SYNDROMIC MULTIPLEX PANELS MARKETS 2024 to 2028
Strategies and Trends. Forecasts by Syndrome (Respiratory, Sepsis, GI etc.) by Place and by Product. With Market Analysis and Executive Guides.
Howe Sound Research Published June 2024 – 555 pages
“The Syndromic Diagnostics Market enters a new post-pandemic growth phase as new entrants jockey for position in a New Diagnostic World…..”
Infectious disease Dx is changing and will change more in the future. Can a rapidly growing market expand even faster? Find out all about it in this comprehensive report on Syndromic Multiplex Diagnostics.
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.
Will diagnostics replace physicians? When will infectious disease testing be moved into the physician’s office or even the home?
Learn about this market including the issues and outlooks. The two key trends of point-of-care testing and Molecular Diagnostics are merging with spectacular success. It could possibly displace most frontline test protocols AND save money at the same time. The report forecasts the market size out for five years and even further with a later updated report with next years numbers.
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1 Market Guides …………………………………………………………………………………………………… 19
1.1 Situation Analysis …………………………………………………………………………………………………… 20
1.2 Guide for Executives and Marketing Staff ………………………………………………………………. 23
1.3 Guide for Investment Analysts and Management Consultants ………………………………… 25
2 Introduction and Market Definition …………………………………………………………………….. 27
2.1 What are Syndromic Multiplex Tests? ……………………………………………………………………… 28
2.2 Syndromic Testing – the quiet revolution in diagnostics …………………………………………… 29
2.2.1 Syndromic Testing – more than Panels. ……………………………………………………………. 30
2.3 Market Definition …………………………………………………………………………………………………… 31
2.3.1 Multiplex Market Size. ……………………………………………………………………………………… 31
2.3.2 Currency. ………………………………………………………………………………………………………. 31
2.3.3 Years. …………………………………………………………………………………………………………….. 32
2.4 Methodology ………………………………………………………………………………………………………… 33
2.4.1 Methodology …………………………………………………………………………………………………. 33
2.4.2 Sources ………………………………………………………………………………………………………….. 33
2.4.3 Authors ………………………………………………………………………………………………………….. 33
2.5 Perspective: Healthcare and the IVD Industry ………………………………………………………… 35
2.5.1 Global Healthcare Spending ………………………………………………………………………….. 35
2.5.2 Spending on Diagnostics ………………………………………………………………………………… 36
2.5.3 Important Role of Insurance for Diagnostics …………………………………………………….. 38
3 Infectious Disease ………………………………………………………………………………………………. 39
3.1 Infections – The Big Picture …………………………………………………………………………………….. 40
3.2 The Pathogens ………………………………………………………………………………………………………. 40
3.2.1 Bacteria …………………………………………………………………………………………………………. 41
3.2.2 Fungi and Protozoa ………………………………………………………………………………………… 43
3.2.3 Viruses ……………………………………………………………………………………………………………. 44
3.2.4 Prions …………………………………………………………………………………………………………….. 46
3.3 Symptoms and Syndromes …………………………………………………………………………………….. 46
3.3.1 Bacterial or viral ……………………………………………………………………………………………… 46
3.3.2 Typical Viral Symptoms …………………………………………………………………………………… 46
3.3.3 Typical Bacterial Symptoms …………………………………………………………………………….. 47
3.4 Disease …………………………………………………………………………………………………………………. 47
3.5 Transmission ………………………………………………………………………………………………………….. 47
3.6 Infectious Disease Diagnostics ……………………………………………………………………………….. 48
3.6.1 Microbial culture…………………………………………………………………………………………….. 49
3.6.2 Microscopy ……………………………………………………………………………………………………. 50
3.6.3 Biochemical tests ……………………………………………………………………………………………. 51
3.6.4 PCR-based diagnostics …………………………………………………………………………………… 52
3.6.5 Metagenomic sequencing …………………………………………………………………………….. 52
3.7 Defining Infections ………………………………………………………………………………………………… 53
3.8 Syndromic Infection ………………………………………………………………………………………………. 54
4 Industry Overview ………………………………………………………………………………………………. 55
4.1 Players in a Dynamic Market………………………………………………………………………………….. 56
4.1.1 Academic Research Lab ……………………………………………………………………………….. 57
4.1.2 Diagnostic Test Developer ………………………………………………………………………………. 57
4.1.3 Instrumentation Supplier …………………………………………………………………………………. 58
4.1.4 Chemical/Reagent Supplier ……………………………………………………………………………. 58
4.1.5 Pathology Supplier …………………………………………………………………………………………. 58
4.1.6 Independent Clinical Laboratory ……………………………………………………………………. 58
4.1.7 Public National/regional Laboratory ……………………………………………………………….. 59
4.1.8 Hospital Laboratory ………………………………………………………………………………………… 60
4.1.9 Physicians Office Lab (POLS) …………………………………………………………………………… 60
4.1.10 Audit Body …………………………………………………………………………………………………….. 61
4.1.11 Certification Body…………………………………………………………………………………………… 61
4.2 The Clinical Laboratory Market Segments ………………………………………………………………. 63
4.2.1 Traditional Market Segmentation…………………………………………………………………….. 63
4.2.2 Laboratory Focus and Segmentation ………………………………………………………………. 64
4.2.3 Segmenting the Syndromic Testing Market ………………………………………………………. 65
4.3 Industry Structure …………………………………………………………………………………………………… 67
4.3.1 Hospital Testing Share …………………………………………………………………………………….. 67
4.3.2 Economies of Scale ………………………………………………………………………………………… 67
4.3.2.1 Hospital vs. Central Lab ……………………………………………………………………………. 68
4.3.3 Physician Office Lab’s …………………………………………………………………………………….. 69
4.3.4 Physician’s and POCT …………………………………………………………………………………….. 69
5 Market Trends ……………………………………………………………………………………………………. 71
5.1 Factors Driving Growth ………………………………………………………………………………………….. 72
5.1.1 Speed of Diagnosis. ………………………………………………………………………………………… 72
5.1.2 Effect of Syndromic Testing on Costs. ………………………………………………………………. 73
5.1.3 Point of Care Advantage. ………………………………………………………………………………. 73
5.1.4 Accuracy and Diagnostic Risk. ……………………………………………………………………….. 73
5.1.5 Single Visits. ……………………………………………………………………………………………………. 73
5.1.6 Improvement in Outcomes. ……………………………………………………………………………. 74
5.1.7 Impact of the Pandemic. ……………………………………………………………………………….. 74
5.2 Factors Limiting Growth …………………………………………………………………………………………. 75
5.2.1 Lower Prices. ………………………………………………………………………………………………….. 75
5.2.2 Administration/reimbursement. ……………………………………………………………………….. 76
5.2.3 Infectious Disease is Declining But…. ……………………………………………………………….. 78
5.2.4 Wellness Hurts. ………………………………………………………………………………………………… 78
5.2.5 Economic Growth improves Living Standards. …………………………………………………. 78
5.2.6 Impact of the Pandemic ………………………………………………………………………………… 79
5.3 Instrumentation, Automation and Diagnostic Trends ………………………………………………. 80
5.3.1 Traditional Automation and Centralization ………………………………………………………. 80
5.3.2 The New Automation, Decentralization and Point of Care ……………………………….. 80
5.3.3 Instruments Key to Market Share ……………………………………………………………………… 82
5.3.4 Bioinformatics Plays a Role ……………………………………………………………………………… 82
5.3.5 PCR Takes Command …………………………………………………………………………………….. 83
5.3.6 Next Generation Sequencing Fuels a Revolution ……………………………………………… 84
5.3.7 NGS Impact on Pricing ……………………………………………………………………………………. 85
5.3.8 Whole Genome Sequencing, A Brave New World …………………………………………… 85
5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment …………………………………… 86
5.3.10 Comparing Syndrome and Targeted Testing …………………………………………………… 87
5.3.11 The Multiplex Paradigm Shift……………………………………………………………………………. 89
5.3.12 The Sepsis Testing Market – Bellwether for Syndromics ………………………………………. 90
5.3.13 The Single Visit and AntiMicrobial Resistance …………………………………………………… 90
5.3.14 Syndromics drives POCT adoption. ………………………………………………………………….. 91
6 Syndromic Testing Recent Developments …………………………………………………………… 92
6.1 Recent Developments – Importance and How to Use This Section ………………………….. 93
6.1.1 Importance of These Developments ……………………………………………………………….. 93
6.1.2 How to Use This Section …………………………………………………………………………………… 93
6.2 BioMérieux Submits Application for Respiratory, Sore Throat Panel …………………………… 93
6.3 Sensible Diagnostics Nabs Award for Respiratory Panel …………………………………………… 94
6.4 Aptitude Medical Systems to Develop At-Home STI Test ………………………………………….. 95
6.5 Multiplex Meningitis/Encephalitis Panel Market Expanding ……………………………………… 95
6.6 Burst Dx to Deliver Lab-Accurate ELISA-in-a-Cartridge …………………………………………… 104
6.7 OpGen Seeking Approval for UTI Panel ………………………………………………………………… 108
6.8 Altratech to Enter MDx, POC Space by Supplanting PCR ………………………………………. 109
6.9 BIOFIRE Announces New SPOTFIRE® System ………………………………………………………….. 114
6.10 Cambridge Nucleomics to Develop ‘Nanobait’ Tech ………………………………………… 115
6.11 Takara Bio Developing Multiplex Panels …………………………………………………………….. 118
6.12 Rover Diagnostics Developing Optical Multiplex PCR ………………………………………… 119
6.13 Nanopath Secures Funding to Develop POC Dx ……………………………………………….. 120
6.14 Genetic Signatures Wins Public Health Wales Contract ……………………………………… 122
6.15 Qiagen Looks to Long-Term Growth ………………………………………………………………….. 122
6.16 LexaGene Gets Investment ………………………………………………………………………………. 127
6.17 Seegene Multiplex COVID-19/Flu/RSV Test Receives Approval …………………………… 127
6.18 BforCure to Adapt Rapid PCR Platform for Cancer ……………………………………………. 128
6.19 Accelerated Growth for Decentralized Testing………………………………………………….. 129
6.20 QuantuMDx Developing Syndromic Panels for European Launch ………………………. 137
6.21 Quidel Gains CE Mark for Savanna Analyzer, Respiratory Panel …………………………. 141
6.22 QuantumDx Gets CE Mark for Rapid PoC PCR System ……………………………………….. 142
6.23 Bio-Rad Laboratories, Seegene Partner for MDx Development …………………………… 143
6.24 Baebies to Expand Finder Platform ……………………………………………………………………. 144
6.25 With Luminex Acquisition, DiaSorin to Broaden MDx Portfolio ……………………………… 147
6.26 Binx Health Targeting Clinics, DTC & OTC With STI Tests ………………………………………. 151
6.27 Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV ………………. 155
6.28 Molzym, Fraunhofer Developing Rapid Sepsis Diagnostic …………………………………… 156
6.29 MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test ……………………………… 160
6.30 New Approach Involves Silicon-Based Test for Infectious Disease Screening ……….. 161
6.31 Scanogen’s Portable Battery Operated Instrument for 90 Minute Multiplex Test ….. 165
6.32 Qiagen sees NeuMoDx as Growth Vehicle ……………………………………………………….. 168
6.33 Torus Biosystems Developing Syndromic Test with 30-Minute Turnaround …………….. 173
6.34 Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests ……………. 176
6.35 BioMérieux’s BioFire SARS-CoV-2 Respiratory Panel Wins FDA EAU ……………………….. 177
6.36 Infectious Disease Testing Firm Curative Acquires KorvaLabs ……………………………… 178
6.37 ChromaCode Raises Additional $10M ………………………………………………………………. 178
6.38 COVID-19 Patients Need Syndromic Testing ………………………………………………………. 179
6.39 GenMark Diagnostics – New Respiratory Panel due in June ……………………………….. 181
6.40 Qiagen Respiratory Panel with Coronavirus Targets Receives CE Mark ……………….. 182
6.41 Exact Diagnostics launches respiratory panel control ………………………………………… 183
6.42 bioMérieux submits enhanced BIOFIRE® BCID2 Panel to FDA …………………………….. 183
7 Profiles of Key Syndromic Testing Companies ……………………………………………………. 186
7.1 Abacus Diagnostica ……………………………………………………………………………………………. 187
7.2 Abbott Laboratories …………………………………………………………………………………………….. 188
7.3 Accelerate Diagnostics ……………………………………………………………………………………….. 189
7.4 Ador Diagnostics …………………………………………………………………………………………………. 190
7.5 ADT Biotech ………………………………………………………………………………………………………… 191
7.6 Akonni Biosystems ……………………………………………………………………………………………….. 192
7.7 Alveo Technologies ……………………………………………………………………………………………… 193
7.8 Antelope Dx ………………………………………………………………………………………………………… 194
7.9 Applied BioCode ………………………………………………………………………………………………… 195
7.10 Aureum Diagnostics …………………………………………………………………………………………. 197
7.11 Aus Diagnostics ……………………………………………………………………………………………….. 198
7.12 Baebies …………………………………………………………………………………………………………… 199
7.13 Beckman Coulter Diagnostics …………………………………………………………………………… 201
7.14 Becton, Dickinson and Company …………………………………………………………………….. 202
7.15 Binx Health ………………………………………………………………………………………………………. 204
7.16 Biocartis …………………………………………………………………………………………………………… 205
7.17 BioFire Diagnostics (bioMérieux) ……………………………………………………………………….. 206
7.18 bioMérieux Diagnostics …………………………………………………………………………………….. 208
7.19 Bio-Rad Laboratories, Inc………………………………………………………………………………….. 210
7.20 Bosch Healthcare Solutions GmbH ……………………………………………………………………. 212
7.21 Cepheid (Danaher) …………………………………………………………………………………………. 213
7.22 Credo Diagnostics Biomedical …………………………………………………………………………. 215
7.23 Cue Health ………………………………………………………………………………………………………. 216
7.24 Curetis N.V. / Curetis GmbH ……………………………………………………………………………… 218
7.25 Detect …………………………………………………………………………………………………………….. 219
7.26 Diagenode Diagnostics ……………………………………………………………………………………. 220
7.27 Diasorin S.p.A. ………………………………………………………………………………………………….. 221
7.28 Domus Diagnostics …………………………………………………………………………………………… 223
7.29 Enzo Biochem ………………………………………………………………………………………………….. 224
7.30 Eurofins Scientific ……………………………………………………………………………………………… 225
7.31 Fluxergy …………………………………………………………………………………………………………… 227
7.32 Fusion Genomics. …………………………………………………………………………………………….. 228
7.33 Genetic Signatures …………………………………………………………………………………………… 230
7.34 GenMark Dx (Roche) ……………………………………………………………………………………….. 231
7.35 Grip Molecular Technologies ……………………………………………………………………………. 233
7.36 Hibergene Diagnostics……………………………………………………………………………………… 234
7.37 Hologic ……………………………………………………………………………………………………………. 235
7.38 Immunexpress ………………………………………………………………………………………………….. 237
7.39 Inflammatix ……………………………………………………………………………………………………… 238
7.40 Invetech ………………………………………………………………………………………………………….. 239
7.41 Janssen Diagnostics …………………………………………………………………………………………. 240
7.42 Karius ………………………………………………………………………………………………………………. 241
7.43 Lexagene ………………………………………………………………………………………………………… 242
7.44 LightDeck Diagnostics ……………………………………………………………………………………… 243
7.45 Lucira Health ……………………………………………………………………………………………………. 244
7.46 Luminex Corp (DiaSorin) …………………………………………………………………………………… 245
7.47 Maxim Biomedical …………………………………………………………………………………………… 247
7.48 Meridian Bioscience …………………………………………………………………………………………. 248
7.49 Mesa Biotech (Thermo Fisher) …………………………………………………………………………… 250
7.50 MicroGem ……………………………………………………………………………………………………….. 251
7.51 Millipore Sigma ………………………………………………………………………………………………… 252
7.52 Minute Molecular …………………………………………………………………………………………….. 253
7.53 Mobidiag (Hologic) ………………………………………………………………………………………….. 254
7.54 Molbio Diagnostics …………………………………………………………………………………………… 255
7.55 Nanomix ………………………………………………………………………………………………………….. 256
7.56 Novel Microdevices …………………………………………………………………………………………. 257
7.57 OnsiteGene …………………………………………………………………………………………………….. 258
7.58 Operon ……………………………………………………………………………………………………………. 259
7.59 Oxford Nanopore Technologies ……………………………………………………………………….. 260
7.60 Panagene ……………………………………………………………………………………………………….. 261
7.61 Perkin Elmer ……………………………………………………………………………………………………… 262
7.62 Primerdesign (Novacyt) ……………………………………………………………………………………. 263
7.63 Prominex …………………………………………………………………………………………………………. 264
7.64 Proof Diagnostics ……………………………………………………………………………………………… 265
7.65 Qiagen ……………………………………………………………………………………………………………. 266
7.66 QuantuMDx …………………………………………………………………………………………………….. 268
7.67 QuidelOrtho …………………………………………………………………………………………………….. 269
7.68 Roche Molecular Diagnostics …………………………………………………………………………… 270
7.69 Saw Diagnostics ………………………………………………………………………………………………. 272
7.70 Scope Fluidics ………………………………………………………………………………………………….. 273
7.71 Seegene………………………………………………………………………………………………………….. 274
7.72 Siemens Healthineers ……………………………………………………………………………………….. 276
7.73 Sona Nanotech ……………………………………………………………………………………………….. 277
7.74 SpeeDx ……………………………………………………………………………………………………………. 278
7.75 T2 Biosystems ……………………………………………………………………………………………………. 279
7.76 Talis Biomedical ……………………………………………………………………………………………….. 280
7.77 Thermo Fisher Scientific Inc. ………………………………………………………………………………. 281
7.78 Vela Diagnostics ………………………………………………………………………………………………. 283
7.79 Veramarx ………………………………………………………………………………………………………… 284
7.80 Visby Medical ………………………………………………………………………………………………….. 285
7.81 XCR Diagnostics ………………………………………………………………………………………………. 287
8 The Global Market for Syndromic Multiplex Diagnostics ……………………………………… 288
8.1 Global Market Overview by Country ……………………………………………………………………. 289
8.1.1 Table – Global Market by Country …………………………………………………………………. 289
8.1.2 Chart – Global Market by Country …………………………………………………………………. 290
8.2 Global Market by Syndrome – Overview ………………………………………………………………. 291
8.2.1 Table – Global Market by Syndrome ……………………………………………………………… 291
8.2.2 Chart – Global Market by Syndrome – Base/Final Year Comparison ……………….. 292
8.2.3 Chart – Global Market by Syndrome – Base Year …………………………………………… 293
8.2.4 Chart – Global Market by Syndrome – End Year …………………………………………….. 294
8.2.5 Chart – Global Market by Syndrome – Share by Year …………………………………….. 295
8.2.6 Chart – Global Market by Syndrome – Segments Growth ……………………………….. 296
8.3 Global Market by Place – Overview ……………………………………………………………………… 297
8.3.1 Table – Global Market by Place …………………………………………………………………….. 297
8.3.2 Chart – Global Market by Place – Base/Final Year Comparison ……………………… 298
8.3.3 Chart – Global Market by Place – Base Year………………………………………………….. 299
8.3.4 Chart – Global Market by Place – End Year …………………………………………………… 300
8.3.5 Chart – Global Market by Place – Share by Year ……………………………………………. 301
8.3.6 Chart – Global Market by Place – Segments Growth ……………………………………… 302
8.4 Global Market by Product – Overview ………………………………………………………………….. 303
8.4.1 Table – Global Market by Product …………………………………………………………………. 303
8.4.2 Chart – Global Market by Product – Base/Final Year Comparison …………………… 304
8.4.3 Chart – Global Market by Product – Base Year ………………………………………………. 305
8.4.4 Chart – Global Market by Product – End Year ……………………………………………….. 306
8.4.5 Chart – Global Market by Product – Share by Year ………………………………………… 307
8.4.6 Chart – Global Market by Product – Segments Growth ………………………………….. 308
9 Global Syndromic Multiplex Markets – By Syndrome ………………………………………….. 309
9.1 Respiratory ………………………………………………………………………………………………………….. 310
9.1.1 Table Respiratory – by Country ……………………………………………………………………… 310
9.1.2 Chart – Respiratory Growth ……………………………………………………………………………. 311
9.2 Gastrointestinal……………………………………………………………………………………………………. 312
9.2.1 Table Gastrointestinal – by Country ……………………………………………………………….. 312
9.2.2 Chart – Gastrointestinal Growth …………………………………………………………………….. 313
9.3 Blood ………………………………………………………………………………………………………………….. 314
9.3.1 Table Blood – by Country ……………………………………………………………………………… 314
9.3.2 Chart – Blood Growth ……………………………………………………………………………………. 315
9.4 Meningitis/Encephalitis ………………………………………………………………………………………… 316
9.4.1 Table Meningitis/Encephalitis – by Country …………………………………………………….. 316
9.4.2 Chart – Meningitis/Encephalitis Growth ………………………………………………………….. 317
9.5 Sexually Transmitted Disease ………………………………………………………………………………… 318
9.5.1 Table Sexually Transmitted Disease – by Country ……………………………………………. 318
9.5.2 Chart – Sexually Transmitted Disease Growth …………………………………………………. 319
9.6 Other Syndrome ………………………………………………………………………………………………….. 320
9.6.1 Table Other – by Country ……………………………………………………………………………… 320
9.6.2 Chart – Other Growth ……………………………………………………………………………………. 321
10 Global MDx Infectious Disease Markets – by Place ……………………………………….. 322
10.1 Hospital Lab …………………………………………………………………………………………………….. 323
10.1.1 Table Hospital Lab – by Country ……………………………………………………………………. 323
10.1.2 Chart – Hospital Lab Growth ………………………………………………………………………….. 324
10.2 Outpatient Lab ………………………………………………………………………………………………… 325
10.2.1 Table Outpatient Lab – by Country ……………………………………………………………….. 325
10.2.2 Chart – Outpatient Lab Growth …………………………………………………………………….. 326
10.3 Point of Care ……………………………………………………………………………………………………. 327
10.3.1 Table Point of Care – by Country …………………………………………………………………… 327
10.3.2 Chart – Point of Care Growth ………………………………………………………………………… 328
10.4 Other Place …………………………………………………………………………………………………….. 329
10.4.1 Table Other – by Country ……………………………………………………………………………… 329
10.4.2 Chart – Other Place Growth ………………………………………………………………………….. 330
11 Global MDx Infectious Disease Markets – by Product ……………………………………. 331
11.1 Instruments ………………………………………………………………………………………………………. 332
11.1.1 Table Instruments – by Country ……………………………………………………………………… 332
11.1.2 Chart – Instruments Growth ……………………………………………………………………………. 333
11.2 Cartridges ……………………………………………………………………………………………………….. 334
11.2.1 Table Cartridges – by Country ………………………………………………………………………. 334
11.2.2 Chart – Cartridges Growth …………………………………………………………………………….. 335
11.3 Reagents …………………………………………………………………………………………………………. 336
11.3.1 Table Reagents – by Country ………………………………………………………………………… 336
11.3.2 Chart – Reagents Growth ……………………………………………………………………………… 337
11.4 Other Product ………………………………………………………………………………………………….. 338
11.4.1 Table Other Product – by Country …………………………………………………………………. 338
11.4.2 Chart – Other Product Growth ………………………………………………………………………. 339
12 Appendices ………………………………………………………………………………………………… 340
12.1 United States Medicare System: Clinical Laboratory Fees Schedule …………………… 341
12.2 The Most Used IVD Assays …………………………………………………………………………………. 443
12.3 The Highest Grossing Assays ……………………………………………………………………………… 448
Profiles of Key Syndromic Testing Companies ……………………………………………………. 186
7.1 Abacus Diagnostica ……………………………………………………………………………………………. 187
7.2 Abbott Laboratories …………………………………………………………………………………………….. 188
7.3 Accelerate Diagnostics ……………………………………………………………………………………….. 189
7.4 Ador Diagnostics …………………………………………………………………………………………………. 190
7.5 ADT Biotech ………………………………………………………………………………………………………… 191
7.6 Akonni Biosystems ……………………………………………………………………………………………….. 192
7.7 Alveo Technologies ……………………………………………………………………………………………… 193
7.8 Antelope Dx ………………………………………………………………………………………………………… 194
7.9 Applied BioCode ………………………………………………………………………………………………… 195
7.10 Aureum Diagnostics …………………………………………………………………………………………. 197
7.11 Aus Diagnostics ……………………………………………………………………………………………….. 198
7.12 Baebies …………………………………………………………………………………………………………… 199
7.13 Beckman Coulter Diagnostics …………………………………………………………………………… 201
7.14 Becton, Dickinson and Company …………………………………………………………………….. 202
7.15 Binx Health ………………………………………………………………………………………………………. 204
7.16 Biocartis …………………………………………………………………………………………………………… 205
7.17 BioFire Diagnostics (bioMérieux) ……………………………………………………………………….. 206
7.18 bioMérieux Diagnostics …………………………………………………………………………………….. 208
7.19 Bio-Rad Laboratories, Inc………………………………………………………………………………….. 210
7.20 Bosch Healthcare Solutions GmbH ……………………………………………………………………. 212
7.21 Cepheid (Danaher) …………………………………………………………………………………………. 213
7.22 Credo Diagnostics Biomedical …………………………………………………………………………. 215
7.23 Cue Health ………………………………………………………………………………………………………. 216
7.24 Curetis N.V. / Curetis GmbH ……………………………………………………………………………… 218
7.25 Detect …………………………………………………………………………………………………………….. 219
7.26 Diagenode Diagnostics ……………………………………………………………………………………. 220
7.27 Diasorin S.p.A. ………………………………………………………………………………………………….. 221
7.28 Domus Diagnostics …………………………………………………………………………………………… 223
7.29 Enzo Biochem ………………………………………………………………………………………………….. 224
7.30 Eurofins Scientific ……………………………………………………………………………………………… 225
7.31 Fluxergy …………………………………………………………………………………………………………… 227
7.32 Fusion Genomics. …………………………………………………………………………………………….. 228
7.33 Genetic Signatures …………………………………………………………………………………………… 230
7.34 GenMark Dx (Roche) ……………………………………………………………………………………….. 231
7.35 Grip Molecular Technologies ……………………………………………………………………………. 233
7.36 Hibergene Diagnostics……………………………………………………………………………………… 234
7.37 Hologic ……………………………………………………………………………………………………………. 235
7.38 Immunexpress ………………………………………………………………………………………………….. 237
7.39 Inflammatix ……………………………………………………………………………………………………… 238
7.40 Invetech ………………………………………………………………………………………………………….. 239
7.41 Janssen Diagnostics …………………………………………………………………………………………. 240
7.42 Karius ………………………………………………………………………………………………………………. 241
7.43 Lexagene ………………………………………………………………………………………………………… 242
7.44 LightDeck Diagnostics ……………………………………………………………………………………… 243
7.45 Lucira Health ……………………………………………………………………………………………………. 244
7.46 Luminex Corp (DiaSorin) …………………………………………………………………………………… 245
7.47 Maxim Biomedical …………………………………………………………………………………………… 247
7.48 Meridian Bioscience …………………………………………………………………………………………. 248
7.49 Mesa Biotech (Thermo Fisher) …………………………………………………………………………… 250
7.50 MicroGem ……………………………………………………………………………………………………….. 251
7.51 Millipore Sigma ………………………………………………………………………………………………… 252
7.52 Minute Molecular …………………………………………………………………………………………….. 253
7.53 Mobidiag (Hologic) ………………………………………………………………………………………….. 254
7.54 Molbio Diagnostics …………………………………………………………………………………………… 255
7.55 Nanomix ………………………………………………………………………………………………………….. 256
7.56 Novel Microdevices …………………………………………………………………………………………. 257
7.57 OnsiteGene …………………………………………………………………………………………………….. 258
7.58 Operon ……………………………………………………………………………………………………………. 259
7.59 Oxford Nanopore Technologies ……………………………………………………………………….. 260
7.60 Panagene ……………………………………………………………………………………………………….. 261
7.61 Perkin Elmer ……………………………………………………………………………………………………… 262
7.62 Primerdesign (Novacyt) ……………………………………………………………………………………. 263
7.63 Prominex …………………………………………………………………………………………………………. 264
7.64 Proof Diagnostics ……………………………………………………………………………………………… 265
7.65 Qiagen ……………………………………………………………………………………………………………. 266
7.66 QuantuMDx …………………………………………………………………………………………………….. 268
7.67 QuidelOrtho …………………………………………………………………………………………………….. 269
7.68 Roche Molecular Diagnostics …………………………………………………………………………… 270
7.69 Saw Diagnostics ………………………………………………………………………………………………. 272
7.70 Scope Fluidics ………………………………………………………………………………………………….. 273
7.71 Seegene………………………………………………………………………………………………………….. 274
7.72 Siemens Healthineers ……………………………………………………………………………………….. 276
7.73 Sona Nanotech ……………………………………………………………………………………………….. 277
7.74 SpeeDx ……………………………………………………………………………………………………………. 278
7.75 T2 Biosystems ……………………………………………………………………………………………………. 279
7.76 Talis Biomedical ……………………………………………………………………………………………….. 280
7.77 Thermo Fisher Scientific Inc. ………………………………………………………………………………. 281
7.78 Vela Diagnostics ………………………………………………………………………………………………. 283
7.79 Veramarx ………………………………………………………………………………………………………… 284
7.80 Visby Medical ………………………………………………………………………………………………….. 285
7.81 XCR Diagnostics ………………………………………………………………………………………………. 287
Table of Tables
Table 1 Market Players by Type ……………………………………………………………………………………….. 57
Table 2 Clinical Laboratory Departments and Segments …………………………………………………… 63
Table 3 Laboratory Management Focus – Different Approaches ………………………………………. 64
Table 4 Key Segmentation Variables Going Forward…………………………………………………………. 65
Table 5 Possible Market Segments of Syndromic Multiplex Market ……………………………………… 65
Table 6 Five Factors Driving Growth ………………………………………………………………………………….. 72
Table 7 How SMT Improves Outcomes ………………………………………………………………………………. 74
Table 8 Four Factors Limiting Growth ………………………………………………………………………………… 75
Table 9 Seven Key Diagnostic Laboratory Technology Trends ……………………………………………. 80
Table 10 – Global Market by Region ……………………………………………………………………………….. 289
Table 11 Global Market by Syndrome …………………………………………………………………………….. 291
Table 12 Global Market by Place ……………………………………………………………………………………. 297
Table 13 Global Market by Product ………………………………………………………………………………… 303
Table 14 Respiratory by Country……………………………………………………………………………………… 310
Table 15 Gastrointestinal by Country ……………………………………………………………………………… 312
Table 16 Blood by Country ……………………………………………………………………………………………… 314
Table 17 Meningitis/Encephalitis by Country ……………………………………………………………………. 316
Table 18 Sexually Transmitted Disease by Country …………………………………………………………… 318
Table 19 Other by Country ……………………………………………………………………………………………… 320
Table 20 Hospital Lab by Country ………………………………………………………………………………….. 323
Table 21 Outpatient Lab by Country ………………………………………………………………………………. 325
Table 22 Point of Care by Country …………………………………………………………………………………. 327
Table 23 Other by Country …………………………………………………………………………………………….. 329
Table 24 Instruments by Country ……………………………………………………………………………………. 332
Table 25 Cartridges by Country ………………………………………………………………………………………. 334
Table 26 Reagents by Country ………………………………………………………………………………………. 336
Table 27 Other Product by Country ……………………………………………………………………………….. 338
Table 28 Clinical Lab Fee Schedule ……………………………………………………………………………….. 341
Table 29 The Most Common Assays ……………………………………………………………………………….. 443
Table 30 Largest Revenue Assays ……………………………………………………………………………………. 448
Table of Figures
Figure 1 Global Healthcare Spending ………………………………………………………………………………. 36
Figure 2 The Lab Test Pie ………………………………………………………………………………………………….. 37
Figure 3 The Road to Diagnostics ……………………………………………………………………………………… 56
Figure 4 Chart Death Rates and Infectious Disease Decline ………………………………………………. 77
Figure 5 Centralized vs. Decentralized Laboratory Service ………………………………………………… 81
Figure 6 A Highly Multiplexed Syndromic Testing Unit …………………………………………………………. 81
Figure 7 The Real Cost to Sequence the Human Genome…………………………………………………. 84
Figure 8 The Codevelopment Process ………………………………………………………………………………. 86
Figure 9 Comparing Syndromic and Targeted Testing ……………………………………………………….. 88
Figure 17 The Multiplex Paradigm Shift ………………………………………………………………………………. 89
Figure 11 Global Market Share Chart …………………………………………………………………………….. 290
Figure 12 Global Market by Syndrome – Base vs. Final ……………………………………………………… 292
Figure 13 Global Market by Syndrome Base Year ……………………………………………………………. 293
Figure 14 Global Market by Syndrome End Year ……………………………………………………………… 294
Figure 15 Syndrome Share by Year …………………………………………………………………………………. 295
Figure 16 Syndrome Segments Growth ……………………………………………………………………………. 296
Figure 17 Global Market by Place – Base vs. Final…………………………………………………………….. 298
Figure 18 Global Market by Place Base Year …………………………………………………………………… 299
Figure 19 Global Market by Place End Year ……………………………………………………………………. 300
Figure 20 Place Share by Year ………………………………………………………………………………………… 301
Figure 21 Place Segments Growth ………………………………………………………………………………….. 302
Figure 22 Global Market by Product – Base vs. Final …………………………………………………………. 304
Figure 23 Global Market by Product Base Year ……………………………………………………………….. 305
Figure 24 Global Market by Product End Year …………………………………………………………………. 306
Figure 25 Product Share by Year …………………………………………………………………………………….. 307
Figure 26 Product Segments Growth ………………………………………………………………………………. 308
Figure 27 Respiratory Growth ………………………………………………………………………………………….. 311
Figure 28 Gastrointestinal Diagnostics Growth …………………………………………………………………. 313
Figure 29 Blood Growth ………………………………………………………………………………………………….. 315
Figure 30 Meningitis/Encephalitis Growth ………………………………………………………………………… 317
Figure 31 Sexually Transmitted Disease Growth ……………………………………………………………….. 319
Figure 32 Other Growth ………………………………………………………………………………………………….. 321
Figure 33 Hospital Lab Growth ………………………………………………………………………………………… 324
Figure 34 Outpatient Lab Growth …………………………………………………………………………………… 326
Figure 35 Point of Care Growth ………………………………………………………………………………………. 328
Figure 36 Other Growth ………………………………………………………………………………………………….. 330
Figure 37 Instruments Growth …………………………………………………………………………………………. 333
Figure 38 Cartridges Growth …………………………………………………………………………………………… 335
Figure 39 Reagents Growth ……………………………………………………………………………………………. 337
Figure 40 Other Product Growth …………………………………………………………………………………….. 339
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