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Pyrogen Testing Market Research Report, by Product (Instruments, Services), Test Type (Recombinant Factor C Assay (rFC), LAL Test, and RPT), Application (Pharmaceutical & Biologics), End-User (Pharmaceutical Companies)—Global Forecast till 2032


ID: MRFR/LS/5322-HCR | 90 Pages | Author: Kinjoll Dey| April 2024


Pyrogen Testing Market Overview:


The pyrogen testing market was valued at USD 1.35 billion in 2021 and is predicted to grow at a CAGR of 10% to reach USD 4.6 billion by 2032. Pyrogen testing is used in e pharmaceutical business to detect pyrogen contamination. Pyrogen testing is critical to avoiding life-threatening infections caused by both non-microbial and microbial chemicals. In recent years, several methodologies and tests have been developed to give solutions for evaluating pyrogens and endotoxins.The primary variables driving the industry include growth in pharmaceutical and biotech firms, an increase in pharmaceutical product demand, and stringent government regulations governing medication safety. However, concerns such as excessive government regulation associated with testing, a lack of in-depth understanding of testing, and a rising revolution in existing technologies may provide a threat to this sector.Market Segmentation:The global pyrogen testing market is segmented on the basis of product, test type, by application and end-user. The market, by product is segmented into instruments, services, kits and reagents. By test type the market is segmented into recombinant factor C assay (rFC), limulus amoebocyte lysate (LAL) test, monocyte activation test (MAT), and rabbit pyrogen test (RPT). On the basis of application, the market is segmented into pharmaceutical & biologics, medical devices, and other applications systems. On the basis of end-user, the market is segmented into medical devices companies, pharmaceutical companies, biotechnology companies, food and beverage companies.On the basis of region, the global pyrogen testing market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The Americas is sub-segmented into North America and South America. The North American region is further segmented into the US and Canada. The European region is divided into two, namely, Western Europe and Eastern Europe. Western Europe is further classified into Germany, Italy, France, the UK, Spain, and the rest of Western Europe. The Asia-Pacific region is sub-segmented into Japan, China, India, Australia, the Republic of Korea, and the rest of Asia-Pacific. The Middle Eastern and African region is sub-segmented into the United Arab Emirates, Saudi Arabia, Oman, Kuwait, Qatar, and the rest of the Middle East and Africa.Regional Market SummaryAmerica dominated the global pyrogen testing market owing to the increasing pharmaceutical and biotech companies and increase in research and development for new drug development in this region. According to the SELECTUSA the US is the biggest market for biopharmaceutical industry, also the third largest market globally, and worlds leader in R&D. It was also reported that the US Food and Drug Administration (FDA) approved 27 medicines, along 22 new medicines approved by Center for Drug Evaluation (CDER) in 2016. Additionally, it was mentioned that according to the Pharmaceutical Research and Manufacturers Association (PhRMA), U.S. business rewards USD 75 billion for pharmaceutical R&D and accounts the intellectual property rights on new medicines. The increase in funding for drug development will support the market in this region.Europe stood second largest in the market owing to the increase in development of recombinant products and increasing occurrence of various diseases. Also increase in demand for medical devices will increase the pyrogen test demand. According, to the Healthcare Quality Improvement Partnership Ltd. (HQIP) July 2016, there is 25% increase in pacemaker implant among the population over the last few years, due to increase in geriatric population which will increase the pyrogen testing demand. Asia-Pacific was anticipated to be the rapidly growing region for the market. The market is expected to witness growth owing to the increase in geriatric population and rising demand for pharmaceutical products.According to the National Center for Biotechnology Information 2015, publication chronic sinusitis was dominant among people with some medical conditions, such as allergic rhinitis, asthma, and chronic obstructive pulmonary disease which will increase the demand for healthcare products. The increase in demand for healthcare product boost the market growth in this region. These factors are responsible for the growth of pyrogen testing market growth in Asia-Pacific countries. The Middle East and Africa holds low share in the global market due to a smaller number of pharmaceutical industries and manufacturing units. However, the market is expected to witness growth due to increasing hospitals and rising demand for the products in the Middle East.Market Segmentation




Global Pyrogen Testing Market, by Product





  • Instruments

  • Services

  • Kits

  • Reagents



Global Pyrogen Testing Market, by Test Type



  • Recombinant Factor C Assay (rFC)

  • Limulus Amoebocyte Lysate (LAL) Test

  • Monocyte Activation Test (MAT)

  • Rabbit Pyrogen Test (RPT) Test



Global Pyrogen Testing Market, by Application



  • Pharmaceutical & Biologics

  • Medical Devices

  • Other applications Systems



Global Pyrogen Testing Market, by End-Users



  • Pharmaceutical Companies

  • Biotechnology Companies

  • Medical Device Companies

  • Food and Beverage Companies    

  • Others



Global Pyrogen Testing Market, by Region



  • Americas

  • Europe

  • Asia-Pacific

  • Middle East & Africa



The report for Global Pyrogen Testing Market by Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain a deeper insight of the market and industry performance. The report gives a clear picture of the current market scenario which includes past and estimated future market size with respect to value and volume, technological advancement, macro economical and governing factors in the market. The report provides detail information about and strategies used by top key players in the industry. The report also gives a broad study of the different market segments and regions.Recent DevelopmentCharles River Laboratories International provides contract research organization (CRO) services to pharmaceutical companies as well as other industries and universities at an early stage. Through its Discovery and Safety Assessment section, the firm offers contract drug discovery services such as target identification and toxicology. Its Research Models and Services (RMS) sector is a global leader in the breeding of research models (lab rats and mice) for use in medical tests. The Manufacturing Support division provides biologics testing as well as chicken eggs for vaccinations. The preponderance of its profits comes from the United States. Charles River was founded in 1947 and became public in 2000.

Ellab A/S is a Danish manufacturer of measurement and control equipment. The firm offers data loggers, thermocouple systems, temperature indicators, and medical solutions, as well as software support, leasing, certification, and validation. Ellab has a global customer base. Ellab A/S has been a leading manufacturer of complete Thermal Validation Solutions for the food and pharmaceutical industries.Market Key players:Some of the key players in the pyrogen testing market are Charles River Laboratories, Inc. (US), Ellab A/S (UK), Merck KGaA (UK), GenScript, Hyglos GmbH (UK), Lonza (UK), Thermo Fisher Scientific, Inc. (US), Associates of Cape Cod, Inc. (US), Pyrostar, Wako Chemicals (US), Sanquin (UK), WuXi PharmaTech (Cayman), Inc (China) and Others.Intended Audience





  • Government and private laboratories

  • Pharmaceutical manufacturers

  • Biopharmaceutical companies

  • Contract laboratories

  • Tissue establishments

  • Authorities




Report Attribute/Metric Details
  Market Size   USD 4.6 Billion
  CAGR   10%
  Base Year   2021
  Forecast Period   2023-2032
  Historical Data   2020
  Forecast Units   Value (USD Billion)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   By Product, Test Type, Application, End User
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Charles River Laboratories, Inc. (US), Ellab A/S (UK), Merck KGaA (UK), GenScript, Hyglos GmbH (UK), Lonza (UK), Thermo Fisher Scientific, Inc. (US), Associates of Cape Cod, Inc. (US), Pyrostar, Wako Chemicals (US), Sanquin (UK), WuXi PharmaTech (Cayman), Inc (China)
  Key Market Opportunities   Joint ventures, strategic alliances, mergers and acquisitions and new product developments
  Key Market Drivers ·  Increasing application in food and beverages and cosmetic products ·  Increase in demand for pharmaceutical products


Frequently Asked Questions (FAQ) :

The pyrogen testing market is projected to grow at a 10% CAGR between 2023-2032.

The pyrogen testing market is predicted to touch USD 4.6 billion by 2032.

Charles River Laboratories, Inc. (US), Ellab A/S (UK), Merck KGaA (UK), GenScript, Hyglos GmbH (UK), Lonza (UK), Thermo Fisher Scientific, Inc. (US), Associates of Cape Cod, Inc. (US), Pyrostar, Wako Chemicals (US), Sanquin (UK), WuXi PharmaTech (Cayman), Inc (China)

Increasing application in food and beverages and cosmetic products are adding market growth.

Strict government regulation may limit market growth.

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