Global Pyrogen Testing Market Size, Share & Trends Analysis Report By Product & Service (Reagents & Kits, Services, and Instruments), By Test Type (LAL Test, Rabbit Pyrogen Test, and Others), By End User, By Regional Outlook and Forecast, 2023 - 2030

Global Pyrogen Testing Market Size, Share & Trends Analysis Report By Product & Service (Reagents & Kits, Services, and Instruments), By Test Type (LAL Test, Rabbit Pyrogen Test, and Others), By End User, By Regional Outlook and Forecast, 2023 - 2030


The Global Pyrogen Testing Market size is expected to reach $2.6 billion by 2030, rising at a market growth of 7.9% CAGR during the forecast period.

Europe has a well-established regulatory framework for pharmaceutical and medical device industries. The European Medicines Agency (EMA) and other national agencies' implementation of rigorous regulatory standards to guarantee adherence to quality and safety protocols propels the need for this testing. Consequently, the Europe region would acquire nearly, 30% of the total market share by 2030. Additionally, the EU has been witnessing advancements in the biopharmaceutical sector, focusing on biologics, biosimilars, and gene therapies. These complex and novel products often require sophisticated testing methodologies, driving the need for expanded testing capabilities. Hence, the segment will witness increased demand in the upcoming years.

Pyrogens, particularly bacterial endotoxins, can cause adverse reactions in humans. Regulatory agencies mandate that pharmaceuticals and medical devices are free from pyrogens to ensure patient safety. This testing is conducted to detect and quantify the presence of pyrogens in products. Moreover, products are often subjected to sterilization procedures in the pharmaceutical and medical device manufacturing processes. Validation of these processes, including the absence of pyrogens post-sterilization, is crucial. Therefore, these factors will help in the expansion of the market. Additionally, the rise in chronic diseases necessitates the development of a diverse range of pharmaceuticals, including traditional small-molecule drugs, biologics, and medical devices. Each of these modalities undergoes extensive testing to ensure product safety, and this testing is one of the critical tests to detect potential contaminants. Moreover, chronic diseases often require long-term or frequent treatments, making patient safety paramount. Pyrogens, particularly bacterial endotoxins, can lead to severe adverse reactions. Rigorous testing helps mitigate these risks by ensuring the products intended for chronic disease management are free from harmful contaminants. Thus, these factors will assist in the growth of the market.

Moreover, the unprecedented demands placed on healthcare systems during the pandemic led to a reprioritization of resources. Many pharmaceutical and medical device companies directed their focus and resources toward developing, producing, and distributing COVID-19 related products, affecting the attention given to routine quality control processes, including this testing. Moreover, the pandemic accelerated the adoption of technological solutions in various industries. In the market, there was a heightened interest in automation, digitalization, and remote monitoring solutions to ensure continuity and efficiency in testing processes despite disruptions caused by the pandemic. Thus, the COVID-19 pandemic moderately impacted the market.

However, advanced testing methods may require specialized equipment, which can be expensive to acquire and maintain. This includes instruments such as endotoxin testing systems, spectrophotometers, and other analytical devices contributing to the overall cost of setting up a testing facility. In addition, conducting this testing, especially with advanced methods, requires personnel with specialized knowledge and skills. Hiring and retaining skilled professionals in this testing can be costly, and smaller companies may find it challenging to compete for qualified talent. Thus, these factors will decrease the demand for this testing in the upcoming years.

By Product & Service Analysis

Based on product & service, the market is segmented into reagents & kits, instruments, and services. In 2022, the instruments segment garnered a significant revenue share in the market. The progression of technology has resulted in the creation of sophisticated instruments utilized in this testing. Innovative technologies, such as automated liquid handling systems, microfluidics, and sophisticated detection techniques, have enhanced pyrogen detection methods' sensitivity, accuracy, and efficiency. Hence, the segment will witness increased demand in the coming years.

By Test Type Analysis

On the basis of test type, the market is divided into LAL test, rabbit pyrogen test, and others. In 2022, the others segment witnessed a substantial revenue share in the market. The "others" category in the context of this testing may include emerging technologies, innovative testing methods, or specific applications that do not fit within the conventional categories, like Limulus amebocyte lysate (LAL) testing or monocyte activation testing (MAT). Therefore, owing to these factors, the segment will witness enhanced growth in the upcoming years.

By End User Analysis

Based on end user, the market is divided into pharmaceutical & biotechnology companies, medical device companies, and others. In 2022, the medical device companies segment witnessed a substantial revenue share in the market. Ongoing advancements in the testing technologies, including more sensitive and efficient methods, may attract medical device companies looking to adopt state-of-the-art testing solutions. Improved testing technologies can offer quicker and more accurate results, contributing to medical devices' overall safety and quality. Therefore, the segment will grow rapidly in the coming years.

By Regional Analysis

By region, the market is segmented into North America, Europe, Asia Pacific, and LAMEA. The North America segment procured the highest revenue share in the market in 2022. The pharmaceutical and biotechnology sectors in North America have been consistently growing. The region is a hub for research and development activities, leading to the development of new drugs, biologics, and medical devices. The need for rigorous testing, including this testing, grows in tandem as the industry expands. Therefore, these factors will boost the demand in the segment.

List of Key Companies Profiled
  • Merck KGaA
  • Charles River Laboratories International, Inc.
  • Genscript Biotech Corporation
  • WuXi AppTec Co., Ltd.
  • Lonza Group Ltd.
  • Fujifilm Holdings Corporation
  • Eurofins Scientific SE
  • Thermo Fisher Scientific, Inc.
  • Seikagaku Corp.
  • InvivoGen SAS
Global Pyrogen Testing Market Report Segmentation

By Product & Service
  • Reagents & Kits
  • Services
  • Instruments
By Test Type
  • LAL Test
  • Rabbit Pyrogen Test
  • Others
By End User
  • Pharmaceutical & Biotechnology Companies
  • Medical Device Companies
  • Others
By Geography
  • North America
  • US
  • Canada
  • Mexico
  • Rest of North America
  • Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
  • Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
  • LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA


Chapter 1. Market Scope & Methodology
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 Global Pyrogen Testing Market, by Product & Service
1.4.2 Global Pyrogen Testing Market, by Test Type
1.4.3 Global Pyrogen Testing Market, by End User
1.4.4 Global Pyrogen Testing Market, by Geography
1.5 Methodology for the research
Chapter 2. Market at a Glance
2.1 Key Highlights
Chapter 3. Market Overview
3.1 Introduction
3.1.1 Overview
3.1.1.1 Market Composition and Scenario
3.2 Key Factors Impacting the Market
3.2.1 Market Drivers
3.2.2 Market Restraints
3.2.3 Market Opportunities
3.2.4 Market Challenges
3.3 Porter Five Forces Analysis
Chapter 4. Global Pyrogen Testing Market, by Product & Service
4.1 Global Reagents & Kits Market, by Region
4.2 Global Services Market, by Region
4.3 Global Instruments Market, by Region
Chapter 5. Global Pyrogen Testing Market, by Test Type
5.1 Global LAL Test Market, by Region
5.2 Global Rabbit Pyrogen Test Market, by Region
5.3 Global Others Market, by Region
Chapter 6. Global Pyrogen Testing Market, by End User
6.1 Global Pharmaceutical & Biotechnology Companies Market, by Region
6.2 Global Medical Device Companies Market, by Region
6.3 Global Others Market, by Region
Chapter 7. Global Pyrogen Testing Market, by Region
7.1 North America Pyrogen Testing Market
7.1.1 North America Pyrogen Testing Market, by Product & Service
7.1.1.1 North America Reagents & Kits Market, by Country
7.1.1.2 North America Services Market, by Country
7.1.1.3 North America Instruments Market, by Country
7.1.2 North America Pyrogen Testing Market, by Test Type
7.1.2.1 North America LAL Test Market, by Country
7.1.2.2 North America Rabbit Pyrogen Test Market, by Country
7.1.2.3 North America Others Market, by Country
7.1.3 North America Pyrogen Testing Market, by End User
7.1.3.1 North America Pharmaceutical & Biotechnology Companies Market, by Country
7.1.3.2 North America Medical Device Companies Market, by Country
7.1.3.3 North America Others Market, by Country
7.1.4 North America Pyrogen Testing Market, by Country
7.1.4.1 US Pyrogen Testing Market
7.1.4.1.1 US Pyrogen Testing Market, by Product & Service
7.1.4.1.2 US Pyrogen Testing Market, by Test Type
7.1.4.1.3 US Pyrogen Testing Market, by End User
7.1.4.2 Canada Pyrogen Testing Market
7.1.4.2.1 Canada Pyrogen Testing Market, by Product & Service
7.1.4.2.2 Canada Pyrogen Testing Market, by Test Type
7.1.4.2.3 Canada Pyrogen Testing Market, by End User
7.1.4.3 Mexico Pyrogen Testing Market
7.1.4.3.1 Mexico Pyrogen Testing Market, by Product & Service
7.1.4.3.2 Mexico Pyrogen Testing Market, by Test Type
7.1.4.3.3 Mexico Pyrogen Testing Market, by End User
7.1.4.4 Rest of North America Pyrogen Testing Market
7.1.4.4.1 Rest of North America Pyrogen Testing Market, by Product & Service
7.1.4.4.2 Rest of North America Pyrogen Testing Market, by Test Type
7.1.4.4.3 Rest of North America Pyrogen Testing Market, by End User
7.2 Europe Pyrogen Testing Market
7.2.1 Europe Pyrogen Testing Market, by Product & Service
7.2.1.1 Europe Reagents & Kits Market, by Country
7.2.1.2 Europe Services Market, by Country
7.2.1.3 Europe Instruments Market, by Country
7.2.2 Europe Pyrogen Testing Market, by Test Type
7.2.2.1 Europe LAL Test Market, by Country
7.2.2.2 Europe Rabbit Pyrogen Test Market, by Country
7.2.2.3 Europe Others Market, by Country
7.2.3 Europe Pyrogen Testing Market, by End User
7.2.3.1 Europe Pharmaceutical & Biotechnology Companies Market, by Country
7.2.3.2 Europe Medical Device Companies Market, by Country
7.2.3.3 Europe Others Market, by Country
7.2.4 Europe Pyrogen Testing Market, by Country
7.2.4.1 Germany Pyrogen Testing Market
7.2.4.1.1 Germany Pyrogen Testing Market, by Product & Service
7.2.4.1.2 Germany Pyrogen Testing Market, by Test Type
7.2.4.1.3 Germany Pyrogen Testing Market, by End User
7.2.4.2 UK Pyrogen Testing Market
7.2.4.2.1 UK Pyrogen Testing Market, by Product & Service
7.2.4.2.2 UK Pyrogen Testing Market, by Test Type
7.2.4.2.3 UK Pyrogen Testing Market, by End User
7.2.4.3 France Pyrogen Testing Market
7.2.4.3.1 France Pyrogen Testing Market, by Product & Service
7.2.4.3.2 France Pyrogen Testing Market, by Test Type
7.2.4.3.3 France Pyrogen Testing Market, by End User
7.2.4.4 Russia Pyrogen Testing Market
7.2.4.4.1 Russia Pyrogen Testing Market, by Product & Service
7.2.4.4.2 Russia Pyrogen Testing Market, by Test Type
7.2.4.4.3 Russia Pyrogen Testing Market, by End User
7.2.4.5 Spain Pyrogen Testing Market
7.2.4.5.1 Spain Pyrogen Testing Market, by Product & Service
7.2.4.5.2 Spain Pyrogen Testing Market, by Test Type
7.2.4.5.3 Spain Pyrogen Testing Market, by End User
7.2.4.6 Italy Pyrogen Testing Market
7.2.4.6.1 Italy Pyrogen Testing Market, by Product & Service
7.2.4.6.2 Italy Pyrogen Testing Market, by Test Type
7.2.4.6.3 Italy Pyrogen Testing Market, by End User
7.2.4.7 Rest of Europe Pyrogen Testing Market
7.2.4.7.1 Rest of Europe Pyrogen Testing Market, by Product & Service
7.2.4.7.2 Rest of Europe Pyrogen Testing Market, by Test Type
7.2.4.7.3 Rest of Europe Pyrogen Testing Market, by End User
7.3 Asia Pacific Pyrogen Testing Market
7.3.1 Asia Pacific Pyrogen Testing Market, by Product & Service
7.3.1.1 Asia Pacific Reagents & Kits Market, by Country
7.3.1.2 Asia Pacific Services Market, by Country
7.3.1.3 Asia Pacific Instruments Market, by Country
7.3.2 Asia Pacific Pyrogen Testing Market, by Test Type
7.3.2.1 Asia Pacific LAL Test Market, by Country
7.3.2.2 Asia Pacific Rabbit Pyrogen Test Market, by Country
7.3.2.3 Asia Pacific Others Market, by Country
7.3.3 Asia Pacific Pyrogen Testing Market, by End User
7.3.3.1 Asia Pacific Pharmaceutical & Biotechnology Companies Market, by Country
7.3.3.2 Asia Pacific Medical Device Companies Market, by Country
7.3.3.3 Asia Pacific Others Market, by Country
7.3.4 Asia Pacific Pyrogen Testing Market, by Country
7.3.4.1 China Pyrogen Testing Market
7.3.4.1.1 China Pyrogen Testing Market, by Product & Service
7.3.4.1.2 China Pyrogen Testing Market, by Test Type
7.3.4.1.3 China Pyrogen Testing Market, by End User
7.3.4.2 Japan Pyrogen Testing Market
7.3.4.2.1 Japan Pyrogen Testing Market, by Product & Service
7.3.4.2.2 Japan Pyrogen Testing Market, by Test Type
7.3.4.2.3 Japan Pyrogen Testing Market, by End User
7.3.4.3 India Pyrogen Testing Market
7.3.4.3.1 India Pyrogen Testing Market, by Product & Service
7.3.4.3.2 India Pyrogen Testing Market, by Test Type
7.3.4.3.3 India Pyrogen Testing Market, by End User
7.3.4.4 South Korea Pyrogen Testing Market
7.3.4.4.1 South Korea Pyrogen Testing Market, by Product & Service
7.3.4.4.2 South Korea Pyrogen Testing Market, by Test Type
7.3.4.4.3 South Korea Pyrogen Testing Market, by End User
7.3.4.5 Singapore Pyrogen Testing Market
7.3.4.5.1 Singapore Pyrogen Testing Market, by Product & Service
7.3.4.5.2 Singapore Pyrogen Testing Market, by Test Type
7.3.4.5.3 Singapore Pyrogen Testing Market, by End User
7.3.4.6 Malaysia Pyrogen Testing Market
7.3.4.6.1 Malaysia Pyrogen Testing Market, by Product & Service
7.3.4.6.2 Malaysia Pyrogen Testing Market, by Test Type
7.3.4.6.3 Malaysia Pyrogen Testing Market, by End User
7.3.4.7 Rest of Asia Pacific Pyrogen Testing Market
7.3.4.7.1 Rest of Asia Pacific Pyrogen Testing Market, by Product & Service
7.3.4.7.2 Rest of Asia Pacific Pyrogen Testing Market, by Test Type
7.3.4.7.3 Rest of Asia Pacific Pyrogen Testing Market, by End User
7.4 LAMEA Pyrogen Testing Market
7.4.1 LAMEA Pyrogen Testing Market, by Product & Service
7.4.1.1 LAMEA Reagents & Kits Market, by Country
7.4.1.2 LAMEA Services Market, by Country
7.4.1.3 LAMEA Instruments Market, by Country
7.4.2 LAMEA Pyrogen Testing Market, by Test Type
7.4.2.1 LAMEA LAL Test Market, by Country
7.4.2.2 LAMEA Rabbit Pyrogen Test Market, by Country
7.4.2.3 LAMEA Others Market, by Country
7.4.3 LAMEA Pyrogen Testing Market, by End User
7.4.3.1 LAMEA Pharmaceutical & Biotechnology Companies Market, by Country
7.4.3.2 LAMEA Medical Device Companies Market, by Country
7.4.3.3 LAMEA Others Market, by Country
7.4.4 LAMEA Pyrogen Testing Market, by Country
7.4.4.1 Brazil Pyrogen Testing Market
7.4.4.1.1 Brazil Pyrogen Testing Market, by Product & Service
7.4.4.1.2 Brazil Pyrogen Testing Market, by Test Type
7.4.4.1.3 Brazil Pyrogen Testing Market, by End User
7.4.4.2 Argentina Pyrogen Testing Market
7.4.4.2.1 Argentina Pyrogen Testing Market, by Product & Service
7.4.4.2.2 Argentina Pyrogen Testing Market, by Test Type
7.4.4.2.3 Argentina Pyrogen Testing Market, by End User
7.4.4.3 UAE Pyrogen Testing Market
7.4.4.3.1 UAE Pyrogen Testing Market, by Product & Service
7.4.4.3.2 UAE Pyrogen Testing Market, by Test Type
7.4.4.3.3 UAE Pyrogen Testing Market, by End User
7.4.4.4 Saudi Arabia Pyrogen Testing Market
7.4.4.4.1 Saudi Arabia Pyrogen Testing Market, by Product & Service
7.4.4.4.2 Saudi Arabia Pyrogen Testing Market, by Test Type
7.4.4.4.3 Saudi Arabia Pyrogen Testing Market, by End User
7.4.4.5 South Africa Pyrogen Testing Market
7.4.4.5.1 South Africa Pyrogen Testing Market, by Product & Service
7.4.4.5.2 South Africa Pyrogen Testing Market, by Test Type
7.4.4.5.3 South Africa Pyrogen Testing Market, by End User
7.4.4.6 Nigeria Pyrogen Testing Market
7.4.4.6.1 Nigeria Pyrogen Testing Market, by Product & Service
7.4.4.6.2 Nigeria Pyrogen Testing Market, by Test Type
7.4.4.6.3 Nigeria Pyrogen Testing Market, by End User
7.4.4.7 Rest of LAMEA Pyrogen Testing Market
7.4.4.7.1 Rest of LAMEA Pyrogen Testing Market, by Product & Service
7.4.4.7.2 Rest of LAMEA Pyrogen Testing Market, by Test Type
7.4.4.7.3 Rest of LAMEA Pyrogen Testing Market, by End User
Chapter 8. Company Profiles
8.1 Merck KGaA
8.1.1 Company Overview
8.1.2 Financial Analysis
8.1.3 Segmental and Regional Analysis
8.1.4 Research & Development Expense
8.1.5 SWOT Analysis
8.2 Charles River Laboratories International, Inc.
8.2.1 Company Overview
8.2.2 Financial Analysis
8.2.3 Segmental and Regional Analysis
8.2.4 Recent strategies and developments:
8.2.4.1 Product Launches and Product Expansions:
8.2.4.2 Acquisition and Mergers:
8.2.5 SWOT Analysis
8.3 Genscript Biotech Corporation
8.3.1 Company Overview
8.3.2 Financial Analysis
8.3.3 Regional & Segmental Analysis
8.3.4 Research & Development Expenses
8.3.5 SWOT Analysis
8.4 WuXi AppTec Co., Ltd.
8.4.1 Company Overview
8.4.2 Financial Analysis
8.4.3 Segmental Analysis
8.4.4 Research & Development Expenses
8.5 Lonza Group Ltd.
8.5.1 Company Overview
8.5.2 Financial Analysis
8.5.3 Segmental and Regional Analysis
8.5.4 Research & Development Expenses
8.5.5 Recent strategies and developments:
8.5.5.1 Partnerships, Collaborations, and Agreements:
8.5.5.2 Product Launches and Product Expansions:
8.5.6 SWOT Analysis
8.6 Fujifilm Holdings Corporation
8.6.1 Company Overview
8.6.2 Financial Analysis
8.6.3 Segmental and Regional Analysis
8.6.4 Research & Development Expenses
8.6.5 SWOT Analysis
8.7 Eurofins Scientific SE
8.7.1 Company Overview
8.7.2 Financial Analysis
8.7.3 Regional Analysis
8.7.4 SWOT Analysis
8.8 Thermo Fisher Scientific, Inc.
8.8.1 Company Overview
8.8.2 Financial Analysis
8.8.3 Segmental and Regional Analysis
8.8.4 Research & Development Expenses
8.8.5 SWOT Analysis
8.9 Seikagaku Corp.
8.9.1 Company Overview
8.9.2 Financial Analysis
8.9.3 Segmental Analysis
8.9.4 Research & Development Expenses
8.9.5 SWOT Analysis
8.10. InvivoGen SAS
8.10.1 Company Overview
8.10.2 SWOT Analysis
Chapter 9. Winning Imperatives of Pyrogen Testing Market

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