Amebocyte Lysate Market to Reach $1.9 Billion, Globally, by 2033 at 11.8% CAGR: Allied Market Research
Wilmington, Delaware, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Allied Market Research published a report, titled, "Amebocyte Lysate Market by Type (Limulus Amebocyte Lysate and Tachypleus Amebocyte Lysate) and Application (Drug Testing, Clinical Diagnosis, and Others): Global Opportunity Analysis and Industry Forecast, 2024-2033". According to the report, the amebocyte lysate market was valued at $0.6 billion in 2023, and is estimated to reach $1.9 billion by 2033, growing at a CAGR of 11.8% from 2024 to 2033.
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Prime determinants of growth
The global amebocyte lysate market is experiencing notable growth due to several factors such stringent regulatory standards ensuring high-quality and contamination-free medical products, growing pharmaceutical industry, and increasing emphasis on product quality and safety. Stringent regulatory standards enforced by agencies like the FDA and European Pharmacopoeia mandate the testing of pharmaceuticals, medical devices, and other healthcare products for endotoxin contamination. Amebocyte lysate assays provide a reliable means of meeting these requirements, driving demand for amebocyte lysate products. In addition, the pharmaceutical industry continues to expand globally, driven by factors such as aging population, increasing prevalence of chronic diseases, and advancements in drug development. This growth fuels the need for effective pyrogen testing methods, including amebocyte lysate assays. Furthermore, with heightened awareness of patient safety and quality control, there is a growing emphasis on ensuring the absence of pyrogenic contaminants in healthcare products. Amebocyte lysate assays offer rapid and sensitive detection of endotoxins, contributing to enhanced product safety and quality.
Report coverage & details:
| Report Coverage | Details |
| Forecast Period | 2024–2033 |
| Base Year | 2023 |
| Market Size in 2023 | $0.6 billion |
| Market Size in 2033 | $1.9 billion |
| CAGR | 11.8% |
| No. of Pages in Report | 280 |
| Segments Covered | Type, application, and region |
| Drivers |
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| Opportunity |
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| Restraint |
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Segment Highlights
The amebocyte lysate market is segmented into type, application, and region. By type, the market is divided into limulus amebocyte lysate and tachypleus amebocyte lysate. On the basis of application, it is segregated into drug testing, clinical diagnosis, and others.
By type, the limulus amebocyte lysate segment was the major shareholder in 2023. This is attributed to the fact that limulus amebocyte lysate is highly sensitivity to endotoxins, making it an indispensable tool for detecting even trace amounts of bacterial contamination in pharmaceuticals, medical devices, and other healthcare products. This high sensitivity ensures that limulus amebocyte lysate assays can reliably identify pyrogenic contaminants, thus safeguarding patient safety and product quality.
Depending on application, the drug testing segment garnered the major share in 2023. This is attributed to the fact that amebocyte lysate assays offer a sensitive and reliable means of detecting endotoxin contamination in pharmaceutical formulations, including injectable drugs, parenteral solutions, and sterile medical devices. Furthermore, stringent regulatory requirements governing drug approval and manufacturing further bolster the demand for amebocyte lysate-based assays in drug testing. Regulatory agencies such as the FDA and European Medicines Agency (EMA) mandate comprehensive pyrogen testing to assess the safety and purity of pharmaceutical products before they can be brought to market.
Regional Outlook
In Asia Pacific, the amebocyte lysate market is expected to experience rapid growth driven by key factors such as rapidly growing pharmaceutical industry in the emerging economies such as India and China and high adoption of outsourcing of pharmaceutical manufacturing and contract testing services to Asia-Pacific countries. North America dominated the market for amebocyte lysate owing to stringent FDA regulations and a robust pharmaceutical industry, emphasizing product quality and safety.
Key Market Players
- Lonza Group AG
- Charles River Laboratories
- Associates Of Cape Cod
- Xiamen Bioendo Technology
- Zhanjiang A&c Biological
- GenScript
- Nelson Laboratories, LLC
- Thermo Fisher Scientific, Inc.
- Merck and Co
- Microcoat Biotechnologie GmbH.
The report provides a detailed analysis of these key players in the global amebocyte lysate market. These players have adopted different strategies such as innovation to increase their market share and maintain dominant shares in different regions. The report is valuable in highlighting business performance, operating segments, product portfolio, and strategic moves of market players to showcase the competitive scenario.
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Recent Development
- In March 2024, AmeboGenesis announced a major achievement in sustainable amebocyte production. The company introduced an innovative technology that allows for the production of bio-identical amebocytes required for limulus amebocyte lysate production for medical endotoxin testing without the need to harvest horseshoe crab blood. Horseshoe crab blood is crucial for the production of limulus amebocyte lysate, which is essential for ensuring the safety of injectable drugs, vaccines, and implantable devices globally. This new technology represents a significant advancement in sustainability and has the potential to revolutionize the way limulus amebocyte lysate is produced.
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Report Review:
Amebocyte lysate is a critical component in the detection of bacterial endotoxins, which are lipopolysaccharides found in the outer membrane of Gram-negative bacteria. These endotoxins can cause severe immune responses and toxicity in humans if present in pharmaceuticals, medical devices, or other products. Amebocyte lysate is derived from the blood cells (amebocytes) of the horseshoe crab, particularly species like Limulus polyphemus. These cells are highly sensitive to bacterial endotoxins and release clotting proteins in response to their presence, making amebocyte lysate a crucial tool in the pharmaceutical and medical industries for endotoxin testing.
The market for amebocyte lysate is primarily driven by stringent regulatory requirements for endotoxin detection in pharmaceutical and medical device manufacturing. Regulatory bodies such as the U.S. Food and Drug Administration and the European Pharmacopoeia mandate thorough testing for endotoxins to ensure product safety. As a result, there is a consistent demand for reliable and sensitive methods of endotoxin detection, with amebocyte lysate being one of the most established and effective options available. Additionally, the increasing complexity and diversity of pharmaceutical formulations and medical devices further contribute to the demand for versatile and high-performance endotoxin testing solutions. Moreover, advancements in biotechnology and healthcare, coupled with growing awareness of contamination risks, continue to propel the growth of the amebocyte lysate market as manufacturers seek robust methods to ensure product safety and regulatory compliance.
The global amebocyte lysate market is segmented into type, application, and region. By type, the market is divided into limulus amebocyte lysate and tachypleus amebocyte lysate. On the basis of application, it is segregated into drug testing, clinical diagnosis, and other. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
North America dominated the market share in 2023, owing to well established pharmaceutical and biotechnology industry, advanced healthcare infrastructure and research capabilities. Additionally, the region's proactive approach towards healthcare quality and safety standards, coupled with strong economic growth and investment in healthcare R&D, contributes to the steady expansion of the amebocyte lysate market in North America. The presence of major pharmaceutical companies, biotech firms, and academic research institutions provides a conducive environment for the development and adoption of advanced technologies related to endotoxin detection. Furthermore, the Asia-Pacific region is expected to register the fastest growth in the amebocyte lysate market during the forecast period owing to rapid expansion of the pharmaceutical and biotechnology industries across countries like China, India, Japan, and South Korea. These nations are experiencing robust economic growth, increasing healthcare expenditure, and rising investments in healthcare infrastructure.
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