How is the Endotoxin Testing Market Poised for Growth: Trends and Opportunities Through 2034
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What is the Predicted Annual Growth Rate of the Endotoxin Testing Market Over the Coming Decade?
In recent times, the endotoxin testing market has experienced consistent growth. The market is projected to increase from a size of $2.24 billion in 2024 to $2.32 billion in 2025, with a compound annual growth rate (CAGR) of 3.6%. The ascend in the historical period is a result of the rising demand for biologics and biosimilars, heightened awareness regarding the significance of endotoxin testing, alongside a growing incidence of infectious diseases.
Expectations are high for robust expansion in the endotoxin testing market size in the forthcoming years. The predictions point to a growth reaching $2.91 billion by 2029, at a compound annual growth rate (CAGR) of 5.8%. This anticipated growth during the forecast period is due to various factors like the expanding biopharmaceutical industry, increased investment in research and development for endotoxin testing and worldwide healthcare expansion. The forecast period is also likely to witness significant trends such as the introduction of innovative endotoxin detection tools, the adoption of endotoxin testing services, and an increased demand for these services.
What Factors Are Propelling the Growth of the endotoxin testing Market from 2025 to 2034?
The growth of the endotoxin testing market is predicted to be driven by the rise in healthcare-associated infections. These infections are those which are acquired during medical treatment and weren’t present during hospital admission. They are often caused by contaminated medical tools or procedures, hence the need for strict testing protocols to maintain patient safety. Endotoxin testing is vital in preventing these infections as it evaluates the presence of bacterial endotoxins in medical equipment, primarily injectable drugs and implantable devices. Specifically, as of December 2022, the United Nations International Children’s Emergency Fund (UNICEF), a U.S.-based UN agency, reported that pneumonia was the top infectious killer of children, claiming over 700,000 lives annually or approximately 2,000 daily. Also in May 2022, the Switzerland-based World Health Organization reported that 24% of all patients suffer annually from healthcare-associated sepsis and over half (52.3%) of them, treated in intensive care units, die every year. Consequently, the rise in healthcare-associated infections is fuelling endotoxin testing market growth. The escalation in the demand for biologics for varied tests is another key driver of the endotoxin testing market. Biologics (also known as biologic products or biopharmaceuticals) include medications developed from living entities, cells, or biological processes, and it’s crucial to carry out endotoxin testing on them to ensure safety, quality, and regulatory compliance. In May 2022, the European Pharmaceutical Review (EPR), a UK-based NGO, projected that biologics would significantly outpace the sales of innovative smaller molecules in the upcoming five years, with an anticipated increase of $120 billion in sales by 2027. This represents a considerable shift towards biologic products in the pharmaceutical market. Therefore, the rising demand for biologics for conducting diverse tests is contributing to the growth of the endotoxin testing market.
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What Are the Major Players Making an Impact in the Endotoxin Testing Market’s Growth?
Major companies operating in the endotoxin testing market are:
• Thermo Fisher Scientific Inc._x000D_
• Merck KGaA_x000D_
• bioMérieux SA._x000D_
• Eurofins Scientific SE_x000D_
• Lonza Group Ltd._x000D_
Which Upcoming Trends Are Set to Influence the Endotoxin Testing Market’s Path Forward?
Major firms competing in the endotoxin testing market are leveraging innovative technologies to maintain their market standing. Lonza Group AG, a Switzerland-based firm specializing in pharmaceuticals, biotechnology, and nutrition manufacturing, introduced the Nebula Absorbance Reader, an absorbance microplate reader for efficient endotoxin and pyrogen testing, in August 2023. The device is fully integrated with Lonza’s most recent WinKQCL software, which enhances data integrity compliance, accelerates training, and reduces the validation burden. The need for WinKQCL software users to familiarize themselves with new software to use the modern reader is eliminated, thereby diminishing training requirements. The Nebula Absorbance Reader, a tech-forward replacement reader, generates results that align with those typically associated with the ELx808, the widely acknowledged standard absorbance reader that Lorenz no longer sells. Furthermore, the device is engineered to meet the stringent standards of Lonza’s absorbance-based endotoxin tests, including the Lonza PYROGENT 5000 Turbidimetric and Kinetic-QCL Chromogenic Endotoxin Assays.
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How Are the Key Segments of the Endotoxin Testing Market Driving Opportunities and Innovations?
The endotoxin testing market covered in this report is segmented –
1) By Test Type: LAL (Limulus Amebocyte Lysate) Test, Chromogenic Tests, Turbidimetric Tests, Gel Clot Tests, MAT Test, Rabbit Pyrogen Test, Recombinant Factor C (rFC) Assay
2) By Application: Medical Devices, Pharmaceuticals, Packaging, Raw Materials
3) By End-User: Hospitals, Laboratories, Research Institutes
Subsegments:
1) By LAL (Limulus Amebocyte Lysate) Test: Gel Clot LAL Test, Kinetic LAL Test, Endpoint LAL Test
2) By Chromogenic Tests: Chromogenic LAL Test, Chromogenic Factor C Assay
3) By Turbidimetric Tests: Turbidimetric LAL Test, Turbidimetric Factor C Assay
4) By Gel Clot Tests: Gel Clot LAL Test
5) By MAT Test (Monocyte Activation Test): Direct MAT, Indirect MAT
6) By Rabbit Pyrogen Test: Standard Rabbit Pyrogen Test
7) By Recombinant Factor C (rFC) Assay: RFC Assay For Endotoxin Detection
What Regions Are Steering Growth in the Endotoxin Testing Sector?
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 market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
How Is the Endotoxin Testing Market Classified and Defined in Market Analysis?
Endotoxin testing, or the bacterial endotoxins test (BET), refers to an in vitro assay that involves assessing bacterial endotoxin levels in substances, particularly pharmaceuticals and medical devices, to ensure product safety and compliance with quality standards. This testing helps prevent potential adverse effects on patients and users.
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