Pyrogen Testing Market: Competitive Strategies, Regional Analysis Forecast 2026

With the growing importance of health care and rising awareness regarding toxicity in drugs and medical devices, the demand for pyrogen testing has increased drastically in the pharmaceutical and biological products industries. Moreover, to ensure safety measures in medical devices and pharmaceutical products with parenteral administration, pyrogen testing plays a crucial role in it. Players operating in this market are engaged in research and development, expansion through merger and acquisition, collaboration, or partnership, and development of type of testing. For example, in 2016, Thermo Fisher Scientific, Inc. partnered with Siemens with an objective to develop a new type of molecular testing. This new product is projected to be associated with Siemens’ VERSANT kPCR molecular solution and Thermo Fisher Scientific’s real-time PCR system.

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Competition in the global pyrogen testing market is expected to be high, as more and more players are putting efforts in research and development activities. Presence of large number of players is also triggering competition among the players. To mention some of the prominent players in the global pyrogen testing market are GenScript, Charles River Laboratories International, Inc., Sanquin, Lonza Group, and WuXi AppTec.

Based on Transparency Market Research report, the global pyrogen testing market is expected to generate revenue of nearly US$ 1.7 bn by the end of 2026. This market is expected to witness significant growth in terms of revenue during the forecast period, in 2017, the market was valued at US$ 0.65 bn.

Aim To Reduce Toxicity in Drugs Augmenting Use of Pyrogen Testing

Pharmaceuticals companies, medical devices companies, and biotechnology companies all are adopting pyrogen testing before they release parenteral drugs. As pyrogen contaminated injection can cause fever, inflammation, shock, and multiorgan failure; pyrogen detection tests are carried on drugs and medical devices to ensure their use on patients. Thus to ensure drugs are pyrogen safe, newer tests are being developed with the help of the LSP (lipopolysaccharides) signal pathway to create sensitive cell model especially for pyrogen test. MD2, CD14 and TLR4 play major part in the LPS-mediated pyrogen reaction. Moreover, the homologous recombination and CRISPR/CAS9 technology are used to identify LPS by establishing a new TLR4/MD2/CD14-specific overexpressing knock-in cell model.

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Complying With Regulatory Polices To Increase Pyrogen Testing

Globally, governments and other regulatory bodies are making efforts to ensure safety of drugs and medical devices, which has lead the growth of pyrogen testing. Nowadays, application of pyrogen testing is also seen in purification of water, implants, medical devices, and in the food and beverages industry. For instance, in 2016, the Committee for Medicinal Products for VeterinaryUse (CVMP) introduced a guidance report on safety and efficacy, and environmental testing of medicinal, pharmaceutical, quality, and immunological products. This information is based on the European Medicines Agency (EMA). Other countries are also coming up with some or the other regulations, which in turn are expanding application of pyrogen tests of products for safety.

Additionally, various workshops, programs, and other activities are conducted to discuss limitations, usages, and importance of further research of pyrogen tests. For example, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the PETA International Science Consortium together hosted a workshop to argue on in vitro approaches that will used for medical device pyrogen testing.

The study presented here is based on a report by Transparency Market Research (TMR) titled “Pyrogen Testing Market (Test Type – Monocyte Activation Test (MAT), Limulus Amoebocyte Lysate (LAL) Test, Rabbit Pyrogen Test (RPT); Component – Instruments, Kits, Reagents; End user – Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies) – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 – 2026”.



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