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

  • Pages: 280
  • Published: July 2017
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  • Report Code: GDHC070POA
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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. CDIs begin with colonization of the intestinal tract with C. difficile through community-acquired or healthcare-associated means. Observed most frequently in healthcare settings, CDIs often occur when normal intestinal flora are disrupted by antibiotic administration, which can give C. difficile a competitive growth advantage if patients are exposed to the pathogen. Since 2000, CDIs have become more frequent, more severe, more difficult to treat using existing therapies, and more likely to recur than previously described. These realities, along with increasing threat of antibiotic resistance, underscore the importance of developing CDI-specific therapies and bringing them to market.

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.

Companies mentioned

GlaxoSmithKline

Shire

OpenBiome

Akthelia Pharmaceuticals

MGB Biopharma

Merck & Co.,

Actelion

Summit Therapeutics

Otsuka Pharmaceuticals

Seres Therapeutics

Rebiotix

Sanofi Pasteur

Pfizer

Valneva

Synthetic Biologics

GlaxoSmithKline

Shire

OpenBiome

Akthelia Pharmaceuticals

MGB Biopharma

Merck & Co.,

Actelion

Summit Therapeutics

Otsuka Pharmaceuticals

Seres Therapeutics

Rebiotix

Sanofi Pasteur

Pfizer

Valneva

Synthetic Biologics

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Significant Growth Is ...

Table of Contents

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 Epidemiologist

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

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 ...

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 HIV

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

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 ...

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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