The Market Reports

Synopsis

The global market for Microbiome Therapeutics was estimated to be worth US$ 568 million in 2024 and is forecast to a readjusted size of US$ 3351 million by 2031 with a CAGR of 30.5% during the forecast period 2025-2031.

Microbiome Therapeutics refers to novel therapeutic approaches that utilize modulation of the human microbiome—especially gut microbiota—to treat or prevent diseases. These therapies include live biotherapeutic products (LBPs), fecal microbiota transplantation (FMT), engineered bacteria, and microbiota-derived metabolites aimed at rebalancing microbial ecosystems.

They are being developed for a wide range of conditions, including metabolic disorders, immune dysfunction, neurological diseases, inflammatory bowel disease (IBD), and as adjuncts to cancer immunotherapy. Compared to traditional pharmaceuticals, microbiome-based therapies offer high specificity, personalization, and long-term safety, making them the “fourth therapeutic modality” following small molecules, biologics, and cell/gene therapies.

As the global push for personalized medicine, chronic disease management, and immune-oncology adjunct therapies gains momentum, microbiome therapeutics is entering a critical commercialization window. Regulatory agencies such as the FDA and EMA are streamlining approval pathways for live biotherapeutic products (LBPs), while landmark approvals of Rebyota and Vowst mark a turning point. Strategic alliances between biotech startups and global pharma are accelerating late-stage clinical programs, supported by both capital and platform synergies.

Despite its transformative potential, the microbiome therapeutics sector faces multiple uncertainties. Manufacturing and regulatory frameworks remain inconsistent across countries, slowing clinical translation. Microbiota therapies face inherent variability and complexity, posing challenges in standardizing efficacy and trial design. Technical bottlenecks in sample sourcing, cold-chain logistics, and microbial viability maintenance elevate development costs. Additionally, market education and patient acceptance still require time, particularly in emerging regions like Asia, where applications are largely limited to early-stage R&D and clinical trials.

Demand is expanding beyond gastrointestinal conditions into systemic diseases such as IBD, recurrent Clostridioides difficile infection (CDI), cancer immunotherapy, Parkinson’s, and autism spectrum disorders. Partnerships between CROs and pharma are intensifying, while genomics, metabolomics, and AI are enabling high-throughput microbial strain screening.

The clinical sector is seeking more reproducible, orally deliverable LBPs and microbiome-derived metabolite products, which align with industrial scalability. With public and private insurers beginning to cover these new modalities, microbiome therapeutics is on the path to becoming a standard pillar of precision medicine.

This report aims to provide a comprehensive presentation of the global market for Microbiome Therapeutics, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of Microbiome Therapeutics by region & country, by Type, and by Application.

The Microbiome Therapeutics market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Microbiome Therapeutics.

Market Segmentation

By Company

• Seres Therapeutics
• Assembly Biosciences
• Synthetic Biologics
• Finch Therapeutics
• PureTech
• Synlogic
• Enterome BioScience
• 4D Pharma
• Second Genome
• Ferring
• C3 Jian
• Rebiotix
• MicroBiome Therapeutics LLC
• Metabiomics
• Ritter Pharmaceuticals
• Symberix
• OpenBiome
• Azitra
• Symbiotix Biotherapies
• Vedanta Biosciences
• Metabogen

Segment by Type

• Upper GIT
• Lower GIT

Segment by Application

• C. difficile Infection (CDI)
• Inflammatory Bowel Disease (IBD)
• Orphan Drug
• Immuno-oncology
• Others
• North America: United States, Canada, and Mexico
• Europe: United Kingdom, Germany, France, Spain, Italy, and Rest of Europe
• Asia Pacific: China, India, Japan, Australia, South Korea, and Rest of Asia Pacific
• Middle East & Africa: Saudi Arabia, South Africa, and Rest of MEA
• Latin America: Brazil, Argentina, and Rest of Latin America

*If you need a regional or country-specific version, or customized segmentation, we can tailor the report to your requirements.