Pyrogen Testing Market to Reach $3.6 billion, Globally, by 2033 at 8.4% CAGR: Allied Market Research

Increase in prevalence of chronic diseases, growing initiatives for minimizing pyrogen contamination, and rise in R&D activities drive the growth of the global pyrogen testing market.

PORTLAND, Ore., Feb. 16, 2026 /PRNewswire/ -- Allied Market Research published a report, titled, "Pyrogen Testing Market by Product and Service (Reagents & Kits, Instruments, and Services), Test Type (LAL Test, Rabbit Pyrogen Test, and Others), and End User, (Pharmaceutical & Biotechnology Companies, Medical Device Companies, and Others): Global Opportunity Analysis and Industry Forecast, 2024 - 2033". According to the report, the global pyrogen testing industry generated $1.6 billion in 2023, and is anticipated to generate $3.6 billion by 2033, witnessing a CAGR of 8.4% from 2025 to 2033.

Prime Determinants of Growth

Rise in prevalence of chronic diseases, growing initiatives for minimizing pyrogen contamination, and rise in R&D activities are the factors that drive the growth of the global pyrogen testing market. However, the limited standardization for pyrogen testing restricts market growth. Moreover, the high growth potential in emerging countries and rise in technological advancements in pyrogen testing presents new opportunities in the coming years.

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Report Coverage & Details:

Recession Impact

• During a recession, individuals and governments might tighten their budgets, leading to reduced healthcare spending. This could affect patients' ability to access and afford pyrogen testing, potentially leading to decreased demand for pyrogen testing products.
• However, the surge in prevalence of chronic diseases, rise in technological advancements and growing awareness about pyrogen contamination risks. This could boost the need for pyrogen testing that is experiencing a moderately positive impact from the global recession.

Why Is Demand Increasing in This Market?

Rise in demand for pyrogen testing solutions across pharmaceutical, biotech, and medical device sectors boosts the growth of the market. Biopharmaceutical products require meticulous safety testing to ensure that they are free from pyrogens. There is an increase in production in the biopharmaceutical sector with surge in innovative drugs and personalized therapies. This increases the volume of products that need pyrogen testing which further fosters the growth of the market.

Regulatory requirements are another key driver that drives the market growth. Governing bodies mandate pyrogen testing before products can be approved for market release. These regulations are designed to protect patients. The need to meet regulatory standards consistently drives manufacturers to adopt validated testing methods. Further, there is a rise in focus on quality assurance and contamination control in drug manufacturing. Healthcare providers and patients demand safer medicines, and this demand has influenced pharmaceutical companies to invest in pyrogen testing infrastructure and services.

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The reagents and kits segment to maintain its leadership status throughout the forecast period 

By product and service, the reagents and kits segment held the largest market share in 2022, accounting for nearly half of the global pyrogen testing market revenue and is estimated to maintain its leadership status throughout the forecast period. This is attributed to high adoption of regents & kits as they are serving as critical tools in detecting and quantifying pyrogens in pharmaceutical and biotechnology products.

However, the instruments segment is expected to register the highest CAGR of 8.9% during the forecast period. This is attributed to the continuous innovation in instrument design and functionality which enhances their efficiency and accuracy in detecting and quantifying pyrogens, making them attractive to companies seeking advanced testing methods.

The LAL test segment to maintain its leadership status throughout the forecast period

By test type, the LAL test segment held the largest market share in 2022, accounting for more than half of the global pyrogen testing market revenue and is estimated to maintain its leadership status throughout the forecast period. This is attributed to technological advancements in LAL testing methodologies, including the development of kinetic turbidimetric and chromogenic assays, have enhanced the efficiency and accuracy of pyrogen detection.

However, the others segment is expected to register the highest CAGR of 8.6% during the forecast period. This is attributed to surge in demand for monocyte activation tests which provide a direct assessment of the human immune response to pyrogens and offering specificity that aligns closely with human physiology.

The pharmaceutical and biotechnology companies segment to maintain its lead position during the forecast period 

By end user, the pharmaceutical and biotechnology companies segment accounted for the largest share in 2022, contributing to more than half of the global pyrogen testing market revenue, and is projected to maintain its lead position during the forecast period. This is attributed to the growth of the biopharmaceutical sector, which includes the development of complex drugs such as monoclonal antibodies, vaccines, and cell therapies led to rise in demand for advanced and precise pyrogen testing methodologies.

However, the medical device companies segment is expected to register the highest CAGR of 9.1% during the forecast period. This is attributed to the surge in the development of sophisticated and complex medical devices, ranging from diagnostic equipment to implantable devices. The intricate nature of these devices necessitates stringent quality control measures, including pyrogen testing, contributing to the segment growth.

North America to maintain its dominance by 2032 

By region, North America held the largest market share in terms of revenue in 2022, accounting for more than two-fifths of the global pyrogen testing market revenue and is likely to dominate the market during the forecast period. This is attributed to its well-developed healthcare infrastructure. Technological advancements in testing methodologies, pharmaceutical innovation and research and development activities have led to an increased demand for pyrogen testing.

However, the Asia-Pacific region is expected to witness the fastest CAGR of 9.4% from 2023 to 2032. This is attributed to expanding pharmaceutical and biotechnology sectors, the rise of contract manufacturing & research activities, and increased healthcare investments. 

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Leading Market Players:

• Merck KGaA
• Lonza Group
• Thermo Fisher Scientific Inc.
• FUJIFILM Holdings Corporation
• GenScript
• SEIKAGAKU CORPORATION
• Charles River Laboratories
• STERIS
• WuXi AppTec
• Eurofins Scientific

The report provides a detailed analysis of these key players in the global pyrogen testing market. These players have adopted strategy such as product launch to increase their market share and maintain dominant shares in different regions. The report is valuable in highlighting business performance, operating segments, product portfolio, and strategic moves of market players to showcase the competitive scenario.

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