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The “Live Biotherapeutic Products and Microbiome Contract Manufacturing Market
https://www.rootsanalysis.com/reports/view_document/microbiome-contract-manufacturing/306.html
Key Inclusions
§ A detailed review of the overall landscape of companiesoffering contract services for manufacturing of microbiome therapeutics, includinginformation on year of establishment, company size, scale of operation(preclinical, clinical and commercial), location of headquarters, type ofservice(s) offered (strain isolation, media / culture development,fermentation, lyophilization, fill / finish, cell banking, and analyticalservices), 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 andsolutions), injectables and others), type of primary packaging used (ampoules /vials, blister packing, glass / plastic bottles, pouches / sachets, andothers), number and location of manufacturing facilities (country-wise),facility size (if available), as well as their certifications, and company'scontact details.
§ A list of companies with in-house manufacturing facilitiesfor 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).
§ Elaborate profiles of key industry players (large andmid-sized companies, established before 2000) based in North America, Europeand Asia-Pacific that offer contract manufacturing services for microbiometherapeutics at both clinical and commercial scales. Each profile features a briefoverview of the company, microbiome-related service portfolio, information onmicrobiome manufacturing facilities (if available), and recent developments andan informed future outlook.
§ An assessment of microbiome contract manufacturingcapability in different regions, based on a number of relevant parameters, suchas number of CMOs, number of completed / active / planned clinical trials,number of patients enrolled, number of manufacturing facilities, number ofcompanies offering API / FDF manufacturing, number of companies havingcapabilities for preclinical / clinical / commercial manufacturing, number ofcompanies dedicated to aerobic / anaerobic fermentation, installedmanufacturing capacity, and number of in-house players.
§ A list of nearly 50 microbiome-focused drug developers thatare anticipated to partner with contract manufacturers and have beenshortlisted on the basis of parameters, such as developer strength (which takesinto account the company's size and its experience in this field), company'spipeline strength and maturity (based on the number of pipeline drugs andaffiliated stage of development) and the availability of in-house manufacturingcapabilities.
§ A detailed clinical trial analysis of more than 150completed, ongoing and planned studies of various microbiome therapeuticssponsored by both industry and non-industry players; it highlights prevalenttrends across various relevant parameters, such as trial registration year,trial phase, number of patients enrolled, trial recruitment status, studydesign and trial focus, highlighting leading sponsors (in terms of number oftrials conducted), type of organization, popular therapeutic areas, andregional distribution of trials.
§ An estimate of the overall, installed capacity for manufacturingof microbiome therapeutics, taking into consideration the capabilities ofvarious stakeholders, based on data gathered via secondary and primaryresearch; it presents the distribution of available capacity in terms ofquantity of microbiome therapeutics produced (in liters, per year), acrossimportant market segments, such as company size (small-sized, mid-sized andlarge companies), scale of operation (clinical and commercial), and keygeographical regions (North America, Europe and Asia-Pacific and rest of theworld).
§ An informed estimate of the annual clinical demand formicrobiome therapeutics, taking into account the target patient population inongoing and planned clinical trials of microbiome therapeutics, sponsored byboth industry and non-industry players.
§ A qualitative analysis, highlighting the various factorsthat need to be taken into consideration by microbiome therapeutics developerswhile deciding whether to manufacture their respective products in-house orengage the services of a CMO.
§ A review of the varied microbiome-focused initiatives ofbig pharma players (shortlisted from the top 20 pharmaceutical companies as of2019), featuring a [A] heat map representation that highlights microbiometherapeutics under development (in partnership with core microbiome-focusedentities), along with information on funding, partnership activity, and diversity of product portfolio (in termsof disease indication(s) being treated and focus therapeutic area(s)), and [B]a spider web representation, comparing the initiatives of big pharma players onthe basis of multiple relevant parameters.
The report also features thelikely distribution of the current and forecasted opportunity across importantmarket segments, mentioned below:
§ Type of ProductManufactured
§ Active PharmaceuticalIngredients (APIs)
§ Finish DrugFormulations (FDFs)
§ Type of Type ofFormulation
§ Solid Formulations
§ Oral Liquids
§ Injectables
§ Others
§ Scale of Operation
§ Clinical
§ Commercial
§ Company Size
§ Small-sized
§ Mid-sized
§ Large
§ Key GeographicalRegions
§ North America
§ Europe
§ Asia-Pacific and Restof the World
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Key Questions Answered
§ Who are the leadingCMOs offering microbiome contract manufacturing services, across the world?
§ What are the keychallenges faced by microbiome contract manufacturers?
§ Who are the most likely partners (microbiome-based livebiotherapeutic drug developers) for microbiome contract 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 the anticipatedfuture trends related to live biotherapeuticsmanufacturing?
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Gaurav Chaudhary
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