Microbiome Disease - Pipeline Insight, 2025

The “Microbiome Disease- Pipeline Insight, 2025” report provides comprehensive insights about 140+ companies and 180+ pipeline drugs in Microbiome Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Microbiome Disease: Understanding

Microbiome Disease: Overview

Microbiome refers to collection of microbes and their interaction with the human body. Microbiome plays an important role in human physiology and disease. The microbes and their interaction with the human body show the various aspects of human biology. Human body possess a number of different species particularly bacteria and fungi which help in digesting food, preventing infections and performing numerous life-supporting tasks. Microbes can also be harmful to their human hosts.

• Role in Metabolic Disorders: Various studies have demonstrated that microbiota plays a very important role in pathophysiology of metabolic disorders especially obesity and diabetes. In metabolic diseases the characteristic features of metabolic disorders such as insulin resistance, increased intestinal absorption of monosaccharides, increased expression levels of lipogenetic enzymes (acetyl-CoA carboxylase and fatty acid synthase), enhanced triglyceride synthesis and increased leptin level has been observed.
• Role in Inflammatory Bowel Diseases: Microbiome affects the inflammatory disease by causing changes to the metabolism of the host. Inflammatory bowel diseases can affect the intestinal tract which leads to microbial changes. The inflammatory process in IBD could be affected by the host genetics and certain environmental factors like diet.
• Role in Cancers: Studies have shown tumor-promoting effects of the microbiota in spontaneous, genetically-induced and carcinogen-induced cancers in various organs, including the skin, colon, liver, breast and lungs. Cancer has seen to promote dysbiotic microbiomes.

Microbiome if well understood can be used as personalized medicine which can be tailor made according to the patient’s need. The reprogramming of the gut bacteria to perform certain functions can be used for treating various conditions by restoring the gut microbiome. Since body’s own gut microbes are going to be modified or altered, there are no chances of serious side effects that could be seen. The main focus why microbiome can be the future medicine is their important property of changeability. Depending on the requirement of gut environment the microbes and the community changes from time to time which can help us target specific microbiome that might be causing a disease or is causing an imbalance and thus improper functioning. Using these properties one can alter the functioning and thus be a potential therapeutic treatment method.  

"Microbiome Disease- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Microbiome Disease pipeline landscape is provided which includes the disease overview and Microbiome Disease treatment guidelines. The assessment part of the report embraces, in depth Microbiome Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Microbiome Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Microbiome Disease R&D. The therapies under development are focused on novel approaches to treat/improve Microbiome Disease.

Microbiome Disease Emerging Drugs Chapters

This segment of the Microbiome Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Microbiome Disease Emerging Drugs

• MaaT 013: MaaT Pharma

MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (group of bacterial genera known to produce immuno-regulatory metabolites). It aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use. Currently the drug is in Phase III stage of development for the treatment of Graft-versus-host disease.

• QBKPN: Qu Biologics

QBKPN SSI, a first-in-class immune modulator designed to optimize immunity and barrier function in the lungs. The clinical trial is designed to assess QBKPN’s effectiveness in restoring innate immunity, the prevention of serious morbidity and mortality from respiratory infections, including COVID-19 and its variants, and reduction in all-cause mortality. QBKPN SSI is designed to restore and enhance innate immune function, the body’s first line of defense against all infections and other diseases such as cancer. Currently the drug is in Phase II stage of development for the treatment of immunodeficiency disorders.

• BMC128: Biomica Ltd.

BMC128 is a rationally-designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform. Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbour specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes. Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria. The drug is currently in Phase I stage of development for the treatment of patients with colorectal cancer.

• SER-155: Seres Therapeutics

SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development MbTx platform technologies. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays, and in vivo disease models. The SER-155 composition is designed to prevent and decrease the colonization and abundance of bacterial pathogens that can harbor antibiotic resistance and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections and GvHD. SER-155 has received FDA Fast Track Designation. The drug is currently in Phase I stage of development for the treatment of patients with Bacteraemia.

• MVT-201: Micro Viable Therapeutics

MVT-201, is an orally administered capsule generated under cGMP conditions representing the complete gut microbiota of a clinically validated healthy donor and will get into the clinical trials in 2024 for undisclosed targets. The lead product, MVT-201, is under evaluation at pre-clinical stage with positive results, and it is a unique in its kind biological drug based on complete microbiota (HiPMTM) for undisclosed targets. The microbiota-derived product development platform also includes rationally design and defined bacterial consortia that will be advanced with this funding. This investment will enable to consolidate Microviable’s growth and focus towards the therapeutics, while increasing their facilities and headcount. The drug is currently in Preclinical stage of development for the treatment of patients with infectious diseases.

Microbiome Disease: Therapeutic Assessment

This segment of the report provides insights about the different Microbiome Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Microbiome Disease

There are approx. 140+ key companies which are developing the therapies for Microbiome Disease. The companies which have their Microbiome Disease drug candidates in the most advanced stage, i.e. Phase III include, MaaT Pharma

Phases

The report covers around 180+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Microbiome Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Microbiome Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Microbiome Disease therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Microbiome Disease drugs.

Microbiome Disease Report Insights

• Microbiome Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Microbiome Disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Microbiome Disease drugs?
• How many Microbiome Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Microbiome Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Microbiome Disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Microbiome Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• MaaT Pharma
• Qu Biologics
• Biomica Ltd.
• Seres Therapeutics
• Micro Viable Therapeutics
• Metagen Therapeutics, Inc
• Microbiotica
• Enterome
• Azitra
• Vedanta Biosciences, Inc

Key Products

• MaaT 013
• QBKPN
• BMC128
• SER-155
• MVT-201
• MaaT03X
• MGT-001
• MGT-007
• MB097
• MB310
• EO2463
• ATR-12
• ATR-04
• VE202
• VE303
• VE707

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