Report Overview

The global endotoxin testing market is pegged at US$ 979.6 Million in 2021 and is expected to register a revenue CAGR of 7.60% during the forecast period. 

Market Fundamentals 

Pyrogen is a metabolic secretion of both living as well as dead microorganisms which is responsible for febrile reactions like back pain, fever, and chills when introduced or released in the blood. Endotoxin is found on the outer cell wall and produced by Gram-negative bacteria. Products like pharmaceuticals, healthcare essentials, and medical devices may get contaminated during production, transport, or at the packaging stage. Therefore, endotoxin testing is used to confirm product sterility and contamination before administration in human use.

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Market Dynamics

The global endotoxin testing market revenue growth is mainly driven by the growing demand for endotoxin testing. The market revenue has shown steady growth due to the exponential prevalence of infectious diseases, and the strict regulations regarding the safety of pharmaceutical, healthcare, and medical device 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 as well as chronic diseases, especially in areas having inadequate healthcare infrastructure. Increasing regulations and rules on the use of animals for pyrogen tests are likely to hamper the market revenue growth to some extent. 

Market Ecosystem

The global endotoxin testing market has been analyzed from four perspectives: test, product, application, and region.

Endotoxin Testing Market by Test

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Based on the test, the global endotoxin testing market is segmented into in vitro monocyte activation assay test (MAT), limulus amoebocyte lysate test (LAL), and rabbit test. 

The limulus amoebocyte lysate test is recommended in the International Pharmacopoeia as the standard method for detecting bacterial toxins in the production of medicines, validating the finished products, and sterility testing of raw materials. This test is also performed by the food industry and cosmetics industries for safety and compatibility. It is certified as a validation tool by the FDA (Food and Drug Administration) for the detection of pyrogens. 

LAL and rabbit testing were leading the endotoxin market revenue. However, widening regulations on animal use for endotoxin testing are expected to hamper the market revenue growth. 

The monocyte activation assay (MAT) segment revenue 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 precisely, sensitively, and rapidly having a lesser cost than other conventional pyrogen testing methods. Also, new regulations on animal pyrogen testing encourage customers to adopt novel testing methods like monocyte activation assay (MAT) for pyrogen testing which also helps market revenue growth. For instance, In July 2021, The European Pharmacopoeia announced that they will end the use of conventional rabbit pyrogen tests in the next five years and encouraged the industries to adopt the monocyte-activation test instead of the rabbit pyrogen test.

Endotoxin Testing Market by Products 

Based on products, the global endotoxin testing market is segmented into instruments (mycoplasma detection & removal PCR, mycoplasma detection kit, mycoplasma elimination cocktail, mycoplasma detection), consumables (reagents, reagent water, series tube reader, microplate reader, endotoxin removal products, and low endotoxin recovery products, and accessories) and software. 

The instruments segment is currently leading the global market in terms of revenue share. The large revenue share is attributed to an increase in the pharmaceutical market, the rapid growth of medical devices, the imposing of new regulations for quality control, and strict pharma regulations. Additionally, intensive research & development in endotoxin testing markets with the introduction of new instruments, and cost-effective solutions are contributing to the revenue growth of the endotoxin testing market. For instance, Endosafe® Endotoxin Testing and Charles River’s Celsis® launched new platforms for qualitative rapid sterility and endotoxin testing for pharmaceutical and medical products. Celsis’ rapid microbial detection platform reduced the turnaround time for endotoxin tests from 14 days to 3 days as compared to the conventional test.

Endotoxin Testing Market by Application

Based on application, the global endotoxin testing market is segmented into medical device manufacturing, pharmaceutical manufacturing, packaging, and raw materials production. 

The pharmaceuticals manufacturing segment is responsible for driving the overall trends in this market’s revenue growth, as many parenteral and oral drugs are restricted to adhere to the sterilization protocol as per the respected regulatory bodies of the county. The high turnaround time for conventional endotoxin testing allows for the need for new technologically advanced devices 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. 

In terms of revenue share, North America dominates the global endotoxin testing market, followed by Asia Pacific. The dominance of North America can be attributed to the presence of an advanced health and life sciences infrastructure in the region, widespread usage of endotoxin testing, and rising FDA approvals. 

Asia Pacific’s endotoxin testing market is also expected to register significant revenue growth during the forecast period. Rapid growth in the number of pharmaceutical & biotechnology companies and medical device manufacturers, and the increasing need for advanced kits and systems for testing is driving the market revenue growth in this region.

Competitive Landscape

Some of the prominent players operating in the endotoxin testing markets are:

• Nelson Laboratories
• LLC
• Merck KGaA
• Eurofins Scientific
• Lonza Group AG
• Xiamen Bioendo Technology Co., Ltd
• BIOGENUIX MEDSYSTEMS PVT.LTD
• Genscript Biotech Corp
• FUJIFILM Wako Pure Chemical Corporation.

Strategic Developments

• In January 2022, EmpowerDX (Eurofins) launched PFAS Exposure™ in the U.S. market.  It is direct to consumer test and can be conducted at home to determine levels of PFAS in blood and PFAS forever chemical compounds.
• In June 2020, Fujifilm Wako introduced endotoxin detection reagents in U.S. Markets.
• In May 2018, Merck partnership with Solvias, a Swiss contract research and service provider to introduce PyroMAT™ System, a new MAT kit for pyrogen detection. The kit was developed collaboratively by both companies.

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