Pyrogens are fever-inducing substances usually derived from microorganisms. They can lead to severe signs of inflammation, shock, multiorgan failure, and even death in humans if present systemically in sufficient quantity. Pyrogenicity, associated with microbiological contamination is checked in products including vaccines, adjuvants, medical devices, among others. The most widely used pyrogen test methods include the Rabbit Pyrogen Test (RPT) and Limulus Amebocyte Lysate (LAL) test.
The global pyrogen testing market is mainly driven by rising incidences of chronic diseases & pandemic and increasing investment for the development & launch of novel innovative drugs to meet the needs of the healthcare sector. Favorable regulatory policies are also playing a pivotal role in contributing to the growth of the market globally. However, increasing efforts to ban the use of animals for pyrogen testing is likely to restrain the market growth to a certain extent.
The global pyrogen testing market has been analyzed from four perspectives: Products & Services, Test Type, End User and Region.
Based on products & services, the market has been segmented into instruments, kits & reagents and services. The kits & reagents segment accounted for the largest share in the market owing to its easy accessibility and its frequent purchase for each test performed as compared to the one-time purchase of instruments.
Based on test type, the pyrogen testing market has been segmented into rabbit pyrogen test (RPT), monocyte activation test (MAT), limulus amoebocyte lysate (LAL) test and others. The limulus amoebocyte lysate (LAL) test segment holds the largest share in the market. LAL test is widely used test in pharmaceuticals for the screening of bacterial endotoxins owing to its benefits over other tests.
Based on end user, the pyrogen testing market has been segmented into pharmaceutical industry, biotechnology industry and others. The pharmaceutical industry segment holds the largest share in the market. Bacterial endotoxins are significant risk to many pharmaceutical products, especially parenteral products. Pyrogen testing is a critical test in-process samples and before final release of pharmaceutical products into the market to ensure the absence of pyrogens in water systems, raw materials, in-process steps, and finished product.
Based on region, the global pyrogen testing market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (ROW). North America dominated the pyrogen testing market, followed by Asia Pacific. The large share of North America in the global market can largely be attributed to the developed healthcare infrastructure, presence of key prominent players, stringent regulations, presence of major pharmaceutical & biotechnology companies and rising number of drug approvals.
The pyrogen testing market is marked by presence of prominent players such as Merck KGaA, Thermo Fisher Scientific Inc., Charles River Laboratories, Lonza, GenScript, WuXi AppTec, ASSOCIATES OF CAPE COD, INC., Ellab, BIOMÉRIEUX SA, Sanquin. Other players operating in the market are FUJIFILM Wako Pure Chemical Corporation, Eurofins Scientific, Hycult Biotech, InvivoGen, among others.
|Market Size Period||2018-2031|
|Market Segments||Asessment of Pyrogen Testing Market By:
• Products & Services
• Test Type
|Geographic Scope||• North America
◦ Rest of Europe (RoE)
• Asia Pacific
◦ Rest of Asia Pacific (RoAPAC)
• Rest of the World
◦ Latin America
◦ Middle East & Africa
|Companies Covered||Merck KGaA, Thermo Fisher Scientific Inc., Charles River Laboratories, Lonza, GenScript, WuXi AppTec, ASSOCIATES OF CAPE COD, INC., Ellab, BIOMÉRIEUX SA, Sanquin, FUJIFILM Wako Pure Chemical Corporation, Eurofins Scientific, Hycult Biotech, InvivoGen, among others.|
1 RESEARCH ENVELOPE
1.1 Market Classification
1.2 Scope of the Study
1.2.1 Timeline Considered for Market Study
· Historic Years – 2018 & 2019
· Base Year – 2020
· Projected Years – 2021 to 2031
1.3 Currency Used in the Report
2 RESEARCH METHODOLOGY
2.1 Research Approach
2.2 Data Collection Methodology
2.3 Data Sources
2.3.1 Secondary Sources
2.3.2 Primary Sources
2.4 Market Crackdown Methodology
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Data Forecasting Model
2.6 Limitations and Assumptions for Study
3 HEADWINDS & TAILWINDS ASSESSMENT
4 MARKET OPPORTUNITIES ASSESSMENT
5 PREMIUM INSIGHTS
5.1 Key Market Trends
5.2 Key Players & Their Competitive Positioning (2020)
5.3 COVID-19 Impact Assessment
6 GLOBAL PYROGEN TESTING MARKET - ANALYSIS & FORECAST, BY PRODUCTS & SERVICES
6.2 Kits & Reagents
7 GLOBAL PYROGEN TESTING MARKET - ANALYSIS & FORECAST, BY TEST TYPE
7.1 Rabbit Pyrogen Test (RPT)
7.2 Monocyte Activation Test (MAT)
7.3 Limulus Amoebocyte Lysate (LAL) Test
8 GLOBAL PYROGEN TESTING MARKET - ANALYSIS & FORECAST, BY END USER
8.1 Pharmaceutical Industry
8.2 Biotechnology Industry
9 GLOBAL PYROGEN TESTING MARKET - ANALYSIS & FORECAST, BY REGION
9.1 North America Pyrogen Testing Market
9.1.1 North America Pyrogen Testing Market, By Country
9.1.2 North America Pyrogen Testing Market, By Products & Services
9.1.3 North America Pyrogen Testing Market, By Test Type
9.1.4 North America Pyrogen Testing Market, By End User
9.2 Europe Pyrogen Testing Market
9.2.1 Europe Pyrogen Testing Market, By Country/Region
18.104.22.168 Rest of Europe (ROE)
9.2.2 Europe Pyrogen Testing Market, By Products & Services
9.2.3 Europe Pyrogen Testing Market, By Test Type
9.2.4 Europe Pyrogen Testing Market, By End User
9.3 Asia Pacific Pyrogen Testing Market
9.3.1 Asia Pacific Pyrogen Testing Market, By Country/Region
22.214.171.124 Rest of Asia Pacific (RoAPAC)
9.3.2 Asia Pacific Pyrogen Testing Market, By Products & Services
9.3.3 Asia Pacific Pyrogen Testing Market, By Test Type
9.3.4 Asia Pacific Pyrogen Testing Market, By End User
9.4 Rest of the World (RoW) Pyrogen Testing Market
9.4.1 Rest of the World Pyrogen Testing Market, By Region
126.96.36.199 Latin America
188.8.131.52 Middle East & Africa
9.4.2 Rest of The World Pyrogen Testing Market, By Products & Services
9.4.3 Rest of The World Pyrogen Testing Market, By Test Type
9.4.4 Rest of The World Pyrogen Testing Market, By End User
10 COMPANY PROFILES
10.1 Merck KGaA
10.1.1 Business Overview
10.1.2 Financial Metrics*
10.1.3 Product & Services Portfolio
10.1.4 Key Developments
10.2 Thermo Fisher Scientific Inc.
10.3 Charles River Laboratories
10.6 WuXi AppTec
10.7 ASSOCIATES OF CAPE COD, INC.
10.9 BIOMÉRIEUX SA
*Insights on financial metrics is subject to availability of information in the public domain
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