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生物製程验证市场:2023-2028 年全球产业趋势、份额、规模、成长、机会与预测Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028 |
2022年,全球生物製程验证市场规模达3.346亿美元。展望未来,IMARC集团预计到2028年该市场将达到5.736亿美元,2023-2028年复合年增长率(CAGR)为8.78%。
生物製程验证是指透过展示产品生产和测试期间进行的各种程序、流程和活动来获取文件证据的方法,以在所有阶段保持所需的合规水准。它涉及可提取物、微生物、相容性、完整性和理化测试服务作为标准方法。这些技术有助于在生物製品和动物药物的开发过程中评估多种活性药物成分 (API) 和可能的污染物,包括内毒素、支原体和细菌。除此之外,生物製程验证具有成本效益,可以监控实务和药物製造程序。因此,製药、生物製药以及合约开发和製造组织 (CMO) 使用它来确保药物品质、安全性、功效和预定属性。
医院和诊所对外包生物製程验证服务的需求不断增长,以维持符合良好生产规范 (GMP),这主要推动了市场的成长。政府执行严格的品质和产品安全法规进一步支持了这一点。此外,各种慢性疾病的盛行率不断上升以及对生物製药的需求不断增加,补充了生物製程验证在整个医疗保健领域的广泛采用,从而有利于市场成长。此外,製药和 CMO 公司在生产新型疫苗和生物相似药时广泛使用生物製程验证来监测药物的准确性、纯度、效率和安全性,特别是在 COVID-19 期间,这是另一个成长诱导因素。与此一致的是,生物製造基础设施的重大技术进步以及生物反应器的持续生物製程验证以确保药物生产的成本效益和可扩展性正在推动市场成长。除此之外,外包实验室检测服务的新兴趋势、对个人化药物不断增长的需求以及确保药物最佳品质的持续研发(R&D)活动正在为市场创造积极的前景。
The global bioprocess validation market size reached US$ 334.6 Million in 2022. Looking forward, IMARC Group expects the market to reach US$ 573.6 Million by 2028, exhibiting a growth rate (CAGR) of 8.78% during 2023-2028.
Bioprocess validation refers to an approach of acquiring documentary evidence by demonstrating various procedures, processes, and activities that are conducted during the production and testing of the product to maintain the desired level of compliance at all phases. It involves extractable, microbiological, compatibility, integrity, and physiochemical testing services as standard methods. These techniques help evaluate multiple active pharmaceutical ingredients (APIs) and possible contaminants, including endotoxin, mycoplasma, and bacteria, during the development of biological products and animal drugs. Apart from this, bioprocess validation is cost-effective and monitors practices and medication manufacturing procedures. As a result, it is used by pharmaceutical, biopharmaceutical, and contract development and manufacturing organization (CMO) to assure drug quality, safety, efficacy, and predetermined attributes.
The increasing need for outsourcing bioprocess validation services in hospitals and clinics to maintain compliance with good manufacturing practices (GMP) is majorly driving the market growth. This is further supported by the execution of stringent quality and product safety regulations by governments. Additionally, the rising prevalence of various chronic ailments and the escalating demand for biopharmaceuticals are supplementing the widespread adoption of bioprocess validation across the healthcare sector, thus favoring the market growth. Moreover, the extensive usage of bioprocess validation by pharmaceutical and CMO companies to monitor the accuracy, purity, efficiency, and safety of drugs while manufacturing novel vaccines and biosimilars, especially during COVID-19, is acting as another growth-inducing factor. In line with this, significant technological advancements in bio-manufacturing infrastructure and the ongoing bioprocess validation of bioreactors to ensure the cost-effective and scalable production of medications are propelling the market growth. Apart from this, the emerging trend of outsourcing laboratory testing services, the escalating need for personalized medicines, and continuous research and development (R&D) activities to ensure the optimal quality of drugs are creating a positive outlook for the market.
IMARC Group provides an analysis of the key trends in each sub-segment of the global bioprocess validation market report, along with forecasts at the global, regional and country level from 2023-2028. Our report has categorized the market based on test type, process component and end user.
Extractables Testing Services
Microbiological Testing Services
Physiochemical Testing Services
Integrity Testing Services
Compatibility Testing Services
Others
Filter Elements
Media Containers and Bags
Freezing And Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Others
Pharmaceutical and Biotechnology Companies
Contract Development and Manufacturing Organizations
Others
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
The competitive landscape of the industry has also been examined along with the profiles of the key players being Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SA and Thermo Fisher Scientific Inc.