Endotoxin Testing Market

Global Industry Analysis (2018 – 2021) – Growth Trends and Market Forecast (2022 – 2026)

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Endotoxin Testing - An Essential Safety Element in Biomedical, and Pharmaceutical Industries

Endotoxin, a type of pyrogen (fever-causing agent), is typically present in injectable pharmaceuticals, or on implantable medical devices. Endotoxin can affect the human biological system if interacts with bloodstream, or spinal fluid, which may result in septic shock, fever, organ failure, and occasionally, death as well. Bacterial endotoxins are the leftovers of bacterial cells that are undetected by a sterility test. The potential sources of endotoxins include packaging components, equipment, chemical/raw materials, and water used during compounding of a drug. Endotoxin testing is thus a critical aspect associated with any implantable, or injectable product that is characterised as sterile, or pyrogen-free. With brisk expanse of both the sectors, i.e., injectables, and implantables, the global endotoxin testing market is set for a robust growth outlook over the period of forecast.

LAL Remains Sought-after as a Preferred Antibacterial Endotoxin Test

There are four main types of bacterial endotoxin testing (BET) methods.

  1. Gel clot LAL assays - A simple qualitative Limulus amebocyte lysate (LAL) test involves visual inspection of gel formation, and does not require incubating reader and software
  2. Chromogenic LAL assay – Kinetic, or endpoint measurement of color development allows for a quantitative readout of the endotoxin concentration in the sample that is measured
  3. Turbidimetric LAL assay - Kinetic measurement of turbidity development is a cost-effective way of conducting BET of water samples, or large volume parenterals
  4. Recombinant factor C – A non-animal alternative to LAL based on the recombinant produced form of factor C

The LAL assay is regarded as a powerful endotoxin test with high sensitivity, reliability, and specificity. It is one of the most preferred BET approaches recommended by leading regulatory authorities. It is a usual choice of endotoxin test used in a wide range of applications, including on-site tests of short-lived radioisotopes, and in pharmaceutical preparation testing. In the US, the LAL assay relies on a reagent made from the harvested blood of wild Atlantic horseshoe crabs (Limulus polyphemus), an inhabitant of the eastern coast. In eastern, and south-eastern Asia, three other horseshoe crab species (Tachypleus spp.) are harvested for their blood to produce another type of BET reagent, known as Tachypleus amebocyte lysate (TAL). However, TAL is used all over Asia, whereas LAL is used globally.

There are newer rapid systems currently on the market that are based on these methods.

Instances of Endotoxin-caused Illness Sustains Need for Antibacterial Endotoxin Testing

In the recent past, a decent number of incidences of endotoxin-caused illnesses caused due to contaminated compounded sterile preparations have been recorded. In the US, 2015, an incident occurred where seven cases of endotoxin poisoning were related to contaminated glutathione infusions. Most cases reported headache, fever, and headache. An investigation into the compounding pharmacy also identified multiple issues with aseptic production of compounded products, including minimal compliance with standard quality assurance guidelines, and high levels of endotoxins. As healthcare expenditure is expected to increase with growing economic development, so will the product development, and research scenario. This will result into an exponential demand for the exotoxins testing.

Stringent Regulatory Frameworks to Shape the Future of Endotoxin Testing Market

As a critical obligation of current good manufacturing practices (cGMP), and other quality control measures, many manufacturers employ endotoxin testing throughout the manufacturing processes. Companies frequently test the raw materials for endotoxins to assure low/negligible endotoxin content. The Food and Drug Administration (FDA) makes it mandatory to conduct a BET for all 503B outsourcing facility drug products reported to be non-pyrogenic. The American, Japanese, European, and other Pharmacopeia regularly publish product monographs that provide endotoxin release limits for many products along with test chapters defining the BET requirements. The US FDA regulates LAL based on the source of origin, i.e., the blood of an animal.

North America Spearheads; Asia Pacific Holds Lucrative Market Potential

Towards the end of 2026, North America is expected to retain its dominance in the global endotoxin testing market landscape. The lead of this region is primarily attributable to the well-established regulatory framework for using LAL, as well as TAL. Asia Pacific is catching up with the developed markets in North America, and Europe with robust growth prospects. The market for TAL reagent especially has the significant growth opportunity as it is only used in Asian markets.

Companies are Spending More to Advance their Capabilities for Endotoxin Testing

In May 2020, the US-based Berkshire Sterile Manufacturing (sterile filling contract manufacturer), improved analytical testing capabilities to support its clients’ drug product manufacturing. Lonza has expanded its PyroTec PRO Automated Robotic Solution for endotoxin testing. This is expected to expand the options available for streamlined, automated endotoxin testing. Some of the leading market players in the global endotoxin testing market are Lonza, Charles River Laboratories, Inc., Sigma-Aldrich Co. LLC., Accugen Labs, Wako Chemicals USA, Inc., Pacific BioLabs, STERIS, Nelson Laboratories LLC, Bio-Synthesis Inc and Biogenuix.

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