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1419137

單核細胞活化測試市場規模和預測（2020 - 2030）、全球和地區佔有率、趨勢和成長機會分析報告範圍：按來源（PMBC 和細胞株）、產品（MAT 試劑盒和試劑）和應用

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個工作天內

價格

簡介目錄

2022年單核細胞活化測試市場規模為6,517.4萬美元，預計2030年將達到2,3671.4萬美元；預計2022年至2030年CAGR為17.5%。

單核細胞活化測試市場分析包括對市場促進因素的研究，例如患者安全擔憂的增加以及製藥、生物技術和醫療設備等最終用戶行業對更安全的熱原測試方法的需求激增。此外，預計單核細胞活化測試方法的技術發展將推動預測期內單核細胞活化測試市場的成長。

根據來源，單核細胞活化測試市場分為 PMBC 和細胞系。 PMBC 細分市場在 2022 年佔據更大佔有率，預計在預測期內將繼續保持類似趨勢。根據產品，單核細胞活化測試市場分為 MAT 試劑盒和試劑。 MAT 套件細分市場在 2022 年佔據更大佔有率，預計在預測期內將繼續保持類似趨勢。另一方面，預計試劑領域在預測期內將錄得更高的CAGR。根據應用，單核細胞活化測試市場分為藥物開發、疫苗開發、醫療設備和其他（研究等）。藥物開發領域在 2022 年佔據了最大佔有率，預計 2022 年至 2030 年將出現同樣的趨勢。

單核細胞活化測試檢測內毒素和非內毒素熱原的協同作用所增強的細胞激素釋放。單核細胞活化試驗 (MAT) 是一種體外試驗，旨在測試腸外藥物、生物製品和醫療器材中所有類別的熱原。在過去五年中，先前使用兔熱原測試作為釋放測定的疫苗已成為單核細胞活化測試（MAT）的最初採用者之一。此外，與 MAT 不同，細菌內毒素測試通常不適用於本質熱原產品或含有疫苗中常見添加劑（例如氫氧化鋁）的產品，這些產品往往會干擾檢測。 MAT 在疫苗檢測中的應用包括腦膜炎奈瑟菌疫苗、超免疫血清、腦膜炎雙球菌疫苗、黃熱病疫苗、宋內志賀氏菌疫苗、狂犬病疫苗、B型肝炎疫苗和蜱傳腦炎病毒疫苗。

基於來源的見解

根據來源，單核細胞活化測試市場分為 PMBC 和細胞系。 PMBC 細分市場在 2022 年佔據更大佔有率，預計在預測期內將繼續保持類似趨勢。預計該細分市場從 2022 年到 2030 年將出現更高的CAGR。目前，全球有兩種商業化的單核細胞活化測試細胞來源——Mono-Mac-6 (MM6)細胞株和週邊血單核細胞(PBMC)。 MM6源自於一名急性單核細胞白血病患者的血液；因此，單核細胞有時不具有反映健康人持續檢測致熱污染物和啟動細胞因子釋放所需的穩定表達的 TLR。因此，使用此細胞來源的 MAT 結果的重現性較低。歐洲博士。 (2.6.30) 也描述基於 MM6 的 MAT 試劑盒在檢測非內毒素熱原方面「有限」。

另一方面，基於 PBMC 的 MAT 試劑盒從經過篩選的健康捐贈者的混合血液中獲取 PBMC，這意味著當與加標產品樣本一起孵育時，單核細胞活化可以幫助健康人的生長。因此，基於此細胞來源的 MAT 試劑盒的結果始終具有可重複性。歐洲博士。 (2.6.30) 認為此細胞源能夠熟練檢測內毒素和非內毒素熱原。

目前，市場上還有另外三個商業化的基於 PBMC 的單核細胞活化測試供應商。每種的 LoD 分別為 0.125 EU/ml、0.02 EU/ml 和 0.016 EU/ml。 CTL-MAT 檢測的 LoD 為市場領先的 0.004 EU/ml，使其成為全球最靈敏的單核細胞活化檢測。

基於產品的洞察

根據產品，單核細胞活化測試市場分為 MAT 試劑盒和試劑。 MAT 套件細分市場在 2022 年佔據更大佔有率，預計在預測期內將繼續保持類似趨勢。另一方面，預計試劑領域在預測期內將出現更高的CAGR。

區域分析

單核細胞活化測試市場按地區細分：北美、歐洲、亞太地區、南美洲和中美洲以及中東和非洲。北美在 2022 年佔據了最大的市場佔有率，預計在預測期內將繼續保持類似的趨勢，其次是歐洲。美國藥典 (USP) 和加拿大政府等組織對單核細胞活化測試的監管實踐進一步推動了該地區單核細胞活化測試市場的整體成長。此外，日益關注病患安全問題和改善醫療保健結果是幫助北美市場成長的因素之一。

德國達姆施塔特 Merck KGaA 和/或其附屬公司；查爾斯河實驗室國際有限公司；賽默飛世爾科技；桑昆；和 Lonza Group 是單核細胞活化測試市場的領先公司之一。

2023 年 10 月，Lonza 推出了兩種新型快速單核細胞活化測試 (MAT) 系統：PyroCell MAT 快速系統和 PyroCell MAT 人類血清 (HS) 快速系統，以簡化和簡化兔子無熱原測試。該系統將取代 Lonza 傳統的 MAT 系統套件產品，新推出的產品包含新的 PeliKine 人 IL-6 快速 ELISA 套件，可最大限度地減少動手時間並將獲得結果的時間從兩天縮短到兩小時。新測試為製藥和生物技術製造商提供了更簡單的產品安全測試 MAT 測試選項，同時有助於減少對動物的依賴。

在進行單核細胞活化測試市場時參考的一些來源包括治療產品管理局、美國人道協會和美國國立衛生研究院等。

歐洲
- 德國
- 法國
- 義大利
- 西班牙
- 英國
- 歐洲其他地區
亞太
- 澳洲
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 阿拉伯聯合大公國
- 中東和非洲其他地區
南美洲和中美洲
- 巴西
- 阿根廷
- 南美洲和中美洲其他地區

第 11 章：Covid-19 前後的影響

第 12 章：產業格局

併購
協議、合作、合資企業
新產品發布
擴張和其他策略發展

第13章：競爭格局

關鍵參與者的熱圖分析
公司定位與專注

第 14 章：單核細胞活化測試市場 - 主要公司簡介

Merck KGaA, Darmstadt,Germany and/or its Affiliates

注意 - 將為以下公司列表提供類似資訊

查爾斯河實驗室國際有限公司
賽默飛世爾科技
桑昆
龍沙集團
馬特生物科技
Cellmade實驗室
勞工 LS SE & Co. KG
BD生物科學公司
貝克曼庫爾特

第 15 章：附錄

詞彙表
關於 Insight Partners
市場情報雲

簡介目錄

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