Pyrogens are a heterogeneous group of microbial and non-microbial substances that cause fever. Most common and potent variants lipopolysaccharides or endotoxins; gram positive bacteria are also some sources of pyrogens. Since contamination from pyrogens in biotherapeutics, medical devices, pharmaceuticals and cosmetics can possibly compromise health and wellbeing, it is mandatory for manufacturers to check on the limit of pyrogen.
The purpose of this research study titled ‘Pyrogen Testing Market - Growth, Future Prospects, and Competitive Analysis, 2017 – 2025’ is to provide investors, developers, company executives and industry participants with in-depth analysis to allow them to take strategic initiatives and decisions related to the prospects in the global pyrogen testing market. This report presents and analyzes the major trends prevalent in the global pyrogen testing market and the market size and forecast.
This report categorizes the global pyrogen testing market in terms of test type, products, applications and geographical distribution. Based on test type, the global pyrogen testing market is categorized into rabbit pyrogen test (RPT), limulus amoebocyte lysate (LAL) assay (chromogenic tests, turbidimetric tests and gel clot tests) and monocyte activation test (MAT) (In-vitro test). Reagents and Kits, Instruments and Systems, and Services are the products/solutions considered for the purpose of this study. Additionally, based on applications, the global pyrogen testing market is categorized into pharmaceutical and biotech manufacturing, medical device manufacturing and others. Market size and forecast for each mentioned segment for the period 2015-2025 is presented in the report along with respective CAGRs for the forecast duration 2017-2025.
The market size and forecast of each considered geographical market is presented for the period 2015-2025 along with CAGRs for the forecast period 2017-2025 in this study and are further cross-sectional analysis is presented in terms of products, test type, applications and constituent region/country level markets.
This report also includes qualitative assessment factors such as market dynamics (drivers, restraints and opportunities) to have a good understanding of the current and anticipated trends in the global pyrogen testing market. Competition assessment tools such as market attractiveness assessment and competitive landscape analysis by key players are also demonstrated in the study. Furthermore, this report concludes with profiling of key market players currently enjoying prominent position in the pyrogen testing market. The key players profiled in this report are Associates of Cape Cod, Inc., Charles River Laboratories, Inc., Ellab A/S, GenScript, Hyglos GMBH (bioMérieux), Lonza Group, Merck KGaA (Merck Millipore), Sigma-Aldrich Corporation, Thermo Fisher Scientific, Inc., Wako Chemicals USA, Inc. (Pyrostar), and WUXI Pharmatech, Inc.
Among the considered test types, rabbit pyrogen test and LAL tests are the most widely known. Monocyte activation test is an in-vitro method and is newer to the industry. Since this method is based on human fever reaction, its results are aligned closely to human situation. The protocol for RPT was first introduced in 1942; however the recent concern around animal welfare and the risk of result variability is urging the users to consider other alternatives. It is observed that LAL tests are continuously replacing RBTs and are being recommended by pharma companies and international bodies. However, reported cases such as testing for Hepatitis B vaccine the use of RBT is still recommended. It is also suggested that the use of RBT is justified only when other test types cannot be validated.
Reagents and kits form the largest revenue generating segment for pyrogen testing, followed by instruments. Extensive requirement of consumables for research supported by large scale research and development and, drug discovery activities being taking place in the market due to the growing need for breakthrough drugs and medical devices is the main growth driver of this segment. On the other hand, growing pressure for ensuring good manufacturing practices, and constant technological innovation has urged the need for replacing obsolete instruments and thus support the demand for new pyrogen testing instruments. Additionally, growing CRO activities has led to rise of several new testing establishments, which further supports the demand for instruments and equipment, along with testing services.
Pharmaceutical and biotechnology manufacturing is the largest revenue generating application segment in the global pyrogen testing market. Since the R&D activities of pharma and biotech industries has plummeted, several new trends in these industries are being observed. With the incidence of chronic diseases increasing, there is an increasing pressure on pharmaceuticals manufacturers to come up with novel drugs. The demand for medicines is rapidly growing in the emerging countries and economies witnessing rapid industrialization. As treatments are becoming more sophisticated there is an emerging need for creating new treatment models that are safe as well as effective to critical patients. Furthermore, stringent regulations in terms of operation, production and commercialization has further ensured compliance to safety measures, thus driving the demand for pyrogen testing in these markets.
Geographically, the global pyrogen testing market is cumulative to North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
North America, followed by Europe is the largest market for pyrogen testing in 2016, and it is expected that the region will continue to retain its dominance through the forecast period 2017-2025. Being large and diversified, the U.S. is the largest and the most critical market for pyrogen testing. The country houses several occupations ranging between scientific research to manufacturing. The pharmaceuticals sector in the U.S. has consistently been the most research intensive industries. However, the research and development activities performed in the U.S. are consistently being outsourced to Asian countries such as China, Singapore and India, mainly due to increasing R&D expenses.
Historical & Forecast Period
This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Pyrogen Testing market are as follows:
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
| ATTRIBUTE | DETAILS |
|---|---|
| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
| Segmentation | |
Test
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Product
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Application
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Region Segment (2022-2032; US$ Million)
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Key questions answered in this report
