Table of Content

i. Market Guides......................................................................................................................19
iA. Situation Analysis and COVID-19 Market Analysis ................................................................ 20 iB. Guide for Executives and Marketing Staff............................................................................. 22 iC. Guide for Investment Analysts and Management Consultants.......................................... 23
1. Introduction and Market Definition ...................................................................................24
1.1 What is OTC and DTC Testing? .............................................................................................. 25 1.2 OTC/DTC Testing – the quiet revolution in diagnostics........................................................ 26 1.3 Self vs. Send – who knew? ..................................................................................................... 27 1.4 Market Definition .................................................................................................................... 28
1.4.1 Retail vs. Wholesale.......................................................................................................... 28 1.42 OTC, DTC, HxV and HSG ................................................................................................... 28 1.4.3 Currency ........................................................................................................................... 29 1.4.4 Years .................................................................................................................................. 29
1.5 Methodology .......................................................................................................................... 30 1.5.1 Authors .............................................................................................................................. 30 1.5.2 Sources.............................................................................................................................. 30
1.6 U.S. Medical Market and Clinical Laboratory Testing - Perspective................................... 31 1.6.1 U.S. Medicare Expenditures for Clinical Testing ............................................................. 32
2. The Infectious Diseases – Guide to the Pathogens ..........................................................34
2.1 HIV - Human Immunodeficiency Virus (AIDS)....................................................................... 35 2.1.1 Virology ............................................................................................................................. 35 2.1.1.1 Classification............................................................................................................. 35 2.1.1.2 Structure and genome ............................................................................................ 36
 
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2.1.1.3 Tropism ...................................................................................................................... 38 2.1.1.4 Replication cycle ..................................................................................................... 40 2.1.1.5 Genetic variability .................................................................................................... 46
2.1.2 Diagnosis ........................................................................................................................... 48 2.1.3 Testing................................................................................................................................ 49 2.1.3.1 Antibody tests ........................................................................................................... 49 2.1.3.2 Point of Care Tests (POCT)....................................................................................... 52 2.1.3.4 Antigen Tests ............................................................................................................. 54 2.1.3.5 Nucleic acid-based tests (NAT)............................................................................... 55 2.1.3.6 Other tests used in HIV treatment ........................................................................... 56 2.2 HBV – Hepatitis B ..................................................................................................................... 58 2.2.1 Virology ............................................................................................................................. 59 2.2.1.1 Genome.................................................................................................................... 60 2.2.1.2 Pathogenesis ............................................................................................................ 61 2.2.1.3 Hepatitis B virus replication ...................................................................................... 61 2.2.1.4 Serotypes and genotypes ....................................................................................... 62 2.2.2 Mechanisms...................................................................................................................... 62 2.2.3 Diagnosis ........................................................................................................................... 63 2.2.4 Market Opportunity Analysis............................................................................................ 64 2.3 HCV – Hepatitis C ................................................................................................................... 66 2.3.1 Taxonomy.......................................................................................................................... 67 2.3.2.1 Structure .................................................................................................................... 67 2.3.2.2 Genome.................................................................................................................... 68 2.3.3 Molecular biology ............................................................................................................ 69 2.3.4 Replication........................................................................................................................ 70 2.3.5 Genotypes ........................................................................................................................ 72
 
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2.3.5.1 Clinical importance ................................................................................................. 72 2.3.6 Market Opportunity Analysis............................................................................................ 73 2.4 HPV - Human papillomavirus ................................................................................................. 75 2.4.1 Virology ............................................................................................................................. 77 2.4.1.1 E6/E7 proteins ........................................................................................................... 77 2.4.1.2 Role in cancer .......................................................................................................... 77 2.4.1.3 E2 research ............................................................................................................... 78 2.4.1.4 Latency period ......................................................................................................... 79 2.4.1.5 Clearance................................................................................................................. 79 2.4.2 Diagnosis ........................................................................................................................... 80 2.4.2.1 Cervical testing......................................................................................................... 80 2.4.2.2 Oral testing................................................................................................................ 82 2.4.2.3 Testing men............................................................................................................... 82 2.4.2.4 Other testing ............................................................................................................. 83 2.4.3 Market Opportunity Analysis............................................................................................ 84 2.5 Coronavirus ............................................................................................................................. 90 2.5.1 Severe acute respiratory syndrome (SARS).................................................................... 92 2.5.2 Middle East respiratory syndrome (MERS) ...................................................................... 94 2.5.3 COVID-19. The SARS CoV 2 Virus.................................................................................... 95 2.5.3.1 Signs and symptoms................................................................................................. 96 2.5.3.2 Transmission............................................................................................................... 97 2.5.3.3 Diagnosis ................................................................................................................... 98 2.5.3.4 Prevention............................................................................................................... 100 2.5.3.5 Management ......................................................................................................... 101 2.5.3.6 Prognosis ................................................................................................................. 102 2.5.4 Pandemic Diagnostics ................................................................................................... 103
 
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2.5.4.1 Risk Management – Spark and Spread................................................................ 103 2.5.4.2 Dx Technology – Nucleic Acid Based................................................................... 105 2.5.4.3 Dx Technology - Immunoassay ............................................................................. 105 2.5.4.4 Time to Market and Preparedness Issues ............................................................. 106
2.5.5 COVID-19 Market Opportunity Analysis – A Special Case.......................................... 106
2.5.6 Current COVID-19 DTC Tests.......................................................................................... 107 2.6 Influenza ................................................................................................................................ 110 2.6.1 Flu..................................................................................................................................... 111 2.6.1.1 Types of virus ........................................................................................................... 111 2.6.1.2 Influenzavirus A ....................................................................................................... 111 2.6.1.3 Influenzavirus B........................................................................................................ 112 2.6.1.4 Influenzavirus C....................................................................................................... 112 2.6.1.5 Structure, properties, and subtype nomenclature .............................................. 113 2.6.1.6 Replication.............................................................................................................. 114 2.6.2 Testing.............................................................................................................................. 116 2.6.2.1 Advantages/Disadvantages of Molecular Assays .............................................. 118 2.6.3 Market Opportunity Analysis.......................................................................................... 119 2.7 CT/NG - Chlamydia/Gonorhea .......................................................................................... 127 2.7.1 Gonorrhea ...................................................................................................................... 127 2.7.1.1 Diagnosis ................................................................................................................. 128 2.7.1.2 Screening ................................................................................................................ 128 2.7.2 Chlamydia ...................................................................................................................... 128 2.7.2.1 Diagnosis ................................................................................................................. 129 2.7.2.2 Screening ................................................................................................................ 130 2.7.3 Testing.............................................................................................................................. 131 2.7.3.1 Nucleic acid amplification tests (NAATs). ............................................................ 131
 
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2.7.3.2 Performance of NAAT Tests ................................................................................... 139 2.7.4 Market Opportunity Analysis.......................................................................................... 140 2.8 UTI........................................................................................................................................... 142 2.8.1 Diagnosis ......................................................................................................................... 142 2.8.2 Testing.............................................................................................................................. 144 2.8.2.1 Nitrites test............................................................................................................... 144 2.8.2.2 Leukocytes test....................................................................................................... 145 2.8.3 Market Opportunity Analysis.......................................................................................... 146 2.9 GAS........................................................................................................................................ 147 2.9.1 Infectious Agents............................................................................................................ 147 2.9.2 Market Opportunity Analysis.......................................................................................... 149 2.10 RESP ..................................................................................................................................... 150 2.10.1 Diagnosis ....................................................................................................................... 151 2.10.2 Market Opportunity Analysis........................................................................................ 152
3. Industry Overview .............................................................................................................154
3.1 Industry Participants ............................................................................................................. 155 3.1.1 IVD Supplier..................................................................................................................... 155 3.1.2 Independent lab specialized/esoteric ......................................................................... 156 3.1.3 Independent lab national/regional.............................................................................. 156 3.1.4 Independent lab analytical .......................................................................................... 157 3.1.5 Public National/regional lab ......................................................................................... 157 3.1.6 Hospital lab ..................................................................................................................... 157 3.1.7 Physician lab................................................................................................................... 158 3.1.8 Pharmacies ..................................................................................................................... 158 3.1.9 Audit body ...................................................................................................................... 159 3.2 The Clinical Laboratory Market Segments.......................................................................... 161
 
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3.2.1 Traditional Market Segmentation.................................................................................. 161 3.2.2 Laboratory Focus and Segmentation........................................................................... 162 3.2.3 Segmenting the OTC/DTC Market ................................................................................ 163
3.3 Industry Structure .................................................................................................................. 165 3.3.1 Hospital Testing Share .................................................................................................... 165 3.3.2 Economies of Scale........................................................................................................ 165
3.3.2.1 Hospital vs. Central Lab ......................................................................................... 166 3.3.3 Physician Office Lab’s.................................................................................................... 167 3.3.3.1 The Problem with POLS........................................................................................... 167 3.3.4 Physician’s and OCT/DTC.............................................................................................. 168 3.3.5 Pharmacies and OCT/DTC ............................................................................................ 168 3.3.5.1 The Diagnostic Plight of Pharmacies – Trying to do good .................................. 168 3.3.5.2 The Theranos Legacy ............................................................................................. 169
4. Market Trends....................................................................................................................171
4.1 Factors Driving Growth......................................................................................................... 172 4.1.1 Privacy and Anonymity.................................................................................................. 172 4.1.2 The Internet Effect. ......................................................................................................... 172 4.1.3 Rapid Result. ................................................................................................................... 173 4.1.4 The Wellness Movement ................................................................................................ 173 4.1.5 The COVID-19 Impact. ................................................................................................... 173 4.2 Factors Limiting Growth........................................................................................................ 175 4.2.1 Trust Factor ...................................................................................................................... 175 4.2.2 Infectious Disease is Declining But................................................................................ 177 4.2.3 Wellness Hurts.................................................................................................................. 177 4.2.4 Economic Growth improves Living Standards ............................................................. 177 4.3 Diagnostic Technology Development................................................................................ 179
 
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4.3.1 The Multiplex Paradigm Shift.......................................................................................... 179 4.3.2 NAT vs. Lateral Flow........................................................................................................ 181 4.3.3 The Unusual Role of GPS ................................................................................................ 181 4.3.4 Self and Send Competition ........................................................................................... 181 4.4.5 The Relationship to DTC Genetic .................................................................................. 183 4.4.6 The Relationship to TeleHealth ...................................................................................... 183 4.4.7 Sample Collection – Who Knew?.................................................................................. 183
5. OTC/DTC Infectious Disease Testing Recent Developments ........................................184 Recent Developments – Importance and How to Use This Section....................................... 185 Importance of These Developments ..................................................................................... 185 How to Use This Section .......................................................................................................... 185 FemtoDx Launches Rapid At-Home Test Development for COVID-19 .................................. 185 FDA approves first at-home coronavirus test ........................................................................... 186 Free Home HIV Tests Detect More Infections ........................................................................... 186 Biohacking trend supports self testing. ..................................................................................... 187 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market .............................. 189 Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test ................ 190
Miraca Holdings Inc. and Seventh Sense Biosystems, Inc. Announce Distribution Agreement ..................................................................................................................................................... 191
OraSure Technologies, Inc. Announces Two Acquisitions....................................................... 191 Mylan signs HIV test commercialisation deal with Atomo Diagnostics.................................. 194 Nigerian Govt Approves Alere HIV Self-Test Kit ........................................................................ 195 Rapid HIV tests vary in their accuracy...................................................................................... 196 Montreal researchers develop HIV self-testing app ................................................................ 197 Boots launches UTI test and treat service across 37 branches ............................................... 198
Scanwell Health moves beyond home UTI testing with nationwide kidney disease study partnership .................................................................................................................................. 199
 
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Healthy.io raises $18 million for at-home urinalysis tests .......................................................... 200 LetsGetChecked collects $30M more for at-home health testing......................................... 202 TestCard, a $4 Urine Test Read by Smartphone ...................................................................... 204 Digital Health Startup EverlyWell Raises $50M .......................................................................... 204 Thriva adds test-at-home kits for female hormone and cortisol stress ................................... 206 Tasso scores $6.1M for patch-based home blood testing ...................................................... 208 LabCorp to offer self-testing home kits..................................................................................... 210 1Drop Diagnostics draws $4.25M for portable blood diagnostic panel ................................ 210 DBS Systems HEMAXIS receives CE/IVD mark........................................................................... 211 myLAB Box Announces $1.56M in Seed Funding ..................................................................... 212 Abbott HbA1c point-of-care test reliably diagnoses diabetes .............................................. 214
6. Profiles of Key Diagnostic Testing Companies...............................................................216 1DropDiagnostics ....................................................................................................................... 217 Abbott Diagnostics (Alere) ........................................................................................................ 218 Atomo Diagnostics ..................................................................................................................... 219 Ador Diagnostics ........................................................................................................................ 220 Akkoni Biosystems ....................................................................................................................... 221 Alveo Technologies.................................................................................................................... 222 Applied BioCode........................................................................................................................ 223 Atlas Genetics............................................................................................................................. 225 Aus Diagnostics........................................................................................................................... 226 BD Diagnostics ............................................................................................................................ 228 Biocartis ....................................................................................................................................... 230 BioFire Diagnostics...................................................................................................................... 231 bioMérieux .................................................................................................................................. 233 Bio-Rad Laboratories.................................................................................................................. 234
 
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Bosch Healthcare Solutions GmbH ........................................................................................... 236 Cepheid ...................................................................................................................................... 237 Curetis.......................................................................................................................................... 238 DBS Systems................................................................................................................................. 239 Diagenode Diagnostics ............................................................................................................. 240 Diasorin........................................................................................................................................ 241 Everlywell..................................................................................................................................... 242 Fusion Genomics. ....................................................................................................................... 243 GenePOC Diagnostics............................................................................................................... 245 GenMark Dx................................................................................................................................ 246 Healthy.IO ................................................................................................................................... 247 Hologic ........................................................................................................................................ 248 Inflammatix ................................................................................................................................. 250 Inui Health ................................................................................................................................... 251 Invetech ...................................................................................................................................... 252 Janssen Diagnostics ................................................................................................................... 253 Karius ........................................................................................................................................... 254 Labcorp - Pixel ............................................................................................................................ 255 Letsgetchecked ......................................................................................................................... 257 Lexigene...................................................................................................................................... 258 Luminex ....................................................................................................................................... 259 Mbio Diagnostics ........................................................................................................................ 261 Mesa Biotech.............................................................................................................................. 262 Mobidiag..................................................................................................................................... 263 myLabBox.................................................................................................................................... 264 Mylan........................................................................................................................................... 265
 
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Nanomix ...................................................................................................................................... 266 Orasure........................................................................................................................................ 267 Oxford Nanopore ....................................................................................................................... 269 Panagene ................................................................................................................................... 270 Primerdesign ............................................................................................................................... 271 Prominex...................................................................................................................................... 272 Qiagen (Statdx).......................................................................................................................... 273 Quantumdx................................................................................................................................. 275 Quest Diagnostics – Quest Direct.............................................................................................. 276 Roche Molecular Diagnostics ................................................................................................... 277 Scanwell Health.......................................................................................................................... 279 Seegene...................................................................................................................................... 280 Sensovation................................................................................................................................. 281 Seventh Sense Biosystems.......................................................................................................... 282 Siemens Healthineers (Fast Track Diagnostics)......................................................................... 283 SkylineDx...................................................................................................................................... 289 T2 Biosystems............................................................................................................................... 290 TestCard Diagnostics.................................................................................................................. 291 Thermo Fisher .............................................................................................................................. 292 Thriva ........................................................................................................................................... 294 Veramarx .................................................................................................................................... 295 XCR Diagnostics.......................................................................................................................... 296
7. Global Market Size............................................................................................................297
7.1 OTC/DTC ID Global Market Size by Country with Charts .................................................. 298 7.2 OTC/DTC ID Global Market Size by Syndrome with Charts............................................... 300
8. Global Market by Syndrome ...........................................................................................303
 
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8.1 Respiratory Syndrome Market (including COVID-19) ........................................................ 304 8.1.1 Respiratory Syndrome Market by Country .................................................................. 304 8.2 STD Market ............................................................................................................................ 306 8.2.1 STD Market by Country with Chart................................................................................ 306 8.3 UTI Market.............................................................................................................................. 308 8.3.1 UTI Market by Country with Chart ................................................................................. 308 8.4 HxV Market............................................................................................................................ 310 8.4.1 HxV Market by Country with Chart ............................................................................... 310 8.5 Other Market......................................................................................................................... 312 8.5.1 Other Market by Country with Chart ............................................................................ 312
9. Global Market by Channel..............................................................................................314
9.1 OTC/DTC Market by Channel ............................................................................................. 315 9.1.1 OTC/DTC Market by Channel with Chart..................................................................... 315 9.2 OTC Market........................................................................................................................... 316 9.2.1 OTC Market by Country ................................................................................................. 316 9.3 DTC Market ........................................................................................................................... 318 9.3.1 DTC Market by Country with Chart............................................................................... 318 9.4 HSG Market ........................................................................................................................... 320 9.4.1 HSG Market by Country with Chart............................................................................... 320
Appendices ..........................................................................................................................322
I. United States Medicare System: 2020 Clinical Laboratory Fees Schedule ......................... 322 II. FDA Approved Microbial Tests............................................................................................... 383

Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2024 ($Billion) ............ 33
 
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Table 2 Classification of HIV Species.............................................................................................. 36 Table 3 HBV Tests - CMS Codes & Prices........................................................................................ 66 Table 4 HCV Tests - CMS Codes & Prices ....................................................................................... 73 Table 5 HPV Clearance Rates ........................................................................................................ 80 Table 6 HPV Tests - CMS Codes & Prices........................................................................................ 85 Table 7 HPV Tests, Technology, Types ............................................................................................ 86 Table 8 Characteristics of Coronavirus Pandemic Infections ...................................................... 95 TABLE 9 COVID-19 SYMPTOMS ............................................................................................................. 97 Table 10 DTC COVID-19 TESTS and CURRENT STATUS .................................................................. 108 Table 11 Types of Influenza Tests .................................................................................................. 116 Table 12 Influenza Tests - CMS Codes & Prices............................................................................ 119 Table 13 FDA Cleared Molecular Assays for Influenza ............................................................... 120 Table 14 FDA Cleared NAAT CTGC Tests ..................................................................................... 132 Table 15 CTGC NAAT Target Sequences and Possible False Reactions ................................... 137 Table 16 CT/NG Tests - CMS Codes & Prices ............................................................................... 141 Table 17 GAS Panel BioFire .......................................................................................................... 149 Table 18 BioFire RESP Panel........................................................................................................... 152 Table 19 Market Players by Type ................................................................................................. 155 Table 20 Clinical Laboratory Departments and Segments ........................................................ 161 Table 21 Laboratory Management Focus – Different Approaches .......................................... 162 Table 22 Key Segmentation Variables Going Forward............................................................... 163 Table 23 Possible Market Segments of OTC/DTC Market ........................................................... 163 Table 24 Five Factors Driving Growth ........................................................................................... 172 Table 25 Four Factors Limiting Growth ......................................................................................... 175 Table 26 Self vs. Send TAT .............................................................................................................. 182 Table 27 OTC/DTC ID Global Market by Country/Region.......................................................... 298
 
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Table 28 OTC/DTC ID Global Market by Syndrome.................................................................... 300 Table 29 STD Testing market by country ...................................................................................... 306 Table 30 UTI Testing market by country........................................................................................ 308 Table 31 HxV Testing market by country...................................................................................... 310 Table 32 Other Testing market by country................................................................................... 312 Table 33 DTC Testing market by country ..................................................................................... 318 Table 34 HSG Testing market by country ..................................................................................... 320 Table 35 2020 Clinical Lab Fee Schedule .................................................................................... 322
 
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Table of Figures
Figure 1 Medicare Clinical Lab Expenditures 2014 to 2024 ($Million).......................................... 32 Figure 2 HIV Virion ............................................................................................................................ 37 Figure 3 Diagram of the HIV Replication Cycle ............................................................................ 41 Figure 4 The Structure of the HBV Virus........................................................................................... 60 Figure 5 Hepatitis B Replication ...................................................................................................... 61 Figure 6 Structure of the HCV Virus................................................................................................. 68 Figure 7 HCV Replication Cycle ..................................................................................................... 71 FIGURE 8 STRUCTURE OF CORONAVIRUSES ............................................................................................... 91 Figure 9 Structure of the Influenza Virion ..................................................................................... 113 Figure 10 Influenza Replication..................................................................................................... 114 Figure 11 Chart Death Rates and Infectious Disease Decline ................................................... 176 Figure 11 The Multiplex Paradigm Shift......................................................................................... 180 Figure 13 Market Size by Country - Key Countries....................................................................... 299 Figure 14 Chart of Global Market by Syndrome by Year ........................................................... 300 Figure 15 Syndrome Segment Shares 2019 vs 2014..................................................................... 301 Figure 16 Syndrome Share 2019.................................................................................................... 302 Figure 17 Syndrome Share 2024.................................................................................................... 302 Figure 18 Chart - Respiratory market 5 Year Growth .................................................................. 305 Figure 19 Chart – STD market 5 Year Growht .............................................................................. 307 Figure 20 Chart – UTI 5 Year market Growth................................................................................ 309 Figure 21 Chart - HxV market 5 Year Growth .............................................................................. 311 Figure 22 Chart – Other market 5 Year Growth........................................................................... 313
 
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Figure 23 Channel Share by Year................................................................................................. 315 Figure 24 Chart - OTC Channel 5 Year Growth........................................................................... 317 Figure 25 Chart – DTC Channel 5 Year Growth........................................................................... 319 Figure 26 Chart – HSG Channel 5 Year Growth .......................................................................... 321