Pyrogen Testing Market By Product and Service (Reagents and Kits, Instruments, Services) , By Test Type (LAL Tests, Rabbit Pyrogen Test, Others) By End User (Pharmaceutical Companies & Biotechnology,, and, Medical Device Companies, Others) : Global Opportunity Analysis and Industry Forecast, 2024-2033
The pyrogen testing market was valued at $1.6 billion in 2023, and is projected to reach $3.6 billion by 2033, growing at a CAGR of 8.3% from 2024 to 2033.
Pyrogen testing is a laboratory procedure used to detect the presence of pyrogens, which are fever-inducing substances often found in medical products, especially injectables, implants, and other sterile materials intended for use in or on the human body. Pyrogens, including bacterial endotoxins or other microbial contaminants, can cause fever and severe immune responses if introduced into the bloodstream. To prevent these harmful reactions, rigorous testing is conducted on pharmaceutical products and medical devices to ensure they are free of pyrogens before they reach the market.
Rise in production of biologics, vaccines, and injectable drugs has heightened the need for reliable pyrogen testing to ensure product safety, which acts as the key driving force of the global pyrogen testing market. Furthermore, increase in pharmaceutical and medical device manufacturing, particularly in emerging markets, is boosting the need for pyrogen testing for new products to meet quality and safety requirements before they reach consumers. In addition, alarming rise in prevalence of chronic diseases significantly contributes toward the growth of the global market. This is attributed to the fact that the global prevalence of diseases requiring sterile treatments has led to higher demands for injectables and implantable medical devices. As a result, manufacturers are more focused on stringent pyrogen testing to prevent adverse reactions in patients. As per a 2023 study published by the World Health Organization, chronic diseases are responsible for 41 million deaths each year. However, high cost of advanced testing methods such as monocyte activation test and automated endotoxin detection systems acts as the key deterrent factor of the global market. In addition, dearth of skilled technicians and specialized training to ensure accurate results restrains the market growth. On the contrary, technological advancements, such as automated endotoxin detection systems, and enhanced sensitivity of pyrogen tests, to improve testing efficiency and safety standards are expected to offer lucrative opportunities for the growth of the market during the forecast period. Moreover, rise in investments in R&D for pyrogen-free products, combined with government and private funding in life sciences, are fueling advancements in pyrogen testing technologies. which are likely to open new avenues for the market growth in the near future.
The global pyrogen testing industry is segmented on the basis of product & service, test type, end user, and region. By product & service, the market is classified into reagents & kits, instruments, and services. On the basis of test type, it is divided into LAL tests, rabbit pyrogen test, and others. Depending on end user, it is segregated into pharmaceutical & biotechnology companies, medical device companies, and others. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
Key FindingsBy product & service, the reagents & kits segment dominated the pyrogen testing market share in 2023.On the basis of test, the LAL tests segment garnered the largest share in 2023.
Depending on end user, the pharmaceutical & biotechnology companies segment was the major shareholder in 2023.
Region wise, North America accounted for a majority of the market share in 2023, and is anticipated to remain dominant from 2024 to 2033.
Competition AnalysisCompetitive analysis and profiles of the major players in the global pyrogen testing market include Merck KGaA, Lonza Group AG, Thermo Fisher Scientific Inc., FUJIFILM Corporation, Genscript Technology Corporation, SEIKAGAKU CORPORATION, Charles River Laboratories, Steris Corporation, Wuxi AppTec, and Eurofins Scientific SE. These major players have adopted various key development strategies such as business expansion, new product launches, and partnerships to strengthen their foothold in the competitive market.
Key Market SegmentsBy Product And ServiceReagents and Kits
Instruments
Services
By Test TypeLAL Tests
Rabbit Pyrogen Test
Others
By End UserPharmaceutical Companies Biotechnology,, and
Medical Device Companies
Others
By RegionNorth America
U.S.
Canada
Mexico
Europe
Germany
France
UK
Italy
Spain
Rest of Europe
Asia-Pacific
Japan
China
Australia
India
South Korea
Rest of Asia-Pacific
LAMEA
Brazil
Saudi Arabia
South Africa
Rest of LAMEA
Key Market PlayersMerck KGaA
Lonza Group AG
Thermo Fisher Scientific Inc.
FUJIFILM Corporation
Genscript Technology Corporation
SEIKAGAKU CORPORATION
Charles River Laboratories
Steris Corporation
Wuxi AppTec
Eurofins Scientific SE