![]() |
市場調查報告書
商品編碼
1766026
2032 年細胞庫外包市場預測:按類型、細胞類型、階段、最終用戶和地區進行的全球分析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 |
根據 Stratistics MRC 的數據,全球細胞銀行外包市場預計在 2025 年達到 175.1 億美元,到 2032 年將達到 569.3 億美元,預測期內的複合年成長率為 18.34%。
細胞庫外包是指將細胞庫(包括主細胞庫 (MCB) 和工作細胞庫 (WCB))的創建、儲存和維護委託給專業的第三方服務供應商。透過利用 CDMO 的基礎設施和經驗,該策略可幫助生物製藥公司確保合規性、降低成本並加快開發週期。外包細胞庫服務通常包括細胞株檢查、良好生產規範 (GMP) 儲存和穩定性測試,為臨床和商業生產需求提供可靠且靈活的解決方案。
根據 FDA 細胞、組織和基因治療辦公室 (CBER) 的數據,2017 年至 2021 年期間 CDER 發布的臨床暫停通知中約有 40% 用於細胞和基因治療試驗,這凸顯了監管的複雜性以及標準化外包細胞庫能力的必要性。
對細胞療法和生技藥品的興趣日益濃厚
疫苗、單株抗體以及先進的細胞和基因治療藥物等生技藥品正日益取代傳統藥物,成為現代醫學的支柱。隨著臨床研究活動和核准的增加,可追溯、可靠且符合國際監管標準的大規模主細胞庫和工作細胞庫的重要性日益凸顯。此外,外包使製藥公司能夠利用現有的基礎設施和成熟的專業知識,從而縮短開發時間並保持這些生物製藥的完整性和品質。
對保護智慧財產權 (IP) 和資料安全的擔憂
將細胞株係等關鍵生物資源委託給外部供應商時,資料保密性和智慧財產權所有權方面存在嚴重問題。高價值治療產品通常基於患者來源或專有細胞株細胞株,生物製藥公司經常使用這些細胞系。企業,尤其是早期生技公司,可能會因為擔心資料外洩、未授權存取和智慧財產權濫用而不願進行委託。此外,《一般資料保護規範》(GDPR) 和《健康保險流通與責任法案》(HIPAA) 等法規使敏感資料管理更加困難,尤其是在跨國外包的情況下。
保存和冷凍保存技術的發展
自動化庫存系統、數位追蹤、低溫儲存和細胞凍存介質等技術進步正在提升細胞庫的品質和安全性。除了降低細胞劣化的可能性外,這些技術進步還透過可擴展性、效率和可追溯性賦予外包公司競爭優勢。此外,提供技術整合、全天候監控的細胞庫的公司將佔據有利地位,為未來的生技藥品和細胞治療技術提供支援。
監管不確定性和不斷變化的指導方針
基因和細胞治療,以及細胞庫的法規環境瞬息萬變。美國生物製藥物料輸送(FDA)、歐洲藥品管理局 (EMA)、日本藥品管理局 (PMDA) 和國家藥品監督管理局 (NMPA) 等機構會定期更新生物製劑物料處理的 GMP 法規、文件標準和品質預期。細胞庫外包服務提供者必須不斷適應有關文件、可追溯性和無菌性的新法規。違規可能導致許可證被撤銷、客戶流失以及批次不合格。此外,不同國家的監管要求各不相同,這使得全球外包更具挑戰性。
新冠疫情對細胞庫外包市場產生了許多影響,但最終是革命性的。最初,供應鏈中斷和關閉阻礙了生物材料的運輸和儲存,並推遲了正在進行的生物製藥計劃。然而,全球對疫苗研發和治療研究的日益重視,導致對符合GMP標準的細胞庫服務的需求增加,尤其是在病毒載體和單株抗體的生產方面。疫情也凸顯了可擴展且可靠的外包模式對於降低營運風險的重要性,促使許多生物製藥公司重新評估其供應鏈,並將細胞庫等非核心功能外包。
主細胞庫(MCB)細分市場預計將在預測期內佔據最大佔有率
預計在預測期內,主細胞庫 (MCB) 細分市場將佔據最大市場佔有率,因為 MCB 是用於生產生技藥品和細胞療法的細胞株的來源,因此對品質、一致性和合規性至關重要。由於 MCB 是在嚴格的 GMP 指導下開發的,並經過了身份、純度和穩定性的全面測試,因此將其開發外包可確保一流的資源和知識。此外,單株抗體、疫苗和基因療法日益成長的需求推動了 MCB 的市場主導地位,這使得製藥公司依賴外包合作夥伴來建立和營運 MCB。
預計預測期內 CRO(委外研發機構)部門的複合年成長率最高。
預計合約研究組織 (CRO) 細分市場將在預測期內呈現最高成長率。 CRO 提供高度專業化、靈活且價格合理的服務,深受大型製藥公司和尋求最佳化研發流程的新興生技公司的青睞。對快速生技藥品開發、法規遵循和風險規避的需求日益成長,促使 CRO 逐漸成為細胞株表徵、GMP 細胞庫和品質保證的策略夥伴。此外,CRO 的擴充性、技術專長和全球影響力使其在支持基因和細胞療法等複雜計劃佔據優勢,從而推動了 CRO 在外包市場的爆炸式成長。
預計北美將在預測期內佔據最大的市場佔有率,這得益於頂級CDMO、嚴格的法規環境以及先進的生物製藥行業。美國在細胞療法和生技藥品開發方面處於主導地位,因此對符合GMP標準的細胞庫服務的需求很高。該地區還受益於大量的研發支出、強大的醫療保健體係以及製藥公司與專業外包供應商之間的定期合作。此外,早期採用最尖端科技、重視品管和法規遵循進一步鞏固了北美在全球細胞庫外包市場的主導地位。
預計亞太地區將在預測期內實現最高的複合年成長率。這得益於中國、印度、韓國和新加坡等國生物技術和製藥產業的爆炸性成長。這些國家的政府正透過資金援助、基礎建設和扶持政策積極推動生物製造業的發展。該地區擁有高素質人才,且營運成本低廉,非常適合細胞庫服務的外包。此外,由於亞太地區企業擴大參與生技藥品、生物學名藥和細胞療法的開發,對可擴展且合規的細胞儲存解決方案的需求不斷增加,該地區有望成為外包目的地,並實現高成長。
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.