Monocyte Activation Tests Market

The monocyte activation tests market was valued at US$ 89.57 million in 2024 and is projected to reach US$ 284.48 million by 2031, with an estimated CAGR of 17.5% from 2025 to 2031.

Analyst's Perspective

The analysis of the monocyte activation tests market highlights key drivers such as increasing safety concerns among patients and a growing demand for safer pyrogen testing methods in industries like pharmaceuticals, biotechnology, and medical devices. Additionally, advancements in technology related to monocyte activation test methods are expected to drive market growth throughout the forecast period.

By source, the monocyte activation tests market is divided into PMBC and cell line categories. The PMBC segment held a larger market share in 2022 and is anticipated to maintain this trend during the forecast period. In terms of products, the market is categorized into MAT kits and reagents, with the MAT kits segment also holding a larger share in 2022 and expected to continue this trend. Conversely, the reagents segment is projected to experience a higher CAGR during the forecast period. The market is further segmented by application into drug development, vaccine development, medical devices, and others (such as research). The drug development segment accounted for the largest share in 2022 and is expected to maintain this trend from 2022 to 2030.

The monocyte activation test identifies enhanced cytokine release due to the combined effects of endotoxin and non-endotoxin pyrogens. The MAT is an in-vitro assay designed to evaluate parenteral drugs, biologics, and medical devices for all types of pyrogens. Over the past five years, vaccines that previously relied on the Rabbit Pyrogen Test for release assays have been among the first to adopt the monocyte activation test (MAT). Unlike MAT, bacterial endotoxin tests are often inadequate for products that are inherently pyrogenic or contain additives commonly found in vaccines, such as aluminum hydroxide, which can interfere with the assay. Examples of MAT's application in vaccine testing include the Neisseria meningitidis vaccine, Hyperimmune Sera, Meningococcal vaccines, Yellow fever vaccine, Shigella sonnei vaccine, Rabies vaccine, Hepatitis B Vaccine, and Tick-borne encephalitis virus vaccine.

Strategic Insights

Market Insights

Increasing Demand from the Medical Device Sector

Monocyte activation tests (MATs) are human cell-based assays used to detect and quantify pyrogens such as bacteria, fungi, and viruses. MATs employ an ELISA assay to measure cytokine release from treated blood cells. Although MATs are widely available, they are seldom used as substitutes for animal-based pyrogen tests in assessing the biocompatibility of medical devices. In September 2018, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the PETA International Science Consortium Ltd. (PISC) held a workshop at the National Institutes of Health to discuss the necessary steps for implementing MAT in medical device testing. According to Luxoft, a DXC Technology Company, medical devices are facilitating the digital transformation of healthcare by enabling accurate diagnoses, effective treatments, and personalized care through predictive algorithms and patient data analysis. Innovations in personalized medicine, implantable devices, smart medical devices, and non-invasive surgery are transforming the healthcare landscape by providing better care, improved patient outcomes, and reduced costs. The growth of the medical device industry has, in turn, supported the expansion of monocyte activation test methods and is expected to continue this trend during the forecast period.

Market Opportunity

Technological Advancements in Monocyte Activation Test Methods

Monocyte activation test methods were primarily introduced as alternatives to animal-based testing, providing the opportunity to conduct pyrogen testing in a human in vitro environment. The Monocyte Activation Test (MAT) was incorporated into the European Pharmacopeia (EP) in 2010 following international validation publications. Ongoing innovations and advancements in MAT assays and reagents by market players have significantly improved reproducibility, sensitivity, and specificity, making it a reliable and safer choice for pyrogen detection. The MAT assay is utilized to identify both endotoxins and non-endotoxin pyrogens in parenteral products, including pharmaceuticals and medical devices. Typically, the MAT serves as an in vitro alternative to traditional animal testing in compliance with regulatory guidelines. The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are commonly used for pyrogen detection, but both methods involve animal use and have certain limitations. The rabbit pyrogen test lacks robustness, as animal reactions may differ from human responses. Additionally, the LAL test only detects endotoxins, posing a safety risk by overlooking non-endotoxin pyrogens that may be present in the sample. To address these limitations, the monocyte activation test (MAT) was introduced in the European Pharmacopoeia in 2010 as a compendial method to replace the Rabbit Pyrogen Test (EP Chapter 2.6.30) and is specified in FDA guidance for industries. Continuous innovations and developments in MAT assays and reagents by market participants have led to enhancements in reproducibility, sensitivity, and specificity, establishing it as a reliable and safer option for pyrogen detection.

Report Segmentation and ScopeSource-based Insights

By source, the monocyte activation tests market is divided into PMBC and cell line categories. The PMBC segment held a larger market share in 2022 and is expected to maintain this trend during the forecast period, with a higher CAGR anticipated from 2022 to 2030. Currently, there are two commercialized sources of monocyte activation test cells available globally: the Mono-Mac-6 (MM6) cell line and Peripheral Blood Mononuclear Cells (PBMC). The MM6 cell line is derived from the blood of a single patient with acute monocytic leukemia, which can result in monocytes that do not consistently express TLRs necessary for detecting pyrogenic contaminants and triggering cytokine release as would occur in a healthy human. Consequently, the reproducibility of MAT results using this cell source has been found to be low. The Ph. Eur. (2.6.30) also describes MM6-based MAT kits as "limited" in their ability to detect non-endotoxin pyrogens. In contrast, PBMC-based MAT kits utilize PBMC sourced from pooled blood of screened, healthy donors, allowing for a more accurate simulation of human monocyte activation when incubated with a spiked product sample. As a result, MAT kits based on this cell source have consistently demonstrated reproducible results. The Ph. Eur. (2.6.30) recognizes this cell source as proficient in detecting both endotoxins and non-endotoxin pyrogens.

Currently, there are three other commercialized PBMC-based monocyte activation test vendors in the market, each with a limit of detection (LoD) of 0.125 EU/ml, 0.02 EU/ml, and 0.016 EU/ml. The CTL-MAT assay boasts one of the leading market LoDs at 0.004 EU/ml, making it the most sensitive monocyte activation test available globally.

Products-based InsightsIn terms of products, the monocyte activation tests market is divided into MAT kits and reagents. The MAT kits segment held a larger market share in 2022 and is expected to continue this trend during the forecast period, while the reagents segment is projected to experience a higher CAGR during the forecast period.

Application-based InsightsBy application, the monocyte activation tests market is segmented into drug development, vaccine development, medical devices, and others (such as research). The drug development segment captured the largest share in 2022 and is expected to maintain this trend from 2022 to 2030. According to the National Library of Medicine, pharmaceuticals are a group of emerging organic compounds that have significantly improved patients' quality of life. The pharmaceutical sector is involved in the production, development, and marketing of both branded and generic pharmaceuticals. For the first time in 2014, global pharmaceutical revenues surpassed US$ 1 trillion. The pharmaceutical market has been growing at an annual rate of 5.8% since 2017, with worldwide pharmaceutical market revenue reaching US$ 1,143 billion in 2017 and US$ 1,462 billion in 2021. The monocyte activation test (MAT) is designed to evaluate parenteral drugs, biologics, and medical devices for all classifications of pyrogens. Parenteral-administered pharmaceutical products must be free from pyrogenic (fever-inducing) contamination, as these substances can trigger a life-threatening systemic response in the patient's innate immune system. Ensuring that biological products are free from contaminating pyrogenic material before administration to patients is crucial. Initially, the Rabbit Pyrogen Test (RPT) and the Bacterial Endotoxin Test (BET)/Limulus Amebocyte Lysate Assay (LAL) were used as ex-vivo options.

However, stringent regulations regarding animal testing methods have compelled market participants to develop alternative methods that minimize animal use. Given the limitations of the RPT and BET, along with the increasing production of complex products, the European Pharmacopoeia introduced MAT activation testing methods that simulate the human immune response and combine the advantages of the RPT (assessing pyrogenicity beyond gram-negative endotoxin) with the benefits of an in vitro method. Unlike the RPT, MAT can be applied as a fully quantitative test without animal use, making it more suitable for inherently pyrogenic vaccines and physiologically relevant since it utilizes human cells. MAT testing assays can detect blood-derived products, cell-derived products, biologics, and vaccines. The MAT testing methods can also assess a wide range of drug products and medical devices, including those that cannot undergo in vivo testing (for example, products containing hyaluronic acid). These factors have contributed to the overall growth of the monocyte activation tests market in recent years and are expected to continue this trend during the forecast period.

Monocyte Activation Tests Market Report Scope

Regional Analysis

Regionally, the monocyte activation tests market is segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. North America held the largest market share in 2022 and is expected to maintain this trend during the forecast period, followed by Europe. Regulatory practices governing monocyte activation tests by organizations such as the United States Pharmacopeia (USP) and the Government of Canada have further stimulated the overall growth of the monocyte activation tests market in the region. Additionally, an increasing focus on patient safety and improved healthcare outcomes is contributing to market growth in North America.

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

In October 2023, Lonza introduced two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, aimed at simplifying and expediting rabbit-free pyrogen testing. These systems will replace Lonza's traditional MAT system kit offerings, and the newly launched products feature the new PeliKine Human IL-6 Rapid ELISA Kit, which reduces hands-on time and shortens time-to-results from two days to two hours. The new tests provide pharmaceutical and biotechnology manufacturers with more accessible MAT testing options for product safety testing while helping to decrease reliance on animal testing.