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全球生物安全检测产品和服务市场研究报告 - 2024 年至 2032 年行业分析、规模、份额、成长、趋势和预测Global Biological Safety Testing Products And Services Market Research Report - Industry Analysis, Size, Share, Growth, Trends and Forecast 2024 to 2032 |
全球生物安全检测产品和服务市场的需求预计将从2023年的50.1亿美元达到2032年的近128.8亿美元,2024-2032年研究期间的复合年增长率为11.06%。
生物安全检测产品和服务包括一系列用于评估疫苗、单株抗体、细胞疗法、基因疗法和重组蛋白等生物製药产品的安全性、纯度和效力的测定、试剂、消耗品、设备和实验室服务。这些产品和服务对于确保遵守监管机构(包括美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA))制定的监管要求和品质标准至关重要。生物安全测试涉及透过细胞测定、分子测定、免疫测定、微生物测定和生物测定来评估生物製品中是否存在污染物、毒素、外来物质和杂质。
对生物药物、疫苗和生物製剂不断增长的需求推动了对原料、中间产品和最终製剂进行严格测试的需要,以确保其临床使用的安全性、纯度和有效性。随着生物製药研发的兴起、新型生物製剂和生物相似药的开发以及药品供应链的日益全球化等因素,人们越来越重视综合测试方案、风险缓解策略和品质控制措施,以应对新出现的生物危害、污染风险和监管要求。此外,分析技术、基于细胞的测定和分子生物学方法的进步使得创新的生物安全检测产品和服务的开发成为可能,这些产品和服务可以对生物製药产品和製造中的微生物污染物、外来物质和杂质进行灵敏、特异且可靠的检测流程。
此外,越来越多地采用体外和体内测试方法,例如细胞培养测定、核酸扩增技术和动物模型,推动了生物安全测试产品和服务市场的创新,因为公司寻求成本效益、高通量和预测测试平台可简化产品开发、加速监管核准并确保病患安全。此外,生物製药产品、製造流程和监管要求日益复杂,推动了市场对专业测试服务、咨询和外包解决方案的需求。然而,监管要求、技术进步和安全标准日益复杂可能会挑战未来几年生物安全检测产品和服务市场的成长。
研究报告涵盖波特五力模型、市场吸引力分析和价值链分析。这些工具有助于清晰地了解行业结构并评估全球范围内的竞争吸引力。此外,这些工具也对全球生物安全检测产品和服务市场的各个细分市场进行包容性评估。生物安全检测产品和服务业的成长和趋势为本研究提供了整体方法。
生物安全检测产品和服务市场报告的这一部分提供了国家和区域级别细分市场的详细资料,从而帮助策略师确定相应产品或服务的目标人群以及即将到来的机会。
本节涵盖区域展望,重点介绍北美、欧洲、亚太地区、拉丁美洲以及中东和非洲生物安全检测产品和服务市场当前和未来的需求。此外,该报告重点关注所有主要地区各个应用领域的需求、估计和预测。
该研究报告还涵盖了市场主要参与者的全面概况以及对全球竞争格局的深入了解。生物安全检测产品和服务市场的主要参与者包括 Charles River Laboratories、BSL Bioservice、Merck KGaA (MilliporeSigma)、Samsung Biologics、Sartorius AG、Eurofins Scientific、SGS Societe Generale de Surveillance SA、Thermo Fisher Scientific Inc.、Biomerieux、龙沙。本节包含竞争格局的整体视图,包括各种策略发展,例如关键併购、未来产能、合作伙伴关係、财务概况、合作、新产品开发、新产品发布和其他发展。
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The global demand for Biological Safety Testing Products And Services Market is presumed to reach the market size of nearly USD 12.88 Billion by 2032 from USD 5.01 Billion in 2023 with a CAGR of 11.06% under the study period 2024 - 2032.
Biological safety testing products and services encompass a range of assays, reagents, consumables, equipment, and laboratory services used for assessing the safety, purity, and potency of biopharmaceutical products such as vaccines, monoclonal antibodies, cell therapies, gene therapies, and recombinant proteins. These products & services are crucial for ensuring compliance with regulatory requirements and quality standards set forth by regulatory agencies, including the U.S. Food and Drug Administration (FDA) & the European Medicines Agency (EMA). Biological safety testing involves evaluating the presence of contaminants, toxins, adventitious agents, and impurities in biological products through cell-based assays, molecular assays, immunoassays, microbiological assays, and bioassays.
The growing demand for biological drugs, vaccines, and biologics drives the need for rigorous testing of raw materials, intermediate products, and final formulations to ensure their safety, purity, and efficacy for clinical use. With factors such as the rise in biopharmaceutical R&D, the development of novel biologics and biosimilars, and the increasing globalization of pharmaceutical supply chains, there is a growing emphasis on comprehensive testing protocols, risk mitigation strategies, and quality control measures to address emerging biological hazards, contamination risks, and regulatory requirements. Additionally, advancements in analytical techniques, cell-based assays, and molecular biology methods enable the development of innovative biological safety testing products and services that offer sensitive, specific, and reliable detection of microbial contaminants, adventitious agents, and impurities in biopharmaceutical products and manufacturing processes.
Moreover, the increasing adoption of in vitro and in vivo testing methods, such as cell culture assays, nucleic acid amplification techniques, and animal models, drives biological safety testing products and services market innovation as companies seek cost-effective, high-throughput, and predictive testing platforms that streamline product development, accelerate regulatory approval, and ensure patient safety. Furthermore, the growing complexity of biopharmaceutical products, manufacturing processes, and regulatory requirements drives market demand for specialized testing services, consultancy, and outsourcing solutions. However, the increasing complexity of regulatory requirements, technological advancements, and safety standards may challenge the growth of the biological safety testing products and services market in the coming years.
The research report covers Porter's Five Forces Model, Market Attractiveness Analysis, and Value Chain analysis. These tools help to get a clear picture of the industry's structure and evaluate the competition attractiveness at a global level. Additionally, these tools also give an inclusive assessment of each segment in the global market of biological safety testing products and services. The growth and trends of biological safety testing products and services industry provide a holistic approach to this study.
This section of the biological safety testing products and services market report provides detailed data on the segments at country and regional level, thereby assisting the strategist in identifying the target demographics for the respective product or services with the upcoming opportunities.
This section covers the regional outlook, which accentuates current and future demand for the Biological Safety Testing Products And Services market across North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. Further, the report focuses on demand, estimation, and forecast for individual application segments across all the prominent regions.
The research report also covers the comprehensive profiles of the key players in the market and an in-depth view of the competitive landscape worldwide. The major players in the Biological Safety Testing Products And Services market include Charles River Laboratories, BSL Bioservice, Merck KGaA (MilliporeSigma), Samsung Biologics, Sartorius AG, Eurofins Scientific, SGS Societe Generale de Surveillance SA, Thermo Fisher Scientific Inc., Biomerieux, Lonza. This section consists of a holistic view of the competitive landscape that includes various strategic developments such as key mergers & acquisitions, future capacities, partnerships, financial overviews, collaborations, new product developments, new product launches, and other developments.
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