Microbiome Manufacturing Market (3rd Edition): Industry Trends and Global Forecasts, till 2035: Distribution by Type of Product Manufactured, Type of Formulation, Type of Primary Packaging Used, Scale of Operation, Company Size, Key Geographical Regions and Leading Developers

The analyst believes that a lot of start-ups have entered the market, however, only a few companies have established their own facilities to manufacture microbiome-based products. This is primarily due to the fact that the cost of establishing an LBP production facility is high, and therefore, requires significant capital investment. As a result, companies have demonstrated preference to outsource manufacturing operations.

The global microbiome manufacturing market size is estimated to grow from USD 27 billion in 2023 to USD 187 billion by 2035, representing a CAGR of 17% during the forecast period 2023-2035. The human body is known to harbor numerous communities of microbes, including both beneficial and harmful species, which are collectively referred to as microbiota. Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome. Given the role of the microbiota in both disease development and pathogenesis, the concept of microbiome-based therapeutics has, over time, piqued the interest of the medical science community.

In fact, the last two decades have witnessed several developments in the field of microbiome therapy research and their therapeutic applications. Live biotherapeutic products (LBP), a class of microbiome therapy, involve the use of live microorganisms, such as bacteria, viruses, or fungi, to prevent or treat various disease conditions. LBPs are specifically designed for therapeutic purposes and are regulated as medicinal products or biologics in many countries. These therapeutic modalities consist of well-characterized specific strains of microorganisms that are extensively researched for their intended medical applications, followed by rigorous testing and clinical trials to demonstrate safety and efficacy for treating or preventing specific medical condition. Further, the microbiome-based therapeutic approach has the potential to profile the microbiome composition of the patient using gene sequencing; this will lead to the development of tailored treatment options.

It is worth highlighting that in November 2022, the US Food and Drug Administration (FDA) approved the first microbiome-based therapy, RBX2660 (developed by Rebiotix) for the treatment of recurrent Clostridium difficile infection.

With the advancement of several promising microbiome-based live biotherapeutic products through clinical pipelines, this upcoming therapeutic segment is anticipated to become one of the fastest growing global market within the pharmaceutical industry in the coming years. Despite several developments in the field of microbiome-based therapies, and decades of experience growing bacteria to produce biologics, the biotech industry is still ill-equipped for microbiome manufacturing, including live biotherapeutic products manufacturing.

Manufacturing of live bacterial therapies at large scale is fraught with various challenges. Some of the key concerns of contemporary innovators include prolonged development timelines, stringent temperature control requirements, complex engineering of diverse aerobic / anaerobic strains (depending on the type of microbe) and inconsistencies related to quality attributes of the final product. Therefore, outsourcing of microbiome therapeutics manufacturing to CMOs and CDMOs emerged as a lucrative option for human microbiome therapy developers to overcome the existing manufacturing issues. These CMOs and CDMOs (which are a part of the broader biologics contract manufacturing market) are increasingly focusing on enhancing their offerings by incorporating novel technologies in order to streamline microbiome manufacturing processes, increase production efficiency, and improve quality. This will further propel the microbiome market as well as the microbiome manufacturing market.

Microbiome Manufacturing Market Key Market Insights

The report features an extensive study of the current market landscape, market size and future opportunities for the microbiome manufacturing companies, including those involved in live biotherapeutic manufacturing, during the given forecast period. Further, this microbiome manufacturing market analysis highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the microbiome manufacturing market report are briefly discussed below.

Competitive Landscape of Microbiome Manufacturing Companies

The microbiome manufacturing market features a mix of large, mid-sized and small in-house players and contract manufacturing organizations that are engaged in the production of microbiome therapy across different scales of operations, such as preclinical, clinical, and commercial. Currently, 50% of the microbiome therapy contract manufacturers offer services for both API and FDF manufacturing; notable examples (in alphabetical order) include Arranta Bio, BacThera, Biose, Capsugel and Cerbios-Pharma. In addition, majority of the microbiome companies offer probiotic manufacturing services on a contract basis.

It is worth mentioning several microbiome-based products, including fecal microbiota transplantation (FMT) procedures, and dietary supplements, have been approved in the US; of which probiotics / prebiotics are the most commonly available formulations in the market as they do not require marketing approval from the regulatory agencies. Notably, in April 2023, SER-109, a microbiome-based first oral therapy developed by Seres Therapeutics for the prevention of recurring Clostridium difficile infection, received marketing approval from the FDA. The growing demand for novel microbiome therapeutics, approvals from various regulatory bodies and technological advancements in order to streamline the manufacturing process, are expected to drive the microbiome manufacturing market growth during the forecast period.

Clinical Trials Analysis: Close to 170 Trials are Evaluating Microbiome Therapeutics to Treat Various Infectious Diseases and Oncological Disorders

Over the years, microbiome companies involved in the manufacturing of microbiome therapeutics have made significant efforts to conduct clinical trials for evaluating the efficacy of microbiome therapies targeting various disorders, including infectious diseases (bacterial vaginosis, clostridium difficile infection, COVID-19, cystic fibrosis, tinea pedis and urinary tract infections), neurological disorders (autism, bipolar depression, Parkinson’s disease, stroke) and oncological disorders (advanced malignant solid tumor, breast cancer, colon cancer, gastric cancer, melanoma and non-small cell lung cancer). Close to 170 clinical trials have been conducted across different geographical regions to evaluate various microbiome therapies, of which, majority (70%) were registered in North America. Further, the maximum number of patients (10,138) were observed to be enrolled in clinical trials conducted in North America, which account for 52% of the overall enrollment. It is worth mentioning that AOBiome is conducting the maximum number of trials in this industry for different dermatological, respiratory and CNS disorders. In addition, VE303 (developed by Vedanta Biosciences) for the treatment of recurrent Clostridium difficile infection has demonstrated positive results in the Phase II clinical trials.

Market Trends Analysis: Partnerships and Collaborations have Fueled Microbiome Manufacturing Market Growth

Several stakeholders have been forging alliances with other industry / non-industry players in the microbiome therapeutics contract manufacturing industry. It is worth highlighting that since 2018, over 50 strategic partnerships have been established in this domain, of which the majority are focused on research, product development, and technology utilization. In June 2023, Biose entered into a technology utilization agreement with SBT Instruments in order to integrate the latter company’s technology into the former company’s manufacturing process, with an aim to shorten the drug development timelines from clinical trials to market. Earlier, in April 2023, Microbiotica had signed an agreement with MSD to evaluate the clinical activity of its live biotherapeutic product, MB097, in combination with KEYTRUDA®, MSD’s anti-PD-1 therapy, in melanoma patients with primary resistance to an anti-PD-1-containing immunotherapy. This can be attributed to the incessant efforts of microbiome manufacturers to further advance the development of their product offerings, across different phases.

Microbiome Contract Manufacturing Companies’ Capacity Utilization Rate is Expected to Increase Significantly in the Coming Years

Around 43% of the global microbiome contract manufacturing capacity is installed in facilities owned by small contract manufacturing companies. Further, majority share (57%) of the overall microbiome manufacturing capacity is installed in facilities located in Europe; within Europe, more than 35% of this capacity is installed in facilities owned by players based in Austria. This can be attributed to the fact that majority of the manufacturing facility dedicated to the production of microbiome are located in Europe. It is worth mentioning that, over the past few years, the microbiome manufacturing capacity installed in Asia-Pacific and rest of the world has also increased at a commendable pace. This is primarily driven by the technical advances, low labor costs and socio-economic reforms favoring the growth of specialty industries, such as the microbiome industry.

Microbiome Manufacturing Market Size: Europe to Hold the Largest Market Share

The microbiome manufacturing market is estimated to be worth USD 27 million in 2023. Driven by the growing pipeline of microbiome-based products, the microbiome manufacturing market is anticipated to grow at a CAGR of 17% during the forecast period. Specifically, in terms of type of product manufactured, majority of the market share is anticipated to be captured by APIs by 2035. Further, the liquid dosage form continues to hold the largest share (50%) in the contract manufacturing industry.

Leading Contract Manufacturing Companies Engaged in Microbiome Manufacturing Market

Examples of key microbiome contract manufacturing companies (which have also been profiled in this report) offering manufacturing services include (in alphabetical order) Biose, BJP Laboratories, Capsugel, Cerbios-Pharma, Chr. Hansen, Inpac Probiotics, NIZO, WACKER and Winclove. In addition, MaaT Pharma is in the process of expanding its cGMP manufacturing capacity through the addition of a new plant in France that will exclusively focus on microbiome therapeutics manufacturing; the plant is set to be operational before the end of 2023. This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.

Recent Developments in Microbiome Manufacturing Market

Several recent developments have taken place in the field of microbiome manufacturing. These developments, even if they took place post the release of the market report, substantiate the overall market trends that have been outlined in the analyses. Some of the recent instances have been mentioned below.

• In July 2023, MaaT Pharma joined Microbiome Therapeutics Innovation Group, a company leading the research and development of FDA-approved microbiome live biotherapeutics.
• In March 2023, Mbiomics, a German-based microbiome company, raised USD 13 million in a series A round led by MIG Capital. The company plans to use the funds for the development of its proprietary platform, in order to accelerate the identification of the lead drug candidates and expedite the research towards clinical validation.

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in microbiome manufacturing industry, across different segments, as defined below:

• Base Year: 2022
• Forecast Period: 2023-2035
• Market Size 2023: $27 Million
• CAGR: 17%
• Customization Scope: 15% Customization Available
• PowerPoint Presentation: (Complimentary)
• 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
• Key Companies Profiled
  • Biose
  • BJP Laboratories
  • Capsugel
  • Chr. Hansen
  • Inpac Probiotics
  • NIZO
  • WACKER
  • Winclove
  • (Full list of more than 60 companies captured is available in the report)
• Excel Data Packs: (Complimentary)
  • Market Landscape Analysis
  • Company Competitiveness Analysis
  • Likely Partner Analysis
  • Big Pharma Initiatives
  • Recent Developments and Initiatives
  • Clinical Trial Analysis
  • Capacity Analysis
  • Demand Analysis
  • Market Forecast and Opportunity Analysis

The microbiome manufacturing market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different geographies.

Amongst other elements, the market research report features:

• A preface providing an introduction to the full report, Microbiome Manufacturing Market, 2023-2035.
• An outline of the systematic research methodology adopted to conduct the study on microbiome manufacturing market, including live biotherapeutic products, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
• An overview of economic factors that impact the overall microbiome manufacturing industry, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during the research, offering a high-level view on the current state of the microbiome manufacturing market and its likely evolution in the short to mid and long term.
• A general overview of the concept of the human microbiota and microbiome, along with information on the various types of microbiome therapeutics. It also features an elaborate discussion on the functions of the microbiota, emphasizing on the key insights generated from the human microbiome project (HMP). Further, the chapter features the various steps that are involved in the manufacturing of microbiome therapeutics. In addition, it highlights the challenges associated with manufacturing such products and the growing need for outsourcing in this domain. Finally, it provides a list of key factors that need to be considered by innovator companies while selecting a CMO partner.
• A overview of the current market landscape of companies engaged in offering microbiome manufacturing services for the development of microbiome therapeutics, along a detailed analysis based on several relevant parameters, such as year of establishment, company size, location of headquarters, scale of operation (preclinical, clinical and commercial, type of product manufactured (API and FDF), type of formulation (solids, liquids and other forms), type of primary packaging used (blister packs, sachets / pouches, glass / plastic bottles and vials), type of microbe used (aerobic, anaerobic and genetically engineered strains), type of service offered (strain isolation, lyophilization, fill-finish, cell banking, analytical services / quality control, process development), number and location of manufacturing facilities and bioprocessing capacity, type of microbial species used (Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, E.coli, Bacillus, Clostridium, Faecalibacterium, Others).
• A detailed landscape of the microbiome manufacturing facilities established across key geographical regions (North America, Europe and Asia-Pacific), highlighting the key manufacturing hubs for microbiomes.
• An in-depth company competitiveness analysis of microbiome manufacturing service providers based on supplier strength (in terms of years of experience), 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.
• Detailed profiles of the key players (large and mid-sized companies, established before 2000) based in North America, Europe and Asia-Pacific that offer contract manufacturing services for live biotherapeutic products at both clinical and commercial scales of operations. Each profile features a brief overview of the company, microbiome-related service portfolio, along with information on microbiome manufacturing facilities, and recent developments and an informed future outlook.
• A list of nearly 70 microbiome-focused drug developers that are likely to partner with manufacturers engaged in this domain. These players have been shortlisted based on several relevant parameters, such as developer score (which takes into account the company’s size and its experience in this field), pipeline maturity (which takes into account the number of pipeline drugs and their affiliated stage of development), pipeline strength (which takes into account the number of microbiome drugs in the company’s pipeline), and availability of in-house manufacturing capabilities.
• An analysis of the various microbiome-focused initiatives undertaken by big pharma players (shortlisted based on the revenues generated by the top 15 pharmaceutical companies in 2022) featuring heat map representations of these players highlighting their initiatives (in terms of partnerships, funding and investments, early stage pipeline, late stage pipeline, therapeutic areas and portfolio diversity), and a spider web representation comparing the initiatives of big pharma players based on several relevant parameters.
• An analysis of recent developments in the microbiome manufacturing industry, featuring information on several partnerships and collaborations, mergers and acquisitions, and expansion initiatives that have taken place in this domain, during the period 2016-2023.
• An in-depth analysis of completed, ongoing, and planned clinical studies of various microbiome therapeutics, based on several relevant parameters, such as trial registration year, trial status, trial phase, enrolled patient population, type of sponsor, most active industry players (in terms of number of trials conducted), study design, therapeutic area and key geographical regions.
• An estimate of the overall installed capacity for manufacturing of microbiome-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity based on the company size (small, mid-sized, and large and very large firms) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
• An informed estimate of the annual clinical and commercial demand for microbiome therapeutics, taking into account the target patient population in ongoing and planned clinical trials of microbiome therapeutics, sponsored by both industry and non-industry players.
• A qualitative analysis, highlighting various factors that need to be taken into consideration by microbiome therapeutics developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
• A case study on the current market landscape of microbiome contract research organizations and dietary supplement providers, including information on their year of establishment, company size and location of headquarters.

The key objective of this market report is to provide a detailed market forecast analysis in order to estimate the existing microbiome manufacturing market size and future opportunity for microbiome manufacturers over the next decade. Based on several parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the current and forecasted opportunity within the microbiome manufacturing market across various relevant parameters, such as distribution by type of product manufactured (API and FDF), type of formulation (solid, liquid and others), type of primary packaging used (blister packs, glass / plastic bottles, pouches / sachets and vials), scale of operation (clinical and commercial), company size (small, mid-sized, and large and very large), key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World) and leading developers. In order to account for future uncertainties with some of the key parameters and add robustness to the model, the analyst has 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 the market report were influenced by discussions held with stakeholders in the industry:

• Founder and Executive Chairman, Small Company, US
• Managing Director and Scientific Head, Large Company, India
• Managing Director and Chief Executive Officer, Mid-sized Company, India
• Co-Founder and Chief Executive Officer, Small Company, Belgium
• Founder and Chief Executive Officer, Small Company, US
• Chief Business Officer, Mid-sized Company, Israel
• Chief Operating Officer, Mid-sized Company, US
• Vice President, Business Development, Small Company, US
• Vice President, Commercial Operations, Mid-sized Company, US
• Vice President, Business Development, Mid-sized Company, US
• Vice President, Sales and Business Development, Small Company, US
• Head of Business Development, Mid-sized Company, Australia
• Business Development Manager, Large Company, Germany

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.