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I believe 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
-Vice President, Sales and Business Development, a US based Small-sized Company
The global microbiome manufacturing market size is estimated to grow from USD 40.6 million in 2024 to USD 186.7 million by 2035, representing a CAGR of 14.9% during the forecast period.
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.
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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.
The “Microbiome Manufacturing Market 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: Industry Trends and Global Forecasts, Till 2035” 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.
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The microbiome manufacturing market features a mix of large, mid-sized and small in-house players and continuous 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.
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.
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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.
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.
The microbiome manufacturing market is estimated to be worth USD 40.6 million in 2024. 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.
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. This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.
Several recent developments have taken place in the field of microbiome manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
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The study presents an in-depth analysis of the various firms / organizations that are engaged in microbiome manufacturing industry, across different segments, as defined in the below table:
| Report Attribute | Details | |
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Market Size, 2024 |
$40.6 Million | |
| Forecast Period | Till 2035 | |
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Market Size, 2035 |
$186.7 Million |
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| CAGR |
14.9% |
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| Type of Product Manufactured |
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| Type of Formulation |
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| Type of Primary Packaging Used |
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| Scale of Operation |
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| Company Size |
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| Key Geographical Regions |
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| Leading Developers |
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| Key Companies Profiled |
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| Customization Scope | 15% customization available | |
| PowerPoint Presentation (Complimentary) |
Available |
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| Excel Data Packs (Complimentary) |
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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:
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, we have provided an informed estimate on the market evolution during the forecast period till 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 our model, we have 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.
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.