市場調查報告書
商品編碼
1475203
全球生物安全檢測產品和服務市場研究報告 - 2024 年至 2032 年行業分析、規模、佔有率、成長、趨勢和預測Global Biological Safety Testing Products And Services Market Research Report - Industry Analysis, Size, Share, Growth, Trends and Forecast 2024 to 2032 |
全球生物安全檢測產品和服務市場的需求預計將從2023年的50.1億美元達到2032年的近128.8億美元,2024-2032年研究期間的複合年成長率為11.06%。
生物安全檢測產品和服務包括一系列用於評估疫苗、單株抗體、細胞療法、基因療法和重組蛋白等生物製藥產品的安全性、純度和效力的測定、試劑、消耗品、設備和實驗室服務。這些產品和服務對於確保遵守監管機構(包括美國食品和藥物管理局 (FDA) 和歐洲藥品管理局 (EMA))制定的監管要求和品質標準至關重要。生物安全測試涉及透過細胞測定、分子測定、免疫測定、微生物測定和生物測定來評估生物製品中是否存在污染物、毒素、外來物質和雜質。
對生物藥物、疫苗和生物製劑不斷成長的需求推動了對原料、中間產品和最終製劑進行嚴格測試的需要,以確保其臨床使用的安全性、純度和有效性。隨著生物製藥研發的興起、新型生物製劑和生物相似藥的開發以及藥品供應鏈的日益全球化等因素,人們越來越重視綜合測試方案、風險緩解策略和品質控制措施,以應對新出現的生物危害、污染風險和監管要求。此外,分析技術、基於細胞的測定和分子生物學方法的進步使得創新的生物安全檢測產品和服務的開發成為可能,這些產品和服務可以對生物製藥產品和製造中的微生物污染物、外來物質和雜質進行靈敏、特異且可靠的檢測流程。
此外,擴大採用體外和體內測試方法,例如細胞培養測定、核酸擴增技術和動物模型,推動了生物安全測試產品和服務市場的創新,因為公司尋求成本效益、高通量和預測測試平台可簡化產品開發、加速監管核准並確保病患安全。此外,生物製藥產品、製造流程和監管要求日益複雜,推動了市場對專業測試服務、諮詢和外包解決方案的需求。然而,監管要求、技術進步和安全標準日益複雜可能會挑戰未來幾年生物安全檢測產品和服務市場的成長。
研究報告涵蓋波特五力模型、市場吸引力分析和價值鏈分析。這些工具有助於清晰地了解行業結構並評估全球範圍內的競爭吸引力。此外,這些工具也對全球生物安全檢測產品和服務市場的各個細分市場進行包容性評估。生物安全檢測產品和服務業的成長和趨勢為本研究提供了整體方法。
生物安全檢測產品和服務市場報告的這一部分提供了國家和區域級別細分市場的詳細資料,從而幫助策略師確定相應產品或服務的目標人群以及即將到來的機會。
本節涵蓋區域展望,重點介紹北美、歐洲、亞太地區、拉丁美洲以及中東和非洲生物安全檢測產品和服務市場當前和未來的需求。此外,該報告重點關注所有主要地區各個應用領域的需求、估計和預測。
該研究報告還涵蓋了市場主要參與者的全面概況以及對全球競爭格局的深入了解。生物安全檢測產品和服務市場的主要參與者包括 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、龍沙。本節包含競爭格局的整體視圖,包括各種策略發展,例如關鍵併購、未來產能、合作夥伴關係、財務概況、合作、新產品開發、新產品發布和其他發展。
如果您有任何客製化要求,請寫信給我們。我們的研究團隊可以根據您的需求提供客製化報告。
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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