Clostridioides difficile Infection – Market Insights, Epidemiology, and Market Forecast – 2034
Description
Key Highlight
The total market size of CDI in the 7MM was ~USD 500 million in 2024. This is expected to increase by 2034.
Over the past decade, healthcare-associated CDI incidence and mortality have declined, attributed to enhanced infection prevention, reduced use of high-risk antibiotics (notably fluoroquinolones), and targeted stewardship initiatives. The prevalence of the hypervirulent ribotype 027 strain has also declined, though it remains a significant cause of healthcare-associated CDI.
CDI management requires a comprehensive, multifaceted approach. Key priorities include treating the acute episode, identifying and mitigating risk factors, and minimizing recurrence. Effective antimicrobial options include metronidazole, oral vancomycin (in various dosing regimens), and fidaxomicin.
Vancomycin and fidaxomicin are the foundational treatments for CDI, offering the most reliable efficacy across patient populations. Metronidazole may be considered in limited cases, specifically in younger patients with mild-to-moderate disease and low risk for recurrence.
Live biotherapeutic products such as REBYOTA and VOWST are well-positioned to bridge the gap between innovative microbiome science and clinical application. By targeting the restoration of eubiosis, these FDA-approved therapies offer a novel, mechanism-based approach supported by regulatory assurance.
In the prevention space, REBYOTA distinguishes itself as the only single-dose therapy currently available, while VOWST offers competitive convenience with its oral route of administration.
The total market size of the CDI treatment market is anticipated to experience growth during the forecast period due to promising emerging treatments and prevention options that include Ibezapolstat, CRS3123, LMN-201, MBK-01, VE303, and others.
In February 2025, Mikrobiomik announced it has 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.
DelveInsight’s “Clostridioides difficile Infection – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Clostridioides difficile Infection (CDI), historical and forecasted epidemiology as well as the CDI market trends in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Clostridioides difficile Infection market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Clostridioides difficile Infection market size from 2020 to 2034. The report also covers current Clostridioides difficile Infection treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Geography Covered
The United States
EU4 (Germany, France, Italy, and Spain), and the United Kingdom
Japan
Study Period: 2020–2034
CDI Disease Understanding and Treatment Algorithm
Clostridioides difficile Infection (CDI) Overview
Clostridioides difficile, formerly Clostridium difficile, is a gram-positive and spore-forming bacterium. This obligate anaerobic bacillus is recognized for its ability to produce toxins and is the leading cause of antibiotic-associated diarrhea worldwide. C difficile infections can range from an asymptomatic carrier to diarrhea, progressing to severe conditions such as pseudomembranous colitis and toxic megacolon with septic shock, often resulting in a high mortality rate.
Clostridioides difficile Infection (CDI) Diagnosis
CDI diagnosis is primarily clinical but should be supported by laboratory tests and, when necessary, imaging and endoscopic findings. A prompt diagnosis is crucial both for correct patient management and implementation of infection control measures, especially in healthcare settings.
Stool Examination
Imaging
Endoscopy
Histologic Features
Biomarkers
Clostridioides difficile Infection (CDI) Treatment
CDI treatment should begin only in symptomatic patients, as detecting C. difficile toxin without symptoms does not warrant therapy. Metronidazole and oral vancomycin have been standard treatments since the 1980s. While early studies showed similar efficacy, newer evidence indicates higher failure rates for metronidazole in severe cases. Oral vancomycin is generally well-tolerated, though rare systemic absorption can occur. Metronidazole may cause gastrointestinal side effects, alcohol-related reactions, and peripheral neuropathy with prolonged use. Approved therapies for the management of CDI, includes DIFICID, VOWST, REBYOTA, and others.
Further details related to diagnosis and treatment are provided in the report…
CDI Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total incident cases of CDI, type-specific incident cases of CDI, gender-specific incident cases of CDI, severity-specific incident cases of CDI, age-specific incident cases of CDI, and CDI recurrence pool and mortality pool in the 7MM market covering the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The epidemiology segment also provides the CDI epidemiology data and findings across the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The total incident population of CDI in the 7MM comprised nearly 610,800 cases in 2024 and is projected to increase during the forecast period.
The total incident cases of CDI in the US was nearly 380,000 in 2024.
The US contributed the largest prevalent population of CDI, accounting for ~62% of the 7MM in 2024.
In EU4 and the UK, the incident cases of CDI was found to be maximum in Germany, followed by France. While the least number of cases were found in Spain in 2024.
In 2024, the incident cases of mild to moderate CDI in the US were identified to be ~76%, and severe as ~24%.
In Japan, nearly 67% of CDI cases accounted for age group 65 years and above and ~33% cases were below 65 years in 2024.
CDI was predominantly a HA-CDI, especially affecting older adults and those with recent antibiotic exposure or hospitalization. However, there is a growing recognition of CA-CDI, which now constitutes a significant portion of cases. Community cases often involve younger, previously healthy individuals, although severe outcomes remain more common in older or immunocompromised patients.
CDI Drug Chapters
The drug chapter segment of the CDI report encloses the detailed analysis of CDI mid and late-stage pipeline drugs. It also helps understand the CDI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug, and the latest news and press releases.
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 CDI (also known as CDAD).
DIFICID has received global approvals for treating CDI. 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 CDI in adults following antibacterial treatment for rCDI. VOWST is not indicated for the treatment of CDI. VOWST is the first orally administered microbiota-based therapeutic for the prevention of recurrent CDI.
In January 2025, Seres Therapeutics announced the receipt of a USD 50 million installment payment related to the Company’s previously announced sale of its VOWST business to Société des Produits Nestlé S.A (SPN, and with certain of its affiliates, collectively, Nestlé Health Science). This installment payment was expected as Seres is fulfilling its transition obligations
Emerging Drugs
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.
In June 2025, Acurx Pharmaceuticals announced the publication of results in Lancet Microbe of its Phase IIb clinical study entitled: “Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with CDI: A Phase IIb, randomized, double-blind, active-controlled, multicenter study.
In January 2025, Acurx Pharmaceuticals announced that they received positive regulatory guidance from the EMA for the Ibezapolstat Phase III clinical trial program. The EMA guidance also confirmed Ibezapolstat’s regulatory pathway for a Marketing Authorization Application (MAA) to be filed by the company after successful completion of the Phase III clinical trials.
MBK-01: Mikrobiomik
MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for CDI. 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.
In February 2025, Mikrobiomik announced it has 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.
In January 2025, Mikrobiomik announced it has received the best innovation in the healthcare sector and the highest distinction of the competition, Innovation of Innovations at Quality Innovation Awards 2024.
As per Mikrobiomik’s pipeline, the company anticipates CTD and MAA submission of MBK-01 in 2026, followed by market launch in 2027.
Note: Detailed therapy assessment will be provided in the final report.
Drug Class Insights
CDI has traditionally been treated with antibiotics like fidaxomicin, a RNA polymerase inhibitor approved in 2011, which effectively kills the bacteria but often leads to high recurrence rates due to continued disruption of the gut microbiome. In recent years, the treatment landscape has shifted with the introduction of microbiota-based therapeutics such as VOWST (Seres Therapeutics/Nestlé Health Science) and REBYOTA (Ferring), both approved for preventing recurrent CDI. These live biotherapeutic products aim to restore the natural gut flora after antibiotic treatment—REBYOTA via rectal delivery of standardized fecal microbiota, and VOWST as an oral capsule containing purified bacterial spores. Their popularity has grown as they offer a novel, targeted approach to reducing CDI recurrence by addressing the root cause—gut dysbiosis—marking a significant evolution in CDI management.
CDI Market Outlook
In the current market, multiple treatment options are available for Clostridioides difficile infection (CDI), 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 CDI. 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 CDI 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 CDI treatment and possibly provide curative outcomes.
Key Findings
This section includes a glimpse of the CDI in the 7MM
The total market size of CDI in the 7MM is nearly USD ~ 494 million in 2024 and is projected to grow during the forecast period (2025–2034).
According to DelveInsight’s estimates, the largest market size of CDI is captured by the US in 2024.
In EU4 and the UK, Germany has the maximum market share, followed by France in 2024 while Spain had the lowest market share.
The market size of CDI in Japan was USD ~9 million in 2024, which is expected to rise during the forecast period (2025–2034).
The upcoming therapies for CDI are expected to combat the current unmet needs faced by patients with CDI.
CDI Drugs Uptake
This section focuses on the anticipated uptake of emerging therapies for Clostridioides difficile infection (CDI) expected to enter the market during the 2020–2034 study period. The analysis covers drug adoption trends, patient uptake across therapeutic approaches, and projected sales performance. One of the most notable developments in this space is the advancement of microbiota-based therapies, such as VOWST (Seres Therapeutics/Nestlé Health Science), an oral live biotherapeutic, and REBYOTA (Ferring), a rectally administered microbiota suspension.
These therapies represent a significant shift from traditional antibiotics, as they aim to restore gut microbial balance rather than simply eliminate C. difficile. Their unique mechanisms of action, which involve re-establishing a healthy microbiome environment, have shown improved outcomes in preventing recurrence, especially in patients at high risk for repeated infections. Among these, VOWST has garnered strong clinical interest due to its oral route of administration, enabling greater patient convenience and adherence. These next-generation therapies are expected to capture increasing market share over time, particularly as awareness grows around the limitations of conventional antibiotics and the need for sustained, microbiome-targeted treatment strategies in CDI management.
CDI Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for CDI emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies and treatment patterns or CDI market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
“Recurrence remains a significant clinical challenge in the management of CDI, with many patients experiencing multiple episodes. This pattern of relapse complicates treatment decisions and contributes to increased morbidity and overall healthcare burden.”
– Harvard Medical School, Boston, USA
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial’s primary and secondary outcome measures are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
Market Access and Reimbursement
Antibiotics are typically prescribed for short durations, often just two weeks, and face reimbursement challenges. Government and private insurers generally use bundled payments for antibiotic treatments, covering the entire course rather than itemizing costs for the drug, administration, and other services. Hospitals receive a fixed amount, so if they manage treatment at a lower cost, they can keep the savings, improving margins. However, this system has led to poor returns for antibiotic developers, resulting in numerous company failures, bankruptcies, and low-value acquisitions in the sector.
To be continue in the final report…
Scope of the Report
The report covers the descriptive overview of CDI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
Comprehensive insight has been provided into the CDI epidemiology and treatment.
Additionally, an all-inclusive account of both the current and emerging therapies for CDI is provided, along with the assessment of new therapies that will have an impact on the current treatment landscape.
A detailed review of the CDI market, historical and forecasted, is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM CDI market.
Report Highlights
In the coming years, the CDI market is set to change due to emerging therapies in the pipeline and incremental healthcare spending across the world, which would expand the size of the market to enable drug manufacturers to penetrate more into the market.
The companies and academics are working to assess challenges and seek opportunities that could influence CDI R&D. The therapies under development are focused on novel approaches to treat or improve the disease condition.
The report also encompasses other major segments, i.e., type-specific, gender-specific, age-specific, severity-specific cases of CDI, and recurrent pool and mortality pool of CDI.
Expected launch of potential therapies, Ibezapolstat, CRS3123, LMN-201, MBK-01, VE303, and others might change the landscape in the treatment of CDI.
CDI Report Insights
Patient Population
Therapeutic Approaches
CDI Pipeline Analysis
CDI Market Size and Trends
Market Opportunities
Impact of Upcoming Therapies
CDI Report Key Strengths
10 Year Forecast
7MM Coverage
CDI Epidemiology Segmentation
Key Cross Competition
Highly Analyzed Market
Drugs Uptake
CDI Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
SWOT and Conjoint Analysis
Key Questions
FAQs
What was the CDI market share (%) distribution in 2020, and what it would look like in 2034?
What would be the CDI total market size as well as market size by therapies across the 7MM during the study period (2020–2034)?
What are the key findings pertaining to the market across the 7MM, and which country will have the largest CDI market size during the study period (2020–2034)?
At what CAGR, the CDI market is expected to grow at the 7MM level during the study period (2020–2034)?
What would be the CDI market outlook across the 7MM during the study period (2020–2034)?
What would be the CDI market growth till 2034, and what will be the resultant market size in 2034?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
What are the disease risk, burden, and unmet needs of CDI?
What is the historical CDI patient pool in the US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan?
What would be the forecasted patient pool of CDI at the 7MM level?
What will be the growth opportunities across the 7MM with respect to the patient population pertaining to CDI?
Out of the above-mentioned countries, which country would have the highest prevalent population of CDI during the study period (2020–2034)?
At what CAGR is the population expected to grow across the 7MM during the study period (2020–2034)?
Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the CDI market.
To understand the future market competition in the CDI market and an insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for CDI in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for the CDI market.
To understand the future market competition in the CDI market.
The total market size of CDI in the 7MM was ~USD 500 million in 2024. This is expected to increase by 2034.
Over the past decade, healthcare-associated CDI incidence and mortality have declined, attributed to enhanced infection prevention, reduced use of high-risk antibiotics (notably fluoroquinolones), and targeted stewardship initiatives. The prevalence of the hypervirulent ribotype 027 strain has also declined, though it remains a significant cause of healthcare-associated CDI.
CDI management requires a comprehensive, multifaceted approach. Key priorities include treating the acute episode, identifying and mitigating risk factors, and minimizing recurrence. Effective antimicrobial options include metronidazole, oral vancomycin (in various dosing regimens), and fidaxomicin.
Vancomycin and fidaxomicin are the foundational treatments for CDI, offering the most reliable efficacy across patient populations. Metronidazole may be considered in limited cases, specifically in younger patients with mild-to-moderate disease and low risk for recurrence.
Live biotherapeutic products such as REBYOTA and VOWST are well-positioned to bridge the gap between innovative microbiome science and clinical application. By targeting the restoration of eubiosis, these FDA-approved therapies offer a novel, mechanism-based approach supported by regulatory assurance.
In the prevention space, REBYOTA distinguishes itself as the only single-dose therapy currently available, while VOWST offers competitive convenience with its oral route of administration.
The total market size of the CDI treatment market is anticipated to experience growth during the forecast period due to promising emerging treatments and prevention options that include Ibezapolstat, CRS3123, LMN-201, MBK-01, VE303, and others.
In February 2025, Mikrobiomik announced it has 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.
DelveInsight’s “Clostridioides difficile Infection – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Clostridioides difficile Infection (CDI), historical and forecasted epidemiology as well as the CDI market trends in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Clostridioides difficile Infection market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Clostridioides difficile Infection market size from 2020 to 2034. The report also covers current Clostridioides difficile Infection treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Geography Covered
The United States
EU4 (Germany, France, Italy, and Spain), and the United Kingdom
Japan
Study Period: 2020–2034
CDI Disease Understanding and Treatment Algorithm
Clostridioides difficile Infection (CDI) Overview
Clostridioides difficile, formerly Clostridium difficile, is a gram-positive and spore-forming bacterium. This obligate anaerobic bacillus is recognized for its ability to produce toxins and is the leading cause of antibiotic-associated diarrhea worldwide. C difficile infections can range from an asymptomatic carrier to diarrhea, progressing to severe conditions such as pseudomembranous colitis and toxic megacolon with septic shock, often resulting in a high mortality rate.
Clostridioides difficile Infection (CDI) Diagnosis
CDI diagnosis is primarily clinical but should be supported by laboratory tests and, when necessary, imaging and endoscopic findings. A prompt diagnosis is crucial both for correct patient management and implementation of infection control measures, especially in healthcare settings.
Stool Examination
Imaging
Endoscopy
Histologic Features
Biomarkers
Clostridioides difficile Infection (CDI) Treatment
CDI treatment should begin only in symptomatic patients, as detecting C. difficile toxin without symptoms does not warrant therapy. Metronidazole and oral vancomycin have been standard treatments since the 1980s. While early studies showed similar efficacy, newer evidence indicates higher failure rates for metronidazole in severe cases. Oral vancomycin is generally well-tolerated, though rare systemic absorption can occur. Metronidazole may cause gastrointestinal side effects, alcohol-related reactions, and peripheral neuropathy with prolonged use. Approved therapies for the management of CDI, includes DIFICID, VOWST, REBYOTA, and others.
Further details related to diagnosis and treatment are provided in the report…
CDI Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total incident cases of CDI, type-specific incident cases of CDI, gender-specific incident cases of CDI, severity-specific incident cases of CDI, age-specific incident cases of CDI, and CDI recurrence pool and mortality pool in the 7MM market covering the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The epidemiology segment also provides the CDI epidemiology data and findings across the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The total incident population of CDI in the 7MM comprised nearly 610,800 cases in 2024 and is projected to increase during the forecast period.
The total incident cases of CDI in the US was nearly 380,000 in 2024.
The US contributed the largest prevalent population of CDI, accounting for ~62% of the 7MM in 2024.
In EU4 and the UK, the incident cases of CDI was found to be maximum in Germany, followed by France. While the least number of cases were found in Spain in 2024.
In 2024, the incident cases of mild to moderate CDI in the US were identified to be ~76%, and severe as ~24%.
In Japan, nearly 67% of CDI cases accounted for age group 65 years and above and ~33% cases were below 65 years in 2024.
CDI was predominantly a HA-CDI, especially affecting older adults and those with recent antibiotic exposure or hospitalization. However, there is a growing recognition of CA-CDI, which now constitutes a significant portion of cases. Community cases often involve younger, previously healthy individuals, although severe outcomes remain more common in older or immunocompromised patients.
CDI Drug Chapters
The drug chapter segment of the CDI report encloses the detailed analysis of CDI mid and late-stage pipeline drugs. It also helps understand the CDI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug, and the latest news and press releases.
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 CDI (also known as CDAD).
DIFICID has received global approvals for treating CDI. 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 CDI in adults following antibacterial treatment for rCDI. VOWST is not indicated for the treatment of CDI. VOWST is the first orally administered microbiota-based therapeutic for the prevention of recurrent CDI.
In January 2025, Seres Therapeutics announced the receipt of a USD 50 million installment payment related to the Company’s previously announced sale of its VOWST business to Société des Produits Nestlé S.A (SPN, and with certain of its affiliates, collectively, Nestlé Health Science). This installment payment was expected as Seres is fulfilling its transition obligations
Emerging Drugs
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.
In June 2025, Acurx Pharmaceuticals announced the publication of results in Lancet Microbe of its Phase IIb clinical study entitled: “Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with CDI: A Phase IIb, randomized, double-blind, active-controlled, multicenter study.
In January 2025, Acurx Pharmaceuticals announced that they received positive regulatory guidance from the EMA for the Ibezapolstat Phase III clinical trial program. The EMA guidance also confirmed Ibezapolstat’s regulatory pathway for a Marketing Authorization Application (MAA) to be filed by the company after successful completion of the Phase III clinical trials.
MBK-01: Mikrobiomik
MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for CDI. 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.
In February 2025, Mikrobiomik announced it has 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.
In January 2025, Mikrobiomik announced it has received the best innovation in the healthcare sector and the highest distinction of the competition, Innovation of Innovations at Quality Innovation Awards 2024.
As per Mikrobiomik’s pipeline, the company anticipates CTD and MAA submission of MBK-01 in 2026, followed by market launch in 2027.
Note: Detailed therapy assessment will be provided in the final report.
Drug Class Insights
CDI has traditionally been treated with antibiotics like fidaxomicin, a RNA polymerase inhibitor approved in 2011, which effectively kills the bacteria but often leads to high recurrence rates due to continued disruption of the gut microbiome. In recent years, the treatment landscape has shifted with the introduction of microbiota-based therapeutics such as VOWST (Seres Therapeutics/Nestlé Health Science) and REBYOTA (Ferring), both approved for preventing recurrent CDI. These live biotherapeutic products aim to restore the natural gut flora after antibiotic treatment—REBYOTA via rectal delivery of standardized fecal microbiota, and VOWST as an oral capsule containing purified bacterial spores. Their popularity has grown as they offer a novel, targeted approach to reducing CDI recurrence by addressing the root cause—gut dysbiosis—marking a significant evolution in CDI management.
CDI Market Outlook
In the current market, multiple treatment options are available for Clostridioides difficile infection (CDI), 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 CDI. 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 CDI 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 CDI treatment and possibly provide curative outcomes.
Key Findings
This section includes a glimpse of the CDI in the 7MM
The total market size of CDI in the 7MM is nearly USD ~ 494 million in 2024 and is projected to grow during the forecast period (2025–2034).
According to DelveInsight’s estimates, the largest market size of CDI is captured by the US in 2024.
In EU4 and the UK, Germany has the maximum market share, followed by France in 2024 while Spain had the lowest market share.
The market size of CDI in Japan was USD ~9 million in 2024, which is expected to rise during the forecast period (2025–2034).
The upcoming therapies for CDI are expected to combat the current unmet needs faced by patients with CDI.
CDI Drugs Uptake
This section focuses on the anticipated uptake of emerging therapies for Clostridioides difficile infection (CDI) expected to enter the market during the 2020–2034 study period. The analysis covers drug adoption trends, patient uptake across therapeutic approaches, and projected sales performance. One of the most notable developments in this space is the advancement of microbiota-based therapies, such as VOWST (Seres Therapeutics/Nestlé Health Science), an oral live biotherapeutic, and REBYOTA (Ferring), a rectally administered microbiota suspension.
These therapies represent a significant shift from traditional antibiotics, as they aim to restore gut microbial balance rather than simply eliminate C. difficile. Their unique mechanisms of action, which involve re-establishing a healthy microbiome environment, have shown improved outcomes in preventing recurrence, especially in patients at high risk for repeated infections. Among these, VOWST has garnered strong clinical interest due to its oral route of administration, enabling greater patient convenience and adherence. These next-generation therapies are expected to capture increasing market share over time, particularly as awareness grows around the limitations of conventional antibiotics and the need for sustained, microbiome-targeted treatment strategies in CDI management.
CDI Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for CDI emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies and treatment patterns or CDI market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
“Recurrence remains a significant clinical challenge in the management of CDI, with many patients experiencing multiple episodes. This pattern of relapse complicates treatment decisions and contributes to increased morbidity and overall healthcare burden.”
– Harvard Medical School, Boston, USA
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial’s primary and secondary outcome measures are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
Market Access and Reimbursement
Antibiotics are typically prescribed for short durations, often just two weeks, and face reimbursement challenges. Government and private insurers generally use bundled payments for antibiotic treatments, covering the entire course rather than itemizing costs for the drug, administration, and other services. Hospitals receive a fixed amount, so if they manage treatment at a lower cost, they can keep the savings, improving margins. However, this system has led to poor returns for antibiotic developers, resulting in numerous company failures, bankruptcies, and low-value acquisitions in the sector.
To be continue in the final report…
Scope of the Report
The report covers the descriptive overview of CDI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
Comprehensive insight has been provided into the CDI epidemiology and treatment.
Additionally, an all-inclusive account of both the current and emerging therapies for CDI is provided, along with the assessment of new therapies that will have an impact on the current treatment landscape.
A detailed review of the CDI market, historical and forecasted, is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM CDI market.
Report Highlights
In the coming years, the CDI market is set to change due to emerging therapies in the pipeline and incremental healthcare spending across the world, which would expand the size of the market to enable drug manufacturers to penetrate more into the market.
The companies and academics are working to assess challenges and seek opportunities that could influence CDI R&D. The therapies under development are focused on novel approaches to treat or improve the disease condition.
The report also encompasses other major segments, i.e., type-specific, gender-specific, age-specific, severity-specific cases of CDI, and recurrent pool and mortality pool of CDI.
Expected launch of potential therapies, Ibezapolstat, CRS3123, LMN-201, MBK-01, VE303, and others might change the landscape in the treatment of CDI.
CDI Report Insights
Patient Population
Therapeutic Approaches
CDI Pipeline Analysis
CDI Market Size and Trends
Market Opportunities
Impact of Upcoming Therapies
CDI Report Key Strengths
10 Year Forecast
7MM Coverage
CDI Epidemiology Segmentation
Key Cross Competition
Highly Analyzed Market
Drugs Uptake
CDI Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
SWOT and Conjoint Analysis
Key Questions
FAQs
What was the CDI market share (%) distribution in 2020, and what it would look like in 2034?
What would be the CDI total market size as well as market size by therapies across the 7MM during the study period (2020–2034)?
What are the key findings pertaining to the market across the 7MM, and which country will have the largest CDI market size during the study period (2020–2034)?
At what CAGR, the CDI market is expected to grow at the 7MM level during the study period (2020–2034)?
What would be the CDI market outlook across the 7MM during the study period (2020–2034)?
What would be the CDI market growth till 2034, and what will be the resultant market size in 2034?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
What are the disease risk, burden, and unmet needs of CDI?
What is the historical CDI patient pool in the US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan?
What would be the forecasted patient pool of CDI at the 7MM level?
What will be the growth opportunities across the 7MM with respect to the patient population pertaining to CDI?
Out of the above-mentioned countries, which country would have the highest prevalent population of CDI during the study period (2020–2034)?
At what CAGR is the population expected to grow across the 7MM during the study period (2020–2034)?
Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the CDI market.
To understand the future market competition in the CDI market and an insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for CDI in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for the CDI market.
To understand the future market competition in the CDI market.
Table of Contents
192 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. Executive Summary
- 4. Key Events
- 4.1. Upcoming Key Catalysts
- 4.2. Key Transactions and Collaborations
- 4.3. News Flow
- 5. Epidemiology and Market Forecast Methodology
- 6. CDI Market Overview at a Glance
- 6.1. Marketed and emerging analysis
- 6.2. Market Share (%) Distribution of CDI by Class in 2020
- 6.3. Market Share (%) Distribution of CDI by Class in 2034
- 7. Disease Background and Overview of Clostridium Difficile Infection (CDI)
- 7.1. Introduction to CDI
- 7.2. Symptoms Associated With CDI
- 7.3. Causes
- 7.4. Risk Factors
- 7.5. Pathophysiology of CDI
- 7.5.1. Pathogenic factors
- 7.6. Clinical Manifestations
- 7.7. Infection Prevention and Control
- 7.8. Diagnosis
- 7.8.1. Diagnostic algorithm
- 7.9. Treatment
- 7.9.1. Treatment algorithm
- 7.1. Diagnosis and Treatment Guidelines
- 7.10.1. Infectious Diseases Society of America (IDSA)/Society for Healthcare Epidemiology of America (SHEA)
- 7.10.2. American College of Gastroenterology (ACG)
- 7.10.3. VASF CDI Treatment Guidelines (2023)
- 7.10.4. SHC Clinical Pathway: Guidelines for the Treatment of Clostridioides difficile Infection
- 7.10.5. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for C. difficile (ESGCD)
- 7.10.6. Scottish Antimicrobial Prescribing Group (2025)
- 7.10.7. Japanese Guidelines for the Management of CDI
- 8. 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 Pool and Mortality Pool in the US
- 8.6. EU4 and the UK
- 8.6.1. Incident Cases of CDI in EU4 and the UK by Type (HA-CDI and CA-CDI)
- 8.6.2. Gender-specific Incident Cases of CDI in EU4 and the UK
- 8.6.3. Severity-specific Incident Cases of CDI in EU4 and the UK
- 8.6.4. Age-specific Incident Cases of CDI in EU4 and the UK
- 8.6.5. CDI Treated Pool and Mortality Pool in EU4 and the UK
- 8.7. Japan
- 8.7.1. Incident Cases of CDI in Japan by Type (HA-CDI and CA-CDI)
- 8.7.2. Gender-specific Incident Cases of CDI in Japan
- 8.7.3. Severity-specific Incident Cases of CDI in Japan
- 8.7.4. Age-specific Incident Cases of CDI in Japan
- 8.7.5. CDI Treated Pool and Mortality Pool in Japan
- 9. Patient Journey
- 10. Marketed 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 pivotal trial
- 10.2.5. Analyst Views
- 10.3. VOWST: Seres Therapeutics/Nestlé Health Science
- 10.3.1. Product Description
- 10.3.2. Regulatory Milestones
- 10.3.3. Other Developmental Activities
- 10.3.4. Summary of pivotal trial
- 10.3.5. Analyst views
- 10.4. REBYOTA: Ferring Pharmaceuticals
- 10.4.1. Product Description
- 10.4.2. Regulatory Milestones
- 10.4.3. Other Developmental Activities
- 10.4.4. Summary of Pivotal Trials
- 10.4.5. Analyst Views
- 11. Emerging 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
- 11.3.1. Product Description
- 11.3.2. Other Development Activities
- 11.3.3. Clinical Development
- 11.3.3.1. Clinical Trial Information
- 11.3.4. Safety and Efficacy
- 11.3.5. Analyst Views
- 11.4. LMN-201: Lumen Bioscience
- 11.4.1. Product Description
- 11.4.2. Other Development Activities
- 11.4.3. Clinical Development
- 11.4.3.1. Clinical Trial Information
- 11.4.4. Safety and Efficacy
- 11.4.5. Analyst Views
- 11.5. Ibezapolstat: Acurx Pharmaceuticals
- 11.5.1. Product Description
- 11.5.2. Other Development Activities
- 11.5.3. Clinical Development
- 11.5.3.1. Clinical Trial Information
- 11.5.4. Safety and Efficacy
- 11.5.5. Analyst Views
- 11.6. CRS3123: Crestone
- 11.6.1. Product Description
- 11.6.2. Other Development Activities
- 11.6.3. Clinical Development
- 11.6.3.1. Clinical Trial Information
- 11.6.4. Safety and Efficacy
- 11.6.5. Analyst Views
- 11.7. NTCD-M3 (VP20621): Destiny Pharma/Sebela Pharmaceuticals
- 11.7.1. Product Description
- 11.7.2. Other Development Activities
- 11.7.3. Clinical Development
- 11.7.3.1. Clinical Trial Information
- 11.7.4. Safety and Efficacy
- 11.7.5. Analyst Views
- 11.8. PF-07831694: Pfizer
- 11.8.1. Product Description
- 11.8.2. Other Development Activities
- 11.8.3. Clinical Development
- 11.8.3.1. Clinical Trial Information
- 11.8.4. Analyst Views
- 12. CDI: 7MM Analysis
- 12.1. Key Findings
- 12.2. Market Outlook
- 12.3. Key Market Forecast Assumptions
- 12.3.1. Cost Assumptions
- 12.3.2. Pricing Trends
- 12.3.3. Analogue Assessment
- 12.3.4. Launch Year and Therapy Uptakes
- 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 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 Market Size
- 12.8.1. Total Market Size of CDI in EU4 and the UK
- 12.8.2. Market Size of CDI by Therapies in EU4 and the UK
- 12.9. Japan
- 12.9.1. Total Market Size of CDI in Japan
- 12.9.2. Market Size of CDI by Therapies in Japan
- 13. Unmet Needs
- 14. SWOT Analysis
- 15. KOL Views
- 16. Market Access and Reimbursement
- 16.1. The United States
- 16.1.1. Centre for Medicare and Medicaid Services (CMS)
- 16.2. EU4 and the UK
- 16.2.1. Germany
- 16.2.2. France
- 16.2.3. Italy
- 16.2.4. Spain
- 16.2.5. The United Kingdom
- 16.3. Japan
- 16.3.1. MHLW
- 16.4. Market Access and Reimbursement of CDI Therapies
- 17. Appendix
- 17.1. Bibliography
- 17.2. Report Methodology
- 18. DelveInsight Capabilities
- 19. Disclaimer
- 20. About DelveInsight
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