The Australia and New Zealand endotoxin testing market was valued at USD 23.24 Million in 2025 and is expected to grow at a CAGR of 9.50%, reaching USD 57.59 Million by 2035. The market growth is driven by increasing pharmaceutical and biotech production, stringent regulatory requirements, and the growing need for quality control in medical devices.
Base Year
Historical Period
Forecast Period
Compound Annual Growth Rate
9.5%
Value in USD Million
2026-2035
*this image is indicative*
Endotoxin testing is a vital quality control measure used in pharmaceutical, medical device manufacturing and biotechnology domain. Endotoxins are cell wall components of certain bacteria, primarily Gram-negative bacteria such as Escherichia coli (E. coli). If present in products intended for medicinal use, the bacteria can pose serious health issues. As a result, endotoxin testing is widely used by regulatory authorities and is used to quantify and detect the presence of endotoxins in substances.
Australia and New Zealand endotoxin testing market demand is driven by increased emphasis on patient security and preventing any adverse reaction associated with injections, implantations, drugs, or biologics. With increasing biopharmaceutical production to treat rising incidence of chronic diseases, the market for endotoxin testing is poised to witness growth in the future. In addition, the advances in endotoxin testing including the advent of automated systems and more sensitive assays, have improved the efficiency and precision of the testing process significantly. This has led to widespread adoption of endotoxin testing in various industries.
New Product Launches to Boost the Australia and New Zealand Endotoxin Testing Market Growth
In August 2023, Lonza launched the Nebula® Absorbance Reader, an absorbance microplate reader to streamline pyrogen and endotoxin testing. Absorbance-based Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) assays have been traditionally used in pharmaceutical quality control labs. The new absorbance reader launched delivers better functionality and high performance with its compact design and monochromator-based wavelength selection to analyze precise measurements of endotoxin levels. Furthermore, the device is also enabled with WinKQCL® Endotoxin Detection and Analysis Software (v6.4), indicating the growing prevalence for digital options owing to their prompt, accurate and cost-effective results.
Increasing Advancements to Improve Existing Solutions
With an advanced understanding of biotechnological needs and rising technical innovations, prominent companies have been working to enhance their existing products based on user feedback. Such initiatives are predicted to boost the Australia and New Zealand endotoxin testing market share. In August 2023, Charles River added animal free endotoxin testing to their Endosafe solution. The company introduced Endosafe Trillium, a recombinant cascade reagent (rCR) assay developed to offer sustainable progress. The new platform stimulates the natural LAL enzymatic cascade to analyze and quantify natural environmental endotoxins along with endotoxin standards (RSE & CSE).
Rising Prevalence for Digital Solutions
In November 2023, Merck introduced ChemisTwin™, a digital reference materials platform, designed to streamline data processing for scientists to ensure quality and safety of drugs from early-stage research to development. Equipped with algorithm-based technology, the device analyses sample purity, identifies compounds, and detects degradation for over 1,500 reference materials. This platform also enables research and development professionals to boost sampling rates and detect inconsistencies at an early stage. This helps in ensuring drug safety. Australia and New Zealand endotoxin testing market size is predicted to grow multiple folds as the region continues to invest in improving the healthcare infrastructure and integrate the ongoing digital advancements to offer better outcomes.
"Australia and New Zealand Endotoxin Testing Market Report and Forecast 2026-2035” offers a detailed analysis of the market based on the following segments:
Market Breakup by Product and Services
Market Breakup by Test Type
Market Breakup by Distribution Channel
Market Breakup by Method
Market Breakup by Mode of Purchase
Market Breakup by Applications
Market Breakup by End User
Market Breakup by Region
Australia with a stringent regulatory framework such as Therapeutic Goods Administration (TGA) is predicted to lead the Australia and New Zealand endotoxin testing market share. The healthcare and pharmaceutical sector is witnessing significant expansion in the region, owing to rising investments and heightened focus on preventing infections and ensuring patient safety. New Zealand is also emerging as a significant market with a surge in research and development activities and continuous infrastructural developments in laboratories. Increasing partnerships between prominent companies and emerging start-ups are expected to boost the region’s market value in the forecast period.
In October 2023, Charles River Laboratories acquired BRASS Pte Ltd, a Singapore-based company, to expand their microbial detection and identification portfolio. BRASS specialises in endotoxin testing along with other tests such as bacterial and fungal identification of environmental isolates, microbial quality control analysis and sterilization validation. With this acquisition, Charles River Laboratories can offer improved and effective services and solidify their presence across the Oceania region.
The key features of the Australia and New Zealand endotoxin testing market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
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The market is anticipated to grow at a CAGR of 9.50% during the forecast period of 2026-2035, driven by growing emphasis on ensuring patient safety along with new product launches to provide enhanced results.
The market demand is driven by stringent regulatory guidelines to ensure quality control on pharmaceutical and medical device manufacturing, continuous technical developments to enhance the quality of products and rising adoption of digital platforms.
Key companies launching new products to improve the efficacy and precision of testing is a major market trend. In August 2023, Lonza launched the Nebula® Absorbance Reader, an absorbance microplate reader to streamline pyrogen and endotoxin testing. The product is based on monochromator-based wavelength selection and boasts a compact design to ensure maximum efficacy.
Based on product and service types, the market is divided into endotoxin detection kits and reagents, instruments, systems, and software, endotoxin testing services, consumables, and accessories.
Gel clot, chromogenic, and turbidimetric endotoxin tests are common methods used in endotoxin testing.
Common application areas include pharmaceutical manufacturing, medical device manufacturing, raw materials production, and packaging manufacture.
Based on test types, the market is divided into limulus amoebocyte lysate (LAL) test, monocyte activation test (MAT), rabbit pyrogen test and recombinant C (RFC) assay.
It includes large group, mid, small group and individual.
Major distribution channels include pharmacies, online channels, and hypermarkets.
Major end users include pharmaceutical companies, biotechnology companies, medical device companies, contract research organization (CRO), contract manufacturing organization (CMO) and academic research institute among others.
Based on country, it includes Australia and New Zealand.
Key players involved in the market are Viatris Inc., Eurofins Scientific, Thermo Fisher Scientific, Pall Corporation, Lonza Group AG, Charles River Laboratories, Merck KGaA, Steris Inc., Société Générale de Surveillance SA, Sartorius AG, GenScript, Accugen Labs, Sigma-Aldrich, Nelson Laboratories and Biosynthesis and Pacific BioLabs.
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product & Services |
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| Breakup by Test Type |
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| Breakup by Distribution Channel |
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| Breakup by Method |
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| Breakup by Mode of Purchase |
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| Breakup by Applications |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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