Limulus amoebocyte lysate test is a type of pyrogen test. This test is utilized for the detection of minute quantity of bacterial toxins or pyrogens in pharmaceuticals, medical devices, and others. Pyrogen is a substance that leads to increase in body temperature after it is injected. Limulus amoebocyte lysate test is the most widely accepted and adopted test method for the quality control of parenteral drugs as it is an aqueous extract of blood cells from horseshoe crabs. Associates of Cape Cod, Inc., a company specialized in chromogenic and turbid metric reagent technologies, received the first U.S. FDA approval for limulus amoebocyte lysate testing methodology and pioneered in manufacturing the first FDA licensed limulus amoebocyte lysate test reagent. In May 2014, the company launched Pyrosate, a limulus amoebocyte lysate gel-clot test and the U.S. FDA approved rapid endotoxin detection kit. This detection kit is ideal for dialysis centers, compounding pharmacies, medical devices, and pharmaceutical companies.
The test is more sensitive than the rabbit pyrogen test method. Implantable medical devices, anesthesia, and radioactive drugs are subjected to limulus amoebocyte lysate test. The test is carried out by manufacturers at the last stage of the manufacturing process to keep a quality control on the final product. It is the most preferred testing option for vaccines and the most testing type method used among the health care professionals owing to factors such as low cost, reliability, sensitivity, and no-animal use. Globally, shifting focus of the people toward the treatment of chronic and lifestyle diseases, growing number of biotechnology and pharmaceutical companies, and increasing health care awareness are driving the growth of the global limulus amoebocyte lysate test market. In addition, rising incidences of chronic diseases, increasing research and development activities in the health care industry, and rising new drug approvals are driving the market growth.
Growing pharmaceutical outsourcing, increasing government focus on the prevention of diseases in order to curb health care costs, and rising preference for animal-free detection tests are trends that are further supporting the growth of the global market. The global limulus amoebocyte lysate test market is segmented on the basis of test type, end-user, and region. Based on test type, the market is categorized into single test and multi test. In terms of end-user, the market is divided into pharmaceuticals industry, biotechnology industry, medical devices industry, and others.
Geographically, the limulus amoebocyte lysate test market is distributed over North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the market in terms of share in 2016 due to growing health care awareness coupled with key players domiciled in the region and rising technological advancements in research and development activities. The Asia Pacific market is anticipated to grow during the forecast period owing to increasing focus of key companies on expanding their presence in the region to meet the growing demand that is observed in the market. In addition, increasing government initiatives for health care awareness and rising patient population diagnosed with chronic diseases are projected to drive the growth of the Asia Pacific market in the near future. Latin America and Middle East & Africa are anticipated to grow during the forecast period owing to increasing government initiatives.
Key players operating in the global limulus amoebocyte lysate test market include Thermo Fisher Scientific, Inc.; Merck & Co., Inc.; Associates of Cape Cod, Inc.; Charles River Laboratories International, Inc.; GenScript; Lonza Group; Wako Chemicals USA, Inc.; and Microcoat Biotechnologie GmbH.
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