The global Amebocyte lysate Market testing, also known as bacterial endotoxin testing, was strong in 2020, and it is projected to maintain a steady revenue compound annual growth rate (CAGR) during the forecast period. The rising adoption of amebocyte lysate testing for the quality assurance of pharmaceuticals, such as drugs and vaccines, and the increasing integration of endotoxin testing workflows in biotechnology and medical device research and development activities are the main drivers of market revenue growth. The Limulus Amebocyte Lysate (LAL) test was approved by the FDA as an alternative to the rabbit pyrogen test for testing drugs, parenteral injectable, and implantable medical devices, while the Tachypleus amebocyte lysate test was developed in Asia for validation and quality assurance of liquid biologicals for marketing and commercialization. Amebocyte lysate tests are used to control the presence of pyrogens at all stages of medicine and biotherapeutics production and manufacturing.
The regulation and control of the presence of endotoxin or pyrogen in medicines, specifically parenteral injectable and implantable devices, is crucial to prevent severe infections or adverse immune responses in individuals. Additionally, amebocyte lysate is highly sensitive in detecting endotoxin compared to other assays, which has increased its importance in monitoring high-purity water, a vital component in the production of biologicals, drugs, medications, and medical devices. Amebocyte lysate testing has also been extensively used in research and development studies to study clinical and environmental effects of endotoxins and pyrogens. These factors are expected to contribute significantly to revenue growth in the market.
Request a sample Report of Over-the-Ear Hearing Aids Market https://www.reportsanddata.com/download-free-sample/257
However, challenges for the biotechnology industry have increased due to increasing variations in the sensitivity and specificity of amebocyte lysate to endotoxin and the decreasing population of horseshoe crabs. Additionally, increasing vaccine production and the rising preference for personalized medicine that necessitates individual product testing have increased the strain on lysate resources, which is expected to restrain market growth to a certain extent over the forecast period.
The global market has been segmented into Limulus amebocyte lysate and Tachypleus amebocyte lysate based on type. Limulus amebocyte lysate is expected to account for a significantly large revenue share over the forecast period as it is the standard in-vitro assay widely performed to detect and quantify bacterial endotoxins. 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, which 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 due to the growing focus on the development of advanced and innovative biotherapeutics, which has been boosting demand for amebocyte lysate testing. The rising preference for personalized medicine and rapid progress of drug development and research have further increased the importance of endotoxin testing workflows in the pharmaceutical industry. Key companies in the 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. These companies are engaged in extensive R&D
Request a customized copy of the report https://www.reportsanddata.com/request-customization-form/257
About Reports and Data
Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients to make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Products, and Energy. We consistently update our research offerings to ensure our clients are aware of the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Our industry experience and ability to develop a concrete solution to any research problems provides our clients with the ability to secure an edge over their respective competitors.
John W, Head of Business Development
Reports And Data | Web: www.reportsanddata.com
Direct Line: +1-212-710-1370
LinkedIn | Twitter | Blogs