单核细胞激活测试市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPRE00004912
  • Category : Medical Device
  • Status : Data Released
  • No. of Pages : 150
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【研究报告】2022年单核细胞激活测试市场规模为6517.436万美元,预计到2030年将达到23671.417万美元;预计 2022 年至 2030 年复合年增长率为 17.5%。
分析师观点
单核细胞激活测试市场分析包括对市场驱动因素的研究,例如患者安全担忧的增加以及对单核细胞激活测试的需求激增制药、生物技术和医疗器械等最终用户行业中更安全的热原测试方法。此外,预计单核细胞激活测试方法的技术发展将推动预测期内单核细胞激活测试市场的增长。
根据来源,单核细胞激活测试市场分为 PMBC 和细胞系。 PMBC 细分市场在 2022 年占据更大份额,预计在预测期内将继续保持类似趋势。根据产品,单核细胞激活测试市场分为 MAT 试剂盒和试剂。 MAT 套件细分市场在 2022 年占据更大份额,预计在预测期内将继续保持类似趋势。另一方面,预计试剂领域在预测期内将录得更高的复合年增长率。根据应用,单核细胞激活测试市场分为药物开发、疫苗开发、医疗设备和其他(研究等)。药物开发领域在 2022 年占据了最大份额,预计 2022 年至 2030 年将出现同样的趋势。
单核细胞激活测试可检测内毒素和非内毒素热原协同作用导致的细胞因子释放增强。单核细胞激活试验 (MAT) 是一种体外试验,旨在测试肠外药物、生物制品和医疗器械中所有类别的热原。在过去五年中,以前使用兔热原测试作为释放测定的疫苗已成为单核细胞活化测试(MAT)的最初采用者之一。此外,与 MAT 不同,细菌内毒素测试通常不适合本质上热原的产品或含有氢氧化铝等疫苗中常见添加剂的产品,这些添加剂往往会干扰检测。 MAT 在疫苗测试中的应用包括脑膜炎奈瑟菌疫苗、超免疫血清、脑膜炎球菌疫苗、黄热病疫苗、宋内志贺氏菌疫苗、狂犬病疫苗、乙型肝炎疫苗和蜱传脑炎病毒疫苗。
战略见解
市场洞察
医疗器械行业不断增长的需求
单核细胞激活测试 (MAT) 是基于人体细胞的测试,用于检测和量化细菌、真菌和病毒等热原。 MAT 使用 ELISA 测定来测量经过处理的血细胞释放的细胞因子。 MAT 广泛使用,但很少用来代替基于动物的热原测试来评估医疗器械的生物相容性。国家毒理学计划替代毒理学方法评估跨机构中心 (NICEATM) 和 PETA 国际科学联盟有限公司 (PISC) 于 2018 年 9 月在美国国立卫生研究院召开了一次研讨会,详细阐述了在医疗领域实施 MAT 的必要步骤设备测试。 DXC 技术公司 Luxoft 表示,医疗设备通过预测算法和患者数据分析提供准确的诊断、有效的治疗和个性化护理,从而帮助医疗保健的数字化转型。个性化医疗、植入式设备、智能医疗设备和无创手术方面的技术进步通过提供更好的护理、改善患者的治疗效果和降低成本,正在彻底改变整个医疗保健行业。医疗器械行业的增长反过来促进了目前单核细胞激活测试方法的增长,预计在预测期内将继续保持类似的趋势。
市场机会
单核细胞激活测试方法的技术发展
单核细胞活化测试方法主要作为动物方法的替代方法而引入,旨在提供在人体体外系统中进行热原测试的机会。在国际验证发布后,单核细胞激活试验 (MAT) 于 2010 年被纳入欧洲药典 (EP)。市场参与者对 MAT 测定和试剂的不断创新和开发从根本上提高了重现性、灵敏度和特异性,从而使其成为检测热原的可靠且更安全的选择。 MAT 检测用于检测药物和医疗器械等胃肠外产品中的内毒素和非内毒素热原。通常,MAT 根据监管指南提供传统动物测试的体外替代方案。兔热原测试和鲎变形细胞裂解物(LAL)测试广泛用于热原检测。这两种方法都使用动物并显示出一些局限性。兔子热原测试表明缺乏稳健性,因为动物反应可能与人类反应不同。此外,鲎试剂检测仅检测内毒素,忽略了测试样品中可能存在的非内毒素热原,从而存在安全风险。因此,为了克服这些限制,单核细胞活化试验 (MAT) 于 2010 年在欧洲药典中首次作为药典方法取代兔热原试验(EP 第 2.6.30 章),并在 FDA 行业指南中指定。市场参与者对 MAT 测定和试剂的不断创新和开发基本上提高了重现性、灵敏度和特异性,从而使其成为检测热原的可靠且更安全的选择。
报告细分和范围
基于来源见解
根据来源,单核细胞激活测试市场分为 PMBC 和细胞系。 PMBC 细分市场在 2022 年占据更大份额,预计在预测期内将继续保持类似趋势。预计该细分市场从 2022 年到 2030 年将出现更高的复合年增长率。目前全球有两种商业化的单核细胞激活测试细胞来源——Mono-Mac-6 (MM6) 细胞系和外周血单核细胞 (PBMC)。 MM6源自一名急性单核细胞白血病患者的血液;因此,单核细胞有时不具有反映健康人持续检测致热污染物和启动细胞因子释放所需的稳定表达的 TLR。因此,使用该细胞来源的 MAT 结果的重现性较低。欧洲博士。 (2.6.30) 还描述了基于 MM6 的 MAT 试剂盒检测非内毒素热原的能力“有限”。另一方面,基于 PBMC 的 MAT 试剂盒从经过筛选的健康捐赠者的混合血液中获取 PBMC,这意味着当与加标产品样本一起孵育时,单核细胞激活过程可以帮助健康人的生长。因此,基于该细胞来源的 MAT 试剂盒的结果始终具有可重复性。欧洲博士。 (2.6.30) 认为该细胞源能够熟练检测内毒素和非内毒素热原。
目前市场上还有其他三个商业化的基于 PBMC 的单核细胞激活测试供应商。每种的 LoD 分别为 0.125 EU/ml、0.02 EU/ml 和 0.016 EU/ml。 CTL-MAT 检测具有 0.004 EU/ml 的市场领先 LoD 之一,使其成为全球最灵敏的单核细胞激活测试。
基于产品的见解
基于产品,单核细胞激活测试市场是分为 MAT 试剂盒和试剂。 MAT 套件细分市场在 2022 年占据更大份额,预计在预测期内将继续保持类似趋势。另一方面,预计试剂领域在预测期内将实现更高的复合年增长率。
基于应用的见解
根据应用,单核细胞激活测试市场分为药物开发、疫苗开发、医疗器械,以及其他(研究等)。药物开发领域在 2022 年占据最大份额,预计 2022 年至 2030 年将出现同样的趋势。根据国家医学图书馆的数据,药品是一组新兴有机化合物,有助于改善患者的生活质量。制药行业涉及品牌药品和仿制药的生产、开发和营销。 2014年,全球药品总收入首次突破1万亿美元。自2017年以来,药品市场以每年5.8%的速度扩张。同年,全球药品市场收入为11,430亿美元,2021年达到14,620亿美元。单核细胞激活测试(MAT)旨在测试适用于所有热原类别的肠胃外药物、生物制品和医疗设备。肠外给药的药品必须不含热原(引起发烧)污染,因为这些物质可能会引起患者先天免疫系统的危及生命的全身反应。这是为了确保生物制品在给予患者之前不含污染的热原物质。最初,RPT 和细菌内毒素测试 (BET)/鲎变形细胞裂解物测定 (LAL) 被用作离体选项。然而,对动物测试方法采取的严格规定迫使市场参与者开发一种替代方法,尽量减少此类动物测试方法的使用。考虑到RPT和BET的局限性以及复杂产品生产的增加,欧洲药典引入了MAT激活测试方法,该方法模拟人性免疫反应,并结合了RPT(评估革兰氏阴性内毒素以外的热原性)的优点和优点的体外方法。与 RPT 相比,MAT 可以在不使用动物的情况下作为完全定量测试,使其更适合具有固有热原性且具有生理相关性的疫苗,因为它们使用人体细胞。 MAT 检测方法能够检测血液衍生产品、细胞衍生产品以及生物制剂和疫苗。 MAT测试方法还可以检测多种测试范围的药品和医疗器械以及无法进行体内测试的产品(例如含有透明质酸的产品)。这些因素近年来对整体单核细胞激活测试市场有所帮助,预计在预测期内将遵循类似的趋势。
单核细胞激活测试市场,按应用划分 - 2022 年和 2030 年
区域分析
基于单核细胞激活测试市场分为北美、欧洲、亚太地区、南美洲和中美洲以及中东和非洲。北美在 2022 年占据了最大的市场份额,预计在预测期内将继续保持类似的趋势,其次是欧洲。美国药典 (USP) 和加拿大政府等组织对单核细胞激活测试的监管实践进一步推动了该地区单核细胞激活测试市场的整体增长。此外,日益关注患者安全问题和改善医疗保健结果是促进北美市场增长的因素之一。
德国达姆施塔特默克公司和/或其附属公司;查尔斯河实验室国际有限公司;赛默飞世尔科技;桑昆;和 Lonza 集团是单核细胞激活测试市场的领先公司之一。
2023 年 10 月,Lonza 推出了两种新型快速单核细胞激活测试 (MAT) 系统:PyroCell MAT 快速系统和 PyroCell MAT 人血清 (HS) 快速系统,用于简化和简化兔子无热原测试。该系统将取代 Lonza 传统的 MAT 系统套件产品,新推出的产品包含新的 PeliKine 人 IL-6 快速 ELISA 套件,可最大限度地减少动手时间并将获得结果的时间从两天缩短到两小时。新测试为制药和生物技术制造商提供了更简单的产品安全测试 MAT 测试选项,同时有助于减少对动物的依赖。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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Frequently Asked Questions


What is the segmentation for the Monocyte Activation Tests market?

Based on source, the monocyte activation tests market is bifurcated into PMBC and cell line. The PMBC segment held a larger share in 2022 and is expected to continue a similar trend during the forecast period. Based on products, the monocyte activation tests market is bifurcated into MAT kits and reagents. The MAT kits segment held a larger share in 2022 and is expected to continue a similar trend during the forecast period. On the other hand, the reagents segment is anticipated to record a higher CAGR during the forecasted period. Based on application, the monocyte activation tests market is segmented into drug development, vaccine development, medical devices, and others (research etc.). The drug development segment captured the largest share in 2022 and is expected to witness the same trend from 2022 to 2030.

What are the driving and restraining factors for the Monocyte Activation Tests market across the region?

The monocyte activation tests market analysis includes the study of market drivers such as a rise in safety concerns among patients and a surge in demand for safer pyrogen testing methods in end user industries such as pharmaceutical, biotech, and medical devices. Further, technological developments in monocyte activation test methods are anticipated to propel the monocyte activation tests market growth during the forecast period.

Who are the key players in the Monocyte Activation Tests market?

Merck KGaA, Darmstadt, Germany and/or its affiliates; Charles River Laboratories International, Inc.; Thermo Fisher Scientific; Sanquin; and Lonza Group are among the leading companies operating in the monocyte activation tests market.

Which is the largest country in the Monocyte Activation Tests market?

Based on region, the monocyte activation tests market is segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. North America captured the largest market share in 2022 and is expected to continue a similar trend during the forecast period, followed by Europe. Regulatory practices of monocyte activation tests by organizations such as United States Pharmacopeia (USP) and the Government of Canada have further fueled the overall growth of the monocyte activation tests market in the region. Also, increasing focus on patient safety concerns and improved healthcare outcomes is one of the factors aiding the market growth in North America.

The List of Companies - Monocyte Activation Tests Market

  1. Merck KGaA, Darmstadt, Germany and/or its affiliates
  2. Charles River Laboratories International, Inc.
  3. Thermo Fisher Scientific
  4. Sanquin
  5. Lonza Group
  6. MAT Biotech
  7. Cellmade Laboratories
  8. Labor LS SE & Co. KG
  9. BD Biosciences
  10. Beckman Coulter

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

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The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

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Research Methodology

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  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

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The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

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We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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