Microbiome Therapeutics Market Size, Share and Trends Analysis, By Product Type (Probiotics, Prebiotics, Synbiotics, Live Biotherapeutic Products (LBPs), Fecal Microbiota Transplantation (FMT), and Others), By Mode of Administration, By Therapeutic Area, By End-Use (Hospitals & Clinics, Research Institutes & Academic Centers, Pharmaceutical & Biotechnology Companies, and Others), and By Region, Forecast 2025-2032

Microbiome Therapeutics Market Overview and Key Insights:

The microbiome therapeutics market size reached USD 176.4 million in 2024 and is expected to register a revenue CAGR of 32.8% during the forecast period. Microbiome therapeutics aim to manipulate the gut microbiome by additive, subtractive, or modulatory therapy that includes native or created bacteria, antibiotics, bacteriophages, and bacteriocins.

Market Drivers:

Rising burden of chronic and lifestyle-related diseases is a key driver of revenue growth in the microbiome therapeutics market. According to the International Diabetes Federation (IDF), diabetes affects 589 million adults aged 20 to 79 worldwide, accounting for one in every nine. By 2050, the overall number of adults with diabetes is expected to reach 853 million, accounting for one in every eight. Diabetes was responsible for an estimated USD 1.015 trillion in worldwide health spending in 2024. 635 million persons globally (1 in 8) have impaired glucose tolerance, and 488 million have impaired fasting glucose (1 in 11), putting them at high risk for type 2 diabetes. Hyperglycemia during pregnancy affects one out of every five live babies.

With increasing understanding about the potential of gut microorganisms, the field of therapeutics expanded, bringing new promise for disease detection, test methodologies, and novel data gathering and manipulation techniques. Live biotherapeutics are being developed to introduce bacteria into the body.

Technological advancements have made it possible to examine the pleiotropic effects of the human gut microbiome in health and disease. To manage dysbiosis-related illnesses, strategies such as fecal microbiota transplantation (FMT) or probiotics based on the introduction of exogenous bacteria may be used. Recent advances in synthetic biology have enabled the prospect of targeted cell therapy by probiotic engineering that targets specific cells, tissues, or processes.

On July 2024, Kanvas Biosciences, a full-stack spatial biology firm, announced that it has raised USD 12.5 million in fresh funding, led by existing investors DCVC and Lions Capital LLC, with participation from FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures, as well as previous investors. The funds will be utilized to enhance the company’s spatial biology platform as well as two new medicines in its Immuno-oncology Program, KAN-001 and KAN-003, with KAN-001 slated for an Investigational New Drug (IND) filing in 2025.

Market Opportunity:

Emergence of AI and multi-omics platforms and pipeline growth in oncology, CNS, and immunotherapy acts as opportunities for microbiome therapeutics market. The gut microbiome has a role in human health and disease, and a thorough understanding is required to use it as a diagnostic or therapeutic tool. Multi-omics methods, such as metagenomics, metatranscriptomics, metabolomics, and metaproteomics, allow for the visualization of the gut microbial ecosystem’s complexity.

Artificial intelligence and machine learning are rapidly being used to analyse multi-omics information in a variety of illnesses related with microbiome disruption, including chronic disorders and cancer. Such methods have clinical applications, such as identifying microbial biomarkers for disease classification or prediction, predicting treatment response, and fine-tuning microbiome-modulating medications.

On April 2024, Seed Health has introduced CODA, a computational biology platform for the discovery and development of next-generation precision probiotics and microbiome-directed therapies. The platform is driven by the Human Phenotype Project, the world’s largest multi-omics data set at the Weizmann Institute of Science. CODA uncovers previously unknown relationships between the microbiome and health to create targeted, outcome-specific therapies.

Recent Trends:

Emerging trends include Intelligent Responsive Bacteria for Diagnosis and Therapy (iROBOT) system, microbiome-immune axis in oncology, global expansion and clinical trials, and shift toward defined consortia and precision therapies.

Rapid advances in synthetic biology have increased interest in created microorganisms capable of diagnosing and treating disease. Intelligent responsive bacteria for diagnosis and therapy (i-ROBOT) is made up of E. coli Nissle 1917, which responds to inflammatory marker thiosulfate levels by activating a base-editing machinery that generates a heritable genomic DNA sequence as well as a colorimetric signal.

The immuno-oncology-microbiome (IOM) axis is a novel idea based on the complex interactions between the immune system, cancer cells, and microbial components. The developing single-cell and spatial profiling approaches can reveal strain-level genetic variants with great precision and show dynamic network connections between microbiota, cancer cells, and immune components.

Encouraging research in the IOM axis has spurred strong interest in using microbiota-based treatments to enhance immunotherapy. Furthermore, synthetic biotechnology and microbial engineering are expanding the possibility for targeted and individualized cancer therapies.

Restraints & Challenges:

Lack of standardization and scientific consensus acts as restraints for microbiome therapeutics market.

Despite their great therapeutic promise, microbiome data remain challenging to study and interpret due to a variety of variables, including compositional structure, which introduces a negative correlation bias, sparsity, and collinearity. The diversity of microbial ecosystems has resulted in a lack of understanding of individual microbial–host interactions. Consequently, the effects of probiotics and synbiotics are not entirely known.

The human microbiome comprises a complex array of microorganisms, and knowledge of their individual roles in human health remains limited. There is a lack of a comprehensive understanding of how successfully these microbial species perform their roles, their interactions with the host and other microbial species, and their specific locations within the host where they exert their influence. This knowledge gap highlights the need for further research to better understand these complex relationships.

Product Type Segment Insights and Analysis:

Based on the product type, the microbiome therapeutics market is segmented into probiotics, prebiotics, synbiotics, Live Biotherapeutic Products (LBPs), Fecal Microbiota Transplantation (FMT), and others.

Probiotics segment contributed the highest market share in 2024. Probiotic therapy is one of the most convenient forms of additional therapy. Probiotics have been shown to effectively treat a variety of disorders, including inflammatory bowel disease, diarrhoea, Crohn’s disease, ulcerative colitis, and cancer. Probiotics modulate the host’s innate and adaptive immune responses via controlling immune cells such dendritic cells, macrophages, and B and T lymphocytes.

Furthermore, some studies have demonstrated the efficacy of probiotics in treating allergic diseases. Although probiotics cannot cure allergies, they can help to reduce the severity and duration of allergy symptoms. Researchers discovered that probiotic efficiency is impacted by factors such as the composition and activity of the individual’s gut microbiota, as well as the metabolites produced by the probiotic species.

On September 2024, ZBiotics, a biotechnology business that develops purpose-built genetically engineered probiotics to improve daily life, has announced the launch of Sugar-to-Fiber Probiotic Drink Mix, the first product of its kind for the consumer market. Sugar-to-Fiber, developed by a team of PhD microbiologists, is a genetically engineered probiotic that addresses deficits in the American diet by continually converting dietary sugar (sucrose) into a specific form of prebiotic fiber (levan).

Mode of Administration Segment Insights and Analysis:

Based on the mode of administration, the microbiome therapeutics market is segmented into oral capsules/tablets, rectal, injectable, and others.

Oral capsules/tablets segment contributed the largest market share in 2024. Oral capsules/tablets are key enablers in the commercialization and market expansion of microbiome therapeutics. These are convenient, non-invasive, and ideal for chronic or preventive therapies. They are easier and cheaper to manufacture as scale. Advanced formulations like freeze-dried or spore-based probiotics can remain stable at room temperature.

On April 2023, the US FDA has approved Vowst, the first oral fecal microbiota product. The FDA has licensed Vowst to prevent the recurrence of Clostridioides difficile (C. difficile) infection (CDI) in people aged 18 and older who have completed antibiotic treatment for recurrent CDI. Patients take Vowst by swallowing four capsules once daily for three consecutive days. Manufacturers create Vowst using live bacteria derived from human fecal matter donated by certified individuals.

Therapeutic Area Segment Insights and Analysis:

Based on the therapeutic area, the microbiome therapeutics market is segmented into gastrointestinal disorders, metabolic disorders, oncology, autoimmune disorders, neurological disorders, infectious diseases, and others.

Gastrointestinal disorders segment contributed the largest market share in 2024. Gastrointestinal disorders is further sub-segmented into Clostridium difficile infection (CDI), Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), and others. According to the Centre of Disease Control and Prevention (CDC), IBD is estimated to affect 2.4 to 3.1 million people in the United States, with varying burdens across demographics. North America has the highest global rates of IBD. The incidence of IBD in the United States is 721 cases per 100,000 person-years. Ulcerative colitis has a greater overall prevalence in the United States (378 per 100,000 person-years) than Crohn’s disease (305). Crohn’s disease is more common among children under the age of ten, with 2.4 cases per 100,000 person-years compared to 1.5 for ulcerative colitis.

On April 2023, Finch Therapeutics Group, Inc., a microbiome technology company with a portfolio of intellectual property and microbiome assets, announced that it has signed a clinical trial agreement with Brigham and Women’s Hospital to evaluate CP101, a Complete Consortia microbiome therapeutic, in ulcerative colitis patients. The company also provided changes to its license agreement with the University of Minnesota.

Geographical Outlook:

Microbiome therapeutics market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America Microbiome Therapeutics Market:

North America is registered to have largest market share in microbiome therapeutics market in 2024. This is mainly driven by rising burden of chronic and lifestyle-related diseases. According to the American Cancer Society, approximately 104,960 new melanomas will be diagnosed in the United States in 2025 (60,550 men and 44,410 women). Melanoma is anticipated to kill approximately 8,430 people (5,470 males and 2,960 women). Having lighter skin is a significant risk factor for melanoma. Overall, the lifetime chance of developing melanoma is approximately 3% (1 in 33) for Whites, 0.1% (1 in 1,000) for Blacks, and 0.5% (1 in 200) for Hispanics.

On June 2024, Kanvas Biosciences, a full-stack spatial biology business, has unveiled KAN-003, its newest immuno-oncology therapeutic candidate. The Kanvas platform stands out for its capability to map interactions between the host and microbiome, leveraging this data to develop live biotherapeutic products (LBPs). These products support the creation of innovative microbiome-based therapies that enhance current treatments and offer a safe, targeted approach to addressing the root causes of disease.

Asia Pacific Microbiome Therapeutics Market:

Asia Pacific is expected to register the fastest growth rate during the forecasted period, driven by growing scientific validation and research investments and expansion in personalized and preventive medicine. In Japan, research into the emerging subject of precision medicine is progressing, and various studies are underway to apply precision medicine to cancer, which continues to affect an increasing number of people worldwide. Japan has the primary advantage of having universal health insurance, which means that all citizens are covered by some form of medical insurance.

For instance, in Japan, Antibiotic Fecal Microbiota Transplantation (A-FMT) for ulcerative colitis was approved as an Advanced Medical Care B Program in January 2023. This program aims to provide patients with access to promising healthcare technologies through government assessments and National Health Insurance coverage.

On April 2024, Metagen Therapeutics, Inc. has launched J-Kinso Bank, Japan’s first intestinal microbiota bank, to research pharmacological therapies based on the gut microbiome for diverse disorders. The bank has begun recruiting gut microbiota donation candidates.

Europe Microbiome Therapeutics Market:

Europe is expected to have considerable market share in 2024, driven by pipeline growth in oncology, CNS, and immunotherapy. The UK is a global leader in microbiome science, with a focus on using public funds to benefit society. The NHS and government are conducting research on gastrointestinal tract problems and the microbiome’s impact on public health, such as obesity. The UK is Europe’s premier life sciences biotech country, with the highest private money raised, followed by Switzerland and Germany.

On July 2024, GitLife Biotech announced that it has received Innovate UK funding to research ground-breaking medicinal solutions in conjunction with NCIMB Ltd. This collaboration aims to use synthetic biology and living microbes to develop novel health-improving medicines. The Innovate UK funding funds a 12-month initiative centered on GitLife’s advanced genetic engineering platform, CellRepo, and its proprietary GenoSegnature technology. This initiative will improve the provenance and integrity of microbial strains, which is essential for generating safe and effective live biotherapeutics.

Competition Analysis:

The microbiome therapeutics market is characterized by a fragmented structure, with several players competing across various segments and regions. list of major players included in the microbiome therapeutics market report are:

• Seres Therapeutics
• BIOSE INDUSTRIE
• BiomeSense
• Rebiotix Inc.
• Infant Bacterial Therapeutics AB
• MaaT Pharma SA
• Enterome
• Vedanta Biosciences
• Freya Biosciences
• Finch Therapeutics Group, Inc
• Axial Therapeutics, Inc.
• Genetic Analysis
• Alveolus Bio
• Microba Life Sciences
• Siolta Therapeutics
• Altis Biosystems

Strategic Developments in Microbiome Therapeutics Market:

• In September 2024, Nexilico and Siolta Therapeutics, a leader in the development of live biotherapeutic products (LBPs), have signed a collaboration agreement to treat necrotizing enterocolitis (NEC) with novel microbial therapies. This collaboration brings together Nexilico’s modality-agnostic AI-driven discovery platform with Siolta’s experience in creating tailored biotherapeutics, paving the way for novel treatment methods in infant health.
• In March 2024, List Biotherapeutics, Inc. and Sacco System Australia Pty Ltd have entered into a lead-sharing agreement under which they will promote and refer each other’s microbial development and manufacturing services to potential clients. If either company identifies a project that aligns more closely with the other’s expertise or capacity, they will recommend it accordingly. The agreement does not involve any exchange of intellectual property between the two companies.
• In February 2024, Hudson Institute partner BiomeBank has received a multimillion-dollar Federal Government funding to accelerate the development and production of microbiome-based therapies. The Adelaide-based biotech startup has obtained a USD 2,147,887 grant from the Australian Government Cooperative Research Centres Projects (CRC-P) to establish a production facility for cultured microbial therapies. The initiative is a collaboration between BiomeBank, the Hudson Institute of Medical Research, and Cytiva.

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights Of The Microbiome Therapeutics Market Report:

The Microbiome Therapeutics market report offers a detailed analysis of market size, including historical revenue (in USD Million) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Product Type Outlook (Revenue, USD Million; 2022-2032)
  • Probiotics
  • Prebiotics
  • Synbiotics
  • Live Biotherapeutic Products (LBPs)
  • Fecal Microbiota Transplantation (FMT)
  • Others

• Mode of Administration Outlook (Revenue, USD Million; 2022-2032)
  • Oral Capsules/Tablets
  • Rectal
  • Injectable
  • Others

• Therapeutic Area Outlook (Revenue, USD Million; 2022-2032)
  • Gastrointestinal Disorders
    • Clostridium difficile infection (CDI)
    • Inflammatory Bowel Disease (IBD)
    • Irritable Bowel Syndrome (IBS)
    • Others
  • Metabolic Disorders
    • Obesity
    • Type 2 Diabetes
    • Non-alcoholic Fatty Liver Disease (NAFLD)
    • Others
  • Oncology
    • Melanoma
    • Non-small cell lung cancer
    • Lymphomas
  • Autoimmune Disorders
  • Neurological Disorders
  • Infectious Diseases
  • Others

• End-Use Outlook (Revenue, USD Million; 2022-2032)
  • Hospitals & Clinics
  • Research Institutes & Academic Centers
  • Pharmaceutical & Biotechnology Companies
  • Others

• Regional Outlook (Revenue, USD Million; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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