Pyrogen testing is used to measure the presence of pyrogen in an organism that causes fever. Pyrogens are substances that can cause fever and these substances can be found in lipopolysaccharides and lepoteichoic acid. Pyrogen contamination can be found in pharmaceutical drugs & medical devices and thus, it is essential for healthcare companies to conduct pyrogen testing to assess concentration level for pyrogens and ensure that it is well within the prescribed level.
Pyrogen testing is conducted in three ways:
Rabbit pyrogen test,
Limulus amoebeocyte lysate test (LAL) and
Monocyte activation test.
The pyrogen testing market is slowly making a transition from rabbit pyrogen testing to limulus amoebocyte lysate test, due to the growing focus on in-vitro testing.
Growth in the pharmaceutical industry and stringent drug approval will steer the Pyrogen testing market forward
The pharmaceutical market was worth $1 trillion dollars in the fiscal year 2014 and it can potentially reach $1.6 trillion by 2020. Key pharmaceutical companies are making major investments in Research and Development to introduce new and innovative drugs for the emerging markets such as India, China and Japan. However, with the regulatory scenario becoming stringent, the pharmaceutical companies have introduced better quality assurance processes. The demand for pharmaceutical drugs is estimated to increase significantly in countries such as U.S., China and Japan as the population ages. The Market size of Pyrogen testing will be driven by the growth in medical devices industry. The development of advanced medical devices such as stents, pacemakers, and catheters has been a major factor for the growth of pyrogen testing market.
Further, the regulations for drug approval are getting rigorous with FDA and EMA scrutinizing drugs closely for public safety. The FDA issued statement about pyrogen testing, its importance and the need for parenteral drug manufacturing to manage drug safety. Additionally, the regulatory bodies are motivating the pharmaceutical and medical devices companies to opt for Monocyte Activation Test in place of animal testing. An estimated 100,000 rabbits are used on an annual basis in Europe for pyrogen testing and the European authorities inducted MAT in the European Pharmacopoeia in 2010 to counter the animal testing.
Pyrogen testing market will witness significant growth in the Asia Pacific region
North America is the biggest market in terms of geography for pyrogen testing, due to stringent regulations imposed by the US FDA on drugs and medical devices approval. Furthermore, key pharmaceutical companies are making major investments in Research & Development and quality assurance. Europe is the second-largest market for pyrogen testing due to a well-established R&D infrastructure and the extensive government support & funding for the development of novel drugs and medical devices.
China, India and South Korea constitute 40% of global R&D spending. Major pharmaceutical companies are now outsourcing drug development and manufacturing to Asia Pacific region to capitalize on economies of scale, which will drive demand for pyrogen testing in the region. Global medical devices manufacturers will conduct clinical trials totes the safety and efficacy of the devices which will make a positive impact on the pyrogen testing industry. The governments of India and China have been promoting development of novel drugs by providing government funding. Both the countries are projected to invest US$ 100 billion and US$ 300 billion, respectively over the following 10 years in research & development. This in turn will create a highly conducive environment for growth of the pyrogen testing market.
Key players are focusing on transitioning from conducting test on rabbits
The key players in the pyrogen testing market are Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associated of Cape Cod Inc. and Charles River Laboratories Inc, among others. The market has been in a state of consolidation as the key companies hold the dominant share with Merck KGaA leading from the front. These companies are introducing rabbit-free pyrogen testing methods due to the growing concern over extensive use of animals. Monocyte Activation Test is emerging as an innovative method, however the challenge lies in the logistical problems associated with the extraction of fresh human blood. The pyrogen testing market is estimated to evolve as the existing players continue to opt for mergers and acquisitions of small companies which will enable them to stay competitive in the market.
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