Gmp Cell Banking Services Market Analysis

GMP Cell Banking Services Market – Insights

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.

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 2027.

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.

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.

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

Global GMP Cell Banking Services 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.

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.

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.

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.

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.

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.

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.