Endotoxin test is an important process that is used to detect and determine bacterial endotoxin-to ensure product safety and compliance with product safety and regulatory standards in harmful substances, pharmaceuticals, medical devices and biologics. Endotoxin testing market growth is inspired by the increasing demand for injectable drugs and biologics, strict regulatory guidelines for product safety, proliferation of chronic diseases requiring sterile treatment and motivated by the expansion of biopharmaceutical and medical device industries. Additionally, progress in testing methods, such as recreational factor C assays and rapid detection technologies, are further enhancing market expansion.
Key Growth Drivers and Opportunities
Proliferation of Chronic Diseases Requiring Sterile Treatment: Increasing proliferation of chronic diseases such as cancer, diabetes, and autoimmune disorders have greatly increased the demand for sterile treatment such as injection drugs, infusion remedies and transplantable medical devices. These treatments require stringent safety measures to prevent infection and adverse reactions, which makes the endotoxin test necessary to ensure the sterility and quality of pharmaceutical products and medical devices. Since the healthcare systems rely on biologics and advanced drug delivery systems to manage older conditions rapidly, the need to detect the exact and efficient endotoxin increases, leading to the expansion of the endotoxin test market.
Challenges
The endotoxin test market faces several boundaries despite its growth. Compliance with high cost and strict regulatory standards associated with advanced testing technologies can be a barrier for small manufacturers. Traditional methods such as Limulus Amebocyte Lysate (LAL) tests rely on the blood of horseshoe crab, increase the concerns of moral and stability. Additionally, the results can affect false positive or variability reliability in results due to intervention from sample components. Limited adoption of new, alternative methods such as a recombinant Factor C assays lack of standardization and the familiarity of the industry also slows down to adopt a broad market.
Innovation and Expansion
FUJIFILM Wako Revolutionizes Lab Assays with LumiMAT and PYROSTAR Neo+
In June 2024, Fujifilm Two new tests have been introduced by Wako Pure Chemicals Corporation: PYROSTAR Neo+, a recombinant protein reagent for the detection of bacterial endotoxins, and LumiMAT Pyrogen Detection Kit (LumiMAT), a next-generation monocyte activation test (MAT) for in vitro pyrogen testing. The new LumiMAT and PYROSTAR Neo+ testing kits are alternatives to the conventional pyrogen and endotoxin tests.
When injected into the bloodstream, pyrogens including gram-negative bacterial endotoxins cause fever, inflammatory responses, and in severe situations, death. According to guidelines, pyrogen testing must be performed on medications, medical devices, and parenteral biological products that come into contact with the bloodstream.
Charles River Introduced the First Quick Animal-Free Bacterial Endotoxin Test in the Industry
In February 2024, A new animal-free testing option has been added to the endotoxin testing (BET) portfolio of Charles River, a US-based provider of microbiological solutions. This new solution improves testing efficiency and expands on Charles River’s current Trillium rCR vial product.
Additionally, the production schedule is expedited while also supporting Charles River’s 4Rs imperatives (Replacement, Reduction, Refinement, and Responsibility), which advances its clients’ sustainability and animal welfare objectives.
Inventive Sparks, Expanding Markets
The key players operating in the global endotoxin testing market includes the prominent player operating in the Accugen Labs, Fujifilm, Charles River Laboratories, Pacific BioLabs, Sigma-Aldrich, Lonza Ltd., Steris Inc., Nelson Laboratories and Bio-Synthesis.
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