Human Microbiome Market is projected to grow at CAGR of 24% by 2035

With the increasing concept of precision medicine, several scientists have demonstrated interest in the therapeutic manipulation of human microbiome (commonly gut bacteria) for the treatment of a wide range of disease indications

Roots Analysis has announced the addition of “The Human Microbiome Market, (4th Edition) 2022-2035” report to its list of offerings.  

The microbiome-based therapies pipeline features six drugs in phase III clinical development, over 200 candidates in other clinical and preclinical stages of development along with more than 60 diagnostics and screening / profiling tests that are commercialized for the detection of various diseases. However, the current microbiome market is driven by the fecal microbiota therapies approved by the FDA, particularly for the recurrent CDI and the commercialized diagnostic tests available to the patients. 

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Key Market Insights

Over 230 drug candidates are currently being developed by more than 70 drug developers

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.

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. More than 40 companies are engaged in providing these tests; these are primarily based in North America (45%) and Europe (39%). It is worth highlighting that majority (68%) of the players are small companies.

FMTs are the only commercially available microbiome therapies approved by the FDA

These therapies are primarily used for the treatment of recurrent Clostridium difficile infection (rCDIs). It is worth mentioning that more than 400 trials have been registered for evaluating these therapies for a wide range of indications.

Partnership activity in this domain has increased at a CAGR of 26%, between 2017 and 2021

Maximum number of partnerships were established in 2021, indicating a recent rise in the interest of players engaged in this domain. 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.

More than USD 1 billion has been invested by both private and public investors, since 2017

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.

Outsourcing has become an integral part of the microbiome and live biotherapeutics development process

Presently, over 25 service providers claim to offer a multitude of contract manufacturing services for microbiome and live bio therapeutic products. It is worth noting that close to 10 firms were established post 2010 and around 45% of the players are located in Europe.

Microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035

As late-stage therapeutics will get approved by the FDA in the foreseen future, the microbiome therapeutics market is likely to grow at an annualized rate of 37% till 2035. It is worth mentioning that microbiome diagnostics is likely to capture 20% of the total microbiome market share by 2035.   

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Key Questions Answered

• Who are the leading players engaged in the development of microbiome therapeutics?
• Which are the key microbiome based drugs being developed across various stages of development?
• Which companies are actively involved in conducting clinical trials for microbiome therapeutics and FMTs?
• Who are the leading players engaged in the development of microbiome diagnostics and screening / profiling tests?
• Which types of partnership models are commonly adopted by industry stakeholders?
• Who are the key investors in the field of human microbiome therapeutics and diagnostics?
• What are the different initiatives undertaken by big pharma players for the development of human microbiome therapeutics in the recent past?
• What is the role of various start-ups engaged in developing human microbiome therapeutics?
• Which are the most commonly targeted therapeutic indications for which microbiome therapeutics are being developed?
• What are the various steps involved in the manufacturing of microbiome therapeutics?
• What are the key considerations for selecting a CMO / CRO for manufacturing of microbiome therapeutics?
• What are the various algorithms / tools used to analyze data generated from microbiome research?
• How is the current and future opportunity, related to microbiome therapeutics, diagnostics and FMT likely to be distributed across key market segments?
• What are the various non-pharma applications of microbiome products?

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The financial opportunity within the human microbiome therapeutics market has been analyzed across the following segments:

Type of Product

• Probiotic Drugs
• Other Drugs

Target Indication

• Recurrent C. difficile Infection
• Necrotizing Enterocolitis
• Primary Hyperoxaluria
• Graft versus Host Disease

Therapeutic Area

• Infectious Diseases
• Digestive and GI Disorders
• Rare Disorders

Route of Administration

• Oral Route
• Rectal Route

Type of Formulation

• Capsules
• Suspensions
• Enemas

Key Geographical Regions

• North America
• Europe
• Asia Pacific

The financial opportunity within the human microbiome diagnostics and screening / profiling tests market has been analyzed across the following segments:

Target Indication

• Irritable Bowel Syndrome
• Inflammatory Bowel Disease
• Colorectal Cancer
• Diabetes Mellitus

Key Geographical Regions

• North America
• Europe
• Asia Pacific

The report features inputs from eminent industry stakeholder(s), who were very optimistic concerning the growth of the human microbiome market. It includes detailed transcripts of the discussions held with the senior representatives of the stakeholder firms, including:

• 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)

The report also includes detailed profiles of the companies (listed below) engaged in developing microbiome therapeutics, diagnostics and screening / profiling test; each profile features an overview of the company, its financial information (if available), details on its product portfolio, recent developments, and an informed future outlook.

• 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

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Chapter Outlines

Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the current state and likely evolution of microbiome therapeutics, diagnostics and FMT therapies market in the short-mid term and long term.

Chapter 3 provides a general overview of human microbiome, concepts pertaining to microbiota and microbiome, a discussion on the role of resident microorganisms in disease development (particularly for conditions caused by an imbalance in the microbiome) and in certain cases, prevention. It presents an elaborate assessment on various functions of the microbiota, emphasizing on the key aspects of the Human Microbiome Project (HMP). Further, the chapter describes the various types of microbiome therapeutics, such as probiotics and prebiotic drugs, which are available / under development. It also provides an overview of the regulatory requirements for live biotherapeutic products (LBPs), in addition to highlighting the challenges associated with the development of microbiome therapeutics.

Chapter 4 includes 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 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 companies engaged in the development of microbiome therapeutics, along with information on their year of establishment, company size and location of headquarters.

Chapter 5 features detailed profiles of key players 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 players engaged in more than six therapeutic programs, along with a company overview, financial information (if available), drug portfolio and an informed future outlook. 

Chapter 6 features an analysis on 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.

Chapter 7 presents elaborate profiles of key players 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.

Chapter 8 presents review of the historical evolution and other relevant aspects of FMT, including details on the process of donor selection, therapy procedure, route of administration, important clinical guidelines, regulatory guidelines and insurance coverage, along with detailed assessment of the current market landscape of FMT, providing information on various parameters of FMT 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 FMT provider(s), along with information on their year of establishment, company size and location of headquarters.

Chapter 9 highlights a detailed analysis of completed and ongoing clinical trials of FMT, 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.