Product Code: A00669
Pyrogen testing involves in vitro methods using substances derived from bacterial sources, such as the Limulus amebocyte lysate (LAL) test, which is commonly employed for endotoxin detection. Other methods include the monocyte activation test (MAT) and rabbit pyrogen test, although these are less commonly used due to ethical concerns and the availability of more sensitive and specific alternatives. The goal of pyrogen testing is to ensure the safety and quality of medical products by preventing exposure to pyrogenic contaminants that could compromise patient health.
Key factors that drive the growth of the pyrogen testing market include a rise in emphasis on ensuring the safety and quality of pharmaceutical and medical devices, surge in the prevalence of chronic diseases, such as heart disease, diabetes, arthritis, cancer, & diabetes, and rise in demand for pharmaceuticals & medical devices. The development of advanced formulations in the pharmaceutical and biotechnology industries is a significant driver for the pyrogen testing market expansion. The increase in complexity of pharmaceutical products has necessitated the implementation of more quality control measures, leading to the adoption of pyrogen testing. In addition, the rise in number of pharmaceutical & biotechnology industries introducing complex formulations and cutting-edge medical technologies have led to the need for advanced and sensitive pyrogen testing methodologies, which propel the market growth.
Furthermore, growing initiatives for minimizing pyrogen contamination have led to global regulatory bodies and healthcare organizations to set strict standards. This mandates the adoption of strong pyrogen testing methods, contributing to the growth of the pyrogen testing market. For instance, regulatory authorities, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, have established clear guidelines and standards for pyrogen testing. These guidelines outline the regulatory expectations and requirements for pharmaceutical and medical device manufacturers to conduct thorough pyrogen testing as part of their quality control processes. Thus, stringent adherence to these guidelines contributes significantly to market growth.
Moreover, the rise in technological advancements in pyrogen testing further boosts market growth. The development of innovative pyrogen detection methods, such as in vitro and in vivo testing, endotoxin testing, and recombinant factor C assays, enhances the accuracy and efficiency of pyrogen testing processes. For instance, Lonza Group company manufacture PyroTec PRO, an automated endotoxin testing platform that incorporates advanced technology to enhance the efficiency and accuracy of pyrogen testing. The system utilizes the well-established Limulus Amoebocyte Lysate (LAL) test method automates and streamlines the testing process. These technological advancements enable pharmaceutical manufacturers to adopt more reliable and rapid testing procedures, thereby propelling the market growth.
However, limited standardization for pyrogen testing hinders market growth. In addition, lack of knowledge and education about pyrogen contamination risks and testing methodologies hinder the widespread adoption of pyrogen testing in emerging regions. In contrast, expanding the medical device industry, with a focus on innovation and product development, and high growth potential in emerging countries are expected to provide lucrative opportunities during the forecast period.
The pyrogen testing market is segmented on the basis of product & service, test type, end user, and region. By product & service, the market is classified into reagents & kits, instruments, and services. By test type, the market is divided into LAL tests, rabbit pyrogen test, and others. By end user, it is segregated into pharmaceutical & biotechnology companies, medical device companies, and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), LA (Brazil, Colombia, Argentina, and rest of LA), and MEA (GCC, South Africa, North Africa, and rest of MEA).
Major key players that operate in the pyrogen testing market are Merck KGaA, Lonza Group, Thermo Fisher Scientific Inc., FUJIFILM Holdings Corporation, GenScript, SEIKAGAKU CORPORATION, Charles River Laboratories, STERIS, WuXi AppTec, and Eurofins Scientific. Key players have adopted product launch as a key developmental strategy to improve the product portfolio of the pyrogen testing market. For instance, in August 2023, Lonza Group launched the Nebula Absorbance Reader, a new absorbance microplate reader which joins the company's portfolio of optimized instruments for streamlined endotoxin and pyrogen testing.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the pyrogen testing market analysis from 2022 to 2032 to identify the prevailing pyrogen testing market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the pyrogen testing market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global pyrogen testing market trends, key players, market segments, application areas, and market growth strategies.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the pyrogen testing market analysis from 2022 to 2032 to identify the prevailing pyrogen testing market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the pyrogen testing market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global pyrogen testing market trends, key players, market segments, application areas, and market growth strategies.
Additional benefits you will get with this purchase are:
- Quarterly Update and* (only available with a corporate license, on listed price)
- 5 additional Company Profile of client Choice pre- or Post-purchase, as a free update.
- Free Upcoming Version on the Purchase of Five and Enterprise User License.
- 16 analyst hours of support* (post-purchase, if you find additional data requirements upon review of the report, you may receive support amounting to 16 analyst hours to solve questions, and post-sale queries)
- 15% Free Customization* (in case the scope or segment of the report does not match your requirements, 15% is equivalent to 3 working days of free work, applicable once)
- Free data Pack on the Five and Enterprise User License. (Excel version of the report)
- Free Updated report if the report is 6-12 months old or older.
- 24-hour priority response*
- Free Industry updates and white papers.
Possible Customization with this report (with additional cost and timeline, please talk to the sales executive to know more)
- Regulatory Guidelines
- Additional company profiles with specific to client's interest
- Additional country or region analysis- market size and forecast
- Expanded list for Company Profiles
- Historic market data
- Key player details (including location, contact details, supplier/vendor network etc. in excel format)
Key Market Segments
By Product and Service
- Reagents and Kits
- Instruments
- Services
By Test Type
- LAL Test
- Rabbit Pyrogen Test
- Others
By End User
- Pharmaceutical and Biotechnology Companies
- Medical Device Companies
- Others
By Region
- North America
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Latin America
- Brazil
- Colombia
- Argentina
- Rest Of La
- Middle East and Africa
- Gcc
- South Africa
- North Africa
- Rest Of Mea
Key Market Players:
- Lonza Group AG
- Thermo Fisher Scientific Inc.
- Fujifilm Holdings Corporation
- GenScript
- SEIKAGAKU CORPORATION
- Charles River Laboratories
- STERIS plc
- Wuxi AppTec
- Eurofins Scientific SE
- Merck KGaA
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION
- 1.1. Report description
- 1.2. Key market segments
- 1.3. Key benefits to the stakeholders
- 1.4. Research methodology
- 1.4.1. Primary research
- 1.4.2. Secondary research
- 1.4.3. Analyst tools and models
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
- 3.1. Market definition and scope
- 3.2. Key findings
- 3.2.1. Top impacting factors
- 3.2.2. Top investment pockets
- 3.3. Porter's five forces analysis
- 3.3.1. Low bargaining power of suppliers
- 3.3.2. Low threat of new entrants
- 3.3.3. Low threat of substitutes
- 3.3.4. Low intensity of rivalry
- 3.3.5. Low bargaining power of buyers
- 3.4. Market dynamics
- 3.4.1. Drivers
- 3.4.2. Restraints
- 3.4.3. Opportunities
CHAPTER 4: PYROGEN TESTING MARKET, BY PRODUCT AND SERVICE
- 4.1. Overview
- 4.1.1. Market size and forecast
- 4.2. Reagents and Kits
- 4.2.1. Key market trends, growth factors and opportunities
- 4.2.2. Market size and forecast, by region
- 4.2.3. Market share analysis by country
- 4.3. Instruments
- 4.3.1. Key market trends, growth factors and opportunities
- 4.3.2. Market size and forecast, by region
- 4.3.3. Market share analysis by country
- 4.4. Services
- 4.4.1. Key market trends, growth factors and opportunities
- 4.4.2. Market size and forecast, by region
- 4.4.3. Market share analysis by country
CHAPTER 5: PYROGEN TESTING MARKET, BY TEST TYPE
- 5.1. Overview
- 5.1.1. Market size and forecast
- 5.2. LAL Test
- 5.2.1. Key market trends, growth factors and opportunities
- 5.2.2. Market size and forecast, by region
- 5.2.3. Market share analysis by country
- 5.3. Rabbit Pyrogen Test
- 5.3.1. Key market trends, growth factors and opportunities
- 5.3.2. Market size and forecast, by region
- 5.3.3. Market share analysis by country
- 5.4. Others
- 5.4.1. Key market trends, growth factors and opportunities
- 5.4.2. Market size and forecast, by region
- 5.4.3. Market share analysis by country
CHAPTER 6: PYROGEN TESTING MARKET, BY END USER
- 6.1. Overview
- 6.1.1. Market size and forecast
- 6.2. Pharmaceutical and Biotechnology Companies
- 6.2.1. Key market trends, growth factors and opportunities
- 6.2.2. Market size and forecast, by region
- 6.2.3. Market share analysis by country
- 6.3. Medical Device Companies
- 6.3.1. Key market trends, growth factors and opportunities
- 6.3.2. Market size and forecast, by region
- 6.3.3. Market share analysis by country
- 6.4. Others
- 6.4.1. Key market trends, growth factors and opportunities
- 6.4.2. Market size and forecast, by region
- 6.4.3. Market share analysis by country
CHAPTER 7: PYROGEN TESTING MARKET, BY REGION
- 7.1. Overview
- 7.1.1. Market size and forecast By Region
- 7.2. North America
- 7.2.1. Key market trends, growth factors and opportunities
- 7.2.2. Market size and forecast, by Product and Service
- 7.2.3. Market size and forecast, by Test Type
- 7.2.4. Market size and forecast, by End User
- 7.2.5. Market size and forecast, by country
- 7.2.5.1. U.S.
- 7.2.5.1.1. Market size and forecast, by Product and Service
- 7.2.5.1.2. Market size and forecast, by Test Type
- 7.2.5.1.3. Market size and forecast, by End User
- 7.2.5.2. Canada
- 7.2.5.2.1. Market size and forecast, by Product and Service
- 7.2.5.2.2. Market size and forecast, by Test Type
- 7.2.5.2.3. Market size and forecast, by End User
- 7.2.5.3. Mexico
- 7.2.5.3.1. Market size and forecast, by Product and Service
- 7.2.5.3.2. Market size and forecast, by Test Type
- 7.2.5.3.3. Market size and forecast, by End User
- 7.3. Europe
- 7.3.1. Key market trends, growth factors and opportunities
- 7.3.2. Market size and forecast, by Product and Service
- 7.3.3. Market size and forecast, by Test Type
- 7.3.4. Market size and forecast, by End User
- 7.3.5. Market size and forecast, by country
- 7.3.5.1. Germany
- 7.3.5.1.1. Market size and forecast, by Product and Service
- 7.3.5.1.2. Market size and forecast, by Test Type
- 7.3.5.1.3. Market size and forecast, by End User
- 7.3.5.2. France
- 7.3.5.2.1. Market size and forecast, by Product and Service
- 7.3.5.2.2. Market size and forecast, by Test Type
- 7.3.5.2.3. Market size and forecast, by End User
- 7.3.5.3. UK
- 7.3.5.3.1. Market size and forecast, by Product and Service
- 7.3.5.3.2. Market size and forecast, by Test Type
- 7.3.5.3.3. Market size and forecast, by End User
- 7.3.5.4. Italy
- 7.3.5.4.1. Market size and forecast, by Product and Service
- 7.3.5.4.2. Market size and forecast, by Test Type
- 7.3.5.4.3. Market size and forecast, by End User
- 7.3.5.5. Spain
- 7.3.5.5.1. Market size and forecast, by Product and Service
- 7.3.5.5.2. Market size and forecast, by Test Type
- 7.3.5.5.3. Market size and forecast, by End User
- 7.3.5.6. Rest of Europe
- 7.3.5.6.1. Market size and forecast, by Product and Service
- 7.3.5.6.2. Market size and forecast, by Test Type
- 7.3.5.6.3. Market size and forecast, by End User
- 7.4. Asia-Pacific
- 7.4.1. Key market trends, growth factors and opportunities
- 7.4.2. Market size and forecast, by Product and Service
- 7.4.3. Market size and forecast, by Test Type
- 7.4.4. Market size and forecast, by End User
- 7.4.5. Market size and forecast, by country
- 7.4.5.1. Japan
- 7.4.5.1.1. Market size and forecast, by Product and Service
- 7.4.5.1.2. Market size and forecast, by Test Type
- 7.4.5.1.3. Market size and forecast, by End User
- 7.4.5.2. China
- 7.4.5.2.1. Market size and forecast, by Product and Service
- 7.4.5.2.2. Market size and forecast, by Test Type
- 7.4.5.2.3. Market size and forecast, by End User
- 7.4.5.3. India
- 7.4.5.3.1. Market size and forecast, by Product and Service
- 7.4.5.3.2. Market size and forecast, by Test Type
- 7.4.5.3.3. Market size and forecast, by End User
- 7.4.5.4. Australia
- 7.4.5.4.1. Market size and forecast, by Product and Service
- 7.4.5.4.2. Market size and forecast, by Test Type
- 7.4.5.4.3. Market size and forecast, by End User
- 7.4.5.5. South Korea
- 7.4.5.5.1. Market size and forecast, by Product and Service
- 7.4.5.5.2. Market size and forecast, by Test Type
- 7.4.5.5.3. Market size and forecast, by End User
- 7.4.5.6. Rest of Asia-Pacific
- 7.4.5.6.1. Market size and forecast, by Product and Service
- 7.4.5.6.2. Market size and forecast, by Test Type
- 7.4.5.6.3. Market size and forecast, by End User
- 7.5. Latin America
- 7.5.1. Key market trends, growth factors and opportunities
- 7.5.2. Market size and forecast, by Product and Service
- 7.5.3. Market size and forecast, by Test Type
- 7.5.4. Market size and forecast, by End User
- 7.5.5. Market size and forecast, by country
- 7.5.5.1. Brazil
- 7.5.5.1.1. Market size and forecast, by Product and Service
- 7.5.5.1.2. Market size and forecast, by Test Type
- 7.5.5.1.3. Market size and forecast, by End User
- 7.5.5.2. Colombia
- 7.5.5.2.1. Market size and forecast, by Product and Service
- 7.5.5.2.2. Market size and forecast, by Test Type
- 7.5.5.2.3. Market size and forecast, by End User
- 7.5.5.3. Argentina
- 7.5.5.3.1. Market size and forecast, by Product and Service
- 7.5.5.3.2. Market size and forecast, by Test Type
- 7.5.5.3.3. Market size and forecast, by End User
- 7.5.5.4. Rest Of La
- 7.5.5.4.1. Market size and forecast, by Product and Service
- 7.5.5.4.2. Market size and forecast, by Test Type
- 7.5.5.4.3. Market size and forecast, by End User
- 7.6. Middle East and Africa
- 7.6.1. Key market trends, growth factors and opportunities
- 7.6.2. Market size and forecast, by Product and Service
- 7.6.3. Market size and forecast, by Test Type
- 7.6.4. Market size and forecast, by End User
- 7.6.5. Market size and forecast, by country
- 7.6.5.1. Gcc
- 7.6.5.1.1. Market size and forecast, by Product and Service
- 7.6.5.1.2. Market size and forecast, by Test Type
- 7.6.5.1.3. Market size and forecast, by End User
- 7.6.5.2. South Africa
- 7.6.5.2.1. Market size and forecast, by Product and Service
- 7.6.5.2.2. Market size and forecast, by Test Type
- 7.6.5.2.3. Market size and forecast, by End User
- 7.6.5.3. North Africa
- 7.6.5.3.1. Market size and forecast, by Product and Service
- 7.6.5.3.2. Market size and forecast, by Test Type
- 7.6.5.3.3. Market size and forecast, by End User
- 7.6.5.4. Rest Of Mea
- 7.6.5.4.1. Market size and forecast, by Product and Service
- 7.6.5.4.2. Market size and forecast, by Test Type
- 7.6.5.4.3. Market size and forecast, by End User
CHAPTER 8: COMPETITIVE LANDSCAPE
- 8.1. Introduction
- 8.2. Top winning strategies
- 8.3. Product mapping of top 10 player
- 8.4. Competitive dashboard
- 8.5. Competitive heatmap
- 8.6. Top player positioning, 2022
CHAPTER 9: COMPANY PROFILES
- 9.1. Lonza Group AG
- 9.1.1. Company overview
- 9.1.2. Key executives
- 9.1.3. Company snapshot
- 9.1.4. Operating business segments
- 9.1.5. Product portfolio
- 9.1.6. Business performance
- 9.1.7. Key strategic moves and developments
- 9.2. Thermo Fisher Scientific Inc.
- 9.2.1. Company overview
- 9.2.2. Key executives
- 9.2.3. Company snapshot
- 9.2.4. Operating business segments
- 9.2.5. Product portfolio
- 9.2.6. Business performance
- 9.2.7. Key strategic moves and developments
- 9.3. Fujifilm Holdings Corporation
- 9.3.1. Company overview
- 9.3.2. Key executives
- 9.3.3. Company snapshot
- 9.3.4. Operating business segments
- 9.3.5. Product portfolio
- 9.3.6. Business performance
- 9.3.7. Key strategic moves and developments
- 9.4. GenScript
- 9.4.1. Company overview
- 9.4.2. Key executives
- 9.4.3. Company snapshot
- 9.4.4. Operating business segments
- 9.4.5. Product portfolio
- 9.4.6. Business performance
- 9.4.7. Key strategic moves and developments
- 9.5. SEIKAGAKU CORPORATION
- 9.5.1. Company overview
- 9.5.2. Key executives
- 9.5.3. Company snapshot
- 9.5.4. Operating business segments
- 9.5.5. Product portfolio
- 9.5.6. Business performance
- 9.5.7. Key strategic moves and developments
- 9.6. Charles River Laboratories
- 9.6.1. Company overview
- 9.6.2. Key executives
- 9.6.3. Company snapshot
- 9.6.4. Operating business segments
- 9.6.5. Product portfolio
- 9.6.6. Business performance
- 9.6.7. Key strategic moves and developments
- 9.7. STERIS plc
- 9.7.1. Company overview
- 9.7.2. Key executives
- 9.7.3. Company snapshot
- 9.7.4. Operating business segments
- 9.7.5. Product portfolio
- 9.7.6. Business performance
- 9.7.7. Key strategic moves and developments
- 9.8. Wuxi AppTec
- 9.8.1. Company overview
- 9.8.2. Key executives
- 9.8.3. Company snapshot
- 9.8.4. Operating business segments
- 9.8.5. Product portfolio
- 9.8.6. Business performance
- 9.8.7. Key strategic moves and developments
- 9.9. Eurofins Scientific SE
- 9.9.1. Company overview
- 9.9.2. Key executives
- 9.9.3. Company snapshot
- 9.9.4. Operating business segments
- 9.9.5. Product portfolio
- 9.9.6. Business performance
- 9.9.7. Key strategic moves and developments
- 9.10. Merck KGaA
- 9.10.1. Company overview
- 9.10.2. Key executives
- 9.10.3. Company snapshot
- 9.10.4. Operating business segments
- 9.10.5. Product portfolio
- 9.10.6. Business performance
- 9.10.7. Key strategic moves and developments