热原测试市场- 按产品和服务（消耗品、仪器、服务）、测试类型（LAL [显色、凝胶凝块]、体外热原、兔子测试）、最终用途（製药、生物技术、医疗器械公司） - 全球预测（2024 - 2032）

由于慢性病盛行率不断上升，2024 年至 2032 年全球热原测试市场规模的复合年增长率将超过 9.1%。据 Physiopedia 称，全球约有三分之一的成年人患有多种慢性病。随着糖尿病、癌症和心血管疾病等疾病变得越来越普遍，对管理和治疗这些疾病的药物和医疗器材的需求将显着增加。这种过量需要严格的安全测试，以确保这些产品不含可能对患者产生不利影响的热原污染物。因此，製药公司和医疗器材製造商正在增加热原测试的投资，以满足严格的监管标准并确保其产品的安全性和有效性。

个人化医疗的发展正在成为市场的一个突出趋势。根据患者个别特征调整治疗的个人化医疗需要非常具体且精确的医疗产品和医疗器材。这种客製化增加了对严格热原测试的需求，以确保这些个人化疗法对个别患者的安全性和有效性。随着製药公司专注于标靶治疗和生物製剂的开发，对先进、可靠的热原测试方法的需求不断增加。这一趋势强调了确保个人医疗产品不含污染物以提高病患安全和治疗效果的重要性。

热原测试产业根据产品和服务、测试类型、最终用途和地区进行分类。

到 2032 年，仪器领域将快速成长，因为内毒素测试系统和热循环仪对于执行可靠和可重复的测试至关重要。对高通量筛选不断增长的需求以及对自动化高效测试解决方案的需求导致了先进热原测试设备的开发。这些设备不仅提高了测试结果的准确性和可靠性，而且还简化了测试过程，减少了所涉及的时间和精力。由于製药公司和研究实验室努力满足严格的官方标准并确保其产品的安全性，预计将进一步成长。

到 2032 年，医疗器材领域将稳定成长，因为医疗器材製造商需要对其产品进行热原测试，以确保其不含热原污染物。随着医疗器材复杂性和多样性的增加，严格的安全测试的需求变得更加突出。热原测试对于许多设备（包括导管、植入物和手术器械）非常重要，可防止患者发生热原反应。

在严格的监管框架和强大的医疗基础设施的推动下，到 2032 年，欧洲热原测试产业将以前所未有的速度成长。包括德国、法国和英国在内的欧洲国家已经制定了药品和医疗器材生产中热原测试的综合指南。该地区主要製药和生物製药公司的存在将有助于市场的成长。此外，欧盟严格的药物和器械安全法规鼓励采用先进的热原测试。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • 治疗药物的需求不断增加
    • 慢性病盛行率上升
    • 研发投入不断增加
    • 食品安全意识不断提高
  • 产业陷阱与挑战
    • 严格的政府法规
• 成长潜力分析
• 监管环境
• 技术景观
• 波特的分析
• PESTEL分析

第 4 章：竞争格局

• 介绍
• 公司市占率分析
• 竞争定位矩阵
• 战略展望矩阵

第 5 章：市场估计与预测：按产品和服务划分，2021 - 2032 年

• 主要趋势
• 耗材
• 仪器
• 服务

第 6 章：市场估计与预测：按测试类型，2021 - 2032 年

• 主要趋势
• 鲎试剂测试
  • 显色试验
  • 比浊测试
  • 凝胶凝块试验
• 体外热原测试
  • 单核细胞活化试验（MAT）
  • 重组 C 因子测定 (rFC)
• 兔子测试

第 7 章：市场估计与预测：按最终用途，2021 - 2032 年

• 主要趋势
• 製药和生物技术公司
• 医疗器材企业
• 其他最终用户

第 8 章：市场估计与预测：按地区，2021 - 2032

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 欧洲其他地区
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 澳洲
  • 韩国
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地区
• 中东和非洲
  • 沙乌地阿拉伯
  • 南非
  • 阿联酋
  • 中东和非洲其他地区

第 9 章：公司简介

• Almac Group
• bioMérieux SA
• Charles River Laboratories International, Inc.
• Eurofins Scientific
• Fujifilm Holdings Corporation
• GenScript Biotech Corporation
• Lonza
• Merck KGaA
• STERIS plc
• Thermo Fisher Scientific Inc.

Global Pyrogen testing market size will grow over 9.1% CAGR from 2024 to 2032 due to the increasing prevalence of chronic diseases. According to Physiopedia, globally, about 1 in 3 adults suffer from multiple chronic conditions. As diseases such as diabetes, cancer, and cardiovascular diseases become more common, the demand for drugs and medical devices to manage and treat these diseases will increase significantly. This excess requires rigorous safety testing to ensure that these products do not contain pyrogenic contaminants that could adversely affect patients. As a result, pharmaceutical companies and medical device manufacturers are investing more in pyrogen testing to meet strict regulatory standards and ensure the safety and efficacy of their products.

The development of personalized medicine is emerging as a prominent trend in the market. Personalized medicine that adapts treatment to the patient's individual characteristics requires very specific and precise medical products and medical devices. This customization increases the need for rigorous pyrogen testing to ensure the safety and efficacy of these personalized therapies for individual patients. As pharmaceutical companies focus on the development of targeted therapies and biologics, the demand for advanced and reliable pyrogenic testing methods is increasing. This trend underscores the importance of ensuring that personal medical products are free of contaminants to improve patient safety and treatment outcomes.

The pyrogenic testing industry is classified based on products and services, test type, end use, and region.

The instruments segment will grow rapidly through 2032, as endotoxin testing systems and thermal cyclers are critical to performing reliable and reproducible tests. The growing demand for high-throughput screening and the need for automated and efficient testing solutions has led to the development of advanced pyrogen testing equipment. These devices not only improve the accuracy and reliability of test results but also simplify the testing process, reducing the time and effort involved. As pharmaceutical companies and research laboratories strive to meet strict official standards and ensure the safety of their products, further growth is expected.

The medical device segment will grow steadily through 2032, as medical device manufacturers are required to perform pyrogen testing on their products to ensure they are free of pyrogenic contaminants. As the complexity and diversity of medical devices increases, the need for rigorous safety testing has become more prominent. Pyrogen testing is important for many devices, including catheters, implants, and surgical instruments, to prevent pyrogenic reactions in patients.

Europe Pyrogen Testing industry will grow at an unprecedented rate through 2032, driven by strict regulatory frameworks and strong healthcare infrastructure. European countries, including Germany, France, and the UK, have developed comprehensive guidelines for testing pyrogens in the manufacture of medicines and medical devices. The presence of major pharmaceutical and biopharmaceutical companies in the region will help the growth of the market. In addition, the European Union's strict drug and device safety regulations encourage the adoption of advanced pyrogen testing.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing demand for therapeutic drugs
    • 3.2.1.2 Rising prevalence of chronic diseases
    • 3.2.1.3 Growing investment in R&D
    • 3.2.1.4 Rising awareness about food safety
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Stringent government regulations
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Porter's analysis
• 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Competitive positioning matrix
• 4.4 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Product and Services, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Consumables
• 5.3 Instruments
• 5.4 Services

Chapter 6 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 LAL test
  • 6.2.1 Chromogenic test
  • 6.2.2 Turbidimetric test
  • 6.2.3 Gel clot test
• 6.3 In-vitro pyrogen test
  • 6.3.1 Monocyte activation test (MAT)
  • 6.3.2 Recombinant factor C assay (rFC)
• 6.4 Rabbit test

Chapter 7 Market Estimates and Forecast, By End-Use, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Pharmaceutical and biotechnology companies
• 7.3 Medical devices companies
• 7.4 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 South Africa
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 Almac Group
• 9.2 bioMérieux SA
• 9.3 Charles River Laboratories International, Inc.
• 9.4 Eurofins Scientific
• 9.5 Fujifilm Holdings Corporation
• 9.6 GenScript Biotech Corporation
• 9.7 Lonza
• 9.8 Merck KGaA
• 9.9 STERIS plc
• 9.10 Thermo Fisher Scientific Inc.