Global Endotoxin and Pyrogen Testing Market – Industry Trends and Forecast to 2031

Global Endotoxin and Pyrogen Testing Market, By Product and Services (Detection Kits and Reagents, Instruments and Systems, Endotoxin and Pyrogen Testing Services, and Consumables and Accessories), Test Type (Limulus Amoebocyte Lysate (LAL) Test, TAL Tests, Monocyte Activation Test (MAT), Recombinant C (RFC) Assay,  In-Vitro, and Rabbit Pyrogen Test), Type (Pre-Formed Endotoxin and Pyrogen Testing, Proendotoxin and Pyrogen Testing and Combine Endotoxin and Pyrogen Testing), Product Category (Clean Labeled Ingredient and Conventional), Form (Powder and Liquid) Application (Pharmaceutical Manufacturing, Medical Device Manufacturing, Raw Materials Production, and Packaging Manufacture), Method (Gel Clot Endotoxin and Pyrogen Test, Chromogenic Endotoxin and Pyrogen Test, and Turbidimetric Endotoxin and Pyrogen Test),  Mode of Purchase (Large Group, Mid and Small Group, and Individual), End Product (Vaccines and/ Or CGT, Biologics, Injectable, and Others), End User (Pharmaceutical Companies, Biotechnology Companies, Biomedical Companies, Medical Device Companies, Contract Research Organization (CRO), Contract Manufacturing Organization (CMO), and Others) – Industry Trends and Forecast to 2031.

Endotoxin and Pyrogen Testing Market Analysis and Size

Endotoxin and pyrogen tests are essential for ensuring the safety and quality of injectable drugs, implants, and medical devices, as they detect bacterial toxins that can cause adverse reactions in patients. Methods such as the LAL Test, MAT, Rabbit Pyrogen Test, and RFC Assay are employed for endotoxin testing, crucial for regulatory compliance and product safety.                                

Data Bridge Market Research analyses that the global endotoxin and pyrogen testing market, which was USD 1.14 billion in 2023, is expected to reach USD 2.67 billion by 2031, and is expected to undergo a CAGR of 11.3% during the forecast period of 2024 to 2031. This indicates that the market value. 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 depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation

Market Definition

Endotoxin and pyrogen tests are crucial in pharmaceutical and medical device manufacturing, ensuring product safety. Endotoxin tests detect bacterial lipopolysaccharides, while pyrogen tests identify fever-inducing substances. These tests evaluate product purity and sterility, mitigating potential health hazards.           

Global Endotoxin and Pyrogen Testing Market Dynamics

Drivers

• Technological Advancements in Rapid and Automated Testing

Advancements in rapid and automated testing systems offer vast opportunities for the endotoxin and pyrogen testing market. These innovations boost efficiency, accuracy, and capabilities, meeting the growing need for stringent quality control in pharmaceutical and medical device manufacturing, thereby fueling market growth.

• Increasing Investment in Healthcare Infrastructure and Testing Protocols

Growing investments in healthcare infrastructure globally propel demand for stringent quality control, fueling the endotoxin and pyrogen testing market. Expanding healthcare facilities necessitate rigorous testing protocols, driving market expansion and ensuring product safety in pharmaceutical and medical device sectors.

Opportunities

• Rapidly Growing Pharmaceutical and Medical Device Industries

The endotoxin and pyrogen testing market experiences rapid expansion due to robust growth in the pharmaceutical and medical device sectors. Stringent quality control mandates drive demand for advanced testing solutions, ensuring safety, compliance, and efficacy in these industries.

• Increasing Adoption of Single-Use Systems in Biopharmaceutical Manufacturing

The increasing use of single-use systems in biopharmaceutical manufacturing highlights the crucial requirement for rigorous endotoxin and pyrogen testing. This emerging trend presents a notable market opportunity, emphasizing the criticality of maintaining stringent quality and safety standards to uphold excellence in biopharmaceutical production.

Restraints/Challenges

• Data Security Concerns Among Patient

Implementing LIS faces major data security challenges, necessitating robust cybersecurity measures and compliance with strict data protection laws. Inadequate safeguarding of patient data invites breaches and cyber threats, jeopardizing privacy and leading to legal and reputational fallout for healthcare entities.

• Complexity in Testing Procedures Hinder Adoption

Endotoxin and pyrogen testing's intricate procedures require specialized expertise, impeding their smooth integration into healthcare settings. This complexity presents a hurdle for the market, affecting accessibility and potentially stalling widespread adoption in diverse healthcare facilities. 

This global endotoxin and pyrogen testing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the global endotoxin and pyrogen testing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In October 2023, Lonza launches two Monocyte Activation Test (MAT) systems, PyroCell MAT Human Serum (HS) Rapid System and PyroCell MAT Rapid System, elevating capabilities in the laboratory information system (LIS) market. These advancements enhance testing efficiency and data integration, aligning laboratory technologies with information management
• In September 2023, Intravacc collaborates with Sanquin Diagnostic Services to enhance the in vitro Monocyte Activation Test (MAT) for OMV vaccines, highlighting the significance of advanced laboratory technologies. This partnership may drive demand for laboratory information system solutions, streamlining data management and analysis to support vaccine development
• In October 2020, Lonza Bioscience launches the PyroCell MAT System, a sustainable in vitro pyrogen testing solution, bolstering safety in parenteral pharmaceuticals. Leveraging Lonza's primary cells expertise and Sanquin's MAT production know-how, this release ensures efficacy across development, manufacturing, and product release stages
• In July 2020, Lonza Sales AG and Sanquin Reagents BV form a strategic partnership to commercialize specialized reagents for pyrogen testing, focusing on utilizing the Monocyte Activation Test (MAT) for assessing healthcare products' safety. This collaboration enhances safety standards and regulatory compliance in the healthcare industry

Global Endotoxin and Pyrogen Testing Market Scope

The global endotoxin and pyrogen testing market is segmented on the basis of product and services, test type, type, product category, form, application, method, mode of purchase, end product, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Product and Services

• Detection Kits and Reagents
• Instruments and Systems
• Endotoxin and Pyrogen Testing Services
• Consumables and Accessories

 Test Type

• Limulus Amoebocyte Lysate (LAL) Test
• TAL Tests
• Monocyte Activation Test (MAT)
• Recombinant C (RFC) Assay
• In-Vitro
• Rabbit Pyrogen Test

Type

• Pre-Formed Endotoxin and pyrogen testing
• Proendotoxin and pyrogen testing
• Combine Endotoxin and pyrogen testing

Product Category

• Clean Labeled Ingredient
• Conventional

 Form

• Powder
• Liquid

 Application

• Pharmaceutical Manufacturing
• Medical Device Manufacturing
• Raw Materials Production
• Packaging Manufacture

 Method

• Gel Clot Endotoxin and Pyrogen Test
• Chromogenic Endotoxin and Pyrogen Test
• Turbidimetric Endotoxin and Pyrogen Test

 Mode of Purchase

• Large Group
• Mid and Small Group
• Individual

 End Product

• Vaccines and/ Or CGT
• Biologics
• Injectable
• Others

 End User

• Pharmaceutical Companies
• Biotechnology Companies
• Biomedical Companies
• Medical Device Companies
• Contract Research Organization (CRO)
• Contract Manufacturing Organization (CMO)
• Others

Global Endotoxin and Pyrogen Testing Market Regional Analysis/Insights

The global endotoxin and pyrogen testing market is analysed and market size insights and trends are provided by country, product and services, test type, type, product category, form, application, method, mode of purchase, end product, and end user as referenced above.

The countries covered in the global endotoxin and pyrogen testing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America is expected to dominate in the endotoxin and pyrogen testing market, driven by increased usage and growing demand in the pharmaceutical and biotechnology industry.

In the Asia-Pacific region, technological advancements drive the development of novel endotoxin and pyrogen testing methods. This innovation propels the region to dominate the endotoxin and pyrogen testing market with cutting-edge solutions.

Europe is growing in the endotoxin and pyrogen testing market due to increasing adoption of quality check products, particularly in Germany, aimed at preventing product recalls and ensuring product safety.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The global endotoxin and pyrogen testing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global endotoxin and pyrogen testing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the global endotoxin and pyrogen testing market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Endotoxin and Pyrogen Testing Market Share Analysis

The global endotoxin and pyrogen testing 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 global endotoxin and pyrogen testing market.

Some of the major players operating in the global endotoxin and pyrogen testing market are:

• Pall Corporation.  (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
•  Charles River Laboratories. (U.S.)
•  Eurofins Scientific (Luxembourg)
•  SGS Société Générale de Surveillance SA. (Switzerland)
•  Lonza (Switzerland)
• Merck KGaA (Germany)
•  STERIS (Ireland)
•  Sartorius AG (Germany)
•   BIOMÉRIEUX (France
•  Ellab A/S. (Denmark)
• Wako Pyrogen (U.S.)
•  ASSOCIATES OF CAPE COD, INC. (U.S.)
• WuXi AppTec (China)
•  Microcoat Biotechnologie GmbH (Germany)