Endotoxin Testing Market - Global Industry Trend Analysis 2012 to 2017 and Forecast 2017 - 2025


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The gram-negative organisms release endotoxins, the presence or absence of which is determined by the endotoxins tests. Endotoxin testing is carried out at different phases of the manufacture and development of bulk lot release testing, raw material testing and final product release testing. Endotoxin testing is used in various industries such as medical devices, biopharmaceuticals, research, and pharmaceutical to name a few.

In early 1950’s, Frederick Bang discovered that the horseshoe crab' s blood cells contain a clotting agent which attached to the endotoxins produced by gram-negative bacteria. In 1983, the test was further approved by the FDA. Soon FDA, established guidelines for Limulus Amebocyte Lysate testing of medical devices and pharmaceuticals in 1987. Endotoxins can be found in water, air, via human contact, soil and any other non-sterile environment. 

Endotoxin Testing Market: Drivers and Restraints

Limulus Amebocyte Lysate assay is the choice of endotoxin test used in the parenteral pharmaceuticals. Tachypleus Amebocyte Lysate is one more approved test, but only in Asia. The demand of biologics has triggered the need for more limulus amebocyte lysate and tachypleus amebocyte lysate testing. As more countries are moving toward economic development, healthcare needs are expected to increase and so will the product development and research scenario. This is expected to create an exponential demand for the exotoxins testing market.

Endotoxin Testing Market: Segmentation

On the testing methods, the endotoxin testing market can be segmented as:

  • Gel Clot Endotoxin Test
  • Chromogenic Endotoxin Test
  • Turbidimetric Endotoxin Test 

On the type of products the endotoxin testing market can be segment as: 

  • Endotoxin Detection Products
  • LAL Test Reagents
  • Mycoplasma Detection & Removal
  • PCR Mycoplasma Detection Kit
  • Mycoplasma Elimination Cocktail
  • Mycoplasma Detection and Elimination Custom Services
  • Accessories
  • Instrumentation
    • Series Tube Reader
    • Microplate Reader
  • Endotoxin Removal Products
  • Low Endotoxin Recovery (LER) Products
  • Lipopolysaccharides 

On the basis of application the endotoxin testing market can be segment as

  • Medical device manufacturing
  • Pharmaceutical manufacturing
  • Packaging manufacture
  • Raw materials production 

Endotoxin Testing Market: Overview

The demand for the endotoxins market is expected to propel in the near future as industry players are bringing in newer methods such as the USP chromogenic method by Sigma-Aldrich Co. LLC or the Endosafe-PTS test by Charles River Laboratories, Inc. Moreover, industry is consolidating by acquiring companies’ expertise in proving the e   ndotoxin test. For instance, in December 2016, Fujifilm agreed to acquire Wako Pure Chemical Industries, Ltd. for US$ 1.40 billion. The synergy is expected to help Fujifilm in the field of regenerative medicine, contract development and manufacturing organization and in-vitro diagnostics.

Endotoxin Testing Market: Region-wise Outlook

In terms of geography, endotoxin testing market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America is the dominating region with most established regulatory guidelines for taking care of the limulus amebocyte lysate and tachypleus amebocyte lysate shortage. Moreover, the region is experiencing many takeovers by the pharmaceutical industry to lead in the exotoxing testing market.

Economically developing region such as AsiaPacific is expected to be the fastest growing region during the forecast testing.

Endotoxin Testing Market: Key Market Participants

Some of the endotoxin testing market participants 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 and Biogenuix.

MRR.BIZ has been compiled in-depth market research data in the report after exhaustive primary and secondary research. Our team of able, experienced in-house analysts has collated the information through personal interviews and study of industry databases, journals, and reputable paid sources.

The report provides the following information:

  • Tailwinds and headwinds molding the market’s trajectory
  • Market segments based on products, technology, and applications
  • Prospects of each segment
  • Overall current and possible future size of the market
  • Growth pace of the market
  • Competitive landscape and key players’ strategies

The main aim of the report is to:

  • Enable key stakeholder’s in the market bet right on it
  • Understand the opportunities and pitfalls awaiting them
  • Assess the overall growth scope in the near term
  • Strategize effectively with respect to production and distribution

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