Human Microbiome Market Industry Research 2025-2035: 70+ Developers, 230+ Pipeline Drugs And 75+ Screening Tests Drive Global Growth

(MENAFN- GlobeNewsWire - Nasdaq) The human microbiome market, driven by growing R&D and therapeutic advancements, presents key opportunities in microbiome therapeutics and diagnostics. With over 70 companies developing therapies and 75+ diagnostics tests available, partnerships and significant investments further boost growth across various therapeutic areas, particularly infectious and gastrointestinal disorders.

Dublin, Sept. 30, 2025 (GLOBE NEWSWIRE) -- The "Human Microbiome Market Industry Trends and Global Forecasts to 2035, by Type of Product, Type of Molecule, Target Indication, Therapeutic Area, Route of Administration and Key Geographical Regions" report has been added to ResearchAndMarkets's offering.

The global human microbiome market is estimated to grow from USD 791 million in 2025 to USD 6.09 billion by 2035, at a CAGR of 20.4% during the forecast period, till 2035.

The term microorganism was previously associated with harmful disease-causing agents, until the discovery of certain beneficial microbial colonies in the human system. Humans and a variety of microbial species of bacteria, yeast and protozoa, are known to co-exist in mutually beneficial relationships. Moreover, it is estimated that the human gut microbiome consists of about 100 trillion microorganisms. Notably, this figure significantly outnumbers the total number of cells in the human body.

The majority of microorganisms provide significant benefits to humans by conferring traits and capabilities that would otherwise be absent. The healthy variety of bacteria in the gut has significant potential to enhance immunity and offer a wide range of health benefits. This has led to extensive research and development efforts by human microbiome based live biotherapeutics/ diagnostic developers to make significant strides, in terms of progressing proprietary product candidates into the clinic. In addition, owing to the strong association between the human microbiome and health, a myriad of therapeutic interventions based on manipulation of commensal microbes are under development.

Human Microbiome Market: Key Insights

• Presently, over 70 companies, worldwide, have taken initiatives to develop therapies that can manipulate the human microbiome; the market is characterized by the presence of small companies.
• The pipeline features 230+ human microbiome therapeutics that are currently being evaluated across different phases of development; the majority of these are designed for oral delivery.
• Nearly 30% of the pipeline drugs are in clinical phase of development, while more than 150 drugs are in preclinical and discovery stages. Clinical stage drugs are primarily being developed for infectious diseases and digestive disorders, while candidates in preclinical and discovery stages are focused on oncological disorders.
• Currently, over 40 companies, worldwide, are engaged in providing various diagnostics and screening / profiling test kits for the purpose of disease detection and analysis of human microflora composition and function.
• More than 75 diagnostics and screening / profiling test are available / under development.
• Of these, around 80% of the tests are available in the market, while rest are under development.
• Over 70 microbiome focused diagnostic and screening / profiling tests are available in the market; such test kits allow testing of different sample types across various therapeutic areas.
• Presently, FMTs are the only commercially available microbiome product; in fact, more than 400 clinical trials evaluating FMTs, sponsored by non-industry players, have been registered in the past decade.
• Several well-funded start-ups have entered this domain; our proprietary start-up health indexing analysis confirms the presence of a number of players that offer significant promise in developing microbiome therapeutics.
• The rising interest is also reflected in the wide array of partnerships being established between various stakeholders in the recent past; research agreements emerged as the most popular type of partnership model.
• Partnership activity in this domain increased at a CAGR of 26%, since 2017. It is worth highlighting that majority of the deals were R&D agreements, representing over 35% of the total number of partnerships signed in the given time period.
• Numerous investors, having realized the benefits and future opportunities of microbiome therapeutics in the treatment of various disorders, have invested more than USD 1 billion in start-ups, since 2019.
• Of the total amount invested, over USD 563 million was raised through venture capital financing, representing over 56% of the overall funding activity in this domain. Further, 36 instances of grants / awards were also reported, wherein players collectively raised more than USD 137 million.
• More than 25 industry players claim to be engaged in the manufacturing of microbiome-based biologics for various therapeutic purposes; majority of these firms are headquartered in Europe.
• Driven by ongoing research and advancements, the human microbiome therapeutics and diagnostics market is anticipated to grow at a significant pace in the coming years.
• Specifically, the human microbiome therapeutics market is anticipated to grow at a CAGR of 20.4%; the opportunity is likely to be well-distributed across different products, therapeutic areas and geographies.
• In the coming decade, we anticipate the opportunity for microbiome diagnostics market to grow at an annualized rate of ~53% across different supply channels.
• As late-stage therapeutics will get approved by the FDA in the foreseen future, microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035.

Human Microbiome Market: Research Coverage

• Microbiome Diagnostics and Screening / Profiling Tests Market Landscape: A comprehensive evaluation of various types of microbiome diagnostic and screening / profiling tests, based on several relevant parameters, such as stage of development, type of sample analyzed, type of screening technique, target indication(s), key therapeutic area(s) and purpose of diagnosis. Additionally, a comprehensive evaluation of diagnostics and screening / profiling test providers(s), based on several relevant parameters, such as year of establishment, company size and location of headquarters.
• Microbiome Diagnostics and Screening / Profiling Tests Providers Company Profiles: In-depth profiles of key players that are currently engaged in the development of microbiome diagnostics and screening / profiling tests, focusing on overview of the company, financial information (if available), diagnostic or screening / profiling test portfolio and recent developments and an informed future outlook.
• Clinical Trial Analysis: An insightful analysis of clinical trials related to fecal transplant, based on several parameters, such as trial status, trial registration year, trial phase, year-wise trend of completed and recruiting trials, study design, number of patients enrolled, age category of the patients enrolled, type of sponsor / collaborator, active industry and non-industry players, and location of the trials.
• Attractiveness Competitiveness (AC) Matrix: A comprehensive business portfolio analysis based on an attractiveness and competitiveness (AC) framework, featuring the current market attractiveness and competition across the most popular disease indication(s) for which microbiome therapeutics are under investigation.
• Start-Up Health Indexing: An assessment of the start-ups / small-sized players that are engaged in the development of microbiome therapeutics and diagnostics, based on relevant parameters, such as number of microbiome therapeutics under development, diversity of product portfolio, funding amount, partnership activity and disease indication(s) being treated.
• Key Therapeutic Areas: In-depth analysis of the most commonly targeted therapeutic indications and information on microbiome-based drugs that are being developed against them, based on key epidemiological facts about specific diseases, available methods of diagnosis and currently available treatment options and their side effects.
• Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the human microbiome market, based on several parameters, such as year of partnership, type of partnership, type of product, target indication, therapeutic area, type of company, type of partner, most active players and geographical distribution of the partnership activity.
• Funding and Investments: An in-depth analysis of the fundings raised by human microbiome companies, based on relevant parameters, such as year of investment, amount invested, type of funding, type of company, purpose of funding, type of product, target indication, therapeutic area, geographical analysis, most active players and most active investors.
• Case Study: A detailed discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, along with information of contract manufacturers, focusing on year of establishment, location of headquarters, company size, scale of operation, type of product manufactured and type of formulation. Additionally, a detailed discussion on the key considerations that are required for selecting a CMO / CRO partner.
• Big Data and Microbiome Therapeutics: A comprehensive assessment of the emerging role of big data, representing efforts made to develop and implement various algorithms / tools to analyze data generated from microbiome research. Further, a detailed google trends analysis demonstrating a rising interest in stakeholders to use big data tools for supporting microbiome research over the past decade.

Key Questions Answered in this Report

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

Reasons to Buy this Report

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

Companies Featured

• 4D Pharma
• Biosotia Microbiomics
• DNA Genotek
• Finch Therapeutics
• GoodGut
• Infant Bacterial Therapeutics
• Invivo Healthcare
• MaaT Pharma
• OxThera
• Qu Biologics
• Rebiotix
• Seres Therapeutics
• Servatus
• Shoreline Biome

Market Segmentation

Type of Product

• Probiotic Drugs
• Other Drugs

Type of Molecule

• Small Molecules
• Biologics

Target Indication

• Colorectal Cancer
• Diabetes Mellitus
• Inflammatory Bowel Disease
• Irritable Bowel Syndrome
• Graft vs. Host Disease
• Necrotizing Enterocolitis
• Primary Hyperoxaluria
• Recurrent CDI

Therapeutic Area

• Digestive and Gastrointestinal Disorders
• Infectious Diseases
• Metabolic Disorders
• Oncological Disorders
• Rare Disorders

Route of Administration

• Oral
• Rectal

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older

For more information about this report visit

About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Attachments

• Distribution by Stage of Development
• Type of Molecule
• Development Pipeline

CONTACT: CONTACT: Laura Wood,Senior Press Manager ... For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

MENAFN30092025004107003653ID1110128811