According to the report, the global pyrogen testing market was valued at US$ 638.2 Mn in 2016 and is projected to expand at a high CAGR of 12% from 2017 to 2025 to reach US$ 1,842.8 Mn in 2025. The report suggests that rise in demand for pyrogen testing in various pharmaceutical and biological industry is anticipated to drive the global pyrogen testing market between 2017 and 2025.
North America and Europe are projected to dominate the global pyrogen testing market. The market in North America is driven by highly structured health care industry and availability of well-defined FDA regulations for pharmaceutical and medical device product manufacturing. Europe is projected to account for 30% market share by 2025. The market in Asia Pacific is anticipated to expand at a high CAGR of 14% during the forecast period from 2017 to 2025. Asia Pacific is expected to be the fastest growing market for pyrogen testing during the forecast period. The pyrogen testing market in Latin America is likely to grow at a moderate pace during the forecast period.
Pyrogen testing was introduced in pharmaceutical products such as drugs and immunological products. Presently, it is used in medical devices, implants, purification of water, and the food & beverage industry. The Food and Drug Administration (FDA) provides testing recommendations to biological products, drugs, and medical device companies. However, there are concerns about the testing recommendations and acceptance criteria through the United States Pharmacopeia (USP). According to the European Medicines Agency (April 2016), the Committee for Medicinal Products for Veterinary Use (CVMP) developed a guidance report on quality, safety & efficacy, and environmental testing of medicinal, pharmaceutical, and immunological products. These factors demand more number of pyrogen tests of products for safety. According to the FDA, the Center for Devices and Radiological Health (CDRH) has adopted the USP Endotoxin Reference Standard and limits for medical device extracts which are expressed in EU/ml (Endotoxin Units/ml). These improved and additional applications increased demand for pyrogen testing products.
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The pharmaceutical companies segment accounted for the largest share of 32% of the global pyrogen testing market in 2016, due to growing importance of these companies not only in the field of conventional research, but also in the development and production of vital biomolecules and therapeutics. A large number of toxic/immune-modulatory drugs are injectables; hence, pyrogen and endotoxin testing is a must before launch in the market. Discovery and launch of new products fuel the growth of the pharmaceutical companies and biotechnology companies segments. This, in turn, is projected to boost the global pyrogen testing market during the forecast period.
Limulus amoebocyte lysate (LAL) is the most widely accepted and adopted test method for quality control of parenteral drugs, as it is an aqueous extract of blood cells from the horseshoe crab. LAL test is utilized for the detection of minute quantity of bacterial toxins or pyrogen in pharmaceuticals, medical devices, and others. Increase in drug discovery and biological medical devices has driven the pyrogen testing market. The test is the first solution enabling adequate pyrogen testing of cell therapies, including blood transfusions and medical devices. This drives adoption of limulus amoebocyte lysate (LAL) test in the pharmaceutical and biotechnology industries.
Kits comprise pyrogen-free test vials that already contain lyophilized LAL. These kits eliminate some of the tedious pipetting steps and are suitable for small labs with few samples. The kits segment is anticipated to witness relatively high growth rate in terms of revenue during the forecast period, owing to continuous innovation of new products by major as well as emerging players. Reagents used to perform pyrogen tests are limulus amoebocyte lysate (LAL), endotoxin extracting solutions, etc. Kits and reagents are also available in a single pack. Most of the reagents are required in large quantity, and hence are available in different packing. The reagents segment held a major share of the market due to regular use of reagents for pyrogen testing. Reagents are also available in single packs because most reagents are required in large quantities.
Presence of well-established players in the region and increase in research and development activities by these players are attributed to North America’s dominance of the global pyrogen testing market. The U.S. held a major share of the market in North America as well as globally. Additionally, increase in awareness about animal welfare plays an important role in increasing expenditure on animal-free pyrogen testing in the region. Europe and Asia Pacific were the other regions that dominated the global market. The global pyrogen testing market is well-developed in regions such as North America and Europe; however, regions such as Latin America and Asia Pacific exhibit potential for high growth. The market in Middle East & Africa is growing at a steady pace due to increase in number research & development facilities in the region. The market in Saudi Arabia and South Africa is driven by increase in number of biotechnology companies.
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The global pyrogen testing market is fragmented, with presence of several small scale and large scale companies. The report provides profiles of leading players operating in the global pyrogen testing market. Key players operating in the global pyrogen testing market are Charles River Laboratories International, Inc., Hyglos GmbH, Lonza Group, Merck KGaA, Associates of Cape Cod, Inc., Genscript, Wako Chemicals, Sanquin, and WuXi PharmaTech (Cayman), Inc. Merck KGaA dominated the global pyrogen testing market in terms of revenue in 2016. The dominance of the company was majorly attributed to its products which are alternatives to rabbit pyrogen testing.