熱原測試市場- 按產品和服務（消耗品、儀器、服務）、測試類型（LAL [顯色、凝膠凝塊]、體外熱原、兔子測試）、最終用途（製藥、生物技術、醫療器械公司） - 全球預測（2024 - 2032）

由於慢性病盛行率不斷上升，2024 年至 2032 年全球熱原測試市場規模的複合年成長率將超過 9.1%。據 Physiopedia 稱，全球約有三分之一的成年人患有多種慢性病。隨著糖尿病、癌症和心血管疾病等疾病變得越來越普遍，對管理和治療這些疾病的藥物和醫療器材的需求將顯著增加。這種過量需要嚴格的安全測試，以確保這些產品不含可能對患者產生不利影響的熱原污染物。因此，製藥公司和醫療器材製造商正在增加熱原測試的投資，以滿足嚴格的監管標準並確保其產品的安全性和有效性。

個人化醫療的發展正在成為市場的一個突出趨勢。根據患者個別特徵調整治療的個人化醫療需要非常具體且精確的醫療產品和醫療器材。這種客製化增加了對嚴格熱原測試的需求，以確保這些個人化療法對個別患者的安全性和有效性。隨著製藥公司專注於標靶治療和生物製劑的開發，對先進、可靠的熱原測試方法的需求不斷增加。這一趨勢強調了確保個人醫療產品不含污染物以提高病患安全和治療效果的重要性。

熱原測試產業根據產品和服務、測試類型、最終用途和地區進行分類。

到 2032 年，儀器領域將快速成長，因為內毒素測試系統和熱循環儀對於執行可靠和可重複的測試至關重要。對高通量篩選不斷成長的需求以及對自動化高效測試解決方案的需求導致了先進熱原測試設備的開發。這些設備不僅提高了測試結果的準確性和可靠性，而且還簡化了測試過程，減少了所涉及的時間和精力。由於製藥公司和研究實驗室努力滿足嚴格的官方標準並確保其產品的安全性，預計將進一步成長。

到 2032 年，醫療器材領域將穩定成長，因為醫療器材製造商需要對其產品進行熱原測試，以確保其不含熱原污染物。隨著醫療器材複雜性和多樣性的增加，嚴格的安全測試的需求變得更加突出。熱原測試對於許多設備（包括導管、植入物和手術器械）非常重要，可防止患者發生熱原反應。

在嚴格的監管框架和強大的醫療基礎設施的推動下，到 2032 年，歐洲熱原測試產業將以前所未有的速度成長。包括德國、法國和英國在內的歐洲國家已經制定了藥品和醫療器材生產中熱原測試的綜合指南。該地區主要製藥和生物製藥公司的存在將有助於市場的成長。此外，歐盟嚴格的藥物和器械安全法規鼓勵採用先進的熱原測試。

目錄

第 1 章：方法與範圍

第 2 章：執行摘要

第 3 章：產業洞察

• 產業生態系統分析
• 產業影響力
  • 成長動力
    • 治療藥物的需求不斷增加
    • 慢性病盛行率上升
    • 研發投入不斷增加
    • 食品安全意識不斷提高
  • 產業陷阱與挑戰
    • 嚴格的政府法規
• 成長潛力分析
• 監管環境
• 技術景觀
• 波特的分析
• PESTEL分析

第 4 章：競爭格局

• 介紹
• 公司市佔率分析
• 競爭定位矩陣
• 戰略展望矩陣

第 5 章：市場估計與預測：按產品和服務分類，2021 - 2032 年

• 主要趨勢
• 耗材
• 儀器
• 服務

第 6 章：市場估計與預測：按測試類型，2021 - 2032 年

• 主要趨勢
• 鱟試劑測試
  • 顯色試驗
  • 比濁測試
  • 凝膠凝塊試驗
• 體外熱原測試
  • 單核細胞活化試驗（MAT）
  • 重組 C 因子測定 (rFC)
• 兔子測試

第 7 章：市場估計與預測：按最終用途，2021 - 2032 年

• 主要趨勢
• 製藥和生物技術公司
• 醫療器材企業
• 其他最終用戶

第 8 章：市場估計與預測：按地區，2021 - 2032

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 歐洲其他地區
• 亞太地區
  • 日本
  • 中國
  • 印度
  • 澳洲
  • 韓國
  • 亞太地區其他地區
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地區
• 中東和非洲
  • 沙烏地阿拉伯
  • 南非
  • 阿拉伯聯合大公國
  • 中東和非洲其他地區

第 9 章：公司簡介

• 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.