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

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

Summary

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). In late 2016, the sepsis and septic shock market abandoned the concept of a systemic immune response syndrome in the presence of an infection as a potential cause for sepsis; in the new consensus definitions, sepsis is defined as an infection leading to organ dysfunction.

It is estimated that in 2015, the overall sales for sepsis and septic shock to be approximately US$2.8 Billion, comprising annual drug sales of US$2.2 Billion in sepsis and US$0.6 Billion in septic shock across the 7MM. Differences in revenue generated by disease area are due to higher incidence rates for sepsis compared with septic shock. GlobalData expects the sepsis and septic shock market to grow by a strong Compound Annual Growth Rate (CAGR) of 7.9% from 2016-2026, reaching annual sales of US$5.9 Billion by the end of the forecast period.

In order to combat these market realities, we believe developers will have to leverage innovative R&D strategies to establish the strong clinical evidence needed for approval and uptake post-licensure. Some of the key approaches identified by KOLs include adaptive clinical trial design, including interim analyses leveraging multiple clinically relevant biomarkers and companion diagnostics to limit heterogeneity among enrolled patients; targeting highly specific sepsis patient populations based on sepsis-induced conditions; and investigating novel targets with combination therapies that are relevant to sepsis pathophysiology.

The report OpportunityAnalyzer: Sepsis and Septic Shock - Opportunity Analysis and Forecasts to 2026, covers overview of sepsis and septic shock, including epidemiology, etiology, pathophysiology, as well as current routine sepsis and septic shock recommendations of all 7MM covered.

This report provides the following in-depth analysis -

  • 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.
Companies mentioned in this report: AM-Pharma, Asahi Kasei Pharma Corp, Bristol-Myers Squibb, CytoSorbents, Faron, Ferring Holding, Pfizer, RevImmune, Shionogi, Spectral Diagnostics.

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.


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
1.1 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 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
1.2 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 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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