Major players in the pyrogen testing market are Thermo Fisher Scientific, Inc., Merck KGaA, Charles River Laboratories, Inc., Lonza Group, Ellab A/S, Nelson Laboratories Inc., Associates of Cape Cod, Inc., GenScript, BioMerieux, Hyglos GmbH, Sanquin, Wako Chemicals USA, Inc., and Pyrostar.
The global pyrogen testing market is expected to grow from $1.03 billion in 2020 to $1.20 billion in 2021 at a compound annual growth rate (CAGR) of 16.2%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $1.78 billion in 2025 at a CAGR of 10.4%.
The pyrogen testing market consists of sales of pyrogen testing and related services by entities (organizations, sole traders and partnerships) that provide pyrogen testing to check the presence or absence of pyrogens in all aqueous parenterals.Pyrogen testing determines the presence of bacterial toxins in vaccines, biotechnological products, and drugs, which induces fever in humans.
It also determines the presence of microbes and their metabolites in drugs during the manufacturing process.
The main types of pyrogen tests are LAL test, in vitro test, and rabbit test.The LAL (Limulus Amebocyte Lysate) test is a test for the determination of bacterial endotoxins, which uses the amebocyte lysate of the Limulus crab.
The rabbit pyrogen test is a test in which a small amount of batched test material is injected into a rabbit’s bloodstream, and the body temperature of the rabbit is monitored. The products used for pyrogen tests include assays, kits, and reagents, instruments and related services, and are used in pharmaceutical and biologics, medical devices, and other industries.
North America was the largest region in the pyrogen testing market in 2020.Asia Pacific is expected to continue to be the fastest growing region in the forecast period.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
Companies are focusing on the evolution of various animal-free pyrogen testing methods such as monocyte activation assay (MAT) to overcome constraints of rabbit pyrogen testing method and LAL test, and to produce a human treatment of animals.MAT provides a high level of prediction of pyrogenic activity and also stimulates fever reaction better than the RPT or BET/LAL.
MAT pyrogen testing method is used to detect both endotoxin and non-endotoxin pyrogens, but the LAL test is limited to detect only endotoxin pyrogen. For instance, Merck focused on two MAT systems for the detection of pyrogens namely PyroDetect, PyroMAT.
The rising investments in research and development in the pharmaceutical and biotechnology industries contributed to the growth of the pyrogen testing market.Pyrogen testing is used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and introduction of infection-free products into the market.
For instance, in 2019, major players in the pharmaceuticals market Roche, AstraZeneca and Merck have invested heavily in R&D activities. Roche invested around $12 billion which represented 19% of its $63.3 billion in sales. Therefore, high investments in research and development by pharmaceuticals companies drive the pyrogen testing market.
The countries covered in the pyrogen testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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