Market Outlook:

Many cases of hospital-acquired infections and healthcare-associated illnesses are attributable to C. difficile infection (CDI). Although standard-of-care antibiotics are relatively effective, the virulence of CDI has increased and standard antibiotic therapies are associated with a risk of recurrence. Due to the high rates of CDI recurrence, risk of mortality, need for prolonged hospitalization, and financial burden that these infections impose on healthcare systems, CDI represents an important segment of the hospital antibiotic market. Because CDI has been recognized as a condition linked to the disruption of the natural flora, interest is growing in restoring and maintaining a healthy and diverse intestinal microbiome, and the utility of narrow-spectrum agents and microbiome-based therapies as treatment strategies is being explored. Thought leaders note that preventive strategies and treatments for severe and recurrent CDI remain critical areas of unmet need in this market.

Questions Answered:

  • How do physicians make treatment choices for CDI across treatment settings and severity? What factors drive treatment switching and the use of alternative therapies (e.g., pulsing, fecal transplantation, Merck’s Zinplava)?
  • How will emerging therapies be integrated into the current treatment algorithm by severity and CDI episode status? Which treatment will dominate the severe and severe, complicated segment by 2026?
  • How will emerging microbiome-based therapies, immunological therapies, and vaccines change the treatment landscape for CDI, and will the antibiotic segment face pressure from these unconventional approaches?

Scope:

Market covered: United States, France, Germany, Italy, Spain, and the United Kingdom.

Primary research: Six country-specific interviews with C. difficile infection specialists.

Epidemiology: Diagnosed events of CDI by country, recurrence, and severity of disease.

Emerging therapies: Phase III/PR: 6, Phase II: 2; coverage of select preclinical and Phase I products.

Market forecast: Drug-level sales and patient share of key C. difficile infection therapies in 2026. Sales and patient share of current therapies in the U.S. and EU5 in 2016.

Key companies: Merck, Rebiotix, Seres Therapeutics, Summit Therapeutics

Key drugs: vancomycin, metronidazole, fidaxomicin, bezlotoxumab, fecal microbiota transplantation, SER-109, RBX2660, ridinilazole

Table of contents

  • Clostridium Difficile Infection - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Key Findings
        • Regional Sales of Key Therapies to Treat Primary and Recurrent Clostridium Difficile Infection: 2016 and 2026
        • C. Difficile Infection SWOT Analysis
        • Actionable Recommendations in the CDI Market, According to Infectious Disease Specialists and Gastroenterologists
    • Commercial Outlook
      • Key Findings
        • Expert Insight
      • Drivers and Constraints
        • What Factors Are Driving Sales in Clostridium Difficile Infection?
        • What Factors Are Constraining Sales in Clostridium Difficile Infection?
      • Antibiotic-Specific Trends
        • FMT-Specific Trends
          • Toxin Binder-Specific Trends
            • Alternative Market Scenarios
              • Alternative Scenarios for the Clostridium Difficile Infection Market Through 2026
          • Forecast
            • Sales of Key Therapies for Clostridium Difficile Infection
          • Etiology and Pathophysiology
            • Key Findings
              • Expert Insight
              • Disease Overview
            • Clinical Features
              • Definitions of Community- and Hospital-Acquired CDI
              • Definition of Severity of CDI According to U.S. Guidelines
              • Definition of Severe CDI According to ESCMID (Europe)
              • Definition of Recurrent CDI According to Different Guidelines
            • Etiology
              • Risk Factors
            • Pathophysiology
              • Key Pathways and Drug Targets
              • Epidemiology Overview
                • Introduction
                  • Epidemiology Populations
                    • Disease Definition
                    • Methods
                    • Sources Used for Diagnosed Events of Hospitalized Clostridium Difficile Infection
                    • Number of Diagnosed Events of Hospitalized Clostridium Difficile in the Major Pharmaceutical Markets, 2016-2026
                    • Disease Definition
                    • Methods
                    • Sources Used for Hospitalized Events Transferred from Nursing Homes
                    • Number of Diagnosed Events of Clostridium Difficile Infection (Transferred from Nursing Home) in the Major Pharmaceutical Markets, 2016-2026
                    • Disease Definition
                    • Methods
                    • Sources Used for Recurrent Events of Clostridium Difficile Infection
                    • Number of Diagnosed Events of Hospitalized Clostridium Difficile Infection in the Major Pharmaceutical Markets by Recurrence Status, 2016-2026
                    • Drug-Treated Events of Clostridium Difficile Infection: 2016-2026
                    • Disease Definition
                    • Methods
                    • Sources Used for Severity of Clostridium Difficile Infection
                    • Diagnosed Events of Clostridium Difficile Infection by Severity of Disease: 2016-2026
                    • Drug-Treated Events of Clostridium Difficile Infection by Severity of Disease: 2016-2026
                • Current Treatment Overview
                  • Key Findings
                    • Expert Insight
                  • Diagnosis
                    • Laboratory Diagnostic Assays for Clostridium Difficile
                    • Treatment Providers and Referral Patterns
                  • Treatment Goals
                    • Key End Points Used in Clinical Trials for Clostridium Difficile Infection
                    • Physician Insights on Clinical End Points
                    • Expert Insight: Clinical End Points
                  • Key Current Therapies
                    • Overview
                    • Mechanism of Action of Key Current Therapies Used for Clostridium Difficile Infection
                    • Current Treatments Used for Clostridium Difficile Infection
                    • Market Events Impacting the Use of Key Current Therapies for Clostridium Difficile Infection
                    • Advantages and Disadvantages of Metronidazole
                    • Expert Insight: Metronidazole
                    • Advantages and Disadvantages of Vancomycin
                    • Expert Insight: Vancomycin
                    • Clinical Trial Outcomes for Fidaxomicin
                    • Clinical Analysis of Fidaxomicin in the Treatment of Clostridium Difficile Infection
                    • Advantages and Disadvantages of Fidaxomicin
                    • Ongoing Clinical Development
                    • Key Ongoing Clinical Trials of Fidaxomicin in the Treatment of CDI
                    • Expert Insight: Fidaxomicin
                    • Clinical Analysis of Bezlotoxumab for the Treatment of Clostridium Difficile Infection
                    • Advantages and Disadvantages of Bezlotoxumab
                    • Ongoing Clinical Development
                    • Expert Insight: Bezlotoxumab
                    • Expectations for Launch and Sales Opportunity of Bezlotoxumab in Clostridium Difficile Infection
                    • Clinical Trial Outcomes for Fecal Microbiota Transplantation
                    • Clinical Analysis of Fecal Microbiota Transplantation for the Treatment of Clostridium Difficile Infection
                    • Advantages and Disadvantages of Fecal Microbiota Transplantation
                    • Ongoing Clinical Development
                    • Expert Insight: Fecal Microbiota Transplantation
                    • Rifaximin
                    • Tigecycline
                  • Medical Practice
                    • Overview
                    • Country and/or Regional Clostridium Difficile Treatment Guidelines
                    • Region-Specific Treatment
                    • Region-Specific Treatments
                    • Generalized Treatment Decision Tree for Primary Clostridium Difficile Infection
                    • Generalized Treatment Decision Tree for Recurrent Clostridium Difficile Infection
                • Unmet Need Overview
                  • Key Findings
                    • Expert Insight
                  • Attainment of Unmet Needs
                    • Current Attainment of Unmet Needs in Clostridium Difficile Infection
                    • Future Attainment of Unmet Needs in Clostridium Difficile Infection
                    • Top Unmet Needs in Clostridium Difficile Infection: Current and Future Attainment
                    • Expert Insight: Unmet Needs in Clostridium Difficile Infection
                • Emerging Therapies Overview
                  • Key Findings
                    • Expert Insight
                    • Pipeline Trends for Clostridium Difficile Infection
                  • Key Emerging Therapies
                    • Notable Developments Among Key Emerging Therapies for Clostridium Difficile Infection
                    • Key Emerging Therapies in Development for Clostridium Difficile Infection
                    • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Clostridium Difficile Infection
                    • Expert Insight on Use of Antibiotics in the Treatment of Clostridium Difficile Infection
                    • Expert Insight: Antibiotics
                    • Ridinilazole Profile
                    • Ridinilazole Clinical Development
                    • Key Ongoing Clinical Trials of Ridinilazole in the Treatment of Clostridium Difficile Infection
                    • Expectations for Launch and Sales Opportunity of Ridinilazole in Clostridium Difficile Infection
                    • Cadazolid Profile
                    • Cadazolid Clinical Development
                    • Key Ongoing Clinical Trials of Cadazolid in the Treatment of Clostridium Difficile Infection
                    • Expectations for Launch and Sales Opportunity of Cadazolid in Clostridium Difficile Infection
                    • Expert Insight: Microbiome-Based Therapies
                    • SER-109 Profile
                    • Key Ongoing Clinical Trials of SER-109 in the Treatment of Clostridium Difficile Infection
                    • Expert Insight on Use of SER-109 in the Treatment of Clostridium Difficile Infection
                    • Expert Insight: SER-109
                    • Expectations for Launch and Sales Opportunity of SER-109 in Clostridium Difficile Infection
                    • RBX-2660 Profile
                    • Key Ongoing Clinical Trials of RBX-2660 in the Treatment of Clostridium difficile Infection
                    • Expectations for Launch and Sales Opportunity of RBX-2660 in Clostridium Difficile Infection
                    • Vaccines in Phase II or III Testing for CDI
                    • Expert Insight: Vaccines
                    • Expert Insight: Ribaxamase
                  • Early-Phase Pipeline Analysis
                    • Notable Developments in the Early-Phase Pipeline for Clostridium Difficile Infections
                    • Select Compounds in Early-Phase Development for Clostridium Difficile Infections
                  • Key Discontinuations and Failures in Clostridium Difficile Infection
                    • Generating Antibiotic Incentives Now (GAIN)
                      • Orphan Drug Designation
                        • Agents for Clostridium Difficile Infection Designated as Orphan Drugs
                    • Access & Reimbursement Overview
                      • Region-Specific Reimbursement Practices
                      • Appendix
                        • Key Abbreviations Related to Clostridium Difficile Infection
                        • Brands, Marketers, and Generic Availability of Key Therapies for Clostridium Difficile Infection, by Market
                        • Clostridium Difficile Infection Bibliography

                    Author(s): Nuno Tiago Giao Antunes, PhD

                    Nuno T. Antunes, Ph.D., is senior business insights analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, specializing in antibacterial agents. Previously, he was a Latin America Market Access senior analyst in the Global Market Access Insights Team, where he developed expertise in market access, pricing and reimbursement, health technology assessment, and health policy.

                    Nuno holds a Ph.D. in animal health from the Universidad de las Palmas de Gran Canaria, Spain, and a D.V.M. degree from the Universidade de Trás-os-Montes e Alto Douro, Portugal. Prior to joining DRG, he conducted research in antimicrobial resistance and antimicrobial development, and worked in the medical devices industry as a scientist.