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细胞银行外包市场:2023年至2028年预测Cell Banking Outsourcing Market - Forecasts from 2023 to 2028 |
预计细胞银行外包市场在预测期内将以 12.65% 的复合年增长率成长。
细胞库外包包括多种服务,其中包括细胞、细胞株和组织的储存、收集、表征和测试等关键活动。我们为研发和生物製药製造提供细胞株、细胞和组织。细胞库的目标是提供最大功效并最大程度地减少不利事件。细胞银行外包市场主要是由生物技术产业的快速成长和细胞治疗方法的日益采用所推动的。
细胞库涉及在受控环境中处理和储存细胞(通常是干细胞),以供将来用于各种治疗和研究应用。对细胞银行的有利投资可以显着促进细胞银行外包市场的成长。例如,2021 年 9 月,领先的干细胞银行和生殖检测服务提供商 LifeCell International 从 OrbiMed Asia Partners 获得了 225 亿卢比的股权融资。筹集的资金将支持公司各部门的成长策略,并帮助扩大其在基因组学领域的测试范围。
细胞库外包正在细胞疗法中得到利用,以满足对特征明确且可靠的细胞株不断增长的需求,这对于先进再生和个人化医疗。基于细胞的疗法越来越多地被采用,因为它们有潜力解决未满足的医疗需求,提供个体化的治疗选择,并为各种疾病和病症提供有前途的解决方案,从而导致未满足的关键字市场正在推动显着的成长。根据美国基因细胞治疗学会预测,到2022年,基因、细胞和阶段,将呈现7%的显着成长。
细胞库产业受到严格的监管要求的管理,旨在确保药品製造中使用的生物材料的安全性、有效性和可追溯性。这就是为什么信誉良好的细胞银行外包提供者强调严格的品质和遵守监管标准。透过保持严格的合规性和健全的流程,这些提供者为製药公司提供了对其细胞库服务的可靠性和完整性的信心,并帮助推动製药业的研发和製造活动。我们建立重要且值得信赖的合作伙伴关係。
由于政府投资的改善以及旨在促进该地区生物技术产业和推广细胞疗法的倡议,亚太地区将在细胞银行外包市场中占据重要份额。因此,亚太国家正在为生物技术公司的蓬勃发展创造有利的环境,提供大量的财政支持和支持性政策,从而推动对专业细胞银行服务的需求。 2023年2月,印度政府宣布了製药PLI,涵盖细胞和基因疗法药物等一系列产品,以促进高价值药品、关键原料药和高端医疗设备的国内製造。已宣布根据该计划提供16.6 亿卢比的奖励。
生技公司不愿意外包细胞银行业务是因为担心与外部合作伙伴共用敏感资讯或专有知识。这种犹豫是细胞银行外包市场成长的主要抑制因素,因为公司优先考虑保护智慧财产权和管理关键生物资产。透过强有力的资料保护措施解决这些保密和安全问题,并与外包供应商建立值得信赖的合作伙伴关係,将增强人们对外包流程的信心,并最大限度地发挥细胞银行外包市场的潜力,这对于退出来说极为重要。
The cell banking outsourcing market is estimated to grow at a CAGR of 12.65% during the forecast period.
Cell banking outsourcing consists of a diverse array of services that encompass essential activities like the storage, collection, characterization, and testing of cells, cell lines, and tissues. It offers cell lines, cells, and tissues for research and development, as well as biopharmaceutical production. Cell banks aim to provide maximum efficacy and minimize adverse events. The cell banking outsourcing market is primarily driven by the rapid growth of biotech industries and the increasing adoption of cell-based therapies.
Cell banking processes and preserves cells, typically stem cells, in controlled environments for future use in various medical treatments and research applications. Favorable Investments in cell banking can significantly boost the growth of the cell banking outsourcing market. For instance, in September 2021, LifeCell International, a leading provider of stem cell banking and reproductive testing services, secured Rs 225 crore in equity funding from OrbiMed Asia Partners. The raised capital would be instrumental in supporting the company's growth strategy for its various divisions, as well as expanding its range of tests in the genomic sector.
Cell banking outsourcing is utilized in cell-based therapies to meet the growing demand for well-characterized and reliable cell lines, which are crucial for the development of advanced regenerative and personalized medicines. The expanding adoption of cell-based therapies stems from their potential to address unmet medical needs, provide personalized treatment options, and offer promising solutions for various diseases and conditions, driving significant growth in the cell banking outsourcing market. According to the American Society of Gene Cell Therapy, In the year 2022, the pipeline of gene, cell, and RNA therapies witnessed a notable growth of 7%, encompassing preclinical to pre-registration stages.
The cell banking industry is governed by stringent regulatory requirements aimed at guaranteeing the safety, efficacy, and traceability of biological materials utilized in pharmaceutical production. As a result, reputable cell banking outsourcing providers place great emphasis on adhering to rigorous quality and regulatory standards. By maintaining strict compliance and implementing robust processes, these providers instill confidence in pharmaceutical companies regarding the reliability and integrity of their cell banking services, thus fostering a trustworthy partnership that is essential for advancing research, development, and manufacturing activities in the pharmaceutical sector.
Asia Pacific will hold a significant share of the cell banking outsourcing market due to the improved government investments and initiatives aimed at fostering biotech industries and advancing cell-based therapies in the region. Hence, with substantial financial support and supportive policies, Asian-Pacific countries have cultivated a conducive environment for biotech companies to flourish, thereby increasing the demand for specialized cell banking services. In Feb 2023, to boost domestic production of high-value formulations, critical APIs (Active Pharmaceutical Ingredients), and high-end medical devices, the government of India released Rs. 166 Crores in incentives under the PLI scheme for Pharmaceuticals encompassing various products, including cell-based or gene-therapy drugs.
The reluctance of biotech companies to engage in cell banking outsourcing stems from their concerns about sharing sensitive information and proprietary knowledge with external partners, primarily due to the perceived risk of data breaches or breaches of confidentiality. This hesitancy can act as a significant restraint for the cell banking outsourcing market growth, as companies prioritize safeguarding their intellectual property and maintaining control over critical biological assets. Addressing these confidentiality and security concerns through robust data protection measures and building trusted partnerships with outsourcing providers is crucial to fostering greater confidence in the outsourcing process and unlocking the full potential of the cell banking outsourcing market.