Monocyte Activation Tests Market Size and Forecasts (2020 – 2030)

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 [Drug Development, Vaccine Development, Medical Devices, and Others (Research, etc.)]

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Description

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.

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TABLE OF CONTENTS

1. Introduction
1.1 Scope of the Study
1.2 Research Report Guidance
1.3 Market Segmentation
1.3.1 Europe Immunodiagnostics Market – by Product
1.3.2 Europe Immunodiagnostics Market – by Clinical Indication
1.3.3 Europe Immunodiagnostics Market – by End User
1.3.4 Europe Immunodiagnostics Market – by Country
2. Europe Immunodiagnostics Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Europe Immunodiagnostics Market – Market Landscape
4.1 Overview
4.2 Europe PEST Analysis
4.3 Expert’s Opinion
5. Europe Immunodiagnostics Market – Key Market Dynamics
5.1 Market Drivers
5.1.1 Increasing Prevalence of Infectious Diseases
5.1.2 Growing Use of Point-of-Care Immunodiagnostics
5.2 Market Restraints
5.2.1 Inadequate Reimbursement Scenario
5.3 Market Opportunities
5.3.1 Rising Focus on R&D Investment and Expansion by Key Players
5.4 Future Trends
5.4.1 Technological Advancements in Immunodiagnostics
5.5 Impact Analysis
6. Immunodiagnostics Market – Europe Analysis
6.1 Europe Immunodiagnostics Market Revenue Forecast and Analysis
7. Europe Immunodiagnostics Market Analysis – by Product
7.1 Overview
7.2 Europe Immunodiagnostics Market, By Product, 2022 & 2030 (%)
7.3 Enzyme-linked Immunosorbent Assays (ELISA)
7.3.1 Overview
7.3.2 Enzyme-linked Immunosorbent Assays (ELISA): Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.4 Chemiluminescence Immunoassays (CLIA)
7.4.1 Overview
7.4.2 Chemiluminescence Immunoassays (CLIA): Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.4.3 Vitamin D Assay
7.4.3.1 Overview
7.4.3.2 Vitamin D Assay: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.4.4 HIV Detection
7.4.4.1 Overview
7.4.4.2 HIV Detection: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.4.5 HIV Ag/Ab Combo assay
7.4.5.1 Overview
7.4.5.2 HIV Ag/Ab Combo Assay: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.4.6 Other Tests
7.4.6.1 Overview
7.4.6.2 Other Tests: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.5 Radioimmunoassays (RIA)
7.5.1 Overview
7.5.2 Radioimmunoassays (RIA): Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
7.6 Others
7.6.1 Overview
7.6.2 Others: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8. Europe Immunodiagnostics Market Analysis – Clinical Indication
8.1 Overview
8.2 Europe Immunodiagnostics Market Share by Clinical Indication – 2022 & 2030 (%)
8.3 Infectious Diseases:
8.3.1 Overview
8.3.2 Infectious Diseases: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.1 COVID-19
8.3.2.1.1 Overview
8.3.2.1.2 COVID-19: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.2 Tuberculosis
8.3.2.2.1 Overview
8.3.2.2.2 Tuberculosis: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.3 Lyme
8.3.2.3.1 Overview
8.3.2.3.2 Lyme: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.4 Infection Management
8.3.2.4.1 Overview
8.3.2.4.2 Infection Management: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.5 Zika
8.3.2.5.1 Overview
8.3.2.5.2 Zika: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.6 Treponema
8.3.2.6.1 Overview
8.3.2.6.2 Treponema: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.7 TORCH
8.3.2.7.1 Overview
8.3.2.7.2 TORCH: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.8 Measles and Mumps
8.3.2.8.1 Overview
8.3.2.8.2 Measles and Mumps: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.9 VZV
8.3.2.9.1 Overview
8.3.2.9.2 VZV: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.3.2.10 EBV
8.3.2.10.1 Overview
8.3.2.10.2 EBV: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.4 Hepatitis+HIV:
8.4.1 Overview
8.4.2 Hepatitis+HIV: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.5 Gastrointestinal
8.5.1 Overview
8.5.2 Gastrointestinal: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.6 Metabolic Disorders
8.6.1 Overview
8.6.2 Metabolics: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7 Endocrinology
8.7.1 Overview
8.7.2 Endocrinology: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7.3 Hypertension
8.7.3.1 Overview
8.7.3.2 Hypertension: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7.4 Growth
8.7.4.1 Overview
8.7.4.2 Growth: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7.5 Diabetes
8.7.5.1 Overview
8.7.5.2 Diabetes: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7.6 Thyroid
8.7.6.1 Overview
8.7.6.2 Thyroid: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.7.7 Reproductive Endocrinology
8.7.7.1 Overview
8.7.7.2 Reproductive Endocrinology: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
8.8 Others
8.8.1 Overview
8.8.2 Others: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
9. Europe Immunodiagnostics Market Analysis – End User
9.1 Overview
9.2 Europe Immunodiagnostics Market Share by End User – 2022 & 2030 (%)
9.3 Hospitals
9.3.1 Overview
9.3.2 Hospitals: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
9.4 Clinics
9.4.1 Overview
9.4.2 Clinics: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
9.5 Diagnostic Laboratories
9.5.1 Overview
9.5.2 Diagnostic Laboratories: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
9.6 Academic and Research Institutes
9.6.1 Overview
9.6.2 Academic and Research Institutes: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
9.7 Others
9.7.1 Overview
9.7.2 Others: Europe Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
10. Europe Immunodiagnostics Market – Revenue and Forecast to 2030 – Country Analysis
10.1 Overview
10.1.1.1 UK: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.1 Overview
10.1.1.1.2 UK: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.3 UK: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.1.3.1 UK: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.4 UK: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.4.1 UK: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.4.2 UK: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.5 UK: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
10.1.1.2 Germany: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.1 Overview
10.1.1.2.2 Germany: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.3 Germany: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.2.3.1 Germany: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.4 Germany: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.4.1 Germany: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.4.2 Germany: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.5 Germany: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
10.1.1.3 France: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.1 Overview
10.1.1.3.2 France: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.3 France: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.3.3.1 France: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.4 France: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.4.1 France: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.4.2 France: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.5 France: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
10.1.1.4 Italy: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.1 Overview
10.1.1.4.2 Italy: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.3 Italy: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.4.3.1 Italy: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.4 Italy: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.4.1 Italy: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.4.2 Italy: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.4.5 Italy: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
10.1.1.5 Spain: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.1 Overview
10.1.1.5.2 Spain: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.3 Spain: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.5.3.1 Spain: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.4 Spain: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.4.1 Spain: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.4.2 Spain: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.5.5 Spain: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
10.1.1.6 Rest of Europe: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.1 Overview
10.1.1.6.2 Rest of Europe: Immunodiagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.3 Rest of Europe: Immunodiagnostics Market, by Product, 2020–2030 (US$ Million)
10.1.1.6.3.1 Rest of Europe: Immunodiagnostics Market, by Chemiluminescence Immunoassays (CLIA)– Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.4 Rest of Europe: Immunodiagnostics Market, by Clinical Indication – Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.4.1 Rest of Europe: Immunodiagnostics Market, by Infectious Diseases – Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.4.2 Rest of Europe: Immunodiagnostics Market, by Endocrinology – Revenue and Forecast to 2030 (US$ Million)
10.1.1.6.5 Rest of Europe: Immunodiagnostics Market, by End User, 2020–2030 (US$ Million)
11. Europe Immunodiagnostics Market –Industry Landscape
11.1 Overview
11.2 Inorganic Growth Strategies
11.2.1 Overview
11.3 Organic Growth Strategies
11.3.1 Overview
12. Company Profiles
12.1 Abbott Laboratories
12.1.1 Key Facts
12.1.2 Business Description
12.1.3 Products and Services
12.1.4 Financial Overview
12.1.5 SWOT Analysis
12.1.6 Key Developments
12.2 F. Hoffmann-La Roche Ltd
12.2.1 Key Facts
12.2.2 Business Description
12.2.3 Products and Services
12.2.4 Financial Overview
12.2.5 SWOT Analysis
12.2.6 Key Developments
12.3 DiaSorin SpA
12.3.1 Key Facts
12.3.2 Business Description
12.3.3 Products and Services
12.3.4 Financial Overview
12.3.5 SWOT Analysis
12.3.6 Key Developments
12.4 Danaher Corp
12.4.1 Key Facts
12.4.2 Business Description
12.4.3 Products and Services
12.4.4 Financial Overview
12.4.5 SWOT Analysis
12.4.6 Key Developments
12.5 Thermo Fisher Scientific Inc
12.5.1 Key Facts
12.5.2 Business Description
12.5.3 Products and Services
12.5.4 Financial Overview
12.5.5 SWOT Analysis
12.5.6 Key Developments
12.6 PerkinElmer Inc
12.6.1 Key Facts
12.6.2 Business Description
12.6.3 Products and Services
12.6.4 Financial Overview
12.6.5 SWOT Analysis
12.6.6 Key Developments
12.7 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
12.7.1 Key Facts
12.7.2 Business Description
12.7.3 Products and Services
12.7.4 Financial Overview
12.7.5 SWOT Analysis
12.7.6 Key Developments
12.8 bioMerieux SA
12.8.1 Key Facts
12.8.2 Business Description
12.8.3 Products and Services
12.8.4 Financial Overview
12.8.5 SWOT Analysis
12.8.6 Key Developments
12.9 Svar Life Science AB
12.9.1 Key Facts
12.9.2 Business Description
12.9.3 Products and Services
12.9.4 Financial Overview
12.9.5 SWOT Analysis
12.9.6 Key Developments
12.10 Siemens Healthcare GmbH
12.10.1 Key Facts
12.10.2 Business Description
12.10.3 Products and Services
12.10.4 Financial Overview
12.10.5 SWOT Analysis
12.10.6 Key Developments
13. Appendix
13.1 About
13.2 Glossary of Terms

In progress
In progress

The List of Companies – Monocyte Activation Tests Market
– Merck KGaA, Darmstadt, Germany and/or its affiliates
– Charles River Laboratories International, Inc.
– Thermo Fisher Scientific
– Sanquin
– Lonza Group
– MAT Biotech
– Cellmade Laboratories
– Labor LS SE & Co. KG
– BD Biosciences
– Beckman Coulter

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