The contract manufacturing market for live biotherapeutics and microbiome products is estimated to be worth USD 300 million by 2030, growing at a CAGR of 46%, claims Roots Analysis
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.

development,the demand for R&D and manufacturing services for such products isanticipated to increase beyond the capabilities of innovator companies alone




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


Manufacturinglive biotherapeutic products is both technically challenging and financiallydemanding; as a result, innovator firms are becoming increasingly reliant oncontract service providers to access specialized facilities and optimizeoverall costs.


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KeyMarket Insights


Over25 players claim to provide microbiome-based live biotherapeutics contract manufacturing

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


35+ manufacturing facilities focused on live biotherapeuticshave been established worldwide

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


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


Over170 registered clinical trials involved the use of microbiome-based livebiotherapeutics

Majority of these studies are being conducted at varioushospitals / centers across the US. Examples of leading non-industry playersinclude (in decreasing order of number of trials) University ofCalifornia, National Institute of Allergy and Infectious Diseases, RadboudUniversity, and The University of Texas Health Science Center.


Theglobal clinical demand for microbiome-based live biotherapeutic products is anticipated to grow at a CAGRof 23%, between 2020 and 2030

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


Several big pharma players are actively engaged in the microbiomelive biotherapeutics domain

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


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

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


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Key Questions Answered

§ Who are the leading CMOsoffering microbiome contract manufacturing services, across the world?

§ What are the keychallenges faced by microbiome contract manufacturers?

§ Who are the most likelypartners (microbiome-based live biotherapeutic drug developers) for microbiomecontract manufacturers?

§  Whatis the annual clinical demand for microbiome-based live biotherapeutic products?

§  What is the current, installed contract manufacturing capacity for livebiotherapeutics?

§  Whatare the key factors influencing the make (manufacture in-house) versusbuy (outsource) decision in this field?

§  Whatare the various initiatives undertaken by big pharma players in this domain?

§  Whatpercentage of live biotherapeuticsmanufacturing operations are outsourced to service providers?

§  Howis the current and future market opportunity likely to be distributed acrosskey market segments?

§ What are theanticipated future trends related to livebiotherapeutics manufacturing?


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

§ Type of ProductManufactured

§ Active PharmaceuticalIngredients (APIs)

§ Finish Drug Formulations(FDFs)


§ Type of Type ofFormulation

§ 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 Restof the World


Thereport features inputs from eminent industry stakeholders, according to whom themicrobiome therapeutics contract manufacturing services market is likely towitness substantial growth in the foreseen future. The report includes detailedtranscripts of discussions held with the following experts:

§ Veronika Oudova(Co-founder and Chief Executive Officer, S-Biomedic)

§ Gaurav Kaushik (ChiefExecutive Officer and Managing Director, MeteoricBiopharmaceuticals)

§ Assaf Oron (ChiefBusiness Officer, BiomX)

§ Alexander Segal (VicePresident, Business Development, UniversalStabilization Technologies)

§ Debbie Pinkston (VicePresident, Sales and Business Development, List BiologicalLaboratories)

§ JP Benya (VicePresident, Business Development, AssemblyBiosciences)

§ Rob van Dijk(Business Development Manager, Wacker Biotech)

§ Alexander Lin(Associate General Manager, Chung MeiPharmaceutical)


Theresearch covers detailed profiles brief profiles of several companies (includingthose listed below); each profile features an overview of the company, itsfinancial information (if available),microbiome-related service portfolio, facilities dedicated to microbiomemanufacturing, and an informed future outlook.

§ Biose®

§ BJP Laboratories

§ Capsugel (acquired byLonza)

§ Cerbios-Pharma

§ Cobra Biologics(acquired Cognate Bioservices)

§ Inpac Probiotics

§  ParagonBioservices (a unit of Catalent Biologics)

§ UAS Labs


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