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Global Limulus Amebocyte Lysate (LAL) Testing Market – Industry Trends and Forecast to 2029

  • Healthcare
  • Upcoming Report
  • Sep 2022
  • Global
  • 350 Pages
  • No of Tables: 220
  • No of Figures: 60
  • Healthcare
  • Upcoming Report
  • Sep 2022
  • Global
  • 350 Pages
  • No of Tables: 220
  • No of Figures: 60

Global Limulus Amebocyte Lysate (LAL) Testing Market, By Testing Methods (Gel Clot Endotoxin Test, Chromogenic Endotoxin Test, Turbidimetric Endotoxin Test), Application (Medical Device Manufacturing, Pharmaceutical Manufacturing) – Industry Trends and Forecast to 2029.

Limulus Amebocyte Lysate (LAL) Testing Market

Limulus Amebocyte Lysate (LAL) Testing Market Analysis and Size

An aqueous extract of blood cells (amoebocytes) from the Limulus polyphemus, an Atlantic horseshoe crab, is called Limulus amebocyte lysate (LAL). LAL reagents are generally used to check for endotoxins in biological products, medical devices, and injectable medicines. They also have a variety of other uses, including in renal dialysis facilities. The limulus amoebocyte lysate (LAL) test with chromogenic substrate is faster than the gelation method, and it can be automated.

Data Bridge Market Research analyses that the limulus amebocyte lysate (LAL) testing market which was USD 186.2 million in 2021, would rocket up to USD 371.02 million by 2029, and is expected to undergo a CAGR of 9.00% during the forecast period 2022 to 2029. In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Limulus Amebocyte Lysate (LAL) Testing Market Scope and Segmentation      

Report Metric

Details

Forecast Period

2022 to 2029

Base Year

2021

Historic Years

2020 (Customizable to 2014 - 2019)

Quantitative Units

Revenue in USD Million, Volumes in Units, Pricing in USD

Segments Covered

Testing Methods (Gel Clot Endotoxin Test, Chromogenic Endotoxin Test, Turbidimetric Endotoxin Test), Application (Medical Device Manufacturing, Pharmaceutical Manufacturing)

Countries Covered

U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

Market Players Covered

Pacific BioLabs (U.S.), Lonza (Switzerland), Nelson Laboratories, LLC (U.S.), Bio-Synthesis Inc (U.S.), Biogenuix (India), GenScript (U.S.), Thermo Fisher Scientific, Inc, (U.S.), SGS SA (Switzerland), WuXi AppTec (China), Sartorius AG (Germany), AstraZeneca (U.K.), Novasep (France), Merck KGaA (Germany), Charles River Laboratories (U.K.)

Market Opportunities

  • A growing number of biotechnology and pharmaceutical companies
  • Technological advancements in limulus amebocyte lysate (LAL) methods

Market Definition

The LAL (limulus amebocyte lysate) testing, also known as bacterial endotoxin testing, is a crucial component of pharmaceutical microbiology and is used to determine the presence and concentration of bacterial endotoxins in medicines and biological products. Lipopolysaccharides called endotoxins, a subclass of pyrogen, are found in the cell walls of gram-negative bacteria. Pyrogens are a group of compounds that raise the body temperature and can be dangerous or even lethal if delivered to people above a particular dose.

Global Limulus Amebocyte Lysate (LAL) Testing Market Dynamics

Drivers

  • Innovative laboratory testing procedure

New Brighton, Minnesota, TÜV SÜD declares its intentions to increase the size of its Medical and Health Services (MHS) facilities. By June 2022, the 36,000 square foot test facility's 20,000 square foot laboratory addition will offer an end-to-end testing solution for all medical devices. To supplement TÜV SÜD's present active medical device testing capabilities, the cutting-edge laboratory will also offer a wide variety of biological and chemical testing of medical equipment.

With the new component, TÜV SÜD will be able to complete healthcare equipment and medical device testing even more quickly. This will also enable the professionals at TÜV SÜD to give clients the most recent solutions to fulfil the constantly changing regulatory standards of the medical device industry. This will boost the market growth.

  • Increasing investment for healthcare infrastructure

Another significant factor influencing the growth rate of limulus amebocyte lysate (LAL) market is the rising healthcare expenditure which helps in improving its infrastructure. Using a photometric device, the turbidimetric LAL test method determines the cloudiness (turbidity) of the clotted test solution kinetically. This LAL variant is better suited for endotoxin release testing of straightforward pharmaceutical products than the gel-clot method (LoD of 0.001 EU/ml), as it provides quantifiable results.

Also, various government organizations aim to improve the healthcare infrastructure by increasing funding and this will further influence the market dynamics.

Opportunities

Endotoxins, the most frequent pyrogen detected in medical equipment, can seriously endanger patients. High amounts of endotoxins can enter the bloodstream through a medical device if they go undetected, leading to unpleasant reactions such hemorrhagic shock, diarrhoea, meningitis, fever, altered bacterial infection resistance, a sharp drop in blood pressure, and countless other serious biological effects. This will boost the market growth.

Restraints/Challenges

  • Lack of healthcare infrastructure

On the other hand, the stringent regulations of the government on animal testing and increasing cost of endotoxin detection systems will obstruct the market's growth rate. The dearth of skilled professionals and lack of healthcare infrastructure in developing economies will challenge the limulus amebocyte lysate (LAL) testing market.

This limulus amebocyte lysate (LAL) testing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the limulus amebocyte lysate (LAL) testing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

COVID-19 Impact on Limulus Amebocyte Lysate (LAL) Testing Market

The COVID-19 epidemic had a positive impact on the market, but it had a detrimental effect on the sales of routine testing kits, which are mostly used to screen cancer, blood sugar, cardiac indicators, lipid profile, cholesterol, and other infectious diseases. Various governments have launched a number of initiatives during the COVID-19 crisis to support the testing requirements of their different nations at the start of COVID-19. For instance, the German federal government mandated in April 2021 that companies provided free COVID-19 self-testing kits once a week to workers who are not working from home.

Recent Development

  • In July 2020, Lonza Sales AG and Sanquin Reagents BV announced a strategic partnership to commercialize a collection of specialized reagents for the monocyte activation test-based pyrogen testing of parenteral pharmaceuticals and medical devices (MAT).

Global Limulus Amebocyte Lysate (LAL) Testing Market Scope

The limulus amebocyte lysate (LAL) testing market is segmented on the basis of application and testing methods. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

 Testing Methods

  • Gel Clot Endotoxin Test
  • Chromogenic Endotoxin Test
  • Turbidimetric Endotoxin Test

 Application

  • Medical Device Manufacturing
  • Pharmaceutical Manufacturing

Limulus Amebocyte Lysate (LAL) Testing Market Regional Analysis/Insights

The limulus amebocyte lysate (LAL) testing market is analysed and market size insights and trends are provided by country, application and testing methods as referenced above.

The countries covered in the limulus amebocyte lysate (LAL) testing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the limulus amebocyte lysate (LAL) testing market due to the increasing government initiatives to promote research activities related to infectious diseases.

Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2022 to 2029 owing to factors such as improving healthcare infrastructure, rising awareness about novel diagnostic techniques.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Competitive Landscape and Limulus Amebocyte Lysate (LAL) Testing Market Share Analysis

The limulus amebocyte lysate (LAL) testing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to limulus amebocyte lysate (LAL) testing market.

Some of the major players operating in the limulus amebocyte lysate (LAL) testing market are:

  • Pacific BioLabs (U.S.)
  • Lonza (Switzerland)
  • Nelson Laboratories, LLC (U.S.)
  • Bio-Synthesis Inc (U.S.)
  • Biogenuix (India)
  • GenScript (U.S.)
  • Thermo Fisher Scientific, Inc, (U.S.)
  • SGS SA (Switzerland)
  • WuXi AppTec (China)
  • Sartorius AG (Germany)
  • AstraZeneca (U.K.)
  • Novasep (France)
  • Merck KGaA (Germany)
  • Charles River Laboratories (U.K.)


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Frequently Asked Questions

The Limulus Amebocyte Lysate (LAL) Testing Market is projected to grow at a CAGR of 9.0% during the forecast period by 2029.
The future market value of the Limulus Amebocyte Lysate (LAL) Testing Market is expected to reach USD 371.02 million by 2029.
The major players in the Limulus Amebocyte Lysate (LAL) Testing Market are Pacific BioLabs (U.S.), Lonza (Switzerland), Nelson Laboratories, LLC (U.S.), Bio-Synthesis Inc (U.S.), Biogenuix (India), GenScript (U.S.), Thermo Fisher Scientific, Inc, (U.S.), SGS SA (Switzerland), etc.
The countries covered in the Limulus Amebocyte Lysate (LAL) Testing Market are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, etc.