GMP CELL BANKING SERVICES MARKET ANALYSIS | Coherent Market Insights

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• 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

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• 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 RD 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.

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

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• 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.

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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 MA 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
  FDC 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.

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21 CFR 211.22(d)

• Requirement of the quality unit of a
  pharmaceutical company to monitor adherence to
  regulations by a CMO

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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 RD 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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