Microbial cell culture or microbiological culture are the cell of bacteria and algae. These cell cultures are used to produce organic chemicals and proteins. Insect cell lines are derived from Drosophila melanogaster, Spodoptera frugiperda, and Trichoplusia ni for study of insect developmental biology, physiology, and microbial pathology and to produce vaccines.
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 2027.
Global GMP Cell Banking Services Market: Drivers
Limited in-house storage and testing capabilities are expected to propel growth of the global GMP cell banking services market over the forecast period. Large biopharmaceutical companies have several manufacturing sites that typically produce commercially marketed therapeutics as well as material for clinical development. As a result, the in-house capacity for storage of GMP cell banks are limited.
Global GMP Cell Banking Services Market: Opportunities
Government initiatives to support the growth of the domestic biotechnology industry is expected to offer lucrative growth opportunities for players in the market. For instance, in March 2020, the state government of Telangana, India, announced its plans to increase the market value of biotech and life sciences industry from US$ 50 billion to US$ 100 billion.
Global GMP Cell Banking Services Market: Restraints
Inconsistent demand for services is expected to hamper growth of the global GMP cell banking services market. Considering that outsourcing happens on a molecule-by-molecule basis, cell banking service providers experience fluctuating demand as large biopharmaceutical clients alternate between storage of cell banks in-house and outsourcing to service providers. The decision to outsource also depends on the performance of candidates in clinical trials, which can be quite unpredictable. Hence, service providers have to ensure a consistent source of revenue in these situations.
The Mammalian cell type segment in the global GMP cell banking services market was valued at US$ 286.6 Mn in 2019 and is expected to reach US$ 917.8 Mn by 2027 at a CAGR of 15.7% during the forecast period. Increasing demand for stem cell is expected to propel the growth of the segment during the forecast period.
The Biopharmaceutical Companies segment held dominant position in the global GMP cell banking services market in 2019, accounting for 70.1% share in terms of value during the forecasted period. Increasing funding for R&D in rare diseases is expected to boost growth of the segment during the forecast period.
Major players in the market are focused on conducting training regarding culture media. For instance, in October 2019, Lonza Group Ltd. hosted a free 60-minute webinar addressing current concerns regarding the use of serum in cell culture media.
Major players in the market are also focused on expanding their production capacity. For instance, in March 2019, Goodwin Biotechnology, Inc. purchased the two-acre site where the company is based in order to expand its capacity to meet the needs of its long-term clients.
ICH guidelines issued by FDA
Various ICH guidelines have been published that are relevant to cGMP recommendations for contract manufacturing arrangements
21 CFR 211.22(d)
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
November 2019: Lonza Group Ltd. launched eCHO Basal Medium and Feed, a system designed to optimize protein production, in order to expand its cell culture media portfolio
November 2018: Goodwin Biotechnology, Inc. received contract from Radimmune Therapeutics to develop a process and manufacture Radimmune Therapeutics’ lead therapeutic oncology candidate for clinical development
Scope of the report