Cell Line Development Services Global Market estimated to be worth $1,702.2 million by 2028
Cell lines are one of the major tools used in research for studying the normal physiology, & biochemistry of cells, the effects of drugs & toxic compounds on the cells, drug screening, development & large scale manufacturing of biological compounds. The increasing demand of biologics or biosimilars owes a great deal to development of advanced cell line development platforms to generate a stable and consistently expressing monoclonal cell line for the production high quantity and desired quality recombinant proteins through an efficient and cost-effective manufacturing process. Most of CDO or CDMO are developing advanced cell line development platforms to generate high-performance, highly stable, production cell lines. 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. These advanced platforms will attract pharma or biotech companies to outsource cell line development, for the development and production of novel 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. Based on expression system, cell line development service global market is segmented into microbial, mammalian and others. 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. Based on the cell line type, global cell line development service market is segmented into CHO, Mouse Myeloma (NS0; Sp2/0), Human Embryonic Kidney (HEK), Baby Hamster Kidney (BHK), Hybridoma, Human Embryonic Retina (PER.C6) and others. Among cell line type, CHO cell lines is the largest & fastest growing segment and is expected to grow at a low ten CAGR from 2020 to 2028 due its major advantageous like being versatile, relatively easy to work with, having well-understood glycosylation patterns and also increasing approvals of biologics which are produced from CHO cell lines. For instance, CHO is used in the manufacture of more than 65% of currently approved biologics. Cell lines are essential for a wide range of applications including gene function studies, drug discovery assays, the production of biotherapeutics and diagnostics. Based on application, cell line development service global market is segmented into research, bio production and diagnostics. 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.
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.
Newer technologies such as automated screening methods, cell line engineering, enhanced expression systems, improved process monitoring, and use of single use bioreactor & micro bioreactor for large scale bioproduction are further expected to provide this market with lucrative future growth opportunities. Microbioreactors are replacing scaled-down batch modes and traditional small-scale perfusion-mimic systems that used media exchanges and centrifugation for cell settling instead of cell-retention devices. New methods help developers to predict large-scale performance faithfully, including characteristics such as cell-specific perfusion rates, harvest rates, and links to downstream processing units. Nanofluidic screening technologies will offer a promising solution to further miniaturize cell culture processes. For instance, Berkeley Lights have developed optofluidic platform (single-cell screening and analysis technology) which significantly shortened the time required to identify and select the optimal cell line manufacturing clones within the CLD process. In November 2019, Samsung Biologics adopts Beacon optofluidic platform for cell line development from Berkeley Lights. In August 2020, Samsung Biologics launched, new proprietary CHO-based cell line technology, S-CHOice technology combination with Berkeley Lights’ Beacon technology, this will emerge as company’s excellent platform for cell line development.
Funding is needed for small CDMO companies to optimise the cell line development process for development of novel biologics. By receiving financial support and the right partnership, companies are able to develop and produce an integrated platform for the manufacture of life-saving biological medicines. For instance, in March 2019, Consortium of three companies Valitacell, Solentim and Microcoat has been awarded $4.2 million (€3.5 million) funding ($3.0 million from H2020 Fast Track to Innovation (FTI) initiative, and $1.2 million from other sources) to optimise the development of new biologics and cell therapies.
The cell line development service global market is consolidated, top six players occupy a share of xx% and other companies occupy a share of xx% in 2020. 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).