Monocyte Activation Test Market Size, Share, and Industry Analysis, By Product Type (Kits and Reagents), By Source (Cell Line Based and Peripheral Blood Mononuclear Cells (PBMCs)), By Application (Drug Development, Vaccine Development, Medical Devices, and Others), By End-user (Pharmaceutical & Biotechnology Companies, Medical Device Industries, and Others), and Regional Forecast, 2024-2032

The monocyte activation test (MAT) is an in-vitro assay that uses human blood to mimic the early stages of the human immune response. It is designed to detect all types of pyrogens in parenteral drugs, biologics, and medical devices. The monocyte activation test (MAT) replaces traditional methods, such as the rabbit pyrogen test, which has limitations and ethical concerns. The monocyte activation test (MAT) exposes the human blood cells to the test sample and measures the release of cytokines, which are signaling molecules produced by monocytes and other immune cells. The level of cytokine production indicates the presence and amount of pyrogens in the sample.

The monocyte activation test uses two primary cell sources: cell line-based and peripheral blood mononuclear cells (PBMCs). The cell lines employ the monocytic cell line based on blood derived from patients with acute monocytic leukemia. On the other hand, peripheral blood mononuclear cells (PBMCs) utilize the monocytes derived from the whole blood of healthy donors. Monocytic cell lines are capable of the detection of bacterial endotoxins but have limited capability in the detection of non-endotoxin pyrogens. In contrast, peripheral blood mononuclear cells (PBMCs) have a significant ability to detect bacterial endotoxins and non-endotoxin pyrogens.

The monocyte activation test (MAT) provides a more accurate and relevant assessment of the safety of pharmaceutical and medical products compared to the other pyrogen and endotoxin tests. It can detect the broadest range of pyrogens, including gram-positive and gram-negative bacteria, as well as yeasts, molds, and viruses. It reflects the human immune system with a LoD of 0.004 EU/ml and is capable of testing all product categories where the bacterial endotoxin test (BET) and rabbit pyrogen test (RPT) fail. These benefits are expected to surge the adoption of these tests in the coming years, thereby driving market growth.

The market growth is primarily attributed to the increasing adoption of monocyte activation tests (MAT) to ensure the safety of products in the pharmaceutical and medical device industries. The growing importance of such tests in the pharmaceutical and medical device industries is contributing to the development and discovery of new pharmaceutical products and medical devices that have better safety, efficacy, and outcomes for several diseases. This is expected to boost the market growth in the coming years.

• For instance, as of June 2024, Merck KGaA’s PyroMAT kit is being increasingly used to ensure the safety of global parenteral pharmaceutical products and medical devices. The greater availability of such products worldwide is expected to fuel the market growth.

Moreover, the growing awareness of the importance of patient safety and the need for more reliable pyrogen testing methods is increasing the demand for the monocyte activation test (MAT), which offers a more accurate and relevant assessment of product safety compared to other traditional methods such as the rabbit pyrogen test. To contribute to this growing awareness, regulatory authorities are recommending the use of monocyte activation tests (MAT).

For instance, in June 2021, the European Pharmacopoeia (Ph. Eur.) recommended using in-vitro alternatives, such as the monocyte activation test (MAT), for pyrogen testing as a replacement for traditional methods. This is expected to increase the adoption of monocyte activation test (MAT), driving market growth during the forecast period.

The COVID-19 pandemic had a significant impact on the monocyte activation test market. The market experienced a surge in demand for monocyte activation tests (MATs) due to the increased need for pyrogen testing in various industries, including pharmaceutical, biotechnology, and medical devices, during the pandemic. The high use of monocyte activation tests (MATs) in the pharmaceutical industry was mainly attributed to its significant application in vaccine development. This surged the market growth in 2020.

Segmentation

Key Insights

The report covers the following key insights:

• New Product Launches, By Key Players


• Regulatory Guidelines and Recommendations for Industry Pyrogen and Endotoxin Testing


• Key Industry Developments (Mergers, Acquisitions, Partnerships)


• Impact of COVID-19 on the Market

Analysis by Source

Based on the source, the market is segmented into cell line based and peripheral blood mononuclear cells (PBMCs). The peripheral blood mononuclear cells (PBMCs) segment is projected to account for a significant share of the global monocyte activation test market during the forecast period. The growth of this segment is attributed to a high preference for peripheral blood mononuclear cells (PBMCs) in the monocyte activation test (MAT) due to their high capability of detecting bacterial endotoxins and non-endotoxin pyrogens. This is leading to an increase in the recommendation of peripheral blood mononuclear cells (PBMCs) in the monocyte activation test (MAT) globally, which is expected to boost segmental growth.

• For instance, in 2023, MAT Research B.V. stated that the European pharmacopeia (EP) underlined the cryopreserved, pooled peripheral blood mononuclear cells (PBMCs) as an appropriate cell source for detection of bacterial endotoxins and non-endotoxin pyrogens.

On the other hand, the cell line based segment is anticipated to grow at a noteworthy CAGR during the forecast period. Cell lines provide a standardized source of monocytes, which ensures consistent results across different batches and trials for the detection of bacterial endotoxins. This is expected to increase their use in monocyte activation tests (MAT), propelling segment growth in the forthcoming years.

Regional Analysis

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The global market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to hold a significant share of the monocyte activation test market during the forecast period. The regulatory authorities, such as the U.S. Pharmacopeia (USP) and the Food and Drug Administration (FDA), are promoting the usage of in-vitro alternatives, such as the monocyte activation test (MAT) for parenteral products. This is mainly attributed to the need for more reliable and efficient testing methods.

• For instance, as of June 2024, MAT BioTech reports that the U.S. FDA, in its 2009 notes, has recommended the use of a monocyte activation test (MAT) for parental products once the PSV is carried out. This is increasing the utilization of monocyte activation tests (MAT) in the region, which is anticipated to boost market growth.

Asia Pacific is projected to grow at a significant CAGR during the forecast timeframe. The growth of the region is mainly attributed to the expanding number of pharmaceutical and healthcare industries in the region. This is driving the demand for monocyte activation tests, which are used to detect pyrogens in parenteral formulations of human serum albumin and other products manufactured by pharmaceutical companies.

Key Players Covered

The market consists of significant players, such as Merck KGaA, Lonza Group, CTL, Sanquin Diagnostiek B.V., BD, and MAT BioTech B.V. The increasing focus of these key players on new product launches is expected to fuel their revenue growth in the coming years.

Key Industry Developments

• In October 2023, Lonza Group announced the launch of two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Human Serum (HS) Rapid System, and the PyroCell MAT Rapid System, to streamline and simplify rabbit-free pyrogen testing.


• In April 2021, MAT BioTech B.V. launched a monocyte activation test (MAT) to support the pharmaceutical sector's research, development, and quality control.


• In May 2020, Lonza Group collaborated with Sanquin Reagents B.V. to commercialize a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices utilizing the monocyte activation test (MAT).