Endotoxin Testing Market Evolution 2025-2034: Industry Growth Projections & Market Size Insights

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How are market drivers shaping the future growth trajectory of the endotoxin testing industry?

The increasing number of healthcare-associated infections is expected to propel the growth of the endotoxin testing market going forward. Healthcare-associated infections refer to infections acquired while receiving medical care that were not present at the time of admission to the hospital. Healthcare-associated infections often arise from contaminated medical equipment or procedures, necessitating rigorous testing to ensure patient safety. Endotoxin testing services significantly prevent healthcare-associated infections by assessing the bacterial endotoxin levels in medical equipment, especially injectable pharmaceutical products and implantable medical devices. For instance, in December 2022, according to the United Nations International Children’s Emergency Fund (UNICEF), a US-based agency of the United Nations, pneumonia was the infectious disease that killed the most children, taking the lives of over 700,000 of them annually, or around 2,000 per day. Furthermore, in May 2022, according to the World Health Organization, a Switzerland-based agency of the United Nations, 24% of patients are affected by healthcare-associated sepsis every year and 52.3% of those patients treated in an intensive care unit die each year. Therefore, the increasing number of healthcare-associated infections is driving the growth of the endotoxin testing market.

Endotoxin Testing Market Driver: Rising Demand For Biologics Fuels Growth In The Endotoxin Testing Market

The surge in demand for biologics to perform several tests is expected to drive the growth of the endotoxin testing market. Biologics, also known as biologic products or biopharmaceuticals, encompass pharmaceuticals developed using living organisms, cells, or biological procedures. Endotoxin testing is essential for biologics to guarantee their safety, quality, and compliance with regulatory standards. For instance, in May 2022, according to the European Pharmaceutical Review (EPR), a UK-based non-governmental organization, biologics are expected to greatly surpass sales of innovative small molecules in the next five years, with a projected $120 billion increase in sales by 2027. This indicates a significant shift in the pharmaceutical market towards biologic products. Therefore, the surge in demand for biologics to perform several tests drives the growth of the endotoxin testing market.

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What is the estimated market size of the endotoxin testing sector by 2029, based on current forecasts?

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.

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Who are the top players in the endotoxin testing market?

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.

What are the major trends in the endotoxin testing market?

Major companies operating in the endotoxin testing market are focused on adopting new technological solutions to sustain their position in the market. For instance, in August 2023, Lonza Group AG, a Switzerland-based pharmaceutical, biotechnology and nutrition manufacturing company, launched the Nebula absorbance reader, a new absorbance microplate reader for streamlined endotoxin and pyrogen testing. The instrument is fully connected with Lonza’s most recent WinKQCL software to facilitate data integrity compliance, speed training and lessen validation load. There is no longer a requirement for WinKQCL software users to learn new software to utilize the contemporary reader, reducing training demands. The Nebula Absorbance Reader is an innovative and technologically advanced replacement reader that produces outcomes similar to those frequently observed with the ELx808, the industry-standard absorbance reader that Lorenz no longer offers for sale. Additionally, it is designed to be compatible with and adhere to the exacting requirements of Lonza’s absorbance-based endotoxin assays, including the Lonza PYROGENT 5000 Turbidimetric and Kinetic-QCL Chromogenic Endotoxin Assays.

Which geography holds the highest endotoxin testing market share?

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.

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How do different segments contribute to the overall expansion of the endotoxin testing market?

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

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What defines the structure and scope of the endotoxin testing market?

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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