During our research, we identified over 220 players that provide cell line development services. The market is characterized by the presence of start-ups or small-sized (less than 50 employees), and mid- sized firms (501-5000 employees), which constitute about 85% of the service providers. We also came across many established players engaged in this domain, such as (in alphabetical order) Catalent Pharma Solutions, Charles River Laboratories and Samsung Biologics. Further, nearly 70% of the companies were established during 2000-2015. In addition, we came across 15 companies that were established post-2015. Examples of such companies include (in alphabetical order) ACE Biolabs (2016), CMAB BioPharma (2017), Porton Biologics (2018) and QuaCell Biotechnology (2018).
Although, players engaged in development of cell lines are well-distributed across different regions of the globe, however, majority of the developers (45%) are based in North America; of these 91 are headquartered in the US, while 8 are in Canada. Examples of the companies based in North America include (in alphabetical order, no specific selection criteria) AGC Biologics, Creative Biogene and NorClone Biotech Laboratories.
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With regard to distribution by sources of cell lines / expression systems, majority of the players (195) prefer using mammalian cell lines and expression systems, such as CHO, HEK-293, HeLa, HepG2, MDCK NIH/3T3, NS0, PER.C6, SH-SY5Y, Sp2/0, U2OS, Vero and other unique cell lines. The popularity of mammalian cell lines, particularly CHO and HEK-293, can be attributed to their ability to exhibit both stable and transient expression of complex therapeutic proteins. In addition, these cell lines provide the most authentic folding and post-translational modifications.
Development of recombinant cell lines involves the introduction of vector DNA, having the gene of interest, into the host cell. This process is facilitated by a variety of physical methods (electroporation, nucleofection, microinjection), chemical methods (liposome mediated, calcium phosphate mediated, polyethylenimine mediated, DEAE-dextran mediated) and biological methods (virus-mediated). Majority of the cell line development service providers (43) prefer to use viral vectors, such as retroviral and lentiviral vectors, for the delivery of gene of interest into the host cells; this is followed by gene delivery using chemical reagents.
In the recent years, the evolution of CRISPR and other gene editing technologies, has led to the development of customized knock-in, knockout and protein over-expressing cell lines, in an efficient manner. It is interesting to note that 32% players offer services for the development of cell lines using genome editing tools. Notable examples include (in alphabetical order) American Type Culture Collection (ATCC), Biotechnology Hub Africa and KYinno.
In terms of applications of cell lines, maximum number of companies (174) produce cell lines for R&D purposes, followed by companies (168) producing cell lines for biomanufacturing purposes. It is interesting to note that close to 30% players, including Abzena, ProBioGen and Sartorius Stedim Cellca, offer services for the development of cell lines expressing biosimilar proteins.
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