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1419137

单核细胞活化测试市场规模和预测（2020 - 2030）、全球和地区份额、趋势和成长机会分析报告范围：按来源（PMBC 和细胞株）、产品（MAT 试剂盒和试剂）和应用

Monocyte Activation Tests Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Source (PMBC and Cell Line), Products (MAT Kits and Reagents), and Application

出版日期: 2023年12月05日 | 出版商:

The Insight Partners | 英文 150 Pages | 商品交期: 1-5个工作天内

价格

简介目录

2022年单核细胞活化测试市场规模为6,517.4万美元，预计2030年将达到2,3671.4万美元；预计2022年至2030年CAGR为17.5%。

单核细胞活化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製药、生物技术和医疗设备等最终用户行业对更安全的热原测试方法的需求激增。此外，预计单核细胞活化测试方法的技术发展将推动预测期内单核细胞活化测试市场的成长。

根据来源，单核细胞活化测试市场分为 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，单核细胞活化测试市场分为 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CAGR。根据应用，单核细胞活化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。

单核细胞活化测试检测内毒素和非内毒素热原的协同作用所增强的细胞激素释放。单核细胞活化试验 (MAT) 是一种体外试验，旨在测试肠外药物、生物製品和医疗器材中所有类别的热原。在过去五年中，先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用于本质热原产品或含有疫苗中常见添加剂（例如氢氧化铝）的产品，这些产品往往会干扰检测。 MAT 在疫苗检测中的应用包括脑膜炎奈瑟菌疫苗、超免疫血清、脑膜炎双球菌疫苗、黄热病疫苗、宋内志贺氏菌疫苗、狂犬病疫苗、B型肝炎疫苗和蜱传脑炎病毒疫苗。

基于来源的见解

根据来源，单核细胞活化测试市场分为 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CAGR。目前，全球有两种商业化的单核细胞活化测试细胞来源——Mono-Mac-6 (MM6)细胞株和週边血单核细胞(PBMC)。 MM6源自于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，使用此细胞来源的 MAT 结果的重现性较低。欧洲博士。 (2.6.30) 也描述基于 MM6 的 MAT 试剂盒在检测非内毒素热原方面「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，单核细胞活化可以帮助健康人的生长。因此，基于此细胞来源的 MAT 试剂盒的结果始终具有可重复性。欧洲博士。 (2.6.30) 认为此细胞源能够熟练检测内毒素和非内毒素热原。

目前，市场上还有另外三个商业化的基于 PBMC 的单核细胞活化测试供应商。每种的 LoD 分别为 0.125 EU/ml、0.02 EU/ml 和 0.016 EU/ml。 CTL-MAT 检测的 LoD 为市场领先的 0.004 EU/ml，使其成为全球最灵敏的单核细胞活化检测。

基于产品的洞察

根据产品，单核细胞活化测试市场分为 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出现更高的CAGR。

区域分析

单核细胞活化测试市场按地区细分：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活化测试的监管实践进一步推动了该地区单核细胞活化测试市场的整体成长。此外，日益关注病患安全问题和改善医疗保健结果是帮助北美市场成长的因素之一。

德国达姆施塔特 Merck KGaA 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 Group 是单核细胞活化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活化测试 (MAT) 系统：PyroCell MAT 快速系统和 PyroCell MAT 人类血清 (HS) 快速系统，以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。新测试为製药和生物技术製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。

在进行单核细胞活化测试市场时参考的一些来源包括治疗产品管理局、美国人道协会和美国国立卫生研究院等。

欧洲
- 德国
- 法国
- 义大利
- 西班牙
- 英国
- 欧洲其他地区
亚太
- 澳洲
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
中东和非洲
- 南非
- 沙乌地阿拉伯
- 阿联酋
- 中东和非洲其他地区
南美洲和中美洲
- 巴西
- 阿根廷
- 南美洲和中美洲其他地区

第 11 章：Covid-19 前后的影响

第 12 章：产业格局

併购
协议、合作、合资企业
新产品发布
扩张和其他策略发展

第13章：竞争格局

关键参与者的热图分析
公司定位与专注

第 14 章：单核细胞活化测试市场 - 主要公司简介

Merck KGaA, Darmstadt,Germany and/or its Affiliates

注意 - 将为以下公司列表提供类似信息

查尔斯河实验室国际有限公司
赛默飞世尔科技
桑昆
龙沙集团
马特生物科技
Cellmade实验室
劳工 LS SE & Co. KG
BD生物科学公司
贝克曼库尔特

第 15 章：附录

词彙表
关于 Insight Partners
市场情报云

简介目录

Product Code: TIPRE00004912

The monocyte activation tests market size was valued at US$ 65.174 million in 2022 and is expected to reach US$ 236.714 million by 2030; it is estimated to register a CAGR of 17.5% from 2022 to 2030.

The monocyte activation tests market analysis includes the study of market drivers such as a rise in patient safety concerns 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.

Based on the source, the monocyte activation tests market is bifurcated into PMBC and cell lines. 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.

The monocyte activation test detects potentiated cytokine release from the synergistic effect of endotoxin and non-endotoxin pyrogens. The monocyte activation test (MAT) is an in-vitro assay designed to test parenteral drugs, biologics, and medical devices for all classifications of pyrogens. Over the last five years, vaccines that previously used the Rabbit Pyrogen Test as their release assay has been among the initial adopters of the monocyte activation test (MAT). Moreover, unlike MAT, bacterial endotoxin tests are often unsuitable for intrinsically pyrogenic products or those that include additives commonly included in vaccines, such as aluminum hydroxide, which tend to interfere with the assay. A few instances of MAT's uptake in testing vaccines included Neisseria meningitidis vaccine, Hyperimmune Sera, Meningococcal vaccines, Yellow fever vaccine, Shigella sonnei vaccine, Rabies vaccine, Hepatitis B Vaccine, and Tick-borne encephalitis virus vaccine.

Source-based Insights

Based on the source, the monocyte activation tests market is bifurcated into PMBC and cell lines. The PMBC segment held a larger share in 2022 and is expected to continue a similar trend during the forecast period. The same segment is expected to witness a higher CAGR from 2022 to 2030. Currently, two commercialized monocyte activation test cell sources are available globally-the Mono-Mac-6 (MM6) cell line and Peripheral Blood Mononuclear Cells (PBMC). The MM6 derives from the blood of a single acute monocytic leukemia patient; as a result, the monocytes sometimes do not have TLRs that reflect the stable expression required to consistently detect pyrogenic contaminants and initiate the release of cytokines by a healthy human. Hence, the reproducibility of MAT results is low using this cell source. The Ph. Eur. (2.6.30) also describes MM6-based MAT kits as "limited" in detecting non-endotoxin pyrogens.

On the other hand, PBMC-based MAT kits source their PBMC from the pooled blood of screened, healthy donors-which means that when incubated with a spiked product sample, the monocyte activation can assist the growth of a healthy human being. As a result, results for MAT kits based on this cell source have been consistently found to be reproducible. The Ph. Eur. (2.6.30) counts this cell source as proficient in detecting both endotoxins and non-endotoxin pyrogens.

Currently, three other commercialized PBMC-based monocyte activation test vendors are on the market. Each has a LoD of 0.125 EU/ml, 0.02 EU/ml, and 0.016 EU/ml. The CTL-MAT assay has a market-leading LoD of 0.004 EU/ml, making it the most sensitive monocyte activation test available worldwide.

Products-based Insights

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 expected to register a higher CAGR during the forecasted period.

Regional Analysis

The monocyte activation tests market is segmented based on region: 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 factor aiding North America's market growth.

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.

In October 2023, Lonza launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, to streamline and ease rabbit-free pyrogen testing. The systems will replace Lonza's traditional MAT system kit offerings, and the newly launched products contain the new PeliKine Human IL-6 Rapid ELISA Kit that minimizes hands-on time and reduces time-to-results from two days to two hours. The new tests give pharmaceutical and biotechnology manufacturers easier MAT testing options for product safety testing while helping to reduce the reliance on animals.

Some sources referred while conducting the monocyte activation tests market are Therapeutic Goods Administration, The Humane Society of the United States, and the National Institutes of Health, among others.

1. Introduction

1.1 Scope of the Study
1.2 Market Definition, Assumptions and Limitations
1.3 Market Segmentation

2. Executive Summary

2.1 Key Insights
2.2 Market Attractiveness Analysis

3. Research Methodology

4. Monocyte Activation Tests Market Landscape

4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
- 4.3.1 List of Vendors in the Value Chain

5. Monocyte Activation Tests Market - Key Market Dynamics

5.1 Key Market Drivers
5.2 Key Market Restraints
5.3 Key Market Opportunities
5.4 Future Trends
5.5 Impact Analysis of Drivers and Restraints

6. Monocyte Activation Tests Market - Global Market Analysis

6.1 Monocyte Activation Tests - Global Market Overview
6.2 Monocyte Activation Tests - Global Market and Forecast to 2030

7. Monocyte Activation Tests Market - Revenue Analysis (USD Million) - By Source, 2020-2030

7.1 Overview
7.2 PMBC
7.3 Cell Line

8. Monocyte Activation Tests Market - Revenue Analysis (USD Million) - By Products, 2020-2030

8.1 Overview
8.2 MAT Kits
8.3 Reagents

9. Monocyte Activation Tests Market - Revenue Analysis (USD Million) - By Application, 2020-2030

9.1 Overview
9.2 Drug Development
9.3 Vaccine Development
9.4 Medical Devices
9.5 Others (Research etc.)

10. Monocyte Activation Tests Market - Revenue Analysis (USD Million), 2020-2030 - Geographical Analysis

10.1 North America
- 10.1.1 North America Monocyte Activation Tests Market Overview
- 10.1.2 North America Monocyte Activation Tests Market Revenue and Forecasts to 2030
- 10.1.3 North America Monocyte Activation Tests Market Revenue and Forecasts and Analysis - By Source
- 10.1.4 North America Monocyte Activation Tests Market Revenue and Forecasts and Analysis - By Products
- 10.1.5 North America Monocyte Activation Tests Market Revenue and Forecasts and Analysis - By Application
- 10.1.6 North America Monocyte Activation Tests Market Revenue and Forecasts and Analysis - By Countries
  - 10.1.6.1 United States Monocyte Activation Tests Market
    - 10.1.6.1.1 United States Monocyte Activation Tests Market, by Source
    - 10.1.6.1.2 United States Monocyte Activation Tests Market, by Products
    - 10.1.6.1.3 United States Monocyte Activation Tests Market, by Application
  - 10.1.6.2 Canada Monocyte Activation Tests Market
    - 10.1.6.2.1 Canada Monocyte Activation Tests Market, by Source
    - 10.1.6.2.2 Canada Monocyte Activation Tests Market, by Products
    - 10.1.6.2.3 Canada Monocyte Activation Tests Market, by Application
  - 10.1.6.3 Mexico Monocyte Activation Tests Market
    - 10.1.6.3.1 Mexico Monocyte Activation Tests Market, by Source
    - 10.1.6.3.2 Mexico Monocyte Activation Tests Market, by Products
    - 10.1.6.3.3 Mexico Monocyte Activation Tests Market, by Application

Note - Similar analysis would be provided for below mentioned regions/countries

10.2 Europe
- 10.2.1 Germany
- 10.2.2 France
- 10.2.3 Italy
- 10.2.4 Spain
- 10.2.5 United Kingdom
- 10.2.6 Rest of Europe
10.3 Asia-Pacific
- 10.3.1 Australia
- 10.3.2 China
- 10.3.3 India
- 10.3.4 Japan
- 10.3.5 South Korea
- 10.3.6 Rest of Asia-Pacific
10.4 Middle East and Africa
- 10.4.1 South Africa
- 10.4.2 Saudi Arabia
- 10.4.3 U.A.E
- 10.4.4 Rest of Middle East and Africa
10.5 South and Central America
- 10.5.1 Brazil
- 10.5.2 Argentina
- 10.5.3 Rest of South and Central America

11. Pre and Post Covid-19 Impact

12. Industry Landscape

12.1 Mergers and Acquisitions
12.2 Agreements, Collaborations, Joint Ventures
12.3 New Product Launches
12.4 Expansions and Other Strategic Developments

13. Competitive Landscape

13.1 Heat Map Analysis by Key Players
13.2 Company Positioning and Concentration

14. Monocyte Activation Tests Market - Key Company Profiles

14.1 Merck KGaA, Darmstadt,Germany and/or its Affiliates
- 14.1.1 Key Facts
- 14.1.2 Business Description
- 14.1.3 Products and Services
- 14.1.4 Financial Overview
- 14.1.5 SWOT Analysis
- 14.1.6 Key Developments

Note - Similar information would be provided for below list of companies