Overview Of Clostridium difficile Infections Market 2024: Epidemiology, Etiology, Pathophysiology, Symptoms And Diagnosis

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About Clostridium difficile Infections Market

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). CDI onset begins with colonization of the intestinal tract with C. difficile through community-acquired or healthcare-associated means. C. difficile has been identified as a major cause of antibiotic-associated pseudomembranous colitis and diarrhea, with the earliest cases largely attributed to clindamycin. As penicillins and cephalosporins became more widely used throughout the years, their administration also became associated with an increased risk of developing CDAD. 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.

For the purposes of this report, GlobalData defines the global CDI market to include sales of therapeutic and prophylactic agents aimed at treatment and prevention of CDI and CDAD in patients 18 years and older across the 7MM, which is comprised of the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. GlobalData anticipates a major driver of market growth to be the steady increase in uptake of novel CDI-specific antibiotics once they are approved, but the arrival of non-antibiotic products to the market, such as rationally designed microbiologics and vaccines, are poised to make the biggest clinical impact if approved.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the CDI marketplace. Will the leading therapeutic and prophylactic pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
- What research and development (R&D) strategies will companies leverage to compete in the future CDI marketplace?
- What adjunctive therapies to standard of care (SOC) antibiotics are poised to make a major clinical and commercial impact?
- What clinical and commercial factors are likely to influence CDI product uptake in the US and 5EU (France, Germany, Italy, Spain, and the UK) and Japan (7MM)?

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Key Findings

- GlobalData projects CDI therapeutics and prophylactics market in the 7MM to grow from approximately $356m in 2014 to a little over $1.5bn in 2024, at a compound annual growth rate (CAGR) of 15.8%. This growth will be driven by the increased uptake of novel adjunctive therapies to SOC antibiotics, increased use of Mercks first-to-market antibiotic Dificid, and the arrival of ACAM-CDIFF, the worlds first prophylactic vaccine developed by Sanofi Pasteur to prevent primary infections.
- KOLs interviewed by GlobalData were split on the ability of a prophylactic vaccine developer to demonstrate statistically significant prevention of primary infections in a pivotal Phase III study, specifically citing difficulties reliably anticipating CDI transmission in the patient population. Expert consensus was that non-antibiotic approaches, specifically rationally designed microbiologic therapies, have the potential to shift the treatment paradigm for intractable recurrent infections, although antibiotics should remain the main treatment options through 2024.
- GlobalData anticipates that firms will continue to invest in CDI-specific antibiotics development throughout the forecast period, but product differentiation will remain a difficult task due to the high clinical cure rates with current cost-effective generic antibacterials and the superior sustained cure rate exhibited with Mercks Dificid.

Scope

- Overview of CDI, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline CDI therapeutics and prophylactics market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, and R&D strategies for the CDI market.
- 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. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global CDI market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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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 therapeutic and prophylactic markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CDI 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.

Table of Contents

1 Table of Contents 12
1.1 List of Tables 18
1.2 List of Figures 21
2 Introduction 23
2.1 Catalyst 23
2.2 Related Reports 24
2.3 Upcoming Related Reports 25
3 Disease Overview 26
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 26
3.1.2 Pathophysiology 29
3.2 Risk Factors and Symptoms 32
3.3 Disease Management 34
3.3.1 Diagnosis 36
3.3.2 Treatment Guidelines 38
3.3.3 Clinical Practice 39
3.3.4 Prevention and Control 42
3.4 Prognosis and Quality of Life 43

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4 Epidemiology 45
4.1 Disease Background 45
4.2 Risk Factors and Comorbidities 46
4.3 Global Trends 48
4.3.1 7MM: Diagnosed Incidence Rates 50
4.3.2 7MM: Diagnosed Incident Cases by Epidemiological Association 51
4.3.3 7MM: Diagnosed Incident Cases by Recurrence 51
4.4 Forecast Methodology 52
4.4.1 Sources Used 54
4.4.2 Sources Not Used 61
4.4.3 Forecast Assumptions and Methods 63
4.5 Epidemiological Forecast of CDI (2014-2024) 69
4.5.1 Diagnosed Incident Cases of All-CDI 69
4.5.2 Age-Specific Diagnosed Incident Cases of All-CDI 71
4.5.3 Sex-Specific Diagnosed Incident Cases of All-CDI 73
4.5.4 Age-Standardized Diagnosed Incidence Rate of All-CDI 75
4.5.5 Recurrent CDI Cases 76
4.5.6 Diagnosed Incident Cases of All-CDI by Epidemiological Association 78
4.6 Discussion 80
4.6.1 Epidemiological Forecast Insight 80
4.6.2 Limitations of the Analysis 82
4.6.3 Strengths of the Analysis 82
5 Current Treatment Options 83
5.1 Overview 83
5.2 Product Profiles - Recommended Antibiotic Therapies 85
5.2.1 Metronidazole 85
5.2.2 Vancomycin 92
5.2.3 Dificid (fidaxomicin) 97
5.3 Other Antibiotic Therapies 106
5.3.1 Targocid (teicoplanin) 106
5.3.2 Tygacil (tigecycline) 106
5.3.3 Xifaxan (rifaximin) 107
5.4 Other Drug Interventions 108
5.4.1 Immunotherapy 108
5.5 Non-Drug Interventions 108
5.5.1 Fecal Microbiota Transplant 109
5.5.2 Probiotics 112
5.5.3 Surgical Procedures 113
6 Unmet Needs Assessment and Opportunity Analysis 116
6.1 Overview 116
6.2 Improved Treatment Options for Recurrent CDI 119
6.2.1 Unmet Need 119
6.2.2 Gap Analysis 120
6.2.3 Opportunity 123
6.3 Prophylactic Products to Prevent CDI 126
6.3.1 Unmet Need 126
6.3.2 Gap Analysis 127
6.3.3 Opportunity 128
6.4 Standardize, Streamline, and Confirm Long-Term Safety of FMT 129
6.4.1 Unmet Need 129
6.4.2 Gap Analysis 130
6.4.3 Opportunity 131
6.5 Products to Reduce Morbidity and Mortality in Patients with Severe-Complicated CDI 132
6.5.1 Unmet Need 132
6.5.2 Gap Analysis 133
6.5.3 Opportunity 134
6.6 Clinically Proven CDI Risk Criteria and Prediction Models 134
6.6.1 Unmet Need 134
6.6.2 Gap Analysis 135
6.6.3 Opportunity 136
6.7 Improve Surveillance and Prevent Transmission and Outbreaks 137
6.7.1 Unmet Need 137
6.7.2 Gap Analysis 138
6.7.3 Opportunity 139
7 Research and Development Strategies 140
7.1 Overview 140
7.2 Current Approaches to CDI Product Development 142
7.2.1 Antibiotics 142
7.2.2 Non-Antibiotic Adjunctive Therapeutics 143
7.2.3 Non-Antibiotic Prophylactic Agents 148
7.2.4 Vaccines 149
7.3 Clinical Trial Design 150
7.3.1 Therapeutic Agents 150
7.3.2 Prophylactic Agents 153
7.4 Special Considerations for Future Clinical Development 155
7.4.1 Patient Selection in Late-Stage Efficacy Studies for Prophylactic Products 155
7.4.2 Active Comparators and Superiority Trial Designs for New CDI-Specific Antibiotics 157
7.4.3 Rationally Designed Microbiologics Need to Show Superior Safety Profiles Compared to FMT 158

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