Cell line is a permanently established cell culture, which proliferates in fresh medium. Cell line development is utilized for examining efficiency of drug discovery and toxicity. It is essential for the production of recombinant proteins production such as, monoclonal antibodies, bi-specific monoclonal antibodies, growth factors, and enzymes using a wide variety of expression systems. Cell lines saves the crucial time, effort and cost by providing the high yield cells which can be used for in vitro testing and reduce chance of research drug to fail in clinical trial stage.
Development of novel therapy to drive growth of the cell line development market
Cell line development has wide application areas. Development of immunotherapy for the treatment of cancer is major application of cell line development. According to the World Health Organization factsheet 2018, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. Pharmaceutical and biotechnological companies are focusing on developing novel therapies such as immunotherapy due to its specificity and efficiency. Cell line development helps in speeding drug discovery process and optimization of clinical trials by providing high yield of monoclonal antibodies, which is expected to fuel growth of the cell line development market.
Increasing technological advancements in cell line development are expected to boost growth of the cell line development market. For instance, in November 2017, Lonza group launched Multiplex Cell line culture using GS Xceed Gene Expression System., which helps in testing multiple drug candidate at early developmental stage thereby saving four to six months, which otherwise is required in conventional development program.
Cell Line Development Market Taxonomy
On the basis of Product type:
- Reagents & Media
On the basis of source:
On the basis of cell line:
- Continuous Cell Line
- Primary Cell Line
On the basis of application:
- Drug Discovery
- Toxicity Testing
- Tissue Engineering
On the basis of end user:
- Pharmaceutical companies
- Research and Academic Institution
On the basis of Region:
- North America
- Latin America
- Asia Pacific
- Middle East
North America to dominate the market for cell line development due to high investment in research by pharmaceutical companies to develop novel product
North America is expected to hold the dominant position in the global cell line development market, owing to high investment by pharmaceutical companies in developing a novel treatment product and increasing off patenting of major products, which would promote biosimilar drug development. Biosimilar drug having biological molecule needs to match in structure and composition with original product which needs cell line to confirm matching of structure and adhere to quality attribute such as glycoprofile, protein aggregation. For instance, according to 2016 report of International Trade Administration of Department of Commerce (USA), the U.S. generic drug sales reached an estimated US$ 70 billion in 2015, which represents quarter of the global market, due to a large number of drugs going off-patent and healthcare reforms favoring generics development. According to the same report, biologics account for over a third of all new drugs in clinical trials or which are waiting for FDA approval. According to Pharmaceutical Research and Manufacturers of America, companies such as Novartis AG, Merck and Company and F. Hoffmann-LA Roche AG in U.S. together invested in US$ 75 billion in research and development. Legal factors such Affordable Care Act which has already covered most of population would boost the usage for novel products as patients can get treated with insurance coverage without out of pocket expenditure on such medication .
Collaborations by cell line development companies with drug discovery companies to speed up expansion of cell line development market
Some of the major players operating in the global cell line development market include Lonza Group AG, Sigma-Aldrich Corporation, Wuxi App Tec, Inc., American Type Culture Collection, Thermo Fisher Scientific, Inc., PX’Therapeutics SA., Selexis SA, GE Healthcare, European Collection of Cell Cultures , Corning, Inc., Sartorious AG, Goodwin Biotechnology Inc., and Cleancells. These companies are entering into strategic partnership with drug discovery companies to optimize their product development:
- In December 2017, Selexis SA and Turgut Pharmaceuticals announced to enter into a third commercial license agreement, which would provide Turgut with access to Selexis SUREtechnology Platform and SURE CHO-M Cell Line for the development of biosimilar product for the treatment of two rare diseases such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The companies were already in agreement (made in July 2016) to develop biosimilar products to treat inflammatory diseases and certain cancers using the SURE CHO-M Cell Lines.
- In April 2017, CBMG entered into a partnership with GE Healthcare for the manufacture of stem cells used in cell line development.
- In January 2018, PX’Therapeutics announced collaboration with biotech firm Advaxis for process development of immunotherapies of Advaxis
- In February 2018, Denali Therapeutics entered into a partnership with Lonza to develop and produce biologic medicines using the latter’s cell line development technology GS Xceed.
- Industry players are focusing towards expanding business portfolio to consolidate their market position as well as increase consumer base. For instance, in February 2017, Lonza entered into strategic partnership with Sanofi, which aimed at building mammalian cell facilities to produce monoclonal antibodies in Switzerland.