Pyrogen Testing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)
The global pyrogen testing market attained a substantial valuation in 2024, with a projected significant growth over the next decade. This indicates a highly positive trend for market expansion. Detailed industry analysis reveals that revenue from pyrogen testing will surge to a market valuation of US$ 4.58 Bn by the end of 2031.
Key Drivers of Market Growth:
The proliferation of chronic illnesses worldwide has underscored the need for stringent quality testing in medical products and services. Pyrogen testing, governed by standards set by prominent organizations such as the FDA, USP, and EP, has emerged as a critical tool in ensuring the safety and efficacy of pharmaceuticals and medical devices.
Technological Advancements Reshaping the Landscape:
The introduction of innovative testing methodologies such as the Monocyte Activation Test (MAT) has revolutionized the field of pyrogen testing. Offering superior sensitivity and accuracy compared to traditional animal-based tests, MAT has garnered significant traction among healthcare product manufacturers, driving market expansion.
Regional Insights:
• United States: With a market share of 94.2%, the U.S. remains a dominant force in the global pyrogen testing market. Frequent approvals by the FDA fuel product launches, making the country a lucrative destination for manufacturers.
• Germany: Accounting for 23.1% of the European market, Germany boasts a robust presence of major industry players, fostering product availability and market growth.
• China: High levels of research activities and strategic collaborations are propelling China to the forefront of the global pyrogen testing market, offering abundant opportunities for local manufacturers.
• India: With a market share of 48.3% in South Asia, India's pyrogen testing market is buoyed by a pool of skilled labor and favorable manpower costs, driving demand for testing services.
Category-wise Insights:
• Pyrogen Test Kits & Reagents: This segment, accounting for 43.2% of market revenue in 2023, is witnessing heightened demand driven by the emergence of COVID-19 and increased diagnostic activities.
• Animal-based Tests: Despite advancements in alternative methodologies, animal-based tests remain predominant, comprising over 86.5% of the market share in 2023.
End User Dynamics:
Pharmaceutical companies, comprising 44.7% of the market share, are at the forefront of adopting advanced pyrogen testing methods. The transition away from traditional rabbit pyrogen tests towards more sensitive and human-specific alternatives is poised to drive market growth further.
Competitive Analysis:
Key players in the pyrogen testing market are focusing on gaining regulatory approvals, launching innovative products, and strategic acquisitions to enhance their market presence. Recent developments include Eurofins' PFAS Exposure™ test, ACC's PyroSmart NextGen™, and Lonza's Pyro Cell Monocyte Activation Test System.
As the global healthcare landscape continues to evolve, the pyrogen testing market stands poised for exponential growth, propelled by technological innovations, regulatory reforms, and increasing demand for safe and effective medical products.
Key companies functioning in the global pyrogen testing market including:
• Thermo Fisher Scientific
• Merck KGaA
• Lonza
• MAT-BioTech
• Promega Corporation
• GenScript
• Associates of Cape Cod, Inc.
• BIOMERIEUX SA
• Ella A/S
• Hycult Biotech Inc.
• Eurofins Biolab Srl
• Solvias AG
• Wickham Laboratories Ltd.
• Sotera Health (Nelson Laboratories, LLC)
• Charles River Laboratories
• Creative Biolabs
• Sanquin Reagents B.V.
• Fujifilm Wako Pure Chemical Corporation
• MAT Research
• Xiamen Bioendo Technology Co. Ltd.
• Microcoat Biotechnologie GmbH
• PerkinElmer Inc.
• Orchid Scientific & Innovative Pvt Ltd.
Key Segments Covered in Pyrogen Testing Industry Survey
Pyrogen Testing Market by Product & Service:
• Instruments
Digital Tele Thermometers Equipment
Automated Endotoxin Testing Equipment
Portable Endotoxin Testing Equipment
Microplate Readers
• Test Kits & Reagents
Recombinant Factor C Assays
Limulus Amebocyte Lysate (LAL) Tests
Chromogenic Tests
Turbid metric Tests
Gel-Clot Tests
Rabbit Pyrogen Tests
Monocyte Activity Assays
• Consumables
• Services
Endotoxin Testing Services
Monocyte Activation Testing Services
Pyrogen Testing Market by Source:
• In-vitro-based Pyrogen Testing
Whole Blood-based Monocytes
Peripheral Blood Mononuclear Cell (PBMC)-based Monocytes
Cell Line-based Monocytes
• Animal-based Pyrogen Testing
Recombinant Factor (rFC )
Bacterial Endotoxins (BET)
Rabbit Pyrogen Tests
Pyrogen Testing Market by Application:
• Injectable Therapeutics
• Vaccines
• Orally-dosed Pharmaceuticals
• Biologics
• Implantable Medical Devices
• Dialysis Liquids
• Toxic/immune-modulatory Drugs
• Blood-based Products
Pyrogen Testing Market by End User:
• Pharmaceuticals Companies
• Biotechnology Companies
• Medical Device Companies
• Diagnostic Laboratories
• Clinical Research Organizations (CROs)
• Clinical Manufacturing Organizations (CMOs)
Pyrogen Testing Market by Region:
• North America Pyrogen Testing Market
• Latin America Pyrogen Testing Market
• Europe Pyrogen Testing Market
• South Asia Pyrogen Testing Market
• East Asia Pyrogen Testing Market
• Oceania Pyrogen Testing Market
• Middle East & Africa Pyrogen Testing Market
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