Seattle, WA -- (SBWire) -- 09/27/2019 --Pyrogen test is a crucial conducted in advanced healthcare to detect the presence of pyrogene, which is fever-causing organism. Pyrogen can be found in lepoteichoic and ipopolysaccharides acid. Moreover, products contaminated with pyrogenic organism cause harmful effects such as fever in humans.

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).

Growing demand for testing of pyrogen contamination in medical devices and drugs is expected to drive growth of the global pyrogen testing market
Pyrogen testing finds applications in detection of pyrogen contamination in medical devices and pharmaceutical dosage forms. Due to its contamination various diseases such as shock, mutiorgan failure, temperature dysregulation (fever), inflammation, and bodyach can cause.

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Increasing research and development activities in medical devices and therapeutic research is expected to drive growth of global pyrogen testing market over the forecast period. For instance, according to United Nations Educational, Scientific, and CUltureal Organizartio (UNESCO), in November 2016, around US$ 1.7 trillion of global expenditure was recorded in research and development of various medical applications. Moreover, increasing approval from regulatory authorities is expected to drive the market growth. For instance, in 2018, the U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER), approved around 59 novel drugs, compared to 46 approvals of new molecule entities in 2017.           

Insights Analysis
Increasing research and development activities in healthcare sector in North America is expected to boost the market growth in the region

North America holds dominant position in the global pyrogen testing market. This is owing to high prevalence of cardiovascular disease in the region. According to the European Federation of Pharmaceutical Industries and Association (EFPIA) report, in 2018, around US$ 48,111 million and US$ 82,418 million pharmaceutical expenditure was recorded in 2015 and 2016 respectively, in the U.S.
Furthermore, increasing product approvals for new molecule entities (NMEs) by regulatory authorities in this region is expected to propel the market growth in the region during the forecast period. For instance, in 2018, the U.S. Food and Drug Administration (FDA), approved 59 new molecule entities, which enabled new treatment options for patients and advances in healthcare for patients in the U.S.
Moreover, key players in the market are focused on various inorganic growth strategies such as collaboration for development of new kits and reagents used in detection of pyrogen in pharmaceutical products and devices. For instance, in May 2018, Merck collaborated with Solvias to develop PyroMAT System, a new kit for detection of pyrogen.

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Key Players
Key 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

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.

Moreover, key players in the market are focused on collaboration activities for development of new kits and reagents used in detection of pyrogen in pharmaceutical products and devices. For instance, in May 2018, Merck and Solvias announced collaboration plans to develop PyroMAT System, a new kit for detection of pyrogen.

Market Dynamics

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.

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