Cell Line Development Market - Trends, Outlook

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 2012, cancer is one of the leading cause of death from top three causes of non-communicable disease. 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.

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Cell Line Development Market Taxonomy

On the basis of Product type:

Reagents & Media
Equipment

On the basis of source:

Mammalian
Non-Mammalian
On the basis of cell line:

Recombinant
Hybridomas
Continuous Cell Line
Primary Cell Line

On the basis of application:

Bioproduction
Drug Discovery
Toxicity Testing
Tissue Engineering
Research

On the basis of end user:

Pharmaceutical companies
Research and Academic Institution
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, 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 October 2017, Selexis SA and Pelican Therapeutics (subsidiary of Heat Biologics, Inc.) announced to enter into an agreement for the development of Pelican’s immunotherapy clinical candidates PTX-35 and PTX-15. Pelican would utilize Selexis’s SUREtechnology PlatformTM to rapidly develop high-performance research cell banks expressing two of research candidate such as PTX-35, which is humanized monoclonal antibody that is a functional agonist of human TNFRSF25, and PTX-15, which is a human TL1A-Ig fusion protein.

In November 2017, American Type Culture Collection announced the release of an innovative in vitro model system of cell lines for key mechanism of invasion and metastasis in lung cancer

In January 2018, PX’Therapeutics announced collaboration with biotech firm Advaxis for process development of immunotherapies of Advaxis

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