全球热原测试市场规模：依产品类型、测试类型、应用、区域覆盖范围、预测

热原测试市场规模及预测

2024年热原测试市场规模为11.6158亿美元，预计到2031年将达到28.6578亿美元，2024年至2031年复合年增长率为11.95%。热原测试是检测药物和医疗器材中热原的重要步骤，确保人类使用安全，特别是注射和静脉输液。热原测试用于製药和生物技术行业，以确保注射药物、疫苗、静脉注射液、单株抗体和细胞疗法等生物製品不含引起发烧的污染物，从而确保患者安全。在医疗器械领域，我们验证与血液和组织接触的植入式和手术器械的安全性。

此外，热原测试对于透析液至关重要，可防止肾臟治疗中的反应，并确保兽药和医疗器械可安全用于动物。此测试也适用于血液製品、肠外营养液和某些化妆品，以确保它们无热原且可供消费者安全使用。

全球热原测试市场动态

主要市场推动因素

製药和生物产业的成长：

扩大注射药物、疫苗和生物製品的开发和生产需要严格的热原测试，以确保产品的安全性和有效性。根据美国食品药物管理局（FDA）预测，2023年新药核准数量将较上年增加15%，其中大部分为注射剂和生物製剂。

慢性病发生率增加：

慢性病的流行以及相关治疗和干预措施的增加增加了对无热原产品的需求并推动了市场成长。世界卫生组织 (WHO) 于 2023 年底报告称，到 2022 年，非传染性疾病 (NCD) 占全球死亡人数的 74%，高于 2016 年的 71%。

技术进步：

热原测试方法的创新，例如重组 C 因子测定和单核细胞活化测定，可提供更准确、可靠和快速的结果，并正在推动采用。EDQM（European Directorate for the Quality of Medicines &HealthCare）于 2024 年 1 月报告称，2022 年至 2023 年间，欧洲使用重组 C 因子检测进行内毒素检测的数量增加了 25%。

新兴市场的扩张：

新兴国家医疗保健投资和药品生产的增加将推动对全面热原测试的需求，以满足国际安全标准。印度卫生与家庭福利部2024年3月报告称，2023-2024财年该国药品出口成长18%，热原检测服务需求相应成长22%。

主要课题

测试成本高：

先进的热原测试方法和设备的相关成本可能令人望而却步，并限制其采用，尤其是中小型企业。根据美国食品药物管理局 (FDA) 2023 年底发布的报告，检测一批药物热原的平均成本在 500 美元到 2,000 美元之间，具体取决于所使用的方法。

复杂的监理环境：

监管要求因地区而异，不断变化的法规可能难以驾驭且耗时，从而为市场进入和扩张造成障碍。国际人类使用技术要求协调委员会 (ICH) 于 2023 年 12 月报告称，只有 60% 的成员国已将其热原测试法规与最新的 ICH 指南完全一致。

技术限制：

儘管技术取得了进步，但一些热原测试方法缺乏敏感性和特异性，导致假阳性和假阴性，影响可靠性。2024 年 1 月发表在《Journal of Pharmaceutical Sciences》上的一项荟萃分析发现，目前的体外热原检测方法在各项研究中的平均假阳性率为 5%，假阴性率为 2%。

有限的熟练劳动力：

缺乏精通先进热原测试技术的训练有素的专业人员可能会阻碍这些测试方法的采用和有效实施。根据美国药学科学家协会 (AAPS) 于 2023 年底进行的一项调查，65% 的製药公司表示很难招募合格的人员来担任高阶热原测试职位。

主要趋势

转向非动物测试方法：

对伦理考虑的日益关注和来自监管机构的压力正在推动非动物测试方法的采用，例如重组C 因子测定和单核细胞活化测试，取代传统的基于动物的方法，例如兔子热原测试，对检查的依赖较少。美国食品药物管理局 (FDA) 于 2024 年 2 月宣布，2023 年提交药物审批的热原测试数据中约有 60% 使用非动物方法，高于 2020 年的 40%。

将品质控制整合到製造中：

人们越来越重视将热原测试作为整个药品和医疗器材製造过程中更广泛的品质控制措施的一部分，以确保产品的安全性和合规性。国际製药技术协会 (ISPE) 于 2024 年 1 月报告称，2022 年至 2023 年间，生物製药製造中连续热原监测系统的实施量增加了 40%。

生物技术和个人化医疗的扩展：

生物製剂、个人化医疗和先进治疗的兴起需要客製化的热原测试方案，以适应这些治疗和患者群体的独特特征。根据再生医学联盟的报告，到 2023 年，全球临床试验中的细胞和基因疗法数量将比前一年增加 25%，从而推动对专门热原测试解决方案的需求。

目录

第1章简介

• 市场定义
• 市场细分
• 调查方法

第 2 章执行摘要

• 主要发现
• 市场概况
• 市集亮点

第3章市场概况

• 市场规模和成长潜力
• 市场趋势
• 市场驱动力
• 市场制约因素
• 市场机会
• 波特五力分析

第4章热原测试市场：依产品类型

• 试剂盒和试剂
• 用具
• 服务

第5章热原测试市场：依测试类型

• LAL（有限变形细胞裂解物）测试
• MAT（单核细胞活化试验）
• rFC（重组因子 C）测定
• 其他

第6章热原测试市场：依应用分类

• 药品
• 医疗器材
• 生物製剂
• 化妆品和个人护理产品

第7章 区域分析

• 北美
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利
• 亚太地区
• 中国
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东/非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯联合酋长国

第8章市场动态

• 市场驱动力
• 市场制约因素
• 市场机会
• COVID-19 的市场影响

第9章 竞争格局

• 大公司
• 市场占有率分析

第10章 公司简介

• Charles River Laboratories
• Lonza Group
• Merck KGaA
• Thermo Fisher Scientific
• Associates of Cape Cod Inc.
• FUJIFILM Holdings Corporation
• GenScript
• WuXi AppTec
• bioMerieux
• Eurofins Scientific

第11章市场前景与机遇

• 新兴技术
• 未来市场趋势
• 投资机会

第12章附录

• 缩写表
• 来源和参考文献

Pyrogen Testing Market Size And Forecast

Pyrogen Testing Market size was valued at USD 1161.58 Million in 2024 and is projected to reach USD 2865.78 Million by 2031 , growing at a CAGR of 11.95% from 2024 to 2031. Pyrogen testing is a crucial procedure to detect pyrogens in pharmaceutical products and medical devices, ensuring their safety for human use, particularly in injectable drugs and intravenous fluids. Pyrogen testing is essential in the pharmaceutical and biotechnology industries to ensure that injectable drugs, vaccines, intravenous solutions, and biologics like monoclonal antibodies and cell therapies are free from fever-inducing contaminants, ensuring patient safety. In the medical device sector, it verifies the safety of implantable devices and surgical instruments that come into contact with blood or tissues.

Additionally, pyrogen testing is crucial for dialysis fluids to prevent reactions in renal therapy, and it ensures veterinary pharmaceuticals and medical devices are safe for animal use. This testing also applies to blood products, parenteral nutrition solutions, and certain cosmetics, guaranteeing they are pyrogen-free and safe for consumer use.

Global Pyrogen Testing Market Dynamics

The key market dynamics that are shaping the global pyrogen testing market include:

Key Market Drivers

Growth in Pharmaceutical and Biotech Industries:

Expanding development and production of injectable drugs, vaccines, and biologics require rigorous pyrogen testing to ensure product safety and efficacy. According to the U.S. Food and Drug Administration (FDA), the number of new drug approvals increased by 15% in 2023 compared to the previous year, with a significant portion being injectable and biologic products.

Rising Incidence of Chronic Diseases:

The growing prevalence of chronic conditions and the corresponding increase in medical treatments and interventions bolster the need for pyrogen-free products, fueling market growth. The World Health Organization (WHO) reported in late 2023 that non-communicable diseases (NCDs) were responsible for 74% of global deaths in 2022, up from 71% in 2016.

Technological Advancements:

Innovations in pyrogen testing methods, such as recombinant Factor C assays and monocyte activation tests, offer more accurate, reliable, and rapid results, encouraging adoption. The European Directorate for the Quality of Medicines & HealthCare (EDQM) reported in January 2024 that the use of recombinant Factor C assays for endotoxin testing increased by 25% in Europe between 2022 and 2023.

Expansion in Emerging Markets:

Increase in healthcare investments and pharmaceutical production in emerging economies drive demand for comprehensive pyrogen testing to meet international safety standards. India's Ministry of Health and Family Welfare reported in March 2024 that the country's pharmaceutical exports grew by 18% in the fiscal year 2023-2024, with a corresponding 22% increase in demand for pyrogen testing services.

Key Challenges:

High Testing Costs:

The expense associated with advanced pyrogen testing methods and equipment can be prohibitive, limiting their adoption, especially by smaller companies. According to a report by the U.S. Food and Drug Administration (FDA) in late 2023, the average cost of pyrogen testing for a single batch of pharmaceutical products ranged from $500 to $2,000, depending on the method used.

Complex Regulatory Landscape:

Navigating varying and evolving regulatory requirements across different regions can be challenging and time-consuming, posing a barrier to market entry and expansion. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) reported in December 2023 that only 60% of its member countries had fully aligned their pyrogen testing regulations with the latest ICH guidelines.

Technological Limitations:

Despite advancements, certain pyrogen testing methods may lack sensitivity or specificity, leading to potential false positives or negatives, impacting reliability. A meta-analysis published in the Journal of Pharmaceutical Sciences in January 2024 found that current in vitro pyrogen testing methods had an average false-positive rate of 5% and a false-negative rate of 2% across various studies.

Limited Skilled Workforce:

A shortage of trained professionals skilled in advanced pyrogen testing techniques can hinder the adoption and effective implementation of these methods. A survey by the American Association of Pharmaceutical Scientists (AAPS) in late 2023 found that 65% of pharmaceutical companies reported difficulties in hiring qualified personnel for advanced pyrogen testing roles.

Key Trends

Shift Towards Non-animal Testing Methods:

Increasing focus on ethical considerations and regulatory pressures are driving the adoption of non-animal testing methods, such as recombinant Factor C assays and monocyte activation tests, reducing reliance on traditional animal-based tests like the rabbit pyrogen test. The U.S. Food and Drug Administration (FDA) reported in February 2024 that approximately 60% of pyrogen test data submitted for drug approvals in 2023 used non-animal methods, up from 40% in 2020.

Integration of Quality Control in Manufacturing:

Growing emphasis on integrating pyrogen testing as part of broader quality control measures throughout pharmaceutical and medical device manufacturing processes to ensure product safety and compliance. The International Society for Pharmaceutical Engineering (ISPE) reported in January 2024 that implementation of continuous pyrogen monitoring systems in biopharmaceutical manufacturing increased by 40% between 2022 and 2023.

Expansion in Biotechnology and Personalized Medicine:

The rise of biologics, personalized medicine, and advanced therapies necessitates tailored pyrogen testing protocols to accommodate the unique characteristics of these treatments and patient population. The Alliance for Regenerative Medicine reported that the number of cell and gene therapies in clinical trials globally increased by 25% in 2023 compared to the previous year, driving demand for specialized pyrogen testing solutions.

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Global Pyrogen Testing Market Regional Analysis

Here is a more detailed regional analysis of the global pyrogen testing market:

North America

North America currently dominates as a significant regional segment. According to a report by the American Association of Pharmaceutical Scientists (AAPS) in early 2024, the North American pyrogen testing market was valued at approximately $450 million in 2023, with the United States accounting for about 80% of this value. The region's dominance is primarily driven by stringent regulatory standards enforced by agencies like the FDA, which mandate rigorous testing for pyrogens in pharmaceuticals, biologics, and medical devices.

The United States, in particular, houses a mature healthcare sector with advanced pharmaceutical and biotechnology industries that heavily rely on pyrogen testing to ensure product safety and regulatory compliance. The U.S. Food and Drug Administration (FDA) reported in late 2023 that pyrogen testing was required for approximately 65% of all new drug applications (NDAs) and biologics license applications (BLAs) submitted in that year.

This demand is bolstered by a robust framework of quality control measures and a strong emphasis on adhering to international standards, making North America a critical hub for pyrogen testing services and technologies.

Asia Pacific

Asia Pacific is rapidly emerging as a growing regional segment in the pyrogen testing market. The region is experiencing rapid industrialization, economic growth, and increasing investments in healthcare infrastructure, particularly in countries like China, India, Japan, and South Korea.

These nations are witnessing expanding pharmaceutical manufacturing capabilities and rising adoption of advanced healthcare practices, which necessitate stringent quality control measures including pyrogen testing.

Moreover, outsourcing of clinical trials and pharmaceutical production to Asia Pacific countries further propels the demand for pyrogen testing services. As regulatory frameworks in the region evolve and align more closely with international standards, the market for pyrogen testing is expected to continue its rapid growth trajectory in Asia Pacific.

Global Pyrogen Testing Market: Segmentation Analysis

The Global Pyrogen Testing Market is Segmented on the basis of Product Type, Test Type, Application, and Geography.

Pyrogen Testing Market, By Product Type

• Kits and Reagents
• Instruments
• Services

Based on Product Type, the Global Pyrogen Testing Market is bifurcated into Kits and Reagents, Instruments, and Services. In the pyrogen testing market, services is expected to dominate over the forecast period. This is primarily due to the critical need for specialized expertise and regulatory compliance in conducting pyrogen testing across pharmaceutical, biotechnology, and medical device industries. Services encompass a range of offerings including testing protocols, validation services, and consulting, catering to the stringent requirements for product safety and quality assurance. Secondarily, kits and reagents are rapidly growing in the pyrogen testing market.

Pyrogen Testing Market, By Test Type

• LAL (Limulus Amebocyte Lysate) Test
• MAT (Monocyte Activation Test)
• rFC (recombinant Factor C) Assay

Based on Test Type, the Global Pyrogen Testing Market is bifurcated into LAL (Limulus Amebocyte Lysate) Test, MAT (Monocyte Activation Test), rFC (recombinant Factor C) Assay. In the market, the LAL (Limulus Amebocyte Lysate) Test currently dominates as the leading test type. LAL is widely adopted due to its sensitivity in detecting bacterial endotoxins, which are a common type of pyrogen found in pharmaceuticals, medical devices, and biologics. The test's established reliability and validation by regulatory authorities such as the FDA contribute to its widespread use across the pharmaceutical and biotechnology industries. Secondarily, the MAT (Monocyte Activation Test) is rapidly growing in the pyrogen testing market. MAT offers an alternative method to LAL for pyrogen detection, particularly for non-endotoxin pyrogens.

Pyrogen Testing Market, By Application

• Pharmaceuticals
• Medical Devices
• Biologics
• Cosmetics and Personal Care Products

Based on Application, the Global Pyrogen Testing Market is bifurcated into Pharmaceuticals, Medical Devices, Biologics, Cosmetics and Personal Care Products. In the pyrogen testing market by application, pharmaceuticals dominate as the leading segment. Pyrogen testing is critically important in pharmaceutical manufacturing to ensure that drugs are free from pyrogenic contaminants, which could cause adverse reactions in patients. Stringent regulatory requirements worldwide mandate thorough testing of pharmaceutical products, driving the demand for pyrogen testing services and technologies across the entire drug development and manufacturing process. The medical devices are rapidly growing in the pyrogen testing market. As medical devices become more complex and integrated with biological materials or patient interfaces, ensuring they are free from pyrogens is essential to prevent infections and ensure patient safety.

Pyrogen Testing Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the Global Pyrogen Testing Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. In the pyrogen testing market, North America currently dominates as the leading segment. This is primarily driven by stringent regulatory requirements and well-established pharmaceutical and biotechnology industries in the United States and Canada. The FDA regulations in the U.S. mandate rigorous pyrogen testing to ensure product safety and compliance, leading to a substantial demand for testing services and technologies across pharmaceuticals, biologics, and medical devices sectors. The region's advanced healthcare infrastructure and emphasis on quality control further support its dominant position in the global pyrogen testing market. The region is experiencing rapid growth in the pyrogen testing market.

Key Players

• The "Global Pyrogen Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Charles River Laboratories, Lonza Group, Merck KGaA, Thermo Fisher Scientific, Associates of Cape Cod, Inc., GenScript, WuXi AppTec, bioMerieux, Eurofins Scientific.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global Pyrogen Testing Market Key Developments

• In December 2020, Charles River Laboratories International, Inc., a leading provider of essential products and services for the pharmaceutical and biotechnology industries, announced the acquisition of Cognate BioServices, Inc. This acquisition expanded Charles River's cell and gene therapy capabilities, enhancing its position in the growing field of advanced therapeutics.
• In May 2021, Lonza Group AG, a Swiss multinational, announced the expansion of its manufacturing capacity for clinical and commercial supply of cell and gene therapies. This expansion aimed to meet the increasing demand for these therapies globally, supporting the growing biopharmaceutical market.
• In September 2021, Merck KGaA, Darmstadt, Germany, launched a new BioContinuum(TM) Buffer Delivery Platform. This platform aimed to simplify buffer preparation and management in biomanufacturing processes, addressing key challenges in downstream bioprocessing.
• In January 2022, Thermo Fisher Scientific, Inc., a global leader in serving science, completed the acquisition of PPD, Inc., a leading global contract research organization (CRO). This acquisition enhanced Thermo Fisher's capabilities in providing end-to-end solutions for the pharmaceutical and biotech industries, including clinical trial services and laboratory testing.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Pyrogen Testing Market, By Product Type

• Kits and Reagents
• Instruments
• Services

5. Pyrogen Testing Market, By Test Type

• LAL (Limulus Amebocyte Lysate) Test
• MAT (Monocyte Activation Test)
• rFC (recombinant Factor C) Assay
• Others

6. Pyrogen Testing Market, By Application

• Pharmaceuticals
• Medical Devices
• Biologics
• Cosmetics and Personal Care Products

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Charles River Laboratories
• Lonza Group
• Merck KGaA
• Thermo Fisher Scientific
• Associates of Cape Cod Inc.
• FUJIFILM Holdings Corporation
• GenScript
• WuXi AppTec
• bioMerieux
• Eurofins Scientific

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References