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.

1. OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021
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
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
OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021

2. 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
OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021

3. 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
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OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021