Pyrogen Testing Market – Global Outlook & Forecast 2021-2031

Pyrogen Testing Market by Products & Services [Instruments, Kits & Reagents and Services], Test Type [Rabbit Pyrogen Test (RPT), Monocyte Activation Test (MAT) and Limulus Amoebocyte Lysate (LAL) Test], End User [Pharmaceutical Industry and Biotechnology Industry] – Global Analysis & Forecast 2021-2031

Clairvoyance Research conducted an in-depth market analysis study of the global pyrogen testing market. According to the study, the market was valued at ~US$ 867.5 million in 2020. The market is expected to witness a CAGR of ~11.5% from 2021 to 2031. 

Rising incidences of chronic diseases & pandemic, increasing investment for the development & launch of novel innovative drugs to meet the needs of healthcare sector and favorable government policies are some of the pivotal factors propelling the growth of the pyrogen testing market. However, increasing efforts to ban the use of animals for pyrogen testing is likely to hamper the growth of the market to a certain extent.

Government bodies and numerous organizations across the globe are implementing several initiatives, regulations & protocols for pyrogen testing, owing to the increasing public & regulatory concerns over product safety. According to article number 21 CFR 610 of USFDA, respective industries should ensure that the pyrogen concentrations do not exceed the contaminant limits specific to each product. Companies cannot release their products into the market unless they standardize them as per the rules and upon violation of the law by companies, FDA is liable to take legal action against them. This factor is expected to boost the market in the forecast period.

An upsurge in the prevalence of chronic diseases and pandemic has boosted the demand for effective treatments, which in turn is expected to propel growth of the pyrogen testing market. Pyrogen testing is highly effective in evaluating human-relevant airborne pyrogens, which are responsible for airborne diseases such as chronic obstructive lung diseases and childhood asthma. These tests are further useful in detecting contamination related to an inflammatory response in cases of chronic kidney disorders.

Several biopharmaceutical companies across the globe are investing heavily in new product developments and research activities to introduce new & innovative drugs in the market. The approvals for new drugs by the U.S. FDA have increased in the recent past, thereby increasing the number of new drugs entering the market. For instance, U.S. FDA approved 59 new drugs in 2018 and 48 new drugs & biologics in 2019. Thus, with the increasing number of drug approvals, there is a significant need for better quality assurance processes that can help to improve drug discovery and developments. This factor is expected to increase the demand for pyrogen testing during the forecast period.

However, efforts to ban the use of animals for testing may hamper the growth of market to a certain extent. In rabbit pyrogen test (RPT), rabbits suffer from painful reactions including fever, breathing problems, circulatory & organ failure, and even fatal shocks. Similarly, a large number of horseshoe crabs are harvested for limulus amoebocyte lysate (LAL) Tests, which has led to a decline in three Asian horseshoe crab species. Therefore, to save horseshoe crab species from extinction and to end cruelty to rabbits, several organizations, such as PETA and various Pharmacopeias, recommend the use of non-animal test methods.

The Asia Pacific region is expected to be the fastest growing pyrogen testing market. Factors such as developing healthcare infrastructure, rising R&D investments by prominent players to develop & launch parenteral formulations for various diseases and increasing approval of various biologics & vaccines can be attributed to the growth of the market. Countries such as India, China and Japan in the APAC region, are projected to offer significant growth opportunities owing to presence of large patient pool and booming pharmaceutical & biotechnology industry in the region.

The pyrogen testing market is marked by presence of prominent players such as Merck KGaA, Thermo Fisher Scientific Inc., Charles River Laboratories, Lonza, GenScript, WuXi AppTec, ASSOCIATES OF CAPE COD, INC., Ellab, BIOMÉRIEUX SA, Sanquin. Other players operating in the market are FUJIFILM Wako Pure Chemical Corporation, Eurofins Scientific, Hycult Biotech, InvivoGen, among others.

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