Home / Biotechnology / 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 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

Published: Dec 2018 | Report Code: 59470-12-18

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

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

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

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

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

2016 – Historical Year

2017 – Base Year

2018 - 2026 – 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

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.

Endotoxin Testing Product Type Segment (2016–2026; US$ Mn)

  • Endotoxin Detection Kits & Reagents
  • Instruments & Systems
  • Consumables & Accessories

Endotoxin Testing Test Type Segment (2016–2026; US$ Mn)

  • LAL Test
    • Chromogenic Tests
    • Turbidimetric Tests
    • Gel Clot Tests
  • MAT Test
  • Rabbit Pyrogen Test
  • Recombinant Factor C (rFC) Assay

Endotoxin Testing Application Segment (2016–2026; US$ Mn)

  • Medical Device Manufacturing
  • Pharmaceutical Manufacturing
  • Raw Materials Production

Geography Segment (2016–2026; US$ Mn)

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • Rest of Middle East & Africa

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?

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 Endotoxin Testing Market Portraiture
2.2. Global Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
2.3. Global Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
2.4. Global Endotoxin Testing Market, by Application, 2017 (US$ Mn)
2.5. Global Endotoxin Testing Market, by Geography, 2017 vs. 2026 (Value)

Chapter 3. Global Endotoxin Testing 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 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 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 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 Market, by Geography, 2016 – 2026 (US$ Mn)
7.1. Overview
7.2. North America Endotoxin Testing Market Analysis, 2016 – 2026
7.2.1. North America Endotoxin Testing Market, by Product Type, 2016 – 2026 (US$ Mn)
7.2.2. North America Endotoxin Testing Market, by Test Type, 2016 – 2026 (US$ Mn)
7.2.3. North America Endotoxin Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.2.4. North America Endotoxin Testing Market, by Country, 2016 – 2026 (US$ Mn)
7.2.4.1. U.S.
7.2.4.2. Canada
7.3. Europe Endotoxin Testing Market Analysis, 2016 – 2026
7.3.1. Europe Endotoxin Testing Market, by Product Type, 2016 – 2026 (US$ Mn)
7.3.2. Europe Endotoxin Testing Market, by Test Type, 2016 – 2026 (US$ Mn)
7.3.3. Europe Endotoxin Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.3.4. Europe Endotoxin Testing 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 Endotoxin Testing Market Analysis, 2016 – 2026
7.4.1. Asia Pacific Endotoxin Testing Market, by Product Type, 2016 – 2026 (US$ Mn)
7.4.2. Asia Pacific Endotoxin Testing Market, by Test Type, 2016 – 2026 (US$ Mn)
7.4.3. Asia Pacific Endotoxin Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.4.4. Asia Pacific Endotoxin Testing 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 Endotoxin Testing Market Analysis, 2016 – 2026
7.5.1. Latin America Endotoxin Testing Market, by Product Type, 2016 – 2026 (US$ Mn)
7.5.2. Latin America Endotoxin Testing Market, by Test Type, 2016 – 2026 (US$ Mn)
7.5.3. Latin America Endotoxin Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.5.4. Latin America Endotoxin Testing 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) Endotoxin Testing Market Analysis, 2016 – 2026
7.6.1. Middle East & Africa (MEA) Endotoxin Testing Market, by Product Type, 2016 – 2026 (US$ Mn)
7.6.2. Middle East & Africa (MEA) Endotoxin Testing Market, by Test Type, 2016 – 2026 (US$ Mn)
7.6.3. Middle East & Africa (MEA) Endotoxin Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.6.4. MEA Endotoxin Testing 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

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

TABLE 1 Market Snapshot: Global Endotoxin Testing Market
TABLE 2 Global Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 3 Global Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 4 Global Endotoxin Testing Market, by Application, 2017 (US$ Mn)
TABLE 5 Global Endotoxin Testing Market, by Geography, 2016–2026 (US$ Mn)
TABLE 6 North America Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 7 North America Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 8 North America Endotoxin Testing Market, by Application, 2017 (US$ Mn)
TABLE 9 North America Endotoxin Testing Market, by Country, 2016–2026 (US$ Mn)
TABLE 10 Europe Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 11 Europe Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 12 Europe Endotoxin Testing Market, by Application, 2016–2026 (US$ Mn)
TABLE 13 Europe Endotoxin Testing Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 14 Latin America Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 15 Latin America Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 16 Latin America Endotoxin Testing Market, by Application, 2016–2026 (US$ Mn)
TABLE 17 Latin America Endotoxin Testing Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 18 Asia Pacific Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 19 Asia Pacific Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 20 Asia Pacific Endotoxin Testing Market, by Application, 2016–2026 (US$ Mn)
TABLE 21 Asia Pacific Endotoxin Testing Market, by Country/Region, 2016–2026 (US$ Mn)
TABLE 22 Middle East & Africa Endotoxin Testing Market, by Product Type, 2017 (US$ Mn)
TABLE 23 Middle East & Africa Endotoxin Testing Market, by Test Type, 2017 (US$ Mn)
TABLE 24 Middle East & Africa Endotoxin Testing Market, by Application, 2016–2026 (US$ Mn)
TABLE 25 Middle East & Africa Endotoxin Testing 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)

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