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Artificial Intelligence for In Vitro Diagnostics | Howe Sound Research - Howe Sound Research SEE the
Artificial Intelligence for In Vitro Diagnostics | Howe Sound Research - Howe Sound Research
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DocumentDocumentRESEARCH REPORT SMART IN VITRO DIAGNOSTICS ARTIFICIAL INTELLIGENCE FOR IVD MARKETS BY APPLICATION, BY TECHNOLOGY AND BY USER WITH EXECUTIVE AND CONSULTANT GUIDES 2025 - 2029 Smart IVD Markets Page | 2 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 XRay 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. HOWE SOUND RESEARCH Smart IVD Markets Page | 3 All Rights Reserved. This document contains copyrighted intellectual property. No part of it may be circulated, copied, quoted, or otherwise reproduced without the approval of Howe Sound Research. Please respect our intellectual property and do not distribute this document beyond the terms of your license. HOWE SOUND RESEARCH Smart IVD Markets Page | 4 Table of Contents 1 Market Guides ..................................................................................................................20 1.1 Strategic Situation Analysis .............................................................................................. 21 1.2 Guide for Executives, Marketing, and Business Development Staff............................. 25 1.3 Guide for Management Consultants and Investment Advisors ................................... 26 2 Introduction and Market Definition ................................................................................27 2.1 What are Smart Diagnostics? .......................................................................................... 28 2.2 Market Definition .............................................................................................................. 30 2.2.1 Revenue Market Size.................................................................................................... 30 2.3 Methodology.................................................................................................................... 32 2.3.1 Methodology ................................................................................................................ 32 2.3.2 Sources .......................................................................................................................... 32 2.3.3 Authors .......................................................................................................................... 32 2.4 Perspective: Healthcare and the IVD Industry .............................................................. 34 2.4.1 Global Healthcare Spending ...................................................................................... 34 2.4.2 Spending on Diagnostics ............................................................................................. 35 2.4.3 Important Role of Insurance for Diagnostics .............................................................. 37 3 Market Overview..............................................................................................................38 3.1 Players in a Dynamic Market........................................................................................... 39 3.1.1 Academic Research Lab ............................................................................................ 40 HOWE SOUND RESEARCH Smart IVD Markets Page | 5 3.1.2 Diagnostic Test Developer........................................................................................... 40 3.1.3 Instrumentation Supplier .............................................................................................. 41 3.1.4 Chemical/Reagent Supplier........................................................................................ 41 3.1.5 Pathology Supplier ....................................................................................................... 41 3.1.6 Independent Clinical Laboratory ............................................................................... 42 3.1.7 Public National/regional Laboratory .......................................................................... 42 3.1.8 Hospital Laboratory ...................................................................................................... 43 3.1.9 Physicians Office Lab (POLS) ....................................................................................... 43 3.1.10 Audit Body................................................................................................................. 44 3.1.11 Certification Body..................................................................................................... 44 3.2 Understanding Artificial Intelligence............................................................................... 46 3.2.1 Artificial intelligence..................................................................................................... 46 3.2.2 Machine learning ......................................................................................................... 47 3.2.3 Deep learning............................................................................................................... 48 3.2.4 Convolutional neural networks ................................................................................... 50 3.2.5 Generative adversarial networks ................................................................................ 53 3.2.6 Limitations ..................................................................................................................... 53 3.3 AI Applications in IVD....................................................................................................... 56 3.3.1 Infectious Disease......................................................................................................... 56 3.3.1.1 Known vs. Unknown.............................................................................................. 57 3.3.1.2 TMI .......................................................................................................................... 57 3.3.1.3 Disease surveillance ............................................................................................. 57 3.3.1.4 Outbreak detection ............................................................................................. 57 3.3.1.5 Contact tracing .................................................................................................... 58 HOWE SOUND RESEARCH Smart IVD Markets Page | 6 3.3.1.6 Forecasting............................................................................................................ 58 3.3.1.7 Drug discovery ...................................................................................................... 58 3.3.1.8 Resource allocation ............................................................................................. 58 3.3.2 Oncology ...................................................................................................................... 59 3.3.2.1 Electronic health records ..................................................................................... 59 3.3.2.2 Genomic analysis ................................................................................................. 59 3.3.2.3 Treatment planning .............................................................................................. 59 3.3.2.4 Clinical trial matching .......................................................................................... 60 3.3.3 Anatomic Pathology.................................................................................................... 60 3.3.3.1 Image analysis ...................................................................................................... 60 3.3.3.2 Tumor segmentation ............................................................................................ 60 3.3.3.3 Disease classification............................................................................................ 61 3.3.3.4 Predictive modeling ............................................................................................. 61 3.3.3.5 Quality control ...................................................................................................... 61 3.3.3.6 Digital pathology .................................................................................................. 61 3.3.4 Cardiology .................................................................................................................... 62 3.3.4.1 Electrocardiogram analysis ................................................................................. 62 3.3.4.2 Electronic health records ..................................................................................... 62 3.3.4.3 Genomic analysis ................................................................................................. 62 3.3.4.4 Treatment planning .............................................................................................. 63 3.3.4.5 Prediction of outcomes........................................................................................ 63 3.3.5 Diabetes........................................................................................................................ 63 3.3.5.1 Diagnosis ............................................................................................................... 63 3.3.5.2 Blood glucose monitoring .................................................................................... 64 HOWE SOUND RESEARCH Smart IVD Markets Page | 7 3.3.5.3 Personalized treatment plans .............................................................................. 64 3.3.5.4 Medication management ................................................................................... 64 3.3.5.5 Diabetes education ............................................................................................. 65 3.3.5.6 Predictive analytics .............................................................................................. 65 3.3.6 General Medicine ........................................................................................................ 65 3.3.6.1 Diagnosis ............................................................................................................... 65 3.3.6.2 Predictive Analytics .............................................................................................. 65 3.3.6.3 Personalized Treatment Plans .............................................................................. 66 3.3.6.4 Medication Management ................................................................................... 66 3.3.6.5 Disease Monitoring ............................................................................................... 66 3.3.6.6 Telemedicine......................................................................................................... 66 4 Market Trends ...................................................................................................................68 4.1 Factors Driving Growth .................................................................................................... 69 4.1.1 Outcome Improvement .............................................................................................. 69 4.1.2 The Aging Effect ........................................................................................................... 70 4.1.3 Cost Containment........................................................................................................ 72 4.1.4 Physician Impact .......................................................................................................... 72 4.1.5 Cost of Intelligence ...................................................................................................... 73 4.2 Factors Limiting Growth ................................................................................................... 74 4.2.1 State of knowledge...................................................................................................... 74 4.2.2 Genetic Blizzard ............................................................................................................ 75 4.2.3 Protocol Resistance...................................................................................................... 75 4.2.4 Regulation and coverage........................................................................................... 75 4.3 Instrumentation, Automation and Diagnostic Trends ................................................... 76 HOWE SOUND RESEARCH Smart IVD Markets Page | 8 4.3.1 Traditional Automation and Centralization................................................................ 76 4.3.2 The New Automation, Decentralization and Point Of Care ..................................... 76 4.3.3 Instruments Key to Market Share................................................................................. 78 4.3.4 Bioinformatics Plays a Role .......................................................................................... 78 4.3.5 PCR Takes Command .................................................................................................. 79 4.3.6 Next Generation Sequencing Fuels a Revolution...................................................... 80 4.3.7 NGS Impact on Pricing................................................................................................. 81 4.3.8 Whole Genome Sequencing, A Brave New World ................................................... 81 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment .......................................... 81 4.3.10 Shifting Role of Diagnostics ...................................................................................... 83 5 Recent Developments.....................................................................................................84 5.1 Recent Developments Importance and How to Use This Section ............................ 85 5.1.1 Importance of These Developments .......................................................................... 85 5.1.2 How to Use This Section................................................................................................ 85 5.2 Ataraxis AI Launches AI Cancer Dx ................................................................................ 85 5.3 Tempus Immuno-Oncology Portfolio AI-enabled.......................................................... 87 5.4 AI enables precision diagnosis of cervical cancer ....................................................... 89 5.5 UK to Rollout Digital Pathology Across NHS.................................................................... 89 5.6 AI Based Next-Generation Colorectal Cancer Test ...................................................... 90 5.7 Evident, Corista, Sakura Finetek, Visiopharm Form Digital Pathology Alliance........... 94 5.8 Viome Life Sciences Raises $86.5M in Oversubscribed Series C Round....................... 95 5.9 Becton Dickinson Gets Clearance for AI-Based Bacterial Imaging............................. 96 5.10 Paige, Leica Biosystems Expand Digital Pathology Partnership ................................... 97 5.11 Clarapath Acquires Digital Pathology Company Crosscope ...................................... 97 HOWE SOUND RESEARCH Smart IVD Markets Page | 9 5.12 CanSense to Develop Colorectal Cancer Test ............................................................. 99 5.13 Owkin-led Machine Learning Study IDs Cancer Treatment Biomarkers ...................... 99 5.14 Guardant Health to Integrate Lunit's AI PD-L1 Algorithm............................................ 105 5.15 Vésale Bioscience to Develop AI Phage Therapy Diagnostic Platform .................... 106 5.16 Caris Life Sciences To Use AI and Machine Learning.................................................. 106 5.17 Numares Health To Develop AI for "Metabolite Constellations"................................ 107 5.18 Sepsis Testing Startup DeepUll to Use AI for Medical Decisions .................................. 108 5.19 Viome Life Sciences Raises $67M in Series C Financing For AI Cancer Dx ................ 108 5.20 ADM Diagnostics Wins Grant for Brain Injury Test Development ................................ 109 5.21 Paige to Develop New AI-based Pathology Test ........................................................ 110 5.22 Aiforia Gains CE-IVD Mark for AI-Powered Histopathology ........................................ 114 5.23 Genetic Profiling May Identify Patients Who Do Not Need Radiation Therapy ........ 115 5.24 Thermo Fisher Introduces Homologous Score for Cancer Profiling ............................ 116 5.25 Genomic Test IDs Cancer Cells Early ............................................................................ 118 6 Profiles of Key Players .....................................................................................................123 6.1 Adaptive Biotechnologies ............................................................................................. 124 6.2 Aidoc............................................................................................................................... 126 6.3 Anumana........................................................................................................................ 127 6.4 ARUP Laboratories.......................................................................................................... 128 6.5 Atomwise ........................................................................................................................ 130 6.6 Bayesian Health.............................................................................................................. 131 6.7 Behold.ai ......................................................................................................................... 132 6.8 BGI Genomics Co. Ltd ................................................................................................... 133 6.9 bioMérieux Diagnostics.................................................................................................. 135 HOWE SOUND RESEARCH Smart IVD Markets Page | 10 6.10 Bio-Rad Laboratories, Inc............................................................................................... 138 6.11 Cambridge Cognition ................................................................................................... 140 6.12 Cardiologs (Phillips) ........................................................................................................ 142 6.13 CareDx ............................................................................................................................ 143 6.14 Caris Molecular Diagnostics .......................................................................................... 145 6.15 Cleerly ............................................................................................................................. 146 6.16 ClosedLoop AI ................................................................................................................ 148 6.17 CloudMedX Health ........................................................................................................ 149 6.18 Deepcell ......................................................................................................................... 150 6.19 Digital Diagnostics.......................................................................................................... 151 6.20 EKF Diagnostics Holdings ............................................................................................... 152 6.21 Freenome........................................................................................................................ 154 6.22 GE Healthcare................................................................................................................ 155 6.23 Glooko............................................................................................................................. 156 6.24 Idoven ............................................................................................................................. 157 6.25 Illumina ............................................................................................................................ 158 6.26 Infohealth........................................................................................................................ 159 6.27 Jade ................................................................................................................................ 160 6.28 K Health........................................................................................................................... 161 6.29 Lunit ................................................................................................................................. 162 6.30 MaxCyte ......................................................................................................................... 163 6.31 Mayo Clinic Laboratories............................................................................................... 164 6.32 Medtronic ....................................................................................................................... 165 6.33 Merative.......................................................................................................................... 167 HOWE SOUND RESEARCH Smart IVD Markets Page | 11 6.34 Nanox.............................................................................................................................. 168 6.35 NIOX Group .................................................................................................................... 169 6.36 Niramai Health Analytix ................................................................................................. 170 6.37 NVIDIA ............................................................................................................................. 171 6.38 Oncohost ........................................................................................................................ 174 6.39 OraLiva............................................................................................................................ 175 6.40 Owkin .............................................................................................................................. 176 6.41 Oxford Nanopore Technologies ................................................................................... 178 6.42 Pacific Biosciences......................................................................................................... 180 6.43 Paige.AI........................................................................................................................... 182 6.44 PathAI.............................................................................................................................. 183 6.45 Perthera .......................................................................................................................... 184 6.46 Philips Healthcare........................................................................................................... 185 6.47 Prognos ........................................................................................................................... 187 6.48 Qiagen ............................................................................................................................ 188 6.49 Qure.ai ............................................................................................................................ 191 6.50 Renalytix.......................................................................................................................... 192 6.51 Seegene.......................................................................................................................... 194 6.52 Siemens Healthineers ..................................................................................................... 196 6.53 Sophia Genetics ............................................................................................................. 198 6.54 Sysmex............................................................................................................................. 199 6.55 Viz.ai ................................................................................................................................ 202 7 The Global Market for Smart Diagnostics.....................................................................203 7.1 Global Market Overview by Country ........................................................................... 204 HOWE SOUND RESEARCH Smart IVD Markets Page | 12 7.1.1 Table Global Market by Country............................................................................ 204 7.1.2 Chart - Global Market by Country ............................................................................ 205 7.2 Global Market by Application - Overview ................................................................... 206 7.2.1 Table Global Market by Application ..................................................................... 206 7.2.2 Chart Global Market by Application Base/Final Year Comparison ................. 207 7.2.3 Chart Global Market by Application Base Year ................................................ 208 7.2.4 Chart Global Market by Application Final Year................................................. 209 7.2.5 Chart Global Market by Application Share by Year.......................................... 210 7.2.6 Chart Global Market by Application Segment Growth .................................... 211 7.3 Global Market by Technology - Overview................................................................... 212 7.3.1 Table Global Market by Technology ..................................................................... 212 7.3.2 Chart Global Market by Technology Base/Final Year Comparison ................. 213 7.3.3 Chart Global Market by Technology Base Year ................................................ 214 7.3.4 Chart Global Market by Technology Final Year................................................. 215 7.3.5 Chart Global Market by Technology Share by Year.......................................... 216 7.3.6 Chart Global Market by Technology Segment Growth .................................... 217 7.4 Global Market by Place - Overview ............................................................................. 218 7.4.1 Table Global Market by Place................................................................................ 218 7.4.2 Chart Global Market by Place Base/Final Year Comparison ........................... 219 7.4.3 Chart Global Market by Place Base Year........................................................... 220 7.4.4 Chart Global Market by Place Final Year ........................................................... 221 7.4.5 Chart Global Market by Place Share by Year.................................................... 222 7.4.6 Chart Global Market by Place Segment Growth .............................................. 223 8 Global Markets By Application...................................................................................224 HOWE SOUND RESEARCH Smart IVD Markets Page | 13 8.1 Cancer ............................................................................................................................ 225 8.1.1 Table Cancer Testing by Country........................................................................... 225 8.1.2 Chart - Cancer Testing Growth ................................................................................. 226 8.2 Infectious Disease Testing .............................................................................................. 227 8.2.1 Table Infectious Disease Testing by Country ......................................................... 227 8.2.2 Chart Infectious Disease Testing Growth ............................................................... 228 8.3 Metabolic Testing ........................................................................................................... 229 8.3.1 Table Metabolic Testing by Country ...................................................................... 229 8.3.2 Chart - Metabolic Testing Growth............................................................................. 230 8.4 Cardiac Testing .............................................................................................................. 231 8.4.1 Table Cardiac Testing by Country.......................................................................... 231 8.4.2 Chart - Cardiac Testing Growth ................................................................................ 232 8.5 Diabetes Testing ............................................................................................................. 233 8.5.1 Table Diabetes Testing by Country ........................................................................ 233 8.5.2 Chart - Diabetes Testing Growth............................................................................... 234 8.6 Other Disease Testing..................................................................................................... 235 8.6.1 Table Other Disease Testing by Country ................................................................ 235 8.6.2 Chart Other Disease Testing Growth...................................................................... 236 9 Global Markets By Technology ..................................................................................237 9.1 NGS Technology............................................................................................................. 238 9.1.1 Table NGS Technology by Country ........................................................................ 238 9.1.2 Chart NGS Technology Growth.............................................................................. 239 9.2 PCR Technology ............................................................................................................. 240 9.2.1 Table PCR Technology by Country ........................................................................ 240 HOWE SOUND RESEARCH Smart IVD Markets Page | 14 9.2.2 Chart PCR Technology Growth .............................................................................. 241 9.3 Chemistry/IA Technology .............................................................................................. 242 9.3.1 Table Chemistry/IA Technology by Country.......................................................... 242 9.3.2 Chart - Chemistry/IA Technology Growth ................................................................ 243 9.4 Pathology Technology................................................................................................... 244 9.4.1 Table Pathology Technology by Country .............................................................. 244 9.4.2 Chart - Pathology Technology Growth .................................................................... 245 9.5 Other Technology .......................................................................................................... 246 9.5.1 Table Other Technology by Country...................................................................... 246 9.5.2 Chart - Other Technology Growth ............................................................................ 247 10 Global Markets By Place........................................................................................248 10.1 Research ......................................................................................................................... 249 10.1.1 Table Research by Country ................................................................................ 249 10.1.2 Chart Research Growth ...................................................................................... 250 10.2 Pharmaceutical Research............................................................................................. 251 10.2.1 Table Pharmaceutical Research by Country .................................................... 251 10.2.2 Chart - Pharmaceutical Research Growth .......................................................... 252 10.3 Clinical ............................................................................................................................ 253 10.3.1 Table Clinical by Country .................................................................................... 253 10.3.2 Chart - Clinical Growth .......................................................................................... 254 10.4 Other Place .................................................................................................................... 255 10.4.1 Table Other Place by Country ............................................................................ 255 10.4.2 Chart Other Place Growth.................................................................................. 256 11 Appendices ...............................................................................................................257 HOWE SOUND RESEARCH Smart IVD Markets Page | 15 11.1 United States Clinical Laboratory Fees Schedule ........................................................ 258 11.1.1 Laboratory Fees Schedule ..................................................................................... 258 11.1.2 The Most Used IVD Assays ...................................................................................... 382 11.1.3 The Highest Grossing Assays .................................................................................. 387 HOWE SOUND RESEARCH Smart IVD Markets Page | 16 Table of Tables Table 1 Market Players by Type ..................................................................................................... 40 Table 2 Factors Driving Growth....................................................................................................... 69 Table 3 Four Factors Limiting Growth ............................................................................................. 74 Table 4 Seven Key Diagnostic Laboratory Technology Trends .................................................... 76 Table 5 - Global Market by Region .............................................................................................. 204 Table 6 Global Market by Application ........................................................................................ 206 Table 7 Global Market by Technology ........................................................................................ 212 Table 8 Global Market by Place................................................................................................... 218 Table 9 Cancer Testing by Country.............................................................................................. 225 Table 10 Infectious Disease Testing by Country ......................................................................... 227 Table 11 Metabolic Testing by Country ....................................................................................... 229 Table 12 Cardiac Testing by Country........................................................................................... 231 Table 13 Diabetes Testing by Country ......................................................................................... 233 Table 14 Other Disease Testing by Country ................................................................................. 235 Table 15 NGS Technology by Country ......................................................................................... 238 Table 16 PCR Technology by Country ........................................................................................ 240 Table 17 Chemistry/IA Technology by Country........................................................................... 242 Table 18 Pathology Technology by Country ............................................................................... 244 Table 19 Other Technology by Country....................................................................................... 246 Table 20 Research by Country ..................................................................................................... 249 Table 21 Pharmaceutical Research by Country ........................................................................ 251 HOWE SOUND RESEARCH Smart IVD Markets Page | 17 Table 22 Clinical by Country........................................................................................................ 253 Table 23 Other Place by Country................................................................................................ 255 Table 24 Laboratory Fee Schedule ............................................................................................. 258 Table 25 The Most Common Assays ............................................................................................ 382 Table 26 Largest Revenue Assays................................................................................................. 387 HOWE SOUND RESEARCH Smart IVD Markets Page | 18 Table of Figures Figure 1 Global Healthcare Spending ........................................................................................... 35 Figure 2 The Lab Test Pie ................................................................................................................. 36 Figure 3 The Road to Diagnostics ................................................................................................... 39 Figure 4 AI and Learning Methods ................................................................................................. 47 Figure 5 The Changing Age of The World's Population................................................................ 70 Figure 6 Health Care Consumption by Age .................................................................................. 71 Figure 7 Cancer Incidence - Age at Diagnosis............................................................................. 72 Figure 8 Centralized vs. Decentralized Laboratory Service ......................................................... 77 Figure 9 A Highly Multiplexed Syndromic Testing Unit................................................................... 78 Figure 10 The Real Cost to Sequence the Human Genome........................................................ 80 Figure 11 The Codevelopment Process ......................................................................................... 82 Figure 12 Comparing MDx Diagnostic and Traditional Testing .................................................... 83 Figure 13 Base Year Country Global Share ................................................................................. 205 Figure 14 Global Market by Application - Base vs. Final Year.................................................... 207 Figure 15 Market by Application Base Year ................................................................................ 208 Figure 16 Market by Application Final Year................................................................................. 209 Figure 17 Application Share by Year............................................................................................ 210 Figure 18 Application Segment Growth ...................................................................................... 211 Figure 19 Global Market by Technology - Base vs. Final Year.................................................... 213 Figure 20 Market by Technology Base Year ................................................................................ 214 Figure 21 Market by Technology Final Year................................................................................. 215 HOWE SOUND RESEARCH Smart IVD Markets Page | 19 Figure 22 Market by Technology Share by Year ......................................................................... 216 Figure 23 Market by Technology Segment Growth .................................................................... 217 Figure 24 Market by Place - Base vs. Final Year .......................................................................... 219 Figure 25 Market by Place Base Year .......................................................................................... 220 Figure 26 Market by Place Final Year........................................................................................... 221 Figure 27 Market by Place Share by Year ................................................................................... 222 Figure 28 Market by Place Segment Growth .............................................................................. 223 Figure 29 Cancer Testing Growth ................................................................................................. 226 Figure 30 Infectious Disease Testing Growth................................................................................ 228 Figure 31 Metabolic Testing Growth ............................................................................................ 230 Figure 32 Cardiac Testing Growth................................................................................................ 232 Figure 33 Diabetes Testing Growth............................................................................................... 234 Figure 34 Other Disease Testing Growth ...................................................................................... 236 Figure 35 NGS Technology Growth .............................................................................................. 239 Figure 36 PCR Technology Growth .............................................................................................. 241 Figure 37 Chemistry/IA Technology Growth................................................................................ 243 Figure 38 Pathology Technology Growth .................................................................................... 245 Figure 39 Other Technology Growth............................................................................................ 247 Figure 40 Research Growth........................................................................................................... 250 Figure 41 Pharmaceutical Research Growth .............................................................................. 252 Figure 42 Clinical Growth .............................................................................................................. 254 Figure 43 Other Place Growth ...................................................................................................... 256 HOWE SOUND RESEARCH