Pyrogen Testing Global Market Report 2024

The pyrogen testing provides testing services to check the presence or absence of pyrogens in all aqueous parenteral products. Pyrogen testing determines the presence of bacterial toxins in vaccines, biotechnological products, and drugs, which induce fever in humans. It also identifies the presence of microbes and their metabolites in drugs during the manufacturing process.

The main types of pyrogen tests are the Limulus Amebocyte Lysate (LAL) test, in vitro test, and rabbit test. The LAL test is a method for determining bacterial endotoxins, utilizing the amebocyte lysate of the Limulus crab. The rabbit pyrogen test involves injecting a small amount of batched test material into a rabbit's bloodstream, and the rabbit's body temperature is monitored. The products used for pyrogen tests include assays, kits, and reagents, as well as instruments and related services. Pyrogen testing is applied in pharmaceutical and biologics, medical devices, and other industries.

The pyrogen testing market research report is one of a series of new reports that provides pyrogen testing market statistics, including pyrogen testing industry global market size, regional shares, competitors with a pyrogen testing market share, detailed pyrogen testing market segments, market trends and opportunities, and any further data you may need to thrive in the pyrogen testing industry. This pyrogen testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pyrogen testing market size has grown rapidly in recent years. It will grow from $1.46 billion in 2023 to $1.67 billion in 2024 at a compound annual growth rate (CAGR) of 14.2%. The growth in the historic period can be attributed to the growth in the pharmaceutical and biotechnology industry, regulatory requirements for drug safety, advancements in testing methods, an increase in infectious disease outbreaks, and adoption in medical device manufacturing.

The pyrogen testing market size is expected to see rapid growth in the next few years. It will grow to $2.72 billion in 2028 at a compound annual growth rate (CAGR) of 13.0%. The growth in the forecast period can be attributed to customized pyrogen testing solutions, the expansion of rapid and automated testing, innovation in in vitro pyrogen detection, adoption of pyrogen testing in cell therapy, and environmental and sustainable testing practices. Major trends in the forecast period include point-of-care pyrogen testing, regulatory compliance in pyrogen testing, AI-driven pyrogen detection and analysis, personalized and patient-specific pyrogen testing, and transparency and traceability in testing processes.

The growth of the pyrogen testing market has been significantly influenced by increased investments in research and development within the pharmaceutical and biotechnology industries. Pyrogen testing is a critical process utilized by pharmaceutical, biotech, and drug manufacturing companies to ensure the safe production of infection-free products. In 2021, major players in the pharmaceutical market, including Roche, AstraZeneca, and Merck, exhibited substantial investments in research and development. Roche, for instance, increased its R&D investment to approximately $13.5 billion (13.7 bn CHF), reflecting a 14.3% rise from 2020. Consequently, the substantial investments by pharmaceutical companies in research and development are driving the pyrogen testing market.

The anticipated growth of infectious diseases is poised to further elevate the pyrogen testing market. Pyrogen testing plays a pivotal role in guaranteeing the safety of pharmaceutical products by detecting fever-causing contaminants in drugs and medical devices. Notably, the reported increase in central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI) underscores the heightened relevance of pyrogen testing in addressing the surge in infectious diseases. As per the Centers for Disease Control and Prevention's 2021 National and State Progress Report on Healthcare-Associated Infections, there was a 7% rise in CLABSI and a 5% increase in CAUTI between 2020 and 2021. Therefore, the global rise in infectious diseases is a significant driver for the pyrogen testing market.

Companies are actively involved in advancing animal-free pyrogen testing methods, such as the monocyte activation assay (MAT), to overcome limitations associated with traditional methods like the rabbit pyrogen testing method and the Limulus amebocyte lysate (LAL) test. This transition towards animal-free testing is driven by a commitment to ethical treatment of animals. Notably, the MAT method surpasses the LAL test by detecting both endotoxin and non-endotoxin pyrogens. Merck, for instance, has focused on MAT systems, including PyroDetect and PyroMAT.

Innovative product development remains a focal point for major companies operating in the pyrogen testing market. To enhance their business offerings and expand market reach, companies are introducing sustainable monocyte activation test (MAT) systems. Lonza, a Swiss multinational manufacturing company, exemplifies this trend by launching the PyroCell MAT Rapid System and the PyroCell MAT Human Serum (HS) Rapid System. These systems, equipped with the PeliKine Human IL-6 Rapid ELISA Kit, offer efficient MAT testing options for product safety, minimizing hands-on time and reducing time-to-results from two days to two hours. The introduction of such innovative testing options not only aids pharmaceutical manufacturers but also aligns with efforts to reduce reliance on animal testing.

Major companies operating in the pyrogen testing market include Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories Inc., Lonza Group Ltd., Ellab A/S, Nelson Laboratories LLC, Associates of Cape Cod Inc., GenScript Biotech Corporation, bioMérieux SA, Hyglos GmbH, Sanquin Blood Supply Foundation, Wako Chemicals USA Inc., Pyrostar International Inc., Eurofins Scientific SE, SGS SA, WuXi AppTec Group, Sigma-Aldrich Co. LLC, Bio-Rad Laboratories Inc., Microcoat Biotechnologie GmbH, Sartorius AG, Pacific Biolabs Inc., Toxikon Corporation, STERIS Corporation, Avance Biosciences Inc., BioReliance Corporation, Microbiological Consulting LLC, Microbac Laboratories Inc., North American Science Associates Inc., Pace Analytical Life Sciences LLC

North America was the largest region in the pyrogen testing market in 2023. Asia-Pacific is expected to continue to be the fastest growing region in the pyrogen testing market share during the forecast period. The regions covered in the pyrogen testing market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the pyrogen testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

The pyrogen testing market includes revenues earned by entities by endotoxin testing and monocyte activation testing (MAT). The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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