Owingto benefits, such as reduced manufacturing costs, availability of cheap andskilled labor, and a supportive regulatory landscape, biopharmaceuticaldevelopers from across the globe, are increasingly outsourcing theirmanufacturing operations to China based CMOs.
TheUSD 2.6 billion (by 2030) financial opportunity within the Chinabiopharmaceutical contract manufacturing market has been analyzed acrossthe following segments:
KeyInclusions
· A detailed review of the overall landscape ofcompanies offering contract manufacturing services for biopharmaceuticals inChina, along with information on year of establishment, company size, scale ofoperation (preclinical, clinical and commercial), location of headquarters,number of manufacturing facilities, as well as location of these facilities,type of business segment, type of manufacturing service(s) offered (processdevelopment and characterization, method validation and testing, analyticaldevelopment, stability studies, quality assurance and control, scale-up,downstream processing, regulatory support, data analytics and reporting, andothers), type of biologic(s) manufactured (peptides / proteins, antibodies,vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors,biosimilars, nucleic acids and others), type of expression system(s) used(mammalian, microbial and others), type of bioreactor(s) used (single-usebioreactors and stainless steel bioreactors) and its mode of operation (batch,fed-batch and perfusion), type of packaging, and affiliations to regulatoryaccreditations and certifications (if any).
· An analysis of the various partnershipspertaining to biopharmaceutical manufacturing in China, which have beenestablished since 2016, based on several parameters, such as the year ofpartnership, type of partnership model adopted, scale of operation, type ofbiologic, focus area of the deal, target indication, most active players (interms of number of partnerships signed), and geography.
· An analysis of the various expansioninitiatives undertaken by contract manufacturers in China, in order to augmenttheir capabilities, over the period 2016-2020 (till February), taking intoconsideration several relevant parameters, such as year of expansion, type ofexpansion (capability expansion, capacity expansion, facility expansion and newfacility), scale of operation of manufacturing facility, type of biologic andlocation of manufacturing facility.
· A clinical trial analysis of completed andactive studies related to biopharmaceuticals that have been / are being / arelikely to be conducted in China, based on trial registration year, trial phase,trial recruitment status, type of sponsor / collaborator, geography and numberof patients enrolled.
· An estimate of the overall, installedcapacity for manufacturing biopharmaceuticals, based on data reported byindustry stakeholders in the public domain; it highlights the distribution ofavailable biopharmaceutical production capacity on the basis of company size(small, mid-sized, large and very large firms), scale of operation(preclinical, clinical and commercial), key geographical regions (China,Hong-Kong, Taiwan) and expression system used.
· A review of recent initiatives undertaken bybig pharma players in China for the manufacturing of biopharmaceuticals,highlighting trends across various parameters, such as number of initiatives,year of initiative, and benchmark analysis of big pharma players.
· A qualitative analysis, highlighting thevarious factors that need to be taken into consideration by drug / therapydevelopers while deciding whether to manufacture their respective productsin-house or engage the services of a CMO.
· Elaborate profiles of key players that have adiverse range of capabilities for the development, manufacturing and packagingof biopharmaceutical products. Each profile features an overview of thecompany, its financial performance (if available), information on its serviceportfolio, details related to manufacturing capabilities and facilities, recentdevelopments (partnerships and expansions), and an informed future outlook.
· A case study comparing the keycharacteristics of large molecule and small molecule drugs, along with detailson the various steps involved in their respective manufacturing processes.
· A discussion on industry affiliated trends,key drivers and challenges, under a SWOT framework, which are likely to impactthe evolution of this field. It also includes a Harvey ball analysis,highlighting the relative impact of each SWOT parameter on industry dynamics.
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GauravChaudhary
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Gaurav.Chaudhary@rootsanalysis.com
