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Key Inclusions
§ A detailed review ofthe current landscape of companies offering contract manufacturing services forbiologics, using microbial expression systems, along with information on theiryear of establishment, company size, location of headquarters, number andlocation of their production facilities, scale of operation (preclinical,clinical and commercial), type of biologic(s) manufactured (peptides /proteins, antibodies, vaccines, biosimilars, oligonucleotides, plasmid DNA andothers), type of microbial expression system(s) used (bacterial, yeast andothers), type of fermenter(s) employed (single-use fermenters, stainless steelfermenters and others), type of manufacturing service(s) offered (cell banking,process development and characterization, analytical method development andtesting, quality assurance and control, scale-up, downstream processing andregulatory support), and regulatory accreditations / certifications received(if any).
§ A region-wise,company competitiveness analysis, highlighting key players engaged in microbialbased contract manufacturing based on their experience (considering the year ofestablishment of the firm) and expertise (taking into account their serviceportfolio, number of different types of biologics manufactured and number ofdistinct expression system(s) used).
§ An analysis of thevarious partnerships signed within this domain, with a focus on microbialcontract biomanufacturing, since 2016, based on several relevant parameters,such as year of partnership, type of partnership model adopted, scale ofoperation, type of biologic, focus area, therapeutic area, most active players(in terms of number of partnerships signed), and geography. Further, itfeatures a detailed analysis of the various mergers and acquisitions that werecarried out in this domain, highlighting the trend in terms of number ofplayers acquired between 2016-2020 (till May), along with the geographicaldistribution of this activity.
§ An elaborate analysisof the various expansion initiatives undertaken by contract manufacturers usingmicrobial expression systems in order to augment their capabilities, over theperiod 2016-2020 (till May), taking into consideration several relevantparameters, such as year of expansion, type of expansion (capability expansion,capacity expansion, facility expansion and new facility), scale of operation ofmanufacturing facility, type of biologic and location of manufacturingfacility.
§ A review of thevaried microbial based manufacturing initiatives undertaken by big pharmaplayers (shortlisted from the top 20 pharmaceutical companies as of 2019),highlighting trends across various parameters, such as number of initiatives,year of initiative and type of initiative.
§ A detailedproprietary 2×2 representation that was developed to assess the current marketscenario (in terms of existing competition and growth opportunities) acrossemerging and established market segments.
§ Elaborate profiles ofkey players that offer contract biomanufacturing services using microbialexpression systems across different geographies, namely North America, Europeand Asia Pacific. Each profile features a brief overview of the company,information related to its service portfolio, manufacturing capabilities andfacilities, recent developments and an informed future outlook.
§ A discussion onindustry affiliated trends, key drivers and challenges, under a SWOT framework,which are likely to impact the evolution of this field. It also includes aHarvey ball analysis, highlighting the relative impact of each SWOT parameter onindustry dynamics.
§ A case studycomparing the key characteristics of large molecule and small molecule drugs,along with details on the various steps involved in their respectivemanufacturing processes.
§ An insightfuldiscussion on the impact of COVID-19 outbreak on the overall microbial contractbiomanufacturing market, and the key initiatives undertaken by CMOs to combatthe challenges posed due to ongoing situation.
The report also features the likelydistribution of the current and forecasted opportunity across important marketsegments, mentioned below:
§ Type of Product
§ API
§ FDF
§ Typeof Biologic
§ Proteins
§ Enzymes
§ GrowthHormones
§ Antibodybased Drugs
§ Others(plasmid DNA, probiotics, microbiome-based biologics)
§ Type of Microbial Expression System
§ Bacteria
§ Yeast
§ Others(Algae and fungi)
§ Scaleof Operation
§ Commercial
§ Preclinical/ Clinical
§ Typeof End User
§ SmallCompanies
§ Mid-sizedCompanies
§ Large/ Very Large Companies
§ KeyGeographical Regions
§ NorthAmerica
§ Europe
§ AsiaPacific
§ MiddleEast and North Africa
§ LatinAmerica
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Key Questions Answered
§ Whoare the leading CMOs with expertise in production of microbial biologics?
§ What are the preferred microbial expression systems used inbiologic development and manufacturing?
§ What are the key microbial fermentation technologyplatforms?
§ Who could be the potential partners for the microbial CMOs?
§ What kind of partnership models are commonly adopted bystakeholders engaged in this domain?
§ What type of expansion initiatives are being carried out byCMOs in this domain?
§ What initiatives are being undertaken by big pharma playersin this domain?
§ What are the key factors influencing the make (manufacturein-house) versus buy (outsource) decision related to microbial fermentation?
§ What are the key trends within the microbial contractbiomanufacturing market?
§ How is the current and future market opportunity likely tobe distributed across key market segments?
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3. LiveBiotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active PharmaceuticalIngredients and Finished Dosage Forms, 2020 - 2030
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