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Pyrogen Testing Market to Reap Excessive Revenues by 2026

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).
Pyrogen Testing Market Foreseen To Grow
Exponentially Over 2026
Pyrogen Testing Market - Global Forecast to 2026, by Test Type (Limulus
Amoebocyte Lysate Test, TAL Test, Monocyte Activation Test, Rabbit Pyrogen
Test, and Recombinant Factor C Assay), by Product Type (Instruments, Kits, and
Reagents), by End User (Pharmaceutical and Biotech Companies, Food and
Beverages Companies, and Others), and by Region (North America, Latin
America, Europe, Asia Pacific, Middle East, and Africa) — Size, Share, Outlook,
and Opportunity Analysis, 2018-2026
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).
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.
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.
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
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
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Key Players
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
Detailed Segmentation:
•Global Pyrogen Testing Market, By Test Type:
•Limulus Amoebocyte Lysate (LAL) Test
•TAL Test
•Monocyte Activation Test (MAT)
•Rabbit Pyrogen Test (RPT)
•Recombinant Factor C Assay (rFC)
•Global Pyrogen Testing Market, By Product Type:
•Global Pyrogen Testing Market, By End User:
•Pharmaceutical and Biotech Companies
•Food and Beverages Companies
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.
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