市場調查報告書
商品編碼
1370542
生物製程驗證市場:2023-2028 年全球產業趨勢、佔有率、規模、成長、機會與預測Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028 |
2022年,全球生物製程驗證市場規模達3.346億美元。展望未來,IMARC Group預計到2028年該市場將達到5.736億美元,2023-2028年年複合成長率(CAGR)為8.78%。
生物製程驗證是指透過展示產品生產和測試期間進行的各種程序、流程和活動來獲取文件證據的方法,以在所有階段保持所需的合規水準。它涉及可提取物、微生物、相容性、完整性和理化測試服務作為標準方法。這些技術有助於在生物製品和動物藥物的開發過程中評估多種活性藥物成分 (API) 和可能的污染物,包括內毒素、支原體和細菌。除此之外,生物製程驗證具有成本效益,可以監控實務和藥物製造程序。因此,製藥、生物製藥以及合約開發和製造組織 (CMO) 使用它來確保藥物品質、安全性、功效和預定屬性。
醫院和診所對外包生物製程驗證服務的需求不斷成長,以維持符合良好生產規範 (GMP),這主要推動了市場的成長。政府執行嚴格的品質和產品安全法規進一步支持了這一點。此外,各種慢性疾病的盛行率不斷上升以及對生物製藥的需求不斷增加,補充了生物製程驗證在整個醫療保健領域的廣泛採用,從而有利於市場成長。此外,製藥和 CMO 公司在生產新型疫苗和生物相似藥時廣泛使用生物製程驗證來監測藥物的準確性、純度、效率和安全性,特別是在 COVID-19 期間,這是另一個成長誘導因素。與此一致的是,生物製造基礎設施的重大技術進步以及生物反應器的持續生物製程驗證以確保藥物生產的成本效益和可擴展性正在推動市場成長。除此之外,外包實驗室檢測服務的新興趨勢、對個人化藥物不斷成長的需求以及確保藥物最佳品質的持續研發(R&D)活動正在為市場創造積極的前景。
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.