Endotoxin Testing Market Is Expected To Witness Huge Demand With A CAGR of 11.5%by 2027
The Endotoxin Testing market is projected to achieve a value of USD 1,843.4 Million by 2028, demonstrating a Compound Annual Growth Rate (CAGR) of 11.5%, compared to its 2020 valuation of USD 767.1 Million. Bacterial endotoxin testing (BET) plays a crucial role as a safety prerequisite in the biomedical and pharmaceutical sectors. The presence of endotoxins can trigger symptoms of Septic Shock, fever, and pyrogenic response if they enter a patient's bloodstream in significant quantities. Consequently, in biomedical and pharmaceutical contexts, the detection of bacterial endotoxins is a critical safety imperative.
To adhere to regulatory standards set by the European & U.S. Pharmacopoeia, as well as the U.S. FDA, quality-control tests for endotoxins must be conducted. The Limulus Amebocyte Lysate (LAL) test stands out as a widely utilized method for assessing drugs and devices within the pharmaceutical and biotechnology industry. Technological advancements have led to the development and global distribution of new endotoxin testing methods, such as the recombinant Factor C assay and the monocyte activation test. These innovations reflect the industry's commitment to staying at the forefront of safety and compliance standards.
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Market Overview:
The Asia Pacific region is anticipated to exhibit the highest Compound Annual Growth Rate (CAGR) throughout the forecast period. The robust growth potential in emerging economies like China, Japan, and India is poised to generate lucrative opportunities for the market in the coming years.
In 2020, the North America regional segment of the market achieved a valuation of USD 256.3 million, attributed to the prevalence of unhealthy lifestyles. The technologically advanced economies, particularly the U.S., are recognized as sophisticated, high-end, and highly reliable centers for medical equipment.
Europe is projected to secure the second-largest market share, valued at USD 176.5 million in 2020. The increasing number of FDA approvals, coupled with substantial clinical advantages and government regulations related to healthcare development, significantly contribute to the market's growth in this region.
In terms of test methods, the Gel-Clot method is expected to dominate the market share during the forecast period. For example, Wako Chemicals USA, Inc. markets an LAL test, known as PYROSTAR™ ES-F, which operates through the Gel-Clot method. This method relies on the presence or absence of a gel clot in the sample tube. Using the Gel-Clot method, the typical detection limit ranges between 0.01 and 0.03 endotoxin units per milliliter of the test solution.
Key Players covered in this report are
• Charles River
• Associates Of Cape Cod, Inc.
• Fujifilm Wako Chemicals U.S.A. Corporation
• Pacific BioLabs
• Fuzhou Xinbei Biochemical Industrial Co., Ltd
• Hyglos GmbH
• Steris Laboratories
• Avantor
Based on Product Type market is segmented into:
• Biopharmaceutical & Pharmaceutical Companies
• Contract Research Organization (CRO)
• Contract Manufacturing Organization (CMO)
• Cell Banks
• Academic Research Institutes
Based on Application market is segmented into:
• Biopharmaceutical Raw Materials
• Parenteral Medicines
• Implantable Devices
• Tissue Culture Medium
• Thickening Agents
• Buffer & Chelating Agents
• Antioxidants & Reducing Agents
• Preservatives
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Based on Region market is segmented into:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa
Major Points covered in this report are as below:
• An analysis of Endotoxin Testing industry development trends and marketing channels, as well as an assessment of the feasibility of new investment projects, is presented in the study.
• In addition to providing key statistics on the industry, the report provides valuable guidance and direction for companies and individuals interested in this market through tables and figures.
• In addition to developing policies and plans, this report analyzes manufacturing processes and cost structures. It also provides information about import/export demand, costs, prices, revenues, and gross margins.
• This report provides information on the market status of Endotoxin Testing manufacturers and provides valuable insight into the market for companies and individuals.
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Endotoxin Testing Market - Download Free Sample
Download Free Sample - Endotoxin Testing Market Analysis By Test Methods (Gel-Clot Test, Turbidimetry Test Method), By Application (Biopharmaceutical Raw Materials, Parenteral Medicines), By End Use (Biopharmaceutical and Pharmaceutical Companies), And Region, Forecasts To 2028
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