Endotoxins happen to be toxic substances that are produced by the outer membrane of certain gram-negative bacteria. They are also known as lipopolysaccharides (LPS) and can cause a range of harmful effects in humans and animals. Endotoxins are released when the bacteria are killed or break down, which can occur during an infection, or when gram-negative bacteria are present in the environment or on surfaces. The structure of endotoxins consists of three main components: lipid A, core polysaccharide, and O antigen. Lipid A is the toxic component of endotoxins and can stimulate the immune system to produce a range of harmful effects, such as fever, inflammation, septic shock, and even death in severe cases. Endotoxins can be found in a variety of sources, including food, water, air, medical devices, and pharmaceutical products. They are especially concerning in medical settings, as they can be present in surgical instruments, intravenous catheters, and other medical devices, and can cause serious infections and complications in patients.

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Detecting and removing endotoxins is therefore important in ensuring the safety and effectiveness of medical treatments, as well as in maintaining food and environmental safety. The Limulus Amebocyte Lysate (LAL) assay and recombinant Factor C (rFC) assay happen to be the most commonly used methods for detecting endotoxins in various samples. The recombinant factor C (rFC) assay is extremely effective as it works by utilizing a recombinant form of Factor C, which is a key protein involved in the LPS recognition pathway in horseshoe crabs. The recombinant Factor C protein is produced using genetic engineering techniques and can be manufactured in large quantities, ensuring a consistent supply for testing purposes. At the time when endotoxins are present in a sample, they interact with the recombinant Factor C protein, and this causes a conformational change that leads to the activation of an enzymatic cascade. This enzymatic reaction results in the production of a fluorescent or chromogenic signal, which can be detected using specialized equipment. Owing to its efficacy in detecting this toxic bacteria, the global recombinant factor C assay market is growing aggressively. The growth of global recombinant factor C assay market will be drawn backwards due to adverse decline in the horseshoe crab and fear of their extinction. On the other hand, the global recombinant factor C assay market will make massive money owing to rising popularity of newer rFC methods and their consideration as sustainable solution for testing endotoxins.

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Key Takeaways of the Report:

  • Global recombinant factor C assay market was valued at US$ 21 Mn in 2022 growing at a CAGR of 14% over the forecast period (2023 – 2031).
  • The growth of the global recombinant factor C assay market is being driven by the surge in the need for alternative endotoxin detection tests. Along with this, the growing demand for search and adoption of an animal-free endotoxin testing process also helps the market grow.
  • The region of Asia Pacific will account for most of the money made by the global recombinant factor C assay market at the rapid rate in next couple of years. China and India are heavily investing on the advancement of their healthcare sector. Along with entry of several multinational companies in the region is driving the growth of the market.

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Global Recombinant Factor C Assay Market Competitors:

  • BioVendor, LLC
  • Creative Biolabs
  • Eli Lilly
  • Lonza
  • Other Market Participants

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Global Recombinant Factor C Assay Market:

By Type

  • PyroGene
    • Routine
    • Inhibition/ Enhancement
    • RSE/ CSE
    • Initial Qualification
  • EndoNext
    • EndoZyme II
    • EndoZyme II GO
    • EndoLisa

By Application

  • In-process testing
  • Final product testing
  • Water testing
  • Testing plant-based material

By End User

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Contract Research Organizations (CROs)
  • Research Centers
  • Non-profits and Federal Government
  • Others

By Region

  • North America (U.S., Canada, Mexico, Rest of North America)
  • Europe (France, The UK, Spain, Germany, Italy, Nordic Countries (Denmark, Finland, Iceland, Sweden, Norway), Benelux Union (Belgium, The Netherlands, Luxembourg), Rest of Europe
  • Asia Pacific (China, Japan, India, New Zealand, Australia, South Korea, Southeast Asia (Indonesia, Thailand, Malaysia, Singapore, Rest of Southeast Asia), Rest of Asia Pacific
  • Middle East & Africa (Saudi Arabia, UAE, Egypt, Kuwait, South Africa, Rest of Middle East & Africa)
  • Latin America (Brazil, Argentina, Rest of Latin America)

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