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

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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.

Companies mentioned

AM-Pharma

Asahi Kasei Pharma Corp

Bristol-Myers Squibb

CytoSorbents

Faron

Ferring Holding

Pfizer

RevImmune

Shionogi

Spectral Diagnostics

AM-Pharma

Asahi Kasei Pharma Corp

Bristol-Myers Squibb

CytoSorbents

Faron

Ferring Holding

Pfizer

RevImmune

Shionogi

Spectral Diagnostics

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Sepsis and Septic Shock: Executive Summary

2 ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Sepsis and Septic Shock: Executive Summary

2.1 Global Sepsis and Septic Shock Market to Experience Strong Growth on Launch of First-in-Class Pipeline Products

2.2 Developers Must Leverage Innovative R&D Strategies to Target Appropriate Patients and Achieve Sustained Commercial Success

2.3 A High Level of Unmet Need Persists in the Sepsis and Septic Shock Marketplace

2.4 Opportunities Remain for Current and Future Players to Develop Therapies Targeting Sepsis-Specific Pathophysiology

2.5 Immunomodulating Therapies Poised to Transform Sepsis and Septic Shock Market, but Missing Biomarkers Will Limit Their Utility

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.4.3 Diagnosed Incident Cases of Sepsis

5.4.4 Diagnosed Incident Cases of Septic Shock

5.4.5 Diagnosed Incident Cases of Sepsis/Septic Shock by Causative Agent

5.4.6 Organ Dysfunction among Diagnosed Incident Cases of Sepsis

5.4.7 Organ Dysfunction among Diagnosed Incident Cases of Septic Shock

5.4.8 Sepsis In-Hospital Mortality Cases

5.4.9 Septic Shock In-Hospital Mortality Cases

5.5 Epidemiological Forecast for Sepsis and Septic Shock (2016–2026)

5.5.1 Diagnosed Incident Cases of Sepsis

5.5.2 Age-Specific Diagnosed Incident Cases of Sepsis

5.5.3 Sex-Specific Diagnosed Incident Cases of Sepsis

5.5.4 Diagnosed Incident Cases of Sepsis by Causative Agent

5.5.5 Organ Dysfunction among Diagnosed Incident Cases of Sepsis

5.5.6 Sepsis In-Hospital Mortality Cases

5.5.7 Age-Specific In-Hospital Mortality Cases of Sepsis

5.5.8 Diagnosed Incident Cases of Septic Shock

5.5.9 Age-Specific Diagnosed Incident Cases of Septic Shock

5.5.10 Sex-Specific Diagnosed Incident Cases of Septic Shock

5.5.11 Diagnosed Incident Cases of Septic Shock by Causative Agent

5.5.12 Organ Dysfunction among Diagnosed Incident Cases of Septic Shock

5.5.13 Septic Shock In-Hospital Mortality Cases

5.5.14 Age-Specific In-Hospital Mortality Cases of Septic Shock

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

6.2 Diagnosis and Treatment

6.2.1 Diagnosis

6.2.2 Treatment Guidelines

6.3 Clinical Practice

6.3.1 Overview

6.3.2 Surviving Sepsis Campaign Bundles

6.3.3 Country Differences

6.4 Infection Control – Antibiotics and other Anti-infectives

6.4.1 Overview

6.4.2 Timing of Antibiotic Therapy

6.4.3 Dosing of Antibiotic Therapy

6.4.4 Antibiotic Resistance

6.4.5 Other Therapies — Antivirals, Antifungals, and Antiparasitics

6.5 Supportive Treatment Options for Sepsis and Septic Shock

6.5.1 Overview

6.5.2 Fluid Resuscitation, Vasopressors, Dobutamine, and Blood Transfusion

6.5.3 Mechanical Ventilation and Hemodialysis

6.6 Other Therapeutic Approaches to Sepsis and Septic Shock

7 Unmet Needs Assessment and Opportunity Analysis

7.1 Overview

7.2 Improved Biomarkers to Guide Treatment Decisions and Support Drug Development

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Novel Therapeutic Interventions Targeting Sepsis Pathophysiology

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Enhancing Effectiveness of Currently Available Interventions to Help Improve Clinical Outcomes

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Streamlined Regulatory Framework to Stimulate Clinical Research and Drug Development

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

7.6 More reliable animal models to facilitate effective screening of lead candidates

7.6.1 Unmet Need

7.6.2 Gap Analysis

7.6.3 Opportunity

7.7 Improved Awareness among Healthcare Workers and the Public

7.7.1 Unmet Need

7.7.2 Gap Analysis

7.7.3 Opportunity

8 Research and Development Strategies

8.1 Overview

8.1.1 New SEPSIS-3 Consensus Definition to Guide Future R&D Efforts

8.1.2 Immuno-stimulatory Drugs for Late-Step Intervention

8.1.3 Other Specific Development Strategies

8.1.4 Anti-inflammatory Drugs for Early Intervention (IFX-1, Toraymyxin)

8.2 Clinical Trial Design

8.2.1 Overview

8.2.2 Traditional Clinical Trial Design

8.2.3 Adaptive Clinical Trial Design

8.2.4 Participant Enrolment Criteria

8.2.5 Endpoints

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 Selepressin

9.2.2 Thrombomodulin (ART-123)

9.2.3 recAP

9.2.4 Traumakine (Recombinant Human IFN-β-1a)

9.2.5 BMS-936559

9.2.6 CYT107

9.2.7 Cefiderocol

9.2.8 Toraymyxin (PMX-20R)

9.2.9 CytoSorb

9.3 Other Innovative Early-Stage Approaches

9.3.1 IFX-1

9.3.2 LB1148 (tranexamic acid)

9.3.3 ALT-836

9.3.4 Salvecin

9.3.5 Opdivo (nivolumab)

9.3.6 Adrecizumab

9.3.7 LGT-209

9.4 Other Drugs in Development

9.4.1 Cx-611

9.4.2 HU-003

9.4.3 Pooled Human Plasma

9.4.4 BMS-986189

9.4.5 Motrem

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.4 Forecasting Methodology

11.4.1 Diagnosed Sepsis and Septic Shock Patients

11.4.2 Percent Drug-Treated Patients

11.4.3 Drugs Included in Each Therapeutic Class

11.4.4 Launch and Patent Expiry Dates

11.4.5 General Pricing Assumptions

11.4.6 Individual Drug Assumptions

11.4.7 Generic Erosion

11.4.8 Pricing of Pipeline Agents

11.5 Primary Research – KOLsInterviewed for this Report

11.6 Primary Research – Prescriber Survey

11.7 About the Authors

11.7.1 Analyst

11.7.2 Therapy Area Director

11.7.3 Epidemiologist

11.7.4 Managing Epidemiologists

11.7.5 Global Director of Therapy Analysis and Epidemiology

11.7.6 Global Head and EVP of Healthcare Operations and Strategy

11.8 About GlobalData

11.9 Contact Us

11.10 Disclaimer

List of tables

Table 1: Sepsis and Septic Shock: Key Metrics in the Seven Major Pharmaceutical Markets

Table 2: Guidelines for Stratification of Patients with SIRS, Sepsis, Severe ...

Table 1: Sepsis and Septic Shock: Key Metrics in the Seven Major Pharmaceutical Markets

Table 2: Guidelines for Stratification of Patients with SIRS, Sepsis, Severe Sepsis, and Septic Shock

Table 3: SEPSIS-2 Diagnostic Criteria (SIRS, Sepsis, Severe Sepsis, and Septic Shock)

Table 4: SEPSIS-3 Diagnostic Criteria (qSOFA, SOFA, Sepsis, and Septic Shock)

Table 5: Summary of Pathophysiological Events Causing Sepsis and Septic Shock

Table 6: Mediators of the Pro-inflammatory and Anti-inflammatory Responses

Table 7: ICD-10-CM Diagnosis Codes for Sepsis

Table 8: Symptoms Associated with Sepsis and Septic Shock

Table 9: Risk Factors and Comorbidities for Sepsis and Septic Shock

Table 10: 7MM, Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, Selected Years 2016–2026

Table 11: 7MM, Sepsis In-Hospital Mortality Cases, Both Sexes, All Ages, Selected Years 2016–2026

Table 12: 7MM, Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, Selected Years 2016–2026

Table 13: 7MM, Septic Shock In-Hospital Mortality Cases, Both Sexes, All Ages, Selected Years 2016–2026

Table 14: Key Differences in Diagnosis Criteria according to new SEPSIS-3

Table 15: Treatment Guidelines for Sepsis and Septic Shock, 2017

Table 16:SSC Guidelines Compared

Table 17: Treatment Bundles for Sepsis Patients

Table 18: Commonly Used Antibiotics in Sepsis and Septic Shock and Important Gaps in Coverage, 2017

Table 19: Pivotal Studies of Timing of Antibiotic Treatment in Sepsis and Septic Shock

Table 20: Other Supportive Therapies To Be Implemented When Clinically Relevant

Table 21: Evolution of the Standard of Care in Sepsis and Septic Shock, 2017

Table 22: Summary of Minor Supportive Measures, 2017

Table 23: Key Strategies Pursued by Current Sepsis and Septic Shock Drug Developers

Table 24: Common Sepsis Comorbidities Being Targeted by Drug Developers

Table 25: Biomarkers for Assessment of Immune Status

Table 26: Key Late-Stage Pipeline Agents for Sepsis and Septic Shock, 2017

Table 27: Comparison of Therapeutic Classes in Development for Sepsis and Septic Shock, 2016–2026

Table 28: Product Profile – Selepressin

Table 29: Reported SAEs of selepressin During Phase II Study

Table 30: Selepressin SWOT Analysis, 2017

Table 31: Product Profile – Thrombomodulin (ART-123)

Table 32: Thrombomodulin Clinical Efficacy Outcomes from RCTs

Table 33: ART-123 Phase IIb Trial—Important Treatment-Emergent AEs and SAEs Monitored

Table 34: Thrombomodulin SWOT Analysis, 2017

Table 35: Product Profile – recAP

Table 36: Reported Efficacy of Bovine AP in Phase II Studies

Table 37: recAP SWOT Analysis, 2017

Table 38: Product Profile – Traumakine

Table 39: TraumaKine SWOT Analysis, 2017

Table 40: Product Profile – BMS-936559

Table 41: Most Frequently Reported AEs and SAEs of BMS-936559*

Table 42: BMS-936559 SWOT Analysis, 2017

Table 43: Product Profile – CYT107

Table 44: Immunological Effects of CYT107 in Cancer and HIV Patients

Table 45: CYT107 SWOT Analysis, 2017

Table 46: Product Profile – Cefiderocol

Table 47: CefiderocolSWOT Analysis, 2017

Table 48: Product Profile – Toraymyxin

Table 49: EUPHAS Trial — Toraymyxin Physiological End Points by Treatment Group at Baseline and 72 Hours

Table 50: EUPHAS Trial — Change in SOFA Scores by Treatment Group After 72 hours

Table 51: EUPHAS Trial – Event-Free Days and Days Spent in Hospital by Treatment Group

Table 52: Toraymyxin SWOT Analysis, 2017

Table 53: Product Profile – CytoSorb

Table 54: CytoSorb SWOT Analysis, 2017

Table 55: Innovative Early-Stage Therapies for Sepsis and Septic Shock, 2017

Table 56: Hospital Indices — ALT-836

Table 57: Safety Profile – ALT-836

Table 58: Drugs in Development for Sepsis and Septic Shock, 2017

Table 59: Clinical Benchmark of Key Sepsis-Specific Treatment Options – Sepsis and Septic Shock

Table 60: Clinical Benchmark of Key Supportive Care Treatment Options – Sepsis and Septic Shock

Table 61: Clinical Benchmark of Key Infection Control Treatment Options – Sepsis and Septic Shock

Table 62: Commercial Benchmark of Key Sepsis-Specific Treatment Options – Sepsis and Septic Shock

Table 63: Commercial Benchmark of Key Supportive Care Treatment Options – Sepsis and Septic Shock

Table 64: Commercial Benchmark of Key Infection Control Treatment Options – Sepsis and Septic Shock

Table 65: Top-Line Sales Forecast ($m) for Sepsis and Septic Shock, 2016–2026

Table 66: Key Events Impacting Sales for Sepsis and Septic Shock, 2016–2026

Table 67: Sepsis and Septic Shock Market – Global Drivers and Barriers, 2016‒2026

Table 68: Sales Forecasts ($m) for Sepsis and Septic Shock in the US, 2016–2026

Table 69: Sales Forecast ($m) for Sepsis and Septic Shock in the 5EU, 2016–2026

Table 70: Sales Forecasts ($m) for Sepsis and Septic Shock in Japan, 2016–2026

Table 71: Key Projected Launch Dates for Sepsis and Septic Shock

Table 72: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of figures

Figure 1: Global Sales for Sepsis and Septic Shock by Country, 2016 and 2026

Figure 2: Competitive Assessment of Marketed and Pipeline Agents in Sepsis ...

Figure 1: Global Sales for Sepsis and Septic Shock by Country, 2016 and 2026

Figure 2: Competitive Assessment of Marketed and Pipeline Agents in Sepsis and Septic Shock, 2016–2026

Figure 3: Sepsis Definition and Diagnosis Criteria as Outlined in SEPSIS-2 and SEPSIS-3

Figure 4: Common Causes and Origins of Sepsis

Figure 5: Common Manifestations of Sepsis

Figure 6: The Pathogenesis of Sepsis and End-Stage Organ Damage

Figure 7: Current Understanding of Sepsis and Septic Shock Pathophysiology

Figure 8: Biomarkers in Bacterial Sepsis Diagnosis

Figure 9: Potential Target Pathways for Sepsis Treatment

Figure 10: 7MM, Age-Standardized Diagnosed Incidence of Sepsis (Cases per 100,000 Population), Both Sexes, All Ages, 2016

Figure 11: 7MM, Age-Standardized Diagnosed Incidence of Septic Shock (Cases per 100,000 Population), Both Sexes, All Ages, 2016

Figure 12: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Sepsis

Figure 13: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Sepsis/Septic Shock by Causative Agent

Figure 14: 7MM, Sources Used and Not Used, Organ Dysfunction among Sepsis Cases

Figure 15: 7MM, Sources Used and Not Used, In-Hospital Mortality Cases of Sepsis

Figure 16: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of Septic Shock

Figure 17: 7MM, Sources Used and Not Used, Organ Dysfunction of Septic Shock Cases

Figure 18: 7MM, Sources Used, In-Hospital Mortality Cases of Septic Shock

Figure 19: 7MM, Age-Specific Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016

Figure 20: 7MM, Sex-Specific Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016

Figure 21: 7MM, Diagnosed Incident Cases of Sepsis by Causative Agent, Both Sexes, All Ages, 2016

Figure 22: 7MM, Organ Dysfunction among Diagnosed Incident Cases of Sepsis, Both Sexes, All Ages, 2016

Figure 23: 7MM, Age-Specific In-Hospital Mortality Cases of Sepsis, Both Sexes, All Ages, 2016

Figure 24: 7MM, Age-Specific Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016

Figure 25: 7MM, Sex-Specific Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016

Figure 26: 7MM, Diagnosed Incident Cases of Septic Shock by Causative Agent, Both Sexes, All Ages, 2016

Figure 27: 7MM, Organ Dysfunction among Diagnosed Incident Cases of Septic Shock, Both Sexes, All Ages, 2016

Figure 28: 7MM, Age-Specific In-Hospital Mortality Cases of Septic Shock, Both Sexes, All Ages, 2016

Figure 29: Current Treatment Options for Sepsis and Septic Shock, 2017

Figure 30: Disease Management Timeline for Sepsis and Septic Shock

Figure 31: Sepsis and Septic Shock SEPSIS-3 Diagnosis Algorithm

Figure 32: International Treatment Algorithm Overview for Sepsis, Severe Sepsis, and Septic Shock

Figure 33: Key Events Shaping Clinical Practice in Sepsis and Septic Shock

Figure 34: Unmet Need and Opportunity in Sepsis and Septic Shock, 2017

Figure 35: Current Treatment Options and Associated Biomarkers for Sepsis and Septic Shock, 2017

Figure 36: Sepsis and Septic Shock – Phase II‒III Pipeline, 2017

Figure 37: Bullseye Diagram of Products in Clinical Development for Sepsis and Septic Shock, 2017

Figure 38: Competitive Assessment of Marketed and Pipeline Agents for Sepsis-Specific Treatment Options – Sepsis and Septic Shock, 2016–2026

Figure 39: Competitive Assessment of Marketed and Pipeline Agents for Supportive Care Treatment Options – Sepsis and Septic Shock, 2016–2026

Figure 40: Competitive Assessment of Marketed and Pipeline Agents for Infection Control Treatment Options – Sepsis and Septic Shock, 2016–2026

Figure 41: Top-Line Sales for Sepsis and Septic Shock by Country/Region, 2016 and 2026

Figure 42: Top-Line Sales for Sepsis and Septic Shock by Region, 2016‒2026

Figure 43: Global Sales for Sepsis and Septic Shock by Drug Class, 2016 and 2026

Figure 44: Sales for Sepsis and Septic Shock by Drug Class in the US, 2016 and 2026

Figure 45: Sales for Sepsis and Septic Shock by Drug Class in the US, 2016 and 2026

Figure 46: Sales for Sepsis and Septic Shock by Drug Class in the 5EU, 2016 and 2026

Figure 47: Sales for Sepsis and Septic Shock by Drug Class in the 5EU, 2016 and 2026

Figure 48: Global Sales for Sepsis nd Septic Shock by Country in the 5EU, 2016 and 2026

Figure 49: Global Sales for Sepsis and Septic Shock by Country in the 5EU, 2016‒2026

Figure 50: Sales for Sepsis and Septic Shock by Drug Class in Japan, 2016 and 2026

Figure 51: Sales for Sepsis and Septic Shock by Drug Class in Japan, 2016 and 2026

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