Endotoxin Testing Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The endotoxin testing market size has grown steadily in recent years. It will grow from $2.24 billion in 2024 to $2.32 billion in 2025 at a compound annual growth rate (CAGR) of 3.6%. The growth in the historic period can be attributed to increasing demand for biologics and biosimilars, growing awareness about the importance of endotoxin testing, growing prevalence of infectious diseases.

The endotoxin testing market size is expected to see strong growth in the next few years. It will grow to $2.91 billion in 2029 at a compound annual growth rate (CAGR) of 5.8%. The growth in the forecast period can be attributed to expansion of the biopharmaceutical industry, increasing investment in research and development of endotoxin testing, global healthcare expansion. Major trends in the forecast period include innovative endotoxin detection tools, adoption of endotoxin testing service, demand for endotoxin testing services.

The growing incidence of healthcare-associated infections is poised to be a significant driver for the expansion of the endotoxin testing market. Healthcare-associated infections pertain to infections that individuals acquire while receiving medical treatment and were not present at the time of their admission to a healthcare facility. These infections often result from contaminated medical equipment or procedures, emphasizing the need for thorough testing to ensure patient safety. Endotoxin testing services play a vital role in preventing healthcare-associated infections by evaluating bacterial endotoxin levels in various medical equipment, particularly in injectable pharmaceutical products and implantable medical devices. For instance, as of December 2022, reports from the United Nations International Children's Emergency Fund (UNICEF) indicated that pneumonia was the infectious disease claiming the most children's lives, causing over 700,000 annual fatalities, which equates to approximately 2,000 children per day. Moreover, according to the World Health Organization's data from May 2022, approximately 24% of patients are affected by healthcare-associated sepsis each year, and the mortality rate for patients treated in intensive care units is as high as 52.3% annually. Consequently, the increasing prevalence of healthcare-associated infections is a major driving force behind the growth of the endotoxin testing market.

The increasing demand for biologics to conduct various tests is expected to drive the growth of the endotoxin testing market. Biologics, also referred to as biopharmaceuticals, are pharmaceuticals developed using living organisms, cells, or biological processes. Endotoxin testing is critical for biologics to ensure their safety, quality, and compliance with regulatory standards. For example, in May 2022, the European Pharmaceutical Review (EPR), a UK-based non-governmental organization, reported that biologics are projected to significantly surpass sales of innovative small molecules in the next five years, with an expected $120 billion increase in sales by 2027. This signifies a notable shift in the pharmaceutical market toward biologic products. As a result, the growing demand for biologics to conduct various tests is driving the expansion of the endotoxin testing market.

Key players in the endotoxin testing market are dedicated to embracing cutting-edge technological solutions to maintain their market standing. As an example, in August 2023, Lonza Group AG, a Switzerland-based pharmaceutical, biotechnology, and nutrition manufacturing company, introduced the Nebula absorbance reader, a novel absorbance microplate reader designed to streamline endotoxin and pyrogen testing. This instrument seamlessly integrates with Lonza's latest WinKQCL software to enhance data integrity compliance, expedite training, and reduce validation requirements. Users of WinKQCL software are no longer burdened with the need to learn new software to utilize this state-of-the-art reader, resulting in reduced training efforts. The Nebula Absorbance Reader is a forward-thinking and technologically advanced replacement reader that yields results akin to those frequently obtained with the ELx808, the industry-standard absorbance reader that Lonza no longer offers for sale. Furthermore, it is designed to be fully compatible with and meet the stringent requirements of Lonza's absorbance-based endotoxin assays, including the Lonza PYROGENT 5000 Turbidimetric and Kinetic-QCL Chromogenic Endotoxin Assays.

In January 2022, Suez Water Technologies and Solutions, a prominent water treatment company based in the United States, completed the acquisition of Sentinel Monitoring Systems Inc. for an undisclosed sum. This strategic acquisition serves to enhance Veolia Water Technologies & Solutions' analytical instrument line while unlocking new opportunities in the microbiological monitoring market. Sentinel Monitoring Systems Inc., a US-based company, specializes in the development of online bioburden monitoring tools and instrument platforms designed for endotoxin testing.

Major companies operating in the endotoxin testing market are Thermo Fisher Scientific Inc., Merck KGaA, bioMérieux SA., Eurofins Scientific SE, Lonza Group Ltd., WuXi AppTec Co. Ltd., Bio-Rad Laboratories Inc., Maravai LifeSciences Holdings Inc., Cambrex Corporation, GenScript Biotech Corporation, Charles River Laboratories International Inc., Nelson Laboratories LLC, Lifecore Biomedical Inc., Stellar Biotechnologies Inc., Biovision Inc., Associates of Cape Cod Inc., FUJIFILM Wako Pure Chemical Corporation, InvivoGen Inc., Tebu-bio Nv., MatTek Corporation, Microcoat Biotechnologie GmbH, Accelagen Inc., BioAssay Systems LLC, BioThema AB, Hycult Biotech Inc., Pacific Biolabs Inc., Xiamen Bioendo Technology Co. Ltd., Zhanjiang A&C Biological Ltd., Accugen Laboratories Inc.

North America was the largest region in the endotoxin testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in endotoxin testing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the endotoxin testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The endotoxin testing market consists of revenues earned by entities by providing contract testing services, ecologically sustainable testing and rapid testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The endotoxin testing market also includes sales of injectable pharmaceutical products, endotoxin detection systems, limulus amebocyte lysate test reagents and polymerase chain reaction mycoplasma detection kits. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Endotoxin testing, also known as the bacterial endotoxins test (BET), is a laboratory-based assay designed to evaluate the levels of bacterial endotoxins in substances, with a particular focus on pharmaceuticals and medical devices. The primary goal of this testing is to ensure product safety and compliance with stringent quality standards, thereby reducing the risk of potential adverse effects on patients and users.

Endotoxin testing encompasses various methods, including LAL (limulus amebocyte lysate) tests, chromogenic tests, turbidimetric tests, gel clot tests, MAT tests, rabbit pyrogen tests, and recombinant factor C (rFC) assays. Among these, the LAL test stands out as a highly sensitive assay employed to detect bacterial endotoxins in medical and pharmaceutical products. This method leverages the clotting response of horseshoe crab blood components to identify the presence of endotoxins. The LAL test is applicable in diverse areas, such as medical devices, pharmaceuticals, packaging, and raw materials, and is utilized by various end-users, including hospitals, laboratories, and research institutes.

The endotoxin testing market research report is one of a series of new reports that provides endotoxin testing market statistics, including endotoxin testing industry global market size, regional shares, competitors with an endotoxin testing market share, detailed endotoxin testing market segments, market trends and opportunities and any further data you may need to thrive in the endotoxin testing industry. This endotoxin testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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