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市场调查报告书
商品编码
1766026
2032 年细胞库外包市场预测:按类型、细胞类型、阶段、最终用户和地区进行的全球分析Cell Banking Outsourcing Market Forecasts to 2032 - Global Analysis By Type (Master Cell Banks (MCB), Working Cell Banks (WCB) and Viral Cell Banking (VCB)), Cell Type (Stem Cell and Non-stem Cell), Phase, End User and By Geography |
根据 Stratistics MRC 的数据,全球细胞银行外包市场预计在 2025 年达到 175.1 亿美元,到 2032 年将达到 569.3 亿美元,预测期内的复合年增长率为 18.34%。
细胞库外包是指将细胞库(包括主细胞库 (MCB) 和工作细胞库 (WCB))的创建、储存和维护委託给专业的第三方服务供应商。透过利用 CDMO 的基础设施和经验,该策略可帮助生物製药公司确保合规性、降低成本并加快开发週期。外包细胞库服务通常包括细胞株检查、良好生产规范 (GMP) 储存和稳定性测试,为临床和商业生产需求提供可靠且灵活的解决方案。
根据 FDA 细胞、组织和基因治疗办公室 (CBER) 的数据,2017 年至 2021 年期间 CDER 发布的临床暂停通知中约有 40% 用于细胞和基因治疗试验,这凸显了监管的复杂性以及标准化外包细胞库能力的必要性。
对细胞疗法和生技药品的兴趣日益浓厚
疫苗、单株抗体以及先进的细胞和基因治疗药物等生技药品正日益取代传统药物,成为现代医学的支柱。随着临床研究活动和核准的增加,可追溯、可靠且符合国际监管标准的大规模主细胞库和工作细胞库的重要性日益凸显。此外,外包使製药公司能够利用现有的基础设施和成熟的专业知识,从而缩短开发时间并保持这些生物製药的完整性和品质。
对保护智慧财产权 (IP) 和资料安全的担忧
将细胞株係等关键生物资源委託给外部供应商时,资料保密性和智慧财产权所有权方面存在严重问题。高价值治疗产品通常基于患者来源或专有细胞株细胞株,生物製药公司经常使用这些细胞系。企业,尤其是早期生技公司,可能会因为担心资料外洩、未授权存取和智慧财产权滥用而不愿进行委託。此外,《一般资料保护规范》(GDPR) 和《健康保险流通与责任法案》(HIPAA) 等法规使敏感资料管理更加困难,尤其是在跨国外包的情况下。
保存和冷冻保存技术的发展
自动化库存系统、数位追踪、低温储存和细胞冻存介质等技术进步正在提升细胞库的品质和安全性。除了降低细胞劣化的可能性外,这些技术进步还透过可扩展性、效率和可追溯性赋予外包公司竞争优势。此外,提供技术整合、全天候监控的细胞库的公司将占据有利地位,为未来的生技药品和细胞治疗技术提供支援。
监管不确定性和不断变化的指导方针
基因和细胞治疗,以及细胞库的法规环境瞬息万变。美国生物製药物料输送(FDA)、欧洲药品管理局 (EMA)、日本药品管理局 (PMDA) 和国家药品监督管理局 (NMPA) 等机构会定期更新生物製剂物料处理的 GMP 法规、文件标准和品质预期。细胞库外包服务提供者必须不断适应有关文件、可追溯性和无菌性的新法规。违规可能导致许可证被撤销、客户流失以及批次不合格。此外,不同国家的监管要求各不相同,这使得全球外包更具挑战性。
新冠疫情对细胞库外包市场产生了许多影响,但最终是革命性的。最初,供应链中断和关闭阻碍了生物材料的运输和储存,并推迟了正在进行的生物製药计划。然而,全球对疫苗研发和治疗研究的日益重视,导致对符合GMP标准的细胞库服务的需求增加,尤其是在病毒载体和单株抗体的生产方面。疫情也凸显了可扩展且可靠的外包模式对于降低营运风险的重要性,促使许多生物製药公司重新评估其供应链,并将细胞库等非核心功能外包。
主细胞库(MCB)细分市场预计将在预测期内占据最大份额
预计在预测期内,主细胞库 (MCB) 细分市场将占据最大市场占有率,因为 MCB 是用于生产生技药品和细胞疗法的细胞株的来源,因此对品质、一致性和合规性至关重要。由于 MCB 是在严格的 GMP 指导下开发的,并经过了身份、纯度和稳定性的全面测试,因此将其开发外包可确保一流的资源和知识。此外,单株抗体、疫苗和基因疗法日益增长的需求推动了 MCB 的市场主导地位,这使得製药公司依赖外包合作伙伴来建立和营运 MCB。
预计预测期内 CRO(委外研发机构)部门的复合年增长率最高。
预计合约研究组织 (CRO) 细分市场将在预测期内呈现最高成长率。 CRO 提供高度专业化、灵活且价格合理的服务,深受大型製药公司和寻求优化研发流程的新兴生技公司的青睐。对快速生技药品开发、法规遵循和风险规避的需求日益增长,促使 CRO 逐渐成为细胞株表征、GMP 细胞库和品质保证的策略伙伴。此外,CRO 的扩充性、技术专长和全球影响力使其在支持基因和细胞疗法等复杂计划占据优势,从而推动了 CRO 在外包市场的爆炸式增长。
预计北美将在预测期内占据最大的市场占有率,这得益于顶级CDMO、严格的法规环境以及先进的生物製药行业。美国在细胞疗法和生技药品开发方面处于主导地位,因此对符合GMP标准的细胞库服务的需求很高。该地区还受益于大量的研发支出、强大的医疗保健体係以及製药公司与专业外包供应商之间的定期合作。此外,早期采用最尖端科技、重视品管和法规遵循进一步巩固了北美在全球细胞库外包市场的主导地位。
预计亚太地区将在预测期内实现最高的复合年增长率。这得益于中国、印度、韩国和新加坡等国生物技术和製药产业的爆炸性成长。这些国家的政府正透过资金援助、基础建设和扶持政策积极推动生物製造业的发展。该地区拥有高素质人才,且营运成本低廉,非常适合细胞库服务的外包。此外,由于亚太地区企业越来越多地参与生技药品、生物仿製药和细胞疗法的开发,对可扩展且合规的细胞储存解决方案的需求不断增加,该地区有望成为外包目的地,并实现高成长。
According to Stratistics MRC, the Global Cell Banking Outsourcing Market is accounted for $17.51 billion in 2025 and is expected to reach $56.93 billion by 2032 growing at a CAGR of 18.34% during the forecast period. Cell banking outsourcing is assigning specialized third-party service providers to create, store, and maintain cell banks, including master cell banks (MCBs) and working cell banks (WCBs). By utilizing the infrastructure and experience of CDMOs, this strategy assists biopharmaceutical companies in ensuring regulatory compliance, cutting costs, and expediting their development timelines. Outsourced cell banking services often include checking cell lines, storing them according to good manufacturing practices (GMP), and testing their stability, offering reliable and flexible solutions for both clinical and commercial production needs.
According to the FDA Office of Cellular, Tissue and Gene Therapies (CBER), approximately 40 % of clinical holds issued by CDER between 2017-2021 were for cell and gene therapy trials, emphasizing the regulatory complexity and need for standardized, outsourced cell banking capabilities.
Growing interest in cell therapies and biologics
Biologics, such as vaccines, monoclonal antibodies, and sophisticated cell and gene therapies, are quickly taking the place of pharmaceuticals as the mainstay of contemporary medicine. The importance of large-scale master and working cell banks that are traceable, dependable, and compliant with international regulatory standards is growing as clinical research activity and approvals increase. Additionally, pharmaceutical companies can speed up their development timelines and maintain the integrity and quality of these biologic products by outsourcing because it gives them access to ready infrastructure and proven expertise.
Concerns about protecting intellectual property (ip) and data security
There are serious issues with data confidentiality and intellectual property ownership when vital biological resources, such as cell lines, are outsourced to outside vendors. High-value therapeutic products are often based on patient-derived or proprietary cell lines, which biopharmaceutical companies frequently work with. Companies, particularly early-stage biotech firms, may be discouraged from outsourcing due to concerns about data breaches, unauthorized access, or intellectual property misuse. Furthermore, the management of sensitive data is made more difficult by regulations like GDPR and HIPAA, especially when outsourcing crosses international borders.
Technological developments in storage and cryopreservation
The quality and security of cell banking are being improved by advancements in automated inventory systems, digital tracking, cryogenic storage, and cell freezing media. In addition to lowering the chance of cell deterioration, these technological developments give outsourcing companies a competitive edge through scalability, efficiency, and traceability. Moreover, businesses that provide tech-integrated, round-the-clock monitored repositories will be in a better position to support the upcoming biologics and cell therapy technologies.
Uncertainty in regulations and changing guidelines
The regulatory environment surrounding gene and cell therapies, and consequently, cell banking, is always changing. Biologic material handling GMP regulations, documentation standards, and quality expectations are regularly updated by organizations like the FDA, EMA, PMDA, and NMPA. Providers of cell banking outsourcing must constantly adjust to new regulations pertaining to documentation, traceability, and sterility. Any noncompliance may result in license revocations, client losses, or batch failures. Furthermore, global outsourcing is made more difficult by the fact that different countries have different regulatory requirements.
The COVID-19 pandemic affected the cell banking outsourcing market in a variety of ways, but ultimately in a revolutionary way. At first, supply chain interruptions and lockdowns hindered the transportation and storage of biological materials and postponed ongoing biopharmaceutical projects. However, the need for GMP-compliant cell banking services-particularly for the production of viral vectors and monoclonal antibodies-increased due to the global emphasis on vaccine development and therapeutic research. In order to reduce operational risks, the pandemic also highlighted the significance of scalable and trustworthy outsourcing models, leading numerous biopharma companies to re-evaluate their supply chains and outsource non-core functions like cell banking.
The master cell bank (MCB) segment is expected to be the largest during the forecast period
The master cell bank (MCB) segment is expected to account for the largest market share during the forecast period because MCBs are the original source of a cell line used in the production of biologics and cell therapies, they are essential for quality, consistency, and regulatory compliance. Because MCBs are developed under stringent GMP guidelines and thoroughly examined for identity, purity, and stability, outsourcing their creation guarantees access to top-notch resources and knowledge. Moreover, the market dominance of MCBs is fueled by pharmaceutical companies' growing reliance on outsourcing partners to set up and run MCBs in response to the growing demand for monoclonal antibodies, vaccines, and gene therapies.
The contract research organizations (CROs) segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the contract research organizations (CROs) segment is predicted to witness the highest growth rate. CROs provide highly specialized, flexible, and affordable services that are being embraced by big pharmaceutical companies and up-and-coming biotech companies looking to optimize R&D procedures. CROs are evolving into strategic partners in cell line characterization, GMP cell banking, and quality assurance due to the growing demand for quicker biologics development, regulatory compliance, and risk mitigation. Additionally, their scalability, technological know-how, and global reach put them in a strong position to support intricate projects like gene and cell therapies, which has fueled their explosive growth in the outsourcing market.
During the forecast period, the North America region is expected to hold the largest market share, driven by the presence of top CDMOs, a robust regulatory environment, and an advanced biopharmaceutical industry. Due to the United States' leadership in the development of cell therapies and biologics, there is a significant need for GMP-compliant cell banking services. The area also gains from large R&D expenditures, a strong healthcare system, and regular collaborations between pharmaceutical companies and specialized outsourcing providers. Furthermore, the early adoption of cutting-edge technologies, along with an emphasis on quality control and regulatory compliance, further solidifies North America's leading position in the global outsourcing market for cell banking.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by the biotechnology and pharmaceutical industries' explosive growth in nations like China, India, South Korea, and Singapore. These nations' governments are actively promoting biomanufacturing through funding, infrastructure development, and supportive policies. The area is desirable for outsourcing cell banking services due to the availability of qualified personnel at reduced operating expenses. Additionally, Asia-Pacific is becoming a high-growth outsourcing destination as a result of the growing involvement of regional players in the development of biologics, biosimilars, and cell therapies, which is increasing demand for scalable and compliant cell storage solutions.
Key players in the market
Some of the key players in Cell Banking Outsourcing Market include Charles River Laboratories, Inc., Merck KGaA, Texcell, LifeCell International Pvt. Ltd., Cryo-Cell International, Inc., SGS Societe Generale de Surveillance SA, Lonza Group, GBI (Goodwin Biotechnology Inc.), Cordlife Group Limited, WuXi AppTec, Reliance Life Sciences, Bio Outsource (Sartorious), Clean Biologics Inc and BSL Bioservice Inc.
In April 2025, Merck KGaA and SpringWorks Therapeutics Inc have entered into a definitive agreement for Merck KGaA, Darmstadt, Germany, to acquire SpringWorks. The agreed acquisition of SpringWorks is a major step in our active portfolio strategy to position our company as a globally diversified, innovation and technology powerhouse. For our Healthcare sector, it sharpens the focus on rare tumors, accelerates growth, and strengthens our presence in the U.S.
In October 2024, Lonza has announced a long-term extension of its collaboration with a key global biopharmaceutical partner for the manufacture of antibody-drug conjugates (ADCs) at commercial scale. The name of the partner was not disclosed. The extended agreement, Lonza said, will expand the dedicated bioconjugation footprint for the customer through the construction of a new bioconjugation suite at the company's Ibex Biopark in Visp, Switzerland.
In February 2024, Charles River Laboratories International, Inc. announced a strategic agreement with Wheeler Bio, Inc., an antibody contract development and manufacturing organization (CDMO) focused on preclinical and early clinical supply of recombinant proteins, providing clients access to Wheeler's Portable CMC(R) platform. This new alliance provides early-stage biotechnology companies a unique solution to rapidly transition from pre-clinical activities to first-in-human clinical trials.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.