Pyrogen testing is detection of pyrogen in pharmaceutical drugs and devices. The contaminated devices or drugs when introduced in body can cause fever, shock, inflammation, and other problems. Pyrogen testing consists of kits, reagents, and instruments, which enables pyrogen and endotoxins detection by in-vitro methods and minimizes the usage of animal testing.
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Increasing research and development in the field of pyrogen testing and advancements in technology for detection of endotoxin is a major factor driving pyrogen testing market growth. According to the Pharma R&D Annual Review, 2018, an estimated drug count in 2017 was around 14,872, while in 2018 it was around 15,267, resulting in an overall pipeline growth by 2.7% in 2018. Stringent government regulations and rising focus on in-vitro testing for detection of pyrogen is one of the major factors boosting growth of the market. For instance, in June 2012, the U.S. Food and Drug Administration (FDA) provided guidelines for pyrogen and endotoxin testing to industries.
The global pyrogen testing market size was valued at US$ US$ 689.9 million in 2017, and is expected to exhibit a CAGR of 12.4% over the forecast period (2018 – 2026).
Increasing demand for testing of pyrogen contamination in medical devices and drugs is expected to propel growth of the pyrogen testing market
Pyrogen testing is used in detection of pyrogen contamination in pharmaceutical dosage forms and medical devices. Pyrogen contaminated injections post administration can cause temperature dysregulation (fever), bodyache, inflammation, shock, multiorgan failure, and other life threatening problems.
Moreover, increasing research and development of therapeutic drugs and medical devices is propelling growth of the pyrogen testing market over the forecast period. According to the United Nations Educational, Scientific and Cultural Organization (UNESCO), November 2016, an estimated US$ 1.7 trillion of global spending in research and development for various medical applications. Moreover, the U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER), has approved around 59 novel drugs in 2018 compared to 46 approvals of new molecule entities in 2017.
Increasing research and development in healthcare sector in North America is expected to bolster the market growth
North America holds dominant position in the pyrogen testing market, owing to high prevalence of cardiovascular disease. According to the European Federation of Pharmaceutical Industries and Association (EFPIA) report, 2018, an estimated US$ 48,111 million and US$ 82,418 million pharmaceutical expenditure was recorded in 2015 and 2016 respectively, in the U.S.
Increasing number of approvals for new molecule entities (NMEs) by regulatory agencies in this region is expected to bolster the market growth over the forecast period. In 2018, the U.S. Food and Drug Administration (FDA), approved 59 new molecule entities which enables new treatment options for patients and advances in health care for the American people.
Major players operating in the global pyrogen testing market include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin, Ellab A/S, and Pyrostar