Pyrogen Testing Market

Pyrogen Testing Market Size

Pyrogen Testing Market was valued at around USD 1.3 billion in 2023 and is estimated to register a CAGR of over 9.1% between 2024 and 2032. Pyrogen testing entails a series of procedures aimed at detecting and quantifying pyrogens in pharmaceuticals, medical devices, and materials interacting with the human body. Pyrogens substances are capable of inducing fever upon entry into the bloodstream originate from sources such as microbial contamination. The increasing prevalence of chronic disease diseases includes cardiovascular diseases, diabetes, and cancer, fueling the demand for diagnostic testing and monitoring.

For instance, according to the World Health Organization (WHO), in 2022, there were an estimated 20 million new cancer cases and 9.7 million deaths worldwide. These technologies play a crucial role in improving diagnosis, treatment management, and risk prediction of cardiac diseases. Thus, the increasing demand for pyrogen testing underscores the importance of ensuring the safety and efficacy of pharmaceuticals and medical devices, especially in the context of treating patients with compromised health due to chronic conditions.

Furthermore, the increasing demand for therapeutic drugs, growing investment in R&D, rising awareness about food safety, and the escalating need for depyrogenated sterile empty vials, which estimated to reach 1.4 billion by 2026,  are contributing factors stimulating the growth of the market.

Pyrogen Testing Market Trends

Increased research and development (R&D) investment often leads to the development of cutting-edge technologies and methodologies. In the realm of pyrogen testing this translates to the emergence of more sensitive, specific, and efficient testing techniques. Advanced analytical instruments, novel assay platforms, and innovative approaches may enhance the accuracy and reliability of pyrogen detection, thereby improving the overall safety assessment of pharmaceutical products.

• For instance, in 2022, the European Federation of Pharmaceutical Industries and Associations (EFPIA) reported an investment of approximately USD 48.65 billion in research and development (R&D) in Europe.
  
• R&D efforts focused on pyrogen testing can refine assays to detect trace amounts of pyrogens with heightened sensitivity. This sensitivity is critical especially for ensuring the safety of biopharmaceuticals and medical devices, as even minute levels of pyrogens can pose significant risks to patients.
  
• The innovations stemming from R&D investments may streamline pyrogen testing procedures reducing the time required for analysis. Rapid testing methods enable expedited release of pharmaceutical batches, facilitating quicker product availability to meet market demands without compromising safety.
  
• Further, R&D efforts in pyrogen testing can yield cost-effective solutions through protocol optimization, efficient technologies, and minimized resource consumption, benefiting pharmaceutical manufacturers without compromising safety standards, thereby escalating the growth of the market.
  

Pyrogen Testing Market Analysis

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Based on product and services, the pyrogen testing industry is divided into consumables, instruments, and services. The consumables segment is estimated to account for USD 1.5 billion by the end of 2032.

• Consumables such as test tubes, pipette tips, and reagent containers are manufactured under strict quality control measures ensuring uniformity and consistency across batches. This standardization minimizes variability in test results, enhancing the reliability of pyrogen testing.
  
• Disposable consumables help to prevent cross-contamination between samples, reducing the risk of false-positive or false-negative results in pyrogen testing. Single-use consumables eliminate the need for thorough cleaning and sterilization between tests, streamlining the workflow and minimizing the potential for errors.
  
• Additionally, pyrogen testing consumables are typically certified as pyrogen-free, mitigating the risk of introducing contaminants that could interfere with test results. This assurance is critical for maintaining the integrity of the testing process and ensuring accurate detection of pyrogens in pharmaceutical products and medical devices. Thus, stimulating the growth of the segment.

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Based on test type, the pyrogen testing market is bifurcated into LAL test, in-vitro pyrogen test, and rabbit test. Further, the LAL test is segmented into chromogenic test, turbidimetric test, and gel clot test. In-vitro pyrogen test is subdivided into monocyte activation test (MAT) and recombinant factor C assay (rFC). The LAL test segment accounted for USD 580.2 million in 2023.

• The limulus amebocyte lysate (LAL) is highly sensitive to the presence of bacterial endotoxins a common source of pyrogens in pharmaceuticals and medical devices. It can detect endotoxin levels as low as picograms per milliliter (pg/mL), rendering it an effective tool for ensuring the safety of products intended for human use.
  
• This test provides rapid results with most assays yielding quantitative data within a few hours. This quick turnaround time enables timely decision-making in pharmaceutical manufacturing processes facilitating efficient batch release and product distribution.
  
• Additionally, the test allows for the quantitative measurement of endotoxin levels, providing precise information about the extent of contamination in pharmaceutical samples. This quantitative data is valuable for assessing product quality, setting acceptance criteria, and ensuring compliance with regulatory standards.
  
• Thus, such aforementioned factors are expected to augment the segmental growth.
  

Based on end-use, the pyrogen testing industry is classified into pharmaceutical and biotechnology companies, medical devices companies, and other end-users. The pharmaceutical and biotechnology companies segment held a market size of USD 1.6 billion in 2032.

• Pyrogen testing contributes to maintaining high product quality standards by identifying and eliminating sources of contamination. This ensures that pharmaceutical and biotechnology companies deliver safe and effective products to consumers, thereby enhancing their reputation and brand value.
  
• Detecting and quantifying pyrogens in pharmaceutical products and medical devices help mitigate the risk of adverse reactions in patients. By ensuring that their products are free from pyrogenic contaminants, companies safeguard patient health and minimize potential liabilities associated with product recalls or adverse events.
  
• Moreover, implementing robust pyrogen testing protocols can lead to cost savings in the long run. By detecting and addressing pyrogenic contamination early in the manufacturing process, companies can avoid costly production delays, recalls, and regulatory fines associated with non-compliance. Thus, all these aforementioned factors are expected to drive segmental growth.

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North America pyrogen testing market accounted for USD 530.3 million revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.

• North America boasts advanced laboratory infrastructure and technology, facilitating sophisticated pyrogen testing methodologies. State-of-the-art facilities and equipment enable accurate, reliable, and efficient detection of pyrogens in pharmaceutical products and medical devices.
  
• North America is witnessing a notable rise in the prevalence of chronic diseases such as cardiovascular diseases, diabetes, and cancer.
  
• For instance, The National Diabetes Statistics Report for 2022 by the CDC (Centers for Disease Control) reveals that the prevalence of diabetes has increased, reaching an estimated 37.3 million cases. This accounts for 11.3% of the U.S. population. Among these cases, 28.7 million people have received a diabetes diagnosis, while approximately 8.6 million individuals have diabetes but remain undiagnosed.
  
• The region hosts a skilled workforce proficient in pyrogen testing methodologies, expertise aids in developing and implementing robust testing protocols, thereby improving accuracy and reliability of results. Thus, these factors are expected to propel market growth in North America.
  

Pyrogen Testing Market Share

The pyrogen testing services industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products and services based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Pyrogen Testing Market Companies

Some of the eminent market participants operating in the industry include:

• Almac Group
• bioMérieux SA
• Charles River Laboratories International, Inc.      
• Eurofins Scientific    
• Fujifilm Holdings Corporation        
• GenScript Biotech Corporation       
• Lonza 
• Merck KGaA  
• STERIS plc    
• Thermo Fisher Scientific Inc.
  

Pyrogen Testing Industry News:

• In October 2023, Lonza launched two new rapid monocyte activation test (MAT) systems, namely the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, aimed at streamlining and simplifying rabbit-free pyrogen testing. The implementation of these innovative MAT systems benefited Lonza by improving testing processes, reducing reliance on animal testing, and enhancing overall product quality and safety compliance.
  
• In December 2022, Charles River Laboratories International, Inc., launched the Endosafe Nexus 200, expanding its robust endotoxin testing portfolio. This introduction marked a significant milestone for the company, reinforcing its commitment to providing comprehensive solutions for endotoxin detection in pharmaceutical and medical device manufacturing.
  

The pyrogen testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Product and Services

• Consumables
• Instruments  
• Services       

Market, By Test Type

• LAL test       
  • Chromogenic test    
  • Turbidimetric test    
  • Gel clot test  
• In-vitro pyrogen test         
  • Monocyte activation test (MAT)
  • Recombinant factor C assay (rFC)
• Rabbit test

Market, By End-use

• Pharmaceutical and biotechnology companies                       
• Medical devices companies 
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa