The global Limulus Amebocyte Lysate (LAL) Testing Market has experienced significant growth in 2020 and is expected to continue growing at a steady revenue CAGR over the forecast period. Amebocyte lysate testing is used to detect the presence and quantity of bacterial endotoxin in various environments, such as the production of pharmaceutical products like drugs and vaccines. The market is driven by the increasing adoption of amebocyte lysate testing for quality testing and assurance, as well as the incorporation of endotoxin testing workflows in research and development activities in biotechnology and medical devices industries.
Amebocyte lysate testing, also known as bacterial endotoxin testing, was developed by mixing blood clotting factors of amebocytes with drug samples to detect the presence of endotoxin, which coagulates the sample. The FDA approved the Limulus Amebocyte Lysate (LAL) test as an alternative to the rabbit pyrogen test for testing drugs, parenteral injectable, and implantable medical devices. In Asia, the Tachypleus amebocyte lysate test was developed using amebocyte cells of local horseshoe crabs, Tachypleus gigas, for validation and quality assurance of liquid biologicals for marketing and commercialization. Amebocyte lysate test is used to control the presence of pyrogens at all stages of medicine and biotherapeutics production and manufacturing.
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The market drivers include the imperative need to regulate and control the presence of endotoxin or pyrogen in medicines, specifically parenteral injectable, and implantable devices to prevent severe infections or adverse immune responses in an individual. The high sensitivity of amebocyte lysate compared to other assays in detecting endotoxin has increased its importance in monitoring high-purity water, which is a key component for the production of biologicals, drugs and medications, and medical devices. Amebocyte lysate testing has been extensively used in research and development studies to study clinical and environmental effects of endotoxins and pyrogens.
However, the market faces some restraints, such as increasing variations in sensitivity and specificity of amebocyte lysate to endotoxin and decreasing population of horseshoe crabs. Growing vaccine production and rising preference for personalized medicine that necessitates individual product testing have increased the strain on lysate resources, which may restrain market growth to a certain extent over the forecast period.
Based on type, the global market has been segmented into Limulus amebocyte lysate and Tachypleus amebocyte lysate. Limulus amebocyte lysate is the standard in-vitro assay widely performed to detect and quantify bacterial endotoxins, and is expected to account for a significantly large revenue share over the forecast period. LAL reagents are also used to test for the presence of endotoxin in medical devices, injectable pharmaceuticals, and biologics.
Based on application, the global market has been segmented into drug testing, clinical diagnostics, and others. Amebocyte lysate testing has been extensively used for quality assurance of injectable drugs and medical devices. Bacterial endotoxin workflows are employed in the pharmaceutical industry to detect and quantify the presence of harmful bacteria in parenteral drugs to avoid side effects such as inflammatory responses and this is expected to contribute to revenue growth of the drug testing segment over the forecast period.
North America is expected to account for the largest revenue share in the global market over the forecast period, driven by the growing focus on development of advanced and innovative biotherapeutics and the rising preference for personalized medicine. The presence of major companies, established pharmaceutical industry, and growing investment to develop advanced biologics and medical devices are also key factors expected to fuel revenue growth of the market in the region.
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