The microbiome manufacturing market is valued at USD 27 million in 2023 growing at a CAGR of 17% during the forecast period 2023-2035.
The human body hosts diverse microbial communities, collectively known as microbiota, which include beneficial and harmful species. The microbiome refers to the ecological system of microorganisms residing within a host, comprising commensal, symbiotic, and pathogenic organisms. Given their significance in disease development, interest in microbiome-based therapeutics has grown within the medical science community. Over the past two decades, significant progress has been made in microbiome therapy research and applications. Live biotherapeutic products (LBPs), a category of microbiome therapy, utilize live microorganisms like bacteria, viruses, or fungi to prevent or treat diseases. These products are meticulously designed for therapeutic purposes and are regulated as medicinal products or biologics in many countries. They typically involve specific, extensively researched microorganism strains tested through clinical trials for safety and efficacy in treating specific conditions. Furthermore, microbiome-based therapies hold promise in tailoring treatment options based on patient microbiome composition through gene sequencing.

An important milestone occurred in November 2022 when the US Food and Drug Administration (FDA) approved the first microbiome-based therapy, RBX2660 developed by Rebiotix, for recurrent Clostridium difficile infection treatment.
The emergence of microbiome-based live biotherapeutic products in clinical pipelines suggests this therapeutic segment will be a rapidly growing market within the pharmaceutical industry. Despite advancements, challenges persist in microbiome manufacturing, particularly for live bacterial therapies. These challenges include lengthy development timelines, strict temperature control requirements, complex engineering of aerobic/anaerobic strains, and quality attribute inconsistencies in final products. To address these challenges, human microbiome therapy developers are turning to Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) for outsourcing manufacturing. These entities, part of the broader biologics contract manufacturing market, are increasingly integrating novel technologies to streamline microbiome manufacturing processes, enhance production efficiency, and improve quality. This trend is expected to drive growth in both the microbiome and microbiome manufacturing markets.


Key Market Segments

Type of Product Manufactured

  • API
  • FDF

Type of Formulation

  • Solid
  • Liquid
  • Others

Type of Primary Packaging Used

  • Blister Packs
  • Glass / Plastic Bottles
  • Pouches / Sachets
  • Vials

Scale of Operation

  • Clinical
  • Commercial

Company Size

  • Small
  • Mid-sized
  • Large and Very Large

Key Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

Leading Developers

  • Infant Bacterial Therapeutics
  • MaaT Pharma
  • Microbiomik Healthcare
  • OxThera
  • Rebiotix
  • Seres Therapeutics

Research Coverage:

  • The report studies the microbiome manufacturing market based on type of product manufactured, type of formulation, type of primary packaging used, scale of operation, company size, key geographical regions and leading developers
  • The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
  • The report forecasts the revenue of market segments with respect to four major regions
  • The report offers a comprehensive overview of the human microbiota and microbiome concept, encompassing information on different types of microbiome therapeutics. It delves into the functions of the microbiota, emphasizing key insights from the Human Microbiome Project (HMP). Additionally, the chapter outlines the manufacturing process of microbiome therapeutics, including associated challenges and the increasing trend of outsourcing in this field. Lastly, it presents a list of crucial factors for innovator companies to consider when selecting a Contract Manufacturing Organization (CMO) partner.
  • Comprehensive analysis of the current landscape of microbiome manufacturing services for the development of microbiome therapeutics considering parameters such as establishment year, company size, headquarters, scale of operation, type of product manufactured, primary packaging used, type of microbe used, type of service offered, number of manufacturing facilities and type of microbial species used. Further, report also features details on in-house manufacturers of live biotherapeutic products and microbiomes.
  • An in-depth overview of microbiome manufacturing facilities strategically positioned in major geographical regions (North America, Europe, and Asia-Pacific), emphasizing pivotal manufacturing centers for microbiome products.
  • Detailed company competitiveness evaluation of microbiome manufacturing service providers, considering supplier strength in terms of year of establishment, portfolio strength in terms of scale of operation, type of product manufactured, type of formulation, type of primary packaging used and number of manufacturing facilities, and number of services offered.
  • In-depth profiles of companies offering contract manufacturing services for live biotherapeutic products at both clinical and commercial scales of operations, focusing on company overviews, service portfolio, microbiome manufacturing facilities, recent advancements, and informed future prospects.
  • An evaluation of microbiome-centric endeavors pursued by major pharmaceutical corporations. This assessment includes heat map depictions illustrating these companies’ activities, such as partnerships, financial commitments, early-stage and late-stage pipeline development, therapeutic focus areas, and portfolio breadth. Additionally, a spider web analysis is conducted to compare the initiatives of these major pharmaceutical entities across various pertinent parameters.
  • A comprehensive examination of completed, ongoing, and anticipated clinical trials involving diverse microbiome therapeutics, considering several parameters such as trial registration date, trial status, phase of the trial, patient enrollment demographics, sponsoring entity type, leading industry participants, study methodology, therapeutic focus, and primary geographical regions.
  • An estimation of the total manufacturing capacity for microbiome-based therapies, derived from data disclosed by industry participants in publicly available sources. This analysis emphasizes the allocation of capacity across different company scales and major geographic regions.
  • Estimating the annual clinical and commercial demand for microbiome therapeutics involves analyzing the target patient population participating in ongoing and planned clinical trials sponsored by both industry and non-industry entities. This estimation considers factors such as disease prevalence, trial enrollment numbers, and market trends.
  • A qualitative assessment outlining key considerations for microbiome therapeutics developers when determining whether to internally manufacture their products or outsource to a Contract Manufacturing Organization (CMO).
  • A case study examining the present market environment of contract research organizations specializing in microbiome studies and providers of dietary supplements, detailing their founding year, organizational size, and headquarters location.


Key Benefits of Buying this Report

  • The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
  • Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
  • The report provides stakeholders with a pulse on the microbiome manufacturing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.