Opportunity Analysis Clostridium difficile Infections and Forecasts to 2026

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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. 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.


During the 10-year forecast period, there are nine products that are on track to launch, contributing to significant growth within the market. The launch of the first prophylactic options for the prevention of CDIs, beginning with Sanofi Pasteurs vaccine ACAM-CDIFF in 2019, will fulfill a major unmet need, and will have a significant effect on the overall size of the CDI market. The expected launch of the first microbiologic therapies, leveraging the efficacy associated with FMT with respect to CDI recurrence rates, will also have an effect on the overall treatment landscape during the forecast period. In 2026, antibiotics are expected to have remained the highest grossing product class in the CDI market, with novel vaccines also contributing a significant market share.


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.


Table of Contents

1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Executive Summary 10
2.1 Significant Growth Is Projected for the CDI Market from 2016 to 2026 10
2.2 Manufacturers Aiming to Provide Physicians Non-Antibiotic Therapies for Treatment and Prevention of CDI 12
2.3 There Remains Significant Unmet Need for CDI Treatment, in Particular to Reduce CDI Recurrence Rates 13
2.4 Opportunities Exist for Products Proven to be Cost-Effective Versus SOC Antibiotics 14
2.5 An Active Pipeline Poised to Partially Satisfy Unmet Needs for CDI 14
2.6 What do Physicians Think? 16
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 18
3.3 Upcoming Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.1.1 Etiology 20
4.1.2 Pathophysiology 24
4.2 Symptoms 26
4.3 Disease Management 27
4.3.1 Diagnosis 28
4.3.2 Treatment Guidelines 32
4.3.3 Clinical Practice 34
4.3.4 Prevention and Control 37
4.4 Prognosis and Quality of Life 39
5 Epidemiology 41
5.1 Disease Background 41
5.2 Risk Factors and Comorbidities 42
5.3 Global and Historical Trends 44
5.3.1 7MM: Diagnosed Incidence 45
5.3.2 7MM: Diagnosed Incident Cases by Recurrence 46
5.3.3 7MM: Diagnosed Incident Cases by Severity 47
5.4 Forecast Methodology 47
5.4.1 Sources 48
5.4.2 Forecast Assumptions and Methods 51
5.5 Epidemiological Forecast for CDI (2016-2026) 57
5.5.1 Diagnosed Incident Cases of CDI 57
5.5.2 Age-Specific Diagnosed Incident Cases of CDI 58
5.5.3 Sex-Specific Diagnosed Incident Cases of CDI 58
5.5.4 CDI Cases by Recurrence 59
5.5.5 CDI Cases by Severity 61
5.6 Discussion 63
5.6.1 Epidemiological Forecast Insight 63
5.6.2 Limitations of Analysis 65
5.6.3 Strengths of Analysis 65
6 Current Treatment Options 67
6.1 Overview 67
6.2 Product Profiles - Recommended Antibiotic Therapies 68
6.2.1 Metronidazole (numerous brand names) 68
6.2.2 Vancomycin (numerous brand names) 73
6.2.3 Dificid (fidaxomicin) 78
6.3 Product Profiles - Antibodies 85
6.3.1 Zinplava (bezlotoxumab) 85
6.4 Other Antibiotic Therapies 90
6.4.1 Targocid (teicoplanin) 90
6.4.2 Tygacil (tigecycline) 91
6.4.3 Xifaxan (rifaximin) 92
6.5 Non-drug Interventions 92
6.5.1 OpenBiome FMT (stool-bank service) 93
6.5.2 Probiotics 94
6.5.3 Surgical Procedures 95





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