GMP CELL BANKING SERVICES MARKET ANALYSIS | Coherent Market Insights

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2. GMP CELL BANKING SERVICES MARKET ANALYSIS GMP Cell Banking Services Market, By Cell Type (Mammalian, Microbial, Insect, Yeast, Avian, Stem Cell Type, Others), By End User (Biopharmaceutical Companies, Contract Manufacturing Organizations), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027

3. Statistics: The global GMP cell banking services market is estimated to account for US$ 1,326.8 Mn in terms of value by the end of XXX. Global GMP Cell Banking Services Market: Drivers Increasing funding for R&D in rare diseases is expected to boost growth of the global GMP cell banking services market over the forecast period. For instance, the U.S. Food and Drug Administration (FDA) funds research in rare diseases through congressionally mandated programs such as the Orphan Products Grants Program that supports natural history studies and clinical trials for rare diseases. Moreover, establishment of stem cell banking resource centers is also expected to aid in growth of the market. For instance, in March 2020, Stemlife Berhad, a cord blood bank in Malaysia, started a Stem Cell Banking Resource Center in Jerudong Park Medical Center, Brunei.

4. Figure 1. Global GMP Cell Banking Services Market Share (%), by Region, 2019

5. Stringent regulatory requirements are expected to hinder growth of the global GMP cell banking services market. Quality of the master and working cell banks must be monitored and confirmed on a continuous basis to justify the continuation of the production processes. The data collected from these analytical tests is a regulatory requirement for maintaining the biologic license and distribution of marketed product. The European Medicines Agency (EMA) and the U.S. FDA, in collaboration with other regulatory agencies worldwide, formed the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which set forth guidelines for good manufacturing practices. Specifically, ICH guidelines Q5, Q6 and Q7 are applicable to cell banks used in production processes. Global GMP Cell Banking Services Market: Opportunities Several pharmaceutical and biotechnology companies are increasingly seeking full service in the form of global partners that can be outsourced the entire manufacturing process. This in turn is expected to offer lucrative growth opportunities for players in the market.

6. Market Trends/Key Takeaways The demand for ready-to-use bioassay banks has significantly increased. Ready-to-use bioassay banks are used in situations where cells are used straight from the vial in the bioassay, thereby eliminating the cell expansion step. Ready-to-use bioassay banks are typically large in size, commonly ranging between 400-1000 vials and have large cell densities per vial.Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in January 2020, Charles River Laboratories International, Inc. acquired HemaCare Corporation for around US$ 380 million in cash. Regulations: U.S.Section 501(a)(2)(B) of the FD&C Act; 21 CFR parts 210 and 211; and 21 CFR part 600 • All manufacturing facilities to ensure compliance with cGMP regulations • cGMP includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

7. 21 CFR 211.22(d) • Requirement of the quality unit of a pharmaceutical company to monitor adherence to regulations by a CMO

8. Global GMP Cell Banking Services Market: Competitive Landscape Major players operating in the global GMP cell banking services market include, WuXi AppTec Group, Charles River Laboratories International, Inc., Eurofins Scientific, Merck KGaA, Lonza Group Ltd., SGS Ltd., ViruSure GmbH, Austrianova, Goodwin Biotechnology Inc., and Paragon Bioservices, Inc. Global GMP Cell Banking Services Market: Key Developments Major players in the market are focused on adopting collaboration strategies to expand their product portfolio. For instance, in March 2020, Lonza collaborated with Stanford University School of Medicine, Fred Hutchinson Cancer Research Center, and Parker Institute for Cancer Immunotherapy for R&D in cell therapy. Major players in the market are also focused on adopting various marketing strategies to expand their customer base. For instance, in January 2020, Charles River Laboratories International, Inc. presented at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California, U.S.

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