Cell lines are one the major tools used in research for studying the normal physiology and biochemistry of cells, the effects of drugs and toxic compounds on the cells, drug screening and development and large scale manufacturing of biological compounds.
Cell culture is the process by which cells are grown under controlled conditions derived from microbial or animal cells. Cell lines are subculture of primary culture also known as sub-clone. Cell lines derived from primary cultures have a limited life span, after subsequent cultures, cells with the highest growth capacity dominate which are selected for further cell development. Primary cells are cells that are cultured directly from a subject and have a limited lifespan. An immortalized cell line can proliferate indefinitely either through random mutation or deliberate modification which are useful especially for production of therapeutics.
The cell line development service global market is expected to reach $1,702.2 million by 2028 growing at a double digit CAGR from 2020 to 2028. Increasing demand for monoclonal antibodies, recombinant proteins and vaccines, growing incidence rate of oncology, autoimmune disorders, infectious diseases & genetic disorders and growth in research activities related to the diseases and also recombinant cell lines for the production recombinant biopharmaceutical proteins are driving the market. Technological advancements in cell line engineering (gene editing tools) & cell line development technologies, screening technologies and process development are giving immense growth opportunities for the market. However, complexities in the development of stable cell lines and high risk of contamination due to complex purification methods are restraining the market. Furthermore, stringent and complex regulations and the high cost and technical requirement to adhere to accreditations such as GMP are posing threat to the industry.
Cell line development service global market is classified based on the expression system, cell line type, application and geography. Cell lines are essential for a wide range of applications including gene function studies, drug discovery assays, the production of biotherapeutics and diagnostics. The application for cell lines includes research, bioproduction and diagnostics. Among research, cell lines are used for studying disease, screening, cell-based assays are used during discovery phase and preclinical development. Cell lines are used to produce a wide range of biotherapeutics including vaccine, recombinant proteins that include peptides, cytokines, hormones and clotting factors, enzymes and monoclonal antibodies. Bioproduction is the largest & fastest growing segment and is expected to grow at a low ten CAGR from 2020 to 2028 due higher demand of biologics & biosimilars for therapeutics application and increasing collaboration between the companies for the development & production of biotherapeutics using cell line development platforms.
Biotherapeutics including monoclonal antibodies, peptides, recombinant proteins, vaccines, blood related products are produced in a wide variety of platforms, including non-mammalian expression systems (bacterial, yeast, plant and insect) and mammalian expression systems (including human cell lines). However, the most appropriate expression system to be used is dependent on the type of biopharmaceutical to be produced. Based on expression system, cell line development service global market is segmented into microbial, mammalian and others. Microbial systems are used for producing relatively simple recombinant proteins such as insulin or antibody fragments. They are attractive due to their low cost and high productivity. E. coli and S. cerevisiae are the most commonly used systems. However, many biopharmaceuticals including MABs, highly glycosylated proteins or recombinant proteins are large and complex, mammalian cell lines are the most preferred platform used for manufacturing them. Post-translational modifications including glycosylation, carboxylation, hydroxylation, sulphation, amidation are a significant factor to select the type of cells to be used. Among them, glycosylation is the most common modification. Among expression systems, Mammalian expression system is the largest & fastest growing segment and expected to grow at a double digit CAGR from 2020 to 2028 due to utilization of mammalian cell lines for most of biologics development & production and also technological advancements in mammalian cell line development plarforms for higher titer production.
The most common mammalian cell cultures used for production of biopharmaceuticals include Chinese hamster ovary (CHO) cells, baby hamster kidney (BHK21) cells and murine myeloma cells (NS0 and Sp2/0). Among cell line type, CHO cell line is the most frequently used mammalian system, which is used in the manufacture of more than 65% of currently approved biologics. CHO cells have been the industry’s cell line workhorse for production of biopharmaceuticals. These cell line has several major advantages being versatile, relatively easy to work with, having well-understood glycosylation patterns. Approximately 42 monoclonal antibodies and 8 recombinant proteins are produced using CHO cell lines. Murine Myeloma are expected to occupy second largest share is expected to grow at a double digit CAGR % from 2020 to 2028.
Based on the geography, cell line development service global market is segmented into North America, Europe, Asia-Pacific and Rest of the world. North America accounted for the largest revenue in 2020 and is expected growing at a double digit CAGR from 2020 to 2028. The Asia-Pacific is the fastest growing region in cell line development global market and is expected to grow at a low ten CAGR from 2020 to 2028.
In cell line development program, after selecting best clone, the next step is to create fully described and characterized cell banks that store cells of specific genomes complete with cell line characterization and operate in a way that minimizes contamination. According to IQ4I analysis, Cell banking service market generated the revenue of $xx million in 2020 and is expected to grow at a high ten CAGR reach $xx million by 2028. Proper cell line authentication is crucial to assure that inadvertent contamination of cell lines has not occurred during the regular cell culturing work. It is particularly important to authenticate the cell line during the drug development process to ensure the quality of the biopharmaceuticals produced from them. Cell line characterization service market generated the revenue of $xx million in 2020 and is expected to grow at a low ten CAGR to reach $xx million by 2028.
The increasing demand for biologics and biosimilars has increased the demand for production cell lines. The expiration of blockbuster biologics has also driven the emergence of biosimilars. Companies are working to produce efficient and less time consuming expression systems and also using automation and robotics in screening of cell lines to speed up the process. For instance, in January 2019, FUJIFILM Diosynth Biotechnologies introduced next generation Apollo mammalian expression system (Apollo X), capable of delivering industry leading titres in excess of 10 g/L and in July 2020, cergentis’ proprietary targeted locus amplification (TLA) technology integrated into Apollo X cell-line development as a powerful tool for targeted, complete sequencing of transgenes and integration sites. This integration helps to rapid characterization of clonal cell lines during cell line development and clone selection.
The major players in cell line development service global market include Abzena PLC (U.K.), AGC Inc. (AGC Biologics) (Japan), Albany Molecular Research Inc. (AMRI) (U.S.), Boehringer Ingelheim International GmbH (Germany), Catalent Inc. (U.S.), Charles River Laboratories International Inc. (U.S.), Fujifilm Holdings Corporation (Fujifilm Diosynth Biotechnologies) (Japan), Genscript Biotech Corporation (China), JSR Corporation [JSR Life Sciences, LLC (KBI biopharma, Selexis SA, CrownBio)] (Japan), Lonza Group Ltd. (Switzerland), Rentschler Biopharma SE (Germany), Samsung Biologics Co. Ltd. (South Korea), Thermofischer Scientific Inc. (Patheon N.V.) (Brammer Bio) (U.S.), Wuxi Biologics (Cayman) Inc. (China), Sartious Group (Cellca, Bio Outsource) (Germany), Eurofins Scientific S.E (DiscoverX, GATC Biotech AG, Eurofins CDMO, Advinus) (Luxembourg).
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