Monocyte Activation Test Market Size, Share and Trends 2025 to 2034

Monocyte Activation Test Market Size and Forecast 2025 to 2034

The global monocyte activation test market size was accounted for USD 593.45 million in 2024 and is predicted to increase from USD 687.99 million in 2025 to approximately USD 2,602.21 million by 2034, expanding at a CAGR of 15.93% from 2025 to 2034. Growing awareness regarding ethical testing methods is the key factor driving market growth. Also, innovations in monocyte activation test (MAT) technology, coupled with the collaborations between market players, can fuel market growth soon.

Monocyte Activation Test Market Key Takeaways

• North America dominated the global market with the largest market share of 37% in 2024.
• The Asia Pacific market is expected to show significant growth over the forecast period.
• By product, the MAT kits segment contributed the highest market share of 64% in 2024.
• By product, the reagent segment is expected to grow at the fastest CAGR over the forecast period.
• By source, the PBMC-based segment held the largest market share of 63% in 2024.
• By source, the cell line-based segment is anticipated to show the fastest growth over the forecast period.
• By application, the drug development segment captured the biggest market share of 41% in 2024.
• By application, the vaccine development segment is estimated to show the fastest growth over the forecast period.
• By end use, in 2024, the pharmaceutical industry segment generated the major market share of 57% in 2024.
• By end use, the biotechnology industry segment is expected to grow at the fastest CAGR over the projected period.

Role of Artificial Intelligence (AI) in Enhancing the Monocyte Activation Test

Artificial Intelligence plays a substantial role in the monocyte activation test market by improving accuracy, efficiency, and data analysis, contributing to more efficient and safer quality control and drug development processes. Furthermore, AI-powered data analysis techniques help in the effective interpretation of test results, detecting patterns, and facilitating assay parameters to improve overall performance. This enables a more detailed understanding of the test data, which leads to precise and reliable results.

U.S. Monocyte Activation Test Market Size and Growth 2025 to 2034

The U.S. monocyte activation test market size was evaluated at USD 153.70 million in 2024 and is projected to be worth around USD 687.96 million by 2034, growing at a CAGR of 16.17% from 2025 to 2034.

North America held the largest monocyte activation test market share in 2024. The dominance of the region can be attributed to the strong presence of well-established medical devices and pharmaceutical industries. Moreover, the region's emphasis on patient safety and quality control has positively impacted regional growth. The region is increasingly adopting innovative diagnostic technologies to extend its market reach.

• In September 2023, Pace Analytical Services introduced a groundbreaking PFAS test method designed to revolutionize testing efficacy. Known as ASTM D8421/EPA 8327, this method leverages isotope dilution and LC/MS/MS technology to meticulously analyze up to 44 PFAS compounds in both aqueous and solid samples.

In North America, the U.S. led the market. The dominance of the country is owing to the country's strong biotechnology and pharmaceutical sectors, along with the stringent regulatory standards, which have fueled the demand for efficient pyogen testing methods such as MAT.

Asia Pacific is expected to show significant growth over the forecast period. The growth of the region can be credited to the region's escalating biotechnology and pharmaceutical industries. Furthermore, countries such as China, Japan, and India are at the forefront of adopting this process because of rising regulatory demands for humane pyrogen testing methods.

In Asia Pacific, China led the monocyte activation test market in 2024. The dominance of the country is due to the ongoing adoption of MAT by the pharmaceutical sector, boosted by the need for efficient and reliable testing methods. Regulatory bodies are identifying MAT as a crucial option to traditional testing, facilitating its integration into industry practices.

Market Overview

The monocyte activation test market consists of the in vitro assay utilized to identify and quantify pyrogens in medical devices, pharmaceuticals, and other medical products by measuring the human monocyte activation and the release of pro-inflammatory cytokines. It is a human-specific, in vitro option to the conventional rabbit pyogen test, which is being used by government agencies such as the European Pharmacopoeia.

Monocyte Activation Test Market Growth Factors

• The growing regulatory focus on human-relevant pyogen testing is expected to boost the monocyte activation test market growth shortly.
• The increasing need for animal-free and more sustainable methods can propel market growth soon.
• Technological advancements in MAT technology, such as the development of more sensitive and specific assays, will likely contribute to the market expansion over the forecast period.

Market Scope

Market Dynamics

Drivers

Rising incidence of autoimmune diseases

The growing incidence of autoimmune disorders like lupus, rheumatoid arthritis, and multiple sclerosis has substantially raised the demand for monocyte activation tests. In addition, these conditions showcase the subtle interactions between the bodily tissues and the immune system, requiring enhanced diagnostic technologies for trustworthy surveillance and identification.

• In June 2023, Lonza launched the PyroCell® Monocyte Activation Test—Human Serum System, which uses human serum instead of fetal bovine serum. This new in vitro pyrogen testing system exhibits enhanced sensitivity for the detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals.

Restraint

Standardization of protocols

Implementing monocyte activation test market services in a daily quality control landscape needs the establishment of standardized protocols for cell handling, sample preparation, and assay execution. Moreover, another major hurdle for MAT is navigating the regulatory approvals and obtaining clinical validation. The regulatory regulations can shift between countries, complicating the whole process for organizations looking to market their MAT products in other countries.

Opportunity

Increasing need for individualized care

The increasing shift toward individualized care is creating lucrative opportunities in the monocyte activation test market. MAT plays a crucial role in this scenario by analyzing how a patient's immune system reacts to certain medications, which facilitates the prediction of worst-case events and the treatment strategies. Furthermore, high-throughput screening, automation developments, and flow cytometry are enhancing MAT precision and efficiency.

Product Insights

The MAT kits segment dominated the monocyte activation test market in 2024. The dominance of the segment can be attributed to the increasing use of MAT in pharmaceutical and medical device testing, because of growing regulatory pressure for more efficient products. The MAT is an important segment of a much broader market for kits and reagents, especially in the context of pyrogenicity testing for medical device applications. Hence, MAT is becoming the crucial standard for endotoxin testing.

• In June 2024, FUJIFILM Wako Pure Chemicals Corporation announced the launch of two new tests: LumiMAT™ Pyrogen Detection Kit (LumiMAT), a next-generation monocyte activation test (MAT)1 for in vitro2 pyrogen testing, and PYROSTAR™ Neo+, a recombinant protein reagent for the detection of bacterial endotoxins.

The reagent segment is expected to grow at the fastest rate over the forecast period. The growth of the segment can be credited to the increasing focus on the development and manufacturing of biologics.MAT reagents are essential for detecting pyrogens to ensure product safety. Also, MAT is gaining traction as a reliable in vitro option to conventional methods such as the rabbit pyogen test, especially for identifying non-endotoxin pyrogens.

Source Insights

The PBMC-based segment held the largest monocyte activation test market share in 2024. The dominance of the segment can be linked to the growing demand for more precise and human-relevant testing methods, along with the requirement for safer pharmaceutical products. Additionally, PBMC-based MAT provides a more physiologically relevant model by using human cells, which are more responsive to pyrogens. This is especially important in the testing of vaccines and biologics.

The cell line-based segment is anticipated to show the fastest growth over the forecast period. The growth of the segment can be driven by increasing demand for more standardized and reproducible testing methods. Moreover, this segment provides consistency in results, as it utilizes immortalized cell lines. However, some studies show that MM6-based MAT kits have an inability to identify non-endotoxin pyrogens.

• In October 2024, China-based WuXi Biologics, a leading global contract research, development, and manufacturing organization (CRDMO), announced the launch of WuXia RidGS, a high-yield glutamine synthetase (GS)-knockout Chinese hamster ovary (CHO) expression system platform.

Application Insights

The drug development segment led the monocyte activation test market in 2024. The dominance of the segment is owing to the growing need for safer and more effective pharmaceuticals. MAT is important in identifying pyrogenic contaminants in drugs, which can lead to harmful reactions in patients. Furthermore, the pharmaceutical industry extensively depends on these tests during drug development to optimize overall product safety.

The vaccine development segment is estimated to show the fastest growth over the forecast period. The growth of the segment is due to the rising regulatory emphasis on non-animal testing methods. MAT plays a key role in ensuring safety by identifying pyrogens that lead to harmful reactions like fever. MAT, utilizing human immune cells, provides a more precise and ethical solution to animal-based pyrogen testing.

End-Use Insights

In 2024, the pharmaceutical industry segment led the monocyte activation test market by holding the largest market share. The dominance of the segment can be credited to the important role of these companies in drug development and safety testing. MAT is crucial in identifying pyrogens to ensure that pharmaceutical products are free from impurities that lead to adverse immune reactions. Hence, MAT is becoming the preferred choice for pyrogen testing in the pharmaceutical industry.

The biotechnology industry segment is expected to grow at the fastest rate over the projected period. The dominance of the segment can be linked to the increasing awareness of health issues and raised government funding for research and innovations in gene editing. Also, a major driver for MAT adoption is the growing regulatory demand for human-relevant and reliable testing methods. MAT helps to fulfill these requirements by providing faster results.

Monocyte Activation Test Market Companies

• Lonza Group
• Charles River Laboratories
• Bio-Rad Laboratories
• Merck KGaA
• Seikagaku Corporation
• Hyglos GmbH
• Wako Chemicals U.S.
• Thermo Fisher Scientific
• MAT BioTech
• Eurofins Scientific

Latest Announcement by Market Leaders

• In October 2024, Lonza, a healthcare development and manufacturing organization, announced it had completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, California (US) from Roche for USD 1.2 billion. The Vacaville facility significantly extends Lonza's capacity for mammalian manufacturing in the U.S., the world's largest pharmaceutical market.

Recent Developments

• In January 2024, Charles River added a new animal-free analytical solution to its endotoxin testing (BET) segment to provide faster, quantitative results, and this requires less reagent preparation and reduces the chance of compromise by technician error.
• In February 2024, BioMerieux SA established a formal research collaboration with the U.S. FDA, OARSA, CFSAN, and Regulatory Science (ORS) to research and develop new technologies to improve the detection of Cyclospora cayetanensis.

Segments Covered in the Report

By Product

• MAT Kits
• Reagents

By Source

• PBMC Based
• Cell Line Based

By Application

• Drug Development
• Vaccine Development
• Medical Device Testing
• Others

By End Use

• Pharmaceutical Industry
• Biotechnology Industry
• Medical Device Industry
• Others

By Region

• North America
• Latin America
• Europe
• Asia-pacific
• Middle and East Africa