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全球细胞株开发市场 - 2024 年至 2029 年预测Global Cell Line Development Market - Forecasts from 2024 to 2029 |
细胞株开发市场预计将从 2024 年的 42.97 亿美元增至 2029 年的 80.47 亿美元,预测期内复合年增长率为 13.37%。
细胞株係被定义为可以在培养物中长期维持的细胞群。细胞株开发是一种细胞机器产生治疗性蛋白质的技术。这使得生物医学研究人员能够以具有成本效益的规模优化和生产药物。
细胞株开发市场成长的关键驱动力之一是製药和医疗市场的扩张。全球製药和医疗产品的成长使製造商能够开发更具成本效益的药物并进入商业市场。欧盟统计局表示,该地区药品进口额将从2022年的约1,200亿美元(1,120亿欧元)增加到2023年的约1,287亿美元(1,190亿欧元)。在进口方面,比利时是该地区最大的药品进口国,2023年进口额约281亿美元(260亿欧元),其次是德国216亿美元(200亿欧元)和荷兰173亿欧元其次是160 亿美元(160 亿欧元)。
此外,在全球细胞疫苗开发研究计画增加的推动下,细胞株开发市场预计将迅速扩大。预计这将在预测期内对市场产生积极影响。此外,抗体的不断进步预计将进一步增加全球对细胞株开发服务的需求。
单株抗体是实验室开发的抗体变体,可作为替代抗体,也可以模拟对免疫系统细胞的攻击。细胞株开发过程描述了单株抗体和疫苗等多种生物产品的有效工程和生产。全球癌症、COVID-19 和伊波拉出血热等致命疾病病例的增加预计将促进单株抗体的成长,并扩大细胞株开发的全球市场规模。
随着全球疾病病例的增加,全球对疫苗的需求也大幅增加。根据世界综合贸易解决方案,比利时2023年人用医用疫苗进口总额将为124.33亿美元,其次是美国约92.74亿美元,欧盟为73.76亿美元。 2023年,中国和德国的进口额分别约为62.25亿美元和46.65亿美元。
由于基础设施投资成本高昂,全球细胞株开发市场面临挑战。此外,建立细胞培养研究设施需要在设备、无尘室设施、品管设备、合格的劳动力、持续的培训计划、全面的测试和文件记录等方面进行大量投资。招募和留住最优秀的研究人员、工程师和专家成本高昂,而满足监管先决条件则需要更多的时间和金钱。总体而言,这些成本对细胞株开发市场的成长构成了重大挑战。
细胞株开发市场的地域展望
预计美国等新兴经济体在细胞株开发市场的预测期内将显着成长。这是由于研发倡议的增加以及对先进製程的投资增加。
此外,美国公司越来越多地投资于生物相似药的研究,这可能会增加未来几年对细胞株大规模生产的需求。例如,2024年,美国食品药物管理局(USFDA)核准Bkemv(eculizumab-aeeb)作为第一个可互换的生物相似药,用于治疗两种罕见疾病。同样,该机构每年都会批准多种蛋白质,包括重组蛋白质和治疗性蛋白质。这代表了对疫苗、生物相似药、药品和治疗性蛋白质的需求不断增加,并将支持该地区细胞株开发的扩展。
此外,行业公司对新兴市场的开拓预计将有助于长期市场发展。例如,2023年,美国领先主要企业之一的Berkeley Lights, Inc.宣布推出Beacon Select,这是一种用于细胞株开发(CLD)的新型光流控系统。该产品是一种两晶片信标系统,允许科学家使用一个平台在一次运行中培养、克隆和选择顶级克隆。这对于中小型生物製药公司和其他 CRO/CDMO 来说是理想的选择。
此外,CIRM(加州再生医学研究所)在 2024 年 4 月的会议上宣布,将投资约 8,900 万美元用于各种临床计画。预计此类干预措施将为细胞株开发市场增添动力,并在预测期内为细胞疫苗新兴市场提供有利条件。
The global cell line development market is projected to grow at a CAGR of 13.37% over the forecast period, from US$4.297 billion in 2024 to reach US$8.047 billion by 2029.
The cell line is defined as the population of cells that can be maintained in culture for a longer period. Cell line development is the technique through which the cellular machinery manufactures therapeutic proteins. This enables biomedical researchers to optimize and produce drugs at a cost-efficient scale.
One of the major drivers for the global cell line development market growth can be the expanding pharmaceutical and medicine market. Global pharmaceutical and medicine product growth will enable manufacturers to develop more cost-effective drugs to advance in the commercial market. The Eurostat stated that the region's medicine and pharmaceutical products imports increased from about US$120 billion (Euro 112 billion) in 2022 to about US$128.7 billion (Euro 119 billion) in 2023. In this import, Belgium became the biggest importer of medicinal and pharmaceutical products in the region, importing about US$28.1 billion (Euro 26 billion), followed by Germany and the Netherlands at US$21.6 billion (Euro 20 billion) and US$17.3 billion (Euro 16 billion) respectively, in 2023.
Additionally, the global cell line development market is expected to expand rapidly, fueled by rising research programs for cell-based vaccine development worldwide. This is expected to have a favorable market influence during the projected period. Further, the increase in advancement related to antibodies is expected to further elevate the necessity for cell line development services worldwide.
Monoclonal antibodies are the variants of antibodies developed in research laboratories to work as substitute antibodies, which can also mimic the immune system's attack on cells. The cell line development process provides effective engineering and production of diverse biological products, such as monoclonal antibodies and vaccines. The increase in the worldwide cases of deadly diseases, such as cancer, COVID-19, Ebola, and others, is predicted to bolster the growth of monoclonal antibodies, growing the global market size of cell line development.
With the increase in disease cases globally, the worldwide requirement for vaccines has grown substantially. The World Integrated Trade Solution stated that in 2023, Belgium's total import of vaccines for human medicine accounted for US$12.433 billion, followed by the US at about US$9.274 billion and the EU at US$7.376 billion. The imports of China and Germany in 2023 accounted for about US$6.225 billion and US$4.665 billion, respectively.
The worldwide cell line development market faces challenges due to high investment costs in infrastructure. Moreover, setting up a cell culture research facility requires significant investments in equipment, cleanroom facilities, quality control equipment, a talented workforce, persistent training programs, and thorough testing and documentation. Hiring and retaining profoundly qualified researchers, engineers, and professionals is costly, and meeting regulatory prerequisites moreover requires noteworthy time and monetary resources. Overall, these costs substantially challenge the global cell line development market's growth.
Global Cell Line Development Market Geographical Outlook
Developed economies such as the United States are anticipated to account for significant growth during the projected cell line development market period. This is owing to the rising research and development initiatives coupled with increased investment in advanced processes in the country.
Additionally, the increasing investment in research regarding biosimilars by companies in the United States will drive demand for cell line large-scale production in the coming years. For instance, in 2024, the US Food and Drug Administration (USFDA) approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar for the treatment of two rare diseases. Similarly, the administration authorizes various proteins annually, including recombinant and therapeutic proteins. This shows the increasing requirement for vaccines, biosimilars, pharmaceuticals, and therapeutic proteins that will boost the expansion of cell line development in the region.
Moreover, the major developments in the market by industry players are expected to contribute to its long-term development. For instance, in 2023, Berkeley Lights, Inc., one of the leading companies in the United States, announced the launch of Beacon Select, the new optofluidic system for cell line development (CLD). The product is a two-chip beacon system that enables scientists to culture, clone, and select the top clone in a single run using a single platform. This is ideally most suitable for small to mid-sized biopharma set-ups and other CROs/CDMOs as well.
Moreover, CIRM (California Institute of Regenerative Medicine) announced an investment of around US$89 million in various clinical programs in its 2024 April meeting. Such interventions are expected to provide impetus for the cell line development market and thereby also provide favorable ground for advancement in cell-based vaccines in the forecast period.