Global Endotoxin Detecting Reagents Market, By Product (Endotoxin Detection Products, LAL Test Reagents, Mycoplasma Detection and Removal, PCR Mycoplasma Detection Kit, Mycoplasma Elimination Cocktail, Mycoplasma Detection and Elimination Custom Services, Accessories, Instrumentation, Endotoxin Removal Products, Low Endotoxin Recovery (LER) Products, Lipopolysaccharides), Test Type (Gel Clot Endotoxin Test, Chromogenic Endotoxin Test, Turbidimetric Endotoxin Test), Application (Medical Device Manufacturing, Pharmaceutical Manufacturing) – Industry Trends and Forecast to 2029.
Endotoxin Detecting Reagents Market Analysis and Size
The FDA mandates the endotoxin test as the most important quality control test for all pharmaceuticals that are in the final stages of formulation. Endotoxins are usually linked to all gram-negative bacteria, as a result, they adversely affect both people and animals and continue to be highly poisonous even in low concentrations. Additionally, endotoxins are thought to play a significant role in the onset and progression of numerous diseases. GenScript highly advises using a cutting-edge detection method to find endotoxins. Endotoxin Assay Kits from GenScript are used for in vitro end-product endotoxin testing on biological products, medical devices, and parenteral medications for both humans and animals.
Data Bridge Market Research analyses that the endotoxin detecting reagents market which was USD 692.35 million in 2021, would rocket up to USD 1801.84 million by 2029, and is expected to undergo a CAGR of 12.70% 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.
Endotoxin Detecting Reagents Market Scope and Segmentation
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Report Metric
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Details
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Forecast Period
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2022 to 2029
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Base Year
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2021
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Historic Years
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2020 (Customizable to 2014 - 2019)
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Quantitative Units
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Revenue in USD Million, Volumes in Units, Pricing in USD
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Segments Covered
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Product (Endotoxin Detection Products, LAL Test Reagents, Mycoplasma Detection and Removal, PCR Mycoplasma Detection Kit, Mycoplasma Elimination Cocktail, Mycoplasma Detection and Elimination Custom Services, Accessories, Instrumentation, Endotoxin Removal Products, Low Endotoxin Recovery (LER) Products, Lipopolysaccharides), Test Type (Gel Clot Endotoxin Test, Chromogenic Endotoxin Test, Turbidimetric Endotoxin Test), Application (Medical Device Manufacturing, Pharmaceutical Manufacturing, Packaging Manufacture, Raw Materials Production)
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Countries Covered
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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.
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Market Players Covered
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Accugen Laboratories Inc. (U.S.), Wako USA (U.S.), Avantor, Inc. (U.S.), Charles River Laboratories (U.S.), Fujifilm Wako Pure Chemical Corporation (Japan), Pacific BioLabs (U.S.), Merck KGaA (Germany), Lonza (Switzerland), STERIS (U.S.), Nelson Laboratories, LLC (U.S.), Bio-Synthesis Inc (U.S.) and Biogenuix (India)
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Market Opportunities
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Market Definition
Endotoxin detection lipopolysaccharide, also known as endotoxin, is the major cell wall component of gram-negative bacteria. The first method widely used to detect endotoxin in pharmaceuticals was the rabbit pyrogen test, originally described in 1925. Endotoxins are usually linked to all gram-negative bacteria, they adversely affect both people and animals and continue to be highly poisonous even in low concentrations.
Global Endotoxin Detecting Reagents Market Dynamics
Drivers
- Rising infectious diseases
The rising prevalence of major infectious diseases and epidemics has resulted in a steady rise in demand for endotoxin testing techniques over the last decade, due to an increase in the prevalence of infectious diseases around the world, the demand for pyrogen testing methods used for endotoxin and microbiological identification is anticipated to increase during the forecast period. Products for identifying endotoxins have the potential to improve infectious diseases management, especially in places with limited healthcare infrastructure.
- Rising endotoxin products
The market will experience expansion during the forecast period of 2022–2029 due to the availability of a variety of products, including endotoxin detection and removal kits, low endotoxin recovery (LER) products, and endotoxin removal products.
On the other hand, new product launches and rising popularity of animal free tests will further create opportunities that will lead to the growth of endotoxin detecting reagents market during forecast period.
Opportunities
- Technological developments
Richmond, Virginia - FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako), a wholly owned subsidiary of FUJIFILM Wako Pure Chemical Corporation of Japan, has launched the PYROSTARTM ES-F line of limulus amebocyte lysate (LAL) reagents, which are intended to detect the presence of bacterial endotoxins, in the United States.
To reduce bacterial contamination in finished products, endotoxins must be detected in a variety of industries, including the production of vaccines and medical devices. Bacterial endotoxin testing will be an essential quality control method to guarantee patient safety as vaccine production is anticipated to grow as a result of COVID-19.
Restraints/Challenges
- High cost
On the other hand, the high cost of investment for research and affordability issues will obstruct the growth of the endotoxin detecting reagents market's growth rate.
This endotoxin detecting reagents 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 endotoxin detecting reagents market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Recent Development
- In January 2022, EmpowerDX (Eurofins) launched PFAS Exposure™ in U.S. market. It is direct to consumer test and can be conducted at home to determine levels of PFAS in blood and PFAS forever chemical compounds.
- In June 2020, The PYROSTARTM ES-F line of limulus amebocyte lysate (LAL) reagents, which are designed to detect the presence of bacterial endotoxins, have been introduced in the United States, according to FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako), a wholly owned subsidiary of FUJIFILM Wako Pure Chemical Corporation of Japan.
- In July 2021, The European Pharmacopoeia announced that they would stop using the traditional rabbit pyrogen test within the next five years and urged the industry to switch to the monocyte-activation test.
Global Endotoxin Detecting Reagents Market Scope
The endotoxin detecting reagents market is segmented on the basis of product, test type and application. 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.
Product
- Endotoxin Detection Products
- LAL Test Reagents
- Mycoplasma Detection and Removal
- PCR Mycoplasma Detection Kit
- Mycoplasma Elimination Cocktail
- Mycoplasma Detection and Elimination Custom Services
- Accessories
- Instrumentation
- Endotoxin Removal Products
- Low Endotoxin Recovery (LER) Products
- Lipopolysaccharides
Test Type
- Gel Clot Endotoxin Test
- Chromogenic Endotoxin Test
- Turbidimetric Endotoxin Test
Application
- Medical Device Manufacturing
- Pharmaceutical Manufacturing
Endotoxin Detecting Reagents Market Regional Analysis/Insights
The endotoxin detecting reagents market is analysed and market size insights and trends are provided by country, product, test type and application as referenced above.
The countries covered in the endotoxin detecting reagents 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 endotoxin detecting reagents market due to the widespread use of cutting-edge detection kits and the prevalence of leading manufacturers in the United States and Canada.
Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2022 to 2029 due to the growing awareness about endotoxin testing and its utilization in the rising economies such as Japan and China.
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 Endotoxin Detecting Reagents Market Share Analysis
The endotoxin detecting reagents 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 endotoxin detecting reagents market.
Some of the major players operating in the endotoxin detecting reagents market are:
- Accugen Laboratories Inc. (U.S.)
- Wako USA (U.S.)
- Avantor, Inc. (U.S.)
- Charles River Laboratories (U.S.)
- Fujifilm Wako Pure Chemical Corporation (Japan)
- Pacific BioLabs (U.S.)
- Merck KGaA (Germany)
- Lonza (Switzerland)
- STERIS (U.S.)
- Nelson Laboratories, LLC (U.S.)
- Bio-Synthesis Inc (U.S.)
- Biogenuix (India)
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