DELRAY BEACH, Fla., Aug. 20, 2025 /PRNewswire/ -- The global Human Microbiome Market, valued at US$0.91 billion in 2024, stood at US$1.40 billion in 2025 and is projected to advance at a resilient CAGR of 31.0% from 2025 to 2031, culminating in a forecasted valuation of US$7.09 billion by the end of the period. The primary drivers behind the expansion of this industry are the technological advancement in microbiome sequencing, the collaborative efforts between the microbiome industry, organizations, and academia for microbiome research, and the increase in the number of startups and SMEs exploring the microbiome niche, and further opportunities such as the increase in demand for personalized medicine and the emergence of synbiotics may help drive the human microbiome market.

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By type, bacterial consortia transplantation (BCT)/ fecal microbiota transplantation (FMT), live bacteria products, and others segment the human microbiome market. Live bacteria products accounted for the largest share of the human microbiome market in 2024. This category includes probiotics and synbiotics, which are widely used in consumer health supplements and emerging therapeutic applications. The dominance of live bacteria products is driven by strong consumer demand for digestive and immune health solutions, along with increasing clinical validation of specific bacterial strains. These products are often easier to formulate, regulate, and distribute compared to more complex microbiome therapies, allowing for faster commercialization.

Additionally, ongoing advancements in encapsulation and delivery technologies have improved bacterial stability and survivability through the gastrointestinal tract, enhancing their effectiveness. The growing focus on personalized nutrition and preventive health has further expanded the adoption of live bacteria products across various age groups and health segments. Fecal microbiota transplantation/biological combination therapies (FMT/BCT) accounted for the second-largest share, supported by approved drugs such as VOWST and Rebyota for recurrent Clostridioides difficile infection.

By end users, the human microbiome market is segmented by end users, hospitals & clinics, long-term care facilities, and other end users. Hospitals and clinics accounted for the largest share of the human microbiome market in 2024. This is largely due to their critical role in administering, monitoring, and regulating microbiome-based therapeutics, particularly those targeting infectious and gastrointestinal conditions. Approved products such as VOWST and Rebyota, used to prevent recurrent Clostridioides difficile infection, are typically prescribed and delivered in clinical settings under medical supervision. These facilities provide the necessary infrastructure for managing live microbial therapies, which may require cold-chain storage, specialized handling, and follow-up care. Hospitals and clinics are also key sites for clinical research, including patient enrollment for microbiome-based drug trials and real-world evidence studies. Their involvement enables close monitoring of patient outcomes, adverse events, and long-term therapeutic effects, all of which are essential for the advancement of microbiome science and regulatory approval processes. Moreover, the rising prevalence of chronic conditions linked to microbiome imbalance, such as inflammatory bowel disease and metabolic disorders, has led to increased hospital-based consultations and treatment protocols involving microbiome interventions. The presence of trained healthcare professionals, diagnostic tools, and institutional trust further supports the strong uptake of microbiome products within hospital and clinical environments.

By geography, in 2024, North America accounted for the largest share of the human microbiome market. This leading position is supported by a well-established biotechnology ecosystem, strong research and development infrastructure, and the presence of major market players such as Seres Therapeutics, Seed Health, and IFF. The region has seen significant regulatory progress, with the US FDA approving the first microbiome-based drugs, including Rebyota and VOWST, for the prevention of recurrent Clostridioides difficile infection. These approvals have encouraged further investment in microbiome therapeutics and supplements. North America also has high adoption rates for probiotics, prebiotics, and synbiotics, driven by increasing consumer awareness of gut health and preventive wellness. The region supports a growing number of clinical trials and academic collaborations focused on the role of microbiomes in conditions such as gastrointestinal diseases, metabolic disorders, and cancer. Additionally, favorable healthcare spending, innovation funding, and regulatory clarity continue attracting startups and established firms. These combined factors reinforce the dominant position of North America in the global human microbiome market.

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Some of the leading players in the market include Seres Therapeutics (US), Ferring B.V. (Switzerland), BiomeBank (Australia), Seed Health, Inc. (US),  International Flavors & Fragrances Inc. (US), Pendulum (US), Biohm Technologies (US), Actial Farmaceutica Srl (Italy), OptiBiotix Health Plc (UK), resbiotic (US), Infinant Health Inc. (US), BioGaia (Sweden), and ExeGi Pharma (US), among others.

Seres Therapeutics (US):

Seres Therapeutics is one of the emerging players in the human microbiome market. The company's microbiome therapeutics platform significantly reduces the time typically required to advance therapeutics to the clinic and, ultimately, to the market. The company focuses on R&D to launch advanced products in the market. Its R&D expenses were USD 64.6 million for the year ending December 31, 2024. It specializes in creating oral live biotherapeutic products with defined bacterial consortia intended to modulate the human microbiome. Its lead product, VOWST (formerly SER-109), received FDA approval in April 2023 to prevent recurrent Clostridioides difficile infection. VOWST is the first FDA-approved orally administered microbiome therapeutic. In 2023, Seres Therapeutics implemented organizational changes, including workforce reductions and a narrowed R&D focus. In June 2024, the company entered into an agreement with Nestlé Health Science to transfer full commercialization rights for VOWST. The company continues to pursue clinical development of its remaining programs and maintains collaborations with academic and industry partners.

FERRING B.V. (SWITZERLAND)

Ferring Pharmaceuticals is a biopharmaceutical company involved in the development of microbiome-based therapeutics. The company operates in multiple therapeutic areas, including reproductive medicine, maternal health, gastroenterology, and urology. Ferring engages in internal research and external partnerships in the microbiome space. It acquired Rebiotix, a company developing live biotherapeutic products targeting the human microbiome. The company developed Rebyota, a fecal microbiota-based therapeutic indicated for preventing recurrent Clostridioides difficile infection. The product received FDA approval in November 2022 and is administered via enema. It has also collaborated with organizations such as Karolinska Institutet, Intralytix, MyBiotics, and PharmaBiome to explore live microbial consortia, bacteriophage-based therapies, and microbiome diagnostics. The company maintains manufacturing and R&D operations in various regions and continues to advance its microbiome programs across therapeutic categories through preclinical and clinical development stages.

International Flavors & Fragrances Inc. (US)

International Flavors & Fragrances (IFF) operates in the fields of flavor, fragrance, nutrition, and biosciences, with a growing focus on microbiome-based ingredients. The company has developed capabilities in precision fermentation and microbial strain engineering, enabling the industrial-scale production of next-generation probiotics, including strict anaerobes like Akkermansia. These technologies support ingredient development for applications in human and pet health, food, and supplements. IFF's HOWARU brand includes clinically studied probiotic strains such as HN001, HN019, NCFM, Bi-07, and Bl-04. These strains are formulated for specific health outcomes, including immune support, digestive health, stress response, early life development, and healthy aging. HN001 has regulatory recognition in markets like Brazil for reducing eczema risk in infants and pregnant women. IFF offers products such as HOWARU Protect and HOWARU Restore, each targeting different stages of life or health needs. The HOWARU brand includes clinically studied probiotic strains such as HN001, HN019, NCFM, Bi-07, and Bl-04. These strains are formulated for specific health outcomes, including immune support, digestive health, stress response, early life development, and healthy aging. HN001 has regulatory recognition in markets such as Brazil for reducing eczema risk in infants and pregnant women. IFF offers products like HOWARU Protect and HOWARU Restore, each targeting different stages of life or health needs. The microbiome innovation of IFF is supported by ongoing collaborations and a broader portfolio in synthetic biology, enabling the development of functional ingredients across consumer and health product categories.

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