GMP Cell Banking Services Market Size, Share, Growth, and Industry Analysis, By Type (Mammalian, Microbial, Insect, Yeast, Avian, Stem Cell and Others), By Application (Biopharmaceutical Companies and Contract Manufacturing Organizations) and Regional Insights and Forecast to 2031

Updated On: 29 April 2024

GMP CELL BANKING SERVICES MARKET REPORT OVERVIEW

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The global GMP cell banking services market size was USD 189.1 million in 2020 and will touch USD 258 million by 2027, exhibiting a CAGR of 4.1% during the forecast period.

GMP (Good Manufacturing Practice) cell banking services play a crucial role in the biopharmaceutical industry by ensuring the production of safe and consistent cell-based therapies and biologics. GMP regulations set forth strict guidelines for the manufacturing processes of pharmaceutical products, and cell banking services adhere to these standards to maintain the quality and integrity of cell lines used in the production of biopharmaceuticals.

GMP cell banking involves the creation and storage of master and working cell banks, which serve as essential starting materials for the production of biologics. Master cell banks contain well-characterized, fully tested cell lines that have been extensively documented for their stability and genetic integrity. Working cell banks are derived from the master cell banks and are used in routine production to generate therapeutic products.

GMP cell banking services typically include cell line development, characterization, testing, and storage under controlled conditions to prevent contamination and ensure the reproducibility of cell-based therapies. The implementation of GMP cell banking services is critical to meeting regulatory requirements, minimizing the risk of product variability, and ultimately ensuring the safety and efficacy of biopharmaceutical products.

COVID-19 Impact: Market Growth Restrained by Pandemic due to Supply Chain Disruptions

The global COVID-19 pandemic has been unprecedented and staggering, with the GMP cell banking services market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to market’s growth and demand returning to pre-pandemic levels.

The pandemic has disrupted global supply chains, affecting the availability of critical reagents and materials used in GMP cell banking processes. This has led to delays in cell line development and production timelines. Lockdowns and restrictions have led to temporary closures of laboratories and manufacturing facilities. Remote work limitations have impacted the ability of professionals to conduct experiments and monitor processes, causing delays in GMP cell banking activities.

Many clinical trials were put on hold or delayed due to the pandemic. This, in turn, affected the demand for GMP cell banking services, as companies postponed or reevaluated their development timelines. The market is anticipated to boost the GMP cell banking services market growth following the pandemic.

LATEST TRENDS

"Biopharmaceutical Advancements to Drive Market Growth"

The demand for GMP cell banking services continues to grow with the increasing focus on biopharmaceuticals, including monoclonal antibodies, gene therapies, and cell-based therapies. Advances in these fields drive the need for reliable and compliant GMP cell banking solutions. The industry is witnessing an increased adoption of automation and advanced technologies to enhance the efficiency, reliability, and scalability of GMP cell banking processes. This includes the use of robotics, artificial intelligence, and data analytics to streamline workflows and improve quality control.

The rise of personalized medicine and the development of cell therapies are influencing the GMP cell banking services market. Providers are adapting to support the unique requirements of cell therapies and personalized treatments, including patient-specific cell lines. These latest developments are anticipated to boost the GMP cell banking services market share.

GMP CELL BANKING SERVICES MARKET SEGMENTATION

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• By Type

Based on type the global market can be categorized into Mammalian, Microbial, Insect, Yeast, Avian, Stem Cell and Others.

Mammalian: Mammalian cells, often derived from humans or animals, are used for the production of complex proteins and biopharmaceuticals. They offer post-translational modifications similar to those in humans, making them suitable for therapeutic protein production.

Microbial: Microbial cells, such as bacteria (e.g., Escherichia coli), are commonly used for the expression of proteins due to their rapid growth and ease of manipulation. However, they may lack post-translational modifications found in higher organisms.

Insect: Insect cells, often derived from the baculovirus expression system, are used for expressing proteins that may require post-translational modifications not present in microbial systems.

Yeast: Yeast cells, commonly Saccharomyces cerevisiae or Pichia pastoris, are used for protein expression. They offer advantages in terms of glycosylation and can produce high yields of recombinant proteins.

Avian: Avian cells are commonly used for the development and manufacturing of certain vaccines, such as those for influenza. Chicken eggs, for example, have historically been used as a substrate for the production of influenza vaccines.

Stem cell: Stem cells, including embryonic and induced pluripotent stem cells, offer the potential for differentiation into various cell types for therapeutic purposes. They are being explored for regenerative medicine and cell-based therapies.

• By Application

Based on application the global market can be categorized into Biopharmaceutical Companies and Contract Manufacturing Organizations.

Biopharmaceutical companies play a pivotal role in drug discovery and development, researching and identifying potential therapeutic targets, conducting preclinical studies, and progressing candidates through clinical trials. Biopharmaceutical companies are engaged in the large-scale production of biologic drugs, including monoclonal antibodies, recombinant proteins, and gene therapies.

Contract Manufacturing Organizations assist biopharmaceutical companies in developing scalable and efficient bioprocesses for the production of biologics and cell-based therapies. They provide Good Manufacturing Practice (GMP) compliant manufacturing facilities for the production of biopharmaceuticals, ensuring the quality and safety of therapeutic products. They support biopharmaceutical companies in developing and characterizing stable and high-producing cell lines for the production of recombinant proteins and biologics.

DRIVING FACTORS

"Rising Prevalence of Chronic Diseases to Boost the Market"

The global increase in chronic diseases, such as cancer and autoimmune disorders, has driven the development of innovative therapies. GMP cell banking services play a critical role in supporting the production of biologics and cell-based therapies designed to treat these diseases. Recent events, such as the COVID-19 pandemic, have underscored the importance of having robust and scalable manufacturing processes for the rapid development of vaccines and therapeutics. GMP cell banking services play a vital role in ensuring the availability of consistent and safe starting materials for the production of biopharmaceuticals during health crises.

"Increasing Biopharmaceutical R&D to Expand the Market"

The growing focus on biopharmaceuticals, including monoclonal antibodies, gene therapies, and cell-based therapies, has led to an increased demand for GMP cell banking services. Biopharmaceutical companies are actively engaged in research and development activities, driving the need for well-characterized and stable cell lines. The overall growth and expansion of the biotechnology and life sciences sector contribute to the demand for GMP cell banking services. The industry's focus on developing advanced therapeutics and personalized medicines has further intensified the need for high-quality cell lines.

The rise in investments and interest in regenerative medicine, including stem cell therapies, is a significant driver for GMP cell banking services. These services are essential for ensuring the safety and consistency of cell-based regenerative therapies. These factors are anticipated to drive the GMP cell banking services market share.

RESTRAINING FACTOR

"Technical & Scientific Challenges to Potentially Impede Market Growth"

Developing and maintaining well-characterized cell lines that meet GMP standards can be technically demanding. Achieving consistency and stability in cell lines, especially for novel therapies, may present scientific challenges that could impede the efficiency of GMP cell banking processes. The increasing complexity of cell-based therapies, including gene and cell therapies, may introduce additional challenges in GMP cell banking. The unique characteristics of these therapies may require specialized expertise and technologies.

Global events, such as pandemics or geopolitical issues, can disrupt supply chains, affecting the availability of critical materials for GMP cell banking. This can lead to delays in production and impact the reliability of the supply chain. The factors are anticipated to hinder the growth of the GMP cell banking services market growth.

GMP CELL BANKING SERVICES MARKET REGIONAL INSIGHTS

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"North America to dominate the Market due to Rise in Biopharmaceutical Hubs"

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and Middle East & Africa.

North America and the U.S. in particular, is a global hub for the biopharmaceutical industry. The region is home to numerous biotechnology and pharmaceutical companies that are actively engaged in research, development, and manufacturing of biologics and cell-based therapies. The concentration of these companies contributes significantly to the demand for GMP cell banking services. The U.S. has a strong tradition of research and innovation in the life sciences and biotechnology sectors. Academic institutions, research centers, and biotech clusters in the U.S. drive advancements in cell-based therapies, creating a substantial market for GMP cell banking services to support the development and production of novel therapeutics. Biopharmaceutical research and development require substantial investment. North America and the U.S. in particular, provides access to significant funding sources, including venture capital, private equity, and government grants. The availability of funding facilitates the development of innovative therapies, driving the demand for GMP cell banking services.

KEY INDUSTRY PLAYERS

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

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead in 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 portfolio.

List of Market Players Profiled

• WuXi AppTec [China]
• Charles River Laboratories [U.S.]
• Eurofins Scientific [Luxemborg]
• Merck KGaA [Germnay]
• Lonza [Switzerland]

INDUSTRIAL DEVELOPMENT

May 2022: GMP-Compliant Cell Banking Services is a specialized offerings provided by companies like Lonza Group, adhering to Good Manufacturing Practice (GMP) standards in the creation, characterization, and storage of cell banks. These services are critical in the biopharmaceutical industry, ensuring the reproducibility, quality, and safety of cell lines used for the production of therapeutic products.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilizing both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated timeframe. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.