Human Microbiome Market

Market Definition

The market focuses on products and technologies that study, modify, or utilize the microbial communities in the human body. It covers microbiome-based diagnostics, therapeutic formulations such as probiotics, prebiotics, and live biotherapeutics, and microbiome analysis tools.

Applications span gut health, dermatology, immunology, and personalized medicine, supporting both clinical research and commercial development for disease prevention and health monitoring.

The report provides a comprehensive analysis of key drivers, emerging trends, and the competitive landscape expected to influence the market over the forecast period.

Human Microbiome Market Overview

The global human microbiome market size was valued at USD 817.8 million in 2023 and is projected to grow from USD 1030.0 million in 2024 to USD 5395.1 million by 2031, exhibiting a CAGR of 26.69% during the forecast period.

Market growth is driven by the expansion of personalized medicine applications and progress in microbiome sequencing technologies. These advancements enable more precise, microbiome-targeted interventions, supporting the development of condition-specific products and diagnostics. This growing capability is fueling both clinical adoption and commercial investment in the market.

Major companies operating in the human microbiome industry are Seed Health, Inc., BioGaia AB, Codex Labs, AOBiome LLC, MRM Health, ResBiotic, Seres Therapeutics, Inc., Vedanta Biosciences, Inc., Finch Therapeutics Group, Inc., Ferring Pharmaceuticals, Infinant Health, Inc., Exegi Pharma, LLC, Axial Biotherapeutics, OptiBiotix Health plc, and BioHM Health, Inc.

The increasing prevalence of gastrointestinal disorders, autoimmune conditions, and metabolic diseases is leading to increased demand for targeted microbiome-based therapeutics. Companies are investing in precision formulations that use live biotherapeutics or bacterial consortia to restore microbial balance.

The success of approved products such as Vowst and Rebyota shows growing clinical and commercial acceptance. This demand for next-generation treatment options continues to boost the growth of the market.

• In December 2024, MaaT Pharma announced significant progress in developing a microbiome-based therapy for cancer treatment. Following successful early-stage clinical trials, the company is nearing approval for a product that utilizes fecal microbiota to modulate the gut microbiome and enhance cancer treatment outcomes. This positions MaaT Pharma to potentially introduce the first approved microbiome therapy for cancer care.

Key Highlights

1. The human microbiome industry size was valued at USD 817.8 million in 2023.
2. The market is projected to grow at a CAGR of 26.69% from 2024 to 2031.
3. North America held a market share of 40.25% in 2023, with a valuation of USD 2199.1 million.
4. The digestive tract segment garnered USD 497.6 million in revenue in 2023.
5. The therapeutics segment is expected to reach USD 3784.7 million by 2031.
6. The gastrointestinal diseases segment secured the largest revenue share of 36.09% in 2023.
7. The probiotics segment is estimated to grow a robust CAGR of 27.41% through the forecast period.
8. Asia Pacific is anticipated to grow at a CAGR of 27.57% during the forecast period.

Market Driver

"Expansion of Personalized Medicine"

The growth of the human microbiome market is fueled by the progress in personalized medicine. Microbiome profiling is being used to tailor treatment strategies based on an individual’s microbial composition.

This personalized approach is gaining traction in oncology, immunology, and neurology. Startups and major biotech firms are integrating microbiome data with genomics to develop therapies and diagnostics that align with patient-specific biological signatures.

• In October 2024, Microbiotica, a UK-based biopharmaceutical company, commenced its international Phase 1b trial (MELODY-1) for MB097, an oral precision microbiome co-therapy targeting advanced melanoma. This trial aims to recruit up to 40 patients across clinical centers in the UK, France, Italy, and Spain, with initial data expected by the end of 2025. ​

Market Challenge

"Regulatory Uncertainty"

A major challenge limiting the growth of the human microbiome market is the lack of clear and consistent regulatory frameworks across regions. Many microbiome-based products fall between supplements, drugs, and biologics, leading to regulatory delays and market entry challenges. This uncertainty impacts product development timelines and investor confidence.

To address this, key players are collaborating with regulatory agencies, participating in early consultation programs, and investing in strong clinical validation. These efforts aim to ensure compliance, improve transparency, and support smoother regulatory pathways for efficient market entry of microbiome innovations.

Market Trend

"Progress in Microbiome Sequencing Technologies"

Advancements in next-generation sequencing and bioinformatics have made microbiome analysis faster and more affordable, fueling the growth of the human microbiome market. These tools enable detailed profiling of microbial communities, leading to a deeper understanding of their role in health and disease.

Enhanced accuracy in microbial diagnostics is improving therapy design and monitoring, which in turn boosts confidence among healthcare providers.

• In October 2024, Universal Sequencing Technology Corporation introduced a high-throughput microbial whole-genome sequencing (WGS) library preparation kit. This kit enables second-generation short-read sequencers to produce long-range results affordably. The technology allows pooling of more microbial samples in one sequencing run, reducing costs and improving efficiency in microbiome research, which is essential for personalized therapeutic development.

Human Microbiome Market Report Snapshot

Segmentation	Details
By Site	Digestive Tract, Lung, Reproductive Cavity, Skin, Other Sites
By Application	Therapeutics, Diagnostics
By Disease	Infectious Diseases, Gastrointestinal Diseases, Endocrine & Metabolic Diseases, Cancer, Central Nervous System Disorder, Other Diseases
By Product	Drugs, Probiotics, Prebiotics, Diagnostic Tests, Other Products
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation

• By Site (Digestive Tract, Lung, Reproductive Cavity, Skin, and Other Sites): The digestive tract segment earned USD 497.6 million in 2023 due to its central role in microbiome-related research and product development, supported by strong clinical demand for gut health solutions.
• By Application (Therapeutics and Diagnostics): The therapeutics segment held a share of 68.52% in 2023, fueled by increasing clinical adoption of microbiome-based treatments targeting chronic and complex conditions with limited existing therapies.
• By Disease (Infectious Diseases, Gastrointestinal Diseases, Endocrine & Metabolic Diseases, Cancer, Central Nervous System Disorder, and Other Diseases): The gastrointestinal diseases segment is projected to reach USD 2115.8 million by 2031, propelled by the high prevalence of gut-related disorders and the strong clinical focus on microbiome-targeted therapies for treating infections.
• By Product (Drugs, Probiotics, Prebiotics, Diagnostic Tests, and Other Products): The probiotics segment is estimated to grow at a significant  CAGR of 27.41% through the forecast period, attributed to its widespread consumer adoption, strong commercial presence, and proven demand across preventive and therapeutic health applications.

Human Microbiome Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America human microbiome market share stood at around 40.25% in 2023, valued at USD 329.2 million. North America boasts a highly advanced healthcare system, with extensive research, medical facilities, and access to healthcare professionals. This infrastructure supports the integration of microbiome-based therapies into clinical practice.

The availability of cutting-edge technology and a well-established regulatory framework enables quick adoption and commercialization of microbiome products, contributing to regional market growth.

Furthermore, the region attracts substantial investment in biotechnology and microbiome research, both from private venture capital and government funding, which influences the regional market.

• In March 2024, QIAGEN partnered with McGill University to further microbiome research. This collaboration seeks to deepen the understanding of microbial ecosystems and their impact on health, supporting the development of microbiome-based therapies. The focus will be on critical areas, including DNA extraction from low microbial biomass samples and protocols for anaerobic culturing.

Asia Pacific human microbiome industry is set to grow at a robust CAGR of 27.57% over the forecast period. Academic and research institutions in Asia Pacific are increasingly focusing on microbiome research, with several collaborations between universities, healthcare providers, and biotech companies.

The region is witnessing an expansion of clinical trials aimed at understanding the role of the microbiome in various diseases. Additionally, the rapid growth of e-commerce in Asia Pacific has made microbiome-based products more accessible to a larger population.

Online platforms enable direct-to-consumer sales of probiotics, prebiotics, and microbiome-testing kits directly, bypassing traditional retail channels. This model is enhancing market penetration and encouraging a more widespread adoption of microbiome products.

Regulatory Frameworks

• The U.S. Food and Drug Administration (FDA) regulates microbiome-based products under its biologics and drug frameworks. Live Biotherapeutic Products (LBPs), which contain live organisms such as bacteria, are subject to the same regulatory requirements as other biologics. Developers must submit an Investigational New Drug (IND) application to initiate clinical trials. The FDA provides guidance documents to assist developers in meeting regulatory requirements for LBPs.
• The European Medicines Agency (EMA) oversees the regulation of microbiome-based products within the European Union. Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic-cell therapies, and tissue-engineered medicines, are subject to specific guidelines. These guidelines cover aspects such as quality, non-clinical and clinical evaluation, and risk management.
• In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) regulates microbiome-based products under the Pharmaceutical and Medical Device Act. Products intended for therapeutic use must undergo rigorous clinical trials and meet quality standards. The PMDA has issued guidelines for the development of microbiome-based therapies, emphasizing the need for comprehensive data on safety and efficacy.

Competitive Landscape

Key players operating in the human microbiome industry are adopting strategies such as advancing innovative technologies and expanding their product offerings.

These efforts help address emerging health needs and enable companies to provide targeted solutions across various health areas, including cardiometabolic health, brain health, and longevity. By focusing on microbiome-directed interventions, these strategies are promoting further advancements in microbiome science.

• In April 2024, Seed Health introduced CODA, a computational biology platform designed to discover and develop next-generation precision probiotics and microbiome-directed therapies. CODA uncovers previously unexplored links between the microbiome and health, enabling the creation of targeted, outcome-driven interventions. Initial programs focus on areas such as cardiometabolic health, brain health, menopause, and longevity.

List of Key Companies in Human Microbiome Market:

• Seed Health, Inc.
• BioGaia AB
• Codex Labs
• AOBiome LLC
• MRM Health
• ResBiotic
• Seres Therapeutics, Inc.
• Vedanta Biosciences, Inc.
• Finch Therapeutics Group, Inc.
• Ferring Pharmaceuticals
• Infinant Health, Inc.
• Exegi Pharma, LLC
• Axial Biotherapeutics
• OptiBiotix Health plc
• BioHM Health, Inc.

Recent Developments (Partnerships/Product Launch)

• In March 2024, ResBiotic announced its launch at Walmart, making its innovative supplements available to consumers across the U.S. This move aligns with the company's mission to increase access to  provide targeted microbiome solutions for better health management.
• In May 2024, Seed Health introduced VS-01 Vaginal Synbiotic, the first clinically validated vaginal synbiotic designed to establish a balanced vaginal microbiome dominated by Lactobacillus crispatus. VS-01 combines three proprietary L. crispatus strains, each selected for specific genomic characteristics to enhance stability in the vaginal environment.
• In March 2024, BIOHM Health Inc. formed a partnership with Virginia Tech to strengthen its advanced Symbiont platform using artificial intelligence. Symbiont, which has been peer-reviewed in Gastroenterology, identifies ingredients that target bacterial and fungal dysbiosis in specific populations. This collaboration represents a key advancement in the development and commercialization of condition-specific dietary supplements through deeper microbiome insights.