Endotoxin Testing Market By Product Type (Endotoxin Detection Kits & Reagents, Instruments & Systems, Consumables & Accessories), By Test Type (LAL Test, MAT Test, Rabbit Pyrogen Test, Recombinant Factor C (rFC) Assay), By Application (Medical Device Manufacturing, Pharmaceutical Manufacturing, Raw Materials Production) - Growth, Future Prospects & Competitive Analysis, 2018 – 2026

"Endotoxin testing market to exhibit profitable growth during the forecast period"

The global endotoxin testing market is growing significantly, expected to grow at a CAGR of 9.5% from 2018 - 2026. New technological progresses in LAL test is generating major revenue in the global market. Favorable public initiatives in the biotechnology and pharmaceutical sector across various developing countries, and new product launch along with rise in medical device manufacturing will drive the overall market growth. Additionally, increasing lab tests with higher acceptance of instruments, systems and kits will further assist in the growth of the global endotoxin testing market.

Improvements in automating data collection/software, and management and reporting processes are also expected to drive the growth of the market. Technological improvements in endotoxin testing along with innovative laboratory testing procedures are increasing the demand majorly in Europe and Asia Pacific. Widely used bacterial endotoxin methods comprise turbidimetric method (low limits of detection), gel clot method (qualitative), and custom method development. These are mainly utilized for medical device manufacturing, pharmaceutical manufacturing, packaging manufacture and raw materials production. Rising expansion of medical devices, biotechnology and pharmaceutical sector in nations such as China, India, Brazil and others along with healthcare infrastructure improvements will spur revenue growth in this market. However, stringent regulations on animal testing, issues in low endotoxin recovery (LER) products, and high cost of endotoxin detection systems may hamper the growth of the market during the forecast period.

Market Synopsis  

Endotoxin Testing Market

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"Advanced instruments and systems expected to expand in the developing nations by the end of 2026"

Endotoxin testing is imperative in the course of drug and medical device development for ensuring the absence of pyrogenic substances. Availability of top detection systems are gaining traction in the global market from top manufacturers such as ToxinSensor™ endotoxin detection system, PyroMAT™ System, Kinetic-QCLTM Kinetic Chromogenic LAL Assay, PYROGENTTM Gel Clot LAL Assay and others. New product launch with strong linearity, high sensitivity and reproducibility will further generate revenue share globally.  However, as of late, different issues have emerged about the discovery dependability of LAL testing for specific samples in which endotoxin is not fully covered. This alleged low endotoxin recovery phenomenon is a relevant issue nominated by the endotoxin testing community.

Endotoxin Testing Market

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"LAL test type segment is expected to register higher growth in the developing nations by the end of 2026"

Methods such as limulus amoebocyte lysate (LAL) assay, rabbit pyrogen test (RPT), monocyte activation test (MAT) and recombinant factor C assay are employed in endotoxin testing, of which LAL testing will witness the fastest growth during the forecast period from 2018 to 2026. LAL method had been used for pyrogen testing method for over 30 years for the detection of endotoxin. Monocyte activation test is an in-vitro method and is newer to the industry. Growing demand for animal-free testing methods and the proven high precision of LAL tests contribute to the dominance of this segment. It is observed that LAL tests are continuously replacing RBTs and are being recommended by pharmaceutical companies and international bodies.  Additionally, expanding availability of several types of methods, such as chromogenic endotoxin testing, gel clot endotoxin testing, and turbidimetric method, are likely to lift the potential of the overall market globally. Overall demand of biologics has prompted the need for more LAL tests and tachypleus amebocyte lysate testing globally.

Endotoxin Testing Market

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"Market leaders in the U.S. are involved in extensive research for development of cost-efficient testing kits and instruments"

North America captured the largest revenue share in 2017, followed by Europe in the endotoxin testing market in 2016, and it is expected that the region will continue to retain its dominance through the forecast period 2018-2026. Being large and diversified, the U.S. is the largest and the most critical market for endotoxin testing. The country houses several occupations ranging between scientific researches and manufacturing. Expanding number of techniques with endotoxin testing alongside rising approvals from the U.S. FDA are relied upon to drive development of the worldwide endotoxin testing market. The Asia Pacific market is expected to indicate fast development in endotoxin testing market, attributable to heavy investments in pharmaceutical and biotechnology industries, along with rising adoption of advanced kits and systems for cancer research and development of vaccines, biologics, and drugs. Moreover, rising burden of chronic diseases in developed nations is also expected to drive the inclination of researchers toward advanced technologies.

Endotoxin Testing Market

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"Expansion of manufacturing facility, and availability of advance test kits and instruments to be witnessed in developing nations"

Major players in the endotoxin testing market are Accugen Labs, Wako Chemicals USA, Inc., Charles River Laboratories, Inc., Pacific BioLabs, Sigma-Aldrich Co. LLC.

Lonza, STERIS, Nelson Laboratories, LLC, Bio-Synthesis Inc, Biogenuix, Ellab A/S, GenScript Corporation, Thermo Fisher Scientific, Inc., Merck KGaA and others. Top manufacturers are employing growth strategies along with approvals for new endotoxin testing detection kits and systems. For instance, In Nov 2018, Lonza declared recombinant Factor C assay has been utilized for endotoxin testing Emgality™ drug by Eli Lily. In 2016, Charles River Laboratories, Inc. acquired Blue Stream Laboratories, Inc. to further enhance its analytical research capabilities for biologics development and safety assessment.

Endotoxin Testing Market

Historical & Forecast Period

This study report represents analysis for each segment from 2016 to 2026 considering 2017 to be the base year. Compounded annual growth rate (CAGR) for each of the respective segments estimated for the forecast period from 2018 to 2026.

Report Scope by Segments

Endotoxin testing market report comprises current market trends and dynamics along with quantitative analysis of the global industry. The report elucidates thorough information of global endotoxin testing market by segmenting the market in terms of product type, test type, application, and geography. This report would guide healthcare professionals and market players in decision-making and strategizing market position.

Research Period  2016-2026
Base Year 2017
Forecast Period  2018-2026
Historical Year  2016
Unit  USD Million

 Product Type Segment (2016-2026; US$ Mn)
 • Endotoxin Detection Kits & Reagents
 • Instruments & Systems
 • Consumables & Accessories

 Test Type Segment (2016–2026; US$ Mn)
 • LAL Test
   o Chromogenic Tests
   o Turbidimetric Tests
   o Gel Clot Tests
 • MAT Test
 • Rabbit Pyrogen Test
 • Recombinant Factor C (rFC) Assay

 Application Segment (2016-2026; US$ Mn)
 • Medical Device Manufacturing
 • Pharmaceutical Manufacturing
 • Raw Materials Production

 Geography Segment (2016–2026; US$ Mn)
 • North America (United States and Canada)
 • Europe (U.K., Germany, Rest of Europe)
 • Asia Pacific (China, Japan, Rest of Asia Pacific)
 • Latin America (Brazil, Mexico, Rest of Latin America)
 • Middle East and Africa (GCC, Rest of MEA)

The current report also comprehends qualitative market assessment factors such as market trends, key market drivers, restraints and opportunities that gives a better market understanding of the overall endotoxin testing market. Furthermore, the report also comprises graphical representation of competitive landscape based on their market initiatives and strategies, product portfolio and business strengths.

Key questions answered in this report

  • What are the current market trends and dynamics in the endotoxin testing market and valuable opportunities for emerging players?
  • What is the positioning of major key players operating in the market?
  • Which segment accounts for the fastest CAGR during the forecast period?
  • Which end-user holds a larger market share and why?
  • What is the impact of high cost of screening tests on the endotoxin testing market?
  • To what extent are low and middle-income economies investing in the endotoxin testing market?
  • What are the prevailing trends and dynamics in emerging markets such as Japan, Latin America and Middle East & Africa?
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Executive Summary - Brief Global Market Size - Current & Forecast
Regional Market Size - North America
Country Market Size - US
Company Profile – 1
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Published Date:  Dec 2018
Category:  Biotechnology
Report ID:   59470
Report Format:   PDF
Pages:   120
Rating:    4.4 (56)
Delivery Time: 24 Hours to 48 Hours   
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