According to Nova One Advisor, the global pyrogen testing market size was estimated at USD 1,55 billion in 2024 and is expected to hit around USD 3.52 billion by 2034, poised to grow at a CAGR of 8.55% from 2024 to 2034.
The rising demand for pharmaceutical products among consumers and the adherence to strict regulations for manufacturing parenterals is attributing to the growth of the pyrogen testing market.
Pyrogen Testing Market Key Takeaways:
· In 2024, the consumables segment was the largest segment with a share of 55.1% and is estimated to maintain its dominance during the forecast period.
· The LAL test segment dominated the market with a share of 47% in 2024.
· The pharmaceutical and biotechnology companies dominated the overall market with a share of 59.96% in 2024.
· The medical devices companies' segment is expected to grow significantly over the forecast period.
· North America dominated the pyrogen testing market with the largest revenue share of 40.9% in 2024.
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Pyrogen testing is essential for detecting the presence of pyrogen in pharmaceutical products and medical devices to ensure safety and potency while adhering to stringent regulatory standards. Pyrogen testing is essential in the pharmaceutical industry as it can cause fever, inflammation, shock, organ failure and even death. The rising demand for pyrogen testing in the pharmaceutical and biotechnology companies is contributing to the market growth of this industry.
Furthermore, the growing public awareness of the potential risks associated with pyrogens in medicinal products, stringent regulations by regulatory bodies, rising investments in R&D, increasing demand for depyrogenated sterile empty vials, government support and emerging markets in various regions are the factors promoting the growth of the pyrogen testing market.
The integration of artificial intelligence (AI) and machine learning tools in pyrogen testing has been automating and enhancing the detection of pyrogens in pharmaceutical products and medical devices. AI tools have been improving accuracy and streamlining the process of pyrogen testing through image analysis and pattern recognition thereby optimizing the process and encouraging in development of new pyrogen detecting methods. Furthermore, improved sensitivity, specificity of pyrogen detection, reduced human error and cost-effectiveness by incorporating AI tools is expected to significantly expand the pyrogen testing market
Pyrogen Testing Market Trends
· Rising Awareness on Drug Safety: The growing awareness about the safety and efficacy of pharmaceutical products and medical devices utilized by consumers, patients and other medical professionals as well as adherence to strict regulatory guidelines for manufacturing and distribution of these products has been promoting the market growth of the pyrogen testing market.
· Demand in Pharmaceutical Industries: The increased drug development and manufacturing processes in pharmaceutical and biotechnology companies is creating the demand for the advanced and streamlined processes for pyrogen testing with increased productivity.
Pyrogen Testing Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 1.68 billion |
|
Revenue forecast in 2034 |
USD 2.26 billion |
|
Growth rate |
CAGR of 8.54% from 2024 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2023 |
|
Forecast period |
2024 - 2033 |
|
Quantitative units |
Revenue in USD million and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, Test Type, End-use, Region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; Germany; UK; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; South Korea; Australia; Thailand; Brazil; Mexico; Argentina; Saudi Arabia; Kuwait; UAE; South Africa. |
|
Key companies profiled |
Charles River Laboratories; Ellab A/S; Merck KGaA; GenScript; bioMérieux SA; Lonza; Thermo Fisher Scientific, Inc.; Associates of Cape Cod, Inc.; FUJIFILM Wako Chemicals U.S.A. Corporation (Pyrostar) |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Segment Insights
By Product
The consumables segment dominated the market with the largest share of 55.1% in 2024. Consumables are widely utilized in tests for detecting the presence of pyrogens in the sample. Pyrogen tests need consumables such as kits and reagents which are essential for detecting the disease-causing bacteria and organisms. These consumables are mostly designed as single-use design and specific to technique of test for preventing cross contamination and maintaining sterility throughout the testing procedure. Furthermore, the adherence with strict regulatory requirements and current Good Manufacturing Practices (cGMP) for the preparation and distribution of these consumables across various fields is promoting the market growth of this segment.
The instruments segment is expected to grow rapidly over the forecast period. Instruments such as incubators and centrifuges among others are widely applied in pyrogen testing for detecting bacteria, sample preparation and other tests. The availability of cost-effective, convenient instruments with large-scale processing streamlining the productivity process is accelerating the market growth of this segment. Furthermore, the technological advancements in developing innovative instruments with automated and AI integrated platforms are expected to drive the market in the upcoming years.
By Test Type
By test type, The LAL test segment dominated the market with a share of 47.0% in 2024. The LAL tests are highly sensitive and are broadly utilized in the pharmaceutical industry for testing parenteral drugs, medical device testing, raw material quality control and cleaning validation to ensure the accurate detection of endotoxins. Moreover, the pharmaceutical industries need to perform these tests with strict adherence to regulatory guidelines for securing patient safety. These factors are promoting the dominance of this segment in the market.
The rabbit pyrogen test (RPT) segment held a significant market share in 2024. For decades, the traditional method of using rabbits for pyrogen detection to ensure the safety of parenteral drugs has been followed. However, the rising adoption of using rabbit-free pyrogen testing methods would eventually restrict the use of this test. Moreover, the increasing demand for animal-free testing methods to prevent cruelty to animals is surging the development of new methods for reducing animal cruelty. For instance, in June 2024, at its 179th session the European Pharmacopoeia (Ph. Eur.) announced the adoption of 57 revised texts which completely excluded the RPT test with the addition of a new general chapter on Pyrogenicity (5.1.13) ending the RPT era in the Ph. Eur.
By End-Use
The pharmaceutical and biotechnology companies dominated the overall market with a share of 59.96% in 2024. The rising production and distribution of biopharmaceuticals, biologics, biosimilars and other therapies which requires stringent pyrogen testing for confirming the pharmaceutical products safety has been promoting the market growth of this segment. Furthermore, the outsourcing of pharmaceutical businesses to pharmaceutical CDMOs for streamlining the manufacturing process and the rising compliance with strict regulatory guidelines has been expanding the growth of this segment in the pyrogen testing market.
The medical devices companies segment is expected to grow rapidly over the forecast period. Pyrogen testing of medical devices is essential for ensuring patient safety by screening for biological risks like fever. The most common tests for detecting pyrogenicity in medical devices are in vivo RPT, in vivo LAL assay and in vitro monocyte activation test (MAT). These test help in assuring the safety of medical devices coming in direct or indirect contact with blood circulation, cerebrospinal fluid (CSF), lymphatic system or any other systematic interactions with the human body.
Regional Analysis
North America dominated the pyrogen testing market with the largest revenue share of 40.9% in 2024. The market in this region is driven by the rising development of novel drugs and biologics, growing awareness about product safety among consumers, huge investments in R&D, pharmaceutical regulations and the presence of advanced laboratory infrastructure for accurate pyrogen detection.
U.S. Pyrogen Testing Market Trends
The market in the U.S. is expected to grow over the forecast period. The country’s growth is attributed to key players, such as Pfizer Inc., F. Hoffmann-La Roche AG, Merck Group, Celgene Corp., and Amgen Inc. who operate in the pyrogen testing market. Furthermore, several companies in the U.S. manufacture pharmaceuticals, which further boosts the application of pyrogen tests in the country.
Europe's pyrogen testing market was identified as a lucrative region in this industry. The growth is attributed to the exponentially growing biotechnology and pharmaceutical industries. Furthermore, in 2021, the European Pharmacopoeia Commission (EPC), announced an undertaking of process to eliminate rabbit pyrogen test (RPT) in the next five years.
UK Pyrogen Testing Market Trends
The market in the UK is anticipated to expand over the forecast period due to a significant approval of drugs. For instance, in 2021, according to the MHRA ,35 new drugs were approved from the UK.
France Pyrogen Testing Market Trends
The market in France is projected 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.
Germany Pyrogen Testing Market Trends
The market in Germany is anticipated to grow over the forecast period due to the presence of several key players. Moreover, Merck KGaA, a well-known player in the pyrogen testing industry, has its headquarters in Darmstadt, Germany.
The Asia Pacific is projected to exhibit the significant growth rate during the forecast period, owing to untapped opportunities in this region. 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 are some of the major factors responsible for the growth of the sector in this region.
China Pyrogen Testing Market Trends
The 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. For instance, in March 2022, Lonza, one of the market players, expanded its manufacturing plant of active pharmaceutical ingredients (API) in China.
Japan Pyrogen Testing Market Trends
The market in Japan is expected to grow over the forecast period due increasing number of drug approvals, favorable regulations, and several key players operating in the country. Japan focuses on introducing favorable regulations for new drugs developed in other countries. It will increase the number of foreign drug approvals in Japan, thereby increasing the application of pyrogen testing in the country.
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Some of the prominent players in the pyrogen testing market include:
· Ellab A/S
· Lonza Group
· Thermo Fisher Scientific, Inc.
· Associates of Cape Cod, Inc.
· FUJIFILM Wako Chemicals U.S.A. Corporation (Pyrostar )
Pyrogen Testing Market Recent Developments
· In October 2024, Lonza announced the launch of two monocyte activation test (MAT) systems: PyroCell MAT Human Serum (HS) Rapid System and PyroCell MAT Rapid System.
· In September 2024, Intravacc announced a collaboration with Sanquin Diagnostic Services to optimize the in vitro Monocyte Activation Test (MAT) and replace the animal pyrogen test for OMV vaccines.
· In June 2024, Ellab A/S announced its acquisition by Novo Holdings. This acquisition will expand Novo Holdings' business in the pyrogen testing market.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the pyrogen testing market
By Product
· Consumables
· Instruments
· Services
By Test Type
· LAL test
o Chromogenic test
o Turbidimetric test
o Gel clot test
· In vitro pyrogen test
· Rabbit test
By End-use
· Pharmaceutical and biotechnology companies
· Medical devices companies
· Others
By Regional
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East and Africa (MEA)
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