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Pyrogen Testing Market to Reach US$ 1,700 Mn by 2026; Increase in Public and Regulatory Concerns about Product Safety in Pharmaceutical and Medical Device Manufacturing Industry to Fuel Market: Transparency Market Research

The global pyrogen testing market was valued at approximately US$ 680 Mn in 2017. It is projected to expand at a cumulative annual growth rate (CAGR) of 11% from 2018 to 2026, according to a new report published by Transparency Market Research (TMR) titled ‘Pyrogen Testing Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026.’ The report suggests that rising demand for pyrogen testing in various pharmaceutical and biological products industries and rise in awareness about health care are expected to propel the pyrogen testing market in the near future. Additionally, increase in concerns about endotoxins present in drugs and their side-effects are anticipated to drive the global market. North America and Europe are projected to dominate the global market. Highly structured health care industry and availability of well-defined FDA regulations for pharmaceutical and medical device product manufacturing, boost the pyrogen testing market in the region. The market in Asia Pacific is projected to expand at a prominent CAGR between 2018 and 2026. This is due to increased spending on public health care systems, significant rise in the development of pharmaceuticals & CROs, and increase in adoption of MAT test by pharmaceutical companies. The pyrogen testing market in Latin America is likely to expand at a moderate growth rate during the forecast period.

pyrogen testing industry

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Increase in public and regulatory concerns about product safety to fuel market

Pyrogen testing was introduced in pharmaceutical products such as drugs and immunological products. Presently, it has been introduced in medical devices, implants, purification of water, and the food & beverage industry. The Food and Drug Administration (FDA) provides testing recommendations for biological products, drugs, and medical device firms. However, there are concerns about the testing recommendations and acceptance criteria through the United States Pharmacopeia (USP). According to the European Medicines Agency (EMA) (April 2016), the Committee for Medicinal Products for Veterinary Use (CVMP) has developed a guidance report on quality, safety & efficacy, and environmental testing of medicinal, pharmaceutical, and immunological products. These factors are demanding more number of pyrogen tests of products for safety. According to the FDA, the Center for Devices and Radiological Health (CDRH) has adopted the USP Endotoxin Reference Standard and limits for medical device extracts, which are expressed in EU/ml (Endotoxin Units/ml). These improved and additional applications increased the demand for pyrogen testing products.

Adoption of limulus amoebocyte lysate (LAL) test is highest among end-user, which drives the market

Limulus amoebocyte lysate (LAL) is the most widely accepted and adopted test method for quality control of parenteral drugs, as it is an aqueous extract of blood cells from the horseshoe crab. LAL test is utilized for the detection of minute quantity of bacterial toxins or pyrogen in pharmaceuticals and medical devices. Increase in drug discovery and biological medical devices has driven the pyrogen testing market. The test is the first solution enabling adequate pyrogen testing of cell therapies, including blood transfusions, and medical devices. This fuels the adoption of limulus amoebocyte lysate (LAL) tests in several pharmaceutical and biotechnology industries.

Kits and reagents segments are estimated to expand at notable CAGR during the forecast period

Kits comprise pyrogen free test vials that already contain lyophilized LAL. These kits eliminate some of the tedious pipetting steps and are suitable for small labs with few samples. The kits segment is anticipated to expand at a relatively high growth rate, in terms of revenue, during the forecast period, owing to continuous innovations of new products by major as well as emerging players. The reagents used to preform pyrogen test are limulus amoebocyte lysate (LAL) reagent and endotoxin extracting solutions. Kits and reagents are also available in a single pack. Most reagents are required in large quantities and hence, are available in different packing. The reagents segment held a major share of the market due to regular usage of reagents for pyrogen testing. Reagents are also available in single packs, because most reagents are required in large quantities.

Pharmaceutical companies segment dominates the market and is estimated to prominent CAGR

In terms of end-user, the pharmaceutical companies segment accounted for a leading share of the global pyrogen testing market. The market share held by the segment is estimated to increase by the end of 2026. The pharmaceutical companies segment is anticipated to expand at a CAGR of more than 11% during the forecast period, due to growing importance of these companies not only in the field of conventional research, but also in the development and production of vital biomolecules and therapeutics. Discovery and launch of new products is fueling pharmaceutical companies and biotechnology companies segments. This, in turn, is projected to boost the global pyrogen testing market during the forecast period. These factors are expected to fuel the pharmaceutical companies segment at a significant pace between 2018 and 2026.

Asia Pacific offers considerable business development opportunity

North America and Europe accounted for a key share of the global pyrogen testing market in 2017. They are likely to gain market share by the end of 2026. Presence of well-established players in the region and increasing research and development activities by these players are key attributable factors for North America’s dominance of the global pyrogen testing market. Asia Pacific is projected to be a highly attractive market for pyrogen testing, and the region is likely to exhibit a high attractiveness index. The market in Asia Pacific is projected to expand at a high CAGR of more than 13% during the forecast period, due to the rise of pyrogen testing in several pharmaceutical and biotechnology companies which are established in the countries in Asia Pacific country. This, in turn, is attributable to well-developed health care infrastructure, increase in health care expenditure, and rise in the number of local manufacturers providing innovative products at lower cost. The market in Latin America is expected to expand at a moderate pace during the forecast period.

Key trend of research and development among leading players to increase in geographic presence

The report also provides profiles of leading players operating in global pyrogen testing market. Thermo Fisher Scientific, Inc., Merck KGaA, Charles River Laboratories International, Inc., GenScript, Lonza Group, Sanquin, and WuXi AppTec are leading players operating in the global pyrogen testing market. They account for a significant share of the global market. Companies operating in the pyrogen testing industry are focused on increasing their geographic presence by means of strategic acquisitions and collaborations with leading players in their respective domains and geographies. In 2017, the Merck KGaA formed a strategic alliance with Baylor College of Medicine, Houston, Texas and a vaccine product development partnership with Texas Children’s Hospital Center for vaccine development in the U.S. in order to advance vaccine research and development for neglected and emerging infections. In 2017, the Merck KGaA extended its partnership with Samsung BioLogics to accelerate the process of development and clinical material production at small biotech startups, focusing on novel drug development, for which Samsung BioLogics acts as a contract manufacturer. Other prominent players operating in the global pyrogen testing include Hyglos GmbH - a bioMérieux Company, Wako Chemicals USA, Inc., and Associates of Cape Cod, Inc.

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