Table of Content

Table of Contents
i. Market Guides ........................................... 16
iA. Situation Analysi – COVID & Sepsis................................. 17
iB. Guide for Executives and Marketing Staf.............................. 19
iC. Guide for Investment Analysts and Management Consultants ................. 20
1. Introduction and Market Definiton ............................... 21
1.1 An Overview of Sepsi Diagnostics................................. 2
1.1.1 Sepsis the medical emergency................................. 23
1.1.2 Sepsis Diagnosi and Comorbidity............................... 25
1.3 Market Definiton ........................................... 26
1.3.1 Market Size............................................ 26
1.3.2 Curency.............................................. 26
1.3.3 Years ................................................ 26
1.3.4 Microbiology........................................... 26
1.3.5 Other Infectious Disease ..................................... 27
1.3.6 Syndromic PoC.......................................... 27
1.3.7 Biomarkers Molecular Diagnostics............................... 27
1.3.8 Biomarkers Other......................................... 27
1.3.9 Limitations............................................. 27
1.4 Methodology ............................................. 28
1.4.1 Authors............................................... 28
1.4.2 Sources.............................................. 28
1.5 U.S. Medical Market and laboratory Testing - Perspective.................... 29
1.4.1 U.S. Medicare Expenditures for Laboratory Testing...................... 29
2. Sepsis – Curent Science ..................................... 31
2.1 What is Sepsis? ............................................ 32
2.1.1 Organ Damage ......................................... 3
2.1.2 Neonatal sepsi .......................................... 3
2.1.3 Prognosis.............................................. 34
2.2 Diagnosis................................................ 35
2.2.1 Infection Identifcation ...................................... 35
2.2.2 Biomarkers............................................. 35
2.2.3 Diferential diagnosis ....................................... 39
2.2.4 The Cytokine Storm – Diagnostic Needs............................ 39
2.3 Causes of Sepsi............................................ 40
2.3.1 Sepsis Progresion......................................... 40
2.3.2 The Cytokine Storm – COVID and Other Situations...................... 42
2.4 Prevalence .............................................. 42
2.4.1 Impact of COVID on Sepsi Prevalence ............................ 4
3. Industry Overview......................................... 45
3.1 Players in a Dynamic Market .................................... 46
3.1.1 Academic Research Lab.................................... 47
3.1.2 Diagnostic Test Developer.................................... 47
3.1.3 Pharmaceutical/Reagent Supplier............................... 47
3.1.4 Independent Testing Lab.................................... 47
3.1.6 Public National/regional ab .................................. 48
3.1.7 Hospital ab............................................ 48
3.1.8 Physician Lab........................................... 49
3.1.9 Audit Body ............................................ 49
3.1.10 Certifcation Body ....................................... 49
4. Market Trends ........................................... 51
4.1 Factors Driving Growth ........................................ 52
4.1.1 Increasing Prevalence ...................................... 52
4.1.2 Antimicrobial Resitance..................................... 53
4.1.3 Increasing Diagnosis....................................... 54
4.1.4 Multiplex Diagnostics Impacts.................................. 54
4.1.5 The Aging World......................................... 54
4.1.6 COVID Market Impact ...................................... 5
4.2 Factors Limitng Growth ....................................... 57
4.2.1 The Cost Curve Shrinks the Market ............................... 57
4.2.2 The Diagnostics Dilemma.................................... 58
4.2.3 Adoption Lag and Cost Control ................................ 58
4.3 Diagnostic Technology Development............................... 58
4.3.1 The Multiplex Opportunity.................................... 58
4.3.2 Shifting Role of Physicians in Diagnosi............................. 59
4.3.3 Diagnostics Moves Out of the Lab ............................... 60
4.3.4 Biomarkers and Algorithms ................................... 60
4.3.5 Rapid Testing Changing Medical Practice .......................... 60
4.3.6 Genome Role and Big Data................................... 61
4.3.6 The Next Five Years........................................ 62
5. Sepsis Diagnostics - Recent Developments........................... 63
5.1 Recent Developments – Importance and How to Use This Section ............... 64
5.1.1 Importance of These Developments.............................. 64
5.1.2 How to Use This Section..................................... 64
SpeeDx Developing Respiratory Virus Host-Response Test...................... 64
Scanogen Developing Blood Infection Test with Sepsis Application ................ 68
Inflammatix Moving Into COVID Test Market and Developing New Sepsi Dx ........... 71
Immunexpres, Biocartis to Rol Out Sepsis Test............................. 75
Sepset Biosciences Using COVID-19 Patient Samples to Validate Sepsis Test............ 78
Immunexpres to Develop Sepsis Test for Coronavirus Patient Triage................ 81
DNAe Developing POC Sequencing Platform for Coronavirus, Sepsis ............... 82
NGS technique ofers quick, accurate diagnosi of sepsi...................... 86
Portable device diagnoses sepsis faster................................ 8
Ontera and QuantuMDx Colaborate to Advance Sepsi Diagnosis................ 89
Blood Test Accurately Predicts Sepsi Severity ............................. 90
Sepsis diagnostics: HHS to advance development of Cytovale rapid test............. 93
Mologic Developing Sepsis Test Using Multimarker.......................... 94
Abionic: Study Demonstrates Diagnosi of Sepsi in 5 Minutes.................... 97
T2 Biosystems Introduces New Data and Updates for Rapid Diagnostic Technology ....... 98
Sepsis found to fit into 4 subtypes................................... 100
GenMark Diagnostics Receives FDA Clearance for Blood Panel.................. 101
Novacyt, Immunexpres Extend Sepsis Asay Development Partnership ............. 102
New Test Could Diagnose Sepsis Faster ................................ 102
Immunexpres Wins $745K HHS Contract for Rapid Sepsis Asay .................. 103
Curetis’ Unyvero Application Cartridges Receive Regulatory Approvals ............. 103
Luminex to Pay $75M for MiliporeSigma's Flow Cytometry Research Portfolio.......... 105
Experimental 2.5-minute Sepsis Test Discovered ........................... 106
sphingotec raises €20 milion...................................... 108
SeLux Diagnostics Announces Sepsi U.S. HHS/BARDA Research Funding............. 109
Roche PCT asay cleared as tool in fight against Sepsis....................... 10
GeneFluidics selected as finalist for AMR Chalenge ........................ 11
BioDirection, Inc. Announces System to Diagnose and Monitor Sepsi .............. 13
sphingotec Adding Advanced POC Testing Platform ........................ 14
Rapid Detection Using DNAe’s LiDia® Bloodstream Infection Technology............ 16
Septec Team Working on 15 Minute Sepsis Diagnosi........................ 18
Abionic Announces Rapid Sepsis PoC Diagnostic.......................... 19
6. Profiles of Key Companies................................... 120
Abbot Diagnostics........................................... 121
Abionic.................................................. 123
Accel Diagnostics............................................ 124
Accelerate Diagnostics......................................... 125
Axis-Shield Diagnostics Ltd....................................... 126
Beckman Coulter, Inc.......................................... 127
Becton, Dickinson and Company................................... 129
Biocartis.................................................. 131
bioMérieux Diagnostics......................................... 132
Bio-Rad Laboratories, Inc........................................ 134
Bruker................................................... 136
Cube Dx................................................. 138
Curetis N.V. / Curetis GmbH...................................... 139
Cytovale ................................................. 140
EKF Diagnostics Holdings ........................................ 141
GeneFluidics............................................... 143
GenMark Dx ............................................... 14
Grifols................................................... 146
Immunexpres .............................................. 147
Inflammatix................................................ 148
Linear Diagnostics............................................ 149
Luminex Corp.............................................. 150
Mbio Diagnostics ............................................ 152
Mobidiag ................................................. 153
Nanomix................................................. 154
Qiagen Gmbh.............................................. 15
Response Biomedical.......................................... 157
Roche Molecular Diagnostics..................................... 158
SeLux Diagnostics ............................................ 160
Septec.................................................. 161
Siemens Healthineers .......................................... 162
Sphingotec................................................ 164
T2 Biosystems ............................................... 165
Thermo Fisher Scientifc Inc....................................... 16
7. Sepsis Diagnostic Markets................................... 168
7.1 Sepsi Diagnostics – Global Market Overview by Country ................... 169
7.1.1 Table – Global Market by Country .............................. 169
7.1.2 Chart - Global Market by Country............................... 170
8. Global Sepsis Diagnostics Markets – By Asay Type ..................... 171
8.1 Global Market by Diagnostic Type - Overview .......................... 172
8.1.1 Table – Global Market by Diagnostic Type .......................... 172
8.1.2 Chart – Global Market by Asay Type............................. 173
8.1.3 Chart – Global Market by Type – Base Year ......................... 174
8.1.4 Chart – Global Market by Type – Final Year......................... 175
8.1.4 Chart – Global Market by Type – Share by Year ....................... 176
8.2 Sepsi Diagnostic - Microbiology .................................. 17
8.2.1 Table Sepsi Diagnostic Microbiology – by Country..................... 17
8.2.2 Chart - Sepsis Diagnostic Microbiology Growth ....................... 178
8.3 Sepsi Diagnostic - Syndromic PoC Panel ............................. 179
8.3.1 Table Sepsi Diagnostic Syndromic PoC Panel – by Country................ 179
8.3.2 Chart - Sepsis Diagnostic Syndromic PoC Panel Growth .................. 180
8.4 Sepsi Diagnostic – Other Infectious Disease........................... 181
8.4.1 Table Sepsi Diagnostic Other ID – by Country ........................ 181
8.4.2 Chart - Sepsis Diagnostic – Other Infectious Disease Growth ................ 182
8.5 Sepsi Diagnostic – Biomarker Molecular Diagnostic....................... 183
8.5.1 Table Sepsi Diagnostic Biomarker MDx – by Country .................... 183
8.5.2 Chart - Sepsis Diagnostic – Biomarker MDx Growth ..................... 184
8.6 Sepsi Diagnostic – Biomarker Other................................ 185
8.6.1 Table Sepsi Diagnostic Biomarker Other – by Country ................... 185
8.6.2 Chart - Sepsis Diagnostic – Biomarker Other Growth.................... 186
9. Global Sepsis Diagnostics Markets – By Cause ........................ 187
9.1 Global Market by Cause - Overview............................... 18
9.1.1 Table – Global Market by Cause............................... 18
9.1.2 Chart – Global Market by Cause............................... 189
9.1.3 Chart – Global Market by Type – Base Year ......................... 190
9.1.4 Chart – Global Market by Type – Final Year......................... 191
9.1.4 Chart – Global Market by Cause – Share by Year ...................... 192
9.2 Sepsi Diagnostic - GastroIntestinal................................ 193
9.2.1 Table Sepsi Diagnostic GastroIntestinal – by Country.................... 193
9.2.2 Chart - Sepsis Diagnostic GastroIntestinal Growth ...................... 194
9.3 Sepsi Diagnostic – Respiratory COVID-19............................. 195
9.3.1 Table Sepsi Diagnostic Respiratory COVID-19– by Country................ 195
9.3.2 Chart - Sepsis Diagnostic Respiratory COVID-19....................... 196
9.4 Sepsi Diagnostic – Respiratory Other............................... 197
9.4.1 Table Sepsi Diagnostic Respiratory Other – by Country .................. 197
9.4.2 Chart - Sepsis Diagnostic – Respiratory Other Growth.................... 198
9.5 Sepsi Diagnostic – Newborn .................................... 19
9.5.1 Table Sepsi Diagnostic Newborn – by Country....................... 19
9.5.2 Chart - Sepsis Diagnostic – Newborn Growth ........................ 20
9.6 Sepsi Diagnostic – Other Cause.................................. 201
9.6.1 Table Sepsi Diagnostic Other Cause – by Country ..................... 201
9.6.2 Chart - Sepsis Diagnostic – Other Cause Growth...................... 202
Appendices............................................. 203
I. United States Medicare System: 2020 Clinical Laboratory Fees Schedule ............ 204


Table of Tables
Table 1 Lab Spending 2014 to 2024.................................... 30
Table 2 sepsi biomarkers - Established and potential .......................... 36
Table 3 Market Players by Type...................................... 46
Table 4 Five Factors Driving Growth .................................... 52
Table 5 Three Factors Limitng Growth .................................. 57
Table 6 - Global Sepsi Diagnostics Market by Country/Region.................... 169
Table 7 Global Market by Asay Type.................................. 172
Table 8 Sepsis Diagnostic Microbiology by Country.......................... 17
Table 9 Sepsis Diagnostic Syndromic PoC Panel by Country..................... 179
Table 10 Sepsi Diagnostic Other ID by Country ............................ 181
Table 1 Sepsi Diagnostic Biomarker MDx by Country ........................ 183
Table 12 Sepsi Diagnostic Biomarker Other by Country ........................ 185
Table 13 Global Market by Cause.................................... 18
Table 14 Sepsi Diagnostic GastroIntestinal by Country ........................ 193
Table 15 Sepsi Diagnostic Respiratory COVID-19 by Country.................... 195
Table 16 Sepsi Diagnostic Respiratory Other by Country ....................... 197
Table 17 Sepsi Diagnostic Newborn by Country ............................ 19
Table 18 Sepsi Diagnostic Other Cause by Country .......................... 201
Table 19 2020 Clinical Lab Fee Schedule ................................ 204

Table of Figures
Figure 1 Sepsis Survival graph ....................................... 23
Figure 2 Percentage of Sepsis Patients with Comorbidity ........................ 25
Figure 3 Clinical Lab Spending 2014 to 2024............................... 29
Figure 4 Sepsis Clinical Progresion .................................... 41
Figure 5 Deaths From Drug Resistant Infections 2050 .......................... 53
Figure 6 Aggregate Age of World Population .............................. 5
Figure 7 Growth in Health Care Spending Developing World..................... 56
Figure 8 Comparing The New Diagnostics and Traditonal Testing ................... 59
Figure 9 Growth rates of Sepsis Diagnostics ............................... 62
Figure 10 Global Market Share Chart.................................. 170
Figure 1 Sepsi Diagnostics Market Segment Shift Base vs Final year................ 173
Figure 12 Sepsi Diagnostics Market by Type Base Year ........................ 174
Figure 13 Sepsis Diagnostics Market by Type Final Year........................ 175
Figure 14 Type Share by Year ....................................... 176
Figure 15 Sepsi Diagnostic Microbiology Growth........................... 178
Figure 16 SEPSIS DIAGNOSTICS Syndromic POC Panel Growth.................... 180
Figure 17 Sepsi Diagnostic Other Infectious Disease Growth ..................... 182
Figure 18 Sepsi Diagnostic Molecular Diagnostics Growth ...................... 184
Figure 19 Sepsi Diagnostic Biomarker Other Growth ......................... 186
Figure 20 Sepsi Diagnostics Market Cause Segment Shift Base vs Final year ............ 189
Figure 21 Sepsi Diagnostics by Cause Segment Base Year ...................... 190
Figure 2 Sepsi Diagnostics Market by Cause Segment Final Year ................. 191
Figure 23 Cause Share by Year ...................................... 192
Figure 24 Sepsi Diagnostic GastroIntestinal Growth.......................... 194
Figure 25 SEPSIS DIAGNOSTICS Respiratory COVID-19......................... 196
Figure 26 Sepsi Diagnostic Respiratory Other Growth ......................... 198
Figure 27 Sepsi Diagnostic Newborn Growth.............................. 200
Figure 28 Sepsi Diagnostic Other Cause Growth ........................... 202