PUBLISHER: Allied Market Research | PRODUCT CODE: 1446394
PUBLISHER: Allied Market Research | PRODUCT CODE: 1446394
Pyrogen testing involves in vitro methods using substances derived from bacterial sources, such as the Limulus amebocyte lysate (LAL) test, which is commonly employed for endotoxin detection. Other methods include the monocyte activation test (MAT) and rabbit pyrogen test, although these are less commonly used due to ethical concerns and the availability of more sensitive and specific alternatives. The goal of pyrogen testing is to ensure the safety and quality of medical products by preventing exposure to pyrogenic contaminants that could compromise patient health.
Key factors that drive the growth of the pyrogen testing market include a rise in emphasis on ensuring the safety and quality of pharmaceutical and medical devices, surge in the prevalence of chronic diseases, such as heart disease, diabetes, arthritis, cancer, & diabetes, and rise in demand for pharmaceuticals & medical devices. The development of advanced formulations in the pharmaceutical and biotechnology industries is a significant driver for the pyrogen testing market expansion. The increase in complexity of pharmaceutical products has necessitated the implementation of more quality control measures, leading to the adoption of pyrogen testing. In addition, the rise in number of pharmaceutical & biotechnology industries introducing complex formulations and cutting-edge medical technologies have led to the need for advanced and sensitive pyrogen testing methodologies, which propel the market growth.
Furthermore, growing initiatives for minimizing pyrogen contamination have led to global regulatory bodies and healthcare organizations to set strict standards. This mandates the adoption of strong pyrogen testing methods, contributing to the growth of the pyrogen testing market. For instance, regulatory authorities, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, have established clear guidelines and standards for pyrogen testing. These guidelines outline the regulatory expectations and requirements for pharmaceutical and medical device manufacturers to conduct thorough pyrogen testing as part of their quality control processes. Thus, stringent adherence to these guidelines contributes significantly to market growth.
Moreover, the rise in technological advancements in pyrogen testing further boosts market growth. The development of innovative pyrogen detection methods, such as in vitro and in vivo testing, endotoxin testing, and recombinant factor C assays, enhances the accuracy and efficiency of pyrogen testing processes. For instance, Lonza Group company manufacture PyroTec PRO, an automated endotoxin testing platform that incorporates advanced technology to enhance the efficiency and accuracy of pyrogen testing. The system utilizes the well-established Limulus Amoebocyte Lysate (LAL) test method automates and streamlines the testing process. These technological advancements enable pharmaceutical manufacturers to adopt more reliable and rapid testing procedures, thereby propelling the market growth.
However, limited standardization for pyrogen testing hinders market growth. In addition, lack of knowledge and education about pyrogen contamination risks and testing methodologies hinder the widespread adoption of pyrogen testing in emerging regions. In contrast, expanding the medical device industry, with a focus on innovation and product development, and high growth potential in emerging countries are expected to provide lucrative opportunities during the forecast period.
The pyrogen testing market is segmented on the basis of product & service, test type, end user, and region. By product & service, the market is classified into reagents & kits, instruments, and services. By test type, the market is divided into LAL tests, rabbit pyrogen test, and others. By end user, it is segregated into pharmaceutical & biotechnology companies, medical device companies, and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), LA (Brazil, Colombia, Argentina, and rest of LA), and MEA (GCC, South Africa, North Africa, and rest of MEA).
Major key players that operate in the pyrogen testing market are Merck KGaA, Lonza Group, Thermo Fisher Scientific Inc., FUJIFILM Holdings Corporation, GenScript, SEIKAGAKU CORPORATION, Charles River Laboratories, STERIS, WuXi AppTec, and Eurofins Scientific. Key players have adopted product launch as a key developmental strategy to improve the product portfolio of the pyrogen testing market. For instance, in August 2023, Lonza Group launched the Nebula Absorbance Reader, a new absorbance microplate reader which joins the company's portfolio of optimized instruments for streamlined endotoxin and pyrogen testing.
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