Table of Content

i. COVID-19. Strategic Situation Analysis.............................................................................14 ii. COVID-19.
Guidance for Executives ...............................................................................16 iii. COVID-19.
Guidance for Management Consultants and Investment Advisors..........17 1.
Introduction and Market Definition ...................................................................................18
1.1 What are Pandemics? ........................................................................................................... 19
1.2 The Role of Zoonosis ............................................................................................................... 22
1.3 Market Definition .................................................................................................................... 24
1.3.1 Assay Volumes. ................................................................................................................. 24
1.3.2 Healthcare Systems Demand.......................................................................................... 24
1.3.3 Molecular & Serology....................................................................................................... 25
1.4 Methodology .......................................................................................................................... 25
1.4.1 Authors .............................................................................................................................. 25
1.4.2 Sources.............................................................................................................................. 25
1.5 Historical Perspective on Pandemics.................................................................................... 27
1.5.1 HIV/AIDS PANDEMIC 2005-2012....................................................................................... 27
1.5.2 FLU PANDEMIC 1968 ......................................................................................................... 28
1.5.3 ASIAN FLU 1956-1958 ........................................................................................................ 28
1.5.4 SPANISH FLU 1918.............................................................................................................. 29
1.5.5 SIXTH CHOLERA PANDEMIC 1910-1911 ........................................................................... 29
1.5.6 FLU PANDEMIC 1889-1890 ................................................................................................ 30
1.5.7 THE BLACK DEATH 1346-1353 ........................................................................................... 30

2. The Pandemic Overview....................................................................................................32
2.1 What is a Virus?....................................................................................................................... 33
2.1.1 Is a Virus Alive?.................................................................................................................. 34
2.1.2 Viral Structure.................................................................................................................... 35
2.1.3 The Viral Genome ............................................................................................................ 36
2.1.4 Viral Mutation ................................................................................................................... 37
2.2 The Coronavirus ...................................................................................................................... 39
2.2.1 Severe acute respiratory syndrome (SARS).................................................................... 41
2.2.2 Middle East respiratory syndrome (MERS) ...................................................................... 43
2.2.3 COVID-19. The SARS CoV 2 Virus.................................................................................... 44
2.2.3.1 Signs and symptoms................................................................................................. 46
2.2.3.2 Transmission............................................................................................................... 47
2.2.3.3 Diagnosis ................................................................................................................... 48
2.2.3.4 Prevention................................................................................................................. 50
2.2.3.5 Management ........................................................................................................... 51
2.2.3.6 Prognosis ................................................................................................................... 53
2.2.3.7 A Note on Global Statistics Reporting .................................................................... 53
2.3 Pandemic Diagnostics ........................................................................................................... 55
2.3.1 Risk Management – Spark and Spread.......................................................................... 55
2.3.2 Dx Technology – Nucleic Acid Based............................................................................. 57
2.3.3 Dx Technology - Immunoassay ....................................................................................... 58
2.3.4 Time to Market and Preparedness Issues........................................................................ 58
2.3.5 Saliva Direct Test............................................................................................................... 59
2.3.5.1 Research Abstract.................................................................................................... 61
2.3.5.2 FDA Statement on Saliva Direct Test....................................................................... 62
2.3.5.3 Impact of Saliva Direct on Forecasts and Cannibalization .................................. 63

3. Infection/Hospitalization Projections by Country by Quarter. All Case Secenarios ......64
3.1 Scenarios Overview................................................................................................................ 65
3.1.1 WHO Global Health Security Index................................................................................. 67
3.1.2 Pandemic Progression Outlook Methodology............................................................... 70
3.2 Scenario 1. Best Case............................................................................................................ 71
3.3Scenario2. ExpectedCase..................................................................................................72
3.4 Scenario 3. Worst Case ......................................................................................................... 73

4. Diagnostic Company Profiles ............................................................................................74
1drop ............................................................................................................................................. 75
Abbott Diagnostics....................................................................................................................... 76
Accelerate Diagnostics ............................................................................................................... 78
Ador Diagnostics .......................................................................................................................... 79
Advanced Biological Laboratories ............................................................................................. 80
Akkoni Biosystems ......................................................................................................................... 81
Altona Diagnostics ....................................................................................................................... 82
Alveo Technologies...................................................................................................................... 83
Applied BioCode.......................................................................................................................... 84
Applied DNA Sciences................................................................................................................. 86
Anatolia Geneworks .................................................................................................................... 88
Assurance Scientific Laboratories ............................................................................................... 89
Aus Diagnostics............................................................................................................................. 90
Autobio Diagnostics ..................................................................................................................... 92
BD Diagnostics .............................................................................................................................. 93
BGI Genomics Co. Ltd ................................................................................................................. 95
Biocartis ......................................................................................................................................... 97
Biodesix.......................................................................................................................................... 98
BioFire Diagnostics........................................................................................................................ 99
Biolidics........................................................................................................................................ 101
bioMérieux .................................................................................................................................. 102
Bioneer ........................................................................................................................................ 103
Bio-Rad Laboratories.................................................................................................................. 105
BioReference Laboratories ........................................................................................................ 107
Bosch Healthcare Solutions GmbH ........................................................................................... 108
Cepheid ...................................................................................................................................... 109
Cerstest Biotec............................................................................................................................ 111
Chembio Diagnostics................................................................................................................. 112
Color Genomics ......................................................................................................................... 114
Credo Diagnostics Biomedical.................................................................................................. 115
Curetis.......................................................................................................................................... 117
Diagenode Diagnostics ............................................................................................................. 118
Diascopic .................................................................................................................................... 119
Diasorin........................................................................................................................................ 120
Enzo Life Sciences, Inc. .............................................................................................................. 122
Exact Sciences............................................................................................................................ 124
Expedeon.................................................................................................................................... 125
Fulgent Genetics ........................................................................................................................ 126
Fusion Genomics. ....................................................................................................................... 127
Genedrive................................................................................................................................... 129
GenePOC Diagnostics............................................................................................................... 130
Genetic Signatures..................................................................................................................... 131
Genetron..................................................................................................................................... 132
GenMark Dx................................................................................................................................ 133
Gold Standard Diagnostics ....................................................................................................... 134
Hologic ........................................................................................................................................ 135
Immunexpress............................................................................................................................. 137
Inflammatix ................................................................................................................................. 138
Invetech ...................................................................................................................................... 139
Janssen Diagnostics ................................................................................................................... 140
Karius ........................................................................................................................................... 141
Laboratory Corporation of America......................................................................................... 142
Lexagene .................................................................................................................................... 144
Luminex ....................................................................................................................................... 145
Mayo Clinic Laboratories........................................................................................................... 147
Mbio Diagnostics ........................................................................................................................ 148
Meridian Bioscience................................................................................................................... 149
Mesa Biotech.............................................................................................................................. 151
Mobidiag..................................................................................................................................... 152
Nanomix ...................................................................................................................................... 153
Novacyt....................................................................................................................................... 154
Orig3n.......................................................................................................................................... 155
Ortho Clinical Diagnostics ......................................................................................................... 156
Oxford Nanopore ....................................................................................................................... 157
Panagene ................................................................................................................................... 159
PerkinElmer .................................................................................................................................. 160
Primerdesign ............................................................................................................................... 162
Prominex...................................................................................................................................... 163
Qiagen (Statdx).......................................................................................................................... 164
Quantumdx................................................................................................................................. 166
Quest Diagnostics....................................................................................................................... 167
Quidel.......................................................................................................................................... 168
Randox Laboratories .................................................................................................................. 170
Roche Molecular Diagnostics ................................................................................................... 172
Saw Diagnostics.......................................................................................................................... 175
SD Biosensor ................................................................................................................................ 176
Seegene...................................................................................................................................... 177
Sensovation................................................................................................................................. 179
Siemens Healthineers (Fast Track Diagnostics)......................................................................... 180
SkylineDx...................................................................................................................................... 187
Sona Nanotech .......................................................................................................................... 188
T2 Biosystems............................................................................................................................... 190
Thermo Fisher .............................................................................................................................. 192
Veredus Labs .............................................................................................................................. 194
Vircell........................................................................................................................................... 195
YD Diagnostics ............................................................................................................................ 196
Zhejiang Orient Gene Biotech................................................................................................... 197

6. Healthcare Systems Dx Demand Outlook .....................................................................198
6.1 Healthcare System Demand by Country – Best Case....................................................... 199
6.1.1 Table – Healthcare Dx Total Demand by Country – Best Case.................................. 199
6.1.3 Chart – Global Healthcare Dx Total Demand by Quarter – Best Case ..................... 200
6.2 Healthcare System Demand by Country – Expected Case ............................................. 201
6.2.1 Table – Healthcare Dx Total Demand by Country – Expected Case ........................ 201
6.2.3 Chart – Global Healthcare Dx Total Demand by Quarter – Expected Case............ 202
6.3 Healthcare System Demand by Country – Worst Case .................................................... 203
6.3.1 Table – Healthcare Dx Total Demand by Country – Worst Case................................ 203
6.3.3 Chart – Global Healthcare Dx Total Demand by Quarter – Worst Case ................... 204

7. Molecular/SerologyDxDemandOutlook.....................................................................205
7.1 Molecular/Serology Demand by Country – Best Case ..................................................... 206
7.1.1 Table – Molecular Dx Total Demand by Country – Best Case .................................... 206
7.1.2 Table – Serology Dx Total Demand by Country – Best Case ...................................... 207
7.1.3 Chart – Global Molecular Dx Total Demand by Quarter – Best Case ....................... 208
7.1.4 Chart – Global Serology Dx Total Demand by Quarter – Best Case.......................... 209
7.2 Molecular/Serology Demand by Country – Expected Case............................................ 210
7.2.1 Table – Molecular Dx Total Demand by Country – Expected Case .......................... 210
7.2.2 Table – Serology Dx Total Demand by Country – Expected Case............................. 211
7.2.3 Chart – Global Molecular Dx Total Demand by Quarter – Expected Case.............. 212
7.2.4 Chart – Global Serology Dx Total Demand by Quarter – Expected Case ................ 213
7.3 Molecular/Serology Demand by Country – Worst Case................................................... 214
7.3.1 Table – Molecular Dx Total Demand by Country – Worst Case.................................. 214
7.3.2 Table – Serology Dx Total Demand by Country – Worst Case .................................... 215
7.3.3 Chart – Global Molecular Dx Total Demand by Quarter – Worst Case ..................... 216
7.3.4 Chart – Global Serology Dx Total Demand by Quarter – Worst Case ....................... 217
 



Table of Tables
Table 1 Who List of Potential Pandemic Pathogens ..................................................................... 34
Table 2 Characteristics of Coronavirus Pandemic Infections ...................................................... 45
Table 3 COVID-19 Symptoms.......................................................................................................... 47
Table 4 The Three Scenarios............................................................................................................ 66
Table 5 Test Consumption Outlook Based on Mid July Daily Run Rate – Relative Percentages per quarter . 70
Table 6 Scenario 1 Assumptions ..................................................................................................... 71
Table 7 Scenario 2 Assumptions ..................................................................................................... 72
Table 8 Scenario 3 Assumptions ..................................................................................................... 73
Table 9 – Healthcare Dx Total Demand by Country – Best Case .............................................. 199
Table 10 – Healthcare Dx Total Met Demand by Country – Expected Case ........................... 201
Table 11 – Healthcare Dx Total Demand by Country – Worst Case.......................................... 203
Table 12 – Molecular Dx Total Demand by Country – Best Case .............................................. 206
Table 13 – Molecular Dx Total Demand by Country – Expected Case..................................... 210
Table 14 – Serology Dx Total Demand by Country – Expected Case ....................................... 211
Table 15 – Molecular Dx Total Demand by Country – Worst Case............................................ 214
Table 16 – Serology Dx Total Demand by Country – Worst Case .............................................. 215

Table of Figures
Figure 1 Global Distribution Pandemic Preparedness .................................................................. 20
Figure 2 Global Pandemic Pathogen Status ................................................................................. 21
Figure 3 Estimated Economic Impact of Viral Pandemic by Region .......................................... 23
Figure 4 Historical Pandemics Infographic .................................................................................... 31
Figure 5 Antigenic Drift Creates a new Strain of Virus .................................................................. 38
Figure 6 Structure of Coronaviruses................................................................................................ 41
Figure 7 1918 Flu - 2 Infection Curves ............................................................................................. 66
Figure 8 Global Healthcare Diagnostics Demand by Quarter – Best Case.............................. 200
Figure 9 Global Healthcare Diagnostics Demand by Quarter – Expected Case .................... 202
Figure 10 Global Healthcare Diagnostics Demand by Quarter – Worst Case ......................... 204
Figure 11 Global Healthcare Diagnostics Molecular Demand by Quarter – Best Case.......... 208
Figure 12 Global Healthcare Diagnostics Serology Demand by Quarter – Best Case ............ 209
Figure 13 Global Healthcare Diagnostics Molecular Demand by Quarter – Expected Case 212
Figure 14 Global Healthcare Diagnostics Total Demand by Quarter – Expected Case ......... 213
Figure 15 Global Healthcare Diagnostics Molecular Demand by Quarter – Best Case.......... 216
Figure 16 Global Healthcare Diagnostics Serology Demand by Quarter – Worst Case.......... 217