Rising demand for pyrogen products, as well as partnerships, are expected to drive market growth. For instance, Fujifilm Wako Chemicals, offers endotoxin testing instruments such as the Toxinometer ET-6000. This instrument can perform three types of tests: gel-clot, KTA (Kinetic Turbidimetric Assay), and KCA (Kinetic Chromogenic Assay). The toxinometer makes testing easier because it can start a new assay while another is still running, which aids in the retesting of a sample. Furthermore, Fujifilm Wako Chemicals planned to launch the Toxinometer ET-7000 Series in 2019, which is a computer-controlled instrument that has been improved in usability. As a result, increased product launches eventually lead to market growth.
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Data Bridge Market Research analyses that the endotoxin and pyrogen testing market is expected to grow at a CAGR of 11.3% in the forecast period of 2021 to 2028 and is expected to reach USD 1,947.61 million by 2028.
The rising R&D expenditure is expected to drive the market
Rising R&D expenditure has also contributed to the overall market growth. According to the 2019 European Federation of Pharmaceutical Industries and Associations (EFPIA) report, the pharmaceutical industry in Europe invested approximately EUR 36,500 million in research and development in 2018. The rapidly expanding pharmaceutical and biotechnology industries are expected to drive the market's growth. Pharmaceutical, biotech, and other drug manufacturing companies use pyrogen testing to ensure the safe manufacture and release of infection-free products to the market.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2020 to 2027
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Base Year
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2019
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Historic Years
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2018 (Customizable to 2012 - 2017)
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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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Type (Pre-Formed Endotoxin and pyrogen testing, Proendotoxin and pyrogen testing and Combine Endotoxin and pyrogen testing), Product Category (Clean Labeled Ingredient and Conventional), Form (Powder and Liquid), Application (Pharmaceuticals, Food Products, Animal Feed, Personal Care & Cosmetics, Dietary Supplements, Beverages and Others)
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Countries Covered
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U.S., Canada, Mexico in North America, Germany, Sweden, Poland, Denmark, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe in Europe, Japan, China, India, South Korea, New Zealand, Vietnam, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), Brazil, Argentina, Rest of South America as a part of South America, UAE, Saudi Arabia, Oman, Qatar, Kuwait, South Africa, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA)
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Market Players Covered
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Eurofins Scientific (Luxembourg), Thermo Fisher Scientific Inc. (U.S.), Pall Corporation (a subsidiary of Danaher) (U.S.), Lonza (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), STERIS plc (U.S.), SGS SA (Switzerland), Sartorius AG (Germany), bioMérieux SA (France), Ellab A/S (Denmark), Wako USA (A subsidiary of FUJIFILM Wako Pure Chemical Corporation) (U.S.), ASSOCIATES OF CAPE COD, INC. (U.S.), WuXi AppTec (China), Microcoat Biotechnologie GmbH (Germany) among others.
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, geographically represented company-wise production and capacity, network layouts of distributors and partners, detailed and updated price trend analysis and deficit analysis of supply chain and demand.
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Segment Analysis:
Global endotoxin and pyrogen testing market is categorized into seven notable segments which are product type, test type, application, method, mode of purchase, end product and end user.
- On the basis of product type, the endotoxin and pyrogen testing market is segmented into detection kits & reagents, instruments, systems and softwares, endotoxin testing services and consumables & accessories.
In 2021, detection kits & reagents segment is dominating the endotoxin and pyrogen testing market
Detection kits & reagents segment is dominating the market with a market share of 59.73% because of the technological advancement to develop efficient kits and reagents for QC in the healthcare sector.
- On the basis of test type, the endotoxin and pyrogen testing market is segmented into limulus amoebocyte lysate (LAL) test, TAL testmonocyte activation test (MAT), rabbit pyrogen test and recombinant C (RFC) assay.
In 2021, limulus amoebocyte lysate (LAL) test segment is dominating the endotoxin and pyrogen testing market
Limulus amoebocyte lysate (LAL) test segment is dominating the market with the market share of 56.50% because of the increased efficiency and reliability of various consumer and regulatory bodies on the particular test type for endotoxin testing.
- On the basis of application, the endotoxin and pyrogen testing market is segmented into pharmaceutical manufacturing, medical device manufacturing, raw materials production and packaging manufacture. In 2021, pharmaceutical manufacturing segment is dominating the market with a market share of 34.86% because of the flourishing pharmaceutical sector to meet the demand of rising chronic diseases across the globe.
- On the basis of method, the endotoxin and pyrogen testing market is segmented into gel clot endotoxin test, chromogenic endotoxin test and turbidimetric endotoxin test. In 2021, gel clot endotoxin test segment is dominating the market with the market share of 55.45% because modifications of the gel-clot method aids in less requirement of LAL reagent than the basic method.
- On the basis of mode of purchase, the endotoxin and pyrogen testing market is segmented into large group, mid and small group and individual. In 2021, large group segment is dominating the market with the market share of 60.07% because large group serves as an economical option of purchase for any organization or firm which is growing in the endotoxin and pyrogen testing market.
- On the basis of end product, the endotoxin and pyrogen testing market is segmented into vaccines and/ or CGT, biologics, injectable and others. In 2021, vaccine and/or CGT segment is dominating the market with the market share of 59.76% because of the increasing R&D foe development of vaccines for COVID-19 across globe.
- On the basis of end user, the endotoxin and pyrogen testing market is segmented into pharmaceutical companies, biotechnology companies, biomedical companies, medical device companies, contract research organization (CRO) and contract manufacturing organization (CMO). In 2021, pharmaceutical companies segment is dominating the market with the market share of 44.39% because of emergence of COVID-19 pandemic and surging cases of chronic disease leading to flourishment of pharmaceutical sector.
Major Players
Data Bridge Market Research recognizes the following companies as the major endotoxin and pyrogen testing market players in endotoxin and pyrogen testing market are Eurofins Scientific (Luxembourg), Thermo Fisher Scientific Inc. (U.S.), Pall Corporation (a subsidiary of Danaher) (U.S.), Lonza (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), STERIS plc (U.S.), SGS SA (Switzerland), Sartorius AG (Germany), bioMérieux SA (France), Ellab A/S (Denmark), Wako USA (A subsidiary of FUJIFILM Wako Pure Chemical Corporation) (U.S.), ASSOCIATES OF CAPE COD, INC. (U.S.), WuXi AppTec (China), Microcoat Biotechnologie GmbH (Germany) among others.
Market Development
- In May 2020, Ellab A/S acquired QualUs, an Irish company specializing in thermal qualification and validation services for the medical device, bio-pharmaceutical, hospital, and related life science and healthcare sectors. The company's new acquisition will strengthen its product portfolio, resulting in increased demand and sales in the future.
- In July 2020, Merck KGaA opened its new M Lab Collaboration Center in Shanghai, China. To increase market demand, the new integrated lab offers customizable solutions, validation services, and hands-on training for various applications. The company's new manufacturing laboratory will increase its production capacity, resulting in increased product availability and sales in the future.
- In October 2020, Lonza unveiled its latest PyroCell MAT System to detect various pyrogens sensitively and sustainably without the use of laboratory animals. The product was introduced with a complete solution that included optimised MAT reagents from Sanquin as well as media and accessories from Lonza. The introduction of this new product by the company has increased its credibility and market demand.
Regional Analysis
Geographically, the countries covered in the endotoxin and pyrogen testing market report are U.S., Canada, Mexico in North America, Germany, Sweden, Poland, Denmark, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe in Europe, Japan, China, India, South Korea, New Zealand, Vietnam, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), Brazil, Argentina, Rest of South America as a part of South America, UAE, Saudi Arabia, Oman, Qatar, Kuwait, South Africa, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA)
As per Data Bridge Market Research analysis:
North America is the dominant region in endotoxin and pyrogen testing market during the forecast period 2021 - 2028
In 2020, North America dominated the endotoxin and pyrogen testing market due to a large share of the U.S. market due to the increasing usage of endotoxin and pyrogen testing along with increasing demand for endotoxin testing in the pharmaceutical and biotechnology industry.
Asia-Pacific is estimated to be the fastest-growing region in endotoxin and pyrogen testing market the forecast period 2021 - 2028
Asia-Pacific is expected to grow during the forecast period due to growing adoption of quality check products to prevent product recalls is the main reason for Germany growth in the Europe.
COVID-19 Impact Analysis
With the rising COVID-19 pandemic, the demand for pyrogen testing techniques has steadily increased over the last decade as the prevalence of infectious diseases has increased. The demand for pyrogen testing is expected to rise during the forecast period due to an increase in the incidence of infectious diseases. Endotoxin identification products can help improve infectious disease management, particularly in areas with limited healthcare infrastructure. This has resulted in an increase in the adoption of pyrogen testing products, which is assisting the market's growth.
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