Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured (API and FDF)
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Key Inclusions
- A detailed overview of the overall landscape of companies offering contract manufacturing services for the development of microbiome therapeutics, along with information on their 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 fermentation (aerobic and anaerobic), type of formulation (solids, oral liquids and injectables), type of primary packaging used (blister packs, glass / plastic bottles, pouches / sachets, and vials), number and location of manufacturing facilities and bioprocessing capacity. Further, it provides a list of companies with in-house manufacturing facilities for microbiome therapeutics, along with information on their year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities.
- A detailed landscape of the live biotherapeutic products and microbiome manufacturing facilities established across key geographical regions (North America, Europe and Asia-Pacific), highlighting the key manufacturing hubs for microbiomes.
- 70 microbiome therapeutics developers are likely to forge strategic alliances with contract manufacturers Around 57% of the drug developers are based in North America, followed by Europe (33%). In addition, 29% of drug developers are dominated by the presence of start-ups (established post 2015), indicating that the market is likely to be driven by such players.
- More than 140 clinical trials evaluating microbiome drugs have been registered worldwide
- An in-depth company competitiveness analysis of microbiome manufacturing service providers based on their product portfolio strength (in terms of scale of operation, type of product manufactured, type of formulation, type of primary packaging used and number of manufacturing facilities), service strength (based on its experience) and type of service(s) offered.
- 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-based live biotherapeutics across both clinical and commercial scales of operation. Each profile features a brief overview of the company, details related to its microbiome-related service portfolio, microbiome manufacturing facilities, recent developments, and an informed future outlook.
- A list of nearly 70 microbiome-focused drug developers that are likely to partner with manufacturers engaged in this domain. These players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account the company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of in-house manufacturing capabilities.
- A review of the various microbiome-focused initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated by the top 10 pharmaceutical companies in 2021), 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 Live Biotherapeutic Products report features the following companies
- An analysis of recent developments within the microbiome manufacturing industry, highlighting information on several partnerships and collaborations, mergers and acquisitions, and expansion initiatives that have taken place in this domain, during the period 2016-2021.
- An in-depth analysis of completed, ongoing, and planned clinical studies of various microbiome therapeutics, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in
- terms of number of trials conducted), study focus, target disease indication and key geographical regions.
- An estimate of the overall, installed capacity for the manufacturing of microbiome-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity based on the scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).
- An informed estimate of the annual clinical and commercial 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 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 case study on the current market landscape of microbiome contract research organizations and dietary supplement providers, including information on their year of establishment, company size and location of headquarters.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
- Type of Product Manufactured
- API
- FDF
- Type of Formulation
- Solids
- Oral Liquids
- Injectables
- Type of Primary Packaging Used
- Blister Packs
- Glass / Plastic Bottles
- Pouches / Sachets
- Vials
- Scale of Operation
- Clinical
- Commercial
- Company Size
- Small
- Mid-sized
- Large
- Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Rest of the World
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Key Questions Answered
- Who are the key players engaged in offering contract manufacturing services for microbiome therapeutics?
- 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 biotherapeutics?
- 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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