GMP Cell Banking Service Market Poised to Reach New Heights - Persistence Market Research Forecasts

The global GMP (Good Manufacturing Practice) cell banking services market is experiencing significant growth, driven by various factors such as technological advancements, the increasing need for biopharmaceutical companies to outsource production, and the expanding demand for cell-based therapies. Cell banking is the process of creating and storing biological cells, especially for research, development, and production of biopharmaceutical products. GMP-certified cell banking ensures that cells are maintained under strict conditions that comply with regulatory standards, making them suitable for commercial use and clinical trials.

The market has witnessed a notable rise in the number of collaborations between pharmaceutical companies and service providers due to limited in-house storage and testing capabilities. Biopharmaceutical companies, especially large players, are increasingly seeking external service providers to meet regulatory guidelines and to ensure that the quality and integrity of the cell banks are maintained. Persistence Market Research highlights that outsourcing has become a key trend among biopharmaceutical companies seeking to streamline operations and boost productivity, a trend that is expected to persist throughout the forecast period.

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Market Statistics, Key Growth Drivers, Leading Segment, and Leading
Geographical Region

The GMP cell banking services market is expected to see a significant increase in revenue over the forecast period, driven by the rapid growth in cell-based therapies, as well as advancements in gene and cell therapy. Persistence Market Research notes that mammalian cells represent the most attractive segment in the global market, and this trend is likely to continue. The mammalian segment is expected to expand at a robust compound annual growth rate (CAGR) over the forecast period, with a particularly strong performance in North America and Europe.

The growth drivers behind this market's expansion include the growing demand for cell-based therapeutics, increased investments in biotech and pharmaceutical companies, and the rising need for cell banking services due to limited in-house capabilities. The leading geographical region for GMP cell banking services is North America, primarily due to its highly developed healthcare infrastructure, a large number of biopharmaceutical companies, and significant investments in biotechnology. Europe is also expected to show strong growth, supported by regulatory advancements and a well-established biopharmaceutical sector.

Key Highlights from the Report

➤ The mammalian cell type segment is anticipated to dominate the global GMP cell banking services market, with a strong CAGR throughout the forecast period.
➤ Biopharmaceutical companies continue to outsource GMP cell banking services to improve operating efficiency and increase pipeline productivity.
➤ North America is expected to maintain its dominance in the GMP cell banking services market due to the presence of major biopharmaceutical companies.
➤ Limited in-house storage and testing capabilities are driving biopharmaceutical companies to outsource their cell banking services to dedicated service providers.
➤ The mammalian segment is projected to witness significant revenue growth in the European and Asia Pacific markets.
➤ The increasing demand for cell-based therapies and advancements in gene therapies are key growth drivers for the market.

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Market Segmentation

Based on Product Type

The global GMP cell banking services market is segmented into different product types, with mammalian cells being the leading segment. The mammalian segment is expected to continue dominating the market, due to its relevance in the production of biopharmaceutical products. Mammalian cell types, such as Chinese hamster (CHO) cells, are commonly used in the production of monoclonal antibodies, recombinant proteins, and vaccines. This segment is particularly attractive due to its flexibility in accommodating various genetic modifications and its ability to produce large quantities of high-quality therapeutic proteins.

On the other hand, microbial cell banking services are gaining traction as an alternative to mammalian cell banking, especially for certain types of vaccines and biologics. However, the mammalian segment remains the most popular, accounting for the highest revenue share. The growth of the mammalian cell banking services market can be attributed to the increasing demand for monoclonal antibodies, gene therapies, and the rising prevalence of chronic diseases.

Based on End-User

The GMP cell banking services market is also segmented based on end-users, including biopharmaceutical companies, academic research institutions, and biotechnology companies. Biopharmaceutical companies represent the largest segment, accounting for the highest revenue share, primarily due to their ongoing demand for cell-based therapies. These companies prefer outsourcing cell banking services to maintain a streamlined process that adheres to regulatory standards, such as those set by the FDA and EMA.

Academic research institutions are another key end-user of GMP cell banking services, leveraging these services to support their drug discovery programs. Additionally, biotechnology companies, especially small and medium-sized enterprises (SMEs), are increasingly outsourcing cell banking services to mitigate the cost and complexity of establishing in-house facilities. These end-users typically require flexibility in cell line development and testing services, which makes outsourced GMP cell banking services highly beneficial for them.

Regional Insights

North America
North America remains the leading region for GMP cell banking services, owing to its advanced healthcare infrastructure, presence of major pharmaceutical and biotechnology companies, and significant research and development investments. The United States, in particular, accounts for a large share of the market due to the growing adoption of cell-based therapies and the demand for high-quality cell banking services. Additionally, the regulatory environment in North America is robust, and many biopharmaceutical companies prefer to partner with GMP-certified cell banking service providers to ensure compliance with stringent guidelines.

Europe
Europe is another key market for GMP cell banking services, with a growing number of biopharmaceutical companies seeking outsourced cell banking solutions. The market in Europe is characterized by increasing demand for cell-based therapeutics, particularly in the areas of gene and cell therapy. The region benefits from a strong regulatory framework and significant investments in biotechnology and healthcare infrastructure. The mammalian cell banking segment, in particular, is expected to experience significant growth in Europe, with countries like Germany, the UK, and France leading the way.

Market Drivers

The primary driver of the GMP cell banking services market is the increasing demand for cell-based therapies, particularly monoclonal antibodies, recombinant proteins, and vaccines. As biopharmaceutical companies invest heavily in developing new treatments, the need for high-quality cell banks to support clinical trials and production processes has risen dramatically. Additionally, the growing adoption of gene therapies and the rise in chronic diseases, such as cancer and autoimmune disorders, are expected to further fuel market growth.

Another significant driver is the growing trend of outsourcing by biopharmaceutical companies. Many companies, especially large ones, are focusing on their core competencies and prefer to outsource non-core functions such as cell banking services. This helps them optimize costs, improve operational efficiency, and ensure compliance with regulatory standards.

Market Restraints

Despite the positive growth outlook, there are certain challenges hindering the market's growth. One of the major restraints is the high cost of cell banking services, particularly for small and medium-sized enterprises (SMEs). Setting up and maintaining GMP-certified cell banks requires substantial investment in infrastructure, skilled personnel, and regulatory compliance, which can be a barrier for companies with limited budgets.

Furthermore, the complexity of regulatory compliance in different regions can also be a challenge. Companies operating in multiple countries need to navigate varying regulatory requirements, which can delay the approval process and increase operational costs.

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Market Opportunities

The rising demand for personalized medicine and cell-based therapies presents a significant opportunity for growth in the GMP cell banking services market. With increasing investments in gene and cell therapies, the need for high-quality, well-maintained cell banks will continue to rise. Additionally, the growing trend of biopharmaceutical companies and academic institutions partnering with contract development and manufacturing organizations (CDMOs) for cell banking services offers a promising avenue for market expansion.

There is also an opportunity to develop specialized services for niche markets, such as CAR-T cell therapies, gene editing, and rare disease research. These emerging fields require tailored cell banking solutions, which could provide lucrative opportunities for service providers.

Reasons to Buy the Report

✔ Gain in-depth insights into the global GMP cell banking services market and its key growth drivers.
✔ Understand the market's competitive landscape, including the key players and their strategies.
✔ Stay ahead of emerging trends, such as the demand for cell-based therapies and gene editing.
✔ Access detailed market segmentation and regional analysis to make informed business decisions.
✔ Benefit from expert analysis of the market's challenges, opportunities, and future outlook.

Company Insights

Key Players

✦ WuXi AppTec
✦ Charles River Laboratories International, Inc.
✦ Eurofins Scientific
✦ Merck KGaA
✦ Lonza Group Ltd
✦ SGS Ltd
✦ ViruSure GmbH
✦ Austrianova
✦ Goodwin Biotechnology Inc.
✦ Paragon Bioservices, Inc.

Recent Developments

WuXi AppTec expanded its GMP cell banking services by introducing new capabilities for gene and cell therapy manufacturing.

Lonza Group Ltd recently announced a partnership with a leading biotech firm to provide comprehensive cell banking services for a new gene therapy product.

Conclusion

The global GMP cell banking services market is poised for significant growth as the demand for cell-based therapies, gene therapies, and biopharmaceutical production continues to rise. This market expansion is driven by the increasing outsourcing trend among biopharmaceutical companies, the need for high-quality and regulatory-compliant cell banks, and the growing complexity of manufacturing biologics. The mammalian cell segment, with its critical role in producing therapeutic proteins and vaccines, remains the dominant force within this market, and it is expected to maintain its leadership throughout the forecast period.

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