The Clostridioides difficile infection market is predicted to boost mainly owing to an increased aging population, increased focus on R&D on antimicrobial resistance solutions, ongoing public health initiatives, and approval/adoption of next-generation therapies that address both recurrence and antimicrobial resistance. Additionally, CDI prophylactic vaccines are expected to contribute to the market growth for CDI over the forecast period (2025-2034).
LAS VEGAS, Sept. 2, 2025 /PRNewswire/ -- DelveInsight's Clostridioides difficile Infection Market Insights report includes a comprehensive understanding of current treatment practices, Clostridioides difficile infection emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Clostridioides difficile Infection Market Summary
- According to DelveInsight's analysis, the market size for Clostridioides difficile infection was found to be around USD 500 million in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] in 2024. The current Clostridioides difficile infection market is dominated by DIFICID (fidaxomicin), the first antibacterial antibiotic to be approved in the US in over 25 years (May 27, 2011).
- The burden of Clostridioides difficile Infection is highest in the US, followed by EU4 and the UK, with the US representing the largest patient pool for Clostridioides difficile Infection. Incidence trends and disease patterns vary between countries due to differences in diagnostic practices, healthcare infrastructure, and surveillance systems. The total number of incident cases of Clostridioides difficile Infection in the 7MM was around 610,800 in 2024.
- Healthcare-associated Clostridioides difficile Infection (HA-CDI) cases have declined in regions such as the US, EU4, and Japan, driven by stronger infection control measures, reduced antibiotic misuse, and improved diagnostic practices. These efforts have also reduced the prevalence of the hypervirulent ribotype 027 strain. In contrast, the UK has seen a rise in Clostridioides difficile Infection cases, likely linked to increased overall antimicrobial use in recent years.
- Merck's ZINPLAVA was discontinued in January 2025, despite its clinical value, particularly when used in combination with antibiotic regimens. Merck has not cited any specific reason for ZINPLAVA's withdrawal.
- Leading Clostridioides difficile infection companies developing emerging therapies, such as Mikrobiomik, Vedanta Biosciences, Lumen Bioscience, Acurx Pharmaceuticals, Crestone, Destiny Pharma, Immuron, Sebela Pharmaceuticals, Pfizer, Idorsia, and others, are developing new Clostridioides difficile Infection treatment drugs that can be available in the Clostridioides Difficile infection market in the coming years.
- The promising Clostridioides Difficile infection therapies in clinical trials include MBK-01, VE303, LMN-201, Ibezapolstat, CRS3123, NTCD-M3 (VP20621), PF-07831694, IDOR-1134-2831 and others.
- In the EU, fecal microbiota transplantation (FMT) has not been approved. Mikrobiomik' MBK-01 is expected to become Europe's "first intestinal microbiota-based biologic". It is the only emerging single-dose therapeutic agent for the treatment of primary and recurrent CDI.
- The limited availability of parenteral Clostridioides difficile Infection therapies presents a clear opportunity for innovation. Many patients are unable to receive oral treatment due to clinical constraints; however, current non-oral options remain limited to intravenous metronidazole or localized vancomycin delivery, highlighting a critical gap in accessible, effective alternatives.
- With their investigational vaccines, companies such as Pfizer (PF-07831694) and Idorsia (IDOR-1134-2831) are planning to tap the prevention of Clostridioides difficile Infection market.
Discover the CDI new treatment @ New Treatments for CDI
Key Factors Driving the Growth of the Clostridioides difficile Infection (CDI) Market
Aging CDI population and at-risk groups
Advanced age, frequent hospital exposure, comorbidities, and immunosuppression are major risk factors for CDI. Global population aging and increased hospital/long-term care use concentrate vulnerable patients, thereby enlarging the addressable CDI market. According to DelveInsight analysis, in 2024, the incidence of CDI in the US was estimated at approximately 184,000 cases in individuals aged 65 years and older.
Need for next-generation CDI therapies and vaccines
With vancomycin's efficacy declining due to the rise of antimicrobial resistance, there is a clear need for next-generation treatments. While current therapies reduce recurrence, a significant opportunity exists to expand preventive strategies, including CDI vaccines, which hold considerable clinical and economic promise despite the limited number of candidates currently in development.
Ibezapolstat: A dual advantage in CDI treatment
Ibezapolstat demonstrates a dual benefit of clinical efficacy comparable to that of standard-of-care antibiotics, while preserving and positively modulating the gut microbiome - an increasingly significant advantage as microbiome restoration therapies, such as fecal microbiota transplantation and live biotherapeutics, gain traction in managing recurrent CDI by addressing underlying dysbiosis.
Expanding CDI pipeline
The CDI pipeline includes several drugs in mid- to late-stage development that are anticipated to gain approval soon. The evolving landscape features a broad spectrum of therapeutic options, such as MBK-01 (Mikrobiomik), VE303 (Vedanta Biosciences), and LMN-201 (Lumen Bioscience), among others. The anticipated launch of these therapies is likely to drive further positive momentum in the market.
Clostridioides difficile Infection Market Analysis
Clostridioides difficile infection continues to pose a major public health burden globally, particularly within healthcare environments. Although diagnostic and treatment approaches have progressed, the CDI market still faces substantial therapeutic challenges, most notably the high recurrence rate, which impacts 25-45% of patients depending on disease severity and recurrence history. Over the past decade, treatment options have evolved; once dominated by metronidazole and vancomycin, the standard of care has shifted toward fidaxomicin (approved in 2011) due to its targeted, narrow-spectrum activity.
Key therapies currently shaping the CDI treatment space include DIFICID, VOWST, and REBYOTA. In a notable development, Merck withdrew ZINPLAVA from the market in January 2025, signaling a shift in the treatment landscape. ZINPLAVA, approved by the FDA in October 2016, was introduced as a monoclonal antibody targeting toxin B, designed to prevent recurrent Clostridium difficile infection (rCDI) in high-risk adults. DIFICID (fidaxomicin), initially approved in 2011 for adults with CDI, extended its label in 2020 to include children as young as 6 months, solidifying its role as a frontline treatment.
Fecal microbiota transplantation (FMT), previously limited to investigational use, has since become a regulated therapeutic approach. While off-label use in the US began around 2008 to prevent recurrent CDI, challenges such as variability in spore composition due to donor differences remain. Nevertheless, leading guidelines in the US and Europe recommend FMT after the second recurrence. Recently, two FDA-approved FMT-based treatments, VOWST (by Seres Therapeutics and Nestlé) and REBYOTA (by Ferring Pharmaceuticals), have emerged as approved preventive therapies for rCDI.
REBYOTA, the first FDA-approved FMT product (approved in 2022), is rectally administered and, despite its less convenient route, is widely used in institutions for its affordability, single-dose format, and first-mover advantage. In contrast, VOWST is an oral, microbiota-based live biotherapeutic product (LBP) that has gained substantial market traction due to its convenient administration and proven efficacy.
To know more about FDA-approved drugs for CDI, visit @ Approved CDI Treatment
Clostridioides difficile Infection Competitive Landscape
The CDI pipeline possesses some drugs in mid- and late-stage development to be approved in the near future. The CDI drugs landscape holds a diverse range of therapeutic alternatives for treatment, including MBK-01 (Mikrobiomik), VE303 (Vedanta Biosciences), LMN-201 (Lumen Bioscience), Ibezapolstat (Acurx Pharmaceuticals), and others.
MBK-01 is an investigational therapy derived from faecal microbiota transplantation, offering a promising alternative to current treatments for Clostridioides difficile infection. It is the first microbiota-based biologic approved in the EU, developed as Full-spectrum Purified Intestinal Microbiota (FSPIM) and formulated into lyophilized oral capsules.
In February 2025, Mikrobiomik announced a key milestone with the European Medicines Agency (EMA) approving its Paediatric Investigation Plan (PIP) for MBK-01, targeting CDI treatment in children. Earlier, In January 2025, the company received top recognition at the Quality Innovation Awards 2024, winning both the "Best Innovation in the Healthcare Sector" and the overall "Innovation of Innovations" award.
According to Mikrobiomik's development timeline, submission of the Clinical Trial Dossier (CTD) and Marketing Authorisation Application (MAA) for MBK-01 is planned for 2026, with a commercial launch expected in 2027.
VE303, developed by Vedanta Biosciences, is a potential first-in-class live biotherapeutic for the prevention of recurrent CDI. It is an orally delivered, defined bacterial consortium composed of eight precisely selected strains. Unlike donor-derived products, VE303 is produced from pure clonal bacterial cell banks, resulting in a consistent powdered formulation that eliminates variability associated with donor fecal material.
The ongoing Phase III RESTORATiVE303 trial is assessing VE303's safety and efficacy in rCDI patients and is intended to support a future Biologics License Application (BLA) submission to the US FDA. VE303 was granted Orphan Drug Designation (ODD) in 2017 and Fast Track Designation (FTD) in 2023 by the FDA for the prevention of rCDI.
Ibezapolstat, a novel oral antibiotic under development by Acurx Pharmaceuticals, belongs to a new class of DNA polymerase IIIC inhibitors. It targets C. difficile specifically, while preserving beneficial gut bacteria, such as other Firmicutes and Actinobacteria, to help maintain microbiome balance.
In June 2025, Acurx published results from its Phase IIb clinical trial in Lancet Microbe, highlighting the efficacy, safety, pharmacokinetics, and microbiome outcomes of ibezapolstat versus vancomycin in adults with CDI.
Additionally, in January 2025, Acurx received favorable regulatory feedback from the EMA for its Phase III clinical program for ibezapolstat. The agency also confirmed the regulatory path toward a future MAA submission upon successful trial completion.
The anticipated launch of these emerging therapies are poised to transform the Clostridioides difficile infection market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Clostridioides difficile infection market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about Clostridioides difficile infection drugs in development @ Clostridioides difficile Infection Clinical Trials
Recent Developments in the Clostridioides difficile Infection Market
- In June 2025, a significant advancement in the development of Idorsia's first bacterial vaccine for Clostridioides difficile Infection, which is based on the company's synthetic glycan chemistry platform, was reported. Initial data showed that their C. dfficile vaccine is well-tolerated and showed immunogenicity in a Phase I study.
- In April 2025, Lumen Bioscience announced the achievement of a 100% clinical cure rate for CDI in the sentinel cohort (Part A) of its REPREVE clinical trial, with LMN-201.
- In February 2025, Mikrobiomik announced it had reached a new milestone upon receiving the approval of the Paediatric Investigation Plan (PIP) from the EMA for the treatment of CDI in paediatric patients.
- InJanuary 2025, Merck officially discontinued ZINPLAVA injection, used to prevent the rCDI.
- In January 2025, Vedanta Biosciences announced the publication of additional results from the Phase II CONSORTIUM study for its lead candidate, VE303, which is being evaluated for the prevention of rCDI.
Clostridioides difficile Infection Overview
Clostridioides difficile infection is a severe gastrointestinal disease caused by toxin-producing C. difficile bacteria, commonly associated with the use of antibiotics and healthcare environments. It manifests as either healthcare-associated (HA-CDI) or community-associated (CA-CDI) infections and can range in severity from mild diarrhea to severe, potentially fatal colitis. CDI poses a major public health challenge due to its high recurrence rate and the significant strain it places on healthcare systems.
Diagnostic approaches have evolved. The widespread adoption of Nucleic Acid Amplification Tests (NAATs) initially led to a rise in reported cases. However, to curb overdiagnosis, there is now a greater focus on diagnostic stewardship, with a renewed emphasis on confirming positive NAAT results using toxin Enzyme Immunoassay (EIA).
Clostridioides difficile Infection Epidemiology Segmentation
The Clostridioides difficile infection epidemiology section provides insights into the historical and current Clostridioides difficile infection patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Clostridioides difficile infection market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
- Total Incident Cases of CDI by Type (HA-CDI and CA-CDI)
- Gender-specific Incident Cases of CDI
- Severity-specific Incident Cases of CDI
- Age-specific Incident Cases of CDI
- CDI Treated, Recurrent (mortality-adjusted)
Clostridioides difficile Infection Market Report Metrics | Details |
Study Period | 2020-2034 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Clostridioides difficile Infection Market CAGR in the 7MM | 13.5 % |
Clostridioides difficile Infection Market Size in the 7MM (2024) | USD 500 million |
Key Clostridioides difficile Infection Companies | Mikrobiomik, Vedanta Biosciences, Lumen Bioscience, Acurx Pharmaceuticals, Crestone, Destiny Pharma, Sebela Pharmaceuticals, Pfizer, Merck & Co., Tillotts Pharma, Astellas Pharma, Seres Therapeutics, Nestlé Health Science, Idorsia, Ferring Pharmaceuticals, Exeliom Biosciences, AstraZeneca, NuBiyota, Micropharm and others |
Key Clostridioides difficile Infection Therapies | MBK-01, VE303, LMN-201, Ibezapolstat, CRS3123, NTCD-M3 (VP20621), PF-07831694, DIFICID/DIFICLIR/DAFCLIR, VOWST, REBYOTA, IDOR-1134-283, and others |
Scope of the Clostridioides difficile Infection Market Report
- Therapeutic Assessment: Clostridioides difficile Infection current marketed and emerging therapies
- Clostridioides difficile Infection Market Dynamics: Key Market Forecast Assumptions of Emerging Clostridioides difficile Infection Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Clostridioides difficile Infection Market Access and Reimbursement
Download the report to understand which factors are driving Clostridioides difficile infection market trends @ Clostridioides difficile Infection Market Forecast
Table of Contents
1 | Clostridioides difficile Infection Market Key Insights |
2 | Clostridioides difficile Infection Market Report Introduction |
3 | Executive Summary |
4 | Key Events |
5 | Clostridioides difficile Infection Epidemiology and Market Forecast Methodology |
6 | CDI Market Overview at a Glance |
6.1 | Clinical Landscape Analysis (By Phase, RoA, and Molecule Type) |
6.2 | Market Share (%) Distribution of CDI by Class in 2024 |
6.3 | Market Share (%) Distribution of CDI by Class in 2034 |
7 | Disease Background and Overview of CDI |
7.1 | Introduction to CDI |
7.2 | Symptoms Associated With CDI |
7.3 | Clostridioides difficile Infection Causes |
7.4 | Clostridioides difficile Infection Risk Factors |
7.5 | Pathophysiology of CDI |
7.6 | Clinical Manifestations |
7.7 | Infection Prevention and Control |
7.8 | Clostridioides difficile Infection Diagnosis |
7.9 | Clostridioides difficile Infection Treatment |
7.10 | Diagnosis and Treatment Guidelines |
8 | Clostridioides difficile Infection Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: The 7MM |
8.3 | Total Population at Risk of Developing CDI in the 7MM |
8.4 | Total Incident Cases of CDI in the 7MM |
8.5 | The United States |
8.5.1 | Incident Cases of CDI in the US by Type (HA-CDI and CA-CDI) |
8.5.2 | Gender-specific Incident Cases of CDI in the US |
8.5.3 | Severity-specific Incident Cases of CDI in the US |
8.5.4 | Age-specific Incident Cases of CDI in the US |
8.5.5 | CDI Treated, Recurrent, and Mortality Patient Pool in the US |
8.6 | EU4 and the UK |
8.7 | Japan |
9 | Patient Journey of CDI |
10 | Marketed Clostridioides difficile Infection Therapies |
10.1 | Key Cross of Marketed Therapies |
10.2 | DIFICID/DIFICLIR/DAFCLIR (fidaxomicin): Merck & Co./Tillotts Pharma/Astellas Pharma |
10.2.1 | Product Description |
10.2.2 | Regulatory Milestones |
10.2.3 | Other Developmental Activities |
10.2.4 | Summary of Pivotaltrial |
10.2.5 | Analyst Views |
10.3 | VOWST: Seres Therapeutics/Nestlé Health Science |
10.4 | REBYOTA: Ferring Pharmaceuticals |
11 | Emerging Clostridioides difficile Infection Drugs |
11.1 | Key Cross Competition |
11.2 | MBK-01: Mikrobiomik |
11.2.1 | Product Description |
11.2.2 | Other Development Activities |
11.2.3 | Clinical Development |
11.2.3.1 | Clinical Trial Information |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst Views |
11.3 | VE303: Vedanta Biosciences |
11.4 | LMN-201: Lumen Bioscience |
11.5 | Ibezapolstat: Acurx Pharmaceuticals |
11.6 | CRS3123: Crestone |
11.7 | NTCD-M3 (VP20621): Destiny Pharma/Sebela Pharmaceuticals |
11.8 | PF-07831694: Pfizer |
12 | CDI Market: 7MM Analysis |
12.1 | Key Findings |
12.2 | Clostridioides difficile Infection Market Outlook |
12.3 | Key Clostridioides difficile Infection Market Forecast Assumptions |
12.4 | Conjoint Analysis |
12.5 | Total Market Size of CDI in the 7MM |
12.6 | Market Size of CDI by Therapies in 7MM |
12.7 | United States Clostridioides difficile Infection Market Size |
12.7.1 | Total Market Size of CDI in the US |
12.7.2 | Market Size of CDI by Therapies in the US |
12.8 | EU4 and UK Clostridioides difficile Infection Market Size |
12.9 | Japan Clostridioides difficile Infection Market Size |
13 | Clostridioides difficile Infection Market Unmet Needs |
14 | Clostridioides difficile Infection Market SWOT Analysis |
15 | KOL Views on Clostridioides difficile Infection |
16 | Clostridioides difficile Infection Market Access and Reimbursement |
16.1 | The United States |
16.2 | EU4 and the UK |
16.3 | Japan |
16.4 | Market Access and Reimbursement of CDI Therapies |
17 | Bibliography |
18 | Clostridioides difficile Infection Market Report Methodology |
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