Industry Overview
The global pyrogen testing market was valued at USD 1.1 billion in 2023 and is anticipated to reach USD 3.5 billion by 2030, witnessing a CAGR of 12.5% during the forecast period 2025-2030. Pyrogen testing is the compulsory phase in the manufacturing process to eliminate or deactivate probable bacterial contaminants. Its products are used for the treatment and diagnostic purposes. The global pyrogen testing market is growing at a significant rate, due to speedy growth in pharmaceutical and biotechnology industries and a mounting number of novel drug launches. Different products contributed to the pyrogen testing market size. The market has witnessed high demand for kits and reagents in the coming years due to the mounting implementation of kit-based testing and recurrence purchase of kits and reagents as compared to instruments.The global pyrogen testing market has been experiencing growth due to several factors, including the increasing demand for safe and effective healthcare products, stringent regulations and guidelines set by regulatory authorities, and the rising focus on patient safety. The market includes various players, including testing laboratories, contract research organizations (CROs), and manufacturers of pyrogen testing products.
Market Segmentation
Insight by Product
On the basis of product the market is subdivided into kits and reagents, instruments and services. Of all products, kits and reagents segment accounted the largest share in the market due to mounting implementation of kit-based testing and recurrence purchase of kits and reagents as compared to instruments.
Insight by Application
On the basis of application, the market is subdivided into pharmaceutical and biological manufacturing, medical device manufacturing, and other applications. Speedy growth in the pharmaceutical and biotechnology industries, mounting investment in research and development by companies for drug development and large production of therapeutics are some of the factors responsible for the growth of pharmaceutical and biological manufacturing. Of all the applications, pharmaceutical and biological manufacturing accounted foremost share in the pyrogen testing market.
Insight by Test Type
On the basis of test type the market is subdivided into LAL (Limulus Amebocyte Lysate) tests, rabbit tests, and in vitro tests. Benefits such as speed, more cost effective, accuracy, necessity of slight amount of the tested sample and permits detection of lower level of endotoxins, ease of handling, and flexibility in life science research are some of the factors growing the demand of LAL test. Among the all test types, the LAL test accounted the largest share and is expected to grow at fastest rate in the pyrogen testing market. The LAL tests are further subdivided into turbidimetric tests, chromogenic tests and gel clot tests.
Global Pyrogen Testing Market Report Coverage
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Report Metric
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Details
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Historical Period
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2018 - 2023
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Base Year Considered
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2024
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Forecast Period
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2025 - 2030
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Market Size in 2023
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U.S.D. 1.1 Billion
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Revenue Forecast in 2030
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U.S.D. 3.5 Billion
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Growth Rate
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12.5%
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Segments Covered in the Report
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By Product, By Application and By Test Type
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Report Scope
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Market Trends, Drivers, and Restraints; Revenue Estimation and Forecast; Segmentation Analysis; Impact of COVID-19; Companies’ Strategic Developments; Market Share Analysis of Key Players; Company Profiling
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Regions Covered in the Report
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North America, Europe, Asia-Pacific, Middle East, and Rest of the World
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Industry Dynamics
Alter from animal-based testing to in vitro testing are the trends in the pyrogen testing market. Speedy growth in pharmaceutical and biotechnology industries, robust R&D investments in the life sciences industry, mounting number of novel drug launches, and mounting government support for pharmaceutical and biotechnology industries are the primary growth drivers for pyrogen testing market.
Elevated occurrence and burden of chronic diseases such as cancer, diabetes, and cardiovascular diseases is also driving the growth of the market. For instance, according to GLOBOCAN globally approximately 14.1 million new cancer cases were diagnosed and there were 8.2 million cancer deaths in 2012. In addition, according to World Health Organization (WHO), globally in 2015 approximately 8.8 million people died due to cancer. Moreover, approximately 70% of the deaths from cancer occur in low and middle income countries.
Mounting pharmaceutical outsourcing and substantial opportunities for the pyrogen testing market in developing economies are also facilitating the growth for the pyrogen testing market. High degree of consolidation is the major challenges for the growth of pyrogen testing market.
Industry Ecosystem
Globally, the manufacturing companies trying to enter the pyrogen testing market are required to maintain stringent regulatory standards. Moreover, the high level of capital requirement also poses a major barrier for the entry of new players. This offers an edge to the established players in the industry competition.There are several methods used for pyrogen testing, including the Limulus Amoebocyte Lysate (LAL) test, which is the most commonly used method. The LAL test utilizes the blood of the horseshoe crab to detect the presence of endotoxins. Other methods include the monocyte activation test (MAT) and the rabbit pyrogen test, although the latter is being phased out due to ethical concerns.The global pyrogen testing market has been experiencing growth due to factors such as the increasing demand for pharmaceutical and biotechnology products, stringent regulatory guidelines, and the need for quality assurance. Additionally, advancements in testing technologies and the adoption of automated systems have also contributed to market growth.
Geographic Overview
Geographically, North America is the largest pyrogen testing market as in the region the investment by government in healthcare and pharmaceutical industry is increasing. Research and development of novel drugs, mounting burden of chronic diseases, and upsurge in a number of biologic products are also up surging growth of the North American pyrogen testing market. For instance, according to GLOBOCAN in the U.S. approximately 1.6 million new cancer cases were diagnosed and there were 0.6 million cancer deaths in 2012.
Asia-Pacific is observed to witness fastest growth in the market, due to mounting research and development of novel drugs. In addition, mounting occurrence of chronic diseases, and mounting healthcare expenditure are also creating a positive impact on the pyrogen testing market growth in the region.
Competitive Insight
Key players in the pyrogen testing market are catering the demand of these devices by investing on technologically advanced products in their product portfolio across the globe. In March 2018, Associates of Cape Cod, Inc., introduced a new, swift endotoxin recognition kit, Pyrosate, an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test which enables rapid testing. Associates of Cape Cod, Inc., Merck KGaA, Thermo Fisher Scientific, Inc., GenScript, Charles River Laboratories, Inc., Ellab A/S, Lonza Group, and WUXI Pharmatech (Cayman) Inc. are the key players offering pyrogen testing.
The Pyrogen Testing Market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.
Segments Covered in the Report
- By Product
- Kits and Reagents
- Instruments and Services
- By Application
- Pharmaceutical and Biological Manufacturing
- Medical Device Manufacturing
- Others
- By Test Type
- LAL Tests
- Rabbit Tests
- In Vitro Tests
Region Covered in the Report
- North America
- Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia-Pacific (APAC)
- China
- Japan
- India
- South Korea
- Rest of Asia-Pacific
- Rest of the World (RoW)
- Brazil
- Saudi Arabia
- South Africa
- U.A.E.
- Other Countries
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Source: VynZ Research
