Endotoxin Testing Market

The endotoxin testing market is expected to exhibit profitable growth during the forecast period.

The global endotoxin testing market is growing significantly and is expected to grow at a CAGR of 9.5% from 2018 to 2026. New technological progress in LAL testing is generating major revenue in the global market. Favorable public initiatives in the biotechnology and pharmaceutical sectors across various developing countries and new product launches, along with a rise in medical device manufacturing, will drive the overall market’s 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 and 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, primarily in Europe and Asia-Pacific. Widely used bacterial endotoxin methods comprise the turbidimetric method (low limits of detection), the gel clot method (qualitative), and custom method development. These are mainly utilized for medical device manufacturing, pharmaceutical manufacturing, packaging manufacturing, and raw material production. Rising expansion of the medical devices, biotechnology, and pharmaceutical sectors in nations such as China, India, Brazil, and others, along with improvements to healthcare infrastructure, will spur revenue growth in this market. However, stringent regulations on animal testing, issues with low endotoxin recovery (LER) products, and the high cost of endotoxin detection systems may hamper the growth of the market during the forecast period.

Market Synopsis

By the end of 2026, advanced instruments and systems are expected to expand in developing countries.

Endotoxin testing is imperative in the course of drug and medical device development to ensure the absence of pyrogenic substances. The availability of top detection systems is gaining traction in the global market from top manufacturers such as ToxinSensorTM endotoxin detection system, PyroMATTM System, Kinetic-QCLTM Kinetic Chromogenic LAL Assay, PYROGENTTM Gel Clot LAL Assay, and others. A 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 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.

The LAL test-type segment is expected to grow faster in developing countries 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. The LAL method has been used for pyrogen testing for over 30 years for the detection of endotoxins. Monocyte activation testing is an in vitro method that 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, the expanding availability of several types of methods, such as chromogenic endotoxin testing, gel clot endotoxin testing, and the turbidimetric method, is likely to lift the potential of the overall market globally. Global demand for biologics has increased the demand for LAL tests and Tachypleus amebocyte lysate testing.

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

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

In developing countries, manufacturing facilities will be expanded, as will the availability of advanced test kits and instruments.

Major players in the endotoxin testing market are Accugen Labs, Wako Chemicals USA, Inc., Charles River Laboratories, Inc., Pacific BioLabs, and 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 example, in November 2018, Lonza announced that a recombinant Factor C assay had been used for endotoxin testing of Eli Lily’s EmgalityTM drug. In 2016, Charles River Laboratories, Inc. acquired Blue Stream Laboratories, Inc. to further enhance its analytical research capabilities for biologics development and safety assessment.

Periods of History and Forecast

This study report includes an analysis for each segment from 2016 to 2026, with 2017 as the base year. The compound annual growth rate (CAGR) for each of the respective segments is estimated for the forecast period from 2018 to 2026.

Report Scope by Segments

The endotoxin testing market report comprises current market trends and dynamics along with a quantitative analysis of the global industry. The report elucidates thorough information about the global endotoxin testing market by segmenting the market in terms of product type, test type, application, and geography. This report will assist healthcare professionals and market participants in making decisions and strategizing market positions.

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

Key questions are answered in this report.

• What are the current market trends and dynamics in the endotoxin testing market, and what are the valuable opportunities for emerging players?
• What is the positioning of the major 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 the 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, the Middle East, and Africa?

Chapter 1. Preface
1.1. Report Scope and Description
1.1.1. Study Purpose
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I-Secondary Research
1.3.2. Phase II-Primary Research
1.3.3. Phase III-Expert Panel Review
1.3.4. Approach Adopted
1.3.4.1. Top-Down Approach
1.3.4.2. Bottom-Up Approach
1.3.5. Assumptions
1.3.6. Market Segmentation

Chapter 2. Executive Summary
2.1. Global ET Market Portraiture
2.2. Global ET Market, by Product Type, 2017 (US$ Mn)
2.3. Global ET Market, by Test Type, 2017 (US$ Mn)
2.4. Global ET Market, by Application, 2017 (US$ Mn)
2.5. Global ET Market, by Geography, 2017 vs. 2026 (Value)

Chapter 3. Global Endotoxin Testing (ET) Market: Market Dynamics and Future Outlook
3.1. Market Overview
3.2. Current Scenario: New Product Launches, Increase in Animal Free Testing
3.3. Drivers
3.4. Challenges
3.5. Opportunities
3.6. Attractive Investment Proposition, by Geography, 2017
3.7. Competitive Landscape
3.7.1. Competitive Landscape, by Key Players, 2017

Chapter 4. Global Endotoxin Testing (ET) Market, by Product Type, 2016 – 2026 (US$ Mn)
4.1. Overview
4.2. Endotoxin Detection Kits & Reagents
4.3. Instruments & Systems
4.4. Consumables & Accessories

Chapter 5. Global Endotoxin Testing (ET) Market, by Test Type, 2016 – 2026 (US$ Mn)
5.1. Overview
5.2. LAL Test
5.2.1. Chromogenic Tests
5.2.2. Turbidimetric Tests
5.2.3. Gel Clot Tests
5.3. MAT Test
5.4. Rabbit Pyrogen Test
5.5. Recombinant Factor C (rFC) Assay

Chapter 6. Global Endotoxin Testing (ET) Market, by Application, 2016 – 2026 (US$ Mn)
6.1. Overview
6.2. Medical Device Manufacturing
6.3. Pharmaceutical Manufacturing
6.4. Raw Materials Production

Chapter 7. Global Endotoxin Testing (ET) Market, by Geography, 2016 – 2026 (US$ Mn)
7.1. Overview
7.2. North America ET Market Analysis, 2016 – 2026
7.2.1. North America ET Market, by Product Type, 2016 – 2026 (US$ Mn)
7.2.2. North America ET Market, by Test Type, 2016 – 2026 (US$ Mn)
7.2.3. North America ET Market, by Application, 2016 – 2026 (US$ Mn)
7.2.4. North America ET Market, by Country, 2016 – 2026 (US$ Mn)
7.2.4.1. U.S.
7.2.4.2. Canada
7.3. Europe ET Market Analysis, 2016 – 2026
7.3.1. Europe ET Market, by Product Type, 2016 – 2026 (US$ Mn)
7.3.2. Europe ET Market, by Test Type, 2016 – 2026 (US$ Mn)
7.3.3. Europe ET Market, by Application, 2016 – 2026 (US$ Mn)
7.3.4. Europe ET Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.3.4.1. U.K.
7.3.4.2. Germany
7.3.4.3. Rest of Europe
7.4. Asia Pacific ET Market Analysis, 2016 – 2026
7.4.1. Asia Pacific ET Market, by Product Type, 2016 – 2026 (US$ Mn)
7.4.2. Asia Pacific ET Market, by Test Type, 2016 – 2026 (US$ Mn)
7.4.3. Asia Pacific ET Market, by Application, 2016 – 2026 (US$ Mn)
7.4.4. Asia Pacific ET Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.4.4.1. Japan
7.4.4.2. China
7.4.4.3. Rest of APAC
7.5. Latin America ET Market Analysis, 2016 – 2026
7.5.1. Latin America ET Market, by Product Type, 2016 – 2026 (US$ Mn)
7.5.2. Latin America ET Market, by Test Type, 2016 – 2026 (US$ Mn)
7.5.3. Latin America ET Market, by Application, 2016 – 2026 (US$ Mn)
7.5.4. Latin America ET Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.5.4.1. Brazil
7.5.4.2. Mexico
7.5.4.3. Rest of Latin America
7.6. Middle East & Africa (MEA) ET Market Analysis, 2016 – 2026
7.6.1. Middle East & Africa (MEA) ET Market, by Product Type, 2016 – 2026 (US$ Mn)
7.6.2. Middle East & Africa (MEA) ET Market, by Test Type, 2016 – 2026 (US$ Mn)
7.6.3. Middle East & Africa (MEA) ET Market, by Application, 2016 – 2026 (US$ Mn)
7.6.4. MEA ET Market, by Region, 2016 – 2026 (US$ Mn)
7.6.4.1. GCC
7.6.4.2. Rest of MEA

Chapter 8. Company Profiles
8.1. Accugen Labs
8.1.1. Business Description
8.1.2. Financial Information (Subject to data availability)
8.1.3. Product Portfolio
8.1.4. Key Developments
8.2. Wako Chemicals USA, Inc.
8.3. Charles River Laboratories, Inc.
8.4. Pacific BioLabs
8.5. Sigma-Aldrich Co. LLC.
8.6. Lonza
8.7. STERIS
8.8. Nelson Laboratories, LLC
8.9. Bio-Synthesis Inc
8.10. Biogenuix
8.11. Ellab A/S
8.12. GenScript Corporation
8.13. Thermo Fisher Scientific, Inc.
8.14. Merck KGaA

List of Figures

FIG. 1 Global Endotoxin Testing (ET) Market: Research Methodology
FIG. 2 Market Size Estimation – Top Down & Bottom up Approach
FIG. 3 Global ET Market Segmentation
FIG. 4 Global ET Market, by Product Type, 2017 (US$ Mn
FIG. 5 Global ET Market, by Test Type, 2017 (US$ Mn)
FIG. 6 Global ET Market, by Application, 2017 (US$ Mn)
FIG. 7 Global ET Market, by Geography, 2017 (US$ Mn)
FIG. 8 Attractive Investment Proposition, by Geography, 2017
FIG. 9 Global Market Positioning of Key ET Market Manufacturers, 2017
FIG. 10 Global Endotoxin Detection Kits & Reagents Market, 2016–2026 (US$ Bn)
FIG. 11 Global Instruments & Systems Market for Endotoxin Testing, 2016–2026 (US$ Bn)
FIG. 12 Global Consumables & Accessories Market for Endotoxin Testing, 2016–2026 (US$ Bn)
FIG. 13 Global LAL Test Type for ET Market, 2016–2026 (US$ Bn)
FIG. 14 Global MAT Test Type for ET Market, 2016–2026 (US$ Bn)
FIG. 15 Global Rabbit Pyrogen Test Type for ET Market, 2016–2026 (US$ Bn)
FIG. 16 Global Recombinant Factor C (rFC) Assay Test Type for ET Market, 2016–2026 (US$ Bn)
FIG. 17 Global ET Market for Medical Device Manufacturing Application, 2016–2026 (US$ Bn)
FIG. 18 Global ET Market for Pharmaceutical Manufacturing Manufacturing Application, 2016–2026 (US$ Bn)
FIG. 19 Global ET Market for Raw Materials Production Application, 2016–2026 (US$ Bn)
FIG. 20 U.S. ET Market, 2016–2026 (US$ Mn)
FIG. 21 Canada ET Market, 2016–2026 (US$ Mn)
FIG. 22 U.K. ET Market, 2016–2026 (US$ Mn)
FIG. 23 Germany ET Market, 2016–2026 (US$ Mn)
FIG. 24 Rest of Europe ET Market, 2016–2026 (US$ Mn)
FIG. 25 Japan ET Market, 2016–2026 (US$ Mn)
FIG. 26 China ET Market, 2016–2026 (US$ Mn)
FIG. 27 Rest of Asia Pacific ET Market, 2016–2026 (US$ Mn)
FIG. 28 Brazil ET Market, 2016–2026 (US$ Mn)
FIG. 29 Mexico ET Market, 2016–2026 (US$ Mn)
FIG. 30 Rest of Latin America ET Market, 2016–2026 (US$ Mn)
FIG. 31 GCC ET Market, 2016–2026 (US$ Mn)
FIG. 32 Rest of Middle East & Africa ET Market, 2016–2026 (US$ Mn)

List of Tables

TABLE 1 Market Snapshot: Global Endotoxin Testing (ET) Market
TABLE 2 Global ET Market, by Product Type, 2017 (US$ Mn)
TABLE 3 Global ET Market, by Test Type, 2017 (US$ Mn)
TABLE 4 Global ET Market, by Application, 2017 (US$ Mn)
TABLE 5 Global ET Market, by Geography, 2016–2026 (US$ Mn)
TABLE 6 North America ET Market, by Product Type, 2017 (US$ Mn)
TABLE 7 North America ET Market, by Test Type, 2017 (US$ Mn)
TABLE 8 North America ET Market, by Application, 2017 (US$ Mn)
TABLE 9 North America ET Market, by Country, 2016–2026 (US$ Mn)
TABLE 10 Europe ET Market, by Product Type, 2017 (US$ Mn)
TABLE 11 Europe ET Market, by Test Type, 2017 (US$ Mn)
TABLE 12 Europe ET Market, by Application, 2016–2026 (US$ Mn)
TABLE 13 Europe ET Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 14 Latin America ET Market, by Product Type, 2017 (US$ Mn)
TABLE 15 Latin America ET Market, by Test Type, 2017 (US$ Mn)
TABLE 16 Latin America ET Market, by Application, 2016–2026 (US$ Mn)
TABLE 17 Latin America ET Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 18 Asia Pacific ET Market, by Product Type, 2017 (US$ Mn)
TABLE 19 Asia Pacific ET Market, by Test Type, 2017 (US$ Mn)
TABLE 20 Asia Pacific ET Market, by Application, 2016–2026 (US$ Mn)
TABLE 21 Asia Pacific ET Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 22 Middle East & Africa ET Market, by Product Type, 2017 (US$ Mn)
TABLE 23 Middle East & Africa ET Market, by Test Type, 2017 (US$ Mn)
TABLE 24 Middle East & Africa ET Market, by Application, 2016–2026 (US$ Mn)
TABLE 25 Middle East & Africa ET Market, by Region, 2016–2026 (US$ Mn)
TABLE 26 Accugen Labs: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 27 Wako Chemicals USA, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 28 Charles River Laboratories, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 29 Pacific BioLabs: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 30 Sigma-Aldrich Co. LLC.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 31 Lonza: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 32 STERIS: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 33 Nelson Laboratories, LLC: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 34 Bio-Synthesis Inc: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 35 Biogenuix: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 36 Ellab A/S: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 37 GenScript Corporation: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 38 Thermo Fisher Scientific, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
TABLE 39 Merck KGaA: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)