Biotherapeutic Products and Microbiome Contract Manufacturing Market by Roots Analysis

With over 85 microbiome-based, live biotherapeutic products under preclinical and clinical development, the demand for R&D and manufacturing services for such products is anticipated to increase beyond the capabilities of innovator companies alone


Roots Analysis has announced the addition of “Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2020-2030: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030 report to its list of offerings.

Manufacturing live biotherapeutic products is both technically challenging and financially demanding; as a result, innovator firms are becoming increasingly reliant on contract service providers to access specialized facilities and optimize overall costs.

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Key Market Insights

Over 25 players claim to provide microbiome-based live biotherapeutics contract manufacturing

More than 80% of the companies engaged in this domain are mid-sized and large firms; examples of firms established in 2019 include Arranta Bio and BacThera (a Lonza and Chr. Hansen joint venture). Further, nearly 50% of the CMOs have established the necessary expertise for handling both anaerobic and aerobic strains.

35+ manufacturing facilities focused on live biotherapeutics have been established worldwide

Majority (~55%) of the manufacturing facilities are located in Europe, followed by North America. Prominent manufacturing hubs in the Europe include (in decreasing order of number of manufacturing facilities) the UK, France, the Netherlands, Italy, Germany, Switzerland, and Sweden.

Approximately 88% of the total installed capacity is dedicated to commercial scale manufacturing 
Whereas, rest (~10%) of the capacity is being used for preclinical / clinical scale manufacturing of microbiome products. In addition, over 60% of the total current global, installed manufacturing capacity is installed in Europe.

Over 170 registered clinical trials involved the use of microbiome-based live biotherapeutics

Majority of these studies are being conducted at various hospitals / centers across the US. Examples of leading non-industry players include (in decreasing order of number of trials) University of California, National Institute of Allergy and Infectious Diseases, Radboud University, and The University of Texas Health Science Center.

The global clinical demand for microbiome-based live biotherapeutic products is anticipated to grow at a CAGR of 23%, between 2020 and 2030

By 2030, over 31,000 patients are estimated to be enrolled in the clinical trials involving the use of microbiome-based live biotherapeutics. Industry players are anticipated to contribute majority (over 60%) of the demand in the short-term as well as long-term.

Several big pharma players are actively engaged in the microbiome live biotherapeutics domain

In fact, leading pharmaceutical companies have partnered with smaller business entities to develop manufacturing capabilities related to microbiome-based therapies / diagnostics. Examples of such small ventures with players with in-house capability include (in alphabetical order) Assembly Biosciences, Enterome Bioscience, Finch Therapeutics and NuBiyota.

By 2030, North America and Europe are anticipated to capture over 85% of the market opportunity

In terms of type of product manufactured, APIs currently represent the highest share (58%); this trend is unlikely to change in the foreseen future.

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Key Questions Answered

  • Who are the leading CMOs offering microbiome contract manufacturing services, across the world?
  • What are the key challenges faced by microbiome contract manufacturers?
  • Who are the most likely partners (microbiome-based live biotherapeutic drug developers) for microbiome contract manufacturers?
  • What is the annual clinical demand for microbiome-based live biotherapeutic products?
  • What is the current, installed contract manufacturing capacity for live biotherapeutics?
  • What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision in this field?
  • What are the various initiatives undertaken by big pharma players in this domain?
  • What percentage of live biotherapeutics manufacturing operations are outsourced to service providers?
  • How is the current and future market opportunity likely to be distributed across key market segments?
  • What are the anticipated future trends related to live biotherapeutics manufacturing?

The USD 300 million (by 2030) financial opportunity within the microbiome contract manufacturing market has been analysed across the following segments:

  • Type of Product Manufactured
  • Active Pharmaceutical Ingredients (APIs)
  • Finish Drug Formulations (FDFs)

Type of Type of Formulation

  • Solid Formulations
  • Oral Liquids
  • Injectables
  • Others

Scale of Operation

  • Clinical
  • Commercial

Company Size

  • Small-sized
  • Mid-sized
  • Large

Key Geographical Regions

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

The research covers detailed profiles brief profiles of several companies (including those listed below); each profile features an overview of the company, its financial information (if available), microbiome-related service portfolio, facilities dedicated to microbiome manufacturing, and an informed future outlook.

  • Biose®
  • BJP Laboratories
  • Capsugel (acquired by Lonza)
  • Cerbios-Pharma
  • Cobra Biologics (acquired Cognate Bioservices)
  • Inpac Probiotics
  • Paragon Bioservices (a unit of Catalent Biologics)
  • UAS Labs

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at [email protected]

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