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

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About Sepsis and Septic Shock Market

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.

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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.

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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.

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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

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