Global Amebocyte Lysate Market Segmentation and Drivers: The Drug Testing Segment Occupies the Biggest Share with 67.36%

Global Amebocyte Lysate Market Overview

According to Global Market Monitor, the global Amebocyte Lysate market size is $716.09 million in 2024 with a CAGR of 11.27% from 2024 to 2029.

Amebocyte Lysate is an extract obtained from the blue blood of the marine arthropod "Limulus". Amebocyte Lysate can accurately and rapidly detect the presence of bacterial endotoxin and (1,3)-beta-glucan in samples.

Application Fields

By application, the Drug Testing segment occupies the biggest share with 67.36%.

Amebocyte Lysate is widely used in drug testing. The amebocyte lysate has been widely used for ~30 years for the detection of endotoxin in the quality assurance of injectable drugs and medical devices. The LAL constitutes a cascade of serine proteases which are triggered by trace levels of endotoxin, culminating in a gel clot at the end of the reaction.

In clinical diagnosis, Amebocyte Lysate can be used to determine rapidly and specifically the cumulative content of Gram-negative bacteria in foods.

Global Amebocyte Lysate Market Size

Market Risk

At present, there are only four types of turtles in the world, including the American horseshoe crab, the scorpion king crab, the giant king crab, and the Chinese king crab. At present, Amebocyte Lysate is derived from the blood of American horseshoe crabs and Chinese horseshoe crabs. However, due to marine environmental pollution, human hunting, and other factors, there is still a risk of continuous reduction in the number of horseshoe crabs, which in turn affects the continuity of the blood supply of horseshoe crabs. In 2012, IUCN (International Union for Conservation of Nature) listed Limulus americanus as Vulnerable (VU), and in 2019, IUCN listed it as Endangered (EN). The source of Limulus mainly depends on the fishing of fishermen, and the technology of artificial cultivation of Limulus is not mature enough at present. During the horseshoe crab breeding season, on the Atlantic beaches of the United States, pharmaceutical companies capture tens of thousands of horseshoe crabs, take them for blood in the laboratory, and then release them. However, some researchers have found that the mortality rate of horseshoe crabs after blood drawing is very high, as high as 30%. As a result, the number of horseshoe crabs is in danger of decreasing, leading to a crisis in the supply of raw materials for Amebocyte Lysate. The supply crisis of raw materials will be one of the important challenges facing the industry.

Market Driving Force

When exposed to the toxin of the bacteria, the amoebocytes in the blood of the horseshoe crab release a coagulation protein, which causes the blood to coagulate rapidly, forming a barrier that prevents the bacteria from multiplying and prevents the invasion of other bacteria. Amebocyte Lysate can detect a contaminant called "endotoxin" (a type of bacteria) and can be widely used in the fields of medicine and hygiene, food hygiene, environmental hygiene, molecular biology, and microbiology. In the pharmaceutical industry, for example, even small amounts of endotoxin can be fatal in vaccines, injectable drugs, or other sterile medical items such as artificial knees and hip joints. Amebocyte Lysate can be used to test the safety of these products. In food hygiene, Amebocyte Lysate can be used to detect whether drinking water, milk, canned food, and other foods are contaminated by bacteria. As people's safety awareness continues to rise, the government's supervision of medical hygiene and food hygiene will become more and more strict. The demand for Amebocyte Lysate in the market will continue to rise, thereby increasing the demand for Amebocyte Lysate. Overall, the wide application of Amebocyte Lysate is an important reason for the development of the industry.

Drivers

Wide application of Amebocyte Lysate

Development of the global medical industry

Risks

Raw material supply crisis

High R&D costs

Changes in wildlife protection policies


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