GMP Cell Banking Market Size, Share, Growth, and Industry Analysis, By Type (Mammalian Cell, Microbial Cell, Insect Cell and Others), By Application (Biopharmaceutical Companies and Contract Manufacturing Organizations), Regional Forecast to 2028

Updated On: 13 November 2023

REPORT OVERVIEW

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The global GMP cell banking market size was in USD 0.567 billion 2021. As per our research, the GMP cell banking market is expected to reach USD 1.2893  billion by 2028, exhibiting a CAGR of 12.3% during the forecast period. The COVID-19 pandemic has been unprecedented and staggering, with experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The process of establishing and maintaining a master cell bank (MCB) and working cell bank (WCB) in accordance with Good Manufacturing Practice (GMP) regulations is referred to as "GMP cell banking." It is an important stage in the creation of biological products, including cell-based treatments, vaccines, and other biologics. The MCB is used as the raw material for creating therapeutic cells or other biological products. It consists of a large number of vials or containers containing a homogeneous population of well-characterized cells that are preserved under specific conditions to maintain their stability and viability over an extended period. To assure its safety, identity, potency, and consistency, the MCB is rigorously tested and characterized. The WCB, which is used in everyday production, is derived from the MCB.

It represents a smaller-scale working stock that is enlarged to generate a bigger quantity of cells for industrial applications. The WCB undergoes extensive testing to validate its identification, quality, and purity before being utilized for the development of therapeutic products. Both the MCB and WCB must be produced and maintained according to GMP regulations, which include stringent documentation, quality control, and quality assurance measures. These guidelines ensure that the cell banks are traceable, well-documented, and comply with safety and quality standards. GMP cell banking market is crucial for the reproducibility, consistency, and safety of cell-based products throughout their manufacturing and commercialization process.

COVID-19 Impact: Disruption in Supply Chain to Hinder Market Growth

Global supply chains were hampered by the pandemic, which also affected the availability of vital supplies such as GMP cell banking equipment and consumables. This might have delayed the creation or growth of cell banks. Due to lockdown regulations and social distance restrictions, many research and development operations, including cell banking, were temporarily suspended or restricted. To protect the health and safety of their employees, laboratories have to develop new safety procedures, which can have an impact on the effectiveness and capacity of cell banking operations. Numerous clinical experiments had to be delayed or suspended as a result of the epidemic. Delays in trial initiation have an influence on the demand for new cell banks because GMP banking is an essential step in the manufacturing process of biologics for clinical trials.

LATEST TRENDS

"Increased Use of Automation and Robotics to Augment Market Growth"

Automation and robotics are increasingly being used in GMP cell banking procedures. Automated systems can lower the danger of contamination and human mistake while increasing efficiency, accuracy, and reproducibility. In cell banking, single-use technologies are becoming more and more common. By doing away with the requirement for cleaning and sterilisation procedures, these technologies lower the possibility of cross-contamination and enable quicker turnaround times. Cell banking is increasingly using closed-system processing, which uses disposable containers and aseptic connectors. It increases product and operator protection while reducing the danger of microbiological contamination.

SEGMENTATION

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By Type

Based on type market is classified as mammalian cell, microbial cell, insect cell and others.

By Application

Based on application market is classified as biopharmaceutical companies and contract manufacturing organizations.

DRIVING FACTORS

"The Rising Need for Biologics Including Monoclonal Antibodies to Propel Market Growth"

Due to the rising need for biologics including monoclonal antibodies, vaccines, and cell-based therapies, the biopharmaceutical business has been expanding significantly. The manufacture of these biologics relies heavily on cell banking, necessitating the development of strong and dependable cell banking procedures. The use of cell-based therapies to treat a variety of disorders, such as stem cell and CAR-T therapies, has shown encouraging outcomes. Manufacturing these medicines requires GMP cell banking because it guarantees a constant and dependable source of cells for clinical usage. Regulatory organisations with strict standards for biologics' quality, safety, and traceability include the FDA and the European Medicines Agency (EMA). To adhere to these legal requirements and guarantee the reliability and calibre of the cell-based goods, cell banking is required.

"Reduced Hazards of Cell Line Contamination to Enhance Market Growth"

The hazards of cell line contamination, genetic drift, and the loss of priceless cell lines are reduced by cell banking. Biopharmaceutical businesses can preserve the properties and stability of cell lines by setting up master and working cell banks, assuring uniformity in product quality throughout the manufacturing process. The timescales for the development and marketing of biologics are under increasing pressure to be sped up. GMP cell banking reduces the time needed for cell line development and characterisation and enables the quick and effective manufacturing of biologics by offering a ready-to-use source of cells. A growing trend is towards personalised medicine, which adapts therapies to each patient. By conserving patient-specific cells for later use, cell banking facilitates the development of personalised cell-based therapies, allowing for enhanced and more individualised care.

RESTRAINING FACTORS

"Time-Consuming Procedure to Impede Market Expansion"

Regulations and standards must be strictly followed in order to do GMP cell banking, which can be difficult and time-consuming. The substantial documentation, quality control procedures, and validation procedures needed to meet these criteria can be time-consuming and expensive for organisations. Construction and upkeep of GMP-compliant cell banking facilities require specialised hardware and infrastructure. This comprises quality control labs, cleanrooms, specialised storage facilities, and monitoring systems. Particularly for smaller businesses or research organisations with constrained resources, the initial investment and continuous maintenance costs might be substantial.

REGIONAL INSIGHTS

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"North America to Dominate the Market Due to Development of Cell-Based Therapeutics"

The development of cell-based therapeutics and biologics has been spearheaded by North America, primarily the United States. The Food and Drug Administration's (FDA) regulations, which offer direction on GMP compliance, are well-established regulatory frameworks in the area. There is a strong infrastructure for cell banking, and many businesses and academic organisations are actively involved in the production of biologics and cell therapies. Additionally, it is very prevalent in GMP cell banking. Guidelines and standards for GMP compliance in cell-based treatments and biologics are provided by the European Medicines Agency (EMA). Numerous cutting-edge industrial facilities and research institutions active in cell banking can be found in the area. Collaboration across European nations has further fostered standardised cell banking practises through programmes like the European Bank for Induced Pluripotent Stem Cells (EBiSC).

KEY INDUSTRY PLAYERS

"Key Plyers Focus on Partnerships to Gain a Competitive Advantage"

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Many companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios.

List of Market Players Profiled

• Charles River (U.S.)
• Thermo Fisher (U.S.)
• Lonza (Switzerland)
• Wuxi Apptec (China)
• Eurofins Scientific (Luxemburg)
• Merck KgaA (Germany)
• SGS Life Sciences (Switzerland)
• Sartorius (Germany)

REPORT COVERAGE

The report anticipates a detailed analysis of the global market size at the regional and national level, the ssegmentation market growth and market share. The prime objective of the report is to help user understand the market in terms of definition, market potential, influencing trends, and the challenges faced by the market. Aanalysis of sales, the impact of the market players, recent developments, opportunity analysis, strategic market growth analysis, territorial market expansion, and technological innovations are the subject matter explained in the report.