Table of Content

i. Respiratory Infections Diagnostic Market - Strategic Situation Analysis and Impact of COVID- 19. ............................................................................................................................................18
ii. Guide for Executives, Marketing, Sales and Business Development Staff .....................20 iii. Guide for Management Consultants and Investment Advisors ....................................21 1. Introduction and Market Definition ...................................................................................22
1.1 What are Respiratory Infections? .......................................................................................... 23 1.2 The Role of Diagnosis & Treatment........................................................................................ 26 1.3 Market Definition .................................................................................................................... 28
1.3.1 Revenue Market Size........................................................................................................ 28 1.4 Methodology .......................................................................................................................... 29 1.4.1 Authors .............................................................................................................................. 29 1.4.2 Sources.............................................................................................................................. 30 1.5 A Spending Perspective on Clinical Laboratory Testing ..................................................... 31 1.5.1 An Historical Look at Clinical Testing............................................................................... 31
2. Market Overview ................................................................................................................34
2.1 Players in a Dynamic Market ................................................................................................. 35 2.1.1 Academic Research Lab ................................................................................................ 36 2.1.2 Diagnostic Test Developer............................................................................................... 36 2.1.3 Instrumentation Supplier .................................................................................................. 36
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2.1.4 Distributor and Reagent Supplier .................................................................................... 37 2.1.5 Independent Testing Lab................................................................................................. 37 2.1.6 Public National/regional lab ........................................................................................... 38 2.1.7 Hospital lab ....................................................................................................................... 38 2.1.8 Physician Office Labs ....................................................................................................... 39 2.1.9 Audit Body ........................................................................................................................ 39 2.1.10 Certification Body........................................................................................................... 40
2.2 Respiratory Infections ............................................................................................................. 41 2.2.1 Upper vs. Lower - Marketing Implications....................................................................... 41 2.2.2 Understanding the Role of Pneumonia .......................................................................... 43 2.2.3 Bacterial Infections........................................................................................................... 45
2.2.3.1 Streptococcal Infections ......................................................................................... 45 2.2.3.2 Acute Otitis Media ................................................................................................... 45 2.2.3.3 Bacterial Rhinosinusitis .............................................................................................. 46 2.2.3.4 Diphtheria ................................................................................................................. 46 2.2.3.5 Pneumococcal Pneumonia .................................................................................... 47 2.2.3.6 Haemophilus Pneumonia ........................................................................................ 48 2.2.3.7 Mycoplasma Pneumonia (Walking Pneumonia)................................................... 48 2.2.3.8 Chlamydial Pneumonias and Psittacosis................................................................ 49 2.2.3.9 Health Care-Associated Pneumonia...................................................................... 50 2.2.3.10 Pseudomonas Pneumonia .................................................................................... 50 2.2.3.11 Pertussis (Whooping Cough) ................................................................................. 51 2.2.3.12 Legionnaires Disease.............................................................................................. 53
2.2.4 Tuberculosis – A Special Case ......................................................................................... 55
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2.2.5 Viral Infections .................................................................................................................. 59 2.2.5.1 The Common Cold................................................................................................... 59 2.2.5.2 Influenza.................................................................................................................... 60 2.2.5.3 Viral Pneumonia ....................................................................................................... 65 2.2.5.4 SARS and MERS......................................................................................................... 66 2.2.5.5 Measles (Rubeola) ................................................................................................... 67 2.2.5.6 Rubella (German Measles)...................................................................................... 68 2.2.5.7 Chickenpox and Shingles ........................................................................................ 69
2.2.6 Fungal and Other Pathogens.......................................................................................... 72 2.2.6.1 Histoplasmosis ........................................................................................................... 72 2.2.6.2 Coccidioidomycosis................................................................................................. 73 2.2.6.3 Blastomycosis............................................................................................................ 74 2.2.6.4 Mucormycosis........................................................................................................... 74 2.2.6.5 Aspergillosis ............................................................................................................... 76 2.2.6.6 Pneumocystis Pneumonia ....................................................................................... 76 2.2.6.7 Cryptococcosis ........................................................................................................ 77
2.3 Diagnostics – A Changing Role............................................................................................. 79 2.3.1 Historical Practice............................................................................................................. 79 2.3.2 Current Diagnostics.......................................................................................................... 80 2.3.3 The Multiplex Vector......................................................................................................... 82 2.3.4 Future Diagnostics – The Question of When and Where............................................... 83 2.3.5 Respiratory Infection Diagnostics – The Destination ...................................................... 83 2.3.6 Diagnostics as Defensive Weapons................................................................................ 84
3. Market Trends......................................................................................................................85
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3.1 Factors Driving Growth........................................................................................................... 86 3.1.1. Syndromic Multiplexing ................................................................................................... 86 3.1.2 T.A.T.................................................................................................................................... 87 3.1.3 Antimicrobial Resistance Movement.............................................................................. 87 3.1.4 Pandemic Mitigation........................................................................................................ 87 3.1.5 An Aging at Risk Population ............................................................................................ 88
3.2 Factors Limiting Growth.......................................................................................................... 90 3.2.1 The Cost Curve ................................................................................................................. 90 3.2.2 Regulation and coverage............................................................................................... 91 3.2.3 Laissez Faire....................................................................................................................... 91
3.3 Instrumentation and Automation.......................................................................................... 92 3.3.1 The Shrinking Multiplexing Machine ................................................................................ 92 3.3.2 Bioinformatics Networking and Anonymous Reporting ................................................ 92
3.4 Diagnostic Technology Development.................................................................................. 94 3.4.1 The Key Role of Time to Result ......................................................................................... 95 3.4.2 Single Cell Genomics Changes the Picture ................................................................... 95 3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment..................................................... 96 3.4.4 Pathogen Identification – A Projected Timetable of the Future................................... 97
4. Respiratory Infection Diagnostics Recent Developments ...............................................98
4.1 Recent Developments – Importance and How to Use This Section................................... 99 4.1.1 Importance of These Developments .............................................................................. 99 4.1.2 How to Use This Section.................................................................................................... 99 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic................... 99 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test ........................................ 101
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Qiagen Respiratory Panel with Coronavirus Receives CE Mark ............................................. 102 Lumos Diagnostics Closes $15M Series A Funding ................................................................... 103 Fusion Genomics Wins $1M to Assess NGS-Based Respiratory Tract Infection Assay............ 104 Coronavirus Detection Test Development by Co-Diagnostics............................................... 105 Rapid Diagnostics Completes Asset Purchase of Enigma Diagnostics.................................. 107 Flu-Like Epidemic Could Kill 80 Mn Globally ............................................................................. 108 Startup developing AI for TB detection .................................................................................... 111 Nipah Virus a Global Threat....................................................................................................... 113 Novacyt S.A.: New Molecular Respiratory Panel Ready for US Market ................................. 115 New DRC Ebola cases confirmed as FDA OKs rapid test........................................................ 115 CE Mark for Smartphone-based Diagnostic Test for Adult Respiratory Disease.................... 117 Curetis Submits Lower Respiratory Tract Infection Test for FDA Clearance ........................... 118 New rapid test diagnoses pneumonia and other lower respiratory infections ..................... 119 Ontera Awarded Contract for Zika Genotyping Test.............................................................. 122 Two New Members Join Global Diagnostics Network............................................................. 123 BARDA Funding Health Security Solutions ................................................................................ 124
5. Profiles of Key Players .......................................................................................................126 Abbott Diagnostics..................................................................................................................... 127 Accelerate Diagnostics ............................................................................................................. 129 Ador Diagnostics ........................................................................................................................ 130 Akkoni Biosystems ....................................................................................................................... 131 Alveo Technologies.................................................................................................................... 132 Applied BioCode........................................................................................................................ 133 Atlas Genetics............................................................................................................................. 135
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Aus Diagnostics........................................................................................................................... 136 BD Diagnostics ............................................................................................................................ 138 Biocartis ....................................................................................................................................... 140 BioFire Diagnostics...................................................................................................................... 141 bioMérieux .................................................................................................................................. 143 Bio-Rad Laboratories.................................................................................................................. 144 Bosch Healthcare Solutions GmbH ........................................................................................... 146 Cepheid ...................................................................................................................................... 147 Co-Diagnostics ........................................................................................................................... 149 Cue Health.................................................................................................................................. 150 Curetis.......................................................................................................................................... 151 Diagenode Diagnostics ............................................................................................................. 153 Diascopic .................................................................................................................................... 154 Diasorin........................................................................................................................................ 155 Expedeon.................................................................................................................................... 156 Fusion Genomics. ....................................................................................................................... 157 GenePOC Diagnostics............................................................................................................... 159 Genetic Signatures..................................................................................................................... 160 GenMark Dx................................................................................................................................ 161 Hologic ........................................................................................................................................ 162 Immunexpress............................................................................................................................. 164 Inflammatix ................................................................................................................................. 165 Invetech ...................................................................................................................................... 166 Janssen Diagnostics ................................................................................................................... 167
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Karius ........................................................................................................................................... 168 Lexigene...................................................................................................................................... 169 Luminex ....................................................................................................................................... 170 Lumos Diagnostics ...................................................................................................................... 172 Mammoth Biosciences............................................................................................................... 173 Mbio Diagnostics ........................................................................................................................ 174 Meridian Bioscience................................................................................................................... 175 Mesa Biotech.............................................................................................................................. 177 Mobidiag..................................................................................................................................... 178 Nanomix ...................................................................................................................................... 179 Oxford Nanopore ....................................................................................................................... 180 Panagene ................................................................................................................................... 182 Primerdesign ............................................................................................................................... 183 Prominex...................................................................................................................................... 184 Qiagen (Statdx).......................................................................................................................... 185 Quantumdx................................................................................................................................. 187 Quidel.......................................................................................................................................... 188 Roche Molecular Diagnostics ................................................................................................... 190 Saw Diagnostics.......................................................................................................................... 193 Seegene...................................................................................................................................... 195 Sensovation................................................................................................................................. 196 Siemens Healthineers (Fast Track Diagnostics)......................................................................... 197 SkylineDx...................................................................................................................................... 204 Sona Nanotech .......................................................................................................................... 205 
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T2 Biosystems............................................................................................................................... 207 Thermo Fisher .............................................................................................................................. 208 Veradus Labs .............................................................................................................................. 210 Veramarx .................................................................................................................................... 211
6. The Global Market for Respiratory Infection Diagnostics .............................................212
6.1 Global Market Overview by Country.................................................................................. 213 6.1.1 Table – Global Market by Country................................................................................ 213 6.1.2 Chart - Global Market by Country................................................................................ 214 6.2 Global Market by Technology - Overview ......................................................................... 215 6.2.1 Table – Global Market by Technology ......................................................................... 215 6.2.2 Chart – Global Market by Technology – 2019/2024 Comparison .............................. 216 6.2.3 Chart – Global Market by Technology – 2019 ............................................................. 217 6.2.4 Chart – Global Market by Technology –2024 .............................................................. 218 6.2.5 Chart – Global Market by Technology – Share by Year.............................................. 219 6.3 Global Market by Plex - Overview ...................................................................................... 220 6.3.1 Table – Global Market by Plex....................................................................................... 220 6.3.2 Chart – Global Market by Plex – 2019/2024 Comparison ........................................... 221 6.3.3 Chart – Global Market by Plex – 2019........................................................................... 222 6.3.4 Chart – Global Market by Plex –2024............................................................................ 223 6.3.5 Chart – Global Market by Plex – Share by Year........................................................... 224 6.4 Global Market by Place - Overview ................................................................................... 225 6.4.1 Table – Global Market by Place.................................................................................... 225 6.4.2 Chart – Global Market by Place – 2019/2024 Comparison ........................................ 226 6.4.3 Chart – Global Market by Place – 2019........................................................................ 227
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6.4.4 Chart – Global Market by Place –2024......................................................................... 228
6.4.5 Chart – Global Market by Place – Share by Year........................................................ 229 7. Global Respiratory Infection Diagnostic Markets – By Technology .............................. 230
7.1 Microbiology ......................................................................................................................... 231 7.1.1 Table Microbiology – by Country.................................................................................. 231 7.1.2 Chart - Microbiology Growth ........................................................................................ 232
7.2 PCR ........................................................................................................................................ 233 7.2.1 Table PCR – by Country ................................................................................................. 233 7.2.2 Chart - PCR Growth........................................................................................................ 234
7.3 NGS........................................................................................................................................ 235 7.3.1 Table NGS – by Country................................................................................................. 235 7.3.2 Chart - NGS Growth ....................................................................................................... 236
7.4 Immunoassay........................................................................................................................ 237 7.4.1 Table Immunoassay – by Country................................................................................. 237 7.4.2 Chart - Immunoassay Growth ....................................................................................... 238
7.5 Other...................................................................................................................................... 239 7.5.1 Table Other – by Country .............................................................................................. 239 7.5.2 Chart - Other Growth..................................................................................................... 240
8. Global Respiratory Infection Diagnostic Markets – by Plex...........................................241
8.1 Single Plex.............................................................................................................................. 242 8.1.1 Table Single Plex – by Country....................................................................................... 242 8.1.2 Chart - Single Plex Growth............................................................................................. 243 8.2 Duplex ................................................................................................................................... 244 8.2.1 Table Duplex – by Country ............................................................................................ 244
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8.2.2 Chart - Duplex Growth................................................................................................... 245 8.3 Triplex..................................................................................................................................... 246 8.3.1 Table Triplex – by Country.............................................................................................. 246 8.3.2 Chart - Triplex Growth .................................................................................................... 247 8.4 Multiplex Technology ........................................................................................................... 248 8.4.1 Table Multiplex – by Country ......................................................................................... 248 8.4.2 Chart - Multiplex Growth................................................................................................ 249
9. Global Respiratory Infection Diagnostic Markets – by Place........................................250
9.1 Hospital Lab .......................................................................................................................... 251 9.1.1 Table Hospital Lab – by Country ................................................................................... 251 9.1.2 Chart - Hospital Lab Growth.......................................................................................... 252 9.2 Outpatient Lab ..................................................................................................................... 253 9.2.1 Table Outpatient Lab – by Country .............................................................................. 253 9.2.2 Chart - Outpatient Lab Growth .................................................................................... 254 9.3 POC ....................................................................................................................................... 255 9.3.1 Table POC – by Country ................................................................................................ 255 9.3.2 Chart - POC Growth....................................................................................................... 256 9.4 Other Technology................................................................................................................. 257 9.4.1 Table Other – by Country .............................................................................................. 257 9.4.2 Chart - Other Growth..................................................................................................... 258
Appendices ..........................................................................................................................259 I.United States Medicare System: January 2020 Clinical Laboratory Fees Schedule ........... 259
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Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2020 ($million) ........... 33 Table 2 Market Players by Type ..................................................................................................... 35 Table 3 Bacterial Causes of Pneumonia........................................................................................ 44 Table 4 List of Influenza Pandemics................................................................................................ 63 Table 5 Viral Infections of the Respiratory Tract ............................................................................ 71 Table 6 Fungal Infections of the Respiratory Tract ........................................................................ 78 Table 7 Five Factors Driving Growth............................................................................................... 86 Table 8 Three Factors Limiting Growth ........................................................................................... 90 Table 9 Key Diagnostic Laboratory Technology Trends ............................................................... 94 Table 10 - Global Market by Region ............................................................................................ 213 Table 11 Global Market by Technology ...................................................................................... 215 Table 12 Global Market by Plex.................................................................................................... 220 Table 13 Global Market by Place................................................................................................. 225 Table 14 Microbiology by Country ............................................................................................... 231 Table 15 PCR by Country ............................................................................................................. 233 Table 16 NGS by Country.............................................................................................................. 235 Table 17 Immunoassay by Country.............................................................................................. 237 Table 18 Other by Country............................................................................................................ 239 Table 19 Single Plex by Country................................................................................................... 242 Table 20 Duplex by Country ......................................................................................................... 244 Table21 TriplexbyCountry..........................................................................................................246
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Table 22 Multiplex by Country ..................................................................................................... 248 Table 23 Hospital Lab by Country ............................................................................................... 251 Table 24 Outpatient Lab by Country ........................................................................................... 253 Table 25 POC by Country ............................................................................................................ 255 Table 26 Other by Country........................................................................................................... 257 Table 27 2020 Laboratory Fee Schedule ..................................................................................... 259
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Table of Figures
Figure 1 Upper vs. Lower Respiratory Tract .................................................................................... 23 Figure 2 The LRI Mortality Rate Globally......................................................................................... 25 Figure 3 Global Pandemic Pathogen Status ................................................................................. 26 Figure 4 Medicare Clinical Lab Expenditures 2004 to 2020 ($Million).......................................... 32 Figure 5 The BioFire Respiratory Panel ............................................................................................ 42 Figure 6 Pneumonia......................................................................................................................... 43 Figure 7 Bacterial Infections of the Respiratory Tract.................................................................... 55 Figure 8 The Development Cycle of Tuberculosis ......................................................................... 57 Figure 9 A Flu Epidemic in Europe – Historical Pattern.................................................................. 65 Figure 14 The Multiplex Paradigm Shift........................................................................................... 82 Figure 11 Percentage of World Population Over 65..................................................................... 88 Figure 12 2019 Global Market Density Chart ............................................................................... 214 Figure 13 Global Market by Technology - 2019 vs. 2024 ............................................................ 216 Figure 14 Global Market by Technology 2019............................................................................. 217 Figure 15 Global Market by Technology 2024............................................................................. 218 Figure 16 Technology Share by Year............................................................................................ 219 Figure 17 Plex - 2019 vs. 2024 ........................................................................................................ 221 Figure 18 Plex Market 2019............................................................................................................ 222 Figure 19 Plex Market 2024............................................................................................................ 223 Figure 20 Plex Share by Year......................................................................................................... 224 Figure 21 Place - 2019 vs. 2024 ..................................................................................................... 226
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Figure 22 Place Market 2019......................................................................................................... 227 Figure 23 Place Market 2024......................................................................................................... 228 Figure 24 Place Share by Year...................................................................................................... 229 Figure 25 Microbiology Growth .................................................................................................... 232 Figure 26 PCR Diagnostics Growth ............................................................................................... 234 Figure 27 NGS Growth ................................................................................................................... 236 Figure 28 Immunoassay Growth ................................................................................................... 238 Figure 29 Other Growth................................................................................................................. 240 Figure 30 Single Plex Growth......................................................................................................... 243 Figure 31 Duplex Growth............................................................................................................... 245 Figure 32 Triplex Growth ................................................................................................................ 247 Figure 33 Multiplex Growth ........................................................................................................... 249 Figure 34 Hospital Lab Growth...................................................................................................... 252 Figure 35 Outpatient Lab Growth ................................................................................................ 254 Figure 36 POC Growth................................................................................................................... 256 Figure 37 Other Growth................................................................................................................. 258