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OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021

Summary

Sepsis patients suffer from a series of diverse complications arising from the presence of pathogens and/or their toxins in the blood or tissues, which cause a rapidly progressing hyperactive host immune response and cellular dysfunction leading to mortality rates near 50% depending on disease severity. The syndrome places a major burden on the national healthcare systems of the global marketplace, which for the purposes of this report is comprised of the US, France, Germany, Italy, Spain, and the UK. There are currently no marketed drugs to treat sepsis and current treatment options are limited to careful monitoring, pathogen-targeting therapies, and supportive care and symptom management.

For the purposes of this report, GlobalData defines the sepsis market to include sales of sepsis-specific, host-directed products in patients 18 years and older. Therefore a detailed analysis and sales projections for antibiotics is beyond the Scope of this report. The projection of annual sales for medical devices is also beyond the Scope of this report, however anticipated launch dates and patient uptake estimates for these products is included in the forecast. GlobalData expects the market to experience modest growth that is primarily driven by the increased uptake of novel therapies - led by Asahi Kasei Pharma America Corporation’s ART-123 - in select patients as the critical care community regains confidence in sepsis-specific products and as more data is generated on their overall efficacy and safety. Primary research revealed that skepticism, cynicism, and cautious optimism towards sepsis pipeline products is related to recent high profile failures of products in clinical development.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the sepsis marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2016-2021)?
- What research and development (R&D) strategies will companies leverage to compete in the future sepsis marketplace?
- Which patient population(s) are most likely to be targeted for sepsis-specific product development?
- What clinical and commercial factors are likely to influence sepsis product uptake in the US and 5EU (France, Germany, Italy, Spain, and the UK)?

Key Findings

- GlobalData projects the sepsis market in the US and 5EU to grow from approximately $26m in 2016 to $354m in 2021, at a compound annual growth rate (CAGR) of 69%. This solid growth will be driven by the increased uptake of novel therapies - led by AKP’s anticoagulant ART-123 - in select patients as the critical care community regains confidence in sepsis-specific products and more data is generated on their overall efficacy and safety.
- KOLs interviewed by GlobalData were cautiously optimistic regarding the clinical benefits of pipeline products in their currently selected trial participants and reiterated further improvements are necessary in an area with major unmet medical needs.
- GlobalData anticipates that firms will increasingly turn to innovative R&D strategies, in particular the exploration of alternative approaches to clinical trial design and improved patient targeting - such as adaptive design trials and companion diagnostics - in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over rivals.

Scope

- Overview of sepsis, severe sepsis, and septic shock, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline sepsis market revenue from 2016-2021. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included*.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the sepsis market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed 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 market. 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

- 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 market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the sepsis 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.

Table Of Contents

OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021
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

1.1 List of Tables
Table 1: Summary of Temporal Pathophysiological Events Causing Sepsis 29
Table 2: Mediators of the Pro-inflammatory and Anti-inflammatory responses 30
Table 3: Major Biological Events Characteristic to the Hyper-inflammatory Response 32
Table 4: Major Biological Events Characteristic to the Excessive Anti-inflammatory Response 33
Table 5: Symptoms Associated with SIRS, Sepsis, Severe Sepsis, and Septic Shock 36
Table 6: SIRS, Sepsis, Severe Sepsis, and Septic Shock Diagnostic Criteria 38
Table 7: Guidelines for Stratification of Patients with SIRS, Sepsis, Severe Sepsis, and Septic Shock 41
Table 8: Common Comorbidities within Sepsis Patients 43
Table 9: Comorbid Conditions of Sepsis 46
Table 10: ACCP/SCCM Criteria for Classification of Sepsis by Severity 48
Table 11: 6MM, Sources of Diagnosed Incidence Data of Sepsis 49
Table 12: 6MM, Sources of Mortality Data of Sepsis 49
Table 13: 6MM, Sources of Diagnosed Incidence Data of Sepsis by Severity 50
Table 14: 6MM, Sources of Mortality Data of Sepsis by Severity 50
Table 15: 6MM, Sources of Diagnosed Incidence Data of Sepsis by Causative Organism 51
Table 16: 6MM, Sources of Mortality Data of Sepsis by Causative Organism 51
Table 17: 6MM, Sources of Diagnosed Incident Cases of Sepsis with DIC 51
Table 18: 6MM, Sources of Diagnosed Incident Cases of Sepsis with ARDS 52
Table 19: 6MM, Sources of Diagnosed Incident Cases of Sepsis with ALI 52
Table 20: 6MM, Sources of Diagnosed Incident Cases of Sepsis with AKI 52
Table 21: 6MM, Diagnosed Incident Cases of Sepsis, All Ages, Both Sexes, N, 2013-2023 69
Table 22: 6MM, Diagnosed Incident Cases of Sepsis, by Age, Both Sexes, N, (Row %), 2013 71
Table 23: 6MM, Diagnosed Incident Cases of Sepsis, by Sex, All Ages, N (Row %), 2013 73
Table 24: 6MM, Sepsis Mortality Cases, All Ages, Both Sexes, N, 2013-2023 75
Table 25: 6MM, Sepsis Mortality Cases, by Age, Both Sexes, N, (Row %), 2013 77
Table 26: 6MM, Sepsis Mortality Cases, by Sex, All Ages, N (Row %), 2013 79
Table 27: 6MM, Diagnosed Incident Cases of Sepsis by Severity, All Ages, Both Sexes, N (Row %), 2013 81
Table 28: 6MM, Sepsis Mortality Cases by Severity, All Ages, Both Sexes, N, (Row %), 2013 83
Table 29: 6MM, Diagnosed Incident Cases of Sepsis by Causative Organism, All Ages, Both Sexes, N (Row %), 2013 85
Table 30: 6MM, Sepsis Mortality Cases by Causative Organism, All Ages, Both Sexes, N (Row %), 2013 87
Table 31: 6MM, Diagnosed Incident Cases of Sepsis with a Comorbid Condition, All Ages, Both Sexes, N, 2013 89
Table 32: Treatment Bundles for Sepsis Patients 98
Table 33: Commonly Used Antibiotics in Sepsis and Important Gaps in Coverage 102
Table 34: Other Supportive Therapies to be Implemented When Clinically Relevant 106
Table 35: Unmet Need and Opportunity in Sepsis 113
Table 36: Recent High-Profile Failures in the Sepsis Market 134
Table 37: Key Companies in the Sepsis Market, 2014 142
Table 38: Design of Pipeline Clinical Trials in Sepsis 146
Table 39: Sepsis Therapies - Late-Stage Pipeline, 2014 161
Table 40: Product Profile - ART-123 164
Table 41: ART-123 Phase IIb Trial Summary of 28-Day Mortality Rates by Overall Patients and Subgroups 166
Table 42: ART-123 Phase IIb Trial Event-Free and Alive Days 166
Table 43: ART-123 Phase IIb Trial Important Treatment Emergent AEs and SAEs Monitored 168
Table 44: ART-123 SWOT Analysis, 2015 169
Table 45: Product Profile - Toraymyxin 173
Table 46: EUPHAS Trial - Toraymyxin Physiological End Points by Treatment Group at Baseline and 72 Hours 177
Table 47: EUPHAS Trial - Change in SOFA Scores by Treatment Group After 72 hours 177
Table 48: EUPHAS Trial - Event-free Days and Days Spent in Hospital by Treatment Group 177
Table 49: Toraymyxin SWOT Analysis, 2014 179
Table 50: Sepsis Therapies - Innovative Early-Stage Approaches, 2015 180
Table 51: Product Profile - Selepressin 182
Table 52: Product Profile - ALT-836 186
Table 53: Hospital Indices - ALT-836 187
Table 54: Safety Profile - ALT-836 188
Table 55: Product Profile - LB-1148 190
Table 56: Product Profile - recAP 194
Table 57: Safety Profile of BIAP 197
Table 58: Product Profile - IFX-1 200
Table 59: Product Profile - Levosimendan 203
Table 60: Product Profile - Cx-611 206
Table 61: Sepsis Products in Preclinical Development, 2014 207
Table 62: Clinical Benchmark of Key Sepsis Pipeline Products, 2016-2021 210
Table 63: Commercial Benchmark of Key Sepsis Pipeline Products, 2016-2021 212
Table 64: Top-Line Sales Forecasts ($m) for Sepsis Pipeline Products, 2016-2021 217
Table 65: Key Events Impacting Sales for Sepsis Products, 2016-2021 218
Table 66: Sepsis Products Market - Drivers and Barriers, 2016-2021 219
Table 67: Sepsis Patient Population Segmentation - Secondary Sources Leveraged 241
Table 68: Patient Populations Targeted by Sepsis Pipeline Product Developers 242
Table 69: Sepsis Pipeline Products Broken Down by Therapeutic Class 242
Table 70: Key Product Launch Dates by Region 243

1.2 List of Figures
Figure 1: Pathogens Responsible for Causing Sepsis, Severe Sepsis, and Septic Shock 25
Figure 2: The Diagnostic Pathway for SIRS, Sepsis, Severe Sepsis, and Septic Shock 26
Figure 3: Common Causes and Origins of Sepsis 27
Figure 4: Effects of Excessive Specific Mediators on the Host Immune System 31
Figure 5: Competing Theories of the Host Immune Response - the Inflammatory and Anti-inflammatory Response 35
Figure 6: International Treatment Algorithm Overview for Sepsis, Severe Sepsis, and Septic Shock 40
Figure 7: 6MM, Diagnosed Incident Cases of Sepsis, All Ages, Both Sexes, N, 2013-2023 70
Figure 8: 6MM, Diagnosed Incident Cases of Sepsis, by Age, Both Sexes, N, 2013 72
Figure 9: 6MM, Diagnosed Incident Cases of Sepsis, by Sex, All Ages, N, 2013 74
Figure 10: 6MM, Sepsis Mortality Cases, All Ages, Both Sexes, N, 2013-2023 76
Figure 11: 6MM, Sepsis Mortality Cases, by Age, Both Sexes, N, 2013 78
Figure 12: 6MM, Sepsis Mortality Cases, by Sex, All Ages, N, 2013 80
Figure 13: 6MM, Diagnosed Incident Cases of Sepsis by Severity, All Ages, Both Sexes, N, 2013 82
Figure 14: 6MM, Sepsis Mortality Cases by Severity, All Ages, Both Sexes, N, 2013 84
Figure 15: 6MM, Diagnosed Incident Cases of Sepsis by Causative Organism, All Ages, Both Sexes, N, 2013 86
Figure 16: 6MM, Sepsis Mortality Cases by Causative Organism, All Ages, Both Sexes, N, 2013 88
Figure 17: 6MM, Diagnosed Incident Cases of Sepsis with a Comorbid Condition, All Ages, Both Sexes, N, 2013 90
Figure 18: Current Treatment Options for Sepsis, Severe Sepsis, and Septic Shock 95
Figure 19: Competitive Assessment of Sepsis Pipeline Products, 2016-2021 215
Figure 20: Global Sales for Sepsis Products by Region, 2016-2021 217
Figure 21: US Sales for Sepsis Products, 2016-2021 220
Figure 22: 5EU Sales for Sepsis Products, 2016-2021 222

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