Global Pyrogen Testing Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

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Global Pyrogen Testing Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

  • Healthcare
  • Oct 2024
  • Global
  • 350 Pages
  • No of Tables: 220
  • No of Figures: 60
  • Author : Sachin Pawar

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Global Pyrogen Testing Market

Market Size in USD Billion

CAGR :  % Diagram

Bar chart comparing the Global Pyrogen Testing Market size in 2024 - 1.50 and 2032 - 3.99, highlighting the projected market growth. USD 1.50 Billion USD 3.99 Billion 2024 2032
Diagram Forecast Period
2025 –2032
Diagram Market Size (Base Year)
USD 1.50 Billion
Diagram Market Size (Forecast Year)
USD 3.99 Billion
Diagram CAGR
%
Diagram Major Markets Players
  • Charles River Laboratories
  • Lonza
  • Merck KGaA
  • Ellab A/S
  • GenScript

Global Pyrogen Testing Market Segmentation, By Product (Kits and Reagents, Services and Instruments), Application (Pharmaceutical and Biotech Companies, Food and Beverages Companies, Medical Device Manufacturing, Biomedical companies and Others), Test Type (LAL Tests, TAL Test, MAT Test, Recombinant Factor C Assay, In Vitro Tests and Rabbit Pyrogen Tests) – Industry Trends and Forecast to 2032

Pyrogen Testing Market

Pyrogen Testing Market Size

  • The global pyrogen testing market size was valued at USD 1.50 billion in 2024 and is expected to reach USD 3.99 billion by 2032, at a CAGR of 13.00% during the forecast period
  • This growth is driven by factors such as the rising incidence of infectious disease, growing biopharmaceutical and biotechnology industry

Pyrogen Testing Market Analysis

  • Pyrogen Testing is a critical quality control process in the pharmaceutical and biotechnology industries, used to detect and quantify pyrogens (fever-inducing substances) in drugs, biologics, and medical devices. It ensures patient safety by preventing harmful immune responses triggered by contaminated products
  • The demand for pyrogen testing is significantly driven by the stringent regulatory requirements for drug safety, the growing biopharmaceutical industry, and increasing focus on patient safety. The need for accurate and reliable testing methods, such as the Limulus Amebocyte Lysate (LAL) test, recombinant factor C (rFC) assay, and monocyte activation test (MAT), further supports market growth
  • North America is expected to dominate the pyrogen testing market with 45.9% market share, driven by a robust healthcare infrastructure, strict regulatory requirements, and high demand for pyrogen testing in pharmaceutical and medical device manufacturing
  • Asia-Pacific is expected to be the fastest growing region in the pyrogen testing market, with 35.5% market share, driven by rapid industrialization, increasing healthcare expenditure, and growing awareness about the importance of endotoxin testing
  • Kits and reagents segment is expected to dominate the market with a market share of 63.4%. This dominance is attributed to the increasing demand for high-quality reagents and kits essential for pyrogen detection in pharmaceuticals, biologics, and medical devices. The growing focus on ensuring product safety and compliance with stringent regulatory standards further drives the demand for these consumables

Report Scope and Pyrogen Testing Market Segmentation

Attributes

Pyrogen Testing Key Market Insights

Segments Covered

  • By Products:  Kits and Reagents, Services, and Instruments
  • By Application:  Pharmaceutical and Biotech Companies, Food and beverages companies, Medical Device Manufacturing, Biomedical Companies and Other.
  • By Test Type: LAL Tests, TAL Test, MAT Test, Recombinant Factory C Assay, In Vitro Tests and Rabbit Pyrogen Test  

Countries Covered

North America

  • U.S.
  • Canada
  • Mexico

Europe

  • Germany
  • France
  • U.K.
  • Netherlands
  • Switzerland
  • Belgium
  • Russia
  • Italy
  • Spain
  • Turkey
  • Rest of Europe

Asia-Pacific

  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Australia
  • Thailand
  • Indonesia
  • Philippines
  • Rest of Asia-Pacific

Middle East and Africa

  • Saudi Arabia
  • U.A.E.
  • South Africa
  • Egypt
  • Israel
  • Rest of Middle East and Africa

South America

  • Brazil
  • Argentina
  • Rest of South America

Key Market Players

  • Thermo Fisher Scientific Inc. (U.S.)
  • WuXi AppTec (China)
  • ASSOCIATES OF CAPE COD, INC. (U.S.)
  • Sanquin (Netherlands)
  • Minerva Analytix GmbH (Germany)
  • InvivoGen (U.S.)
  • Microcoat Biotechnologie GmbH (Germany)
  • North American Science Associates, LLC (U.S.)
  • Creative Bioarray (U.S.)
  • INDOOR Biotechnologies, Inc. (U.S.)

Market Opportunities

  • Growing demand for biologics and personalized medicines drives the need for reliable pyrogen testing in biopharmaceutical manufacturing
  • Increasing adoption of in-vitro testing methods, such as recombinant factor C (rFC) assays, offers cost-effective and ethical alternatives.

Value Added Data Infosets

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 import export analysis, production capacity overview, production consumption analysis, price trend analysis, climate change scenario, supply chain analysis, value chain analysis, raw material/consumables overview, vendor selection criteria, PESTLE Analysis, Porter Analysis, and regulatory framework.

Pyrogen Testing Market Trends

“Advancements in Pyrogen Testing Technologies”

  • One significant trend in the pyrogen testing market is the growing adoption of advanced, non-animal-based testing methods, driven by the demand for faster, more accurate, and ethically sound alternatives to traditional animal-based tests
  • These innovations include recombinant Factor C (rFC) assays, Monocyte Activation Tests (MAT), and in vitro assays, which offer reliable and reproducible results while reducing the need for animal testing 
    • For instance, rFC assays have gained significant traction due to their high sensitivity, shorter testing times, and compliance with global regulatory guidelines, making them an ideal choice for modern biopharmaceutical and medical device testing
  • These advancements are transforming the pyrogen testing landscape, improving product safety, reducing costs, and supporting the industry's shift towards more sustainable and humane testing practices

Driver

“Rising Demand for Biologics and Vaccines”

  • The increasing demand for biologics, vaccines, and injectable drugs is a major driver for the pyrogen testing market, as these products must undergo rigorous safety testing to prevent harmful pyrogenic reactions in patients
  • With the global biopharmaceutical market expanding rapidly, the need for effective pyrogen detection methods has grown, ensuring the safety and quality of these critical therapeutics
  • In addition, the COVID-19 pandemic has significantly boosted the demand for vaccines and biologics, further driving the need for accurate pyrogen testing solutions

For instance,

  • In March 2023, according to a report by the World Health Organization (WHO), global vaccine production capacity has increased substantially, with an estimated 20 billion vaccine doses being produced annually, highlighting the critical need for effective pyrogen testing to ensure patient safety 
  • As a result, the growing demand for biologics and vaccines is expected to significantly drive the pyrogen testing market, supporting the expansion of the biopharmaceutical industry

Opportunity

“Shifting Focus Towards Non-Animal Testing Methods”

  • The increasing emphasis on ethical testing and the global push to reduce animal-based testing have created significant opportunities for alternative pyrogen testing methods, such as the Monocyte Activation Test (MAT) and recombinant Factor C (rFC) assays
  • These innovative methods offer comparable accuracy to traditional rabbit pyrogen tests while aligning with regulatory requirements and ethical standards

For instance,

  • In April 2024, the European Medicines Agency (EMA) announced support for the transition to non-animal-based pyrogen testing methods, encouraging biopharmaceutical companies to adopt these technologies as part of their quality control processes 
  • The move towards more ethical and sustainable testing approaches is expected to drive the adoption of these advanced pyrogen testing methods, creating significant growth opportunities for the market

Restraint/Challenge

“High Costs of Advanced Testing Methods”

  • The high cost of implementing advanced pyrogen testing methods, such as rFC assays and MAT, poses a significant challenge for small to medium-sized biopharmaceutical companies
  • These methods, while offering superior accuracy and ethical advantages, often require specialized equipment, skilled personnel, and significant upfront investments, limiting their adoption in cost-sensitive markets
  • In addition, the stringent regulatory requirements for validating and adopting these alternative methods can further delay their widespread acceptance

For instance,

  • In June 2024, according to a report by the Biotechnology Innovation Organization (BIO), smaller biotech companies have expressed concerns over the high costs and complex validation processes associated with transitioning to non-animal-based pyrogen testing methods, highlighting a key barrier to market growth 
  • As a result, the high costs and regulatory hurdles associated with advanced pyrogen testing methods continue to pose significant challenges, potentially slowing the market's overall expansion

Pyrogen Testing Market Dynamics

Segmentation

Sub-Segmentation

By Products

  • Kits and Reagents
  • Services
  • Instruments

By Application

  • Pharmaceutical and Biotech Companies
  • Food and Beverages Companies
  • Medical Devices Manufacturing Companies
  • Biomedical Companies
  • Gastric Electrical Stimulation
  • Others

By Test Type

  • LAL Test
  • TAL Test
  • MAT Test
  • Recombinant Factory C Assay
  • In Vitro Tests
  • Rabbit Pyrogen Test

In 2025, the kits and reagents Stimulation is projected to dominate the market with a largest share in products segment

The kits and reagents segment is expected to dominate the pyrogen testing market with the largest share of 63.4% in 2025. This dominance is attributed to the increasing demand for high-quality reagents and kits essential for pyrogen detection in pharmaceuticals, biologics, and medical devices. The growing focus on ensuring product safety and compliance with stringent regulatory standards further drives the demand for these consumables.

The LAL test is expected to account for the largest share during the forecast period in test type market

In 2025, the LAL test segment is expected to dominate the market with the largest market share of 60.8% due to its high sensitivity, cost-effectiveness, and reliability in detecting endotoxins. As the preferred method in pharmaceutical and medical device manufacturing, the LAL test provides rapid results and aligns with stringent regulatory requirements, making it a critical component in ensuring product safety and compliance.

Pyrogen Testing Market Regional Analysis

“North America is Expected to Dominate the Pyrogen Testing Market”

  • North America is expected to account for approximately 45.9% of the global pyrogen testing market share, driven by a robust healthcare infrastructure, strict regulatory requirements, and high demand for pyrogen testing in pharmaceutical and medical device manufacturing
  • U.S. is projected to hold 42.4% of the global market share due to its established pharmaceutical industry, ongoing research activities, and adherence to the U.S. Food and Drug Administration (FDA) regulations regarding endotoxin testing
  • In addition, significant investments in biotechnology, medical devices, and pharmaceuticals, along with the growing focus on safety and regulatory compliance, continue to bolster market growth in the region

“Asia-Pacific to Register the Highest Growth Rate in the Pyrogen Testing Market”

  • Asia-Pacific is anticipated to register the highest CAGR in the pyrogen testing market, accounting for 35.5% of the global market share, driven by rapid industrialization, increasing healthcare expenditure, and growing awareness about the importance of endotoxin testing
  • Countries such as China, India, and Japan are emerging as key markets due to their expanding pharmaceutical and biotechnology industries, large patient populations, and a rising need for compliance with global safety standards in drug and medical device manufacturing
  • India, in particular, is expected to witness the highest growth rate with a CAGR of 12.9%, due to increased government investment in healthcare infrastructure, a growing biotechnology sector, and rising demand for high-quality pharmaceutical products

Pyrogen Testing Market Share

The 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 market.

The Major Market Leaders Operating in the Market Are:

  • Charles River Laboratories (U.S.)
  • Lonza (Switzerland)
  • Merck KGaA (Germany)
  • Ellab A/S (Denmark)
  • GenScript (U.S.) 
  • Thermo Fisher Scientific Inc. (U.S.)
  • WuXi AppTec (China)
  • ASSOCIATES OF CAPE COD, INC. (U.S.)
  • Sanquin (Netherlands)
  • Minerva Analytix GmbH (Germany)
  • InvivoGen (U.S.)
  • Microcoat Biotechnologie GmbH (Germany)
  • North American Science Associates, LLC (U.S.)
  • Creative Bioarray (U.S.)
  • INDOOR Biotechnologies, Inc. (U.S.)

Latest Developments in Global Pyrogen Testing Market

  • In October 2023, Lonza introduced the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, enhancing and streamlining pyrogen testing without the use of rabbits
  • In June 2024, the European Pharmacopoeia Commission announced the removal of the Rabbit Pyrogen Test (RPT) from its monographs, replacing it with in vitro alternatives such as the Monocyte Activation Test (MAT). This change will take effect on July 1, 2025.
  • In August 2023, Lonza launched the Nebula Absorbance Reader, a new absorbance microplate reader, expanding its range of optimized instruments for efficient endotoxin and pyrogen testing

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Research Methodology

Data collection and base year analysis are done using data collection modules with large sample sizes. The stage includes obtaining market information or related data through various sources and strategies. It includes examining and planning all the data acquired from the past in advance. It likewise envelops the examination of information inconsistencies seen across different information sources. The market data is analysed and estimated using market statistical and coherent models. Also, market share analysis and key trend analysis are the major success factors in the market report. To know more, please request an analyst call or drop down your inquiry.

The key research methodology used by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market and primary (industry expert) validation. Data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Patent Analysis, Pricing Analysis, Company Market Share Analysis, Standards of Measurement, Global versus Regional and Vendor Share Analysis. To know more about the research methodology, drop in an inquiry to speak to our industry experts.

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Data Bridge Market Research is a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customized to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analyzed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Fact book) or can assist you in creating presentations from the data sets available in the report.

Frequently Asked Questions

The global pyrogen testing market size was valued at USD 1.33 billion in 2024.
The global pyrogen testing market is to grow at a CAGR of 13.00% during the forecast period of 2025 to 2032.
The pyrogen testing market is segmented into three notable segments based on products, application and test type. On the basis of products, the market is segmented into kits and reagents and services and instruments. On the basis of application, the market is segmented into pharmaceutical and biotech companies, food and beverages companies, medical devices manufacturing companies, biomedical companies, gastric electrical simulation and others. On the basis of Test Type, the market is segmented into LAL test, TAL test, MAT test, recombinant factory C assay, in vitro tests, and rabbit pyrogen test.
Companies such Charles River Laboratories (U.S.), Lonza (Switzerland), Merck KGaA (Germany), Ellab A/S (Denmark) and GenScript (U.S.) are the major companies in the pyrogen testing market.

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