Pyrogen testing determines the presence of endotoxin substances. Pharmaceutical and medical device industries are focused on R&D of more sustainable test methods for the accurate detection of pyrogenic contamination. Rabbit pyrogen test and the bacterial endotoxin test based on Limulus Amebocyte Lysate are some of the widely used pyrogen tests. Other tests include, recombinant factor C assay and monocyte activation assay.
Market Dynamics
Initiatives to commercialize specialized reagents for pyrogen testing are to propel growth of the pyrogen testing market over the forecast period. For instance, in May 2020, Lonza Sales AG partnered with Sanquin Reagents B.V. for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the Monocyte Activation Test (MAT).
Moreover, launch of new products is also expected to aid in growth of the market. For instance, in October 2020, Lonza Bioscience launched PyroCell MAT System, a sustainable and reliable solution for in vitro pyrogen testing. Similarly, in November 2019, Reading Scientific Services Ltd. launched a fast, responsive and flexible sterility testing service for pharmaceutical and medical device companies.
Increasing investment in the pharmaceutical sector is expected to offer lucrative growth opportunities for players in the pyrogen testing market. For instance, according to The European Federation of Pharmaceutical Industries and Associations’ Key Data 2019, the pharmaceutical sector in Europe invested US$ 19, 509 million in 2000, which increased to US$ 39,895 million (est.) in 2018.
Moreover, stringent regulations regarding bacterial endotoxin testing for implants is also expected to aid in growth of the pyrogen testing market. For instance, in the U.S., the Food and Drug Administration (FDA)’s guidance document titled “Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile” specifies new requirements related to bacterial endotoxin testing.
Growing concerns over use of animals in pyrogen testing is expected to hinder growth of the pyrogen testing market.
Competitive Analysis
Major players operating in the 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
Major players in the pyrogen testing market are focused on adopting collaboration strategies to expand their product portfolio. For instance, in May 2018, Merck and Solvias announced collaboration plans to develop PyroMAT System, a new kit for detection of pyrogen.
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