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