List of Figures
1.2 List of Figures
Figure 1: Global Sales for Sepsis and Septic Shock by Country, 2016 and 2026 12
Figure 2: Competitive Assessment of Marketed and Pipeline Agents in Sepsis and Septic Shock, 2016-2026 16
Figure 3: Sepsis Definition and Diagnosis Criteria as Outlined in SEPSIS-2 and SEPSIS-3 26
Figure 4: Common Causes and Origins of Sepsis 33
Figure 5: Common Manifestations of Sepsis 34
Figure 6: The Pathogenesis of Sepsis and End-Stage Organ Damage 36
Figure 7: Current Understanding of Sepsis and Septic Shock Pathophysiology 40
Figure 8: Biomarkers in Bacterial Sepsis Diagnosis 41
Figure 9: Potential Target Pathways for Sepsis Treatment 43
Figure 10: 7MM, Age-Standardized Diagnosed Incidence of Sepsis (Cases per 100,000 Population), Both Sexes, All Ages, 2016 51
Figure 11: 7MM, Age-Standardized Diagnosed Incidence of Septic Shock (Cases per 100,000 Population), Both Sexes, All Ages, 2016 52
Figure 12: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Sepsis 54
Figure 13: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Sepsis/Septic Shock by Causative Agent 55
Figure 14: 7MM, Sources Used and Not Used, Organ Dysfunction among Sepsis Cases 56
Figure 15: 7MM, Sources Used and Not Used, In-Hospital Mortality Cases of Sepsis 57
Figure 16: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Septic Shock 58
Figure 17: 7MM, Sources Used and Not Used, Organ Dysfunction of Septic Shock Cases 59
Figure 18: 7MM, Sources Used, In-Hospital Mortality Cases of Septic Shock 60
Figure 19: 7MM, Age-Specific Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016 81
Figure 20: 7MM, Sex-Specific Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016 82
Figure 21: 7MM, Diagnosed Incident Cases of Sepsis by Causative Agent, Both Sexes, All Ages, 2016 83
Figure 22: 7MM, Organ Dysfunction among Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016 84
Figure 23: 7MM, Age-Specific In-Hospital Mortality Cases of Sepsis, Both Sexes, All Ages, 2016 86
Figure 24: 7MM, Age-Specific Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016 88
Figure 25: 7MM, Sex-Specific Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016 89
Figure 26: 7MM, Diagnosed Incident Cases of Septic Shock by Causative Agent, Both Sexes, All Ages, 2016 90
Figure 27: 7MM, Organ Dysfunction among Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016 91
Figure 28: 7MM, Age-Specific In-Hospital Mortality Cases of Septic Shock, Both Sexes, All Ages, 2016 93
Figure 29: Current Treatment Options for Sepsis and Septic Shock, 2017 98
Figure 30: Disease Management Timeline for Sepsis and Septic Shock 101
Figure 31: Sepsis and Septic Shock SEPSIS-3 Diagnosis Algorithm 103
Figure 32: International Treatment Algorithm Overview for Sepsis, Severe Sepsis, and Septic Shock 104
Figure 33: Key Events Shaping Clinical Practice in Sepsis and Septic Shock 108
Figure 34: Unmet Need and Opportunity in Sepsis and Septic Shock, 2017 125
Figure 35: Current Treatment Options and Associated Biomarkers for Sepsis and Septic Shock, 2017 167
Figure 36: Sepsis and Septic Shock - Phase II?III Pipeline, 2017 174
Figure 37: Bullseye Diagram of Products in Clinical Development for Sepsis and Septic Shock, 2017 175
Figure 38: Competitive Assessment of Marketed and Pipeline Agents for Sepsis-Specific Treatment Options - Sepsis and Septic Shock, 2016-2026 239
Figure 39: Competitive Assessment of Marketed and Pipeline Agents for Supportive Care Treatment Options - Sepsis and Septic Shock, 2016-2026 240
Figure 40: Competitive Assessment of Marketed and Pipeline Agents for Infection Control Treatment Options - Sepsis and Septic Shock, 2016-2026 241
Figure 41: Top-Line Sales for Sepsis and Septic Shock by Country/Region, 2016 and 2026 244
Figure 42: Top-Line Sales for Sepsis and Septic Shock by Region, 2016?2026 245
Figure 43: Global Sales for Sepsis and Septic Shock by Drug Class, 2016 and 2026 246
Figure 44: Sales for Sepsis and Septic Shock by Drug Class in the US, 2016 and 2026 251
Figure 45: Sales for Sepsis and Septic Shock by Drug Class in the US, 2016 and 2026 252
Figure 46: Sales for Sepsis and Septic Shock by Drug Class in the 5EU, 2016 and 2026 255
Figure 47: Sales for Sepsis and Septic Shock by Drug Class in the 5EU, 2016 and 2026 256
Figure 48: Global Sales for Sepsis nd Septic Shock by Country in the 5EU, 2016 and 2026 257
Figure 49: Global Sales for Sepsis and Septic Shock by Country in the 5EU, 2016?2026 258
Figure 50: Sales for Sepsis and Septic Shock by Drug Class in Japan, 2016 and 2026 261
Figure 51: Sales for Sepsis and Septic Shock by Drug Class in Japan, 2016 and 2026 262


List of Tables
1.1 List of Tables
Table 1: Sepsis and Septic Shock: Key Metrics in the Seven Major Pharmaceutical Markets 10
Table 2: Guidelines for Stratification of Patients with SIRS, Sepsis, Severe Sepsis, and Septic Shock 23
Table 3: SEPSIS-2 Diagnostic Criteria (SIRS, Sepsis, Severe Sepsis, and Septic Shock) 29
Table 4: SEPSIS-3 Diagnostic Criteria (qSOFA, SOFA, Sepsis, and Septic Shock) 30
Table 5: Summary of Pathophysiological Events Causing Sepsis and Septic Shock 37
Table 6: Mediators of the Pro-inflammatory and Anti-inflammatory Responses 44
Table 7: ICD-10-CM Diagnosis Codes for Sepsis 45
Table 8: Symptoms Associated with Sepsis and Septic Shock 46
Table 9: Risk Factors and Comorbidities for Sepsis and Septic Shock 50
Table 10: 7MM, Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, Selected Years 2016-2026 80
Table 11: 7MM, Sepsis In-Hospital Mortality Cases, Both Sexes, All Ages, Selected Years 2016-2026 85
Table 12: 7MM, Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, Selected Years 2016-2026 87
Table 13: 7MM, Septic Shock In-Hospital Mortality Cases, Both Sexes, All Ages, Selected Years 2016-2026 92
Table 14: Key Differences in Diagnosis Criteria according to new SEPSIS-3 102
Table 15: Treatment Guidelines for Sepsis and Septic Shock, 2017 105
Table 16:SSC Guidelines Compared 106
Table 17: Treatment Bundles for Sepsis Patients 109
Table 18: Commonly Used Antibiotics in Sepsis and Septic Shock and Important Gaps in Coverage, 2017 112
Table 19: Pivotal Studies of Timing of Antibiotic Treatment in Sepsis and Septic Shock 114
Table 20: Other Supportive Therapies To Be Implemented When Clinically Relevant 119
Table 21: Evolution of the Standard of Care in Sepsis and Septic Shock, 2017 120
Table 22: Summary of Minor Supportive Measures, 2017 123
Table 23: Key Strategies Pursued by Current Sepsis and Septic Shock Drug Developers 149
Table 24: Common Sepsis Comorbidities Being Targeted by Drug Developers 150
Table 25: Biomarkers for Assessment of Immune Status 154
Table 26: Key Late-Stage Pipeline Agents for Sepsis and Septic Shock, 2017 173
Table 27: Comparison of Therapeutic Classes in Development for Sepsis and Septic Shock, 2016-2026 173
Table 28: Product Profile - Selepressin 177
Table 29: Reported SAEs of selepressin During Phase II Study 180
Table 30: Selepressin SWOT Analysis, 2017 181
Table 31: Product Profile - Thrombomodulin (ART-123) 184
Table 32: Thrombomodulin Clinical Efficacy Outcomes from RCTs 187
Table 33: ART-123 Phase IIb Trial-Important Treatment-Emergent AEs and SAEs Monitored 189
Table 34: Thrombomodulin SWOT Analysis, 2017 190
Table 35: Product Profile - recAP 192
Table 36: Reported Efficacy of Bovine AP in Phase II Studies 193
Table 37: recAP SWOT Analysis, 2017 195
Table 38: Product Profile - Traumakine 196
Table 39: TraumaKine SWOT Analysis, 2017 198
Table 40: Product Profile - BMS-936559 200
Table 41: Most Frequently Reported AEs and SAEs of BMS-936559* 202
Table 42: BMS-936559 SWOT Analysis, 2017 203
Table 43: Product Profile - CYT107 205
Table 44: Immunological Effects of CYT107 in Cancer and HIV Patients 206
Table 45: CYT107 SWOT Analysis, 2017 207
Table 46: Product Profile - Cefiderocol 209
Table 47: CefiderocolSWOT Analysis, 2017 210
Table 48: Product Profile - Toraymyxin 212
Table 49: EUPHAS Trial - Toraymyxin Physiological End Points by Treatment Group at Baseline and 72 Hours 214
Table 50: EUPHAS Trial - Change in SOFA Scores by Treatment Group After 72 hours 214
Table 51: EUPHAS Trial - Event-Free Days and Days Spent in Hospital by Treatment Group 214
Table 52: Toraymyxin SWOT Analysis, 2017 217
Table 53: Product Profile - CytoSorb 218
Table 54: CytoSorb SWOT Analysis, 2017 220
Table 55: Innovative Early-Stage Therapies for Sepsis and Septic Shock, 2017 221
Table 56: Hospital Indices - ALT-836 225
Table 57: Safety Profile - ALT-836 225
Table 58: Drugs in Development for Sepsis and Septic Shock, 2017 229
Table 59: Clinical Benchmark of Key Sepsis-Specific Treatment Options - Sepsis and Septic Shock 233
Table 60: Clinical Benchmark of Key Supportive Care Treatment Options - Sepsis and Septic Shock 234
Table 61: Clinical Benchmark of Key Infection Control Treatment Options - Sepsis and Septic Shock 234
Table 62: Commercial Benchmark of Key Sepsis-Specific Treatment Options - Sepsis and Septic Shock 236
Table 63: Commercial Benchmark of Key Supportive Care Treatment Options - Sepsis and Septic Shock 237
Table 64: Commercial Benchmark of Key Infection Control Treatment Options - Sepsis and Septic Shock 238
Table 65: Top-Line Sales Forecast ($m) for Sepsis and Septic Shock, 2016-2026 243
Table 66: Key Events Impacting Sales for Sepsis and Septic Shock, 2016-2026 247
Table 67: Sepsis and Septic Shock Market - Global Drivers and Barriers, 2016?2026 248
Table 68: Sales Forecasts ($m) for Sepsis and Septic Shock in the US, 2016-2026 250
Table 69: Sales Forecast ($m) for Sepsis and Septic Shock in the 5EU, 2016-2026 254
Table 70: Sales Forecasts ($m) for Sepsis and Septic Shock in Japan, 2016-2026 259
Table 71: Key Projected Launch Dates for Sepsis and Septic Shock 299
Table 72: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 314