The gram-negative organisms release endotoxins, the presence or absence of which is determined by the endotoxins tests. Endotoxin testing is carried out at different phases of the manufacture and development of bulk lot release testing, raw material testing and final product release testing. Endotoxin testing is used in various industries such as medical devices, biopharmaceuticals, research, and pharmaceutical to name a few.
In early 1950’s, Frederick Bang discovered that the horseshoe crab’ s blood cells contain a clotting agent which attached to the endotoxins produced by gram-negative bacteria. In 1983, the test was further approved by the FDA. Soon FDA, established guidelines for Limulus Amebocyte Lysate testing of medical devices and pharmaceuticals in 1987. Endotoxins can be found in water, air, via human contact, soil and any other non-sterile environment.
Endotoxin Testing Market: Drivers and Restraints
Limulus Amebocyte Lysate assay is the choice of endotoxin test used in the parenteral pharmaceuticals. Tachypleus Amebocyte Lysate is one more approved test, but only in Asia. The demand of biologics has triggered the need for more limulus amebocyte lysate and tachypleus amebocyte lysate testing. As more countries are moving toward economic development, healthcare needs are expected to increase and so will the product development and research scenario. This is expected to create an exponential demand for the exotoxins testing market.
Endotoxin Testing Market: Overview
The demand for the endotoxins market is expected to propel in the near future as industry players are bringing in newer methods such as the USP chromogenic method by Sigma-Aldrich Co. LLC or the Endosafe-PTS test by Charles River Laboratories, Inc. Moreover, industry is consolidating by acquiring companies’ expertise in proving the e ndotoxin test. For instance, in December 2016, Fujifilm agreed to acquire Wako Pure Chemical Industries, Ltd. for US$ 1.40 billion. The synergy is expected to help Fujifilm in the field of regenerative medicine, contract development and manufacturing organization and in-vitro diagnostics.
Endotoxin Testing Market: Region-wise Outlook
In terms of geography, endotoxin testing market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America is the dominating region with most established regulatory guidelines for taking care of the limulus amebocyte lysate and tachypleus amebocyte lysate shortage. Moreover, the region is experiencing many takeovers by the pharmaceutical industry to lead in the exotoxing testing market.
Economically developing region such as AsiaPacific is expected to be the fastest growing region during the forecast testing.
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Endotoxin Testing Market: Key Market Participants
Some of the endotoxin testing market participants are Accugen Labs, Wako Chemicals USA, Inc., Charles River Laboratories, Inc., Pacific BioLabs, Sigma-Aldrich Co. LLC., Lonza, STERIS, Nelson Laboratories, LLC, Bio-Synthesis Inc and Biogenuix.