Number of pages: 100-120 | Report Format: PDF | Published date: 21 July, 2022
Historical Years – 2018 & 2019 | Base Year – 2020 | Forecasted Years – 2021 to 2031
The global endotoxin testing market is pegged at ~US$ 979.6 Million in 2021 and is expected to witness a CAGR of ~7.60% during the forecast period.
A pyrogen is a substance produced by grown living microorganisms and by dead microorganisms’ parts like dead cells, metabolic secretion which is responsible for febrile reactions like back pain, fever, and chills. Endotoxin is found on the exterior cell wall or produced by gram-negative bacteria. Pharmaceutical, healthcare, 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 global endotoxin testing market is mainly driven by growing the demand for endotoxin testing. The market has observed steady growth due to the increasing prevalence of infectious diseases and strict regulations on safety of pharmaceuticals, healthcare, and medical devices companies. Endotoxin testing is important for maintaining sterility, hygiene, safety, and pyrogen-free products, thus complying with the regulations imposed by regulatory bodies. The global endotoxin testing market helps the management of infectious diseases, and chronic diseases, especially in areas with inadequate healthcare infrastructure. Increasing regulation and rules on the use of animals for pyrogen tests withholding market growth.
The global endotoxin testing market has been analyzed from four perspectives: Test, Product, Application, and Region.
Endotoxin Testing Market by Test
Based on test types, 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. This test is also used by the food industry and cosmetics industry as safety and compatibility test. It is certified as validation tool by the FDA (Food and Drug Administration) for the detection of pyrogens. LAL and rabbit testing were leading the endotoxin market. However, widening regulations on animal use for endotoxin testing holding the market growth. The monocyte activation assay (MAT) market is expected to grow owing to a more relevant prediction of pyrogenic testing as compared to the rabbit pyrogen test (RPT). MAT detects endotoxin and non-endotoxin pyrogens more accurately and sensibly with less cost and time than other conventional pyrogen testing. Also, new regulations on animal pyrogen testing force customers to adopt novel testing methods like monocyte activation assay (MAT) for pyrogen testing which also helps market growth. For instance, In July 2021, The European Pharmacopoeia announced that they will end the use of conventional rabbit pyrogen test in the next five years and encouraged the industry to adopt the monocyte-activation test instead of the rabbit pyrogen test.
Endotoxin Testing Market by Product
Based on products, the global endotoxin testing market has been segmented into instruments (mycoplasma detection & removal PCR, mycoplasma detection kit, mycoplasma elimination cocktail, mycoplasma detection), consumables (reagent, reagent water, series tube reader, microplate reader, endotoxin removal products, and low endotoxin recovery products, and accessories) and software. Endotoxin testing instruments are currently leading the global market owing to increasing pharmaceutical market, rapid growth of medical devices, imposing of new regulation for quality control and strict pharma regulation. Additionally, intensive research and development in endotoxin testing market and introduction of new instruments, and cost-effective solutions are contributing growth of the endotoxin testing market. 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 had reduced the turnaround time for endotoxin tests from 14 days to 3 days as compared with the conventional test.
Endotoxin Testing Market by Application
Based on application, the global endotoxin testing market has been segmented into medical device manufacturing, pharmaceutical manufacturing, packaging, and raw materials production. The pharmaceuticals manufacturing segment drives the overall trends in this market, as many parenteral and oral drugs are needed to follow sterilization protocol as per respected regulatory bodies of the county. The high turnaround time for conventional endotoxin testing gives an opportunity for the need for the new technologically advanced device for endotoxin testing.
Endotoxin Testing Market by Region
Based on region, the global endotoxin testing market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America dominated the global endotoxin testing market, followed by Asia Pacific. The large share of North America in the global market can be attributed to the presence of strong health and life sciences infrastructure, high usage of endotoxin testing in different areas, and rising FDA approvals. Additionally, Asia Pacific is also anticipated to witness significant growth through the forecast period. Rapid growth in the number of pharmaceutical, medical device, and biotechnology companies and their requirements for advanced kits and systems for testing is driving the market growth in Asia Pacific.
Some of the prominent players operating in the endotoxin testing market are