GMP Cell Banking Services Market
                     GMP Cell Banking Services Market Size, Share, Outlook, and Opportunity Analysis, 
2020 - 2027
Cell banking involves storing of cells of specific genome for the purpose of future
use in a product or medicinal needs. Mammalian cells, microbial cells, insect cell 
lines, yeast cells, avian cells, and stem cells are some of the cells that are 
stored in cell banks for various purposes. Mammalian cells are isolated from 
specific tissues such as skin, liver, and glands for production of vaccines and 
various proteins.
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.
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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.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.
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.
Moreover, high costs of services due to nature of material is also expected to 
limit growth of the market. The costs involved in GMP cell banking services are 
considerably high, due to the complex processes involved in generation, storage, 
maintenance, and testing of GMP cell banks and expanses in regulatory adherence.
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.Moreover, focus on fast growing emerging 
markets is also expected to aid in growth of the market. There has been a shift 
from investment in R&D and technology, especially in the healthcare industry, from 
North America and Europe to Asia Pacific. Developing economies such as India have 
ample skilled labor and qualified manpower at affordable costs, thereby increasing 
the scope for outsourcing of biotech projects.
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.
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.
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.
GMP Cell Banking Services  | Coherent Market Insights
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.
 
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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