Manufacturing live biotherapeutic product 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.
Roots Analysis is pleased to announce the publication of its recent study, titled, “Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2020-2030: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030.”
The report features an extensive study of the current landscape and future opportunities related to contract services for microbiome therapeutics. The study features an in-depth analysis, highlighting the capabilities of a diverse set of contract service providers, including CMOs and CDMOs. Amongst other elements, the report includes:
• A detailed review of the overall landscape of companies offering contract services for manufacturing of microbiome therapeutics.
• A list of companies with in-house manufacturing facilities for microbiome therapeutics.
• Elaborate profiles of key industry players (large and mid-sized companies, established before 2000) based in North America, Europe and Asia-Pacific.
• An assessment of microbiome contract manufacturing capability in different regions.
• A list of nearly 50 microbiome-focused drug developers that are anticipated to partner with contract manufacturers.
• A detailed clinical trial analysis of more than 150 completed, ongoing and planned studies of various microbiome therapeutics sponsored by both industry and non-industry players.
• An estimate of the overall, installed capacity for manufacturing of microbiome therapeutics, taking into consideration the capabilities of various stakeholders.
• An informed estimate of the annual clinical 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 the 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 review of the varied microbiome-focused initiatives of big pharma players.
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A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below):
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
Key companies covered in the report
• 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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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?
Chapter Outlines
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the microbiome therapeutics contract manufacturing market and its likely evolution in the short-mid term and long term.
Chapter 3 provides a general introduction to the human 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 also includes a description of 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.
Chapter 4 provides an overview of the microbiome contract manufacturing landscape. It includes information on over 25 contract manufacturers that claim to offer microbiome therapeutics manufacturing services. In addition, it features an in-depth analysis of these companies, based on a number of parameters, such as on 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 pharmaceutical ingredients (API) and finished drug formulations (FDF)), type of drug molecule (small molecules and biologics / live biotherapeutics (LBPs)), type of fermentation (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 microbiome therapeutics along with information on year of establishment, company size, scale of operations (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities (country-wise).
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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]
Contact Information
Roots Analysis Private Limited
Gaurav Chaudhary
+1 (415) 800 3415
[email protected]