敗血症治療薬の世界市場機会分析...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 12
1.1 List of Tables 17
1.2 List of Figures 20

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 24

3 Disease Overview 25
3.1 Etiology and Pathophysiology 25
3.1.1 Etiology 25
3.1.2 Pathophysiology 28
3.2 Symptoms 36
3.3 Disease Management 37
3.3.1 Diagnosis 37
3.3.2 Treatment Guidelines 38
3.3.3 Clinical Practice 41
3.4 Quality of Life Post Sepsis 43

4 Epidemiology 45
4.1 Disease Background 45
4.2 Risk Factors and Comorbidities 46
4.3 Global Trends 46
4.3.1 US 47
4.3.2 5EU 47
4.4 Forecast Methodology 48
4.4.1 Sources Used 53
4.4.2 Forecast Assumptions and Methods – Diagnosed Incident Cases of Sepsis 59
4.4.3 Forecast Assumptions and Methods – Sepsis Mortality Cases 61
4.4.4 Forecast Assumptions and Methods – Diagnosed Incident Cases of Sepsis by Severity 62
4.4.5 Forecast Assumptions and Methods – Sepsis Mortality Cases by Severity 63
4.4.6 Forecast Assumptions and Methods – Diagnosed Incident Cases of Sepsis by Causative Organism 64
4.4.7 Forecast Assumptions and Methods – Sepsis Mortality Cases by Causative Pathogen 66
4.4.8 Forecast Assumptions and Methods – Diagnosed Incident Cases of Sepsis by Comorbid Condition 67
4.5 Epidemiological Forecast for Sepsis (2013-2023) 69
4.5.1 Diagnosed Incident Cases of Sepsis 69
4.5.2 Age-Specific Diagnosed Incident Cases of Sepsis 70
4.5.3 Sex-Specific Diagnosed Incident Cases of Sepsis 72
4.5.4 Sepsis Mortality Cases 75
4.5.5 Age-Specific Sepsis Mortality Cases 77
4.5.6 Sex-Specific Sepsis Mortality Cases 79
4.5.7 Diagnosed Incident Cases of Sepsis by Severity 81
4.5.8 Sepsis Mortality Cases by Severity 83
4.5.9 Diagnosed Incident Cases of Sepsis by Causative Organism 85
4.5.10 Sepsis Mortality Cases by Causative Organism 87
4.5.11 Diagnosed Incident Cases of Sepsis with a Comorbid Condition 89
4.6 Discussion 91
4.6.1 Epidemiological Forecast Insight 91
4.6.2 Limitations of the Analysis 91
4.6.3 Strengths of the Analysis 93

5 Current Treatment Options 94
5.1 Overview 94
5.2 Treatment Bundles 97
5.3 Pathogen-Targeting Approaches to Treating Sepsis 100
5.3.1 Antimicrobial Therapy 100
5.3.2 Other Therapies – Antivirals, Antifungals and Antiparasitics 104
5.4 Host-Targeting Approaches to Treating Sepsis 105
5.4.1 Overview of Current Supportive Care 105
5.5 Country Differences 110

6 Unmet Needs Assessment and Opportunity Analysis 112
6.1 Overview 112
6.2 Unmet Needs Analysis 114
6.2.1 Unmet Need: Sepsis-Specific Therapies 114
6.2.2 Unmet Need: An Improved Understanding of Sepsis Pathophysiology 115
6.2.3 Unmet Need: Clinically Relevant Biomarkers to Guide Clinical Trial Enrollment and Inform Physician Treatment Decisions 116
6.2.4 Unmet Need: Rapid, Accurate, and Sensitive Diagnostic Tools 118
6.2.5 Unmet Need: Refined Sepsis Definitions and Diagnoses 119
6.2.6 Unmet Need: Improved Sepsis Education and Awareness for the Public and Healthcare Professionals 121
6.3 Opportunity Analysis 123
6.3.1 Opportunity: Develop Innovative Immunomodulatory Agents that Target Sepsis-Specific Pathophysiology 123
6.3.2 Opportunity: Improved Supportive Care for Sepsis-Induced Comorbidities and Combination Therapies 125
6.3.3 Opportunity: Identify and Leverage Novel Biomarkers to Streamline Patient Identification and Better Demonstrate Efficacy 127
6.3.4 Opportunity: Leverage Diagnostics to Help Streamline Clinical Development and Improve Patient Care 128
6.3.5 Opportunity: Recruit Experts to Improve Company Insight on Sepsis Pathophysiology 130
6.3.6 Opportunity: Implement Sepsis Awareness Campaigns and Roll Out Educational Tools for Healthcare Professionals 131

7 Research and Development Strategies 134
7.1 Overview 134
7.2 Approaches to Sepsis-specific Therapy Development 136
7.2.1 Novel Targets 136
7.2.2 Immunomodulatory Agents 137
7.2.3 Leverage Novel Biomarkers and Companion Diagnostics 138
7.2.4 Solve Funding Issues and Potential Partnerships 140
7.3 Clinical Trial Design 142
7.3.1 Current Clinical Trial Design 144
7.3.2 Accurate and Efficient Patient Selection and Enrollment Criteria 149
7.3.3 Alternative Efficacy Endpoints 154
7.3.4 Biomarker-Driven Adaptive Design Trials 157
7.3.5 Standardization of Background Care in Multicenter Trials 158

8 Pipeline Assessment 160
8.1 Overview 160
8.2 Promising Products in Late-Stage Clinical Development 162
8.2.1 ART-123 162
8.2.2 Toraymyxin 170
8.3 Promising Products in Early-Stage Clinical Development 180
8.3.1 Selepressin 181
8.3.2 ALT-836 184
8.3.3 LB-1148 188
8.3.4 recAP 192
8.3.5 IFX-1 198
8.3.6 Other Innovative Early-Stage Approaches 201
8.4 Products in Preclinical Development 207

9 Pipeline Valuation Analysis 209
9.1 Clinical Benchmark of Key Pipeline Therapies 209
9.2 Commercial Benchmark of Key Pipeline Therapies 211
9.3 Competitive Assessment 214
9.4 Top-Line Five-Year Forecast 216
9.4.1 US 219
9.4.2 5EU 221

10 Appendix 224
10.1 Bibliography 224
10.2 Abbreviations 236
10.3 Methodology 240
10.4 Forecasting Methodology 240
10.4.1 Sepsis Patient Population Segmentation 240
10.4.2 Percent Product-Treated Patients 241
10.4.3 Products Included in Each Therapeutic Class 242
10.4.4 Product Launch Dates 243
10.4.5 General Pricing Assumptions 243
10.4.6 Individual Product Assumptions 244
10.4.7 Pricing of Pipeline Products 247
10.5 Physicians and Specialists Included in this Study 250
10.6 About the Authors 252
10.6.1 Analyst 252
10.6.2 Epidemiologist 252
10.6.3 Therapy Area Director 253
10.6.4 Global Head of Healthcare 253
10.7 About GlobalData 254
10.8 Disclaimer 254