Pyrogen testing is a process used by drug manufacturers to determine the presence of bacterial toxins present in vaccines and drugs. It determines if microbes or their metabolites are present in intravenous solutions during the manufacturing process. Pyrogens constitute a heterogeneous group of fever causing substances which comprise both microbial and non-microbial substances. The most potent and most widely known are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogens, in particular lipoteichoic acid (LTA) from yeasts and viruses. A newer pyrogen testing technique is called the limulus amoebocyte lysate (LAL) test. Non-microbial pyrogens often emanate from production environments as small particles of packaging materials. A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen free according to regulatory requirements of 21CFR, USP, and EP.
The global pyrogen testing market segmentation is based on product type (instruments, kits and reagents, services), and applications (pharmaceuticals and biologics, medical devices, others).
The global pyrogen testing market report provides market size (Revenue USD Million 2014 to 2021), market share, trends and forecasts growth trends (CAGR%, 2017 to 2021). The global pyrogen testing market research report is further segmented by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World. The global pyrogen testing market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market by company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market.
Major players operating in the global pyrogen testing market and profiled in this report include Associates of Cape Cod, Inc., Charles River Laboratories International, Inc, Ellab A/S, Genscript, Hyglos Gmbh, Lonza Group, Merck & Co., Inc., Sigma-Aldrich Corporation, Thermo Fisher Scientific, Inc., and Wako Chemicals USA, Inc.