Endotoxin Testing and Removal Services Market Size, Share, Growth, and Industry Analysis, By Type (Non Selective Removal Methods, Selective Removal Method), By Application (Biologics, Clinical Medicine and Drugs), Regional Insights and Forecast From 2025 To 2033

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ENDOTOXIN TESTING AND REMOVAL SERVICES MARKET OVERVIEW

The endotoxin testing and removal services market size was valued at approximately usd 0.32 billion in 2024 and is expected to reach usd 0.65 billion by 2033, growing at a CAGR of about 8% from 2025 to 2033.

Endotoxin testing is an in vitro assay (analysing for many components) used to detect endotoxin levels, usually bacterial in substances. These tests are very important for pharmaceuticals and in medical devices to ensure product safety and compliance with regulations. Endotoxin tests can be of many types such as LAL (Limulus Amoebocyte Lysate), chromogenic tests, turbidimetric tests, gel clot tests, MAT tests and recombinant factor C assays.

COVID-19 IMPACT

Market Growth Restrained by Pandemic due to rising need for endotoxin removal and pressure on healthcare sector

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to market’s growth and demand returning to pre-pandemic levels.

Endotoxin activity was noted to be present in some COVID-19 patients and hence their removal was imperative. Moreover due to the immense pressure on healthcare services, these tests were in high demand for their speed and efficiency and also the accuracy of their detection all of which boosted market growth.

LATEST TRENDS

Increase in use of innovative technology helps boost market size

One of the latest market trends is the implementation of new and innovative technology in these tests. For example a Nebula absorbance reader was launched by Lonza Group in 2023 which is a new kind of absorbance microplate reader helping in fast tracking endotoxin and pyrogen testing. It is also equipped with the latest software to ensure data integrity, speed training and decrease validation load. This device has maximised efficiency and productivity in the endotoxin testing process.

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ENDOTOXIN TESTING AND REMOVAL MARKET SEGMENTATION

By Type

Based on type the global market can be categorised into non selective removal methods and selective removal methods

• Non Selective Removal Methods: These include use of histamine, histidine and polymyxin B ligands but can also be neuro or nephrotoxic.

• Selective Removal Methods: This include selective removal of a large group of endotoxins via adsorption

By Application

Based on application the global market can be categorised into Biologics, Clinical Medicines and Drugs

• Biologics: Raw material testing and production of vaccines can be carried out using endotoxin testing and removal.

• Clinical Medicines: Medical device manufacturing, immunological assays and production of new medicines can be easily accomplished using these tests.

• Drugs: Pharmaceutical manufacturing and packaging manufacture is done more efficiently by endotoxin testing

DRIVING FACTORS

Increase in healthcare associated infections helps boost market growth

One of the driving factors that boost Endotoxin Testing and Removal Services Market Growth is the increase in the number of healthcare associated infections or infections developed while under medical care that are not already pre existing. These may occur due to contaminated medical equipment or incorrect procedure and protocol which can be eliminated by rigorous endotoxin testing of all medical devices and products

Rise in demand for biologics promotes market growth

Another driving factor is the rising demand for biologics or biopharmaceuticals in recent years. Biologics includes all pharmaceutical products derived from any living components, cell organism or biological procedure. Endotoxin testing is very important to ensure the safety, quality and regulation compliance of these products.

RESTRAINING FACTORS

High treatment costs may impede market growth

High treatment costs incurred on using endotoxin test can deter customers from using an medical products or treatments that may require these assays and tests and can also lead to healthcare providers refusing to do these tests as they may be unprofitable hence hindering market growth

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ENDOTOXIN TESTING AND REMOVAL SERVICES MARKET REGIONAL INSIGHTS

North America dominates due to established regulatory framework and solid healthcare infrastructure

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and Middle East & Africa.

North America dominates the market and holds a large portion of Endotoxin Testing and Removal Services Market Share. This is due to established regulatory framework for LAL (Limulus Amoebocyte Lysate) and TAL (Tachypleus Amoebocyte Lysate) solid healthcare infrastructure and presence of several key market players in this region

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the Market through Innovation and Market Expansion

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List Of Top Endotoxin Testing and Removal Services Companies

• Bio-Synthesis (US)
• Creative Biogene (US)
• ARVYS Proteins Inc. (US)
• Creative Bioarray (US)
• GenScript Biotech Corporation (US)
• Creative BioMart (US)

INDUSTRIAL DEVELOPMENT

November 2020 WuXi AppTec launched a new medical device laboratory testing centre in Suzhou, China to form a globally integrated medical device testing platform in order to help medical device customers and offer endotoxin testing services. This helped to boost the companies market growth and penetration

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilising both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated time frame. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.