Pyrogen comprises a diverse group of fever-causing substances. It constitutes both microbial and non-microbial substances. The most potent and most widely known pyrogens are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogen, in particular, lipoteichoic acid (LTA), particles from yeasts and viruses. Non-microbial pyrogen often comes from production site of the various manufacturing site. Small particles of packaging materials are a typical example of non-microbial pyrogen. Pyrogen contaminations in pharmaceutical products, biotherapeutics and on medical devices can bring life-threatening fever, as a result, it is mandatory for manufacturers to ensure that the pyrogen concentrations in pharmaceuticals product do not exceed certain limits.
The market for global pyrogen testing has been accelerated by the recent developments of pharmaceutical and biotechnological industry across different parts of the world. Moreover, the rise in a number of the launch of new drugs in the market coupled with the huge investment in research and development of drugs is the driving factor for the growth of pyrogen testing market. Furthermore, growing intervention of government in pharmaceutical industries is expected to fuel the growth of global pyrogen testing market. However, the highly consolidated pharmaceutical industry can restrict the growth of pyrogen testing market. Nonetheless, untapped market/developing countries market are considered as a major opportunity for upcoming growth of pyrogen testing market.
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Based on product, pyrogen testing market is classified into three types: instruments, services, kits, and reagents. In general, all three segments play a very important role in pyrogen testing market. But in 2015, kits and reagent contributed maximum market share in terms of revenue followed by service and instrument. Limulus Amebocyte Lysate test (LAL test) kit is a great example of kits and reagent in pyrogen testing market. Greater demand for LAL test kit is due to ease of handling coupled with accurate result. The Limulus Amebocyte Lysate test recommended in international pharmacopoeias as the method for detecting bacterial toxins both in the raw materials used for the production of medicines and for the final products.
Based on the type of test, pyrogen testing market is classified into three types: in vitro test, LAL test, and rabbit test. These entire tests play a very keen role in the management of pyrogen testing market. However, in 2015, LAL test dominated the pyrogen testing market due to various advantages over another test. The certain advantage of rabbit test includes:
- Simple and easy to perform.
- Results obtained in few hours.
- Animals (Rabbits) not used in testing.
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LAL (Limulus Amebocyte Lysate) method has largely replaced the rabbit test in pyrogen testing market. In rabbit test, rabbits are not only used in the experiments that are conducted in research, but also in the pharmaceutical and food industry as well as other industries. Limulus Amebocyte Lysate test (LAL test) kit is a great example of kits and reagent in pyrogen testing market. Greater demand for LAL test kit is due to ease of handling coupled with accurate result.
Based on application, pyrogen testing market is classified into three types pharmaceutical & biotechnology, medical device, and other applications. Application segment was dominated by pharmaceutical and biotechnology in 2015 due to rapidly increasing pharmaceutical and biotechnology industries and an increasing number of new biologics products. In addition, the launching of new biological drugs is considered as the most important growth driver for this segment during the forecast period.
Based on geography, pyrogen testing market is classified into five regions North America, Europe, Asia-Pacific, Latin America and the Middle East and Africa. North America was dominating the regional market for pyrogen testing in 2015, due to the huge investment in research and development of drugs. In addition, North America holds maximum business center/headquarters of world premium pharmaceutical industries across the world. Growing business in the Asia Pacific serves as a fastest growing regional market for pyrogen testing owing to the huge capital investment in research and manufacturing of medicine.
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The shift of medical business from west to east, especially in China and India, is a meaningful cause for the growth in the Asia Pacific region within the forecast period. Moreover, Latin America and the Middle East & Africa are also expected to have good growth due to growth in the medical tourism sector within the forecast period.
The major players in the pyrogen testing market include Associates of Cape Cod, Inc., Charles River Laboratories, Inc., Ellab A/S, Genscript, Hyglos GmbH, Lonza Group, Merck Kgaa, Thermo Fisher Scientific, Inc., WUXI Pharmatech (Cayman) Inc. and Wako Chemicals Usa, Inc.
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