The Cell Banking Outsourcing Market Size was valued at USD 12.5 billion in 2023 and is projected to reach USD 41.54 Billion by 2031 with a growing CAGR of 16.2% Over the Forecast Period of 2024-2031.
A critical stage in the creation of biologics, advanced therapeutic medical products (ATMPs), and cell-based medicines is cell banking. To ensure the stability, vitality, and genetic integrity of cell lines or primary cells for potential use in future studies, clinical trials, or commercial manufacturing, cell banking entails isolation, characterization, expansion, and cryopreservation.
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The term "Cell Banking Outsourcing Market" describes the practice of contract research organizations (CROs) or contract manufacturing organizations (CMOs) with specialized expertise, infrastructure, and regulatory compliance performing cell banking services on behalf of biopharmaceutical companies, academic institutions, or other entities engaged in the development of cell-based therapies.
The cell banking outsourcing industry is where biopharmaceutical and biotechnology businesses outsource their cell banking needs to specialized service providers. Master cell banks (MCBs) and working cell banks (WCBs), which are used to produce biologics such as therapeutic proteins, vaccines, and cell treatments, must be stored and maintained.
KEY DRIVERS:
Demand for Biologics is Growing
Cost savings and efficiency
Demand for Biologics is Growing: The need for cell banking outsourcing is being driven by the rising demand for biopharmaceuticals such as monoclonal antibodies, therapeutic proteins, and vaccines. To assure their quality and effectiveness, biologics need strong cell lines and trustworthy cell banking services, which presents prospects for outsourcing businesses.
RESTRAIN:
The need for monoclonal antibodies
Lack of stem cells
A lot of stem cells come from tissues that are one-time-only. For instance, once-discarded cord blood can now be used to treat a variety of disorders, such as blood cancers. When therapy is required, these cells, which have been routinely banked and preserved for long periods, can be used right away, and rapid treatment can stop the progression of the disease.
OPPORTUNITY:
Cost reductions and operational effectiveness
Growing Demand for Biologics and Cell-Based Therapies
The ability to treat a variety of ailments, biologics, and cell-based therapies is in increasing demand in the biopharmaceutical sector. The outsourcing market is being driven by the rising demand for effective and dependable mobile banking services.
Biopharmaceutical businesses can reduce costs by outsourcing cell banking services. Companies can avoid having to set up and manage internal cell banking facilities, which call for substantial investments in infrastructure, gear, and qualified employees. Instead, they can work with specialized service providers. Businesses can increase operational efficiency by outsourcing cell banking tasks so they can concentrate on their core skills.
CHALLENGES:
Protection of Intellectual Property Rights
Quality and Compliance
When outsourcing cell banking, it is critical to maintain quality standards and make sure that all legal criteria are met. Strict regulations, such as Good Manufacturing Practises (GMP) and Good Laboratory Practises (GLP), must be followed by cell banks. Regulations may impose sanctions and reputational harm for any departure from these requirements. Cell banking presents several challenges to the protection of intellectual property (IP) rights. Cell banks frequently work with priceless exclusive cell lines, technology, and procedures. To avoid unauthorized use or disclosure, it is crucial to make sure that the right safeguards are in place. Data Security and Confidentiality in Handling sensitive and private data, such as patient and genetic data, is a requirement of cell banking. It's critical to protect data security, privacy, and secrecy.
IMPACT OF THE RUSSIAN-UKRAINE WAR
Regional Disruption & Market Uncertainty are the main impact of the Russian-Ukraine war in the region, there may be a climate of uncertainty due to the geopolitical tensions between Russia and Ukraine. Investment and business decisions are frequently impacted by uncertainty. As a result, businesses can adopt a cautious stance and postpone or evaluate their intentions to outsource their cell banking services. Cell banking entails the preservation and storage of priceless biological assets like stem cells or cell lines. Concerns about the security and safety of these materials may arise as a result of the conflict. Companies may be reluctant to outsource their needs for cell banking to a region that is experiencing war, which could result in a drop in demand for outsourcing services.
IMPACT OF ONGOING RECESSION
Businesses frequently experience financial constraints during a recession and look for methods to cut expenses. This may have a variety of effects on the cell banking outsourcing market. Cost-cutting measures during a recession, businesses may reduce their research and development (R&D) funding, which would result in a decline in outsourcing services like cell banking. Projects involving outsourcing could be postponed or scrapped as businesses prioritize necessary expenses.
Operations are carried out internally to cut expenses, some businesses may decide to carry out particular tasks internally rather than outsourcing them. This might lead to a decline in the need for outsourcing services for cell banking. Priorities may change during a recession; businesses may refocus their priorities and concentrate on their core operations. This can lead to a lessened focus on non-core operations like outsourcing cell banking.
The global cell banking outsourcing business, among other industries, has been significantly impacted by the COVID-19 epidemic. The following are some of the impacts seen in the many sectors. Global supply networks were disrupted by the epidemic as a result of lockdowns, travel restrictions, and decreased production activity. This caused delays in outsourcing projects by affecting the availability of the raw ingredients and reagents needed for cell banking procedures.
Delays in Clinical Trial During the pandemic, numerous clinical trials for innovative treatments and vaccinations were suspended or postponed. As a result of the ambiguous clinical trial landscape, businesses lowered their outsourcing efforts, which directly affected the market for cell banking outsourcing services.
By Type
Master Cell Banking
Working Cell Banking
Viral Cell Banking
By Cell Type
Stem Cell
Cord Cell Banking
Embryonic Stem Cell Banking
Adult Stem Cell Banking
Dental Stem Cell Banking
IPS Stem Cell Banking
Non-Stem Cell
By Phase
Bank Storage
Master Cell Bank Storage
Working Cell Bank Storage
Cell Storage Stability Testing
Bank Characterization & Testing
Safety Testing
Viral Cell Banks
Microbial Cell Banks
Gene Expression Testing
Karyology Testing
Gene Sequencing Testing
Bank Preparation
Master Cell Bank Preparation
Working Cell Bank Preparation
North America is the region anticipated to account for a sizable portion of the global market for cell banking outsourcing.
In 2022, North America led the market and held the greatest share. This market is expanding as a result of the existence of well-established pharmaceutical and biotechnology businesses, cutting-edge healthcare infrastructure, and supportive regulatory frameworks.
Throughout the forecast period, Asia Pacific is anticipated to have exponential growth. The existence of pharmaceutical firms, who are concentrating their priorities on the sizable and comparatively unexplored populations in Asia, is credited with this exponential CAGR.
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North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
South Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of the Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin American
The Major Players are Charles River Laboratories International, Inc., Lonza Group Ltd., SGS SA, Goodwin Biotechnology Inc., Eurofins Scientific SE, ViruSure GmbH, WuXi AppTec, Inc., BioReliance Corporation, a unit of Merck KGaA, Toxikon Corporation, and Texcell, Inc., and other players listed in the final report.
For the study and creation of stem cells, BioTherapeutic Labs Corp. and American CryoStem worked together.
To grow its business units, cryo-Cell International, Inc. partnered with Duke University.
| Report Attributes | Details |
| Market Size in 2023 | US$ 12.5 Bn |
| Market Size by 2031 | US$ 41.54 Bn |
| CAGR | CAGR of 16.2% From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Master Cell Banking, Working Cell Banking, Viral Cell Banking) • By cell Type (Stem Cell, Non-Stem Cell) • By Phase (Bank Storage, Bank Characterization & Testing, Bank Preparation) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Charles River Laboratories International, Inc. and Lonza Group Ltd., SGS SA, Goodwin Biotechnology Inc., Eurofins Scientific SE, ViruSure GmbH, WuXi AppTec, Inc., BioReliance Corporation, a unit of Merck KGaA, Toxikon Corporation, and Texcell, Inc. |
| Key Drivers | • Demand for Biologics is Growing • Cost savings and efficiency |
| Market Opportunities | • Cost reductions and operational effectiveness • Growing Demand for Biologics and Cell-Based Therapies |
ANS: The estimated size of the global cell banking outsourcing market in 2021 was USD 8,969.5 million, and from 2022 to 2030, it is predicted to increase at a CAGR of 17 %.
ANS: Protection of Intellectual Property Rights, Quality, and Compliance are the major challenges in the cell banking outsourcing market.
ANS: Charles River Laboratories Inc., Merck KGaA, Cryo-Cell International Inc., Clean Biologics, and Goodwin Biotechnology Inc. are the major companies operating in Cell Banking Outsourcing Market.
ANS: Protection of Intellectual Property Rights & Quality and Compliance.
ANS: North America is the region that has the highest rate.
Table of Contents
1.Introduction
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 Impact of COVID-19
4.2 Impact of the Russia-Ukraine War
4.3 Impact of Ongoing Recession
4.3.1 Introduction
4.3.2 Impact on major economies
4.3.2.1 US
4.3.2.2 Canada
4.3.2.3 Germany
4.3.2.4 France
4.3.2.5 United Kingdom
4.3.2.6 China
4.3.2.7 Japan
4.3.2.8 South Korea
4.3.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Cell Banking Outsourcing Market Segmentation, By Type
8.1 Master Cell Banking
8.2 Working Cell Banking
8.3 Viral Cell Banking
9. Cell Banking Outsourcing Market Segmentation, By Cell Type
9.1 Steam Cell
9.1.1 Cord Cell Banking
9.1.2 Embryonic Stem Cell Banking
9.1.3 Adult Stem Cell Banking
9.1.4 Dental Stem Cell Banking
9.1.5 IPS Stem Cell Banking
9.2 Non-Steam Cell
10. Cell Banking Outsourcing Market Segmentation, By Phase
10.1 Bank Storage
10.1.1 Master Cell Bank Storage
10.1.2 Working Cell Bank Storage
10.1.3 Cell Storage Stability Testing
10.2 Bank Characterization & Testing
10.2.1 Safety Testing
10.2.2 Viral Cell Banks
10.2.3 Microbial Cell Banks
10.2.4 Gene Expression Testing
10.2.5 Karyology Testing
10.26 Gene Sequencing Testing
10.3 Bank Preparation
10.3.1 Master Cell Bank Preparation
10.3.2 Working Cell Bank Preparation
11. Regional Analysis
11.1 Introduction
11.2 North America
11.2.1 North America Cell Banking Outsourcing Market by Country
11.2.2North America Cell Banking Outsourcing Market by Type
11.2.3 North America Cell Banking Outsourcing Market by Cell Type
11.2.4 North America Cell Banking Outsourcing Market by Phase
11.2.5 USA
11.2.5.1 USA Cell Banking Outsourcing Market by Type
11.2.5.3 USA Cell Banking Outsourcing Market by Cell Type
11.2.5.4 USA Cell Banking Outsourcing Market by Phase
11.2.6 Canada
11.2.6.1 Canada Cell Banking Outsourcing Market by Type
11.2.6.3 Canada Cell Banking Outsourcing Market by Cell Type
11.2.6.4 Canada Cell Banking Outsourcing Market by Phase
11.2.7 Mexico
11.2.7.1 Mexico Cell Banking Outsourcing Market by Type
11.2.7.3 Mexico Cell Banking Outsourcing Market by Cell Type
11.2.7.4 Mexico Cell Banking Outsourcing Market by Phase
11.3 Europe
11.3.1 Europe Cell Banking Outsourcing Market by Country
1.3.3.2 Europe Cell Banking Outsourcing Market by Type
11.3.3 Europe Cell Banking Outsourcing Market by Cell Type
11.3.4 Europe Cell Banking Outsourcing Market by Phase
11.3.5 Germany
11.3.5.1 Germany Cell Banking Outsourcing Market by Type
11.3.5.2 Germany Cell Banking Outsourcing Market by Cell Type
11.3.5.3 Germany Cell Banking Outsourcing Market by Phase
11.3.6 UK
11.3.6.1 UK Cell Banking Outsourcing Market by Type
11.3.6.2 UK Cell Banking Outsourcing Market by Cell Type
11.3.6.3 UK Cell Banking Outsourcing Market by Phase
11.3.7 France
11.3.7.1 France Cell Banking Outsourcing Market by Type
11.3.7.2 France Cell Banking Outsourcing Market by Cell Type
11.3.7.3 France Cell Banking Outsourcing Market by Phase
11.3.8 Italy
11.3.8.1 Italy Cell Banking Outsourcing Market by Type
11.3.8.2 Italy Cell Banking Outsourcing Market by Cell Type
11.3.8.3 Italy Cell Banking Outsourcing Market by Phase
11.3.9 Spain
11.3.9.1 Spain Cell Banking Outsourcing Market by Type
11.3.9.2 Spain Cell Banking Outsourcing Market by Cell Type
11.3.9.3 Spain Cell Banking Outsourcing Market by Phase
11.3.10 The Netherlands
11.3.10.1 Netherlands Cell Banking Outsourcing Market by Type
11.3.10.2 Netherlands Cell Banking Outsourcing Market by Cell Type
11.3.10.3 Netherlands Cell Banking Outsourcing Market by Phase
11.3.11 Rest of Europe
11.3.11.1 Rest of Europe Cell Banking Outsourcing Market by Type
11.3.11.2 Rest of Europe Cell Banking Outsourcing Market by Cell Type
11.3.11.3 Rest of Europe Cell Banking Outsourcing Market by Phase
11.4 Asia-Pacific
11.4.1 Asia Pacific Cell Banking Outsourcing Market by Country
11.4.2 Asia Pacific Cell Banking Outsourcing Market by Type
11.4.3 Asia Pacific Cell Banking Outsourcing Market by Cell Type
11.4.4 Asia Pacific Cell Banking Outsourcing Market by Phase
11.4.5 Japan
11.4.5.1 Japan Cell Banking Outsourcing Market by Type
11.4.5.2 Japan Cell Banking Outsourcing Market by Cell Type
11.4.5.3 Japan Cell Banking Outsourcing Market by Phase
11.4.6 South Korea
11.4.6.1 South Korea Cell Banking Outsourcing Market by Type
11.4.6.2 South Korea Cell Banking Outsourcing Market by Cell Type
11.4.6.3 South Korea Cell Banking Outsourcing Market by Phase
11.4.7 China
11.4.7.1 China Cell Banking Outsourcing Market by Type
11.4.7.2 China Cell Banking Outsourcing Market by Cell Type
11.4.7.3 China Cell Banking Outsourcing Market by Phase
11.4.8 India
11.4.8.1 India Cell Banking Outsourcing Market by Type
11.4.8.2 India Cell Banking Outsourcing Market by Cell Type
11.4.8.3 India Cell Banking Outsourcing Market by Phase
11.4.9 Australia
11.4.9.1 Australia Cell Banking Outsourcing Market by Type
11.4.9.2 Australia Cell Banking Outsourcing Market by Cell Type
11.4.9.3 Australia Cell Banking Outsourcing Market by Phase
11.4.10 Rest of Asia-Pacific
11.4.10.1 APAC Cell Banking Outsourcing Market by Type
11.4.10.2 APAC Cell Banking Outsourcing Market by Cell Type
11.4.10.3 APAC Cell Banking Outsourcing Market by Phase
11.5 The Middle East & Africa
11.5.1 The Middle East & Africa Cell Banking Outsourcing Market by Country
11.5.2 The Middle East & Africa Cell Banking Outsourcing Market by Type
11.5.3 The Middle East & Africa Cell Banking Outsourcing Market by Cell Type
11.5.4 The Middle East & Africa Cell Banking Outsourcing Market by Phase
11.5.6 Israel
11.5.6.1 Israel Cell Banking Outsourcing Market by Type
11.5.6.2 Israel Cell Banking Outsourcing Market by Cell Type
11.5.6.3 Israel Cell Banking Outsourcing Market by Phase
11.5.6 UAE
11.5.6.1 UAE Cell Banking Outsourcing Market by Type
11.5.6.2 UAE Cell Banking Outsourcing Market by Cell Type
11.5.6.3 UAE Cell Banking Outsourcing Market by Phase
11.5.7 South Africa
11.5.7.1 South Africa Cell Banking Outsourcing Market by Type
11.5.7.2 South Africa Cell Banking Outsourcing Market by Cell Type
11.5.7.3 South Africa Cell Banking Outsourcing Market by Phase
11.5.8 Rest of Middle East & Africa
11.5.8.1 Rest of Middle East & Asia Cell Banking Outsourcing Market by Type
11.5.8.2 Rest of Middle East & Asia Cell Banking Outsourcing Market Phase
11.5.8.3 Rest of Middle East & Asia Cell Banking Outsourcing Market by Phase
11.6 Latin America
11.6.1 Latin America Cell Banking Outsourcing Market by Country
11.6.2 Latin America Cell Banking Outsourcing Market by Type
11.6.3 Latin America Cell Banking Outsourcing Market by Cell Type
11.6.4 Latin America Cell Banking Outsourcing Market by Phase
11.6.5 Brazil
11.6.5.1 Brazil Cell Banking Outsourcing Market by Type
11.6.5.2Brazil Cell Banking Outsourcing Market by Cell Type
11.6.2.3 Brazil Cell Banking Outsourcing Market by Phase
11.6.6 Argentina
11.6.6.1 Argentina Cell Banking Outsourcing Market by Type
11.6.6.2 Argentina Cell Banking Outsourcing Market by Cell Type
11.6.6.3 Argentina Cell Banking Outsourcing Market by Phase
11.6.7 Rest of Latin America
11.6.7.1 Rest of Latin America Cell Banking Outsourcing Market by Type
11.6.7.2 Rest of Latin America Cell Banking Outsourcing Market by Cell Type
11.6.7.3 Rest of Latin America Cell Banking Outsourcing Market by Phase
12 Company Profile
12.1 Charles River Laboratories International Inc
12.1.1 Market Overview
12.1.2 Financials
12.1.3 Product/Services/Offerings
12.1.4 SWOT Analysis
12.1.5 The SNS View
12.2 Lonza Group Ltd.
12.2.1 Market Overview
12.2.2 Financials
12.2.3 Product/Services/Offerings
12.2.4 SWOT Analysis
12.2.5 The SNS View
12.3 SGS SA
12.3.1 Market Overview
12.3.2 Financials
12.3.3 Product/Services/Offerings
12.3.4 SWOT Analysis
12.3.5 The SNS View
12.4 Goodwin Biotechnology Inc.
12.4.1 Market Overview
12.4.2 Financials
12.4.3 Product/Services/Offerings
12.4.4 SWOT Analysis
12.4.5 The SNS View
12.5 Eurofins Scientific SE
12.5.1 Market Overview
12.5.2 Financials
12.5.3 Product/Services/Offerings
12.5.4 SWOT Analysis
12.5.5 The SNS View
12.6 Viruses GmbH
12.6.1 Market Overview
12.6.2 Financials
12.6.3 Product/Services/Offerings
12.6.4 SWOT Analysis
12.6.5 The SNS View
12.7 WuXi AppTech Inc.
12.7.1 Market Overview
12.7.2 Financials
12.7.3 Product/Services/Offerings
12.7.4 SWOT Analysis
12.7.5 The SNS View
12.8 Bio Reliance Corporation
12.8.1 Market Overview
12.8.2 Financials
12.8.3 Product/Services/Offerings
12.8.4 SWOT Analysis
12.8.5 The SNS View
12.9 A unit of Merck KGaA,
12.9.1 Market Overview
12.9.2 Financials
12.9.3 Product/Services/Offerings
12.9.4 SWOT Analysis
12.9.5 The SNS View
12.10 Toxikon Corporation
12.10.1 Market Overview
12.10.2 Financials
12.10.3 Product/Services/Offerings
12.10.4 SWOT Analysis
12.10.5 The SNS View
12.11 Texcell Inc.
12.11.1 Market Overview
1211.2 Financials
12.11.3 Product/Services/Offerings
12.11.4 SWOT Analysis
12.11.5 The SNS View
13. Competitive Landscape
13.1 Competitive Benchmarking
13.2 Market Share Analysis
13.3 Recent Developments
14. USE Cases and Best Practices
15. Conclusion
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