Owing to benefits, such as reduced manufacturing costs, availability of cheap and skilled labor, and a supportive regulatory landscape, biopharmaceutical developers from across the globe, are increasingly outsourcing their manufacturing operations to China based CMOs.
The USD 2.6 billion (by 2030) financial opportunity within the China biopharmaceutical contract manufacturing market has been analyzed across the following segments:
- A detailed review of the overall landscape of companies offering contract manufacturing services for biopharmaceuticals in China, along with information on year of establishment, company size, scale of operation (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 (process development and characterization, method validation and testing, analytical development, stability studies, quality assurance and control, scale-up, downstream processing, regulatory support, data analytics and reporting, and others), 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-use bioreactors and stainless steel bioreactors) and its mode of operation (batch, fed-batch and perfusion), type of packaging, and affiliations to regulatory accreditations and certifications (if any).
- An analysis of the various partnerships pertaining to biopharmaceutical manufacturing in China, which have been established since 2016, based on several parameters, such as the year of partnership, type of partnership model adopted, scale of operation, type of biologic, focus area of the deal, target indication, most active players (in terms of number of partnerships signed), and geography.
- An analysis of the various expansion initiatives undertaken by contract manufacturers in China, in order to augment their capabilities, over the period 2016-2020 (till February), taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation of manufacturing facility, type of biologic and location of manufacturing facility.
- A clinical trial analysis of completed and active studies related to biopharmaceuticals that have been / are being / are likely to be conducted in China, based on trial registration year, trial phase, trial recruitment status, type of sponsor / collaborator, geography and number of patients enrolled.
- An estimate of the overall, installed capacity for manufacturing biopharmaceuticals, based on data reported by industry stakeholders in the public domain; it highlights the distribution of available 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 by big 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 the various factors that need to be taken into consideration by drug / therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
- Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biopharmaceutical products. Each profile features an overview of the company, its financial performance (if available), information on its service portfolio, details related to manufacturing capabilities and facilities, recent developments (partnerships and expansions), and an informed future outlook.
- A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on 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 impact the 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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