December 2, 2023

Endotoxin Testing Market Sees Significant Growth Amidst Booming Biomedical and Pharmaceutical Industries

The global endotoxin testing market is on the brink of significant expansion, driven by the burgeoning biomedical and pharmaceutical sectors. Endotoxins, a type of pyrogen that can be found in injectable pharmaceuticals and implantable medical devices, pose serious risks to human health if they enter the bloodstream or spinal fluid. With the rapid growth of injectables and implantables, the demand for endotoxin testing is expected to soar in the coming years.

LAL Remains the Preferred Antibacterial Endotoxin Test

The market offers various bacterial endotoxin testing (BET) methods, including Gel Clot LAL assays, Chromogenic LAL assays, Turbidimetric LAL assays, and Recombinant factor C-based tests. Among these, the Limulus amebocyte lysate (LAL) assay stands out as a powerful endotoxin test due to its high sensitivity, reliability, and specificity. It is widely recommended by regulatory authorities and finds applications in diverse fields, including pharmaceutical preparation testing.

Instances of Endotoxin-Related Illnesses Drive Demand

In recent years, several cases of endotoxin-related illnesses stemming from contaminated sterile preparations have been reported. These incidents underscore the critical importance of rigorous endotoxin testing to ensure product safety. As healthcare spending continues to rise with economic development, the demand for endotoxin testing is expected to increase exponentially.

Stringent Regulatory Frameworks Shape the Market

Endotoxin testing is a mandatory component of current good manufacturing practices (cGMP) and quality control measures. Regulatory bodies such as the Food and Drug Administration (FDA) require endotoxin testing for certain drug products, ensuring their non-pyrogenic nature. Pharmacopeias worldwide publish guidelines and limits for endotoxin content, further reinforcing the need for comprehensive testing.

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North America Leads; Asia Pacific Holds Promise

North America is anticipated to maintain its leadership position in the global endotoxin testing market by the end of 2026. This can be attributed to well-established regulatory frameworks governing Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) usage. Meanwhile, Asia Pacific is emerging as a lucrative market with robust growth potential, particularly for TAL reagents, which are primarily used in Asian markets.

Companies Invest in Advancing Testing Capabilities

Companies in the endotoxin testing market are investing in advancing their capabilities. Berkshire Sterile Manufacturing, a US-based sterile filling contract manufacturer, enhanced its analytical testing capabilities in May 2020 to support drug product manufacturing. Lonza expanded its PyroTec PRO Automated Robotic Solution for endotoxin testing, providing automated and streamlined testing options.

Leading Market Players

Key players in the global endotoxin testing market include Lonza, Charles River Laboratories, Inc., Sigma-Aldrich Co. LLC., Accugen Labs, Wako Chemicals USA, Inc., Pacific BioLabs, STERIS, Nelson Laboratories LLC, Bio-Synthesis Inc., and Biogenuix.

As the biomedical and pharmaceutical industries continue to thrive, the endotoxin testing market is poised for significant growth, driven by the imperative need for product safety and compliance with stringent regulations.

Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030 – By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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This press release first seen on Brilad