-Pyrogen Testing Market Size, Share & Trends Analysis Report By Product (LAL, Gel Clot, Turbidimetric, Chromogenic), By Application (Pharmaceuticals, Biotechnology, Medical Devices), And Segment Forecasts, 2020 – 2027
The global pyrogen testing market is expected to reach USD 1.63 billion by 2027, expanding at a CAGR of 5.4% during the forecast period. The rising demand for pyrogen testing in the pharmaceutical and biotechnology industries is expected to drive the market growth over the forecast period.
Pyrogen testing is used to detect the presence of pyrogens, which are substances that cause fever in humans. The test is used to ensure the safety of drugs, biologics, and medical devices. The FDA requires pyrogen testing for all new drugs and biologics.
The rising demand for biologics and biosimilars is expected to drive the market growth over the forecast period. The increasing prevalence of chronic diseases is expected to drive the demand for biologics. The rising demand for biosimilars is also expected to drive the market growth.
The increasing investment in R&D by pharmaceutical and biotechnology companies is expected to drive the market growth over the forecast period. The rising number of clinical trials is also expected to drive the market growth.
The market is segmented by product, application, and region.
On the basis of product, the market is segmented into LAL, gel clot, turbidimetric, and chromogenic. The LAL segment is expected to hold the largest market share over the forecast period. The growing demand for LAL products is expected to drive the segment growth.
On the basis of application, the market is segmented into pharmaceuticals, biotechnology, medical devices, and others. The pharmaceuticals segment is expected to hold the largest market share over the forecast period. The increasing demand for pyrogen testing in the pharmaceutical industry is expected to drive the segment growth.
On the basis of region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
The market in North America is expected to hold the largest market share over the forecast period. The presence of leading pharmaceutical and biotechnology companies in the region is expected to drive the market growth. The market in Asia Pacific is expected to expand at the highest C
-The global pyrogen testing market size is expected to reach USD 1.31 billion by 2027, expanding at a CAGR of 5.5% over the forecast period.
The global pyrogen testing market size is expected to reach USD 131 billion by 2027 expanding at a CAGR of 55% over the forecast period, according to a new report by Grand View Research, Inc. The market is expected to be driven by the increasing demand for biologics and vaccines, as well as the rising prevalence of chronic diseases.
Pyrogen testing is a critical quality control step in the manufacturing of biologics and vaccines. It is used to detect the presence of pyrogens, which are substances that can cause fever in humans. The test is usually performed on finished products, but it can also be performed on raw materials and in-process materials.
There are two main types of pyrogen tests: the in vitro test and the in vivo test. The in vitro test is the most commonly used test, as it is faster and less expensive than the in vivo test. The in vitro test can be performed using the limulus amoebocyte lysate (LAL) assay or the monocyte activation test (MAT). The in vivo test is usually performed in rabbits and is considered to be the gold standard for pyrogen testing.
The market for pyrogen testing is expected to be driven by the increasing demand for biologics and vaccines. Biologics are proteins that are derived from living cells and are used to treat a variety of diseases, such as cancer, arthritis, and Crohn’s disease. Vaccines are used to prevent the spread of infectious diseases, such as polio, measles, and influenza.
The rising prevalence of chronic diseases is also expected to drive the market for pyrogen testing. Chronic diseases are conditions that last for a long period of time and are usually not curable. Examples of chronic diseases include diabetes, heart disease, and asthma.
The market for pyrogen testing is expected to be restrained by the lack of standardization. There is no single accepted method for pyrogen testing, and different methods are used by different manufacturers. This lack of standardization can lead to inconsistency in results and make it difficult to compare products.
The market for pyrogen testing is segmented by type, application, and end-use.
-The rising demand for pyrogen-free products, especially in the
In the past decade, there has been a significant increase in the demand for pyrogen-free products, especially in the pharmaceutical and medical device industries. This is due to the growing awareness of the potential risks associated with pyrogens, which are substances that can cause fever when introduced into the body.
Pyrogens can be found in a variety of products, including medical devices, injectable drugs, and blood products. Injectable drugs are particularly at risk for contamination because they are directly injected into the bloodstream. Blood products are also at risk because they can come into contact with pyrogens during the manufacturing process.
Medical devices can be contaminated with pyrogens through a variety of means, including contact with contaminated materials during manufacturing, storage, or shipping. Pyrogens can also be introduced into medical devices during sterilization.
The most common type of pyrogen is endotoxin, which is a component of Gram-negative bacteria. Endotoxin can cause a range of symptoms, from fever and chills to septic shock, which can be fatal.
Fortunately, there are a number of methods available for testing for pyrogens, including the limulus amoebocyte lysate (LAL) test and the monocyte activation test (MAT). The LAL test is the most commonly used method for pyrogen testing, and it is considered to be the gold standard.
The MAT is a newer method that is gaining popularity due to its ability to detect a wider range of pyrogens, including those that do not cause fever.
Pyrogen testing is an important part of ensuring the safety of pharmaceutical and medical products. The rising demand for pyrogen-free products is a positive trend that will help to protect patients and consumers from the potentially harmful effects of pyrogens.
KEY PLAYERS COVERED
Charles River, Associates of Cape Cod, Inc., Sanquin, GenScript, Hyglos GmbH, Ellab A/S, Merck KGaA, Wako USA, Lonza and WuXi AppTec., and others.
|Segmentation of the Global Pyrogen Testing Market|
|By Test||· Oncology Monocyte Activation Test (MAT)|
· Limulus Amebocyte Lysate (LAL)
· Rabbit Pyrogen Test
· Recombinant Factor C Assay (RFC)
· In Vitro Pyrogen Test
|By Product||· Instruments|
|By End User||· Food & Beverage Companies|
· Medical Devices Companies
· Pharmaceuticals Companies
· Biotechnology Companies
· Contract Research Organizations (CROS)
|By Geography||· North America (USA and Canada)|
· Europe (UK, Germany, France, Italy, Spain, Scandinavia and Rest of Europe)
· Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)
· Latin America (Brazil, Mexico and Rest of Latin America)
· Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)