Human Microbiome Market

Human Microbiome Market: Industry Trends and Global Forecasts, till 2035 - Focus on Therapeutics, Diagnostics and Fecal Microbiota Therapy: Type of Product, Target Indication, Therapeutic Areas, Route of Administration, Type of Formulation and Key Geographical Regions

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Human Microbiome Market Overview

The human microbiome market is projected to grow from $380 million in 2022 to $6,091 million by 2035, representing a CAGR of 23.8% during the forecast period from 2022 to 2035.

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The new research study consists of pipeline analysis, competitor analysis, clinical trial analysis, start ups analysis, partnerships and collaborations, mergers and acquisitions, and detailed market analysis. The global human microbiome market growth over the next decade is likely to be the result of increasing adoption of approved therapy, encouraging clinical trial results and financial support from investors.

The human microbiome remained a largely unexplored area until 2007 when the Human Microbiome Project (HMP) was initiated. The project was undertaken to understand the concept of core human microbiome and its compatibility with the host physiology. Further, with the significant advancements in the sequencing methods and analytical techniques, and 40% increase in the non-HMP investments, several microbiome-related studies have been conducted. Research insights generated from the HMP and other studies throw light on the role of gut microbiota in governing the overall health / well-being of an individual, and the pathogenesis of several diseases due to the alteration in the composition of resident gut microbiota.

Human Microbiome Market Scope

The human microbiome market research report presents an in-depth analysis of the various companies that are engaged in developing this novel drug class, across different segments, as defined in the table below:

Global Human Microbiome Market: Report Attributes / Market Segmentations

Key Report Attribute Details
Base Year 2022
Forecast Period 2022-2035
Market Size 2022 $380 Million
CAGR 23.8%
Type of Product
  • Probiotic Drugs
  • Other Drugs
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
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  • Market Landscape Analysis
  • Clinical Trial Analysis
  • Partnership and Collaboration Analysis
  • Funding Analysis
  • Market Forecast and Opportunity Analysis

One of the key objectives of this human microbiome market report was to estimate the current market size, opportunity and the future market growth potential of this drug class in pharmaceutical market, over the forecast period. Based on likely approval year, adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2022-2035.

The market report also features the likely distribution of the current and forecasted opportunity within the human microbiome market across various segments, such as type of product (probiotic drugs and other drugs), target indication (colorectal cancer, diabetes mellitus, inflammatory bowel disease, irritable bowel syndrome, graft versus host disease, necrotizing enterocolitis, primary hyperoxaluria and recurrent CDI), therapeutic areas (digestive and gastrointestinal disorders, infectious diseases, metabolic disorders, oncological disorders and rare disorders), route of administration (oral, rectal) and key geographical regions (North America, Europe, Asia Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the human microbiome market growth.

The opinions and insights presented in the market research report were also influenced by discussions held with multiple stakeholders. The market report features detailed transcripts of interviews held with the following individuals:

  • Charlie Badham (Senior Manager, Corporate Development, 4D Pharma)
  • Nicholas Monsul (Co-founder and Chairman, Quorum Innovations)
  • Alicia Scheffer (Chief Executive Officer, Floragraph)
  • Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)
  • Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)
  • Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)
  • Assaf Oron (Chief Business Officer, BiomX)
  • Debbie Pinkston (Former Vice President, Sales and Business Development, List Biological Laboratories)
  • Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)
  • Colleen Cutcliffe (Co-founder and Chief Executive Officer, Pendulum Therapeutics)
  • Nikole Kimes (Co-founder and Chief Executive Officer, Siolta Therapeutics)
  • James Burges (Ex-Co-founder and Vice President of Innovation, OpenBiome)
  • Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)
  • JP Benya (Ex-Vice President, Operations, Assembly Biosciences)
  • Lee Jones (President and Chief Executive Officer, Rebiotix)
  • Mark Heiman (Ex-Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)
  • Pierre-Alain Bandinelli (Chief Strategy Officer, Da Volterra)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Human Microbiome Market: Key Insights

The “Human Microbiome Market (4th Edition) ): Industry Trends and Global Forecasts, till 2035: Focus on Therapeutics, Diagnostics and Fecal Microbiota Therapies: Distribution by Type of Product (Probiotic Drugs and Other Drugs), Target Indication (Colorectal Cancer, Diabetes Mellitus, Inflammatory Bowel Disease, Irritable Bowel Syndrome, Graft Versus Host Disease, Necrotizing Enterocolitis, Primary Hyperoxaluria and recurrent CDI), Therapeutic Areas (Digestive and Gastrointestinal Disorders, Infectious Diseases, Metabolic Disorders, Oncological Disorders and Rare Disorders), Route of Administration (Oral and Rectal), Type of Formulation (Capsules, Suspensions and Enemas) and Key Geographical Regions (North America, Europe and Asia-Pacific” market report features an extensive study of the current market landscape, market size, market share, market analysis, market forecast and future opportunities for the companies offering live biotherapeutic products (including therapeutics, diagnostics and fecal transplant). The report highlights the efforts of several drug developers engaged in this rapidly emerging market segment of the pharmaceutical industry. Key takeaways of the global human microbiome market analysis are briefly discussed below.

The Need for Development of Human Microbiome Therapeutics

The studies suggest that dysbiosis (imbalance of gut bacteria) leads to the development of several chronic conditions, including Clostridium difficile infections (CDIs), Crohn’s disease, irritable bowel disease, ulcerative colitis and diabetes. Given the role of microbiota in disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine. Manipulation of bacteria in the gut emerges to be a potential tool in the treatment of various medical conditions and associated diseases. The ongoing research efforts, focused on targeting and modulating microbiome, have led to the development of treatment options for more than 25 indications. In addition, probiotic therapies with live biotherapeutic products (microbes) are considered to be the most advanced microbiome-based therapies for restoring bacterial symbiosis.

Current Landscape of Human Microbiome Market

At present, the only approved human microbiome therapeutics are fecal microbiota transplantation (FMT) products. FMT involving the transfer of complete microbial community from a healthy donor’s feces to recipient via oral (in form of a capsule) or rectal (enema and colonoscopy). It is the only FDA-approved microbiome therapy for the treatment of recurrent CDI. Ferring Pharmaceutical’s Rebyota was the first FMT approved by the FDA for prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. The human microbiome therapeutic received FDA approval in November 2022, creating a breakthrough for the drug developers active in the human microbiome market. A more recent development has been the approval for second FMT product in the US. In April 2023, FDA announced the approval of Seres and Nestle’s VOWST™ (SER-109) to treat recurrent Clostridium Difficile infection. VOWST™ is the first fecal microbiota product approved by the FDA for oral administration. FDA approved Seres Therapeutics’ VOWST for the same indication as Rebyota, but with a difference in the route of administration.

In addition to companies developing human microbiome therapeutics for infectious diseases, several players are engaged in developing prescription drugs modulating human microbiome for the treatment of various gastrointestinal and non-gastrointestinal disorders as well. Further, a number of microbiome diagnostic and screening / profiling tests are commercially available for the detection of different microbiome-related diseases. In a separate market report, Roots Analysis also provides in-depth analysis on the human microbiome manufacturing market, covering the in-house and contract manufacturing players and their facilities.

Market Drivers: Unmet Need and Support from the Venture Funds

It is worth mentioning that, owing to the rising interest, a number of start-ups / small firms have established in the past few years and the contributions of big pharma players have fueled the overall growth in human microbiome market. Driven by increasing prevalence of disease indications, promising therapeutic potential of microbiome-based therapies, encouraging clinical trial results and financial support from the investors, the human microbiome therapeutics and diagnostics market is likely to witness substantial market growth during the forecast period. A number of microbiome therapeutics and profiling startups have received funding in the past five years. In July 2023, Paris based Exeliom Biosciences, engaged in developing microbiome therapeutics, received EUR 24 million Series A funding.

A number of academic groups have also received grants to progress research on human microbiome. In February 2024, the National Institute of General Medical Science has awarded a USD 1.9 million grant to Jordan Bisanz, an assistant professor of biochemistry and molecular biology in Penn State Eberly College of Science, to understand the impact of complex microbiome communities on human health. In January 2024, the National Institutes of Health awarded Oklahoma State University a USD 10.7 million grant to conduct microbiome research across five projects targeting oral squamous cell carcinoma, novel gut microviruses, dietary carotenoids, aerodigestive tract and opioid abuse disorders in its Oklahoma Center for Microbiome Research.

Market Size Analysis: Human Microbiome Therapeutics for Infectious Diseases to Hold the Largest Market Share

The global human microbiome market size is estimated to reach USD 6.1 billion by 2035. The market growth is expected to be driven by the increasing adoption of the approved drugs, leading to a CAGR of over 23% during the forecast period. Further, in terms of therapeutic indications, the treatment for infectious diseases is anticipated to capture the majority of the market share in the short-term with the currently available Rebyota and Vowst approved for CDI. According to data presented by Seres Therapeutics, approximately 156,000 people in the U.S. are estimated to be affected by recurrent CDI.  The US Centers for Disease Control and Prevention (CDC) has classified CDI as an urgent threat, making it important to focus on the preventive measures.

Key Companies Involved in the Global Human Microbiome Market

Examples of key microbiome companies engaged in human microbiome market (which have also been profiled in this market report; the complete list of microbiome companies is available in the full report) include 4D Pharma, Biosortia Pharmaceuticals, Finch Therapeutics, Infant Bacterial Therapeutics, MaaT Pharma, OxThera, Qu Biologics, Rebiotix (acquired by Ferring Pharmaceuticals) and Seres Therapeutics. This market report includes an easily searchable excel database of all the microbiome companies developing human microbiome therapeutics, worldwide.

Human Microbiome Market Report Coverage

The human microbiome market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:

  • A preface providing an introduction to the full report, Human Microbiome Market, 2022-2035.
This image looks at the emerging trends in human microbiome market. Eminent representatives from various biopharmaceutical companies confirm the sustained interest in microbiome therapeutics and diagnostics, highlighting the upcoming trends driving R&D initiative This image provides list of microbiome therapeutics. 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 image provides details on the current human microbiome therapeutics market landscape. The pipeline features 230+ human microbiome therapeutics that are currently being evaluated across different phases of development; majority of these are designed for oral delivery
  • An outline of the systematic research methodology adopted to conduct the study on human microbiome therapeutics and diagnostics, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An executive summary of the key insights captured during our research, offering a high-level view on the current landscape of the approved and under development human microbiome therapeutics and diagnostics, and their likely evolution in the short to mid and long term.
  • A brief introduction to concept of human microbiome and their applications in the healthcare industry.
  • A detailed assessment of the current market landscape of microbiome therapeutics, providing information on preclinical and clinical drugs along with information on clinical study sponsor(s) or collaborators, phase of development (clinical, preclinical, and discovery) of product candidates, type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, prescription drug and vaccine), target indication(s), therapeutic area(s), route of administration, type of drug formulation, type of microbiome therapy (monotherapy and combination therapy), combination drug (in case of combination therapies), dosing frequency (reported for clinical candidates only), and special drug designations (if any). In addition, the chapter provides details on the microbiome companies engaged in the development of microbiome therapeutics, along with information on their year of establishment, company size and location of headquarters.
  • Elaborate profiles of key microbiome companies engaged in the development of microbiome therapeutics (which are presently in phase III clinical trials); each profile features a brief overview of the company, its financial information (if available), microbiome-based drug portfolio, information on clinical trial (featuring, current status of development and phase III clinical trial information) and an informed future outlook. In addition, the chapter also features profiles of the microbiome companies engaged in more than six therapeutic programs, along with a company overview, financial information (if available), drug portfolio and an informed future outlook.
  • An analysis on the various types of diagnostic and screening / profiling tests, specifically highlighting the importance of next-generation sequencing within this field of research, along with detailed review of the current market landscape of microbiome diagnostic and screening / profiling tests, including the information on stage of development (commercialized and under development), type of sample analyzed (blood, feces, saliva and vaginal swab), type of screening technique (gene sequencing, PCR, microarray, ELISA, DNA analysis, drug metabolites and others) target indication(s), key therapeutic area(s) and purpose of diagnosis. The chapter also features information on the diagnostics and screening / profiling test providers(s) along with information on their year of establishment, company size and location of headquarters.
  • Elaborate profiles of key microbiome companies engaged in the development of microbiome diagnostics and screening / profiling tests. Each profile features a brief overview of the company, its financial information (if available), diagnostic or screening / profiling test portfolio, recent developments and an informed future outlook.
  • A review of the historical evolution and other relevant aspects of fecal transplant, including details on the process of donor selection, microbiome therapy procedure, route of administration, important clinical guidelines, regulatory guidelines and insurance coverage, along with detailed assessment of the current market landscape of fecal transplant, providing information on various parameters of fecal transplant such as,  the status of development (commercialized, clinical, and preclinical stage), target indication(s), key therapeutic area(s), and route of administration. In addition, the chapter includes information on fecal transplant provider(s), along with information on their year of establishment, company size and location of headquarters.
This infographic looks at the grid analysis across highlighting key therapeutic areas. Microbiome therapeutics have demonstrated the potential to target a range of diseases; digestive and GI disorders, oncology, infectious diseases, and metabolic disorders are amongst the prime focus areas This image provides a list of Human Microbiome Diagnostics. 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 This image looks at the geographical distribution of clinical research landscape of fecal microbiota therapies. 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
  • A detailed analysis of completed and ongoing clinical trials of fecal transplant, based on different parameters, such as trial status, trial registration year, trial phase, year-wise trend of completed and recruiting trials, study design, number of patients enrolled. In addition, the chapter highlights age category of the patients enrolled, type of sponsor / collaborator, active industry and non-industry players and location of the trials. Furthermore, the chapter also features information on various stool banks (including year of establishment and location of headquarters), along with brief profiles of the most prominent stool banks located across the globe.
  • A detailed business portfolio analysis based on an attractiveness and competitiveness (AC) framework, highlighting the current market attractiveness and existing competition across the most popular disease indication(s) for which microbiome therapeutics are under investigation.
  • An analysis of the start-ups / small-sized players (established in the last seven years, with less than 50 employees) engaged in the development of microbiome therapeutics and diagnostics, featuring heat map representation based on parameters, such as number of microbiome therapeutics under development, diversity of product portfolio, funding, partnership activity and disease indication(s) being treated.
  • An assessment of the most commonly targeted therapeutic indications and details of microbiome-based drugs that are being developed against them, highlighting key epidemiological facts about specific diseases, available methods of diagnosis, and currently available treatment options and their side effects.
  • An analysis of the partnerships that have been established since 2017, covering various parameters such as, research and development, clinical trials agreement, merger / acquisition, product development and commercialization agreement and product development and manufacturing agreement of the microbiome companies focused on developing microbiome-based therapeutics, diagnostics and fecal transplant.
  • An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small-sized companies (with less than 50 employees) that are focused on developing microbiome therapeutics and diagnostics.
  • An elaborate discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, along with an indicative list of contract manufacturers, along with details on year of establishment, location of headquarters, company size, scale of operation, type of product manufactured and type of formulation. In addition, the chapter highlights key consideration for selecting a CMO / CRO partner.
  • An assessment of the emerging role of big data, highlighting efforts focused on the development and implementation of various algorithms / tools to analyze data generated from microbiome research along with insightful google trends analysis to demonstrate the rising interest of stakeholders in using big data tools to support microbiome research over the past decade. The chapter also features a list of microbiome companies offering big data-related services / tools to support microbiome research, and brief profiles of some of the popular microbiome companies that are engaged in this field of research.
  • A case study on various other applications of live biotherapeutic products, such as agriculture, animal health, plant health, food products, featuring a list of nearly 80 products, including probiotic supplements, cosmetics, and over the counter (OTC) products that are being used as dietary supplements.
  • A detailed market forecast analysis in order to estimate the existing market size and future opportunity for the human microbiome market over the next 11 years. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market size during the forecast period 2024-2035.
This image provides details on human microbiome market size. Driven by ongoing research and advancements, the human microbiome therapeutics and diagnostics market is anticipated to grow at a significant pace, during the period 2022-2035 The image provides segmentaion of human microbiome market. Specifically, the human microbiome therapeutics market is anticipated to grow at a CAGR of 17%; the opportunity is likely to be well-distributed across different products, therapeutic areas and geographies The image provides segmentaion of human microbiome market. Likewise, in the coming decade, we anticipate the opportunity for microbiome diagnostics market to grow at an annualized rate of ~53%across different supply channels

Recent Developments In Human Microbiome Market

Several recent developments have taken place in the field of the human microbiome market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In July 2023, Infant Bacterial Therapeutics received orphan drug designation for its IBP-1016 bacterial product, treating infants suffering from gastroschisis, from the US FDA.
  • In December 2023, MaaT Pharma announced the clinical trial results for MaaT013, being evaluated for the treatment of acute graft-versus-host disease (aGvHD). The drug demonstrated a well-tolerated safety profile with a survival rate of 81%.
  • In July 2023, MaaT Pharma joined Microbiome Therapeutics Innovation Group, a company leading the research, development and integration of FDA approved microbiome therapies into clinical practice.
  • In April 2023, Finch Therapeutics signed a clinical trial agreement with Brigham and Women’s Hospital in order to evaluate CP101, novel microbiome therapeutic for ulcerative colitis.

Frequently Asked Questions

Question 1: What is human microbiome?

Answer: Human microbiome refers to the array of microorganisms including bacteria and viruses that live within or on the human body.

Question 2: What is human microbiome therapeutics?

Answer: Human microbiome therapeutics refers to the modification of the human gut microbiota using native or genetically modified microbes, bacteriophages or antibiotics for treatment of various medical conditions.

Question 3: How big is the human microbiome market?

Answer: The human microbiome market size is estimated to be worth $380 million in 2022.

Question 4: What is the projected market growth of the human microbiome market?

Answer: The global human microbiome market is expected to grow at compounded annual growth rate (CAGR) of 23.8% during the forecast period 2022 - 2035.

Question 5: Who are the leading microbiome companies in the human microbiome industry?

Answer: 4D Pharma, Biosortia Pharmaceuticals, Finch Therapeutics, Infant Bacterial Therapeutics, MaaT Pharma, OxThera, Rebiotix (acquired by Ferring Pharmaceuticals), Seres Therapeutics and Qu Biologics.

Question 6: How many human microbiome therapeutics are presently under development?

Answer: Currently, over 160 product candidates are under development in the human microbiome market.

Question 7: How many human microbiome companies are presently active?

Answer: Currently, more than 70 human microbiome companies are engaged in developing novel microbiome based therapies.

Question 8: Which region is the hub for human microbiome companies?

Answer: North America emerged as the hub for human microbiome companies, with close to 70% of the players established in the region.

Question 9: How much funds have been raised by microbiome startups?

Answer: Investors have invested more than $1 billion in microbiome startups since 2017. The overall funding including mid-sized and large microbiome companies is much higher.


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