Pyrogen Testing Market Research, 2032
The global pyrogen testing market size was valued at $1.5 billion in 2022, and is projected to reach $3.3 billion by 2032, growing at a CAGR of 8.2% from 2023 to 2032. The growth of the pyrogen testing market is driven by an increase in pharmaceutical and biotechnology activities, stringent regulatory requirements for pharmaceutical and medical devices and rise in awareness of the potential risks associated with pyrogens in medical products. The rise in prevalence of chronic diseases worldwide has led to a higher demand for pharmaceutical and biotechnological products. This, in turn, fuels the need for rigorous quality control measures, including pyrogen testing, to ensure the safety of therapeutic products which drive the market growth. For instance, according to Centers for Disease Control and Prevention (CDC), in 2022, about six in ten adults in the U.S. suffer from chronic disease.
Key Takeaways:
By product and service, the reagents and kits segment dominated the global market in 2022.
By test type, the LAL tests segment dominated the global market in 2022.
By end user, the pharmaceutical & biotechnology companies segment dominated the market in terms of revenue in 2022.
By region, North America dominated the market in terms of revenue in 2022. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.
Pyrogens are substances that induce fever when introduced into the body. They come from various sources, including microorganisms like bacteria, viruses, and fungi, as well as from the environment, manufacturing processes, or certain products. Pyrogens pose a serious health hazard as they trigger immune responses that lead to symptoms ranging from vascular alterations to shock and, in severe cases, death. Pyrogen testing is a crucial process in pharmaceutical and medical device manufacturing to detect and quantify the presence of pyrogens in products. Various methods, including the Limulus Amebocyte Lysate (LAL) test, are commonly used for pyrogen testing to identify and measure the levels of pyrogens in products. The testing helps to maintain the safety and quality of healthcare products and protects the health of patients receiving these products.
Market Dynamics
The growing pharmaceutical and medical device industries, along with the rising adoption of pyrogen testing during the production and before the marketing of drugs and medical devices, are major drivers of the pyrogen testing industry. In addition, the increase in prevalence of significant infectious diseases has led to a consistent escalation in the demand for pyrogen testing methods. For instance, the World Health Organization reported that in January 2023, a total of 64 infectious diseases were affecting 235 countries and regions. Thus, rise in prevalence of infectious diseases is a significant driver of the pyrogen testing market expansion, as pyrogen testing is essential in the quality control process for drugs and medical devices.
In addition, the ongoing advancements in testing technologies, such as improvements in the sensitivity and specificity of pyrogen testing methods, contribute to market growth. The adoption of more efficient and accurate testing techniques enhances the ability to detect pyrogens, thereby ensuring better product safety.
Furthermore, the growth of contract manufacturing organizations (CMOs) in the pharmaceutical and biotechnology sectors offers opportunities for pyrogen testing service providers. Outsourcing of research and manufacturing activities increases the demand for reliable testing services. For instance, Charles River Laboratories is actively involved in providing pyrogen testing services as part of its broader portfolio. These services include the use of the Limulus Amebocyte Lysate (LAL) test and other advanced methodologies for detecting pyrogens in drug substances, drug products, and medical devices.
Moreover, the rise in awareness and prioritization of patient safety within the healthcare industry serves as a significant driver for the pyrogen testing market. With an increase in emphasis on delivering pharmaceuticals, biologics, and medical devices that are free from potentially harmful fever-inducing contaminants, there is a heightened demand for stringent quality control measures. Pyrogen testing, positioned as a critical component of ensuring product safety, aligns seamlessly with the overarching goal of safeguarding patient well-being. This commitment to patient safety underscores the necessity of thorough pyrogen testing and propels its widespread adoption, driving sustained growth in the pyrogen testing market.
The absence of standardized testing methods creates challenges in meeting regulatory requirements which negatively impact market growth. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), often provide guidelines for pyrogen testing, however, variations in methods make it challenging for companies to ensure full compliance. This uncertainty results in delays in product approvals and hinders pyrogen testing market size
In contrast, continuous growth of the pharmaceutical and biotechnology sectors, driven by increased research and development activities, novel drug discoveries, and a focus on biologics, presents a significant pyrogen testing market opportunity. The rise in demand for stringent quality control measures to ensure the safety of pharmaceutical products provides an opportunity for pyrogen testing market growth.
During a recession, the pyrogen testing market may experience a range of impacts influenced by broader economic conditions. The pharmaceutical and biotechnology industries, which are primary consumers of pyrogen testing services, often face challenges during economic downturns. Companies within these sectors reduce spending on R&D, leading to a potential slowdown in drug discovery and production activities. In addition, the reduced demand for certain medical products during economic uncertainty could impact the need for rigorous quality control measures, such as pyrogen testing.
Despite these challenges, the critical nature of pyrogen testing in ensuring the safety of pharmaceutical products mitigate some of the recessionary impacts, as regulatory scrutiny remains high, and the industry maintains its commitment to maintaining product quality standard, which is expected to drive market growth.
Segmental Overview
Pyrogen testing market analysis is segmented into product and service, test type, end user, and region. By product and service, the market is categorized into reagents and kits, instruments, and services. By test type, the market is divided into LAL tests, rabbit pyrogen test, and others. By end user, the market is classified into pharmaceutical & biotechnology companies, medical device companies, and others. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, LA, and MEA.
By Product and Service
The reagents and kits segment dominated the global pyrogen testing market share in 2022, owing to its widespread availability and user-friendly nature, providing researchers, laboratories, and pharmaceutical manufacturers with convenient tools for detecting and quantifying pyrogens. However, the instruments segment is expected to register the highest CAGR during the forecast period, owing to the need for efficiency, precision, and scalability in testing processes as advanced instruments offer quicker turnaround times, reduce human error, and enhance the overall reliability of pyrogen testing results.
By Test Type
The LAL tests segment dominated the global pyrogen testing market share in 2022, owing to high adoption of LAL tests as they are highly sensitive and specific, making them the preferred method for pyrogen testing in the pharmaceutical and biotechnology industries. However, the others segment is expected to register the highest CAGR during the forecast period. This is attributed to its ability to mimic the human immune response more accurately than traditional methods and an increasing focus on enhancing the sensitivity and relevance of pyrogen testing.
By End User
The pharmaceutical and biotechnology companies segment held the largest market share in 2022, owing to increasing focus on research and development activities in the pharmaceutical and biotechnology industries has led to a higher adoption rate of pyrogen testing. However, the medical device companies segment is expected to register the highest CAGR during the forecast period. This is attributed to the increasing demand for stringent quality control measures in medical device manufacturing and increasing demand for safe and effective medical devices has led to a higher adoption rate of pyrogen testing in the industry.
By Region
The pyrogen testing industry is analyzed across North America, Europe, Asia-Pacific, LA, and MEA. North America accounted for a major share of the pyrogen testing market in 2022 and is expected to maintain its dominance during the pyrogen testing market forecast period. The presence of several major players, such as Merck KGaA, Lonza Group, Thermo Fisher Scientific Inc., FUJIFILM Holdings Corporation and advancement in manufacturing technology of pyrogen testing in the region drive the growth of the market. In addition, well established infrastructure, technological advancements in testing methodologies, pharmaceutical innovation and research and development activities have led to an increased demand for pyrogen testing.
Asia-Pacific offers profitable opportunities for key players operating in the pyrogen testing market and is expected to register the fastest growth rate during the forecast period, owing to the expanding pharmaceutical and biotechnology sectors, the rise of contract manufacturing & research activities, and increased healthcare investments.
Competition Analysis
Competitive analysis and profiles of the major players in pyrogen testing market, such as Merck KGaA, Lonza Group, Thermo Fisher Scientific Inc., FUJIFILM Holdings Corporation, GenScript, SEIKAGAKU CORPORATION, Charles River Laboratories, STERIS, WuXi AppTec, and Eurofins Scientific are provided in this report. Major players have adopted product launch as a key developmental strategy to improve the product portfolio of the pyrogen testing market.
Recent Developments in the Pyrogen Testing Market
Recent Product Launches in the Pyrogen Testing Market
In August 2023, Lonza Group launched the Nebula Absorbance Reader, a new absorbance microplate reader, which joins the company portfolio of optimized instruments for streamlined endotoxin and pyrogen testing.
In October 2023, Lonza Group launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, to streamline and simplify rabbit-free pyrogen testing.
In March 2022, Lonza Group launched the PyroCell Monocyte Activation Test - Human Serum System (PyroCell MAT HS System), which uses human serum instead of fetal bovine serum. This new in vitro pyrogen testing system exhibits enhanced sensitivity for detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals.
In December 2022, Charles River Laboratories International, Inc. launched the Endosafe Nexus 200, expanding its robust endotoxin testing portfolio.
In December 2021, FUJIFILM Wako Pure Chemical Corporation launched the recombinant protein reagent PYROSTAR Neo for detection of bacterial endotoxin.
Key Benefits For Stakeholders
This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the pyrogen testing market analysis from 2022 to 2032 to identify the prevailing pyrogen testing market opportunities.
The market research is offered along with information related to key drivers, restraints, and opportunities.
Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
In-depth analysis of the pyrogen testing market segmentation assists to determine the prevailing market opportunities.
Major countries in each region are mapped according to their revenue contribution to the global market.
Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
The report includes the analysis of the regional as well as global pyrogen testing market trends, key players, market segments, application areas, and market growth strategies.
Pyrogen Testing Market Report Highlights
| Aspects | Details |
 Forecast period | 2022 - 2032 |
 Report Pages | 286 |
 By Product and Service |
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 By Test Type |
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 By End User |
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 By Region |
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 Key Market Players | GenScript, Charles River Laboratories, Eurofins Scientific SE, Wuxi AppTec, Merck KGaA, STERIS plc, SEIKAGAKU CORPORATION, Lonza Group AG, Thermo Fisher Scientific Inc. , Fujifilm Holdings Corporation |
Analyst Review
This section provides various opinions of pyrogen testing market. The pyrogen testing market is expected to witness a significant growth in the future, owing to growing activities in the pharmaceutical and biotechnology sectors, including research, development, and manufacturing, drive the demand for pyrogen testing. In addition, rise in awareness of the potential risks associated with pyrogen contamination in pharmaceuticals and medical devices and increase in prevalence of chronic and infectious diseases which is expected to drive the market growth. However, lack of standardized testing methods and lack of awareness and knowledge about the importance of pyrogen testing in emerging countries restricts market growth.
In addition, advancements in pyrogen testing technologies and key players adopting strategies such as product launches are expected to boost the growth of the market. For instance, in October 2023, Lonza Group launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, to streamline and simplify rabbit-free pyrogen testing.
Moreover, North America accounted for the largest share in 2022 and is expected to remain dominant during the forecast period. This is attributed to the robust healthcare infrastructure, advanced technological capabilities, and a well-established regulatory framework supporting the growth of pyrogen testing in the region.
However, Asia-Pacific is anticipated to witness notable growth owing to a rise in awareness of healthcare standards and the importance of product safety among consumers and regulatory bodies. In addition, growth in population and the increase in prevalence of chronic diseases have led to rise in demand for a diverse range of drugs and medical devices, which drives the need for quality control measures including pyrogen testing.
The total market value of pyrogen testing market is $1.5 billion in 2022.
The market value of pyrogen testing market in 2032 is $3.3 billion.
The forecast period for pyrogen testing market is 2023 to 2032.
The base year is 2022 in pyrogen testing market.
Reagents and kits segment dominated the market share in 2022, owing to high adoption of reagents & kits as they play a crucial role in facilitating accurate and reliable testing for fever-inducing contaminants.
Merck KGaA, Charles River Laboratories, Lonza Group, Thermo Fisher Scientific Inc., and FUJIFILM Corporation held a high market position in 2022.
Pyrogen testing used to detect and quantify pyrogens in pharmaceuticals, biotechnology products, and medical devices.
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