Global Limulus Amebocyte Lysate Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Global Limulus Amebocyte Lysate Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the Atlantic horseshoe crab Limulus polyphemus. LAL reacts with bacterial endotoxin lipopolysaccharide (LPS), which is a membrane component of gram-negative bacteria. This reaction is the basis of the LAL test, which is widely used for the detection and quantification of bacterial endotoxins. In Asia, a similar Tachypleus amebocyte lysate (TAL) test based on the local horseshoe crabs Tachypleus gigas or Tachypleus tridentatus is occasionally used instead. The recombinant factor C (rFC) assay is a replacement of LAL/TAL based on a similar reaction.

Market Overview:

The latest research study on the global Limulus Amebocyte Lysate market finds that the global Limulus Amebocyte Lysate market reached a value of USD 249.42 million in 2022. It’s expected that the market will achieve USD 225.07 million by 2028, exhibiting a CAGR of -1.7% during the forecast period.

Region Overview:

Geographically, Europe held the largest market share – 38.32% in 2022.

Segmentation Overview:

Among different product types, Limulus Amebocyte Lysate segment is anticipated to contribute the largest market share in 2028.

Limulus Amebocyte Lysate

Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the horseshoe crab, Limulus polyphemus. LAL reagent reacts with bacterial endotoxin and lipopolysaccharide (LPS), which is a membrane constituent of Gram-negative bacteria. This reaction is the base on the LAL reagent, which is then used for the finding and quantification of bacterial endotoxins.
The Gel Clot LAL test provides very simple positive or negative result and is most often mentioned in international pharmacopeia monographs as the official test. Gel Clot assay is a qualitative LAL test for detection of Gram-negative bacteria endotoxins. The Gel Clot assay is run in tubes that are placed in a water bath or in dry heated oven at 37°C. After a one-hour incubation period, the tubes are flipped 180°. A firm clot that stays in the bottom of the tube indicates a positive reaction. If the liquid flows down the side of the tube, the result is negative for endotoxins.

Tachypleus Amebocyte Lysate

The difference between TAL and LAL is the source of the horseshoe crab. The amebocyte of TAL ( Tachypleus Amebocyte Lysate) is extracted form Tachypleus, and LAL(Limulus Amebocyte Lysate) is extracting form Limulus.
TAL assay is the most commonly used test for endotoxin. Tachypleus Amebocyte Lysate (TAL), is a kind of lyophilized product which mainly contains amoebocytes extracted from the blue blood of horseshoe crabs. Using TAL for Endotoxins Test complies with many international regulations, including USP, JP, EP, and WHO. Worldwide, TAL is widely used in the fields of pharmaceutical, clinical, and scientific research for the detection of bacterial endotoxin. In addition, in Asia, the American Limulus reagent is often replaced by the Asian Limulus reagent (English: Tachypleus amebocyte lysate, abbreviated TAL) from the blood of Limulus Limulus or Limulus sinensis.

Application Overview:

The market's largest segment by application is the segment Clinical Diagnosis, with a market share of 33.75% in 2022.

Drug Testing

The Limulus amebocyte lysate (LAL) 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 that are triggered by trace levels of endotoxin, culminating in a gel clot at the end of the reaction.
The LAL assay is a simple and inexpensive, yet robust means to detect even low levels of endotoxins. The assay's active ingredient comes from the horseshoe crab (Limulidae). The crabs' hemolymph (a fluid analogous to blood) contains immune cells called amebocytes. These amebocytes are the key to the LAL assay.
Limulus reagent has three usages: gel method, turbidimetric method, and colorimetric method. Limulus reagent is generally used in the testing of various parenteral drugs and instruments that are in contact with blood or cerebrospinal fluid to ensure that they are not contaminated by endotoxins. Both the US FDA and the Chinese Pharmacopoeia have specific regulations in this regard.
Limulus reagent is also triggered by (1,3)-β-D-glucan. This glucan, like LPS, is also a pathogen-associated molecular pattern.

Clinical Diagnosis

A protein in the blood called Limulus Amebocyte Lysate (LAL) is used by pharmaceutical and medical device manufacturers to test their products for the presence of endotoxins, bacterial substances that can cause fevers and even be fatal to humans.
LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications.
Dealing with various substances that interfere with LAL reagents (causing falsely high or falsely low results) is a time-consuming step in the drug development process. The FDA stipulates that before using the LAL test, an interference test must be carried out and it must be proved that the correct result can be achieved. The LAL assay offers numerous advantages over the rabbit pyrogenic test. The assay allows for direct quantification of endotoxin levels without individual variability while minimizing potential sources of error.

Key Companies in the global Limulus Amebocyte Lysate market covered in Chapter 3:

Seikagaku Corporation
Xiamen Bioendo Technology
Associates of Cape Cod
Fuzhou Xinbei
FUJIFILM Wako Pure Chemicals Corporation
Charles River Laboratories
Zhanjiang Bokang
Genscrip
LONZA

In Chapter 4 and Chapter 14.2, on the basis of types, the Limulus Amebocyte Lysate market from 2018 to 2029 is primarily split into:

Limulus Amebocyte Lysate
Tachypleus Amebocyte Lysate

In Chapter 5 and Chapter 14.3, on the basis of Downstream Industry, the Limulus Amebocyte Lysate market from 2018 to 2029 covers:

Drug Testing
Clinical Diagnosis

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2018-2029) of the following regions are covered in Chapter 8 to Chapter 14:

North America (United States, Canada)
Europe (Germany, UK, France, Italy, Spain, Russia, Netherlands, Turkey, Switzerland, Sweden)
Asia Pacific (China, Japan, South Korea, Australia, India, Indonesia, Philippines, Malaysia)
Latin America (Brazil, Mexico, Argentina)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa)