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OpportunityAnalyzer: Sepsis and Septic Shock - Opportunity Analysis and Forecasts to 2026

Published By :

GlobalData

Published Date : Aug 2017

Category :

Pharmaceutical

No. of Pages : N/A

OpportunityAnalyzer: Sepsis and Septic Shock - Opportunity Analysis and Forecasts to 2026

Summary

Sepsis is a complex disease, which not only involves a wide array of causative agents, but also results in different individual immune responses, causing various single or multiple organ dysfunction(s). Late 2016, the sepsis and septic shock market embraced new consensus definitions for sepsis and septic shock, which for the first time mandate an organ dysfunction underlying an infection to be classified as suffering from sepsis or septic shock. Past clinical development of drugs has been hampered by late stage failures due to recruitment of heterogeneous patient populations. Recent advances in clinical trial design, particularly the adoption of adaptive clinical trials, has awakened the hope of new pipeline products entering the sepsis and septic shock marketplace. However, physicians remain cautious, as reliable biomarkers to stratify these patients to these new pipeline drugs are not anticipated to launch during the forecast period.

Today, the sepsis and septic shock market is dominated by generic products, as the management of patients with sepsis and septic shock is mainly relying on antimicrobial therapy, fluid resuscitation, vasopressors, anticoagulants, steroids, and immunoglobulin therapy. The competition is high for these therapies, and the market is saturated with many suppliers of inexpensive generics. The sepsis and septic shock market is anticipated to experience the arrival of four new first-in-class pipeline drugs (BMS-936559, recAP, Traumakine, and CYT107) and three improved therapeutic options (selepressin, thrombomodulin, and cefiderocol), as well as two new hemoperfusion devices (Toraymyxin and CytoSorb). GlobalData expects the global sepsis and septic shock market - which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan) - to expand during the next decade at an astonishing CAGR of 7.9%, reaching total sales of $5.9 billion by 2026.

Scope

- Overview of sepsis and septic shock, including epidemiology, etiology, pathophysiology, as well current routine sepsis and septic shock recommendations of all 7MM covered.
- Top-line sepsis and septic shock market revenue from 2016-2026. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, clinical trial design, and influence of new consensus definitions for the sepsis and septic shock market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global sepsis and septic shock marketplace. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global sepsis and septic shock market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the sepsis and septic shock market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 8
2 Sepsis and Septic Shock: Executive Summary 10
2.1 Global Sepsis and Septic Shock Market to Experience Strong Growth on Launch of First-in-Class Pipeline Products 11
2.2 Developers Must Leverage Innovative R&D Strategies to Target Appropriate Patients and Achieve Sustained Commercial Success 13
2.3 A High Level of Unmet Need Persists in the Sepsis and Septic Shock Marketplace 13
2.4 Opportunities Remain for Current and Future Players to Develop Therapies Targeting Sepsis-Specific Pathophysiology 14
2.5 Immunomodulating Therapies Poised to Transform Sepsis and Septic Shock Market, but Missing Biomarkers Will Limit Their Utility 15
2.6 What Do Physicians Think? 17
3 Introduction 20
3.1 Catalyst 20
3.2 Related Reports 21
3.3 Upcoming Related Reports 21
4 Disease Overview 22
4.1 Etiology and Pathophysiology 22
4.1.1 Etiology 22
4.1.2 Pathophysiology 34
4.2 Classification or Staging Systems 44
4.3 Symptoms 46
4.4 Prognosis 46
4.5 Quality of Life 47
5 Epidemiology 48
5.1 Disease Background 48
5.2 Risk Factors and Comorbidities 49
5.3 Global and Historical Trends 50
5.4 Forecast Methodology 52
5.4.1 Sources 52
5.4.2 Forecast Assumptions and Methods 60
5.4.3 Diagnosed Incident Cases of Sepsis 60
5.4.4 Diagnosed Incident Cases of Septic Shock 64
5.4.5 Diagnosed Incident Cases of Sepsis/Septic Shock by Causative Agent 66
5.4.6 Organ Dysfunction among Diagnosed Incident Cases of Sepsis 69
5.4.7 Organ Dysfunction among Diagnosed Incident Cases of Septic Shock 72
5.4.8 Sepsis In-Hospital Mortality Cases 74
5.4.9 Septic Shock In-Hospital Mortality Cases 77
5.5 Epidemiological Forecast for Sepsis and Septic Shock (2016-2026) 80
5.5.1 Diagnosed Incident Cases of Sepsis 80
5.5.2 Age-Specific Diagnosed Incident Cases of Sepsis 81
5.5.3 Sex-Specific Diagnosed Incident Cases of Sepsis 82
5.5.4 Diagnosed Incident Cases of Sepsis by Causative Agent 83
5.5.5 Organ Dysfunction among Diagnosed Incident Cases of Sepsis 84
5.5.6 Sepsis In-Hospital Mortality Cases 84
5.5.7 Age-Specific In-Hospital Mortality Cases of Sepsis 85
5.5.8 Diagnosed Incident Cases of Septic Shock 86
5.5.9 Age-Specific Diagnosed Incident Cases of Septic Shock 87
5.5.10 Sex-Specific Diagnosed Incident Cases of Septic Shock 88
5.5.11 Diagnosed Incident Cases of Septic Shock by Causative Agent 89
5.5.12 Organ Dysfunction among Diagnosed Incident Cases of Septic Shock 90
5.5.13 Septic Shock In-Hospital Mortality Cases 91
5.5.14 Age-Specific In-Hospital Mortality Cases of Septic Shock 92
5.6 Discussion 93
5.6.1 Epidemiological Forecast Insight 93
5.6.2 Limitations of Analysis 95
5.6.3 Strengths of Analysis 95
6 Current Treatment Options 97
6.1 Overview 97
6.2 Diagnosis and Treatment 99
6.2.1 Diagnosis 99
6.2.2 Treatment Guidelines 105
6.3 Clinical Practice 107
6.3.1 Overview 107
6.3.2 Surviving Sepsis Campaign Bundles 108
6.3.3 Country Differences 109
6.4 Infection Control - Antibiotics and other Anti-infectives 111
6.4.1 Overview 111
6.4.2 Timing of Antibiotic Therapy 113
6.4.3 Dosing of Antibiotic Therapy 115
6.4.4 Antibiotic Resistance 116
6.4.5 Other Therapies - Antivirals, Antifungals, and Antiparasitics 117
6.5 Supportive Treatment Options for Sepsis and Septic Shock 118
6.5.1 Overview 118
6.5.2 Fluid Resuscitation, Vasopressors, Dobutamine, and Blood Transfusion 119
6.5.3 Mechanical Ventilation and Hemodialysis 121
6.6 Other Therapeutic Approaches to Sepsis and Septic Shock 122
7 Unmet Needs Assessment and Opportunity Analysis 124
7.1 Overview 124
7.2 Improved Biomarkers to Guide Treatment Decisions and Support Drug Development 125
7.2.1 Unmet Need 125
7.2.2 Gap Analysis 128
7.2.3 Opportunity 129
7.3 Novel Therapeutic Interventions Targeting Sepsis Pathophysiology 130
7.3.1 Unmet Need 130
7.3.2 Gap Analysis 131
7.3.3 Opportunity 133
7.4 Enhancing Effectiveness of Currently Available Interventions to Help Improve Clinical Outcomes 134
7.4.1 Unmet Need 134
7.4.2 Gap Analysis 136
7.4.3 Opportunity 137
7.5 Streamlined Regulatory Framework to Stimulate Clinical Research and Drug Development 138
7.5.1 Unmet Need 138
7.5.2 Gap Analysis 139
7.5.3 Opportunity 140
7.6 More reliable animal models to facilitate effective screening of lead candidates 141
7.6.1 Unmet Need 141
7.6.2 Gap Analysis 143
7.6.3 Opportunity 144
7.7 Improved Awareness among Healthcare Workers and the Public 144
7.7.1 Unmet Need 144
7.7.2 Gap Analysis 145
7.7.3 Opportunity 146
8 Research and Development Strategies 147
8.1 Overview 147
8.1.1 New SEPSIS-3 Consensus Definition to Guide Future R&D Efforts 150
8.1.2 Immuno-stimulatory Drugs for Late-Step Intervention 151
8.1.3 Other Specific Development Strategies 156
8.1.4 Anti-inflammatory Drugs for Early Intervention (IFX-1, Toraymyxin) 158
8.2 Clinical Trial Design 161
8.2.1 Overview 161
8.2.2 Traditional Clinical Trial Design 162
8.2.3 Adaptive Clinical Trial Design 163
8.2.4 Participant Enrolment Criteria 166
8.2.5 Endpoints 170
9 Pipeline Assessment 172
9.1 Overview 172
9.2 Promising Drugs in Clinical Development 173
9.2.1 Selepressin 176
9.2.2 Thrombomodulin (ART-123) 181
9.2.3 recAP 190
9.2.4 Traumakine (Recombinant Human IFN--1a) 195
9.2.5 BMS-936559 198
9.2.6 CYT107 203
9.2.7 Cefiderocol 208
9.2.8 Toraymyxin (PMX-20R) 210
9.2.9 CytoSorb 218
9.3 Other Innovative Early-Stage Approaches 221
9.3.1 IFX-1 221
9.3.2 LB1148 (tranexamic acid) 222
9.3.3 ALT-836 223
9.3.4 Salvecin 226
9.3.5 Opdivo (nivolumab) 226
9.3.6 Adrecizumab 227
9.3.7 LGT-209 228
9.4 Other Drugs in Development 229
9.4.1 Cx-611 229
9.4.2 HU-003 230
9.4.3 Pooled Human Plasma 230
9.4.4 BMS-986189 230
9.4.5 Motrem 231
10 Pipeline Valuation Analysis 232
10.1 Clinical Benchmark of Key Pipeline Drugs 232
10.2 Commercial Benchmark of Key Pipeline Drugs 235
10.3 Competitive Assessment 238
10.4 Top-Line 10-Year Forecast 242
10.4.1 US 248
10.4.2 5EU 253
10.4.3 Japan 258
11 Appendix 263
11.1 Bibliography 263
11.2 Abbreviations 291
11.3 Methodology 297
11.4 Forecasting Methodology 297
11.4.1 Diagnosed Sepsis and Septic Shock Patients 297
11.4.2 Percent Drug-Treated Patients 298
11.4.3 Drugs Included in Each Therapeutic Class 298
11.4.4 Launch and Patent Expiry Dates 299
11.4.5 General Pricing Assumptions 300
11.4.6 Individual Drug Assumptions 301
11.4.7 Generic Erosion 308
11.4.8 Pricing of Pipeline Agents 308
11.5 Primary Research - KOLsInterviewed for this Report 311
11.6 Primary Research - Prescriber Survey 313
11.7 About the Authors 314
11.7.1 Analyst 314
11.7.2 Therapy Area Director 314
11.7.3 Epidemiologist 315
11.7.4 Managing Epidemiologists 315
11.7.5 Global Director of Therapy Analysis and Epidemiology 316
11.7.6 Global Head and EVP of Healthcare Operations and Strategy 317
11.8 About GlobalData 317
11.9 Contact Us 317
11.10 Disclaimer 318

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 ($m) for Sepsis and Septic Shock, 2016-2026 243
Table 66: Key Events Impacting Sales for Sepsis and Septic Shock, 2016-2026 247
Table 67: Sepsis and Septic Shock Market - Global Drivers and Barriers, 20162026 248
Table 68: Sales Forecasts ($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

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 IIIII 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, 20162026 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, 20162026 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

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