热原检测市场规模、份额和成长分析（按产品/服务、检测类型、最终用户和地区划分）－2026-2033年产业预测

预计到 2024 年，热原检测市场规模将达到 17 亿美元，到 2025 年将达到 19.3 亿美元，到 2033 年将达到 52.7 亿美元，在预测期（2026-2033 年）内，复合年增长率为 13.4%。

热原检测市场对于医疗设备和製药设备的消毒至关重要，确保设备不含热原，从而保障病患安全。市场成长的驱动因素包括：安全通讯协定的提高、监管要求的日益严格以及药品和生物製药产量的不断增长。此外，对品管的重视、对国际标准的遵守以及检测技术的进步也推动了该行业的发展。然而，法规环境的变化以及对检测方法认识的不足等挑战可能会阻碍其广泛应用。儘管如此，由于检测流程的数位化和自动化程度不断提高，以及生物製药和生物製药行业的扩张，预计该市场仍将实现显着增长。

热原检测市场驱动因素

随着基因疗法、单株抗体和细胞疗法等创新药物类别和先进治疗方法的不断涌现，高效可靠的热原检测方法对于确保这些复杂产品的有效性和安全性至关重要。随着生技和製药业研发投入的不断增加，医疗设备的产量也随之成长，对热原检测的需求也日益迫切。这种对产品安全性和有效性的日益重视，进一步推动了对稳健的热原检测方法的需求，以支持不断发展的治疗方法和医疗创新领域。

限制热原检测市场的因素

由于有效实施热原测试需要专业的知识和技能，因此热原测试市场面临许多挑战。测试过程的复杂性，包括样品製备和结果分析，都要求高水准的专业技术，而这在某些机构可能难以实现。此外，热原测试的多步骤性使其成为一个耗时的过程，不可避免地会影响产品开发週期和监管核准流程。这些限制会阻碍新产品上市的效率和速度，对那些力求满足严格的安全性和有效性标准的企业而言，构成重大障碍。

热原检测市场趋势

热原检测市场正呈现出高通量筛检和自动化融合的显着趋势，这大大提高了检测过程的准确性和效率。能够处理大量样本的自动化系统简化了操作流程，最大限度地减少了人为误差，并降低了营运成本。此外，高通量筛检技术的进步使实验室能够快速、全面地同时分析多个样本，满足了製药和生物製药行业对快速週转时间日益增长的需求。这种发展不仅优化了生产效率，还提高了热原检测的可靠性，使自动化成为推动市场成长的关键因素。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 二手资料和一手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析和影响

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 技术进步
• 监管环境
• 专利分析
• 价值链分析
• 案例研究分析
• PESTEL 分析
• 总体经济指标
• 贸易分析
• Start-Ups分析
• 市场吸引力指数
• 定价分析

全球热原检测市场规模（依产品/服务划分）及复合年增长率（2026-2033 年）

• 检测方法、试剂盒和试剂
• 装置
• 服务

全球热原检测市场规模（按检测类型和复合年增长率划分）（2026-2033 年）

• LAL试验
  • 颜色反应测试
  • 浊度检测法
  • 凝胶凝固试验
• 体外试验
• 兔子试验

全球热原检测市场规模（依最终用户划分）及复合年增长率（2026-2033 年）

• 製药和生物技术公司
• 医疗设备製造商
• 其他最终用户

全球热原检测市场规模及复合年增长率（2026-2033）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 英国
  • 德国
  • 西班牙
  • 法国
  • 义大利
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2025 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2025 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2021-2023年营收年比比较

主要企业简介

• Merck KGaA
• GenScript
• Hyglos GmbH
• Ellab A/S
• Lonza
• Thermo Fisher Scientific, Inc.
• Charles River Laboratories, Inc.
• Associates of Cape Cod, Inc.
• Pyrostar
• Abbott Laboratories
• AstraZeneca
• Heraeus Medical
• Wako Pure Chemical Industries
• Roche Diagnostics
• Biosafe Technologies
• BIOMERIEUX SA
• GENSCRIPT BIOTECH CORPORATION
• EUROFINS SCIENTIFIC
• WUXI APPTEC
• STERIS PLC

结论与建议

Pyrogen Testing Market size was valued at USD 1.7 Billion in 2024 and is poised to grow from USD 1.93 Billion in 2025 to USD 5.27 Billion by 2033, growing at a CAGR of 13.4% during the forecast period (2026-2033).

The pyrogen testing market is essential for the decontamination of medical and pharmaceutical devices, ensuring they are free from fever-inducing elements, thereby prioritizing patient safety. Market growth is fueled by heightened awareness of safety protocols, stringent regulatory requirements, and an uptick in the production of pharmaceuticals and biologics. Additionally, a strong emphasis on quality control and adherence to international standards bolsters the sector, accompanied by advancements in testing technologies. However, challenges such as a shifting regulatory environment and limited awareness about testing practices may hinder adoption. Nevertheless, the landscape is set for substantial growth, driven by increasing digitalization and automation in testing processes, as well as the expansion of the biologics and biopharmaceutical sectors.

Top-down and bottom-up approaches were used to estimate and validate the size of the Pyrogen Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Pyrogen Testing Market Segments Analysis

Global Pyrogen Testing Market is segmented by Product & Service, Test Type, end user and region. Based on Product & Service, the market is segmented into Assays, Kits, & Reagents, Instruments, Services. Based on Test Type, the market is segmented into LAL Tests, Chromogenic Tests, Turbidimetric Tests, Gel Clot Tests,In Vitro Tests, Rabbit Tests. Based on end user, the market is segmented into Pharmaceutical & Biotechnology Companies, Medical Device Companies, Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the Pyrogen Testing Market

The expansion of innovative drug classes and advanced therapies, such as gene therapies, monoclonal antibodies, and cell therapies, necessitates a highly efficient and reliable pyrogen testing process to guarantee the efficacy and safety of these complex products. As biotechnology and pharmaceutical industries engage in heightened research and development efforts, there is a corresponding increase in the need for pyrogen testing due to the growing volume of medical devices being produced. This rising focus on ensuring product safety and effectiveness further drives the demand for robust pyrogen testing methodologies to support the evolving landscape of therapeutics and medical innovations.

Restraints in the Pyrogen Testing Market

The pyrogen testing market faces significant challenges due to the necessity for specialized expertise and knowledge required for effective execution. The intricate nature of testing processes, including sample preparation and result analysis, demands a high level of professionalism that may be difficult for some facilities to procure. Additionally, the multi-stage nature of pyrogen testing renders it a time-intensive procedure, inevitably impacting product development timelines and regulatory approval processes. Such constraints can hinder the efficiency and speed at which new products are brought to market, presenting a notable obstacle for organizations aiming to meet stringent safety and efficacy standards.

Market Trends of the Pyrogen Testing Market

The pyrogen testing market is witnessing a notable trend toward the integration of high-throughput screening and automation, significantly enhancing both accuracy and efficiency in testing processes. Automated systems capable of processing large volumes of samples streamline operations, minimizing human errors and reducing operational costs. Additionally, advancements in high-throughput screening techniques allow laboratories to conduct rapid and comprehensive analyses of multiple samples simultaneously, catering to the increasing demand for quicker turnaround times in pharmaceutical and biopharmaceutical sectors. This evolution not only optimizes productivity but also reinforces the reliability of pyrogen testing, positioning automation as a critical driver in the market's growth trajectory.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Driver & Opportunities
  • Restraints & Challenges
• Porters Analysis & Impact
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Technological Advancement
• Regulatory Landscape
• Patent Analysis
• Value Chain Analysis
• Case Study Analysis
• PESTEL Analysis
• Macro-Economic Indicators
• Trade Analysis
• Startup Analysis
• Market Attractiveness Index
• Pricing Analysis

Global Pyrogen Testing Market Size by Product & Service & CAGR (2026-2033)

• Assays, Kits, & Reagents
• Instruments
• Services

Global Pyrogen Testing Market Size by Test Type & CAGR (2026-2033)

• LAL Tests
  • Chromogenic Tests
  • Turbidimetric Tests
  • Gel Clot Tests
• In Vitro Tests
• Rabbit Tests

Global Pyrogen Testing Market Size by End User & CAGR (2026-2033)

• Pharmaceutical & Biotechnology Companies
• Medical Device Companies
• Other End Users

Global Pyrogen Testing Market Size & CAGR (2026-2033)

• North America, (Product & Service, Test Type, End User)
  • US
  • Canada
• Europe, (Product & Service, Test Type, End User)
  • UK
  • Germany
  • Spain
  • France
  • Italy
  • Rest of Europe
• Asia-Pacific, (Product & Service, Test Type, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America, (Product & Service, Test Type, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa, (Product & Service, Test Type, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

• Merck KGaA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GenScript
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hyglos GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ellab A/S
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Associates of Cape Cod, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pyrostar
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AstraZeneca
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Heraeus Medical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Wako Pure Chemical Industries
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biosafe Technologies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BIOMERIEUX SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GENSCRIPT BIOTECH CORPORATION
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• EUROFINS SCIENTIFIC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WUXI APPTEC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• STERIS PLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendation