Pyrogen Testing Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables, Services), By Test Type (LAL Test, In Vitro Pyrogen Test, Rabbit Test), By End-use, And Segment Forecasts, 2025 - 2030

Pyrogen Testing Market Size & Trends

The global pyrogen testing market size was valued at over USD 1.36 billion in 2024 and is projected to grow at 11.2% from 2025 to 2030. The increasing demand for pyrogen testing products in the pharmaceutical and biotechnology industries is a significant driver of market growth. The rapid expansion of these industries, coupled with the rising number of new therapeutic launches, is expected to propel the demand for pyrogen testing products further. This growth highlights the critical role of pyrogen testing in ensuring the safety and efficacy of pharmaceutical and biotechnological products.

Several regulatory bodies and governments are taking various initiatives to train and create awareness about pyrogen testing. Government initiatives worldwide are pivotal in accelerating this transition. In June 2024, the 179th session of the European Pharmacopoeia (Ph. Eur.) Commission marked a significant advancement for animal welfare and contemporary pyrogen testing practices. During this session, the Commission approved the removal of the Rabbit Pyrogen Test (RPT) from 57 revised texts and introduced a comprehensive new general chapter on Pyrogenicity. This decision effectively abolished the RPT requirement across all Ph. Eur. texts, solidifying the transition toward in vitro testing methodologies, such as the Monocyte Activation Test (MAT).

Increasing investment in R&D by the government and manufacturing companies for product development is one of the major factors contributing to the market's growth. New product development and launch is a key strategy acquired by manufacturers to maintain their dominance and to get maximum revenue-share in the sector. As stated by the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2023, the research-based pharmaceutical industry invested around USD 48.65 billion in R&D in Europe in 2022. Hence, the need for pyrogen testing products is anticipated to upsurge during the forecast period.

Furthermore, the market is driven by the increasing demand for therapeutic drugs. Several companies are actively involved in developing new drug therapies. For instance, in 2023, the FDA approved 55 new drugs. Pyrogen testing in drug development specifies the absence or presence of pyrogens in parenteral pharmaceutical products. Moreover, the sterility of any drug does not indicate that it is pyrogen-free. Therefore, drugs that are expected to be sterile must be tested for the presence of pyrogens to control fevered reactions in patients.

Market Concentration & Characteristics

The market growth stage is medium, and the market growth is accelerating. The innovation in the pyrogen testing market is driven by factors such as technological advancements, increasing demand for pyrogen testing, and the need for animal-free and reliable testing methods.

The pyrogen testing market is also characterized by the leading players' interest in merger and acquisition (M&A) activity. This is due to several factors, including the desire to gain access to new pyrogen technologies, expand the customer base in the pyrogen testing market, the need to consolidate in a rapidly growing market, and its usage in R&D.

The pyrogen testing market is significantly influenced by regulations, which drive the adoption of these testing assays and kits. Strict guidelines from regulatory bodies such as the FDA mandate the use of pyrogen testing to ensure the safety and efficacy of pharmaceutical products. Moreover, it has led to a growing emphasis on animal-free pyrogen testing.

In the pyrogen testing market, regional expansion involves pyrogen testing companies strategically extending their activities beyond current geographic locations. Hence, the market players undertake various business initiatives, such as partnerships, geographical expansion, and collaboration, to gain a regional customer base.

Product Insights

Based on product, the pyrogen testing industry is segmented into consumables, instruments, and services. In 2024, the consumables segment was the largest segment with a share of 43.60% and is estimated to maintain its dominance during the forecast period. The growing adoption of in vitro and non-animal testing methods has intensified the demand for advanced consumables. In June 2024, FUJIFILM Wako Chemicals launched the PYROSTAR Neo+ and LumiMAT, advancing the market with innovative, sustainable consumables. These products exemplify the shift toward recombinant and animal-free testing methods, reflecting the industry's focus on innovation, regulatory compliance, and sustainability.

The instruments segment is expected to show significant growth during the forecast period owing to the technological advancement in products. For instance, the PyroDetect System is a verified non-animal substitute to replace the rabbit test that offers high quality in vitro detection of both non-endotoxin and endotoxin contamination.

Test Type Insights

Based on test type, the pyrogen testing industry has been segmented into LAL tests, in vitro tests, and rabbit tests. The LAL test segment dominated the market with a share of 63.15% in 2024. The growth is attributed to the rising demand for animal-free detection tests and their high reproducibility and reliability during detection. For instance, In February 2023, the European Pharmacopoeia (Ph. Eur.) published 59 texts involving the rabbit pyrogen test replacement approach for public consultation in Pharmeuropa 35.1. LAL test is further categorized into turbidimetric, chromogenic, and gel clot tests.

Furthermore, the in vitro pyrogen test segment had a significant market share in the pyrogen testing market in 2024. This testing method has gained widespread acceptance due to its ability to detect endotoxins and pyrogens in a controlled, animal-free environment, supported by advancements in recombinant technology. Notable innovations such as recombinant Factor C (rFC) and Monocyte Activation Test (MAT) systems have significantly enhanced the efficiency, reliability, and sustainability of endotoxin detection processes. Advancements in automation, recombinant technologies, and efficient endotoxin detection systems are pivotal in this transition, delivering faster, more accurate, and reproducible results that reduce time-to-market for pharmaceutical and medical device companies.

End-use Insights

The pharmaceutical and biotechnology companies dominated the overall market with a share of 62.21% in 2024. The growth is attributed to the rising production of pharmaceuticals, biopharmaceuticals, and other biologic products. Key players offering pyrogen testing instruments include Lonza Group, Thermo Fisher Scientific, and FUJIFILM Wako Chemicals, which are known for their broad portfolio of endotoxin detection products, including LAL-based assays and in vitro pyrogen detection

The medical devices companies' segment is expected to grow significantly over the forecast period. The consideration of applying pyrogen testing for medical devices arises from their potential indirect or direct exposure to human blood cells. Pyrogenicity tests are imperative to assess the safety of products that come into direct or indirect contact with blood circulation, cerebrospinal fluid (CSF), the lymphatic system, and those that interact systemically with the human body. Official methods for assessing the medical devices' pyrogenicity and materials include the in vitro bacterial endotoxin test and the in vivo rabbit pyrogenicity test.

Regional Insights

North America pyrogen testing market dominated the global market with the largest revenue share of 36.65% in 2024. The growth is attributed to the rising number of chronic diseases needing developments in drug therapy. The growing adoption of ethical and efficient in vitro pyrogen tests has become a cornerstone of this dominance. Traditional animal-based tests, like the Rabbit Pyrogen Test, are being steadily replaced by advanced alternatives such as the Monocyte Activation Test and LAL-based assays, which include chromogenic, turbidimetric, and gel clot methods.

U.S. Pyrogen Testing Market Trends

The pyrogen testing market in the U.S. is expected to grow over the forecast period. A recent development in January 2024 exemplifies this evolution: Charles River Laboratories International, Inc. introduced the Endosafe Trillium rCR cartridge, a groundbreaking advancement in BET technology. This innovation integrates their flagship Endosafe cartridge with recombinant cascade reagent (rCR) technology, providing an animal-free alternative that enhances testing efficiency, accelerates manufacturing processes, and supports sustainability initiatives.

Europe Pyrogen Testing Market Trends

The Europe pyrogen testing market is characterized by its robust yet intricate landscape, driven by stringent regulatory frameworks, growing pharmaceutical and biotechnology industries, and the increasing adoption of innovative testing methods. Valued significantly in recent years, the market shows strong growth potential fueled by rising investments in healthcare research, expansion of drug development activities, and heightened focus on patient safety

The pyrogen testing market in UK is expected to grow over the forecast period due to a significant approval of drugs. Demand is primarily driven by pharmaceutical, biotechnology, and medical device sectors, where ensuring product sterility and safety is paramount.

The pyrogen testing market in France is expected to grow over the forecast period. The growth is attributed to the growing initiatives in the therapeutic drugs field. The country is undertaking several initiatives to increase the access of drugs to the targeted patients in France.

The pyrogen testing market in Germany is expected to grow over the forecast period. The pharmaceutical and biotechnology sectors, which heavily rely on pyrogen testing to ensure the safety of their products, continue to expand in the country. For instance, the 12th PharmaLab Congress will be held in Düsseldorf/Neuss, Germany, from November 25-27, 2024, focusing on advancements in analytical and microbiological quality control for the pharmaceutical industry.

Asia Pacific Pyrogen Testing Market Trends

Asia Pacific is estimated to grow at the fastest CAGR of 12.4% over the forecast period. Many manufacturers target Asian countries, such as China & India, for drug discovery, development, and production. In addition, clinical research organizations are focusing on Asian countries for clinical trials. The availability of less stringent government regulations for drug development, the vast genome pool, and the rapidly developing healthcare infrastructure in this region are some of the major factors responsible for the growth of the sector in this region.

The pyrogen testing market in China is expected to grow over the forecast period. The growth is attributed to the increasing presence of key players in the country, owing to the reasonable manufacturing cost. Government policies promoting quality and safety in medical devices and drugs have led to the widespread use of LAL and turbidimetric tests for batch release testing, while the country’s focus on biotechnology innovation encourages the adoption of rabbit tests for specialized products.

The pyrogen testing market in Japan is dominated by global leaders such as Charles River Laboratories and bioMérieux SA, alongside regional players like FUJIFILM Wako Pure Chemical Corporation, which has a strong presence due to its expertise in pyrogen detection kits. In June 2024, FUJIFILM Wako Pure Chemicals Corporation introduced the LumiMAT Pyrogen Detection Kit (LumiMAT) and PYROSTAR Neo+ as innovative alternatives to traditional methods for detecting pyrogens and endotoxins.

Key Pyrogen Testing Company Insights

Some of the leading players in the pyrogen testing market are Lonza and Charles River Laboratories. These companies are actively engaged in business initiatives, such as product launches and acquisition of companies. Moreover, these companies have a global presence, which helps them to get access to affordable manufacturing facilities and a broad customer base. These factors cumulatively strengthen their presence in the pyrogen testing market. The emerging players in the pyrogen testing market mostly focus on partnerships and collaborations to increase their presence in the pyrogen testing market. Companies generally offer a compact product portfolio and focus on capturing local markets.

Recent Developments

• In December 2024, Ellab acquired PharmaProcess in Italy and Switzerland, enhancing its life science services. The partnership integrates PharmaProcess' regulatory expertise with Ellab’s compliance solutions, providing end-to-end support for pharmaceutical and biotech clients in these regions.

• In September 2024, Lonza Walkersville began the expansion of its endotoxin assay production facility in Walkersville, MD. The 18,000-square-foot upgrade will enhance manufacturing capacity to meet the rising demand for endotoxin assays used in ensuring the safety and compliance of injectable drugs and medical devices.

• In June 2024, FUJIFILM Wako Pure Chemicals launched two new pyrogen and endotoxin tests: LumiMAT Pyrogen Detection Kit, a next-generation monocyte activation test, and PYROSTAR Neo+, a recombinant protein reagent for bacterial endotoxin detection, available globally in July 2024.

• In October 2023, Lonza announced the launch of two monocyte activation test (MAT) systems: PyroCell MAT Human Serum (HS) Rapid System and PyroCell MAT Rapid System.

Pyrogen Testing Market Report Scope

Global Pyrogen Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global pyrogen testing market report based on product, test type, end-use, and region.

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • Consumables

  • Instruments

  • Services

• Test Type Outlook (Revenue, USD Billion, Number of Tests, in Thousands, 2018 - 2030)

  • LAL test

    • Chromogenic test

    • Turbidimetric test

    • Gel clot test

  • In vitro pyrogen test

    • Recombinant Factor C (rFC) testing

    • Monocyte Activation Test (MAT)

  • Rabbit test

• End-use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Pharmaceutical and biotechnology companies

  • Medical devices companies

  • Others

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait