- A detailed review of the overall landscape of companies offering contract services for manufacturing of microbiome therapeutics, including information 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).
- Elaborate profiles of key industry players (large and mid-sized companies, established before 2000) based in North America, Europe and Asia-Pacific that offer contract manufacturing services for microbiome therapeutics at both clinical and commercial scales. Each profile features a brief overview of the company, microbiome-related service portfolio, information on microbiome manufacturing facilities (if available), and recent developments and an informed future outlook.
- An assessment of microbiome contract manufacturing capability in different regions, based on a number of relevant parameters, such as number of CMOs, number of completed / active / planned clinical trials, number of patients enrolled, number of manufacturing facilities, number of companies offering API / FDF manufacturing, number of companies having capabilities for preclinical / clinical / commercial manufacturing, number of companies dedicated to aerobic / anaerobic fermentation, installed manufacturing capacity, and number of in-house players.
- A list of nearly 50 microbiome-focused drug developers that are anticipated to partner with contract manufacturers and have been shortlisted on the basis of parameters, such as developer strength (which takes into account the company's size and its experience in this field), company's pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and the availability of in-house manufacturing capabilities.
- 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; it highlights prevalent trends across various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, trial recruitment status, study design and trial focus, highlighting leading sponsors (in terms of number of trials conducted), type of organization, popular therapeutic areas, and regional distribution of trials.
- An estimate of the overall, installed capacity for manufacturing of microbiome therapeutics, taking into consideration the capabilities of various stakeholders, based on data gathered via secondary and primary research; it presents the distribution of available capacity in terms of quantity of microbiome therapeutics produced (in liters, per year), across important market segments, such as company size (small-sized, mid-sized and large companies), scale of operation (clinical and commercial), and key geographical regions (North America, Europe and Asia-Pacific and rest of the world).
- 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 (shortlisted from the top 20 pharmaceutical companies as of 2019), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome-focused entities), along with information on funding, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation, comparing the initiatives of big pharma players on the basis of multiple relevant parameters.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
- Type of Product Manufactured
- Active Pharmaceutical Ingredients (APIs)
- Finish Drug Formulations (FDFs)
- Type of Type of Formulation
- Solid Formulations
- Oral Liquids
- Scale of Operation
- Company Size
- Key Geographical Regions
- North America
- Asia-Pacific and Rest of the World
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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?
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