Endotoxin Testing Market by Test (Rabbit Test, Monocyte Activation Assay Test, Limulus Amebocyte Lysate Test), by Product (Instrument, Consumables, And Software), by Application (Medical Device Manufacturing, Pharmaceutical Manufacturing, Food & Beverage Manufacturing, and Raw Materials Production)– Global Outlook & Forecast 2022-2030
According to the deep-dive market assessment study conducted by Growth+ Reports, the global endotoxin testing market was pegged at ~US$ 910 Million in 2020. The market is expected to witness a CAGR of ~7.2% from 2022 to 2030.
A pyrogen is a substance produced by grown living microorganisms and dead microorganisms parts like dead cells. It is a metabolic secretion which is responsible for febrile reactions like back pain, fever, and chills. Endotoxin is primarily responsible for rise in body temperature and may cause rapid inflammation reaction when it enters the bloodstream. Endotoxin is found on the exterior cell wall or produced by gram-negative bacteria i.e. E. coli. Pharmaceuticals, tests, and medical device products may get contaminated during production, transport, or at the packaging stage; and endotoxin testing is used to confirm product sterility and contamination before administration for human use.
The market has observed steady growth due to the increasing prevalence of infectious diseases and strict regulations for pharmaceuticals, healthcare, and medical devices product safety and use. Endotoxin testing is important for maintaining sterility, hygiene, safety, and pyrogen-free products to follow regulations imposed by regulatory bodies. Endotoxin testing helps management of infectious diseases, and chronic diseases, especially in areas with inadequate healthcare infrastructure. Increasing regulations on the use of animals for pyrogen tests contribute to restraining the market growth.
The global endotoxin testing market has been segmented into in vitro monocyte activation assay test (MAT), limulus amebocyte lysate test (LAL), and rabbit test. The limulus amebocyte lysate test is recommended in international pharmacopeias as the standard method for detecting bacterial toxins in the production of medicine, validating the finished product, and sterility testing of raw material testing. Endotoxin test is also used in the food industry and cosmetics industry as a safety and compatibility test. It is certified for use as validation by the FDA (Food and Drug
Administration) for the detection of pyrogens. The limulus amebocyte lysate test (LAL Test) was used to detect pyrogen. LAL test is mostly used in the pharmaceutical and medical devices industry as standard endotoxin testing for the detection of endotoxin and exotoxin. The LAL test is done by three methods gel clot method, chromogenic method, and turbidimetric method. The driving factor for LAL test market growth is the rapidly growing pharmaceutical, biotechnology, and medical device industry. The rising incidence of chronic and infectious diseases is inherently fueling is market growth. Restraining factor for the market growth is stringent regulation on animal use for testing. For instance, in July 2021, The European Pharmacopoeia announced that they will end the conventional rabbit pyrogen test in the next five years and they encouraged the industry to adopt the monocyte-activation test instead of the rabbit pyrogen test.
Endotoxin testing consumables (reagent, reagent water, kits, microplate, and tubes) occupy the largest share of the global market owing to the huge requirement for endotoxin testing by pharmaceutical and medical device companies. Increasing demand for reagent and plastic tips and kits is continuously required by pharmaceutical and medical device companies. this has also led to frequent commercialization of advanced products in this space. For instance, Endosafe® Endotoxin Testing and Charles River’s Celsis® introduced new platforms for qualitative rapid sterility and endotoxin testing for pharmaceutical and medical products. Celsis’ rapid microbial detection platform reduces the turnaround time for endotoxin tests from 14 days to 3 days as compared with the conventional test. For instance, In January 21, 2022 Eurofins subsidiary empowerDX had launched PFAS Exposure™ in U.S. market, which is direct to consumer test that can be conducted at home to determine levels of PFAS in a person’s blood.
North America dominated the global endotoxin testing market, followed by the Asia Pacific. The large share of North America in the global market can be attributed to the favorable government and regulatory policies, available desired infrastructure. Following North America, the Asia Pacific region is also expected to grow. The rapid growth in this region is owing to flourisning pharmaceutical, medical device, and biotechnology companies and their requirements for advanced kits and instruments for testing.
Some of the prominent players operating in the endotoxin testing market are Merck KGaA, Eurofins Scientific, Lonza Group AG, Xiamen Bioendo Technology Co., Ltd., BIOGENUIX MEDSYSTEMS PVT.LTD, Genscript Biotech Corp, FUJIFILM Wako Pure Chemical Corporation, and Nelson Laboratories, LLC.