DelveInsight’s “Clostridioides Difficile Infection Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Clostridioides Difficile Infection, historical and forecasted epidemiology as well as the Clostridioides Difficile Infection therapeutics market trends in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Clostridioides Difficile Infection Market Report
- On 17 October 2025, Vedanta Biosciences Inc. announced a RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
- The total number of incident cases of Clostridioides Difficile Infection in the 7MM was around 6,11,000 in 2024.
- In the 7MM, the highest incident cases of Clostridioides Difficile Infection were in the US, accounting for nearly 3,80,000 cases in 2024. These cases are anticipated to increase in the upcoming years.
- In 2024, the Clostridioides Difficile Infection incidence cases by type in the US were identified to be HA-Clostridioides Difficile Infection at ~45% and CA-Clostridioides Difficile Infection at ~55% share.
- There are significant gaps in the epidemiological data of Clostridioides Difficile Infection in Japan, and Clostridioides Difficile Infection is frequently underdiagnosed in the country despite its clinical relevance.
- In the United States, the incident cases of Clostridioides Difficile Infection by gender were higher among females compared to males in 2024.
- In the 7MM in 2024, approximately 464,000 Clostridioides Difficile Infection cases were classified as mild to moderate, while around 147,000 cases were categorized as severe.
- In 2024, the incidence cases of Clostridioides Difficile Infection in the UK were estimated at approximately 1,000 in
- The leading Clostridioides Difficile Infection Companies such as Mikrobiomik, Vedanta Biosciences, Lumen Bioscience, Acurx Pharmaceuticals, Crestone, Destiny Pharma, Sebela Pharmaceuticals, Pfizer, and others.
- Promising Clostridioides Difficile Infection Therapies such as MBK-01, VE303, LMN-201, Ibezapolstat, CRS3123, NTCD-M3 (VP20621), PF-07831694, IDOR-1134-2831 and others.
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Clostridioides Difficile Infection Epidemiology Segmentation in the 7MM
- Total Incident Cases of Clostridioides Difficile Infection by Type (HA-CDI and CA-CDI) in the 7MM
- Gender-specific Incident Cases
- Severity-specific Incident Cases
- Age-specific Incident Cases
- Clostridioides Difficile Infection Treated, Recurrent, and Mortality Patient Pool in the 7MM
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Clostridioides Difficile Infection Marketed Drugs
- DIFICID/DIFICLIR/DAFCLIR (fidaxomicin): Merck & Co./Tillotts Pharma/Astellas Pharma
DIFICID, manufactured by Merck & Co and Astellas Pharma, is a macrolide antibiotic used to treat CDAD in adults and children 6 months of age or older. Clostridioides (formerly Clostridium) difficile-associated diarrhea is a bacterium that can cause an infection that can damage the colon and cause stomach pain and severe diarrhea. DIFICID (also known as OPT-80 and PAR-101) is a novel antibiotic agent and the first representative of a new class of antibacterials called macrocycles. It has a narrow-spectrum antibacterial profile mainly directed against CD and exerts moderate activity against some other gram-positive species. The drug product is poorly absorbed and exerts its activity in the GI tract, which is an advantage when used in the applied indication and treatment of Clostridioides Difficile Infection (also known as CDAD). DIFICID has received global approvals for treating Clostridioides Difficile Infection. The US FDA approved DIFICID tablets in 2011 and later expanded approval in 2020 to include pediatric use. In the EU, it was approved as DIFICLIR in 2011, with the first launch in the UK in 2012. In Japan, Astellas Pharma’s DAFCLIR was approved in 2018 for treating C. difficile-related infectious enteritis.
- VOWST: Seres Therapeutics/Nestlé Health Science
VOWST, formerly called SER-109, is an orally administered microbiota-based therapeutic to prevent the recurrence of Clostridioides Difficile Infection in adults following antibacterial treatment for rClostridioides Difficile Infection. VOWST is not indicated for the treatment of Clostridioides Difficile Infection. VOWST is the first orally administered microbiota-based therapeutic for the prevention of recurrent Clostridioides Difficile Infection.
Clostridioides Difficile Infection Emerging Drugs
The Clostridioides Difficile Infection pipeline possesses some drugs in mid- and late stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including MBK-01 (Mikrobiomik), VE303 (Vedanta Biosciences), LMN-201 (Lumen Bioscience) and others. The expected launch of these therapies shall further create a positive impact on the market.
- Ibezapolstat: Acurx Pharmaceuticals
Ibezapolstat is a novel, orally administered antibiotic, being developed as a GPSS antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat’s unique spectrum of activity, which includes CD but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.
- MBK-01: Mikrobiomik
MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides Difficile Infection. MBK-01 is the EU’s first biologic based on intestinal microbiota, Full-spectrum Purified Intestinal Microbiota (FSPIM), in the form of lyophilised capsules for oral administration. As per Mikrobiomik’s pipeline, the company anticipates CTD and MAA submission of MBK-01 in 2026, followed by market launch in 2027.
- VE303: Vedanta Biosciences
VE303 is a potential first-in-class live biotherapeutic product for the prevention of rClostridioides Difficile Infection. VE303 is an orally administered, defined bacterial consortium therapeutic candidate that consists of eight strains that were rationally selected using Vedanta’s product engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition.
Clostridioides Difficile Infection Companies
Mikrobiomik, Vedanta Biosciences, Lumen Bioscience, Acurx Pharmaceuticals, Crestone, Destiny Pharma, Sebela Pharmaceuticals, Pfizer, and others.
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Clostridioides Difficile Infection Market Outlook
In the current market, multiple treatment options are available for Clostridioides Difficile Infection, including traditional antibiotics such as vancomycin and fidaxomicin, the latter being a RNA polymerase inhibitor approved in 2011. While these antibiotics can effectively treat acute infections, they often fail to fully restore the gut microbiota, leading to high recurrence rates. Recently, the treatment paradigm has begun to shift with the emergence of microbiota-based therapies such as REBYOTA (Ferring) and VOWST (Seres Therapeutics/Nestlé Health Science), both approved for preventing recurrent Clostridioides Difficile Infection. REBYOTA, approved in 2022, is a rectally administered live biotherapeutic derived from human fecal microbiota, while VOWST, approved in 2023, is an orally delivered capsule containing purified bacterial spores. These novel approaches aim to re-establish a healthy gut microbiome rather than solely eliminate the pathogen, marking a significant step forward in Clostridioides Difficile Infection management. As of now, the treatment space is increasingly dominated by non-antibiotic therapies targeting recurrence, and the pipeline is rapidly evolving. Key players such as Seres Therapeutics, Ferring, Finch Therapeutics, and others are actively advancing next-generation microbiome-based interventions that have the potential to transform the future of Clostridioides Difficile Infection treatment and possibly provide curative outcomes.
Scope of the Clostridioides Difficile Infection Market Report
- Coverage- 7MM
- Forecast Period- 2025-2034
- Clostridioides Difficile Infection Companies- Mikrobiomik, Vedanta Biosciences, Lumen Bioscience, Acurx Pharmaceuticals, Crestone, Destiny Pharma, Sebela Pharmaceuticals, Pfizer, and others.
- Clostridioides Difficile Infection Therapies- MBK-01, VE303, LMN-201, Ibezapolstat, CRS3123, NTCD-M3 (VP20621), PF-07831694, IDOR-1134-2831 and others.
- Clostridioides Difficile Infection Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Clostridioides Difficile Infection Unmet Needs, KOL's views, Analyst's views, Clostridioides Difficile Infection Market Access and Reimbursement
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Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. Clostridioides Difficile Infection Market Overview at a Glance
7. Disease Background and Overview of Clostridioides Difficile Infection
8. Clostridioides Difficile Infection Epidemiology and Patient Population
9. Clostridioides Difficile Infection Patient Journey
10. Clostridioides Difficile Infection Marketed Therapies
11. Clostridioides Difficile Infection Emerging Drugs
12. Clostridioides Difficile Infection: 7MM Analysis
13. Clostridioides Difficile Infection Unmet Needs
14. SWOT Analysis
15. KOL Views
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
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