Global Pyrogen Testing Market

Global Pyrogen Testing Market

Global pyrogen testing market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031, growing at a CAGR of YY% during the forecast period 2024-2031.

A pyrogen is a substance that causes a rise in temperature in a human or animal through the activation of the innate immune system. They constitute a heterogeneous group of contaminants comprising microbial and non-microbial substances. Pyrogens can be classified into two groups, endotoxins and non-endotoxin pyrogens. Endotoxins are substances found in Gram-negative bacteria. Non-endotoxin pyrogens are other microbial substances, including those derived from Gram-positive bacteria or viruses and pyrogens originating from yeasts and fungi.

Pyrogen testing determines the presence or absence of pyrogens in parenteral pharmaceutical products and is regulated by several standards from organizations such as the Food and Drug Administration (FDA), United States Pharmacopeia (USP) or European Pharmacopeia (EP). The sterility of a product does not imply that it is free of pyrogens. Therefore, drugs that are purported to be sterile must also be tested for pyrogens to prevent febrile reactions in patients.

Market Dynamics: Drivers

Rising advancements in pyrogen testing

The rising advancements in pyrogen testing are expected to drive the market over the forecast period. Advancements in assay technologies like the development of more sensitive reagents and detection systems, enable the detection of lower levels of pyrogens in pharmaceutical products. This increased sensitivity is crucial for ensuring the safety of highly sensitive biopharmaceuticals and medical devices.

For instance, on October 25, 2023, Lonza launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System to streamline and simplify rabbit-free pyrogen testing. The systems, which will replace Lonza’s current MAT system kit offerings, contain the new PeliKine Human IL-6 Rapid ELISA Kit that minimizes hands-on time and reduces time-to-results from two days to two hours. The new tests give pharma manufacturers easier, faster and more efficient MAT testing options for product safety testing while helping to reduce the reliance on animals.

Automation of pyrogen testing processes and the development of high-throughput screening platforms enable faster and more efficient testing of large numbers of samples. This is particularly beneficial for pharmaceutical companies with high-volume manufacturing operations, as it reduces testing time and enhances productivity.

Research and development efforts are focused on developing alternative pyrogen testing methods that reduce reliance on animal-derived reagents, such as the Limulus Amebocyte Lysate (LAL) assay. Alternative methods, such as the recombinant Factor C (rFC) assay and monocyte activation test (MAT), offer advantages in terms of reproducibility, scalability and ethical considerations.

For instance, on June 07, 2022, Lonza launched the PyroCell Monocyte Activation Test - Human Serum System (PyroCell MAT HS System), which uses human serum instead of fetal bovine serum. This new in vitro pyrogen testing system exhibits enhanced sensitivity for the detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals. By replacing fetal bovine serum, the new PyroCell MAT HS System increases sustainability by reducing the need for experimental animals and animal-derived components in pyrogen testing. Pharmaceutical manufacturers globally can now rely on Lonza for a range of high-quality, sensitive and sustainable in vitro pyrogen tests.

Restraints

Factors such as the high cost of advanced pyrogen testing methods, limited awareness and education about the pyrogen testing methods, complexity of sample preparation and handling, unmet needs and uncertainties regarding testing are the factors expected to hamper the market.

Segment Analysis

The global pyrogen testing market is segmented based on product & service, test type, end-user and region.

The instruments segment accounted for approximately 43.2% of the pyrogen testing market share

The instruments segment is expected to hold the largest market share over the forecast period. Endotoxins are a type of pyrogenic contaminant derived from the outer membrane of Gram-negative bacteria. Endotoxin detection systems, such as the Limulus Amebocyte Lysate (LAL) assay, are widely used to quantify endotoxin levels in pharmaceutical products, medical devices and raw materials. These systems utilize reagents derived from horseshoe crab blood to detect and quantify endotoxin levels with high sensitivity.

For instance, on August 15, 2023, Lonza launched the Nebula Absorbance Reader, a new absorbance microplate reader that joins the company’s portfolio of optimized instruments for streamlined endotoxin and pyrogen testing. Pharmaceutical quality control (QC) laboratories worldwide rely on the traditional absorbance-based Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) assays to assure the safety of raw materials in-process samples and manufactured products. The Nebula Absorbance Reader represents a technologically advanced, high-performance replacement reader, which delivers results comparable to those typically found with ELx808 and will facilitate the smooth continuation of current pyrogen and endotoxin testing programs.

Further, several types of pyrogen testing instruments are commonly used in the pharmaceutical, biotechnology and medical device industries to detect and quantify pyrogenic contaminants in products. These instruments employ different technologies and methodologies to achieve accurate and reliable results

Geographical Analysis

North America accounted for approximately 42.1% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing technological advancements. North America especially the United States is very well-known for its strong presence of major players such as pharmaceutical and biotechnology companies. This presence of major players in the region drives the demand for pyrogen testing services and instruments to support drug development, manufacturing and quality control processes.

North America is a very well-known hub for technological advancements and research. The region especially the United States has a strong focus on developing advanced pyrogen testing methods like the adoption of recombinant Factor C (rFC) assays and monocyte activation tests (MAT), which offer advantages in terms of sensitivity, specificity and sustainability. The availability of cutting-edge pyrogen testing technologies further drives market growth in the region.

Competitive Landscape

The major global players in the pyrogen testing market include Merck KGaA, Lonza Group, Ellab A/S, Electronics India, Charles River Laboratories, BioNordika AS, Eurofins Biolab Srl, Charles River Laboratories, CellMade Laboratories and Environmental & Scientific Instruments Co. among others.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global pyrogen testing market. The coronavirus disease 2019 (COVID-19) pandemic disrupted clinical trials and drug development activities worldwide leading to delays and cancellations of trials for non-COVID-19 products. Pyrogen testing is an essential component of drug development and manufacturing processes and disruptions in these activities contributed to a decrease in demand for pyrogen testing services during the pandemic. In addition, the pandemic also disrupted the global supply chain of pyrogen testing products.

Market Segmentation

By Product & Service
• Assays
• Kits
• Reagents
• Instruments
• Services
• Others

By Test Type
• LAL Tests
• Rabbit Pyrogen Test
• Monocyte Activation Test
• Others

By End-User
• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Companies
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?
• To visualize the global pyrogen testing market segmentation based on product & service, test type, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of pyrogen testing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global pyrogen testing market report would provide approximately 61 tables, 62 figures, and 187 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies