RootsAnalysis is pleased to announce the publication of its recent study, titled, “Live Biotherapeutic Products and MicrobiomeContract Manufacturing Market,2020-2030: Focus on Active Pharmaceutical Ingredients and Finished DosageForms, 2020-2030.”
Thereport features an extensive study of the current landscape and futureopportunities related to contract services for microbiome therapeutics. Thestudy features an in-depth analysis, highlighting the capabilities of a diverseset of contract service providers, including CMOs and CDMOs. Amongst otherelements, the report includes:
· A detailed review of the overall landscape ofcompanies offering contract services for manufacturing of microbiometherapeutics.
· A list of companies with in-housemanufacturing facilities for microbiome therapeutics.
· Elaborate profiles of key industry players(large and mid-sized companies, established before 2000) based in NorthAmerica, Europe and Asia-Pacific.
· An assessment of microbiome contractmanufacturing capability in different regions.
· A list of nearly 50 microbiome-focused drugdevelopers that are anticipated to partner with contract manufacturers.
· A detailed clinical trial analysis of morethan 150 completed, ongoing and planned studies of various microbiometherapeutics sponsored by both industry and non-industry players.
· An estimate of the overall, installedcapacity for manufacturing of microbiome therapeutics, taking intoconsideration the capabilities of various stakeholders.
· An informed estimate of the annual clinicaldemand for microbiome therapeutics, taking into account the target patientpopulation in ongoing and planned clinical trials of microbiome therapeutics,sponsored by both industry and non-industry players.
· A qualitative analysis, highlighting thevarious factors that need to be taken into consideration by microbiometherapeutics developers while deciding whether to manufacture their respectiveproducts in-house or engage the services of a CMO.
· A review of the varied microbiome-focusedinitiatives of big pharma players.
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Adetailed market forecast, featuring analysis of the current and projectedfuture opportunity across key market segments (listed below):
Typeof Product Manufactured
· Active Pharmaceutical Ingredients (APIs)
· Finish Drug Formulations (FDFs)
Typeof Type of Formulation
· Solid Formulations
· Oral Liquids
· Injectables
· Others
Scaleof Operation
· Clinical
· Commercial
CompanySize
· Small-sized
· Mid-sized
· Large
KeyGeographical Regions
· North America
· Europe
· Asia-Pacific and Rest of the World
Keycompanies covered in the report
· Biose®
· BJP Laboratories
· Capsugel (acquired by Lonza)
· Cerbios-Pharma
· Cobra Biologics (acquired CognateBioservices)
· Inpac Probiotics
· Paragon Bioservices (a unit of CatalentBiologics)
· UAS Labs
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KeyQuestions Answered
· Who are the leading CMOs offering microbiomecontract manufacturing services, across the world?
· What are the key challenges faced bymicrobiome contract manufacturers?
· Who are the most likely partners(microbiome-based live biotherapeutic drug developers) for microbiome contractmanufacturers?
· What is the annual clinical demand formicrobiome-based live biotherapeutic products?
· What is the current, installed contractmanufacturing 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 undertakenby big pharma players in this domain?
· What percentage of live biotherapeuticsmanufacturing operations are outsourced to service providers?
· How is the current and future marketopportunity likely to be distributed across key market segments?
· What are the anticipated future trendsrelated to live biotherapeutics manufacturing?
ChapterOutlines
Chapter2is an executive summary of the key insights captured in our research. It offersa high-level view on the current state of the microbiome therapeutics contractmanufacturing market and its likely evolution in the short-mid term and longterm.
Chapter3provides a general introduction to the human microbiome, along with informationon the various types of microbiome therapeutics. It also features an elaboratediscussion on the functions of the microbiota, emphasizing on the key insightsgenerated from the Human Microbiome Project (HMP). Further, the chapter alsoincludes a description of the various steps that are involved in themanufacturing of microbiome therapeutics. In addition, it highlights thechallenges associated with manufacturing such products and the growing need foroutsourcing in this domain. Finally, it provides a list of key factors thatneed to be considered by innovator companies while selecting a CMO partner.
Chapter4provides an overview of the microbiome contract manufacturing landscape. Itincludes information on over 25 contract manufacturers that claim to offermicrobiome therapeutics manufacturing services. In addition, it features anin-depth analysis of these companies, based on a number of parameters, such ason year of establishment, company size, scale of operation (preclinical,clinical and commercial), location of headquarters, type of service(s) offered(strain isolation, media / culture development, fermentation, lyophilization,fill / finish, cell banking, and analytical services), type of product manufactured (active pharmaceuticalingredients (API) and finished drug formulations (FDF)), type of drug molecule(small molecules and biologics / live biotherapeutics (LBPs)), type offermentation (aerobic and anaerobic), type of formulation (solids (tablets /capsules / powders / granules), oral liquids (syrups and solutions),injectables and others), type of primary packaging used (ampoules / vials,blister packing, glass / plastic bottles, pouches / sachets, and others),number and location of manufacturing facilities (country-wise), facility size(if available), as well as their certifications, and company’s contact details.A list of companies with in-house manufacturing facilities for microbiometherapeutics along with information on year of establishment, company size,scale of operations (preclinical, clinical and commercial), location ofheadquarters, and location of manufacturing facilities (country-wise).
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