The Global Pyrogen Testing Market size is expected to reach $2.6 billion by 2030, rising at a market growth of 7.9% CAGR during the forecast period.
Europe has a well-established regulatory framework for pharmaceutical and medical device industries. The European Medicines Agency (EMA) and other national agencies' implementation of rigorous regulatory standards to guarantee adherence to quality and safety protocols propels the need for this testing. Consequently, the Europe region would acquire nearly, 30% of the total market share by 2030. Additionally, the EU has been witnessing advancements in the biopharmaceutical sector, focusing on biologics, biosimilars, and gene therapies. These complex and novel products often require sophisticated testing methodologies, driving the need for expanded testing capabilities. Hence, the segment will witness increased demand in the upcoming years.
Pyrogens, particularly bacterial endotoxins, can cause adverse reactions in humans. Regulatory agencies mandate that pharmaceuticals and medical devices are free from pyrogens to ensure patient safety. This testing is conducted to detect and quantify the presence of pyrogens in products. Moreover, products are often subjected to sterilization procedures in the pharmaceutical and medical device manufacturing processes. Validation of these processes, including the absence of pyrogens post-sterilization, is crucial. Therefore, these factors will help in the expansion of the market. Additionally, the rise in chronic diseases necessitates the development of a diverse range of pharmaceuticals, including traditional small-molecule drugs, biologics, and medical devices. Each of these modalities undergoes extensive testing to ensure product safety, and this testing is one of the critical tests to detect potential contaminants. Moreover, chronic diseases often require long-term or frequent treatments, making patient safety paramount. Pyrogens, particularly bacterial endotoxins, can lead to severe adverse reactions. Rigorous testing helps mitigate these risks by ensuring the products intended for chronic disease management are free from harmful contaminants. Thus, these factors will assist in the growth of the market.
Moreover, the unprecedented demands placed on healthcare systems during the pandemic led to a reprioritization of resources. Many pharmaceutical and medical device companies directed their focus and resources toward developing, producing, and distributing COVID-19 related products, affecting the attention given to routine quality control processes, including this testing. Moreover, the pandemic accelerated the adoption of technological solutions in various industries. In the market, there was a heightened interest in automation, digitalization, and remote monitoring solutions to ensure continuity and efficiency in testing processes despite disruptions caused by the pandemic. Thus, the COVID-19 pandemic moderately impacted the market.
However, advanced testing methods may require specialized equipment, which can be expensive to acquire and maintain. This includes instruments such as endotoxin testing systems, spectrophotometers, and other analytical devices contributing to the overall cost of setting up a testing facility. In addition, conducting this testing, especially with advanced methods, requires personnel with specialized knowledge and skills. Hiring and retaining skilled professionals in this testing can be costly, and smaller companies may find it challenging to compete for qualified talent. Thus, these factors will decrease the demand for this testing in the upcoming years.
Europe has a well-established regulatory framework for pharmaceutical and medical device industries. The European Medicines Agency (EMA) and other national agencies' implementation of rigorous regulatory standards to guarantee adherence to quality and safety protocols propels the need for this testing. Consequently, the Europe region would acquire nearly, 30% of the total market share by 2030. Additionally, the EU has been witnessing advancements in the biopharmaceutical sector, focusing on biologics, biosimilars, and gene therapies. These complex and novel products often require sophisticated testing methodologies, driving the need for expanded testing capabilities. Hence, the segment will witness increased demand in the upcoming years.
Pyrogens, particularly bacterial endotoxins, can cause adverse reactions in humans. Regulatory agencies mandate that pharmaceuticals and medical devices are free from pyrogens to ensure patient safety. This testing is conducted to detect and quantify the presence of pyrogens in products. Moreover, products are often subjected to sterilization procedures in the pharmaceutical and medical device manufacturing processes. Validation of these processes, including the absence of pyrogens post-sterilization, is crucial. Therefore, these factors will help in the expansion of the market. Additionally, the rise in chronic diseases necessitates the development of a diverse range of pharmaceuticals, including traditional small-molecule drugs, biologics, and medical devices. Each of these modalities undergoes extensive testing to ensure product safety, and this testing is one of the critical tests to detect potential contaminants. Moreover, chronic diseases often require long-term or frequent treatments, making patient safety paramount. Pyrogens, particularly bacterial endotoxins, can lead to severe adverse reactions. Rigorous testing helps mitigate these risks by ensuring the products intended for chronic disease management are free from harmful contaminants. Thus, these factors will assist in the growth of the market.
Moreover, the unprecedented demands placed on healthcare systems during the pandemic led to a reprioritization of resources. Many pharmaceutical and medical device companies directed their focus and resources toward developing, producing, and distributing COVID-19 related products, affecting the attention given to routine quality control processes, including this testing. Moreover, the pandemic accelerated the adoption of technological solutions in various industries. In the market, there was a heightened interest in automation, digitalization, and remote monitoring solutions to ensure continuity and efficiency in testing processes despite disruptions caused by the pandemic. Thus, the COVID-19 pandemic moderately impacted the market.
However, advanced testing methods may require specialized equipment, which can be expensive to acquire and maintain. This includes instruments such as endotoxin testing systems, spectrophotometers, and other analytical devices contributing to the overall cost of setting up a testing facility. In addition, conducting this testing, especially with advanced methods, requires personnel with specialized knowledge and skills. Hiring and retaining skilled professionals in this testing can be costly, and smaller companies may find it challenging to compete for qualified talent. Thus, these factors will decrease the demand for this testing in the upcoming years.
By Product & Service Analysis
Based on product & service, the market is segmented into reagents & kits, instruments, and services. In 2022, the instruments segment garnered a significant revenue share in the market. The progression of technology has resulted in the creation of sophisticated instruments utilized in this testing. Innovative technologies, such as automated liquid handling systems, microfluidics, and sophisticated detection techniques, have enhanced pyrogen detection methods' sensitivity, accuracy, and efficiency. Hence, the segment will witness increased demand in the coming years.By Test Type Analysis
On the basis of test type, the market is divided into LAL test, rabbit pyrogen test, and others. In 2022, the others segment witnessed a substantial revenue share in the market. The "others" category in the context of this testing may include emerging technologies, innovative testing methods, or specific applications that do not fit within the conventional categories, like Limulus amebocyte lysate (LAL) testing or monocyte activation testing (MAT). Therefore, owing to these factors, the segment will witness enhanced growth in the upcoming years.
By End User Analysis
Based on end user, the market is divided into pharmaceutical & biotechnology companies, medical device companies, and others. In 2022, the medical device companies segment witnessed a substantial revenue share in the market. Ongoing advancements in the testing technologies, including more sensitive and efficient methods, may attract medical device companies looking to adopt state-of-the-art testing solutions. Improved testing technologies can offer quicker and more accurate results, contributing to medical devices' overall safety and quality. Therefore, the segment will grow rapidly in the coming years.By Regional Analysis
By region, the market is segmented into North America, Europe, Asia Pacific, and LAMEA. The North America segment procured the highest revenue share in the market in 2022. The pharmaceutical and biotechnology sectors in North America have been consistently growing. The region is a hub for research and development activities, leading to the development of new drugs, biologics, and medical devices. The need for rigorous testing, including this testing, grows in tandem as the industry expands. Therefore, these factors will boost the demand in the segment.List of Key Companies Profiled
- Merck KGaA
- Charles River Laboratories International, Inc.
- Genscript Biotech Corporation
- WuXi AppTec Co., Ltd.
- Lonza Group Ltd.
- Fujifilm Holdings Corporation
- Eurofins Scientific SE
- Thermo Fisher Scientific, Inc.
- Seikagaku Corp.
- InvivoGen SAS
Market Report Segmentation
By Product & Service- Reagents & Kits
- Services
- Instruments
- LAL Test
- Rabbit Pyrogen Test
- Others
- Pharmaceutical & Biotechnology Companies
- Medical Device Companies
- Others
- North America
- US
- Canada
- Mexico
- Rest of North America
- Europe
- Germany
- UK
- France
- Russia
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- Singapore
- Malaysia
- Rest of Asia Pacific
- LAMEA
- Brazil
- Argentina
- UAE
- Saudi Arabia
- South Africa
- Nigeria
- Rest of LAMEA
Table of Contents
Chapter 1. Market Scope & Methodology
Chapter 2. Market at a Glance
Chapter 3. Market Overview
Chapter 4. Global Pyrogen Testing Market, by Product & Service
Chapter 5. Global Pyrogen Testing Market, by Test Type
Chapter 6. Global Pyrogen Testing Market, by End User
Chapter 7. Global Pyrogen Testing Market, by Region
Chapter 8. Company Profiles
Companies Mentioned
- Merck KGaA
- Charles River Laboratories International, Inc.
- Genscript Biotech Corporation
- WuXi AppTec Co., Ltd.
- Lonza Group Ltd.
- Fujifilm Holdings Corporation
- Eurofins Scientific SE
- Thermo Fisher Scientific, Inc.
- Seikagaku Corp.
- InvivoGen SAS
Methodology
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