………………………………………………….. 61
3.2.3 Disease risk assessment …………………………………………………………………………………… 61
3.2.4 Applications …………………………………………………………………………………………………… 61
3.2.5 Diagnosis and intervention ……………………………………………………………………………… 62
3.2.5.1 Companion Diagnostics ………………………………………………………………………….. 63
3.2.6 Drug development and usage ……………………………………………………………………….. 63
3.2.7 Respiratory proteomics …………………………………………………………………………………… 64
3.2.8 Cancer genomics ………………………………………………………………………………………….. 65
3.2.9 Population screening ……………………………………………………………………………………… 66
3.2.10 Challenges …………………………………………………………………………………………………. 66
3.2.11 Regulatory oversight …………………………………………………………………………………… 66
3.2.12 Intellectual property rights …………………………………………………………………………… 67
3.2.13 Reimbursement policies ………………………………………………………………………………. 67
3.2.14 Patient privacy and confidentiality ……………………………………………………………… 67
3.3 Chromosomes, Genes and Epigenetics ………………………………………………………………. 69
3.3.1 Chromosomes ……………………………………………………………………………………………….. 69
3.3.2 Genes ……………………………………………………………………………………………………………. 71
3.3.3 Epigenetics ……………………………………………………………………………………………………. 74
3.4 Cancer Genes …………………………………………………………………………………………………… 75
3.4.1 Germline vs Somatic ………………………………………………………………………………………. 77
3.4.2 Changing Clinical Role …………………………………………………………………………………… 79
3.5 Structure of Industry Plays a Part …………………………………………………………………………. 80
3.5.1 New Pharmaceutical Funding Market …………………………………………………………….. 80
3.5.2 Economies of Scale ………………………………………………………………………………………… 80
3.5.2.1 Hospital vs. Central Lab ……………………………………………………………………………. 81
3.5.3 Physician Office Labs ……………………………………………………………………………………… 82
3.5.4 Physicians and POCT ………………………………………………………………………………………. 82
4 Market Trends ……………………………………………………………………………………………………. 84
4.1 Factors Driving Growth ………………………………………………………………………………………. 85
4.1.1 Level of Care. ………………………………………………………………………………………………… 85
4.1.2 Immuno-oncology. …………………………………………………………………………………………. 86
4.1.3 Liability. ………………………………………………………………………………………………………….. 86
4.1.4 The Aging World …………………………………………………………………………………………….. 86
4.2 Factors Limiting Growth ……………………………………………………………………………………… 90
4.2.1 State of knowledge. ……………………………………………………………………………………….. 90
4.2.2 Genetic Blizzard. …………………………………………………………………………………………….. 91
4.2.3 Protocol Resistance. ……………………………………………………………………………………….. 91
4.2.4 Regulation and coverage. ……………………………………………………………………………… 91
4.3 Instrumentation, Automation and Diagnostic Trends …………………………………………… 92
4.3.1 Traditional Automation and Centralization ………………………………………………………. 92
4.3.2 The New Automation, Decentralization and Point Of Care ………………………………. 92
4.3.3 Instruments Key to Market Share ……………………………………………………………………… 94
4.3.4 Bioinformatics Plays a Role ……………………………………………………………………………… 94
4.3.5 PCR Takes Command …………………………………………………………………………………….. 95
4.3.6 Next Generation Sequencing Fuels a Revolution ……………………………………………… 96
4.3.7 NGS Impact on Pricing ……………………………………………………………………………………. 97
4.3.8 Whole Genome Sequencing, A Brave New World …………………………………………… 97
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment …………………………………… 97
4.3.10 Shifting Role of Diagnostics ………………………………………………………………………….. 99
5 Companion Diagnostics Recent Developments ………………………………………………… 101
5.1 Recent Developments – Importance and How to Use This Section …………………….. 102
5.1.1 Importance of These Developments ……………………………………………………………… 102
5.1.2 How to Use This Section …………………………………………………………………………………. 102
5.2 Foundation Medicine, Repare to Partner on CDx for Lunresertib ………………………… 102
5.3 Burning Rock, Bayer to Develop NGS Companion Diagnostic ……………………………. 103
5.4 PathAI, Roche to Develop AI-Enabled Companion Diagnostics …………………………. 104
5.5 ARUP and Medicover Expand Companion Diagnostic in EU ………………………………. 105
5.6 Thermo Fisher Signs Companion Diagnostic Agreement …………………………………….. 109
5.7 Agilent CDx Assay IVDR Certified………………………………………………………………………. 110
5.8 ARUP Laboratories Gets Approval for Gene Therapy CDx ………………………………….. 111
5.9 Guardant Health Gets Medicare Coverage for Liquid Biopsy Test ……………………… 112
5.10 Amoy Dx PLC Panel Gets Approval in Japan as CDx …………………………………………. 113
5.11 UnitedHealthcare Expands Precision Oncology Dx Coverage ……………………………. 113
5.12 JaxBio to Create Array-Based Cancer Tests ………………………………………………………. 115
5.13 Agilent, Qiagen Win FDA Approvals Companion Diagnostics …………………………….. 119
5.14 Navignostics Using Single-Cell Spatial Proteomics………………………………………………. 120
5.15 HMNC Brain Health to Develop Companion Diagnostics …………………………………… 123
5.16 Propath UK, Nucleai Partner on Spatial Proteomics ……………………………………………. 124
5.17 Becton Dickinson, Labcorp Develop Flow Cytometry Companion Diagnostics …… 124
5.18 Almac, AstraZeneca Strike CDx Development Pact …………………………………………… 125
5.19 Avalon GloboCare to Develop Cell Therapy CDx ……………………………………………… 126
5.20 Burning Rock Secures Lung Cancer NGS Test Approval in China ………………………… 127
5.21 TenSixteen Bio Developing Drugs, Companion NGS Tests …………………………………… 127
5.22 Guardant Health Plans New Comprehensive Assay …………………………………………… 130
5.23 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs ……………………….. 133
5.24 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test ………………………… 134
5.25 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx ……………….. 135
5.26 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug ……….. 136
5.27 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx …………………………………. 137
5.28 Oncocyte Details Expansions Plans …………………………………………………………………… 141
5.29 Agilent Acquires Resolution Biosciences ……………………………………………………………. 144
5.30 Qiagen, Inovio Expand CDx Partnership ……………………………………………………………. 147
5.31 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance ………………………………. 148
5.32 NeoGenomics to Grow Through CDx Agreements, Acquisitions …………………………. 148
5.33 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction ……. 154
5.34 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform ……… 157
5.35 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies ….. 159
5.36 Promega to Develop MSI Assay as CDx …………………………………………………………….. 164
5.37 Guardant Health to Develop CDx for Janssen …………………………………………………… 165
5.38 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx …………………………. 166
5.39 FDA Approval for FoundationOne®CDx ……………………………………………………………. 166
5.40 FDA finalizes CDx Guidance……………………………………………………………………………… 167
5.41 QIAGEN Launches CDx Therascreen BRAF Test ………………………………………………….. 169
6 Profiles of Key Players ……………………………………………………………………………………….. 171
6.1 10x Genomics, Inc. …………………………………………………………………………………………… 172
6.2 Abbott Laboratories …………………………………………………………………………………………. 174
6.3 AccuraGen Inc. ………………………………………………………………………………………………. 176
6.4 Acuamark Diagnostics……………………………………………………………………………………… 177
6.5 Adaptive Biotechnologies ………………………………………………………………………………… 178
6.6 Admera Health, LLC …………………………………………………………………………………………. 180
6.7 Aethlon Medical ………………………………………………………………………………………………. 181
6.8 Agilent …………………………………………………………………………………………………………….. 182
6.9 Amoy Diagnostics Co., Ltd. ………………………………………………………………………………. 184
6.10 Anchor Dx ……………………………………………………………………………………………………….. 185
6.11 ANGLE plc ……………………………………………………………………………………………………….. 187
6.12 Applied DNA Sciences……………………………………………………………………………………… 188
6.13 ARUP Laboratories ……………………………………………………………………………………………. 190
6.14 AVIVA Systems Biology ……………………………………………………………………………………… 192
6.15 Baylor Miraca Genetics Laboratories ………………………………………………………………… 193
6.16 Beckman Coulter Diagnostics (Danaher) ………………………………………………………….. 194
6.17 Becton, Dickinson and Company …………………………………………………………………….. 195
6.18 Berkley Lights ……………………………………………………………………………………………………. 197
6.19 BGI Genomics Co. Ltd ……………………………………………………………………………………… 198
6.20 BillionToOne …………………………………………………………………………………………………….. 200
6.21 Bioarray Genetics …………………………………………………………………………………………….. 202
6.22 Biocartis …………………………………………………………………………………………………………… 204
6.23 Biocept, Inc. …………………………………………………………………………………………………….. 206
6.24 Biodesix Inc. …………………………………………………………………………………………………….. 208
6.25 BioFluidica ……………………………………………………………………………………………………….. 210
6.26 BioGenex ………………………………………………………………………………………………………… 212
6.27 BioIVT ………………………………………………………………………………………………………………. 214
6.28 Biolidics Ltd ………………………………………………………………………………………………………. 216
6.29 bioMérieux Diagnostics …………………………………………………………………………………….. 217
6.30 Bioneer Corporation ………………………………………………………………………………………… 220
6.31 Bio-Rad Laboratories, Inc………………………………………………………………………………….. 222
6.32 Bio-Reference Laboratories ………………………………………………………………………………. 224
6.33 Bio-Techne ………………………………………………………………………………………………………. 226
6.34 Bioview ……………………………………………………………………………………………………………. 228
6.35 Bristol-Myers Squibb ………………………………………………………………………………………….. 230
6.36 Burning Rock ……………………………………………………………………………………………………. 232
6.37 C2i Genomics ………………………………………………………………………………………………….. 234
6.38 Cardiff Oncology …………………………………………………………………………………………….. 235
6.39 Caris Molecular Diagnostics ……………………………………………………………………………… 236
6.40 Castle Biosciences, Inc. ……………………………………………………………………………………. 237
6.41 CellCarta ………………………………………………………………………………………………………… 238
6.42 CellMax Life …………………………………………………………………………………………………….. 239
6.43 Cepheid (Danaher) …………………………………………………………………………………………. 240
6.44 Charles River Laboratories ………………………………………………………………………………… 242
6.45 Circulogene …………………………………………………………………………………………………….. 244
6.46 Cizzle Biotech ………………………………………………………………………………………………….. 245
6.47 Clearbridge Biomedics …………………………………………………………………………………….. 246
6.48 Clinical Genomics ……………………………………………………………………………………………. 247
6.49 Cytolumina Technologies Corp. ……………………………………………………………………….. 248
6.50 Datar Cancer Genetics Limited ………………………………………………………………………… 249
6.51 Diagnologix LLC……………………………………………………………………………………………….. 250
6.52 Diasorin S.p.A. ………………………………………………………………………………………………….. 251
6.53 Dxcover …………………………………………………………………………………………………………… 252
6.54 Element Biosciences ………………………………………………………………………………………… 253
6.55 Enzo Biochem ………………………………………………………………………………………………….. 256
6.56 Epic Sciences …………………………………………………………………………………………………… 258
6.57 Epigenomics AG………………………………………………………………………………………………. 259
6.58 Eurofins Scientific ……………………………………………………………………………………………… 260
6.59 Fabric Genomics ……………………………………………………………………………………………… 262
6.60 Fluxion Biosciences (Cell Microsystems) …………………………………………………………….. 263
6.61 Freenome ………………………………………………………………………………………………………… 264
6.62 FUJIFILM Wako Diagnostics ……………………………………………………………………………….. 265
6.63 Fujirebio …………………………………………………………………………………………………………… 266
6.64 Fyr Diagnostics …………………………………………………………………………………………………. 267
6.65 GeneDx Holdings …………………………………………………………………………………………….. 269
6.66 GeneFirst Ltd. …………………………………………………………………………………………………… 270
6.67 Genetron Holdings …………………………………………………………………………………………… 271
6.68 GenomOncology …………………………………………………………………………………………….. 273
6.69 GILUPI Nanomedizin …………………………………………………………………………………………. 274
6.70 Guardant Health ……………………………………………………………………………………………… 275
6.71 HansaBiomed ………………………………………………………………………………………………….. 277
6.72 HTG Molecular Diagnostics ………………………………………………………………………………. 278
6.73 iCellate ……………………………………………………………………………………………………………. 280
6.74 ICON PLC ………………………………………………………………………………………………………… 281
6.75 Illumina ……………………………………………………………………………………………………………. 283
6.76 Incell Dx …………………………………………………………………………………………………………… 284
6.77 Inivata …………………………………………………………………………………………………………….. 285
6.78 INOVIQ ……………………………………………………………………………………………………………. 286
6.79 Invitae Corporation ………………………………………………………………………………………….. 287
6.80 Invivogen ………………………………………………………………………………………………………… 288
6.81 Invivoscribe ……………………………………………………………………………………………………… 290
6.82 J&J Innovative Medicine ………………………………………………………………………………….. 291
6.83 KEW …………………………………………………………………………………………………………………. 292
6.84 Lucence Health ……………………………………………………………………………………………….. 293
6.85 Lunglife AI Inc ………………………………………………………………………………………………….. 294
6.86 MDNA Life SCIENCES, Inc. …………………………………………………………………………………. 295
6.87 MDx Health ……………………………………………………………………………………………………… 296
6.88 Menarini Silicon Biosystems ……………………………………………………………………………….. 297
6.89 Mesa Laboratories, Inc. ……………………………………………………………………………………. 298
6.90 Millipore Sigma ………………………………………………………………………………………………… 300
6.91 Miltenyi Biotec …………………………………………………………………………………………………. 301
6.92 miR Scientific ……………………………………………………………………………………………………. 302
6.93 Myriad Genetics ………………………………………………………………………………………………. 304
6.94 Nanostring ……………………………………………………………………………………………………….. 306
6.95 NantHealth, Inc. ………………………………………………………………………………………………. 308
6.96 Natera …………………………………………………………………………………………………………….. 310
6.97 NeoGenomics …………………………………………………………………………………………………. 312
6.98 NGeneBio………………………………………………………………………………………………………… 314
6.99 Novogene ……………………………………………………………………………………………………….. 315
6.100 Oncimmune …………………………………………………………………………………………………. 316
6.101 Oncocyte …………………………………………………………………………………………………….. 317
6.102 OncoDNA ……………………………………………………………………………………………………. 318
6.103 Oncohost …………………………………………………………………………………………………….. 319
6.104 Oxford Nanopore Technologies …………………………………………………………………….. 320
6.105 PamGene…………………………………………………………………………………………………….. 322
6.106 Panagene ……………………………………………………………………………………………………. 323
6.107 Personalis ……………………………………………………………………………………………………… 324
6.108 Perthera ……………………………………………………………………………………………………….. 325
6.109 PGDx (Labcorp) ……………………………………………………………………………………………. 327
6.110 Precipio ……………………………………………………………………………………………………….. 328
6.111 PrecisionMed ……………………………………………………………………………………………….. 329
6.112 Predicine ……………………………………………………………………………………………………… 330
6.113 Predictive Oncology …………………………………………………………………………………….. 331
6.114 Prenetics ………………………………………………………………………………………………………. 333
6.115 Promega ……………………………………………………………………………………………………… 335
6.116 Qiagen ………………………………………………………………………………………………………… 337
6.117 QuidelOrtho …………………………………………………………………………………………………. 339
6.118 Rarecells SAS ………………………………………………………………………………………………… 341
6.119 RareCyte ……………………………………………………………………………………………………… 342
6.120 Revvity …………………………………………………………………………………………………………. 343
6.121 Roche Diagnostics ……………………………………………………………………………………….. 345
6.122 Screencell ……………………………………………………………………………………………………. 347
6.123 Sherlock Biosciences …………………………………………………………………………………….. 348
6.124 Siemens Healthineers ……………………………………………………………………………………. 349
6.125 Singlera Genomics Inc. …………………………………………………………………………………. 351
6.126 Singular Genomics ……………………………………………………………………………………….. 352
6.127 Singulomics ………………………………………………………………………………………………….. 354
6.128 SkylineDx ………………………………………………………………………………………………………. 356
6.129 Standard BioTools …………………………………………………………………………………………. 357
6.130 Stilla Technologies ………………………………………………………………………………………… 359
6.131 Sysmex Inostics ……………………………………………………………………………………………… 360
6.132 Tempus Labs, Inc. …………………………………………………………………………………………. 361
6.133 Thermo Fisher Scientific …………………………………………………………………………………. 362
6.134 Todos Medical ……………………………………………………………………………………………… 364
6.135 Ultima Genomics ………………………………………………………………………………………….. 365
6.136 Veracyte ……………………………………………………………………………………………………… 367
6.137 Vir ………………………………………………………………………………………………………………… 368
6.138 VolitionRX …………………………………………………………………………………………………….. 369
6.139 Vortex Biosciences ……………………………………………………………………………………….. 370
7 The Global Market for Companion Diagnostics …………………………………………………. 371
7.1 Global Market Overview by Country ………………………………………………………………… 372
7.1.1 Table – Global Market by Country …………………………………………………………………. 372
7.1.2 Chart – Global Market by Country …………………………………………………………………. 373
7.2 Global Market by Application – Overview …………………………………………………………. 374
7.2.1 Table – Global Market by Application …………………………………………………………… 374
7.2.2 Chart – Global Market by Application – Base/Final Year Comparison …………….. 375
7.2.3 Chart – Global Market by Application – Base Year ………………………………………… 376
7.2.4 Chart – Global Market by Application – Final Year …………………………………………. 377
7.2.5 Chart – Global Market by Application – Share by Year …………………………………… 378
7.2.6 Chart – Global Market by Application – Segment Growth Rates …………………….. 379
7.3 Global Market Funding Source – Overview ………………………………………………………… 380
7.3.1 Table – Global Market by Funding Source ……………………………………………………… 380
7.3.2 Chart – Global Market Funding Source – Base/Final Year Comparison ……………. 381
7.3.3 Chart – Global Market Funding Source – Base Year ……………………………………….. 382
7.3.4 Chart – Global Market Funding Source – Final Year………………………………………… 383
7.3.5 Chart – Global Market Funding Source – Share by Year …………………………………. 384
7.4 Global Market Technology – Overview ……………………………………………………………… 385
7.4.1 Table – Global Market by Technology …………………………………………………………… 385
7.4.2 Chart – Global Market Technology – Base/Final Year Comparison………………….. 386
7.4.3 Chart – Global Market Technology – Base Year ……………………………………………… 387
7.4.4 Chart – Global Market Technology – Final Year ……………………………………………… 388
7.4.5 Chart – Global Market Technology – Share by Year ……………………………………….. 389
8 Global Companion Diagnostic Markets – By Application …………………………………… 390
8.1 Oncology Breast ………………………………………………………………………………………………. 391
8.1.1 Table Oncology Breast – by Country ……………………………………………………………… 391
8.1.2 Chart – Oncology Breast Growth …………………………………………………………………… 392
8.2 Oncology Lung ………………………………………………………………………………………………… 393
8.2.1 Table Oncology Lung – by Country ……………………………………………………………….. 393
8.2.2 Chart – Oncology Lung Growth …………………………………………………………………….. 394
8.3 Oncology Colorectal ……………………………………………………………………………………….. 395
8.3.1 Table Oncology Colorectal – by Country ………………………………………………………. 395
8.3.2 Chart – Oncology Colorectal Growth ……………………………………………………………. 396
8.4 Oncology Other ………………………………………………………………………………………………. 397
8.4.1 Table Oncology Other – by Country ……………………………………………………………… 397
8.4.2 Chart – Oncology Other Growth …………………………………………………………………… 398
8.5 Neurology ……………………………………………………………………………………………………….. 399
8.5.1 Table Neurology – by Country ……………………………………………………………………….. 399
8.5.2 Chart – Neurology Growth …………………………………………………………………………….. 400
8.6 Cardiology ………………………………………………………………………………………………………. 401
8.6.1 Table Cardiology – by Country ……………………………………………………………………… 401
8.6.2 Chart – Cardiology Growth ……………………………………………………………………………. 402
8.7 Other Application ……………………………………………………………………………………………. 403
8.7.1 Table Other Application – by Country ……………………………………………………………. 403
8.7.2 Chart – Other Application Growth …………………………………………………………………. 404
9 Global Companion Diagnostic Markets – Funding Source …………………………………. 405
9.1 Global Market Pharmaceutical ………………………………………………………………………… 406
9.1.1 Table Pharmaceutical – by Country ………………………………………………………………. 406
9.1.2 Chart – Pharmaceutical Growth ……………………………………………………………………. 407
9.2 Global Market Venture …………………………………………………………………………………….. 408
9.2.1 Table Venture – by Country …………………………………………………………………………… 408
9.2.2 Chart – Venture Growth ………………………………………………………………………………… 409
9.3 Global Market Clinical ……………………………………………………………………………………… 410
9.3.1 Table Clinical – by Country ……………………………………………………………………………. 410
9.3.2 Chart – Clinical Growth …………………………………………………………………………………. 411
9.4 Global Market Other Funding …………………………………………………………………………… 412
9.4.1 Table Other Funding – by Country …………………………………………………………………. 412
9.4.2 Chart – Other Funding Growth ………………………………………………………………………. 413
10 Global Companion Diagnostic Markets – Technology …………………………………… 414
10.1 Global Market Next Generation Sequencing …………………………………………………….. 415
10.1.1 Table Next Generation Sequencing – by Country ………………………………………. 415
10.1.2 Chart – Next Generation Sequencing Growth …………………………………………….. 416
10.2 Global Market PCR ………………………………………………………………………………………….. 417
10.2.1 Table PCR – by Country …………………………………………………………………………….. 417
10.2.2 Chart – PCR Growth …………………………………………………………………………………… 418
10.3 Global Market IHC/ISH ……………………………………………………………………………………… 419
10.3.1 Table IHC/ISH – by Country ………………………………………………………………………… 419
10.3.2 Chart – IHC/ISH Growth ……………………………………………………………………………… 420
10.4 Global Market Other Technology ……………………………………………………………………… 421
10.4.1 Table Other Technology – by Country ………………………………………………………… 421
10.4.2 Chart – Other Technology Growth ……………………………………………………………… 422
11 Appendices ………………………………………………………………………………………………… 423
11.1 United States Medicare System: Clinical Laboratory Fees Schedule …………………… 424
11.2 The Most Used IVD Assays …………………………………………………………………………………. 527
11.3 The Highest Grossing Assays ……………………………………………………………………………… 532
Table of Tables
Table 1 FDA Approved Companion Dx …………………………………………………………………………….. 31
Table 2 Market Players by Type ……………………………………………………………………………………….. 54
Table 3 The Base Pairs………………………………………………………………………………………………………. 72
Table 4 Factors Driving Growth …………………………………………………………………………………………. 85
Table 5 Factors Limiting Growth ……………………………………………………………………………………….. 90
Table 6 Seven Key Diagnostic Laboratory Technology Trends ……………………………………………. 92
Table 7 Global Companion Diagnostic Market by Region ……………………………………………….. 372
Table 8 Global Market by Application ……………………………………………………………………………. 374
Table 9 Global Market by Funding Source ………………………………………………………………………. 380
Table 10 Global Market by Technology ………………………………………………………………………….. 385
Table 11 Oncology Breast by Country …………………………………………………………………………….. 391
Table 12 Oncology Lung by Country ………………………………………………………………………………. 393
Table 13 Oncology Colorectal by Country ……………………………………………………………………… 395
Table 14 Oncology Other by Country……………………………………………………………………………… 397
Table 15 Neurology by Country ……………………………………………………………………………………… 399
Table 16 Cardiology by Country …………………………………………………………………………………….. 401
Table 17 Other Application by Country …………………………………………………………………………… 403
Table 18 Pharmaceutical by Country …………………………………………………………………………….. 406
Table 19 Venture by Country ………………………………………………………………………………………….. 408
Table 20 Clinical by Country ………………………………………………………………………………………….. 410
Table 21 Other Funding by Country ………………………………………………………………………………… 412
Table 22 Next Generation Sequencing by Country ………………………………………………………… 415
Table 23 PCR by Country ……………………………………………………………………………………………….. 417
Table 24 IHC/ISH by Country ………………………………………………………………………………………….. 419
Table 25 Other Technology by Country …………………………………………………………………………… 421
Table 26 Clinical Laboratory Fee Schedule ……………………………………………………………………… 424
Table 27 The Most Common Assays ……………………………………………………………………………….. 527
Table 28 Largest Revenue Assays ……………………………………………………………………………………. 532
Table of Figures
Figure 1 Global Healthcare Spending ………………………………………………………………………………. 49
Figure 2 The Road to Diagnostics ……………………………………………………………………………………… 53
Figure 3 DNA Strands and Chromosomes …………………………………………………………………………. 69
Figure 4 Karyogram of Human Chromosomes …………………………………………………………………… 70
Figure 5 Size of Various Genomes …………………………………………………………………………………….. 73
Figure 6 Germline vs Somatic Mutations ……………………………………………………………………………. 77
Figure 7 Comparing Genomic Diagnostic and Traditional Testing ……………………………………… 79
Figure 8 The Changing Age of The World’s Population ………………………………………………………. 87
Figure 9 Health Care Consumption by Age ………………………………………………………………………. 88
Figure 10 Cancer Incidence by Age ………………………………………………………………………………… 88
Figure 11 Centralized vs. Decentralized Laboratory Service ………………………………………………. 93
Figure 12 A Highly Multiplexed Syndromic Testing Unit ……………………………………………………….. 94
Figure 13 The Real Cost to Sequence the Human Genome ……………………………………………….. 96
Figure 14 The Codevelopment Process …………………………………………………………………………….. 98
Figure 15 Comparing MDx Diagnostic and Traditional Testing ………………………………………….. 100
Figure 16 Base Year Country Market Share Chart ……………………………………………………………. 373
Figure 17 CDx Market by Application – Base vs. Final Year ……………………………………………….. 375
Figure 18 CDx Market by Application Base Year ……………………………………………………………… 376
Figure 19 CDx Market by Application Final Year………………………………………………………………. 377
Figure 20 Application Type Share by Year ……………………………………………………………………….. 378
Figure 21 Application Type Segment Growth Rates …………………………………………………………. 379
Figure 22 Funding Source – Base vs. Final Year ………………………………………………………………… 381
Figure 23 Funding Source Market Base Year ……………………………………………………………………. 382
Figure 24 Funding Source Market Final Year ……………………………………………………………………. 383
Figure 25 Funding Source Share by Year …………………………………………………………………………. 384
Figure 26 Technology – Base vs. Final Year ………………………………………………………………………. 386
Figure 27 Technology Market Base Year …………………………………………………………………………. 387
Figure 28 Technology Market Final Year ………………………………………………………………………….. 388
Figure 29 Technology Share by Year……………………………………………………………………………….. 389
Figure 30 Oncology Breast Growth …………………………………………………………………………………. 392
Figure 31 Oncology Lung Growth …………………………………………………………………………………… 394
Figure 32 Oncology Colorectal Growth ………………………………………………………………………….. 396
Figure 33 Oncology Other Growth ………………………………………………………………………………….. 398
Figure 34 Neurology Growth …………………………………………………………………………………………… 400
Figure 35 Cardiology Growth …………………………………………………………………………………………. 402
Figure 36 Other Application Growth ……………………………………………………………………………….. 404
Figure 37 Pharmaceutical Growth ………………………………………………………………………………….. 407
Figure 38 Venture Growth ………………………………………………………………………………………………. 409
Figure 39 Clinical Growth ……………………………………………………………………………………………….. 411
Figure 40 Other Funding Growth …………………………………………………………………………………….. 413
Figure 41 Next Generation Sequencing Growth ………………………………………………………………. 416
Figure 42 PCR Growth ……………………………………………………………………………………………………. 418
Figure 43 IHC/ISH Growth ……………………………………………………………………………………………….. 420
Figure 44 Other Technology Growth ……………………………………………………………………………….. 422
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