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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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.
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.
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 Pyrostar
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:
-
Instruments
-
Kits
-
Reagents
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