Monocyte Activation Tests Market is expected to reach US$ 236,714.17 thousand by 2030

Publisher: The Insight Partners

According to our new research study on “Monocyte Activation Tests Market Forecast to 2030 — Global Analysis — by Source, Products, and Application,” the monocyte activation tests market size was valued at US$ 65,174.36 thousand in 2022 and is expected to reach US$ 236,714.17 thousand by 2030; it is estimated to register a CAGR of 17.5% from 2022 to 2030.   

Key factors driving the global monocyte activation tests market growth are rise in safety concerns among patients and a surge in demand for safer pyrogen testing methods in end user industries. Technological developments in monocyte activation test methods are expected to propel the overall market growth during the forecast period.

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Market Opportunity

Technological Developments in Monocyte Activation Test Methods

The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are widely used for pyrogen detection. Both methods use animals and show a few limitations. The rabbit pyrogen test indicates a lack of robustness as an animal reaction can differ from a human reaction. Furthermore, only endotoxins are detected in the LAL test, resulting in a safety risk by ignoring non-endotoxin pyrogens that might be present in the tested sample. Thus, to overcome these limitations, the monocyte activation test (MAT) was initiated in the European Pharmacopoeia in 2010 as a compendial method to replace the Rabbit Pyrogen Test (EP Chapter 2.6.30) and specified in FDA guidance for industries. Continuous innovation and developments in MAT assays and reagents by market participants have essentially led to improvements in reproducibility, sensitivity, and specificity, thus making it a reliable and safer option for detecting pyrogens. The MAT assay is used to detect both endotoxins and non-endotoxin pyrogens in parenteral products, including pharmaceuticals and medical devices. Usually, the MAT gives an in vitro alternative to traditional animal testing in accordance with regulatory guidelines. The PyroMAT system is significantly based on the Mono-Mac-6 cell line and IL-6 read-out, which offers various benefits of the monocyte activation test combined with the advantages of using a cell line. Thus, technological developments in monocyte activation test methods are anticipated to create many growth opportunities for the market during the forecast period. In addition, at National Institute for Biological Standards and Control (NIBSC), a monocyte activation test (MAT) was adapted and validated as an alternative. This required setting of a specification in-house and deciding on a decisional procedure using multiple donors, allowing batches equally pyrogenic or less, than those batches shown to be safe in a clinical trial, to be certified as safe. In June 2021, the European Pharmacopoeia Commission (EPC) announced to begin a process that will culminate in the rabbit pyrogen test (RPT) being completely replaced in the European Pharmacopoeia (Ph. Eur.) within approximately 5 years. This decision will duly affect several Ph. Eur. texts covering a wide range of fields such as vaccines for human use to blood products and antibiotics; from radiopharmaceuticals to containers – and the EPC has committed to replacing the RPT with a suitable in vitro alternative in all of them. More recently mechanistically-based in chemico (OECD TG 442C; Direct Peptide Reactivity Assay addressing the first key event of the skin sensitisation AOP), in vitro (OECD TG 442D; ARE-Nrf2 Luciferase Test Method addressing the second key event of the skin sensitisation AOP) , and in vitro (OECD TG 442E; human Cell Line Activation Test (h-CLAT) addressed the third key event of the skin sensitisation AOP). These test methods have been adopted for contributing to the evaluation of the skin sensitisation hazard potential of chemicals. The U-SENS method has been proposed to address the third key event of the skin sensitisation AOP by quantifying the change in the expression of a cell surface marker associated with the process of activation of monocytes and DC (i.e. CD86), in the human histiocytic lymphoma cell line U937, following exposure to sensitisers.

Market Driver

Growing Demand from Medical Device Industry

Monocyte activation tests (MATs) are human cell-based tests to detect and quantify pyrogens such as bacteria, fungi, and viruses. MATs use an ELISA assay to measure cytokine release from treated blood cells. MATs are widely available but rarely used in place of animal-based pyrogen tests for biocompatibility assessment of medical devices. The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the PETA International Science Consortium Ltd. (PISC) convened a September 2018 workshop at the National Institutes of Health to elaborate the necessary steps toward implementation of MAT use in medical device testing. According to Luxoft, a DXC Technology Company, medical devices are aiding the digital transformation of healthcare by providing accurate diagnoses, effective treatments, and personalized care through predictive algorithms and patient data analysis. Technological advancements in personalized medicine, implantable devices, smart medical devices, and noninvasive surgery are revolutionizing the overall healthcare industry by offering better care, improved patient outcomes, and reduced costs. The growth in medical device industry has in-turn enabled the growth of monocyte activation test methods at present and is expected to continue a similar trend during the forecast period. Medical devices for implantation must meet pyrogen limit specifications before they are marketed/sold. According to our recent analysis, the medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly US$800 billion by 2030 . These projections reflect increasing demand for innovative new devices (such as wearables) and services (such as health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets – particularly China and India.

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.

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