SEPSIS MARKETS
BY APPLICATION, BY TECHNOLOGY AND BY USER. WITH EXECUTIVE AND CONSULTANT GUIDES 2024-2028
EYE ON IVD Partner Howe Sound Research – Published June 2024 – 540 pages
Sepsis is a life-threatening condition that arises when the body’s response to infection triggers widespread inflammation, leading to tissue damage, organ failure, and potentially death if not treated quickly. According to the World Health Organization, it affects an estimated 49 million people globally each year, leading to approximately 11 million deaths. Early diagnosis and immediate intervention with antibiotics and supportive care are crucial for improving survival rates.
Diagnostics for sepsis are urgently needed and improvements are a constant concern. This creates an opportunity for test makers. But how to sum up this opportunity for reasonable business planning efforts? This report, Sepsis Markets, is a comprehensive review of the industry. The report looks at both the challenges and opportunities in the diagnostics for sepsis.
This report is based on research conducted over the last four months. Data is derived primarily from executive comments, quarterly reports, and industry association data. While much information is kept confidential by suppliers this report infers revenues based on estimates of individual company activities by channel historically, currently, and as intermittently reported. This report aggregates supplier revenues and compares these to industry and other sources to arrive at estimates of current and historical market size. Forecasts are firstly based on historical growth rates and the current overall economic growth outlook for specific regions and countries. Secondarily the growth outlook is modified to account for factors specific to the market under study.
Sources of information include the World Health Organization, the International Monetary Fund, the World Bank, several U.S. and European Union government bodies and industry associations. Considerable primary information is collected from company annual and quarterly reports, industry associations, industry participants and executives, whose information and insight are regularly solicited. Much company information comes from company websites, investor presentations, press releases, annual reports, 10K filings, news reports, national statistical services and industry blogs. Technical information is primarily based on published academic literature.
Table of Contents
1 Market Guides …………………………………………………………………………………………. 20
1.1 Situation Analysis ………………………………………………………………………………………. 21
1.2 Guide for Executives and Marketing Staff ………………………………………………….. 23
1.3 Guide for Investment Analysts and Management Consultants …………………… 24
2 Introduction and Market Definition …………………………………………………………… 25
2.1 An Overview of Sepsis Diagnostics …………………………………………………………….. 26
2.1.1 Sepsis the medical emergency ………………………………………………………………. 27
2.1.2 Sepsis Diagnosis and Comorbidity ………………………………………………………….. 28
2.2 Market Definition ………………………………………………………………………………………. 29
2.2.1 Market Size ……………………………………………………………………………………………. 29
2.2.2 Currency ……………………………………………………………………………………………….. 29
2.2.3 Years …………………………………………………………………………………………………….. 29
2.2.4 Microbiology …………………………………………………………………………………………. 29
2.2.5 PCR ……………………………………………………………………………………………………….. 30
2.2.6 Immunoassay ………………………………………………………………………………………… 30
2.2.7 Other Infectious Disease ………………………………………………………………………… 30
2.2.8 Syndromic PoC ……………………………………………………………………………………… 30
2.2.9 Biomarkers Molecular Diagnostics ………………………………………………………….. 30
2.2.10 Biomarkers Other ………………………………………………………………………………… 31
2.2.11 Limitations ………………………………………………………………………………………….. 31
2.3 Methodology ……………………………………………………………………………………………. 32
2.3.1 Methodology ………………………………………………………………………………………… 32
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2.3.2 Sources …………………………………………………………………………………………………. 32
2.3.3 Authors ………………………………………………………………………………………………….. 32
2.4 Perspective: Healthcare and the IVD Industry ……………………………………………. 34
2.4.1 Global Healthcare Spending …………………………………………………………………. 34
2.4.2 Spending on Diagnostics ……………………………………………………………………….. 36
2.4.3 Important Role of Insurance for Diagnostics ……………………………………………. 37
3 Sepsis – Current Science …………………………………………………………………………… 38
3.1 What is Sepsis? ………………………………………………………………………………………….. 39
3.1.1 Organ Damage …………………………………………………………………………………….. 40
3.1.2 Neonatal sepsis ……………………………………………………………………………………… 40
3.1.3 Prognosis ……………………………………………………………………………………………….. 41
3.2 Diagnosis ………………………………………………………………………………………………….. 42
3.2.1 Infection Identification …………………………………………………………………………… 42
3.2.2 Biomarkers …………………………………………………………………………………………….. 42
3.2.3 Differential diagnosis ……………………………………………………………………………… 46
3.2.4 The Cytokine Storm – Diagnostic Needs …………………………………………………. 46
3.3 Causes of Sepsis ……………………………………………………………………………………….. 47
3.3.1 Sepsis Progression ………………………………………………………………………………….. 48
3.3.2 The Cytokine Storm – COVID and Other Situations ………………………………….. 49
3.4 Prevalence ……………………………………………………………………………………………….. 49
3.4.1 Impact of COVID on Sepsis Prevalence ………………………………………………….. 51
4 Industry Overview …………………………………………………………………………………….. 52
4.1 Players in a Dynamic Market …………………………………………………………………….. 53
4.1.1 Academic Research Lab ……………………………………………………………………….. 54
4.1.2 Diagnostic Test Developer ……………………………………………………………………… 54
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4.1.3 Instrumentation Supplier ………………………………………………………………………… 55
4.1.4 Chemical/Reagent Supplier …………………………………………………………………… 55
4.1.5 Pathology Supplier…………………………………………………………………………………. 55
4.1.6 Independent Clinical Laboratory …………………………………………………………… 56
4.1.7 Public National/regional Laboratory ………………………………………………………. 56
4.1.8 Hospital Laboratory ……………………………………………………………………………….. 57
4.1.9 Physicians Office Lab (POLS) ………………………………………………………………….. 57
4.1.10 Audit Body …………………………………………………………………………………………. 58
4.1.11 Certification Body ………………………………………………………………………………. 58
5 Market Trends …………………………………………………………………………………………… 60
5.1 Factors Driving Growth ……………………………………………………………………………… 61
5.1.1 Increasing Prevalence …………………………………………………………………………… 61
5.1.2 Antimicrobial Resistance………………………………………………………………………… 62
5.1.3 Artificial Intelligence Impact ………………………………………………………………….. 63
5.1.4 Multiplex Diagnostics Impacts ………………………………………………………………… 63
5.1.5 The Aging World ……………………………………………………………………………………. 63
5.1.6 Developing World Impact ……………………………………………………………………… 66
5.2 Factors Limiting Growth …………………………………………………………………………….. 67
5.2.1 The Cost Curve Shrinks the Market ………………………………………………………….. 67
5.2.2 The Diagnostics Dillemma ………………………………………………………………………. 68
5.2.3 Adoption Lag and Cost Control …………………………………………………………….. 68
5.3 Instrumentation, Automation and Diagnostic Trends ………………………………….. 69
5.3.1 Traditional Automation and Centralization …………………………………………….. 69
5.3.2 The New Automation, Decentralization and Point Of Care …………………….. 69
5.3.3 Instruments Key to Market Share …………………………………………………………….. 71
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5.3.4 Bioinformatics Plays a Role …………………………………………………………………….. 71
5.3.5 PCR Takes Command ……………………………………………………………………………. 72
5.3.6 Next Generation Sequencing Fuels a Revolution ……………………………………. 73
5.3.7 NGS Impact on Pricing …………………………………………………………………………… 74
5.3.8 Whole Genome Sequencing, A Brave New World ………………………………….. 74
5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment ………………………….. 74
5.3.10 Shifting Role of Diagnostics …………………………………………………………………. 76
5.3.11 The Next Five Years …………………………………………………………………………….. 78
6 Sepsis Diagnostics – Recent Developments ……………………………………………….. 79
6.1 Recent Developments – Importance and How to Use This Section …………….. 80
6.1.1 Importance of These Developments ………………………………………………………. 80
6.1.2 How to Use This Section ………………………………………………………………………….. 80
6.2 Microplate Dx to Launch UTI Susceptibility Test …………………………………………… 80
6.3 QC for DiaSorin’s Luminex Sepsis Tests Cleared …………………………………………… 84
6.4 Cytovale IntelliSep ……………………………………………………………………………………. 85
6.5 Prenosis to Study Sepsis in Acute Care ……………………………………………………….. 85
6.6 DiaSorin Gains CE Mark for Sepsis Assay …………………………………………………….. 86
6.7 Cytovale to Launch Sepsis Risk-Scoring Test ……………………………………………….. 87
6.8 Todos Medical to Offer Sepsis PCR Test ……………………………………………………… 92
6.9 SeptiCyte® RAPID Validated …………………………………………………………………….. 92
6.10 Cepheid Group B Strep Test Addresses Neonatal Sepsis …………………………….. 94
6.11 DeepUll Inks Financing Deal ………………………………………………………………………. 95
6.12 Sequencing-Based Approach Shows Promise for Sepsis Dx ………………………… 95
6.13 VolitionRx Studies Cancer, Sepsis Tests ……………………………………………………….. 96
6.14 Cytovale Prepping Sepsis Test for FDA Submission ……………………………………… 97
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6.15 Great North R & I to Develop POC Sepsis Dx ……………………………………………. 101
6.16 Pathogenomix Developing Sepsis Testing Platform …………………………………… 103
6.17 Gradientech Launches Study of AST System …………………………………………….. 108
6.18 Sepsis Test Developers Accelerate Plans ………………………………………………….. 111
6.19 Immunexpress Receives Clearance for Sepsis Assay ………………………………… 116
6.20 Prenosis, Roche Partner on Sepsis Detection ……………………………………………. 117
6.21 Presymptom Health Developing Test for Sepsis …………………………………………. 118
6.22 Ortho Clinical Diagnostics Interleukin-6 Reagent Pack ……………………………… 122
6.23 Cytovale to Enter Sepsis Testing Market …………………………………………………… 122
6.24 Baebies Awarded $11.6M to Develop Diagnostic Platform to ID Sepsis …….. 128
6.25 Personalized Medicine in Sepsis ……………………………………………………………….. 129
6.26 Point-of-care Device can Diagnose Sepsis in 30 Minutes ………………………….. 130
6.27 SpeeDx Developing Respiratory Virus Host-Response Test …………………………. 131
6.28 Scanogen Developing Blood Infection Test with Sepsis Application ………….. 136
6.29 Inflammatix Developing New Sepsis Dx ……………………………………………………. 139
6.30 Immunexpress, Biocartis to Roll Out Sepsis Test …………………………………………. 144
6.31 Sepset Biosciences Using COVID-19 Patient Samples to Validate Sepsis Test 147
6.32 Immunexpress to Develop Sepsis Test ………………………………………………………. 150
6.33 DNAe Developing POC Sequencing for Sepsis …………………………………………. 151
6.34 NGS technique offers quick, accurate diagnosis of Sepsis………………………… 156
6.35 Portable device diagnoses sepsis faster …………………………………………………… 158
7 Profiles of Key Companies ………………………………………………………………………. 161
7.1 Abbott Laboratories ………………………………………………………………………………… 162
7.2 Abionic …………………………………………………………………………………………………… 164
7.3 Accel Diagnostics …………………………………………………………………………………… 165
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7.4 Accelerate Diagnostics …………………………………………………………………………… 167
7.5 ADT Biotech ……………………………………………………………………………………………. 168
7.6 Anatolia Geneworks ……………………………………………………………………………….. 169
7.7 Axis-Shield Diagnostics Ltd. ………………………………………………………………………. 170
7.8 Baebies …………………………………………………………………………………………………… 171
7.9 Beckman Coulter Diagnostics …………………………………………………………………. 173
7.10 Becton, Dickinson and Company ……………………………………………………………. 174
7.11 Biocartis ………………………………………………………………………………………………….. 176
7.12 BioFire Diagnostics (bioMérieux) ………………………………………………………………. 177
7.13 bioMérieux Diagnostics ……………………………………………………………………………. 179
7.14 Bio-Rad Laboratories, Inc. ……………………………………………………………………….. 182
7.15 Bruker ……………………………………………………………………………………………………… 185
7.16 Cube Dx …………………………………………………………………………………………………. 187
7.17 Curetis N.V. / Curetis GmbH …………………………………………………………………….. 188
7.18 Cytovale …………………………………………………………………………………………………. 190
7.19 Deepull Diagnostics ………………………………………………………………………………… 191
7.20 DNAe ……………………………………………………………………………………………………… 192
7.21 EKF Diagnostics Holdings …………………………………………………………………………. 193
7.22 GeneFluidics …………………………………………………………………………………………… 195
7.23 GenMark Dx (Roche) ………………………………………………………………………………. 196
7.24 Grifols ……………………………………………………………………………………………………… 198
7.25 Immunexpress …………………………………………………………………………………………. 199
7.26 Inflammatix …………………………………………………………………………………………….. 200
7.27 LightDeck Diagnostics …………………………………………………………………………….. 201
7.28 Linear Diagnostics …………………………………………………………………………………… 202
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7.29 Luminex Corp (DiaSorin) ………………………………………………………………………….. 203
7.30 Mobidiag (Hologic) …………………………………………………………………………………. 205
7.31 NanoDx ………………………………………………………………………………………………….. 206
7.32 Nanomix …………………………………………………………………………………………………. 207
7.33 Qiagen …………………………………………………………………………………………………… 208
7.34 Response Biomedical ……………………………………………………………………………… 211
7.35 Roche Molecular Diagnostics ………………………………………………………………….. 212
7.36 SeLux Diagnostics ……………………………………………………………………………………. 214
7.37 Septec ……………………………………………………………………………………………………. 215
7.38 Siemens Healthineers ………………………………………………………………………………. 216
7.39 Sphingotec……………………………………………………………………………………………… 218
7.40 T2 Biosystems …………………………………………………………………………………………… 219
7.41 Thermo Fisher Scientific Inc. ……………………………………………………………………… 221
7.42 Vela Diagnostics ……………………………………………………………………………………… 224
Figure 1 Sepsis Survival graph …………………………………………………………………………………. 27
Figure 2 Percentage of Sepsis Patients with Comorbidity ………………………………………… 28
Figure 3 Global Healthcare Spending …………………………………………………………………….. 35
Figure 4 The Lab Test Pie ………………………………………………………………………………………… 36
Figure 5 Sepsis Clinical Progression …………………………………………………………………………. 48
Figure 6 The Road to Diagnostics ……………………………………………………………………………. 53
Figure 7 Deaths From Drug Resistant Infections 2050 ……………………………………………….. 62
Figure 8 The Changing Age of The World’s Population ……………………………………………. 64
Figure 9 Health Care Consumption by Age ……………………………………………………………. 65
Figure 10 Cancer Incidence – Age at Diagnosis ……………………………………………………… 65
Figure 11 Growth in Health Care Spending Developing World ………………………………… 66
Figure 12 Centralized vs. Decentralized Laboratory Service ……………………………………. 70
Figure 13 A Highly Multiplexed Syndromic Testing Unit …………………………………………….. 70
Figure 14 The Real Cost to Sequence the Human Genome …………………………………….. 73
Figure 15 The Codevelopment Process…………………………………………………………………… 75
Figure 16 Comparing MDx Diagnostic and Traditional Testing …………………………………. 76
Figure 17 Growth rates of Sepsis Diagnostics …………………………………………………………… 78
Figure 18 Global Market Share Chart …………………………………………………………………… 227
Figure 19 Sepsis Diagnostics Market Segment Shift Base vs Final year …………………….. 231
Figure 20 Sepsis Diagnostics Market by Assay Base Year ……………………………………….. 232
Figure 21 Sepsis Diagnostics Market by Assay Final Year ………………………………………… 233
Figure 22 Sepsis Diagnostics Market Segment Shift Base vs Final year …………………….. 237
Figure 23 Sepsis Diagnostics Market by Cause Base Year ………………………………………. 238
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Figure 24 Sepsis Diagnostics Market by Cause Final Year ………………………………………. 239
Figure 25 Sepsis Diagnostics Market Segment Shift Base vs Final year …………………….. 243
Figure 26 Sepsis Diagnostics Market by Product Base Year ……………………………………. 244
Figure 27 Sepsis Diagnostics Market by Product Final Year …………………………………….. 245
Figure 28 Sepsis Diagnostics Market Segment Shift Base vs Final year …………………….. 249
Figure 29 Sepsis Diagnostics Market by Lab Base Year ………………………………………….. 250
Figure 30 Sepsis Diagnostics Market by Lab Final Year …………………………………………… 251
Figure 31 Sepsis Diagnostics Market Segment Shift Base vs Final year …………………….. 255
Figure 32 Sepsis Diagnostics Market by Place Base Year ……………………………………….. 256
Figure 33 Sepsis Diagnostics Market by Place Final Year………………………………………… 257
Figure 34 Sepsis Diagnostic Microbiology Growth …………………………………………………. 260
Figure 35 Sepsis Diagnostics Syndromic POC Panel Growth …………………………………… 262
Figure 36 Sepsis Diagnostic Immunoassay Growth ………………………………………………… 264
Figure 37 Sepsis Diagnostic Infectious Disease Other Growth ………………………………… 266
Figure 38 Sepsis Diagnostic Biomarker MDx Growth ………………………………………………. 268
Figure 39 Sepsis Diagnostic Biomarker Other Growth …………………………………………….. 270
Figure 40 Sepsis Diagnostic GastroIntestinal Growth ……………………………………………… 273
Figure 41 Sepsis Diagnostics Respiratory COVID-19 ……………………………………………….. 275
Figure 42 Sepsis Diagnostic Respiratory Other Growth …………………………………………… 277
Figure 43 Sepsis Diagnostic Neonatal Growth ……………………………………………………….. 279
Figure 44 Sepsis Diagnostic Other Cause Growth ………………………………………………….. 281
Figure 45 Sepsis Diagnostic Instrumentation Growth ……………………………………………… 284
Figure 46 Sepsis Diagnostics Consumables ……………………………………………………………. 286
Figure 47 Sepsis Diagnostic Software & Service Growth …………………………………………. 288
Figure 48 Sepsis Diagnostic In Lab Growth …………………………………………………………….. 291
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Figure 49 Sepsis Diagnostics Point of Care …………………………………………………………….. 293
Figure 50 Sepsis Diagnostic GastroIntestinal Growth ……………………………………………… 296
Figure 51 Sepsis Diagnostics Other Place ………………………………………………………………. 298
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