Pyrogen Testing Market

Industry Overview

The global pyrogen testing market was valued at USD 1.1 billion in 2023 and is anticipated to reach USD 3.5 billion by 2030, witnessing a CAGR of 12.5% during the forecast period 2025-2030. Pyrogen testing is the compulsory phase in the manufacturing process to eliminate or deactivate probable bacterial contaminants. Its products are used for the treatment and diagnostic purposes. The global pyrogen testing market is growing at a significant rate, due to speedy growth in pharmaceutical and biotechnology industries and a mounting number of novel drug launches. Different products contributed to the pyrogen testing market size. The market has witnessed high demand for kits and reagents in the coming years due to the mounting implementation of kit-based testing and recurrence purchase of kits and reagents as compared to instruments.The global pyrogen testing market has been experiencing growth due to several factors, including the increasing demand for safe and effective healthcare products, stringent regulations and guidelines set by regulatory authorities, and the rising focus on patient safety. The market includes various players, including testing laboratories, contract research organizations (CROs), and manufacturers of pyrogen testing products.

Market Segmentation

Insight by Product

On the basis of product the market is subdivided into kits and reagents, instruments and services. Of all products, kits and reagents segment accounted the largest share in the market due to mounting implementation of kit-based testing and recurrence purchase of kits and reagents as compared to instruments.

Insight by Application

On the basis of application, the market is subdivided into pharmaceutical and biological manufacturing, medical device manufacturing, and other applications. Speedy growth in the pharmaceutical and biotechnology industries, mounting investment in research and development by companies for drug development and large production of therapeutics are some of the factors responsible for the growth of pharmaceutical and biological manufacturing. Of all the applications, pharmaceutical and biological manufacturing accounted foremost share in the pyrogen testing market.

Insight by Test Type

On the basis of test type the market is subdivided into LAL (Limulus Amebocyte Lysate) tests, rabbit tests, and in vitro tests. Benefits such as speed, more cost effective, accuracy, necessity of slight amount of the tested sample and permits detection of lower level of endotoxins, ease of handling, and flexibility in life science research are some of the factors growing the demand of LAL test. Among the all test types, the LAL test accounted the largest share and is expected to grow at fastest rate in the pyrogen testing market. The LAL tests are further subdivided into turbidimetric tests, chromogenic tests and gel clot tests.

Global Pyrogen Testing Market Report Coverage

Industry Dynamics

Alter from animal-based testing to in vitro testing are the trends in the pyrogen testing market. Speedy growth in pharmaceutical and biotechnology industries, robust R&D investments in the life sciences industry, mounting number of novel drug launches, and mounting government support for pharmaceutical and biotechnology industries are the primary growth drivers for pyrogen testing market.

Elevated occurrence and burden of chronic diseases such as cancer, diabetes, and cardiovascular diseases is also driving the growth of the market. For instance, according to GLOBOCAN globally approximately 14.1 million new cancer cases were diagnosed and there were 8.2 million cancer deaths in 2012. In addition, according to World Health Organization (WHO), globally in 2015 approximately 8.8 million people died due to cancer. Moreover, approximately 70% of the deaths from cancer occur in low and middle income countries.

Mounting pharmaceutical outsourcing and substantial opportunities for the pyrogen testing market in developing economies are also facilitating the growth for the pyrogen testing market. High degree of consolidation is the major challenges for the growth of pyrogen testing market.

Industry Ecosystem

Globally, the manufacturing companies trying to enter the pyrogen testing market are required to maintain stringent regulatory standards. Moreover, the high level of capital requirement also poses a major barrier for the entry of new players. This offers an edge to the established players in the industry competition.There are several methods used for pyrogen testing, including the Limulus Amoebocyte Lysate (LAL) test, which is the most commonly used method. The LAL test utilizes the blood of the horseshoe crab to detect the presence of endotoxins. Other methods include the monocyte activation test (MAT) and the rabbit pyrogen test, although the latter is being phased out due to ethical concerns.The global pyrogen testing market has been experiencing growth due to factors such as the increasing demand for pharmaceutical and biotechnology products, stringent regulatory guidelines, and the need for quality assurance. Additionally, advancements in testing technologies and the adoption of automated systems have also contributed to market growth.

Geographic Overview

Geographically, North America is the largest pyrogen testing market as in the region the investment by government in healthcare and pharmaceutical industry is increasing. Research and development of novel drugs, mounting burden of chronic diseases, and upsurge in a number of biologic products are also up surging growth of the North American pyrogen testing market. For instance, according to GLOBOCAN in the U.S. approximately 1.6 million new cancer cases were diagnosed and there were 0.6 million cancer deaths in 2012.

Asia-Pacific is observed to witness fastest growth in the market, due to mounting research and development of novel drugs. In addition, mounting occurrence of chronic diseases, and mounting healthcare expenditure are also creating a positive impact on the pyrogen testing market growth in the region.

Competitive Insight

Key players in the pyrogen testing market are catering the demand of these devices by investing on technologically advanced products in their product portfolio across the globe. In March 2018, Associates of Cape Cod, Inc., introduced a new, swift endotoxin recognition kit, Pyrosate, an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test which enables rapid testing. Associates of Cape Cod, Inc., Merck KGaA, Thermo Fisher Scientific, Inc., GenScript, Charles River Laboratories, Inc., Ellab A/S, Lonza Group, and WUXI Pharmatech (Cayman) Inc. are the key players offering pyrogen testing.

The Pyrogen Testing Market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.

Segments Covered in the Report

• By Product
  • Kits and Reagents
  • Instruments and Services
• By Application
  • Pharmaceutical and Biological Manufacturing
  • Medical Device Manufacturing
  • Others
• By Test Type
  • LAL Tests
  • Rabbit Tests
  • In Vitro Tests

Region Covered in the Report

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia-Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia-Pacific
• Rest of the World (RoW)
  • Brazil
  • Saudi Arabia
  • South Africa
  • U.A.E.
  • Other Countries

Source: VynZ Research

1.    Research Overview

        1.1.    The Report Offers
        1.2.    Market Coverage
                1.2.1.    By Product
                1.2.2.    By Application 
                1.2.3.    By Test Type                                
                1.2.4.    By Region
        1.3.    Research Phases
        1.4.    Limitations
        1.5.    Market Methodology
                1.5.1.    Data Sources
                        1.5.1.1. Primary Research
                        1.5.1.2. Secondary Research
                1.5.2.    Methodology
                        1.5.2.1. Data Exploration
                        1.5.2.2. Forecast Parameters
                        1.5.2.3. Data Validation
                        1.5.2.4. Assumptions
                1.5.3.    Study Period & Data Reporting Unit

2.    Executive Summary

3.    Industry Overview

        3.1.    Industry Dynamics
                3.1.1.    Market Growth Drivers
                3.1.2.    Market Restraints
                3.1.3.    Key Market Trends
                3.1.4.    Major Opportunities
        3.2.    Industry Ecosystem
                3.2.1.    Porter’s Five Forces Analysis
                3.2.2.    Recent Development Analysis
                3.2.3.    Value Chain Analysis
        3.3.    Competitive Insight
                3.3.1.    Competitive Position of Industry Players
                3.3.2.    Market Attractive Analysis
                3.3.3.    Market Share Analysis

4.    Global Market Estimate and Forecast

        4.1.    Global Market Overview
        4.2.    Global Market Estimate and Forecast to 2030

5.    Market Segmentation Estimate and Forecast

        5.1.    By Product
                5.1.1.    Kits and Reagents
                        5.1.1.1. Market Definition
                        5.1.1.2. Market Estimation and Forecast to 2030  
                5.1.2.    Instruments and Services
                        5.1.2.1. Market Definition
                        5.1.2.2. Market Estimation and Forecast to 2030                
        5.2.    By Application
                5.2.1.    Pharmaceutical and Biological Manufacturing
                        5.2.1.1. Market Definition
                        5.2.1.2. Market Estimation and Forecast to 2030
                5.2.2.    Medical Device Manufacturing
                        5.2.2.1. Market Definition
                        5.2.2.2. Market Estimation and Forecast to 2030
                5.2.3.    Others
                        5.2.3.1. Market Definition
                        5.2.3.2. Market Estimation and Forecast to 2030        
        5.3.    By Test Type   
                5.3.1.    LAL Tests
                        5.3.1.1. Market Definition
                        5.3.1.2. Market Estimation and Forecast to 2030
                5.3.2.    Rabbit Tests
                        5.3.2.1. Market Definition
                        5.3.2.2. Market Estimation and Forecast to 2030
                5.3.3.    In Vitro Tests
                        5.3.3.1. Market Definition
                        5.3.3.2. Market Estimation and Forecast to 2030        
        
6.    North America Market Estimate and Forecast

        6.1.    By Product
        6.2.    By Application 
        6.3.    By Test Type                
        6.4.    By Country
                6.4.1.    U.S. Market Estimate and Forecast
                6.4.2.    Canada Market Estimate and Forecast
                6.4.3.    Mexico Market Estimate and Forecast

7.    Europe Market Estimate and Forecast

        7.1.    By Product
        7.2.    By Application 
        7.3.    By Test Type                
        7.4.    By Country
                7.4.1.    Germany Market Estimate and Forecast
                7.4.2.    France Market Estimate and Forecast
                7.4.3.    U.K. Market Estimate and Forecast
                7.4.4.    Italy Market Estimate and Forecast
                7.4.5.    Spain Market Estimate and Forecast
                7.4.6.    Rest of Europe Market Estimate and Forecast

8.    Asia-Pacific Market Estimate and Forecast

        8.1.    By Product
        8.2.    By Application 
        8.3.    By Test Type                
        8.4.    By Country
                8.4.1.    China Market Estimate and Forecast
                8.4.2.    Japan Market Estimate and Forecast
                8.4.3.    India Market Estimate and Forecast
                8.4.4.    South Korea Market Estimate and Forecast
                8.4.5.    Singapore Market Estimate and Forecast
                8.4.6.    Rest of Asia-Pacific Market Estimate and Forecast

9.    Rest of the World (RoW) Market Estimate and Forecast

        9.1.    By Product
        9.2.    By Application 
        9.3.    By Test Type                
        9.4.     By Country
                9.4.1.    Brazil Market Estimate and Forecast
                9.4.2.    Saudi Arabia Market Estimate and Forecast
                9.4.3.    South Africa Market Estimate and Forecast
                9.4.4.    Other Countries Market Estimate and Forecast

10.    Company Profiles

        10.1.    Associates of Cape Cod Inc.
                10.1.1.    Snapshot
                10.1.2.    Overview
                10.1.3.    Offerings
                10.1.4.    Financial Insight
                10.1.5.    Recent Developments
        10.2.    Merck KGaA
                10.2.1.    Snapshot
                10.2.2.    Overview
                10.2.3.    Offerings
                10.2.4.    Financial Insight
                10.2.5.    Recent Developments
        10.3.    Thermo Fisher Scientific Inc.
                10.3.1.    Snapshot
                10.3.2.    Overview
                10.3.3.    Offerings
                10.3.4.    Financial Insight
                10.3.5.    Recent Developments
        10.4.    GenScript Charles River Laboratories Inc.
                10.4.1.    Snapshot
                10.4.2.    Overview
                10.4.3.    Offerings
                10.4.4.    Financial Insight
                10.4.5.    Recent Developments
        10.5.    Ellab A/S
                10.5.1.    Snapshot
                10.5.2.    Overview
                10.5.3.    Offerings
                10.5.4.    Financial Insight
                10.5.5.    Recent Developments
        10.6.    Lonza Group
                10.6.1.    Snapshot
                10.6.2.    Overview
                10.6.3.    Offerings
                10.6.4.    Financial Insight
                10.6.5.    Recent Developments
        10.7.    WUXI Pharmatech (Cayman) Inc.
                10.7.1.    Snapshot
                10.7.2.    Overview
                10.7.3.    Offerings
                10.7.4.    Financial Insight
                10.7.5.    Recent Developments        

11.    Appendix

        11.1.    Exchange Rates
        11.2.    Abbreviations

Note: Financial insight and recent developments of different companies are subject to the availability of information in the secondary domain.

List of Tables

Table 1 Sources
Table 2 Study Periods
Table 3 Data Reporting Unit

Table 4 Global Pyrogen Testing Market, By Product, 2018 - 2023 (USD Billion)
Table 5 Global Pyrogen Testing Market, By Product, 2025–2030 (USD Billion)
Table 6 Global Pyrogen Testing Market, By Application, 2018 - 2023 (USD Billion)
Table 7 Global Pyrogen Testing Market, By Application, 2025–2030 (USD Billion)
Table 8 Global Pyrogen Testing Market, By Test Type, 2018 - 2023 (USD Billion)
Table 9 Global Pyrogen Testing Market, By Test Type, 2025–2030 (USD Billion)
Table 10 Global Pyrogen Testing Market, by Region, 2018 - 2023 (USD Billion)
Table 11 Global Pyrogen Testing Market, by Region, 2025–2030 (USD Billion)
Table 12 North America Pyrogen Testing Market, By Product, 2018 - 2023 (USD Billion)
Table 13 North America Pyrogen Testing Market, By Product, 2025–2030 (USD Billion)
Table 14 North America Pyrogen Testing Market, By Application, 2018 - 2023 (USD Billion)
Table 15 North America Pyrogen Testing Market, By Application, 2025–2030 (USD Billion)
Table 16 North America Pyrogen Testing Market, By Test Type, 2018 - 2023 (USD Billion)
Table 17 North America Pyrogen Testing Market, By Test Type, 2025–2030 (USD Billion)
Table 18 North America Pyrogen Testing Market, by Region, 2018 - 2023 (USD Billion)
Table 19 North America Pyrogen Testing Market, by Region, 2025–2030 (USD Billion)
Table 20 Europe Pyrogen Testing Market, By Product, 2018 - 2023 (USD Billion)
Table 21 Europe Pyrogen Testing Market, By Product, 2025–2030 (USD Billion)
Table 22 Europe Pyrogen Testing Market, By Application, 2018 - 2023 (USD Billion)
Table 23 Europe Pyrogen Testing Market, By Application, 2025–2030 (USD Billion)
Table 24 Europe Pyrogen Testing Market, By Test Type, 2018 - 2023 (USD Billion)
Table 25 Europe Pyrogen Testing Market, By Test Type, 2025–2030 (USD Billion)
Table 26 Europe Pyrogen Testing Market, by Region, 2018 - 2023 (USD Billion)
Table 27 Europe Pyrogen Testing Market, by Region, 2025–2030 (USD Billion)
Table 28 Asia-Pacific Pyrogen Testing Market, By Product, 2018 - 2023 (USD Billion)
Table 29 Asia-Pacific Pyrogen Testing Market, By Product, 2025–2030 (USD Billion)
Table 30 Asia-Pacific Pyrogen Testing Market, By Application, 2018 - 2023 (USD Billion)
Table 31 Asia-Pacific Pyrogen Testing Market, By Application, 2025–2030 (USD Billion)
Table 32 Asia-Pacific Pyrogen Testing Market, By Test Type, 2018 - 2023 (USD Billion)
Table 33 Asia-Pacific Pyrogen Testing Market, By Test Type, 2025–2030 (USD Billion)
Table 34 Asia-Pacific Pyrogen Testing Market, by Region, 2018 - 2023 (USD Billion)
Table 35 Asia-Pacific Pyrogen Testing Market, by Region, 2025–2030 (USD Billion)
Table 36 RoW Pyrogen Testing Market, By Product, 2018 - 2023 (USD Billion)
Table 37 RoW Pyrogen Testing Market, By Product, 2025–2030 (USD Billion)
Table 38 RoW Pyrogen Testing Market, By Application, 2018 - 2023 (USD Billion)
Table 39 RoW Pyrogen Testing Market, By Application, 2025–2030 (USD Billion)
Table 40 RoW Pyrogen Testing Market, By Test Type, 2018 - 2023 (USD Billion)
Table 41 RoW Pyrogen Testing Market, By Test Type, 2025–2030 (USD Billion)
Table 42 RoW Pyrogen Testing Market, by Region, 2018 - 2023 (USD Billion)
Table 43 RoW Pyrogen Testing Market, by Region, 2025–2030 (USD Billion)
Table 44 Snapshot – Associates of Cape Cod Inc.
Table 45 Snapshot – Merck KGaA
Table 46 Snapshot – Thermo Fisher Scientific Inc.
Table 47 Snapshot – GenScript Charles River Laboratories Inc.
Table 48 Snapshot – Ellab A/S
Table 49 Snapshot – Lonza Group
Table 50 Snapshot – WUXI Pharmatech (Cayman) Inc.

List of Figures

Figure 1 Market Coverage
Figure 2 Research Phases
Figure 3 Secondary Sources for Different Parameters
Figure 4 Methodology
Figure 5 Data Mining & Exploration
Figure 6 Data Triangulation
Figure 7 Assumptions for Market Estimation and Forecast
Figure 8 Market Synopsis
Figure 9 Global Pyrogen Testing Market- Growth Drivers and Restraints
Figure 10 Competitive Benchmark
Figure 11 Global Pyrogen Testing Market Highlight
Figure 12 Global Pyrogen Testing Market, By Product,2018 - 2030 (USD Billion)
Figure 13 Global Pyrogen Testing Market, By Application,2018 - 2030 (USD Billion)
Figure 14 Global Pyrogen Testing Market, By Test Type,2018 - 2030 (USD Billion)
Figure 15 Global Pyrogen Testing Market, by Region,2018 - 2030 (USD Billion)
Figure 16 North America Pyrogen Testing Market Highlight
Figure 17 North America Pyrogen Testing Market, By Product,2018 - 2030 (USD Billion)
Figure 18 North America Pyrogen Testing Market, By Application,2018 - 2030 (USD Billion)
Figure 19 North America Pyrogen Testing Market, By Test Type,2018 - 2030 (USD Billion)
Figure 20 North America Pyrogen Testing Market, by Region,2018 - 2030 (USD Billion)
Figure 21 Europe Pyrogen Testing Market Highlight
Figure 22 Europe Pyrogen Testing Market, By Product,2018 - 2030 (USD Billion)
Figure 23 Europe Pyrogen Testing Market, By Application,2018 - 2030 (USD Billion)
Figure 24 Europe Pyrogen Testing Market, By Test Type,2018 - 2030 (USD Billion)
Figure 25 Europe Pyrogen Testing Market, by Region,2018 - 2030 (USD Billion)
Figure 26 Asia-Pacific Pyrogen Testing Market Highlight
Figure 27 Asia-Pacific Pyrogen Testing Market, By Product,2018 - 2030 (USD Billion)
Figure 28 Asia-Pacific Pyrogen Testing Market, By Application,2018 - 2030 (USD Billion)
Figure 29 Asia-Pacific Pyrogen Testing Market, By Test Type,2018 - 2030 (USD Billion)
Figure 30 Asia-Pacific Pyrogen Testing Market, by Region,2018 - 2030 (USD Billion)
Figure 31 RoW Pyrogen Testing Market Highlight
Figure 32 RoW Pyrogen Testing Market, By Product,2018 - 2030 (USD Billion)
Figure 33 RoW Pyrogen Testing Market, By Application,2018 - 2030 (USD Billion)
Figure 34 RoW Pyrogen Testing Market, By Test Type,2018 - 2030 (USD Billion)
Figure 35 RoW Pyrogen Testing Market, by Region,2018 - 2030 (USD Billion)