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

  • Disease Landscape & Forecast
    • Executive Summary
      • Key Findings
    • 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
    • Forecast
    • Etiology and Pathophysiology
      • Key Findings
        • Expert Insight
        • Disease Overview
      • Clinical Features
      • Etiology
      • Pathophysiology
      • Key Pathways and Drug Targets
    • Epidemiology Overview
      • Introduction
      • Epidemiology Populations
        • Diagnosed Hospitalized CDI Events
        • Hospitalized Events from Nursing Homes
        • Recurrence
        • Drug-Treated Cases of Clostridium Difficile Infection
        • Severity
    • Current Treatment Overview
      • Key Findings
        • Expert Insight
      • Diagnosis
        • Treatment Providers and Referral Patterns
      • Treatment Goals
        • Physician Insights on Clinical End Points
      • Key Current Therapies
        • Overview
        • Nitroimidazoles
        • Glycopeptides
        • Macrolides
        • Toxin Binders
        • Bacteriotherapy
        • Other Therapeutic Approaches
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Drug Selection
        • Region-Specific Treatment Practices
    • 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
    • Emerging Therapies Overview
      • Key Findings
        • Expert Insight
      • Key Emerging Therapies
        • Notable Developments Among Key Emerging Therapies for Clostridium Difficile Infection
        • Antibiotics
        • Microbiome-Based Therapies
        • Preventive Approaches for Clostridium Difficile Infection
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for Clostridium Difficile Infections
      • Key Discontinuations and Failures in Clostridium Difficile Infection
      • Generating Antibiotic Incentives Now (GAIN)
      • Orphan Drug Designation
        • Orphan Drug Provisions: United States
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Emerging Therapy Prices: 2026
        • Generic Erosion
        • Out-Year Forecasting
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Clostridium Difficile Infection Bibliography

Author(s): Nuno Tiago Giao Antunes, PhD

Nuno T. Antunes, ,  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 in animal health from the Universidad de las Palmas de Gran Canaria, Spain, and a 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.