Human Microbiome Market

Human Microbiome Market Overview

The human microbiome market is estimated to be worth $380 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 23.8% during the forecast period. 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. Specifically, 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. 

At present, fecal microbiota transplantation (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) is the only FDA-approved microbiome therapy, for the treatment of recurrent CDI. However, 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. 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.

Key Microbiome Companies in the 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.

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 July 2023, MaaT Pharma announced the publication of clinical trial results for MaaT013, a faecal microbiota derived therapeutic, targeting acute Graft-versus-Host Disease (aGvHD). 
• 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.

Scope of the Report

The ‘The Human Microbiome Market (4th Edition), 2022-2035: 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): Industry Trends and Global Forecasts’ market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the companies offering live biotherapeutic products (including therapeutics, diagnostics and fecal transplant) during the forecast period. The market research report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in human microbiome market across multiple segments, as highlighted in the below table:

Market Segmentation

Report Attribute	Details
Forecast Period	2022 – 2035
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 and Rest of the World

 

In addition to other elements, the market research report includes:

• 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. 
• 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.

One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for microbiome therapeutics, diagnostics and fecal transplant during the forecast period. The research, analyses and insights presented in this market report are based on revenue generation trends of the sales, of approved / late stage (estimated) microbiome therapeutics, diagnostic products and fecal transplant. The market research report also features the likely distribution of the current and forecasted opportunity within microbiome therapeutics market across type of product (probiotic and other drug),  target indication (graft versus host disease, necrotizing enterocolitis, primary hyperoxaluria and recurrent CDI ),  therapeutic area (digestive and gastrointestinal disorders, infectious diseases and rare disorders),  route of administration (oral and rectal), type of formulation (capsules, suspensions and enemas) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world), leading drug developers, and  leading therapeutic products. In addition, it also features the likely distribution of the current and forecasted opportunity within microbiome diagnostic tests market across target indications (colorectal cancer, diabetes mellitus, inflammatory bowel disease and irritable bowel syndrome) therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and oncological disorders) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with the growth of microbiome market 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 industry’s growth. 

The opinions and insights presented in this market report were also influenced by discussions conducted with multiple stakeholders in human microbiome market. The market research report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company / organization names):

• 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)

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 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 market?

Answer: Examples of key microbiome companies engaged in human microbiome market (which have also been profiled in this market report; the complete list of companies is available in the full report) include 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 product candidates are presently under development in the human microbiome market?

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

Question 7: How many microbiome companies are presently engaged in the human microbiome market?

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

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

Answer: North America emerged as the hub for microbiome companies engaged in the human microbiome market, 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.