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GENTEST 325 Table of Contents ?v=1746646699
RESEARCH REPORT
Genetic Testing Markets 12th Edition.
Global Market Analysis with Forecasts by Applications, Technologies, Product and User. With Executive and Consultant
Guides.
2025 to 2029

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Howe Sound Research is a market research and consulting company based in Vancouver, British Columbia, Canada. In our spare time we like to sail in a large body of water nearby called Howe Sound. We publish market research reports that address scientific industries with an emphasis on Biotechnology and Clinical Diagnostic markets. We consider ourselves experts in these areas. We approach market research differently than other companies. At any one time we have a limited number of reports, and we update them frequently, sometimes several times a year. Our reports are prepared by people who understand the industry and have worked and studied in the area. This contrasts with the many research mills who produce canned reports on the Handbag market one day and the X-Ray market the next. Our intellectual property is encryption protected. If you have issues with this or would like to upgrade to a corporate license that is not encrypted, please contact us at the email above. Please feel free to contact us if you have any questions. We believe in customer service and are more than willing to provide after sales assistance and custom data.
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Table of Contents
1 Market Guides ..................................................................................................................25 1.1 Genetic Testing - Strategic Situation Analysis ................................................................ 26 1.2 Guide for Executives, Marketing, Sales and Business Development Staff ................... 28 1.3 Guide for Management Consultants and Investment Advisors ................................... 30 1.4 Impact of Artificial Intelligence....................................................................................... 32
2 Introduction and Market Definition ................................................................................33 2.1 Genetic Testing Definition in This Report......................................................................... 34 2.2 The Genomics Revolution................................................................................................ 35 2.3 Market Definition .............................................................................................................. 37 2.3.1 Revenue Market Size.................................................................................................... 37 2.3.2 Newborn Screening ..................................................................................................... 38 2.3.3 Non Invasise Pregnancy Testing.................................................................................. 38 2.3.4 Predictive ...................................................................................................................... 38 2.3.5 Oncology ...................................................................................................................... 38 2.3.6 Direct to Consumer ...................................................................................................... 38 2.3.7 Other Application......................................................................................................... 39 2.3.8 PCR ................................................................................................................................ 39 2.3.9 NGS................................................................................................................................ 39 2.3.10 Cytogenetic.............................................................................................................. 39 2.3.11 Other Technology..................................................................................................... 39 2.4 Methodology.................................................................................................................... 40
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2.4.1 Methodology ................................................................................................................ 40 2.4.2 Sources .......................................................................................................................... 40 2.4.3 Authors .......................................................................................................................... 40 2.5 Perspective: Healthcare and the IVD Industry .............................................................. 42 2.5.1 Global Healthcare Spending ...................................................................................... 42 2.5.2 Spending on Diagnostics ............................................................................................. 43 2.5.3 Important Role of Insurance for Diagnostics .............................................................. 45 2.6 Chromosomes, Genes and Epigenetics......................................................................... 46 2.6.1 Chromosomes .............................................................................................................. 46 2.6.2 Genes ............................................................................................................................ 48 2.6.3 Epigenetics ................................................................................................................... 51 3 Market Overview..............................................................................................................53 3.1 Players in a Dynamic Market........................................................................................... 54 3.1.1 Academic Research Lab ............................................................................................ 55 3.1.2 Diagnostic Test Developer........................................................................................... 55 3.1.3 Instrumentation Supplier .............................................................................................. 56 3.1.4 Chemical/Reagent Supplier........................................................................................ 56 3.1.5 Pathology Supplier ....................................................................................................... 56 3.1.6 Independent Clinical Laboratory ............................................................................... 57 3.1.7 Public National/regional Laboratory .......................................................................... 57 3.1.8 Hospital Laboratory ...................................................................................................... 58 3.1.9 Physicians Office Lab (POLS) ....................................................................................... 58 3.1.10 Audit Body................................................................................................................. 59 3.1.11 Certification Body..................................................................................................... 59

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3.2 Genetic Tests ­Types, Examples and Discussion ............................................................ 61 3.2.1 Preimplantation Genetic Diagnosis- An Emerging Market ....................................... 61 3.2.2 Prenatal Diagnosis ­ New Technologies Create Opportunity .................................. 62 3.2.3 Newborn Screening ..................................................................................................... 62 3.2.4 Diagnostic Testing ........................................................................................................ 63 3.2.5 Carrier Testing ............................................................................................................... 63 3.2.6 Predictive and Presymptomatic Testing..................................................................... 64 3.2.7 Pharmacogenomics .................................................................................................... 64 3.2.8 Forensic Testing............................................................................................................. 65 3.2.9 Parental Testing ............................................................................................................ 65 3.2.10 Ancestral Testing....................................................................................................... 65
3.3 Industry Structure.............................................................................................................. 67 3.3.1 Hospital's Testing Share................................................................................................ 67 3.3.2 Economies of Scale...................................................................................................... 67 3.3.3 Hospital vs. Central Lab ............................................................................................... 68 3.3.4 Physician Office Lab's.................................................................................................. 69 3.3.5 Physician's and POCT .................................................................................................. 69
4 Market Trends ...................................................................................................................70 4.1 Factors Driving Growth .................................................................................................... 71 4.1.1 Genetic Discoveries Impact. ....................................................................................... 71 4.1.2 The Aging Effect ........................................................................................................... 72 4.1.3 Pharmacogenomics .................................................................................................... 74 4.1.4 Oncology and Liquid Biopsy Factors .......................................................................... 75 4.1.5 Fertility Practice ............................................................................................................ 75

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4.1.6 Direct to Consumer ...................................................................................................... 75 4.2 Factors Limiting Growth ................................................................................................... 76
4.2.1 The Competition Effect ................................................................................................ 76 4.2.2 The Cost Situation ......................................................................................................... 77 4.2.3 Testing usage analysis .................................................................................................. 77 4.2.4 Wellness Effects............................................................................................................. 77 4.3 Instrumentation, Automation and Diagnostic Trends ................................................... 79 4.3.1 Traditional Automation and Centralization................................................................ 79 4.3.2 The New Automation, Decentralization and Point of Care...................................... 79 4.3.3 Instruments Key to Market Share................................................................................. 81 4.3.4 Bioinformatics Plays a Role .......................................................................................... 81 4.3.5 PCR Takes Command .................................................................................................. 82 4.3.6 Next Generation Sequencing Fuels a Revolution...................................................... 83 4.3.7 NGS Impact on Pricing................................................................................................. 84 4.3.8 Whole Genome Sequencing, A Brave New World ................................................... 84 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment .......................................... 85 4.3.10 Shifting Role of Diagnostics ...................................................................................... 86 5 Genetic Testing Recent Developments .........................................................................88 5.1 Recent Developments..................................................................................................... 89 5.1.1 Importance of This Section .......................................................................................... 89 5.1.2 How to Use This Section................................................................................................ 89 5.2 23andMe Launches New Genetic Report ..................................................................... 89 5.3 Natera Revenues Soar on Product Gains ...................................................................... 90 5.4 GeneDx Launches Exome Testing for Epilepsy .............................................................. 91

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5.5 Owkin, AstraZeneca Partner to Develop AI Breast Cancer Prescreening Tool........... 92 5.6 Myriad Genetics Reports Revenue Spike ....................................................................... 93 5.7 GeneDx Revenues Grow 45 Percent.............................................................................. 94 5.8 Revvity Launches NGS Panel for Newborn Screening .................................................. 95 5.9 LetsGetChecked: MyGeneticScreen ............................................................................. 99 5.10 Sysmex, Hitachi to Develop Low-Cost Sequencers ....................................................... 99 5.11 Fore Genomics Offering WGS Newborn Screening to Parents .................................. 100 5.12 Clinical Validation of Long-Read WGS Assay .............................................................. 104 5.13 Resolution Bio Acquisition - Exact Sciences Aims at Liquid Biopsy Market ................ 108 5.14 Novitas Rescinds Coverage for Multiple Genetic Tests............................................... 112 5.15 PerkinElmer (now Revvity) Becomes Dx Life Science Firm .......................................... 115 5.16 New POC Genotyping Tests Based on Electromagnetic Detection.......................... 119 5.17 GenoMe Dx Launching dPCR Cancer Test.................................................................. 123 5.18 mDetect To Trial Breast Cancer Liquid Biopsy.............................................................. 126 5.19 Genomics England, Aims to Sequence 100K Newborns ............................................ 134 5.20 Juno Diagnostics NIPT With At-Home Sample Collection ........................................... 137 5.21 Cardio Diagnostics Launches Genetic Cario Risk Test................................................ 140 5.22 Universal Genetic Testing in Breast Cancer Further Supported.................................. 143 5.23 Aniling Gets CE-IVD Marks for Cancer Sequencing Tests ........................................... 145 5.24 MyOme Lands Investment for WGS .............................................................................. 146 5.25 Type 2 Diabetes GWAS Enables Risk Prediction........................................................... 147 5.26 LetsGetChecked to Acquire Veritas Genetics ............................................................ 149 5.27 Guardant Health Plans New Comprehensive Assay................................................... 150 5.28 Tesis Labs Raises $20M.................................................................................................... 152

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5.29 Sema4: Sema4 Elements ............................................................................................... 153 5.30 Clarified Precision Medicine Acquires Interpares Biomedicine.................................. 153 5.31 Genetic Technologies to Acquire DTC Genetic Test Provider EasyDNA ................... 154 5.32 Illumina, Belgium Genetic Centers Partner on WGS-Based Dx................................... 155 5.33 NIH, Genomics England Launch Sequencing Studies Using Nanopore Technology 155 5.34 Progenity Revenues Fall on COVID-19 Effect............................................................... 157 5.35 Natera Launches Tumor Genomic Profiling Assay ...................................................... 159 5.36 23andMe To Go Public .................................................................................................. 162 5.37 Guardant Health to Offer Tumor Tissue Sequencing................................................... 162 5.38 Ancestry Quits Health Offering...................................................................................... 166 5.39 DTC Firm MyDNA Merges With Gene by Gene ........................................................... 171 6 Profiles of Key Companies .............................................................................................171 6.1 10x Genomics, Inc.......................................................................................................... 172 6.2 23andME Inc................................................................................................................... 174 6.3 Abbott Laboratories....................................................................................................... 175 6.4 Adaptive Biotechnologies ............................................................................................. 177 6.5 Admera Health, LLC....................................................................................................... 179 6.6 Agilent ............................................................................................................................. 180 6.7 Akonni Biosystems .......................................................................................................... 182 6.8 Amoy Diagnostics Co., Ltd. ........................................................................................... 183 6.9 Ancestry.com LLC .......................................................................................................... 184 6.10 Anchor Dx ....................................................................................................................... 186 6.11 Arrayit Corporation ........................................................................................................ 188 6.12 ARUP Laboratories.......................................................................................................... 190

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6.13 Aus Diagnostics .............................................................................................................. 192 6.14 BaseClear........................................................................................................................ 193 6.15 Baylor Miraca Genetics Laboratories ........................................................................... 194 6.16 Beckman Coulter Diagnostics (Danaher) .................................................................... 195 6.17 Becton, Dickinson and Company ................................................................................ 196 6.18 BGI Genomics Co. Ltd ................................................................................................... 198 6.19 Bioarray Genetics........................................................................................................... 200 6.20 BioBam ............................................................................................................................ 201 6.21 Biocept, Inc..................................................................................................................... 202 6.22 Biodesix Inc. .................................................................................................................... 203 6.23 BioFluidica ....................................................................................................................... 204 6.24 BioGenex ........................................................................................................................ 205 6.25 BioGX............................................................................................................................... 207 6.26 Biolidics Ltd...................................................................................................................... 208 6.27 bioMérieux Diagnostics.................................................................................................. 209 6.28 Bioneer Corporation ...................................................................................................... 212 6.29 Bio-Rad Laboratories, Inc............................................................................................... 214 6.30 Bio-Techne ...................................................................................................................... 215 6.31 Burning Rock ................................................................................................................... 217 6.32 C2i Genomics ................................................................................................................. 219 6.33 Cantata Bio .................................................................................................................... 220 6.34 CareDx ............................................................................................................................ 221 6.35 Caris Molecular Diagnostics .......................................................................................... 222 6.36 Celemics ......................................................................................................................... 223

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6.37 CellMax Life .................................................................................................................... 224 6.38 Centogene ..................................................................................................................... 225 6.39 Cepheid (Danaher) ....................................................................................................... 226 6.40 Circulogene.................................................................................................................... 228 6.41 Clearbridge Biomedics .................................................................................................. 229 6.42 Clinical Genomics .......................................................................................................... 230 6.43 Color Genomics ............................................................................................................. 231 6.44 Complete Genomics (MGI Tech) ................................................................................. 232 6.45 CosmosID ........................................................................................................................ 233 6.46 Dante Labs...................................................................................................................... 234 6.47 Datar Cancer Genetics Limited.................................................................................... 236 6.48 Diasorin S.p.A. ................................................................................................................. 237 6.49 DNAe ............................................................................................................................... 238 6.50 Easy DNA......................................................................................................................... 239 6.51 Element Biosciences ...................................................................................................... 240 6.52 Epic Sciences.................................................................................................................. 242 6.53 Epigenomics AG............................................................................................................. 243 6.54 Eurofins Scientific ............................................................................................................ 244 6.55 Excellerate Bioscience................................................................................................... 245 6.56 Fabric Genomics ............................................................................................................ 246 6.57 Freenome........................................................................................................................ 247 6.58 FUJIFILM Wako Diagnostics............................................................................................ 248 6.59 Fujirebio ........................................................................................................................... 249 6.60 Fulgent Genetics ............................................................................................................ 250

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6.61 Gene by Gene, Ltd. ....................................................................................................... 252 6.62 Genedrive....................................................................................................................... 254 6.63 GeneDx Holdings ........................................................................................................... 255 6.64 GeneFirst Ltd. .................................................................................................................. 256 6.65 Genetic Technologies Ltd. ............................................................................................ 257 6.66 Genetron Holdings ......................................................................................................... 258 6.67 Genomics England ........................................................................................................ 259 6.68 Genomics Personalized Health (GPH) .......................................................................... 261 6.69 GenomOncology........................................................................................................... 262 6.70 Genzyme Corporation................................................................................................... 263 6.71 Grifols............................................................................................................................... 265 6.72 Guardant Health ............................................................................................................ 267 6.73 Guardiome ..................................................................................................................... 268 6.74 Helix ................................................................................................................................. 270 6.75 Hologic ............................................................................................................................ 271 6.76 HTG Molecular Diagnostics ........................................................................................... 273 6.77 Human Longevity, Inc. ................................................................................................... 274 6.78 iCellate............................................................................................................................ 276 6.79 Illumina ............................................................................................................................ 277 6.80 Incell Dx........................................................................................................................... 278 6.81 Inivata ............................................................................................................................. 279 6.82 Invitae Corporation........................................................................................................ 280 6.83 Invivoscribe ..................................................................................................................... 281 6.84 Karius ............................................................................................................................... 282

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6.85 Letsgetchecked ............................................................................................................. 284 6.86 Lunglife AI Inc ................................................................................................................. 285 6.87 Macrogen ....................................................................................................................... 286 6.88 MDNA Life SCIENCES, Inc............................................................................................... 287 6.89 MDx Health ..................................................................................................................... 288 6.90 Medgenome .................................................................................................................. 289 6.91 Menarini Silicon Biosystems ............................................................................................ 290 6.92 Meridian Bioscience....................................................................................................... 291 6.93 Mesa Laboratories, Inc. ................................................................................................. 293 6.94 Metabiomics Corp ......................................................................................................... 295 6.95 miR Scientific................................................................................................................... 296 6.96 NantHealth, Inc. ............................................................................................................. 298 6.97 Natera ............................................................................................................................. 300 6.98 Nebula Genomics .......................................................................................................... 302 6.99 NeoGenomics ................................................................................................................ 303 6.100 New England Biolabs, Inc. ......................................................................................... 304 6.101 NGeneBio.................................................................................................................... 305 6.102 Norgen Biotek Corp. .................................................................................................. 306 6.103 Novogene ................................................................................................................... 307 6.104 Omega Bioservices .................................................................................................... 308 6.105 Oncocyte.................................................................................................................... 310 6.106 OncoDNA ................................................................................................................... 311 6.107 OpGen ........................................................................................................................ 312 6.108 Origene Technologies................................................................................................ 314

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6.109 6.110 6.111 6.112 6.113 6.114 6.115 6.116 6.117 6.118 6.119 6.120 6.121 6.122 6.123 6.124 6.125 6.126 6.127 6.128 6.129 6.130 6.131 6.132

Oxford Nanopore Technologies................................................................................ 315 Pacific Biosciences..................................................................................................... 317 Panagene ................................................................................................................... 318 PathoQuest S.A........................................................................................................... 319 Personalis..................................................................................................................... 320 PGDx (Labcorp).......................................................................................................... 321 Precipio ....................................................................................................................... 322 PrecisionMed .............................................................................................................. 323 Predictive Oncology .................................................................................................. 324 Promega ..................................................................................................................... 326 Qiagen ........................................................................................................................ 328 QuantuMDx ................................................................................................................ 330 Revvity ......................................................................................................................... 331 Roche Diagnostics ..................................................................................................... 333 Roswell Biotechnologies............................................................................................. 335 Seegene...................................................................................................................... 336 Sequencing.com........................................................................................................ 337 Siemens Healthineers ................................................................................................. 339 simfo GmbH ................................................................................................................ 340 Singlera Genomics Inc. .............................................................................................. 341 Singular Genomics ..................................................................................................... 342 SkylineDx...................................................................................................................... 344 Standard BioTools ....................................................................................................... 345 Sysmex......................................................................................................................... 347

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6.133 Sysmex Inostics............................................................................................................ 349 6.134 Tempus Labs, Inc. ....................................................................................................... 350 6.135 Thermo Fisher Scientific .............................................................................................. 351 6.136 Ultima Genomics ........................................................................................................ 353 6.137 Ultima Genomics ........................................................................................................ 354 6.138 Variantyx ..................................................................................................................... 355 6.139 Vela Diagnostics......................................................................................................... 356 6.140 VolitionRX .................................................................................................................... 357 6.141 Zymo Research Corp ................................................................................................. 358 7 Global Market Size .........................................................................................................359 7.1 Global Market by Country............................................................................................. 360
7.1.1 Table ­ Global Market by Country............................................................................ 360 7.1.2 Chart ­ Country Market Shares ................................................................................. 361 7.2 Global Market by Application ...................................................................................... 362 7.2.1 Table ­ Global Market by Application ..................................................................... 362 7.2.2 Chart ­ Application Share by Year ........................................................................... 363 7.2.3 Chart ­ Application Segment Growth Rates ........................................................... 364 7.2.4 Chart ­ Application Segment Share Shifts................................................................ 365 7.2.5 Chart ­ Application Segment Share Base Year ....................................................... 366 7.2.6 Chart ­ Application Segment Share Final Year ....................................................... 367 7.3 Global Market by Technology ...................................................................................... 368 7.3.1 Table ­ Global Market by Technology ..................................................................... 368 7.3.2 Chart ­ Technology Share by Year ........................................................................... 369 7.3.3 Chart ­ Technology Segment Growth Rates ........................................................... 370

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7.3.4 Chart ­ Technology Segment Share Shifts................................................................ 371 7.3.5 Chart ­ Technology Segment Share Base Year ....................................................... 372 7.3.6 Chart ­ Technology Segment Share Final Year ....................................................... 373 7.4 Global Market by Product............................................................................................. 374 7.4.1 Table ­ Global Market by Product............................................................................ 374 7.4.2 Chart ­ Product Share by Year.................................................................................. 375 7.4.3 Chart ­ Product Segment Growth Rates.................................................................. 376 7.4.4 Chart ­ Product Segment Share Shifts ...................................................................... 377 7.4.5 Chart ­ Product Segment Share Base Year ............................................................. 378 7.4.6 Chart ­ Product Segment Share Final Year.............................................................. 379 7.5 Global Market by User ................................................................................................... 380 7.5.1 Table ­ Global Market by User .................................................................................. 380 7.5.2 Chart ­ User Share by Year ........................................................................................ 381 7.5.3 Chart ­ User Segment Growth Rates ........................................................................ 382 7.5.4 Chart ­ User Segment Share Shifts ............................................................................ 383 7.5.5 Chart ­ User Segment Share Base Year.................................................................... 384 7.5.6 Chart ­ User Segment Share Final Year .................................................................... 385 8 Market Sizes by Application ..........................................................................................386 8.1 Newborn Testing Market................................................................................................ 387 8.1.1 Table Newborn ­ by Country..................................................................................... 387 8.1.2 Chart ­ Newborn Growth .......................................................................................... 388 8.2 NIPT Market ..................................................................................................................... 389 8.2.1 Table NIPT ­ by Country ............................................................................................. 389 8.2.2 Chart ­ NIPT Growth ................................................................................................... 390

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8.3 Predictive Testing Market .............................................................................................. 391 8.3.1 Table Predictive ­ by Country ................................................................................... 391 8.3.2 Chart ­ Predictive Growth ......................................................................................... 392
8.4 Oncology Testing Market .............................................................................................. 393 8.4.1 Table Oncology ­ by Country ................................................................................... 393 8.4.2 Chart ­ Oncology Growth ......................................................................................... 394
8.5 DTC Testing Market ........................................................................................................ 395 8.5.1 Table DTC ­ by Country ............................................................................................. 395 8.5.2 Chart ­ DTC Growth ................................................................................................... 396
8.6 Other Testing Market...................................................................................................... 397 8.6.1 Table Other ­ by Country .......................................................................................... 397 8.6.2 Chart ­ Other Growth ................................................................................................ 398
9 Global Genetic Testing Market by Technology...........................................................399 9.1 PCR Testing Market ........................................................................................................ 400 9.1.1 Table PCR ­ by Country ............................................................................................. 400 9.1.2 Chart ­ PCR Growth ................................................................................................... 401 9.2 NGS Market..................................................................................................................... 402 9.2.1 Table NGS ­ by Country ............................................................................................. 402 9.2.2 Chart ­ NGS Growth................................................................................................... 403 9.3 Cytogenetic Testing Market .......................................................................................... 404 9.3.1 Table Cytogenetic ­ by Country............................................................................... 404 9.3.2 Cytogenetic ­ Predictive Growth ............................................................................. 405 9.4 Other Testing Market...................................................................................................... 406 9.4.1 Table Other ­ by Country .......................................................................................... 406

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9.4.2 Chart ­ Other Growth ................................................................................................ 407 10 Global Genetic Testing Market by Product ............................................................408
10.1 Instruments Market ......................................................................................................... 409 10.1.1 Table Instruments ­ by Country ............................................................................. 409 10.1.2 Chart ­ Instrument Growth..................................................................................... 410
10.2 Reagents and Kits Market.............................................................................................. 411 10.2.1 Table Reagents and Kits ­ by Country .................................................................. 411 10.2.2 Chart ­ Reagents and Kits Growth........................................................................ 412
10.3 Software Market ............................................................................................................. 413 10.3.1 Table Software ­ by Country ................................................................................. 413 10.3.2 Software Growth..................................................................................................... 414
10.4 Services Market .............................................................................................................. 415 10.4.1 Table Services ­ by Country................................................................................... 415 10.4.2 Chart ­ Services Growth ........................................................................................ 416
11 Global Genetic Testing Market by User ..................................................................417 11.1 Academic Market.......................................................................................................... 418 11.1.1 Table Academic ­ by Country .............................................................................. 418 11.1.2 Chart ­ Academic Growth .................................................................................... 419 11.2 Clinical Market................................................................................................................ 420 11.2.1 Table Clinical ­ by Country .................................................................................... 420 11.2.2 Chart ­ Clinical Growth.......................................................................................... 421 11.3 Pharmaceutical Market................................................................................................. 422 11.3.1 Table Pharmaceutical ­ by Country ..................................................................... 422 11.3.2 Pharmaceutical ­ Predictive Growth ................................................................... 423

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11.4 Industrial and Other Market .......................................................................................... 424 11.4.1 Table Industrial and Other ­ by Country............................................................... 424 11.4.2 Chart ­ Industrial and Other Growth..................................................................... 425
12 The Future of Genetic Testing ..................................................................................426 13 Appendices ...............................................................................................................427
13.1 Growth of Approved IVD Test Menu ............................................................................ 428 13.2 Growth of Approved Average IVD Test Fee ................................................................ 429 13.3 The Most Used IVD Assays.............................................................................................. 430 13.4 The Highest Grossing Assays .......................................................................................... 435 13.5 Laboratory Fees Schedule............................................................................................. 442

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Table of Tables
Table 1 Most Common Traditional Genetic Disorders .................................................................. 35 Table 2 The Base Pairs...................................................................................................................... 49 Table 3 Market Players by Type ..................................................................................................... 55 Table 4 The Different Types of Genetic Tests ................................................................................. 61 Table 5 Five Factors Driving Growth ............................................................................................... 71 Table 6 Four Factors Limiting Growth ............................................................................................. 76 Table 7 Seven Key Diagnostic Laboratory Technology Trends .................................................... 79 Table 8 Global Market by Country............................................................................................... 360 Table 9 Global Market by Application ........................................................................................ 362 Table 10 Global Market by Technology ...................................................................................... 368 Table 11 Global Market by Product ............................................................................................. 374 Table 12 Global Market by User ................................................................................................... 380 Table 13 Newborn Segment by Country ..................................................................................... 387 Table 14 NIPT Segment by Country .............................................................................................. 389 Table 15 Predictive Segment by Country .................................................................................... 391 Table 16 Oncology Segment by Country .................................................................................... 393 Table 17 DTC Segment by Country .............................................................................................. 395 Table 18 Other Segment by Country ........................................................................................... 397 Table 19 PCR Segment by Country .............................................................................................. 400 Table 20 NGS Segment by Country.............................................................................................. 402 Table 21 Cytogenetic Segment by Country ............................................................................... 404

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Table 22 Other Segment by Country ........................................................................................... 406 Table 23 Instruments Segment by Country .................................................................................. 409 Table 24 Reagents and Kits Segment by Country ...................................................................... 411 Table 25 Software Segment by Country ...................................................................................... 413 Table 26 Services Segment by Country ....................................................................................... 415 Table 27 Academic Segment by Country................................................................................... 418 Table 28 Clinical Segment by Country ........................................................................................ 420 Table 29 Pharmaceutical Segment by Country.......................................................................... 422 Table 30 Industrial and Other Segment by Country ................................................................... 424 Table 31 The Most Common Assays ............................................................................................ 430 Table 32 Largest Revenue Assays................................................................................................. 435 Table 33 Clinical Lab Fee Schedule ............................................................................................. 442

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Table of Figures
Figure 1 Global Health Care Spending.......................................................................................... 43 Figure 2 The Lab Test Pie ................................................................................................................. 44 Figure 3 DNA Strands and Chromosomes ..................................................................................... 46 Figure 4 Karyogram of Human Chromosomes .............................................................................. 47 Figure 5 Size of Various Genomes .................................................................................................. 50 Figure 6 The Road to Diagnostics ................................................................................................... 54 Figure 7 The Changing Age of the World Population................................................................... 73 Figure 8 Health Care Consumption by Age .................................................................................. 73 Figure 9 Cancer Incidence - Age at Diagnosis............................................................................. 74 Figure 10 Centralized vs. Decentralized Laboratory Service ....................................................... 80 Figure 11 A Highly Multiplexed Syndromic Testing Unit ................................................................. 80 Figure 12 The Real Cost to Sequence the Human Genome........................................................ 83 Figure 13 The Codevelopment Process ......................................................................................... 85 Figure 14 Comparing MDx Diagnostic and Traditional Testing .................................................... 87 Figure 15 Country Market Shares.................................................................................................. 361 Figure 16 Application Share by Year............................................................................................ 363 Figure 17 Application Segment Growth Rates ............................................................................ 364 Figure 18 Segment Share Shifts .................................................................................................... 365 Figure 19 Application Segment Share Base Year ...................................................................... 366 Figure 20 Application Segment Share Final Year ....................................................................... 367 Figure 21 Technology Share by Year............................................................................................ 369

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Figure 22 Technology Segment Growth Rates............................................................................ 370 Figure 23 Technology Segment Share Shifts ............................................................................... 371 Figure 24 Technology Segment Share Base Year ...................................................................... 372 Figure 25 Technology Segment Share Final Year....................................................................... 373 Figure 26 Product Share by Year .................................................................................................. 375 Figure 27 Product Segment Growth Rates .................................................................................. 376 Figure 28 Product Segment Share Shifts...................................................................................... 377 Figure 29 Product Segment Share Base Year ............................................................................. 378 Figure 30 Product Segment Share Final Year ............................................................................. 379 Figure 31 User Share by Year ........................................................................................................ 381 Figure 32 User Segment Growth Rates......................................................................................... 382 Figure 33 User Segment Share Shifts ............................................................................................ 383 Figure 34 User Segment Share Base Year ................................................................................... 384 Figure 35 User Segment Share Final Year.................................................................................... 385 Figure 36 Newborn vs. Total Market Growth ............................................................................... 388 Figure 37 NIPT vs. Total Market Growth ........................................................................................ 390 Figure 38 Predictive vs. Total Market Growth .............................................................................. 392 Figure 39 Oncology vs. Total Market Growth .............................................................................. 394 Figure 40 DTC vs. Total Market Growth ........................................................................................ 396 Figure 41 Other vs. Total Market Growth ..................................................................................... 398 Figure 42 PCR vs. Total Market Growth ........................................................................................ 401 Figure 43 NGS vs. Total Market Growth........................................................................................ 403 Figure 44 Cytogenetic vs. Total Market Growth.......................................................................... 405 Figure 45 Other vs. Total Market Growth ..................................................................................... 407

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Figure 46 Instrument vs. Total Market Growth.............................................................................. 410 Figure 47 Reagents and Kits vs. Total Market Growth................................................................. 412 Figure 48 Software vs. Total Market Growth ................................................................................ 414 Figure 49 Services vs. Total Market Growth ................................................................................. 416 Figure 50 Academic vs. Total Market Growth ............................................................................. 419 Figure 51 Clinical vs. Total Market Growth................................................................................... 421 Figure 52 Pharmaceutical vs. Total Market Growth.................................................................... 423 Figure 53 Industrial and Other vs. Total Market Growth.............................................................. 425 Figure 54 IVD Test Menu Growth .................................................................................................. 428 Figure 55 IVD Test Average Fees ­ A Ten Year View ................................................................... 429

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References

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