Market Overview

Market Overview:

The global amebocyte lysate market size was significantly robust in 2020 and is expected to register a steady revenue CAGR over the forecast period. Growing adoption of amebocyte lysate testing for quality testing and assurance of pharmaceutical products such as drugs and Vaccines and increasing incorporation of endotoxin testing workflow in research and development activities in Biotechnology and medical devices industries are key factors expected to drive market revenue growth over the forecast period.

Amebocyte lysate testing, also known as bacterial endotoxin testing, is used to determine presence and quantity of bacterial endotoxin in the environment. Research studies on blood clotting mechanism of Atlantic horseshoe crab, Limulus polyphemus, showed its extreme sensitivity to endotoxins. Later, an endotoxin test was developed by mixing blood clotting factors of amebocytes with drug samples, wherein the presence of endotoxin coagulated the sample. The FDA approved Limulus Amebocyte Lysate (LAL) test as an alternative to exhaustive and expensive rabbit pyrogen test for testing drugs, parenteral injectable, and implantable medical devices. LAL is derived from amebocytes of horseshoe crab and is extremely sensitive to lipopolysaccharides, which is also known as endotoxin, found in gram-negative bacterial cell wall. In Asia, a test was developed using amebocyte cells of local horseshoe crabs, Tachypleus gigas, called Tachypleus amebocyte lysate test, for validation and quality assurance of liquid biologicals for marketing and commercialization. Amebocyte lysate test is used to control presence of pyrogens at all stages of medicine and biotherapeutics production and manufacturing.

Market Dynamics:
Drivers:

Amebocyte lysate tests are carried out in wide range of biomedical infrastructure such as pharmaceutical companies, Medical Device manufacturing facilities, and research centers. Regulation and control of presence of endotoxin or pyrogen in medicines, specifically parenteral injectable, and implantable devices is imperative to prevent the onset of severe infections or adverse immune responses in an individual. In addition, high sensitivity of amebocyte lysate as compared to other assays in detecting endotoxin has increased its importance in monitoring high-purity water which is a key component for the production of biologicals, drugs and medications, and medical devices. In addition, amebocyte lysate test has been extensively used in research and development studies to study clinical and environmental effects of endotoxins and pyrogens. These factors are expected to contribute significantly to revenue growth of the market going ahead.

Restraints:

Increasing variations in sensitivity and specificity of amebocyte lysate to endotoxin and decreasing population of horseshoe crabs have increased challenges for the biotechnology industry. In addition, growing vaccine production and rising preference for personalized medicine that necessitates individual product testing has increased the strain on lysate resources and these factors are expected to restrain market growth to a certain extent over the forecast period.

Type Outlook:

Based on type, the global market has been segmented into Limulus amebocyte lysate and Tachypleus amebocyte lysate. Limulus amebocyte lysate segment is expected to account for a significantly large revenue share over the forecast period. Limulus amebocyte lysate is the standard in-vitro assay widely performed to detect and quantify bacterial endotoxins. LAL reagents are also used to test for the presence of endotoxin in medical devices, injectable pharmaceuticals, and biologics. These key factors are expected to drive revenue growth of the segment during the forecast period.

Application Outlook:

Based on application, the global market has been segmented into drug testing, clinical diagnostics, and others. Amebocyte lysate testing has been extensively used for quality assurance of injectable drugs and medical devices. Bacterial endotoxin workflows are employed in the pharmaceutical industry to detect and quantify the presence of harmful bacteria in parenteral drugs to avoid side effects such as inflammatory responses and this is expected to contribute to revenue growth of the drug testing segment over the forecast period.

Regional Outlook:

Based on regional analysis, North America is expected to account for largest revenue share in the global market over the forecast period. Growing focus on development of advanced and innovative biotherapeutics in the region has been boosting demand for amebocyte lysate testing owing to growing risk of endotoxin contamination. Rising preference for personalized medicine and rapid progress of drug development and research have further increased importance of endotoxin testing workflows in the pharmaceutical industry. Presence of major companies, established pharmaceutical industry, and growing investment to develop advanced biologics and medical devices are some key factors expected to fuel revenue growth of the market in the region.

Companies Profiled in the Report:

Key companies in the market include Thermo Fisher Scientific, Inc., Merck & Co., Inc., Associates of Cape Cod, Inc., Charles River Laboratories International, Inc., GenScript; Lonza Group, Wako Chemicals USA, Inc., and Microcoat Biotechnologie GmbH. Key companies are engaged in extensive R&D activities and investing heavily to accelerate drug research and development to meet the growing global demand. Mergers & acquisitions, joint ventures, collaborations, and product launches are key strategies undertaken by major companies to gain a robust footing in the market.

Segments Covered in the Report:

This report offers historical data points and forecasts and revenue growth at a global, regional, and country level, and provides analysis, industry trends, and consumption pattern details for each region, major country, and segment from 2018 to 2028. The global amebocyte lysate market report includes industry trends, drivers, restraints, opportunities, threats, market strategies, segment revenue, and market share contribution by each regional and country market. In addition, the report offers industry analysis and competitive landscape, company financials, and impact analysis. The report includes a detailed view of the global amebocyte lysate market, along with changing dynamics and trends, scenarios, detailed market and regional segmentation, regional landscape, analysis and evaluation, major investments, product offerings, product launches, and details of historical, current, and projected revenues.

For the purpose of this report, Reports and Data has segmented the global amebocyte lysate market on the basis of type, application, and region:

Type Outlook (Revenue, USD Billion; 2018-2028)

  • Limulus Amebocyte Lysate
  • Tachypleus Amebocyte Lysate

Application Outlook (Revenue, USD Billion; 2018-2028)

  • Drug Testing
  • Clinical Diagnostics
  • Others

Regional Outlook (Revenue, USD Billion; 2018-2028)

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • Italy
    • France
    • BENELUX
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • Saudi Arabia
    • U.A.E.
    • Israel
    • South Africa
    • Rest of MEA

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