GMP CELL BANKING SERVICES MARKET ANALYSIS

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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. 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. • North America region held dominant position in the global GMP cell banking services market in 2019, accounting for 45.9% share in terms of value, followed by 2027.

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

5. Market Restraints 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.

6. 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. • Biopharmaceutical Companies segment in the global GMP cell banking services market was valued at US$ 315.4 Mn in 2019 and is expected to reach US$ 993.8 Mn by 2027 at a CAGR of 15.4% during the forecast period.

7. Market Trends • 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.

8. 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. • 21 CFR 211.22(d) • Requirement of the quality unit of a pharmaceutical company to monitor adherence to regulations by a CMO • When a pharmaceutical company uses a contract facility, their quality unit is legally responsible for approving or rejecting drug products manufactured by the contract facility, including for final release. The regulations require that the quality unit’s responsibilities and procedures be in writing and that they be followed. Quality agreements should clearly describe the materials or services to be provided, quality specifications, and communication mechanisms between the owner and contract facility.

10. Competitive Landscape   Major players operating in the global GMP cell banking services market include, WuXiAppTec 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.

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