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OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026

OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026

Summary

Clostridium difficile, a Gram-positive, spore-forming, toxin-producing, non-invasive, anaerobic bacterium, is the causative organism of C. difficile infection (CDI), which is commonly associated with colitis, as well as C. difficile-associated diarrhea (CDAD) (ICD-10; A04.7) (ICD-10 Diagnosis Codes, 2016). The pathogen was first described in 1935 and can exist in spore and vegetative forms, with the spore form being resistant to heat, acid, and antibiotics (Hall and O’Toole, 1935).

The report considers Global CDI market to include sales of therapeutic and prophylactic agents aimed at treatment and prevention of CDIs across the 7MM. In 2016, it is estimated the total CDI market to be valued at $628.8m across the 7MM, and the US accounted for 91% of the market. Over the course of the 10-year forecast period, the CDI market will grow at a Compound Annual Growth Rate (CAGR) of 10.2% across the 7MM. The 5EU will experience the fastest growth with a CAGR of 19.2%, while the US and Japan will experience growth of 9.0% and 13.2%, respectively. At the end of 2026, the US will contribute around 81% of global sales, while the 5EU and Japan will account for around 17% and 2% of sales, respectively.

Major drivers in growth for the CDI market include -

  • The projected launch of prophylactic options for the prevention of C. difficile, led by Sanofi Pasteur’s toxoid vaccine ACAM-CDIFF.
  • The projected launch of microbiologic approaches for the treatment of recurrent CDI (rCDI), with the potential to leverage the efficacy of fecal microbiota transplants (FMT).
  • The projected launch of novel antibiotics for the treatment of CDI, positioned to reduce the rate of CDI recurrence.
  • A projected increase in the incidence of CDI in the US, driven by a higher incidence of community-associated CDI (CA-CDI).
During the 10-year forecast period, there are nine products that are on track to a launch, contributing to a forecast growth in the 7MM at a CAGR of 10.2% from 2016 to 2026.

The report OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026 provides Overview of CDI, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

In particular, this report provides the following -
  • Topline CDI market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting CDI therapeutics and prophylactics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global CDI therapeutics and prophylactics market. 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: GlaxoSmithKline, Shire, OpenBiome, Akthelia Pharmaceuticals, MGB Biopharma, Merck & Co.,, Actelion, Summit Therapeutics, Otsuka Pharmaceuticals, Seres Therapeutics, Rebiotix, Sanofi Pasteur, Pfizer, Valneva, Synthetic Biologics.

Scope
  • Overview of CDI, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline CDI market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting CDI therapeutics and prophylactics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global CDI therapeutics and prophylactics market. 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 CDI therapeutics and prophylactics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CDI therapeutics and prophylactics 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 Executive Summary
2.1 Significant Growth Is Projected for the CDI Market from 2016 to 2026
2.2 Manufacturers Aiming to Provide Physicians Non-Antibiotic Therapies for Treatment and Prevention of CDI
2.3 There Remains Significant Unmet Need for CDI Treatment, in Particular to Reduce CDI Recurrence Rates
2.4 Opportunities Exist for Products Proven to be Cost-Effective Versus SOC Antibiotics
2.5 An Active Pipeline Poised to Partially Satisfy Unmet Needs for CDI
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 Symptoms
4.3 Disease Management
4.3.1 Diagnosis
4.3.2 Treatment Guidelines
4.3.3 Clinical Practice
4.3.4 Prevention and Control
4.4 Prognosis and Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.3.1 7MM: Diagnosed Incidence
5.3.2 7MM: Diagnosed Incident Cases by Recurrence
5.3.3 7MM: Diagnosed Incident Cases by Severity
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for CDI (2016-2026)
5.5.1 Diagnosed Incident Cases of CDI
5.5.2 Age-Specific Diagnosed Incident Cases of CDI
5.5.3 Sex-Specific Diagnosed Incident Cases of CDI
5.5.4 CDI Cases by Recurrence
5.5.5 CDI Cases by Severity
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 Product Profiles - Recommended Antibiotic Therapies
6.2.1 Metronidazole (numerous brand names)
6.2.2 Vancomycin (numerous brand names)
6.2.3 Dificid (fidaxomicin)
6.3 Product Profiles - Antibodies
6.3.1 Zinplava (bezlotoxumab)
6.4 Other Antibiotic Therapies
6.4.1 Targocid (teicoplanin)
6.4.2 Tygacil (tigecycline)
6.4.3 Xifaxan (rifaximin)
6.5 Non-drug Interventions
6.5.1 OpenBiome FMT (stool-bank service)
6.5.2 Probiotics
6.5.3 Surgical Procedures
7 Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.2 Improved Treatment Options for rCDIs
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Prophylactic Products to Prevent Primary CDI
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 More Cost-Effective Treatment Options
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Standardize, Streamline, and Confirm the Long-Term Safety of FMT
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 Reduce CDI Morbidity and Mortality In Vulnerable Patients
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity
7.7 Improve Surveillance and Prevent Transmission and Outbreaks
7.7.1 Unmet Need
7.7.2 Gap Analysis
7.7.3 Opportunity
7.8 Reduce Misdiagnosis of CDI From Diagnostic Testing
7.8.1 Unmet Need
7.8.2 Gap Analysis
7.8.3 Opportunity
8 Research and Development Strategies
8.1 Overview
8.2 Current Approaches to CDI Product Development
8.2.1 Therapeutic Agents
8.2.2 Prophylactic Agents
8.3 Clinical Trial Design
8.3.1 Therapeutic Agents
8.3.2 Prophylactic Agents
9 Pipeline Assessment
9.1 Overview
9.2 Promising Products in Clinical Development
9.3 Therapeutic Agents - Antibiotics
9.3.1 Cadazolid
9.3.2 Ridinilazole
9.3.3 OPS-2071
9.4 Therapeutic Agents - Microbiologics
9.4.1 SER-109 (firmacute eubacterial spores, purified suspensions, encapsulated)
9.4.2 RBX2660 (microbiota suspension)
9.5 Prophylactic Agents - Vaccines
9.5.1 ACAM-CDIFF
9.5.2 PF-06425090
9.5.3 VLA84
9.6 Prophylactic Agents - Drugs
9.6.1 Ribaxamase
9.7 Other Innovative Approaches to CDI Prevention and Treatment
9.7.1 Fecal Microbiota Transplant
9.7.2 DAV-132
9.7.3 Surotomycin
9.7.4 Ramoplanin
9.7.5 VP20621 (non-toxigenic C. difficile strain M3 spores)
9.8 Other Products in Clinical Development
10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Products
10.1.1 Therapeutic Agents
10.1.2 Prophylactic Agents
10.2 Commercial Benchmark of Key Pipeline Products
10.2.1 Therapeutic Agents
10.2.2 Prophylactic Agents
10.3 Competitive Assessment
10.3.1 Therapeutic Agents
10.3.2 Prophylactic Agents
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 CDI Patient Population
11.4.2 Target Patient Populations for Prophylaxis
11.4.3 Percent Drug-Treated Patients
11.4.4 Drugs Included in Each Therapeutic Class
11.4.5 Launch and Patent Expiry Dates
11.4.6 General Pricing Assumptions
11.4.7 Individual Drug Assumptions
11.4.8 Pricing of Pipeline Agents
11.5 Primary Research - KOLs Interviewed for this Report
11.6 Primary Research - Prescriber Survey
11.7 About the Authors
11.7.1 Analysts
11.7.2 Therapy Area Director
11.7.3 Epidemiologists
11.7.4 Director of Epidemiology
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: Clostridium difficile Infections (CDI): Key Metrics in the 7MM
Table 2: Antimicrobial Agents that May Induce CDI, CDAD, and Colitis
Table 3: The Physiological Effects of C. difficile Toxins A and B
Table 4: Symptoms Associated with CDIs
Table 5: Summary of Stool Laboratory Diagnostic Testing for C. difficile
Table 6: CDI Severity Scoring System and Summary of Recommended Treatments
Table 7: Risk Factors and Comorbidities for CDI
Table 8: 7MM, Diagnosed Incident Cases of CDI, Ages ≥18 Years, Both Sexes, N, Select Years 2016-2026
Table 9: Product Profile - Metronidazole
Table 10: Clinical Successa of Metronidazole versus Vancomycin by CDI Severity
Table 11: Summary of AEs Observed In Two Phase III Trials Comparing Metronidazole to Vancomycin
Table 12: Metronidazole SWOT Analysis, 2017
Table 13: Product Profile - Vancomycin
Table 14: Clinical Success of Vancomycin-Treated Subjects in Two Clinical Trials
Table 15: Common AEs for Vancomycin in Treating CDADa
Table 16: Vancomycin SWOT Analysis, 2017
Table 17: Product Profile - Dificid
Table 18: Dificid Pivotal Phase III Clinical Trials Response Rates
Table 19: Dificid Pivotal Phase III Clinical Trials Sustained Clinical Response at 25 Days After Treatment According to C. difficile Strain
Table 20: Selected Adverse Reactions with an Incidence of ≥2% Reported in Patients Treated with Dificid in Controlled Trials
Table 21: Dificid SWOT Analysis, 2017
Table 22: Product Profile - Zinplava (bezlotoxumab)
Table 23: Clinical Efficacy of Zinplava with Regard to Recurrence Rates in MODIFY I and MODIFY II Clinical Trials
Table 24: AEs Associated with Zinplava, Administered Alone or with Actoxumab and Compared to a Placebo Group, as Observed in Both MODIFY I and MODIFY II RCTs
Table 25: Zinplava SWOT Analysis, 2017
Table 26: Key Products in the CDI Market by Therapeutic Class, 2017
Table 27: Clinical Trial Designs for CDI Pipeline Antibiotics
Table 28: Clinical Trial Designs for CDI Pipeline Antibodies
Table 29: Clinical Trial Designs for CDI Pipeline Microbiologics
Table 30: Clinical Trial Designs for CDI Pipeline Vaccines
Table 31: Clinical Trial Designs for CDI Pipeline Prophylactic Adjuvant Therapies.
Table 32: Promising Products in Clinical Development for CDIs, 2017
Table 33: Product Profile - Cadazolid
Table 34: Efficacy Results from Cadazolid Phase II Trial - Modified Intent-to-Treat Populationa
Table 35: Cadazolid SWOT Analysis, 2017
Table 36: Product Profile - Ridinilazole
Table 37: Clinical Success of Ridinilazole versus Vancomycin as Observed in the CoDIFy Phase II Trial
Table 38: Adverse Effects Observed in Phase I Trials Assessing the Safety Profile of Ridinilazole
Table 39: Ridinilazole SWOT Analysis, 2017
Table 40: Product Profile - OPS-2071
Table 41: OPS-2071 SWOT Analysis, 2017
Table 42: Product Profile - SER-109
Table 43: Results from Three Clinical Trials Assessing the Efficacy of SER-109
Table 44: SER-109 SWOT Analysis, 2017
Table 45: Product Profile - RBX2660
Table 46: Results from Three Clinical Trials Assessing the Efficacy of RBX2660
Table 47: Reported AEs in the PUNCH CD2 Trial for RBX2660
Table 48: RBX2660 SWOT Analysis, 2017
Table 49: Product Profile - ACAM-CDIFF
Table 50: Formulations and Dosing Schedules and Seroconversion Rate for ACAM-CDIFF Phase II Trial
Table 51: Adverse Effects Observed in a Phase II Trial Assessing ACAM-CDIFF
Table 52: ACAM-CDIFF SWOT Analysis, 2017
Table 53: Product Profile - PF-06425090
Table 54: Clinical Trials Carried Out to Assess the Safety, Tolerability, and Immunogenicity of PF-06425090
Table 55: PF-06425090 SWOT Analysis, 2017
Table 56: Product Profile - VLA84
Table 57: Seroconversion Rates for VLA84 Observed During a Phase II Trial
Table 58: Doses and Dosing Schedules in VLA84 Phase I Triala
Table 59: VLA84 SWOT Analysis, 2017
Table 60: Product Profile - Ribaxamase
Table 61: Adverse Effects Observed in Two Phase I Trials Assessing the Safety Profile of Ribaxamase
Table 62: Ribaxamase SWOT Analysis, 2017
Table 63: Other Innovative Approaches to CDI Prevention and Treatment, 2017
Table 64: Comparison of Results from Published RCTs Investigating the Efficacy of FMT for Treating Recurrent CDI
Table 65: Efficacy Results from Surotomycin Phase III Trial
Table 66: Efficacy Results from VP20621 Phase III Trial
Table 67: Other CDI Products in Development, 2017
Table 68: Clinical Benchmark of Key Pipeline Therapeutics - CDIs
Table 69: Clinical Benchmark of Key Pipeline Prophylactics - CDIs
Table 70: Commercial Benchmark of Key Pipeline Therapeutics - CDIs
Table 71: Clinical Benchmark of Key Pipeline Prophylactics - CDIs
Table 72: Top-Line Global Sales Forecasts for CDI Therapeutic and Prophylactic Agents, 2016-2026
Table 73: Key Events Impacting Sales for CDIs, 2016-2026
Table 74: CDI Market - Global Drivers and Barriers, 2016-2026
Table 75: Sources Used For Diagnosed CDI Incidence Segmentation in the 7MM
Table 76: Sources Used For Prophylaxis Target Patient Populations in the 7MM
Table 77: Key Historical and Projected Launch Dates for CDI
Table 78: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Global (7MM) Sales Forecast by Country for CDIs in 2016 and 2026
Figure 2: Competitive Assessment of Marketed and Pipeline Therapeutic Products for CDI Benchmarked Against the SOC, Vancomycin
Figure 3: Competitive Assessment of Pipeline Prophylactic Products for CDI
Figure 4: Examples of C. difficile-Associated Diseases
Figure 5: Overview of the Pathogenesis of CDAD
Figure 6: CDI Diagnosis Algorithm Recommended by ESCMID Guidelines
Figure 7: Overview of International Treatment Algorithm for CDI and CDAD
Figure 8: 7MM, Age-Standardized Diagnosed Incidence of CDI, Ages ≥18 Years, 2016
Figure 9: Case Flow Map
Figure 10: Sources Used and Not Used in Epidemiological Analysis of CDI Incidence
Figure 11: Sources Used and Not Used in Epidemiological Analysis of CDI Recurrences
Figure 12: Sources Used and Not Used in Epidemiological Analysis of CDI Severity
Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of CDI, Both Sexes, Ages ≥18 Years, 2016
Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of CDI, Ages ≥18 Years, 2016
Figure 15: 5EU and Japan, CDI Recurrences, Both Sexes, Ages ≥18 Years, 2016
Figure 16: US, CDI Recurrences, Both Sexes, Ages ≥18 Years, 2016
Figure 17: 5EU and Japan, CDI Cases by Severity, Both Sexes, Ages ≥18 Years, 2016
Figure 18: US, CDI Cases by Severity, Both Sexes, Ages ≥18 Years, 2016
Figure 19: Current Treatment Options for CDIs
Figure 20: Unmet Need and Opportunity in CDI
Figure 21: Promising Pipeline Products In Development for CDIs with Key Clinical Trials, 2017
Figure 22: Bullseye Diagram of Products in Clinical Development for CDIs, 2017
Figure 23: Key Clinical Trial Progress for CDI Pipeline Antibiotics
Figure 24: Key Clinical Trial Progress for CDI Pipeline Microbiologics
Figure 25: Key Clinical Trial Progress for CDI Pipeline Vaccines
Figure 26: Key Clinical Trial Progress for CDI Pipeline Prophylactic Adjuvants
Figure 27: Competitive Assessment of Marketed and Pipeline Therapeutic Products for CDI Benchmarked Against the SOC, Vancomycin
Figure 28: Competitive Assessment of Pipeline Prophylactic Products for CDI
Figure 29: Global (7MM) Sales Forecast by Country for CDIs in 2016 and 2026
Figure 30: Global (7MM) Sales Forecast by Product Class for CDIs in 2026
Figure 31: US Sales Forecast By Product Class for CDIs, 2016-2026
Figure 32: Therapeutic Sales Forecast by Product for CDIs in the US in 2016 and 2026
Figure 33: Prophylactic Sales Forecast by Product for CDIs in the US in 2026
Figure 34: 5EU Sales Forecast By Product Class for CDIs, 2016-2026
Figure 35: Therapeutic Sales Forecast by Product for CDIs in the 5EU in 2016 and 2026
Figure 36: Prophylactic Sales Forecast by Product for CDIs in the 5EU in 2026
Figure 37: Japan Sales Forecast By Product Class for CDIs, 2016-2026
Figure 38: Therapeutic Sales Forecast by Product for CDIs in Japan in 2016 and 2026

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