NEW YORK, July 25, 2022 /PRNewswire/ — The global endotoxin testing market is expected to clock US$ ~1,893 Million by 2030 mainly driven by an prevalence of chronic and infectious diseases and the requirement for endotoxin-free pharmaceutical drugs and medical devices, states Growth Plus Reports.
Endotoxin is primarily responsible for rise in body temperature and may cause rapid inflammation reaction when it enters the bloodstream. Endotoxin is found on the exterior cell wall of gram-negative bacteria. Endotoxins may contaminate pharmaceutical, healthcare, and medical device products during production, transport, or packaging. In order to to check their sterility, and avoid contamination before administration for human use endotoxin testing is commonly performed.
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The LAL (Limulus Amebocyte Lysate) test is used to detect the presence of bacterial endotoxins in drugs and biological products and is an important part of pharmaceutical microbiology. The LAL test assay allows direct quantitative detection of endotoxin levels. In addition, test is commercially available, accuracy of results, less turnaround time, low price as compared to other test. The LAL test basically detects endotoxin by gel clot method, turbidimetric method, and chromogenic method, and its most demanded by hospital and research center, pharmaceutical industry, and manufacturing of medical devices.
The global endotoxin market has been analyzed from four different perspectives – Test, Product, Application and Region
Excerpts from ‘By Endotoxin Test’
The global endotoxin market has been segmented majorly into three test segments: –
- Monocyte Activation Assay Test (MAT)
- Limulus Amebocyte Lysate Test (LAL)
- Rabbit Test
Rabbit endotoxin test is commonly performed for the detection of pyrogen and endotoxin which are responsible for inducing body temperature. This is authorized for the detection of endotoxin by the European Pharmacopeia, US Pharmacopeia, and Japanese Pharmacopeia. It is the most conventional endotoxin testing and has the most widespread usage base. The incumbent statis of endotoxin testing is attributed to better sensitivity of the test, low cost, and less turnaround time. Conversely imposing of new regulations on animal use for endotoxin testing restrains the market growth. For instance, in July 2021, The European Pharmacopoeia announced that they will end the conventional rabbit pyrogen test in the next five years and they encouraged the industry to adopt the monocyte-activation test instead of the rabbit pyrogen test.
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Excerpts from ‘By Product’
The global endotoxin testing market based on products has been segmented into instruments (mycoplasma detection & removal PCR, mycoplasma detection kit, mycoplasma elimination cocktail, mycoplasma detection), consumables (reagent, reagent water, series tube reader, microplate reader, endotoxin removal products, and low endotoxin recovery products and elimination custom services, accessories, instrumentation) and endotoxin testing software.
Endotoxin consumables are demonstrating the largest highest market growth owing to an increase in demand for endotoxin tests in chronic and infectious diseases management, continuous research and development in reagent sensitivity, cost-cutting and less turnaround time fueling the market growth of this segment.
Excerpts ‘By Application’
The global endotoxin testing market based on application has been segmented into: –
- Food & Beverage Manufacturing
- Medical Device Manufacturing
- Pharmaceutical Manufacturing
- Raw Materials Production
Among these, medical devices segment has shown significant potential for market growth owing to the growing requirement for endotoxin-free clearance of devices, and an increase in the number of medical devices manufacturing companies. Most of the medical devices are meant for implantation in the human body, thus necessating it to be free from pyrogen and endotoxin.
Excerpts from ‘By Region’
The global endotoxin market has been segmented into :-
- North America
- Asia Pacific
- Rest of the World (RoW)
North America is expected to command the largest share in The global endotoxin testing market, followed by Asia Pacific, Europe & Rest of the World (RoW).
North America dominated the global endotoxin testing market, followed by Asia Pacific. The large share of North America in the global market can be attributed to the presence of robust lifesciences infrastructure, high requirement for endotoxin testing, and rising FDA approvals for endotoxin testing tools.. Furthermore, the Asia Pacific region is also expected to present prominent market growth. Owing to the presence of a high number of pharmaceutical, medical device, and biotechnology companies and their requirements for advanced kits and systems for testing driving the market growth.
Excerpts from ‘Competitive Landscape’
The prominent players operating in the global endotoxin testing market are: –
- Merck KGaA
- Eurofins Scientific
- Lonza Group AG
- Xiamen Bioendo Technology Co., Ltd
- BIOGENUIX MEDSYSTEMS PVT.LTD
- Genscript Biotech Corp
- FUJIFILM Wako Pure Chemical Corporation
- Nelson Laboratories, LLC
Report Scope & Segmentation:
Market Size in 2021
USD ~ 979.6 Million
Revenue forecast in 2030
USD ~ 1,893 Million
CAGR of ~ 7.60% from 2022 to 2030
Base year for estimation
By Material Type, By Usage, By End User
North America, Europe, Asia Pacific, and the Rest of the World (ROW)
Table of Content:
- Market Ecosystem
- Timeline Under Consideration
- Historical Years – 2020
- Base Year – 2021
- Forecasted Years – 2022 to 2030
- Currency Used in the Report
- RESEARCH METHODOLOGY
- Research Approach
- Data Collection Methodology
- Data Sources
- Secondary Sources
- Primary Sources
- Market Estimation Approach
- Bottom Up
- Top Down
- Market Forecasting Model
- Limitations and Assumptions
- PREMIUM INSIGHTS
- Current Market Trend (COVID-19 Perspective)
- Key Players & Competitive Positioning (2021)
- MARKET DYNAMICS
VALUE PROPOSITIONS RELATED TO THE REPORT:
- Powered with Complimentary Analyst Hours and Expert Interviews with Each Report
- Comprehensive quantitative and qualitative insights at segment and sub-segment level
- Covid 19 impact trends and perspective
- Granular insights at global/regional/country level
- Deep-rooted insights on market dynamics (drivers, restraints, opportunities) and business environment
- Blanket coverage on competitive landscape
- Winning imperatives
- Exhaustive coverage on ‘Strategic Developments’ registered by leading players of the market
- Distributor Landscape Assessment
- Pricing Intelligence
- Customer Base Assessment
- Investment & Initiatives Analysis
- ‘Business Profile’ of Key Players
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