Pyrogen Testing Market: Strong Expansion, Expected to Hit USD 3.19 Billion By 2030: A Report By Reports Insights

The global pyrogen testing market is expected to witness significant growth at a remarkable CAGR of 11.6% during the forecast period of 2023-2030. This growth is attributed to the increasing deployment of pyrogen testing by pharmaceutical and biotechnology companies, and the rising trend for clinical research. The market is also driven by the need for improved safety for patients' health, rising technological innovations, and increasing demand for pyrogen products, which have led to the development of highly advanced pyrogen testing.


New York, March 30, 2023 (GLOBE NEWSWIRE) -- According to a recent report by Reports Insights, the pyrogen testing market is poised for strong expansion and is expected to reach USD 3.19 Billion by 2030. The market, which was valued at USD 1.33 Billion in 2022, is predicted to grow at a compound annual growth rate of 11.6% during the period 2023-2030. The report highlights the increasing demand for pyrogen testing by pharmaceutical and biotechnology companies, as well as the need for improved safety for patients' health, rising technological innovations, and increasing demand for pyrogen products, as key factors driving the market growth. Reports Insights' study also provides insights into the market's competitive landscape, market segmentation, regional outlook, and emerging technologies in the pyrogen testing market.

Pyrogen Testing Market Size, Share & Trends Analysis, By Testing Type (Bacterial Endotoxin Testing (BET), Rabbit Pyrogen Testing, Monocyte Activation Test, Recombinant Factor C (rFC) Testing, and Others) Product Type (Kits and Reagents, Instruments, and Others) End-use (Pharmaceutical and Biotechnology Companies, Medical Devices Companies, Biomedical Companies, Food, and Beverages Companies, Test Service and Diagnostic Laboratories, Clinical Research Organizations (CRO), and Others), By Region and Segment, Forecast Period 2023 – 2030

ReportsInsights Consulting Pvt. Ltd. provided an inclusive research report on the pyrogen testing market that evaluates multiple factors, such as market size, value, supply chain, regulatory environment, and trends. The report analyzes significant segments such as testing type, product type, end-use, and region, to identify emerging trends and potential opportunities. By leveraging this information, market players have the opportunity to improve their competitive edge against other manufacturers by engaging in strategic collaborations, mergers, and acquisitions, and introducing innovative products to strengthen their market position.

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The pyrogen testing market is being fueled by rising investments in research and development (R&D) activities. For instance, the pharmaceutical industry, invested approximately EUR 36,500 million in R&D in 2018, as reported by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2019. The substantial R&D investments, along with the expanding pharmaceutical and biotechnology industries, are expected to drive the overall growth of the pyrogen testing market. Increasing focus on R&D activities and the need for reliable and accurate pyrogen testing is further propelling the market growth.

Furthermore, the pyrogen testing market is expected to witness a surge in demand for pyrogen products, fueling the market growth. For instance, Fujifilm Wako Chemicals offers state-of-the-art instruments for endotoxin testing, such as the Toxinometer ET-6000, which can incorporate three testing methods: Gel-clot, KTA (Kinetic Turbidimetric Assay), and KCA (Kinetic Chromogenic Assay). The toxinometer provides ease of use during the testing process by allowing the initiation of a new assay while another assay is still in progress. This feature enables the retesting of a sample, which can boost the accuracy and reliability of the testing results.


Innovations in endotoxin testing technology are poised to unlock substantial business opportunities in the pyrogen testing market in the upcoming years. Advancements in testing methods that are more sensitive and accurate will facilitate the precise detection of pyrogens, which are critical indicators of product safety and quality. This, in turn, will create new avenues for companies operating in the pyrogen testing market to offer advanced products and services, as demand for these testing methods grows.

The increasing regulatory scrutiny and the rising demand for high-quality pharmaceutical products are expected to lead the pyrogen testing market growth during the projected forecast period. Advancements in technology, such as the development of more sensitive and specific testing methods, are also expected to drive market growth and create new opportunities for companies operating in the pyrogen testing market.

Pyrogen Testing Market Snapshot :- 

Report AttributesReport Details
Market Size By 2030 USD 3.19 Billion
Forecast Period2023-2030
CAGR (2023-2030)11.6%
Base Year2022
Study Timeline2017-2030
Key PlayersLonza Group, Merck KGaA (E. Merck KG), Genscript Biotech Corp, Ellab A/S, Charles River Laboratories, Thermo Fisher Scientific Inc., FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako Pure Chemical Corporation), Associates of Cape Cod, Inc., Sanquin, and Microcoat Biotechnologie GmbH
By Testing TypeBacterial Endotoxin Testing (BET), Rabbit Pyrogen Testing, Monocyte Activation Test, Recombinant Factor C (rFC) Testing, and Others
By Product TypeKits and Reagents, Instruments, and Others
By End-usePharmaceutical and Biotechnology Companies, Medical Devices Companies, Biomedical Companies, Food and Beverages Companies, Test Service and Diagnostic Laboratories, Clinical Research Organizations (CRO), and Others
Report CoverageCompany Ranking and Market Share, Growth Factors, Total Revenue Forecast, Regional Competitive Landscape, Business Strategies, and more.
By GeographyNorth America [United States, Canada, Mexico]

Asia-Pacific [China, Japan, India, Southeast Asia, Korea, Western Asia]

South America [Brazil, Argentina, Columbia, Chile, Peru]

Europe [Germany, UK, Turkey, Spain, France, Italy, Russia, Netherlands, Switzerland]

Middle East & Africa [GCC, North Africa, South Africa]

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The rising prevalence of infectious diseases at the global level is boosting the demand for pyrogen testing to ensure the improvement in the management of infectious diseases, which is critical for inadequate healthcare infrastructure facilities. Hence, the growing incidences of infectious diseases are accelerating the pyrogen testing market growth at the global level.

In addition, the emergence of new testing technologies is likely to enable pyrogen testing companies to offer more cost-effective and efficient testing solutions to their clients. This can drive market expansion by expanding the reach of pyrogen testing to a broader range of companies, thereby increasing accessibility and affordability.

Key Market Takeaways

  • The global pyrogen testing market size is expected to garner USD 3.19 Billion by 2030 and expand at a CAGR of 11.6% during the forecast period (2023-2030).
  • Based on testing type, the bacterial endotoxin testing (BET) segment accounted for the highest share contribution to the pyrogen testing market statistics in 2022.
  • By product type, the kits and reagents segment is anticipated to contribute the largest shares to the market growth in 2022.
  • In the context of end-use, the pharmaceutical and biotechnology companies segment is expected to contribute significant shares to the growth of pyrogen testing market statistics during the forecast period.
  • North America will create favorable circumstances for market growth in terms of value and volume due to presence of well-established healthcare infrastructure, the rising prevalence of chronic diseases, and increasing regulatory standards for product safety and quality.
  • The Asia Pacific region is expected to boost the market demand, owing to the increased investment in research & development activities associated for pyrogen testing in countries such as India, China, Japan, and others.

Global Pyrogen Testing Market Segmentation Details:

Based on Testing Type, the bacterial endotoxin testing (BET) method holds the largest market share in 2022. This is due to its high sensitivity in detecting and measuring endotoxins. However, recombinant factor C (rFC) testing is expected to grow rapidly in the coming years due to concerns about horseshoe crab populations and the development of new recombinant technologies.

Based on Product Type, the kits and reagents hold the largest market share in the year 2022. The availability of pyrogen testing kits and reagents in various sizes and formats, such as single-use or multi-use, has made them more accessible and convenient for laboratories and industries to use. This has led to a surge in the demand for pyrogen testing kits and reagents, further cementing their importance in the market. However, the instruments segment is expected to witness the fastest growth over the forecast period. The Instruments segment also offers the potential for significant cost savings in the long run by reducing the need for manual labor and the associated human error.

Based on End-Use, the pharmaceutical and biotechnology companies segment holds the largest market share in the year 2022. To ensure compliance with regulatory standards and minimize the potential for harmful reactions in patients, pyrogen testing is a crucial requirement for these companies. However, medical device companies are anticipated to witness the fastest growth over the forecast period. This is due to the rising adoption of medical devices in healthcare and the imperative to maintain their safety for patients. Furthermore, the escalating regulatory guidelines on medical device safety and effectiveness are contributing to the surge in demand for pyrogen testing in this industry.

Based on Region, North America holds the largest market share in the year 2022. The presence of well-established healthcare infrastructure, the rising prevalence of chronic diseases, and increasing regulatory standards for product safety and quality are driving the demand for pyrogen testing in this region However, Asia Pacific is expected to witness the fastest growth over the forecast period. Factors such as the growing pharmaceutical and biotechnology industry, increasing investments in healthcare infrastructure, and rising awareness of product safety and quality foster the demand for pyrogen testing in this region.

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Pyrogen Testing Market Growth Drivers:

  • The growing need for biologics is resulting in the increasing adoption of pyrogen testing in clinical research organizations (CRO) for the efficient testing of pyrogen presence in vaccines, growth factors, and others.
  • Rising awareness of toxicity in pharmaceutical drugs and medical devices is augmenting the demand for pyrogen testing in the pharmaceutical and biological products industries.
  • Technology advancement associated with pyrogen testing is fostering the development of new and improved pyrogen testing product ranges, which, in turn, is spurring market growth.

Restraints  

  • The increasingly stringent regulation for animal-based pyrogen testing methods will restrain the growth of the pyrogen testing market in the upcoming years.
  • Variability in the results of pyrogen testing methods such as rabbit pyrogen testing is projected to create a bottleneck for the pyrogen testing market growth in the forthcoming years.

Competitive Landscape

As per the research, Lonza Group, Merck KGaA (E. Merck KG), Genscript Biotech Corp, and Ellab A/S are major market players that comprise the latest market circumstances. Such companies are continuously leveraging new technologies such as endotoxin-specific reagents and advanced materials to develop innovative solutions that are more efficient and cost-effective for the accurate testing of pyrogen. Further, the pyrogen testing market is expected to grow steadily due to rising trends for mandatory testing of pharmaceutical drugs, especially in the North America, Asia Pacific, and Europe regions are estimated to boost the market statistics in the coming years. Additionally, the trend towards increasing government aid for the research & development of new therapeutics is also estimated to drive demand for kits and reagents which is anticipated to increase the competition in the market.

Recent Developments:

In August 2021, FUJIFILM Wako Chemicals U.S.A. Corporation has launched PYROSTAR ES-F/Plate Test Kit. This multi-test vial is intended to be used with a microplate reader, making it ideal for testing a large number of samples in one run. To use this configuration, 0.05 mL of the sample should be dispensed into the microplate following 0.05 mL of dissolved LAL reagent. The reagent used in this assay is endotoxin-specific, which helps to avoid false positive results caused by glucans. The vial is available in two volumes, 2.0 mL, which can perform approximately 40 tests, and 5.2 mL, which can perform 100 tests. The assay has a quantitative range of 0.01 to 10 EU/mL using the KTA method.

In July 2020, Lonza and Sanquin Reagents have joined forces in a strategic collaboration aimed at commercializing a specialized range of reagents for the pyrogen testing of parenteral pharmaceuticals and medical devices using the monocyte activation test. This partnership has effectively expanded the comprehensive portfolio of endotoxin testing products offered by Lonza.

List of Major Pyrogen Testing Market Players

• Lonza Group

• Merck KGaA (E. Merck KG)

• Genscript Biotech Corp

• Ellab A/S

• Charles River Laboratories

• Thermo Fisher Scientific Inc.

• FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako Pure Chemical Corporation)

• Associates of Cape Cod, Inc.

• Sanquin

• Microcoat Biotechnologie GmbH 

Global Pyrogen Testing Market Segmentation: 

  • By Testing Type
    • Bacterial Endotoxin Testing (BET)
    • Rabbit Pyrogen Testing
    • Monocyte Activation Test
    • Recombinant Factor C (rFC) Testing
    • Others
  • By Product Type
    • Kits and Reagents
    • Instruments
    • Others
  • By End-use
    • Pharmaceutical and Biotechnology Companies
    • Medical Devices Companies
    • Biomedical Companies
    • Food and Beverages Companies
    • Test Service and Diagnostic Laboratories
    • Clinical Research Organizations (CRO)
    • Others

Key Questions Covered in the Pyrogen Testing Market Report

  • What will be the potential market valuation for the pyrogen testing industry by 2030?
  • What insights are covered by the factors driving the growth of the pyrogen testing market, as well as the opportunities and challenges that may impact the market’s future development?
  • What specific segmentation details are covered in the pyrogen testing market report, and how do they contribute to the overall market analysis?
  • What are some of the most important product type of pyrogen testing, and how do they impact the industry's growth potential?
  • Based on current market trends and future predictions, which geographical region will have the largest impact on the pyrogen testing market's growth in the coming years?

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