The Clostridium difficile infection market is anticipated to surge owing to the launch of emerging therapies. The potential emerging treatment expected to launch in the forecast period includes both preventive and therapeutic agents. Some of them are PF-06425090 (Pfizer's vaccine), CP101 (Finch Therapeutics), VE303 (Vedanta Biosciences), NTCD-M3 (Destiny Pharma), and others
LAS VEGAS, Dec. 14, 2022 /PRNewswire/ -- DelveInsight's Clostridium difficile Infection Market Insights report includes a comprehensive understanding of current treatment practices, Clostridium difficile infection emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), Japan].
Key Takeaways from the Clostridium difficile Infection Market Report
- As per DelveInsight analysis, the Clostridium difficile infection market size in the 7MM was approximately USD 413 million in 2021.
- According to the estimates based on DelveInsight analysis, the total Clostridium difficile infection incident cases in the 7MM were approximately 668K in 2021.
- Leading Clostridium difficile infection companies such as Pfizer, Valneva, GlaxoSmithKline, Summit Therapeutics, MGB Biopharma, Acurx Pharmaceuticals, Da Volterra, Synthetic Biologics, Deinove, Oragenics, XBiotech, Crestone, MicroPharm Ltd., SAb Biotherapeutics, Seres Therapeutics, Nestlé Health Science, Finch Therapeutics, Destiny Pharma, Vedanta Biosciences, Mikrobiomik Healthcare, Lumen Bioscience, Adiso Therapeutics, Recursion Pharmaceuticals, and others are developing novel Clostridium difficile infection drugs that can be available in the Clostridium difficile infection market in the upcoming years.
- The Clostridium difficile infection preventive and therapeutic agents in the pipeline include PF-06425090, VLA84, GSK2904545A, Ridinilazole, MGB-BP-3, Ibezapolstat, DAV132, SYN-004 (ribaxamase), DNV3837, OG716, Research programme: C. difficile Monoclonal Antibody, CRS3123, OraCAb, SAB-195, SER-109, CP101, NTCD-M3, VE303, MBK-01, LMN-201, ADS024, and others.
- The increase in Clostridium difficile infection market size is a direct consequence of a robust pipeline and increasing incidence of Clostridium difficile infection in the 7MM.
- In November 2022, Ferring Pharmaceuticals announced that the FDA had approved REBYOTA® (fecal microbiota, live-jslm), a novel first-in-class microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
- In November 2022, Ferring Pharmaceuticals announced the publication of its pivotal Phase III PUNCHTM CD3 clinical trial data in the journal Drugs, in which a single dose of RBX2660 outperformed placebo in a Bayesian analysis model to reduce the recurrence of Clostridioides difficile infection (CDI) after standard-of-care antibiotic treatment.
- In October 2022, Summit Therapeutics shared the results from its Ri-CoDIFy Phase III clinical trial through an oral abstract presentation at IDWeek 2022; however, the statement provided no update on its plans for ridinilazole.
- In September 2022, the VRBPAC of the US FDA reviewed the data supporting the BLA for RBX2660 and issued a positive vote for REBYOTA (RBX2660). The US FDA has granted FTD, BTD, and ODD to REBYOTA (RBX2660) for treating recurrent Clostridium difficile infection.
- In March 2022, Pfizer announced results from its pivotal Phase III CLOVER trial, evaluating the vaccine candidate, PF-06425090, to prevent Clostridium difficile infection.
Discover which therapies are expected to grab the major Clostridium difficile infection market share @Clostridium difficile Infection Market Report
Clostridium difficile Infection Overview
Clostridium difficile infection is a widespread nosocomial and community-acquired infection that causes diarrhea and colitis. It is caused by gram-positive, anaerobic, spore-forming C. difficile bacteria and accounts for approximately 500,000 infections in the United States annually. Antibiotic exposure, a weakened immune system, and other illnesses disrupt the microbiota, creating an environment favorable for C. difficile spore germination and vegetative cell outgrowth, resulting in overgrowth that would otherwise not be possible in healthy gut microbiota.
The clinical Clostridium difficile infection symptoms are diverse, ranging from mild diarrhea to fulminant colitis, and are accompanied by complications such as toxic megacolon, bowel perforation, sepsis, and death. The detection of toxigenic C. difficile in the stool and colonic histopathology is the gold standard for CDI. Glutamate dehydrogenase (GDH), Toxin enzyme immunoassay (EIA), and Toxin B polymerase chain reaction (PCR) are the most commonly used stool tests.
Clostridium difficile Infection Epidemiology Segmentation
DelveInsight estimates that there were approximately 668K incident cases of Clostridium difficile infection in the 7MM in 2021.
Among the 7MM countries, the US had the highest number of C. difficile infection incident cases in 2021.
The Clostridium difficile infection market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- Total Incident Cases
- Gender-specific Incident Cases
- Type-specific Incident Cases
- Age-specific Incident Cases
- Severity-specific Incident Cases
Download the report to understand which factors are driving Clostridium difficile infection epidemiology trends @Clostridium difficile Infection Epidemiological Insights
Clostridium difficile Infection Treatment Market
The current treatment regimen for Clostridium difficile infection is restrictive and difficult due to the high recurrence rates, with most broad-spectrum antibiotics such as clindamycin, cephalosporins, quinolones, and penicillins increasing the risk of Clostridium difficile infection because they deplete gut microbiota, creating an environment conducive to C. difficile multiplication. On the other hand, Tetracyclines and aminoglycosides are still effective against Clostridium difficile infection.
Most Clostridium difficile infection treatment guidelines recommend vancomycin, fidaxomicin, and metronidazole as the antibiotics of choice for various lines of therapy. However, because metronidazole's pharmacokinetics for intestinal infections are inconsistent, vancomycin or fidaxomicin are preferred options for all clinically significant cases of Clostridium difficile infection.
The current recommended duration of antimicrobial therapy for primary Clostridium difficile infection is 10-14 days, but there is a significant therapeutic conundrum because recovery requires restoration of gut microbiota diversity; however, prolonged antibiotic use disrupts intestinal flora. As a result, probiotic therapy following standard antibiotics may be used to avoid recurrence and restore microbiota, or low-dose antibiotics may be given intermittently to reduce the likelihood of recurrence. The US FDA approved bezlotoxumab, an antitoxin antibody, to prevent recurrent Clostridium difficile infection in adults at high risk of recurrence.
Although antibiotic resistance rates have increased in the last decade, the efficacy of currently recommended Clostridium difficile infection treatments has decreased. The emerging Clostridium difficile infection treatment landscape is robust, with multiple trials for novel targeted antibiotics, vaccines, and regimens to restore intestinal microbiota and provide the much-needed palliative cure currently underway.
To know more about Clostridium difficile infection treatment options, visit @Clostridium difficile Infection Treatment & Management
Clostridium difficile Infection Emerging Vaccines and Key Companies
- PF-06425090: Pfizer
- VLA84: Valneva
- GSK2904545A: GlaxoSmithKline
Emerging Agents for Acute Treatment of Clostridium difficile Infection and Key Companies
- Ridinilazole: Summit Therapeutics
- MGB-BP-3: MGB Biopharma
- Ibezapolstat: Acurx Pharmaceuticals
- DAV132: Da Volterra
- SYN-004 (ribaxamase): Synthetic Biologics
- DNV3837: Deinove
- OG716: Oragenics
- Research programme: C. difficile Monoclonal Antibody: XBiotech
Emerging Agents for Acute Treatment of Clostridium difficile Infection and Prevention/Reduction of Recurrence and Key Companies
- CRS3123: Crestone
- OraCAb: MicroPharm Ltd.
- SAB-195: SAb Biotherapeutics
Emerging Agents for Prevention/Reduction of Recurrence of Clostridium difficile Infection and Key Companies
- SER-109: Seres Therapeutics/Nestlé Health Science
- CP101: Finch Therapeutics
- NTCD-M3: Destiny Pharma
- VE303: Vedanta Biosciences
- MBK-01: Mikrobiomik Healthcare
- LMN-201: Lumen Bioscience
- ADS024: Adiso Therapeutics
Learn more about the drugs used to treat Clostridium difficile infection @Drugs for Clostridium difficile Infection Treatment
Clostridium difficile Infection Market Dynamics
The dynamics of the Clostridium difficile infection market are anticipated to change in the coming years. With C. difficile becoming the most common microbial cause of healthcare-associated infections in hospitals, there is an increased demand for Clostridium difficile infection treatment. As a result of the high prevalence of Clostridium difficile infection, pharmaceutical companies working in the Clostridium difficile infection market have a tremendous opportunity to develop vaccines to prevent initial Clostridium difficile infection.
Given the increasing resistance rates to antibiotic therapy as the primary treatment, there is an opportunity to develop nonantibiotic therapeutics to treat or prevent Clostridium difficile infection. Furthermore, the emerging Clostridium difficile infection pipeline includes several novel mid and late-stage therapies that will overcome the limitations of current therapies, positively impacting the Clostridium difficile infection market.
However, certain factors are limiting the growth of the Clostridium difficile infection market. A large cohort is required for vaccine clinical trials, which could significantly delay the clinical development process and eventual release of the Clostridium difficile infection vaccine, which is currently being developed. Moreover, antibiotic therapy is the current standard of care (SoC) for recurrent Clostridium difficile infection, which leads to high recurrence rates because antibiotics do not address the underlying microbiome disruption that causes recurrence.
Furthermore, drug side effects are a source of concern for both patients and clinicians, and they are frequently the reason for the discontinuation of a new drug's development or result in poor patient compliance. Treatment practices vary between centers, and there is significant heterogeneity among country-specific epidemiology studies. Thus, all these factors collectively will hamper the growth of the Clostridium difficile infection market in the coming years.
Report Metrics |
Details |
Study Period |
2019–2032 |
Coverage |
7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] |
Base Year |
2021 |
Clostridium difficile Infection Market CAGR |
12.5 % |
Clostridium difficile Infection Market Size in 2021 |
USD 413 Million |
Key Clostridium difficile Infection Companies |
Pfizer, Valneva, GlaxoSmithKline, Summit Therapeutics, MGB Biopharma, Acurx Pharmaceuticals, Da Volterra, Synthetic Biologics, Deinove, Oragenics, XBiotech, Crestone, MicroPharm Ltd., SAb Biotherapeutics, Ferring Pharmaceuticals, Seres Therapeutics, Nestlé Health Science, Finch Therapeutics, Destiny Pharma, Vedanta Biosciences, Mikrobiomik Healthcare, Lumen Bioscience, Adiso Therapeutics, Recursion Pharmaceuticals, and others |
Key Clostridium difficile Infection Preventive and Therapeutic Agents in Pipeline |
PF-06425090, VLA84, GSK2904545A, Ridinilazole, MGB-BP-3, Ibezapolstat, DAV132, SYN-004 (ribaxamase), DNV3837, OG716, Research programme: C. difficile Monoclonal Antibody, CRS3123, OraCAb, SAB-195, SER-109, CP101, NTCD-M3, VE303, MBK-01, LMN-201, ADS024, and others |
Scope of the Clostridium difficile Infection Market Report
- Therapeutic Assessment: Clostridium difficile Infection current marketed and emerging therapies
- Clostridium difficile Infection Market Dynamics: Clostridium difficile Infection market drivers and barriers
- Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Clostridium difficile Infection Market Access and Reimbursement
Discover more about Clostridium difficile infection antibiotics in development @Clostridium difficile Infection Clinical Trials
Table of Contents
1. |
Clostridium difficile Infection Market Key Insights |
2. |
Clostridium difficile Infection Market Report Introduction |
3. |
Clostridium difficile Infection Market Overview at a Glance |
4. |
Clostridium difficile Infection Market Executive Summary |
5. |
Disease Background and Overview |
6. |
Clostridium difficile Infection Treatment and Management |
7. |
Clostridium difficile Infection Epidemiology and Patient Population |
8. |
Patient Journey |
9. |
Clostridium difficile Infection Marketed Drugs |
10. |
Clostridium difficile Infection Emerging Drugs |
11. |
Seven Major Clostridium difficile Infection Market Analysis |
12. |
Clostridium difficile Infection Market Outlook |
13. |
Potential of Current and Emerging Therapies |
14. |
KOL Views |
15. |
Clostridium difficile Infection Market Drivers |
16. |
Clostridium difficile Infection Market Barriers |
17. |
Unmet Needs |
18. |
SWOT Analysis |
19. |
Appendix |
20. |
DelveInsight Capabilities |
21. |
Disclaimer |
22. |
About DelveInsight |
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