United States Fecal Transplants Market, By Procedure (Fecal Bacteriotherapy, Fecal Transfusion, Fecal Enema, Human Probiotic Infusion, and Stool Transplant), By Disease (Autism, Parkinson's Disease (PD), Obesity, Diabetes Mellitus, Clostridium Difficile Infection, and Others), By Region, Competition, Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 543.72 Million
CAGR (2026-2031)	6.65%
Fastest Growing Segment	Fecal Bacteriotherapy
Largest Market	West
Market Size (2031)	USD 800.09 Million

Market Overview

The United States Fecal Transplants Market will grow from USD 543.72 Million in 2025 to USD 800.09 Million by 2031 at a 6.65% CAGR. Fecal microbiota transplantation involves transferring stool from a healthy donor into the gastrointestinal tract of a patient to restore gut microbiome balance. The United States market is primarily driven by the high prevalence of recurrent Clostridioides difficile infections and the recent introduction of microbiome therapeutics approved by the FDA like Rebyota and Vowst. These standardized products have improved treatment accessibility and consistency compared to traditional investigational methods which fosters broader clinical adoption across the healthcare sector.

Despite these advancements the market encounters a major challenge due to evolving regulatory requirements that have restricted the distribution of conventional stool preparations from public banks. This transition creates potential access gaps for patients ineligible for new commercial therapies. According to the Infectious Diseases Society of America, in 2025, 71.2% of deaths associated with Clostridioides difficile occurred in inpatient medical facilities. This statistic underscores the continued urgency for effective solutions within hospitals and the necessity of ensuring affordable access within acute care settings to sustain market momentum.

Key Market Drivers

The rising prevalence of recurrent Clostridioides difficile infections and the escalating threat of antibiotic resistance are the primary catalysts propelling market growth. Traditional antibiotic regimens frequently fail to eradicate resistant strains, creating a critical need for microbiome-based interventions that effectually restore gut ecology. This urgency is substantiated by the intensifying clinical burden of resistant pathogens; according to the Centers for Disease Control and Prevention, July 2024, in the 'Antimicrobial Resistance Threats in the United States' report, hospital-onset antimicrobial-resistant infections increased by a combined 20% compared to the pre-pandemic period. The market is responding with effective therapeutic solutions that directly address these failures. For instance, according to Ferring Pharmaceuticals, October 2024, in the 'Real-World Outcomes Data Analyses', 77.6% of patients treated with the biotherapeutic Rebyota remained recurrence-free at eight weeks, demonstrating the robust clinical utility that drives product adoption across acute care facilities.

Technological advancements in oral and non-invasive delivery systems represent the second major driver, fundamentally shifting the treatment paradigm from invasive colonoscopies to patient-friendly capsules. This evolution significantly expands the addressable patient population by streamlining administration logistics and reducing procedural costs associated with traditional delivery methods. The high commercial value placed on these oral innovations is evident in recent industrial consolidation activities. According to Seres Therapeutics, November 2024, in the 'Third Quarter 2024 Financial Results', the company completed the sale of its oral Vowst assets to Nestlé Health Science for approximately $175 million. This substantial investment underscores the industry's pivot toward non-invasive delivery mechanisms, which are expected to sustain long-term market expansion by ensuring broader affordability and compliance among diverse patient groups.

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Key Market Challenges

The restrictive regulatory environment governing the distribution of conventional stool preparations from public banks constitutes a significant impediment to the United States Fecal Transplants Market. This transition disrupts the established supply chain by eliminating the primary source of accessible biobanked materials that healthcare providers previously utilized for a broad range of patients. As the market shifts toward exclusive commercial therapeutics, the associated higher costs and complex reimbursement processes create administrative barriers that limit hospital formulary inclusion. This dynamic forces a contraction in the volume of procedures performed, as providers are unable to treat patients who are ineligible for or cannot afford the new commercial therapies, thereby stalling overall market momentum.

This reduction in accessible treatment options creates a critical bottleneck against the backdrop of sustained infection rates. According to the Gastrointestinal Society, in 2025, approximately 60% of patients who experienced an initial recurrence of Clostridioides difficile infection were found to suffer from subsequent recurrences. This statistic highlights a robust and cyclical clinical demand that is currently being suppressed by supply-side regulatory constraints. Consequently, the disparity between the urgent need for intervention and the restricted availability of therapeutic material directly hampers the market’s potential for revenue expansion and clinical penetration.

Key Market Trends

The expansion of clinical applications into immuno-oncology represents a significant evolution in the market, moving beyond the traditional focus on Clostridioides difficile infection. Developers are increasingly leveraging microbiome therapeutics to mitigate severe complications of cancer treatments, such as Graft-versus-Host Disease (GvHD) in stem cell transplant patients. This clinical widening addresses critical unmet needs in oncology by modulating the gut-immune axis to improve patient survival and treatment tolerability. According to Fierce Biotech, January 2025, in the 'MaaT's phase 3 GvHD trial hits goal' article, the microbiome therapeutic MaaT013 achieved a gastrointestinal overall response rate of 62% in patients with acute GvHD who were refractory to standard therapies, validating the efficacy of these interventions in complex oncological settings.

Concurrently, the industry is undergoing a structural shift toward defined bacterial consortia and synthetic biotherapeutics to overcome the scalability and safety limitations of donor-derived stool. Unlike first-generation products, these next-generation therapies utilize precisely selected strains to deliver consistent biological effects without the variability inherent in human donor material. This transition facilitates rigorous quality control and supports broader regulatory acceptance for indications requiring precise immune modulation. According to Seres Therapeutics, January 2025, in the 'Seres Therapeutics Announces New Translational Biomarker Results' report, the defined consortium SER-155 demonstrated a 77% relative risk reduction in bloodstream infections compared to placebo in a Phase 1b study, highlighting the potential of engineered consortia to prevent severe infectious outcomes.

Segmental Insights

Fecal bacteriotherapy currently represents the fastest growing segment within the United States fecal transplants market, driven primarily by the urgent need to treat recurrent Clostridioides difficile infections. This expansion is significantly accelerated by recent product approvals from the U.S. Food and Drug Administration, which have transitioned the field from experimental procedures to standardized and regulated medical treatments. These regulatory milestones provide healthcare providers with assurance regarding safety and efficacy, leading to increased clinical adoption. Additionally, the development of oral capsules and standardized formulations has simplified administration, effectively overcoming the logistical challenges associated with traditional invasive delivery methods.

Regional Insights

The West US currently stands as the leading region in the United States Fecal Transplants Market, driven by a high concentration of biotechnology hubs and advanced healthcare research facilities, particularly in California. This dominance is underpinned by the robust clinical trial activity and therapeutic innovation spearheaded by major institutions such as the University of California system and Stanford University. Furthermore, the region benefits from a progressive healthcare infrastructure that supports the early adoption of FDA-approved microbiota-based therapies. High patient awareness regarding gut health and significant private investment in local life sciences sectors further consolidate the West US as the primary driver of market expansion.

Recent Developments

• In October 2025, Ferring Pharmaceuticals announced it would explore strategic options for Rebyota, its fecal microbiota-based live biotherapeutic. The company stated that while the product had successfully treated thousands of patients with recurrent Clostridioides difficile infection, it had not achieved the commercial critical mass required within their portfolio. As a result, Ferring Pharmaceuticals decided to reduce its commercial efforts for the product in the United States, although it pledged to maintain patient access during the transition. The company emphasized that it would redirect its focus toward developing second-generation, non-donor-based oral microbiome therapies.
• In December 2024, OpenBiome confirmed that it would continue distributing investigational fecal microbiota transplantation material to partners across the United States through the end of the year. The non-profit stool bank had previously warned of a potential suspension of services due to evolving regulatory enforcement policies but managed to secure a temporary extension. This announcement provided a crucial reprieve for healthcare facilities treating patients with fulminant or resistant Clostridioides difficile infection who relied on the organization's supply. OpenBiome simultaneously worked on submitting an investigational new drug application to ensure long-term regulatory compliance and continued patient access.
• In October 2024, Vedanta Biosciences presented additional data from its Phase 2 CONSORTIUM study of VE303 at IDWeek 2024. The clinical-stage company highlighted that its defined bacterial consortium candidate, designed to prevent recurrent Clostridioides difficile infection, demonstrated an association between strain colonization and a reduction in antibiotic resistance genes within the patient microbiome. The analysis suggested that the therapeutic could potentially lower the reservoir of resistance genes in the gut, offering benefits beyond preventing infection recurrence. The company also confirmed that enrollment was ongoing for its pivotal Phase 3 RESTORATiVE303 global registrational trial.
• In September 2024, Seres Therapeutics completed the sale of its VOWST business to Nestlé Health Science. This transaction transferred the rights to the first Food and Drug Administration-approved orally administered microbiome therapeutic to the global health science company. Upon closing the deal, Seres Therapeutics received significant capital, including an upfront payment, which was utilized to retire existing debt and extend its cash runway. The agreement allowed Seres Therapeutics to streamline its operations and focus on the development of its investigational cultivated live biotherapeutics, while Nestlé Health Science assumed full commercial responsibility for the product in the United States market.

Key Market Players

• OpenBiome
• MaatPharma
• FinchTherapeutics
• Rebiotix
• SeresTherapeutics
• VedantaBioscience
• MicrobiomeTherapeutics
• Crestovo

By Procedure	By Disease	By Region
Fecal Bacteriotherapy Fecal Transfusion Fecal Enema Human Probiotic Infusion Stool Transplant	Autism Parkinson's Disease (PD) Obesity Diabetes Mellitus Clostridium Difficile Infection Others	Northeast Midwest South West

Report Scope:

In this report, the United States Fecal Transplants Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Fecal Transplants Market, By Procedure:

• Fecal Bacteriotherapy
• Fecal Transfusion
• Fecal Enema
• Human Probiotic Infusion
• Stool Transplant

• United States Fecal Transplants Market, By Disease:

• Autism
• Parkinson's Disease (PD)
• Obesity
• Diabetes Mellitus
• Clostridium Difficile Infection
• Others

• United States Fecal Transplants Market, By Region:

• Northeast
• Midwest
• South
• West