MARKET OUTLOOK

Sepsis is a life-threatening organ dysfunction resulting from a dysregulated host response to infection. It is one of the leading causes of death among developed countries, with over 10% mortality rates in sepsis patients and over 40% in patients who develop septic shock. To manage sepsis, immediate interventions are required, which include infection control, hemodynamic restoration with fluid resuscitation and vasopressors, and other supportive care approaches. With the last FDA-approved drug for severe sepsis (Eli Lilly’s Xigris) withdrawn in 2011 due to its failure to show survival benefits, all current therapies for sepsis are either used off-label and/or are generically available. Therefore, opportunity exists for drug developers who can address key areas of unmet need. However, given the field’s limited understanding of sepsis pathophysiology, developers will likely face challenges during clinical development of their novel agents.

QUESTIONS ANSWERED

  • How large are the U.S. and EU5 sepsis patient populations, and how will their size change through 2026? What percentage of these patients progress to septic shock?
  • How are sepsis patients diagnosed and managed? What are the key current therapies prescribed for the treatment of sepsis and what drives their use?
  • How have the updated definitions for sepsis impacted diagnosis and treatment of sepsis and septic shock?
  • What are the key areas of unmet need and to what extent will they be fulfilled by the therapies currently in the pipeline?
  • What challenges will developers encounter when conducting clinical trials for drugs to treat sepsis? What clinical and commercial impact will emerging drugs have on the sepsis market through 2026?​​​​​​

PRODUCT DESCRIPTION

Niche & Rare Disease Landscape & Forecast: Comprehensive market intelligence providing world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Sepsis - Landscape & Forecast - Disease Landscape & Forecast
    • Update
      • Update February 2018
    • Executive Summary
      • Key Findings
        • Regional Sales of Key Therapies to Treat Sepsis: 2016 and 2026
        • Sepsis SWOT Analysis
    • Commercial Outlook
      • Key Findings
        • Drivers and Constraints
          • What Factors Are Driving Sales in Sepsis?
          • What Factors Are Constraining Sales in Sepsis?
        • Drug Class-Specific Trends
          • Novel Antibiotics in Sepsis Market
          • Novel Vasopressors in Sepsis Market
      • Forecast
        • Sales of Key Therapies in Sepsis
      • Etiology and Pathophysiology
        • Key Findings
          • Disease Overview
          • Key Differences Between the 2001 and 2016 Versions of the Sepsis Definition
          • Sequential (Sepsis-Related ) Organ Failure Assessment Score
        • Etiology
          • Common Risk Factors for Developing Sepsis
        • Pathophysiology
          • Typical Clinical Features of Sepsis
          • Pro-Inflammatory and Anti-Inflammatory Responses in Sepsis
        • Key Pathways and Drug Targets
        • Epidemiology Overview
          • Key Findings
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Events of Sepsis
              • Diagnosed Events of Sepsis: 2016-2026
              • Sources Used for Drug-Treated Diagnosis Event Estimates of Sepsis
              • Drug-Treated Diagnosed Events of Severe Sepsis: 2016-2026
              • Drug-Treated Diagnosed Events of Septic Shock: 2016-2026
              • Disease Definition
              • Methods
              • Sources Used for Severity of Sepsis
              • Severity of Sepsis: 2016-2026
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Events of Severe Sepsis by Pathogen
              • Severe Sepsis by Pathogen, 2016-2026
          • Current Treatment Overview
            • Key Findings
              • Diagnosis
                • Treatment Providers and Referral Patterns
              • Treatment Goals
                • Key End Points Used in Clinical Trials for Sepsis
                • Physician Insights on Clinical End Points
              • Key Current Therapies
                • Overview
                • Mechanism of Action in Key Current Drug Classes Used for Sepsis
                • Selected Current Treatments Used for Sepsis
                • Ceftazidime/Avibactam
                • Clinical Trial Outcomes for Ceftazidime/Avibactam
                • Clinical Analysis of Ceftazidime/Avibactam for the Treatment of Gram-Negative Infections
                • Advantages and Disadvantages of Ceftazidime/Avibactam
                • Catecholamines
                • Non-Catecholamines
                • Impact of Key Vasopressors on Relevant Receptors
                • Advantages and Disadvantages of Key Vasopressors
                • Advantages and Disadvantages of Anticoagulants
              • Medical Practice
                • Overview
                • Sepsis Treatment Guidelines by Country
                • Region-Specific Treatment Practices
                • Generalized Treatment Decision Tree for Sepsis
            • Unmet Need Overview
              • Key Findings
                • Attainment of Unmet Needs
                  • Current Attainment of Unmet Needs in Sepsis
                  • Future Attainment of Unmet Needs in Sepsis
                  • Top Unmet Needs in Sepsis: Current and Future Attainment
              • Emerging Therapies Overview
                • Key Findings
                  • Pipeline Trends for Sepsis
                • Key Emerging Therapies
                  • Notable Developments Among Key Emerging Therapies for Sepsis
                  • Key Emerging Therapies in Development for Sepsis
                  • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Sepsis
                  • Beta-Lactam/Beta-Lactamase Inhibitor Fixed Dose Combinations
                  • Meropenem/Vaborbactam Profile
                  • Meropenem/Vaborbactam Clinical Development
                  • Expert Insight on Use of Meropenem/Vaborbactam in the Treatment of Sepsis
                  • Expectations for Launch and Sales Opportunity of Meropenem/Vaborbactam in the Sepsis Market
                  • Imipenem/Cilastatin/Relebactam Profile
                  • Imipenem/Cilastatin/Relebactam Clinical Development
                  • Expert Insight on Use of Imipenem/Cilastatin/Relebactam in the Treatment of Sepsis
                  • Expectations for Launch and Sales Opportunity of Imipenem/Cilastatin/Relebactam in Sepsis
                  • Aminoglycosides
                  • Plazomicin Profile
                  • Plazomicin Clinical Development
                  • Expert Insight on Use of Plazomicin in the Treatment of Sepsis
                  • Expectations for Launch and Sales Opportunity of Plazomicin in Sepsis
                  • Tetracyclines
                  • Eravacycline Profile
                  • Eravacycline Clinical Development
                  • Expert Insight on Use of Eravacycline in the Treatment of Sepsis
                  • Expectations for Launch and Sales Opportunity of Eravacycline in Sepsis
                  • Cephalosporins
                  • Cefiderocol Profile
                  • Cefiderocol Clinical Development
                  • Expert Insight on Use of Cefiderocol in the Treatment of Sepsis
                  • Expectations for Launch and Sales Opportunity of Cefiderocol in Sepsis
                  • Vasopressors
                  • LJPC-501 Profile
                  • LJPC-501 Clinical Development
                  • Expert Insight on Use of LJPC-501 in the Treatment of Sepsis
                  • Expert Insight: LJPC-501
                  • Expectations for Launch and Sales Opportunity of LJPC-501 in Sepsis
                  • Selepressin Profile
                  • Selepressin Clinical Development
                  • Expert Insight on Use of Selepressin in the Treatment of Sepsis
                  • Expert Insight: Selepressin
                  • Expectations for Launch and Sales Opportunity of Selepressin in Sepsis
                  • Anticoagulants
                  • ART-123 Profile
                  • ART-123 Clinical Development
                  • Expert Insight on Use of ART-123 in the Treatment of Sepsis
                  • Expert Insight: ART-123
                  • Expectations for Launch and Sales Opportunity of ART-123 in Sepsis
                • Early-Phase Pipeline Analysis
                  • Notable Developments in the Early-Phase Pipeline for Sepsis
                • Key Discontinuations and Failures in Sepsis
                • Access & Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                  • Methodology
                    • Bottom-Up Forecasting Overview
                      • Patient Populations
                      • Drug-Specific Assumptions
                    • Bottom-Up Forecast Assumptions
                      • General Sources of Data
                      • Drug-Treatment Rate Assumptions in Sepsis
                      • Patient Share Assumptions in Sepsis
                      • General Statements About Pricing
                      • Sources for Drug Prices
                      • 2016 Exchange Rates
                      • Price per Treated Day: 2016
                      • Price per Treated Day: 2026
                      • Dosing, Days of Therapy, and Compliance
                      • Generic Erosion
                      • Generic Erosion Assumptions
                      • Out-Year Forecasting
                      • Emerging Therapy Prices
                    • Primary Market Research
                      • Experts Interviewed
                  • Appendix
                    • Key Abbreviations Related to Sepsis
                    • Brands, Marketers, and Generic Availability of Key Therapies for Sepsis, by Market
                    • Sepsis Bibliography

                Author(s): Jiamin Zhuo, PhD

                Jiamin Zhuo, Ph.D., is a business insights analyst on the infectious, niche, and rare diseases team at Decision Resources Group. He provides expert insight into the commercial aspects of drug development and market dynamics in bacterial infections, including gram-negative infections and Methicillin-resistant Staphylococcus aureus.

                He attained his Ph.D. at the Mayo Graduate School, Mayo Clinic, in Minnesota and his B.Sc. in physiology from Peking University in China. Prior to joining DRG, Dr. Zhuo was a postdoctoral fellow at Boston University and MIT, where he gained extensive experience in quantitative research methods.