体外诊断（IVD）品管市场规模、份额和成长分析（按产品/服务、技术、製造商类型、最终用户和地区划分）－2026-2033年产业预测

全球体外诊断（IVD）品管市场规模预计在 2024 年达到 11.6 亿美元，从 2025 年的 12.1 亿美元成长到 2033 年的 16.7 亿美元，在预测期（2026-2033 年）内复合年增长率为 4.1%。

推动全球体外诊断（IVD）品管市场成长要素包括临床检查室数量的增加、人口老化以及对外部品质评估项目需求的不断增长。已开发地区照护现场（POC​​）设备的日益普及以及第三方品管倡议的激增，进一步推动了市场扩张。此外，包括爱滋病和各种癌症在内的感染疾病的增加，也需要创新的诊断解决方案和强有力的品管措施，以进行有效的治疗监测。然而，品管对实验室带来的额外负担、IVD检测报销政策不合理以及许多开发中国家缺乏严格的临床检查室认证法规等挑战，可能会阻碍市场发展。总体而言，这些趋势为体外诊断（IVD）品管带来了复杂但充满希望的前景。

全球体外诊断（IVD）品管市场驱动因素

各种疾病的日益普及导致检查室检测数量激增，显着提升了全球体外诊断（IVD）市场对品管的需求。为满足这一不断增长的需求，公立和私立实验室都在扩建，尤其在多种健康问题方面，诊断检测数量的激增尤为显着。此外，政府机构也在新建实验室以提升检测能力，进一步推动了市场成长。对维持高标准和高准确性的日益重视凸显了有效品管解决方案的重要性，从而推动了行业内的创新和投资。

限制全球体外诊断（IVD）品管市场的因素

全球体外诊断（IVD）品管市场面临的主要挑战之一是，医院建立有效的品管流程需要大量的投资和专业知识。对于采用低通量品管流程的临床检查室，实施这些流程的经济负担可能相当沉重。此外，许多医疗机构的预算限制进一步阻碍了这些关键品管流程的广泛应用。这些因素共同导致医院和检查室不愿意实施严格的品管措施，阻碍了整个市场的成长和效率。

全球体外诊断（IVD）品管市场趋势

全球体外诊断（IVD）品管市场呈现强劲成长势头，主要受疾病盛行率上升和对诊断设备技术进步日益重视的推动。医疗设备製造商正加速创新，以提高检测的准确性和效率。此外，医院和检查室对能够提供快速且准确结果的就地检验解决方案表现出显着的偏好，进一步推动了市场需求。这种对快速诊断能力的追求不仅改善了患者照护，也推动了整个体外诊断（IVD）品管行业的成长，使其成为现代医疗保健基础设施的关键组成部分。

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
• 波特分析

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
• 市场吸引力指数（2025）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析

全球体外诊断（IVD）品管市场规模（依产品/服务划分）及复合年增长率（2026-2033）

• 品管产品
  • 血清/血浆对照品
  • 全血对照
  • 尿液对照
  • 其他控制
• 资料管理解决方案
  • 实验室资讯管理系统（LIMS）
  • 独立软体
• 品质保证服务

全球体外诊断（IVD）品管市场规模（依技术及复合年增长率划分）（2026-2033 年）

• 免疫化学
• 临床化学
  • 电解质和矿物质
  • 肾功能
  • 肝功能
  • 蛋白质和酵素
  • 心臟标记物
  • 其他的
• 分子诊断
  • 核酸增幅检查
  • DNA定序
  • 基因检测
  • 其他的
• 微生物学
• 血液学
• 凝血/止血
• 其他技术

全球体外诊断（IVD）品管市场规模（按製造商类型和复合年增长率划分）（2026-2033 年）

• 第三方控制
  • 独立控制
  • 设备特定控制
• OEM（原始设备製造商）控制

全球体外诊断（IVD）品管市场规模（按最终用户划分）及复合年增长率（2026-2033 年）

• 医院
• 临床检查室
• 学术研究机构
• 其他最终用户

全球体外诊断（IVD）品管市场规模（按地区划分）及复合年增长率（2026-2033）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 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
  • 2023-2025年营收年比比较

主要企业简介

• Thermo Fisher Scientific（United States）
• Danaher Corporation（United States）
• Sysmex Corporation（Japan）
• Tecan Group Ltd.（Switzerland）
• Eurofins Scientific（France）
• Intertek Group plc（United Kingdom）
• Bio-Rad Laboratories（United States）
• Roche Diagnostics（Switzerland）
• Siemens Healthineers（Germany）
• Abbott Laboratories（United States）
• Becton, Dickinson and Company（United States）
• Agilent Technologies（United States）
• PerkinElmer（United States）
• bioMerieux（France）
• DiaSorin（Italy）
• Ortho Clinical Diagnostics（United States）
• Quidel Corporation（United States）
• Hologic, Inc.（United States）
• Qiagen NV（Netherlands）

结论与建议

Global IVD Quality Control Market size was valued at USD 1.16 Billion in 2024 and is poised to grow from USD 1.21 Billion in 2025 to USD 1.67 Billion by 2033, growing at a CAGR of 4.1% during the forecast period (2026-2033).

The global IVD quality control market is driven by the growing number of clinical laboratories, an aging population, and heightened demand for external quality assessment programs. The increasing adoption of point-of-care (POC) instruments in developed regions and a surge in third-party quality control initiatives further fuel market expansion. Additionally, the rise in infectious diseases, including HIV and various cancers, necessitates innovative diagnostic solutions and robust quality control measures for effective treatment monitoring. However, challenges such as the additional burdens on laboratories associated with quality control, unfavorable reimbursement policies for IVD testing, and the absence of stringent regulations for clinical laboratory accreditation in many developing countries may hinder market development. Overall, these dynamics illustrate a complex yet promising landscape for IVD quality control.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global IVD Quality Control 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.

Global IVD Quality Control Market Segments Analysis

Global IVD Quality Control Market is segmented by Product and Service, Technology, Manufacturer Type, End User and region. Based on Product and Service, the market is segmented into Quality control products, Data Management Solutions and Quality Assurance Services. Based on Technology, the market is segmented into Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation/ Hemostasis and Other Technologies. Based on Manufacturer Type, the market is segmented into Third-party controls and Original Equipment Manufacturer controls. Based on End User, the market is segmented into Hospitals, Clinical Laboratories, Academic and Research Institutes and Other End users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global IVD Quality Control Market

The rising prevalence of various diseases has led to an increased number of laboratory tests, significantly boosting the demand for quality control in the Global IVD market. As both public and commercial laboratories expand to meet this growing need, the surge in diagnostic testing is particularly prominent in response to widespread health concerns. Additionally, government agencies have established new laboratories to enhance testing capacities, further propelling market growth. This heightened focus on maintaining high standards and accuracy in laboratory testing underscores the importance of effective quality control solutions, driving innovation and investment within the industry.

Restraints in the Global IVD Quality Control Market

One significant challenge facing the Global IVD Quality Control market is the substantial investment and specialized expertise required to establish effective quality control procedures in hospitals. For clinical laboratories that operate with low volume QC processes, the financial burden associated with implementation can be quite high. Additionally, the presence of budgetary constraints in numerous healthcare facilities further hampers the widespread adoption of these critical QC procedures. This combination of factors contributes to a reluctance among hospitals and laboratories to integrate robust quality control measures, ultimately inhibiting overall market growth and effectiveness.

Market Trends of the Global IVD Quality Control Market

The Global IVD Quality Control market is experiencing a robust trend driven by the escalating prevalence of diseases and a growing emphasis on the technological advancement of diagnostic devices. Medical device companies are increasingly innovating to enhance accuracy and efficiency in testing. Additionally, hospitals and laboratories are showing a marked preference for point-of-care testing solutions that facilitate timely and precise results, further boosting market demand. This shift towards rapid diagnostic capabilities not only enhances patient care but also propels the overall growth of the IVD quality control sector, positioning it as a vital component in modern healthcare infrastructures.

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
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • 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
• Market Attractiveness Index, 2025
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global IVD Quality Control Market Size by Product and Service & CAGR (2026-2033)

• Market Overview
• Quality control products
  • Serum/ Plasma based controls
  • Whole blood based controls
  • Urine based controls
  • Other controls
• Data Management Solutions
  • Laboratory information management systems (LIMS)
  • Standalone software
• Quality Assurance Services

Global IVD Quality Control Market Size by Technology & CAGR (2026-2033)

• Market Overview
• Immunochemistry
• Clinical Chemistry
  • Electrolytes and minerals
  • Renal function
  • Liver function
  • Proteins and enzymes
  • Cardiac markers
  • Others
• Molecular Diagnostics
  • Nucleic acid amplification tests
  • DNA sequencing
  • Genetic testing
  • Others
• Microbiology
• Hematology
• Coagulation/ Hemostasis
• Other Technologies

Global IVD Quality Control Market Size by Manufacturer Type & CAGR (2026-2033)

• Market Overview
• Third-party controls
  • Independent controls
  • Instrument specific controls
• Original Equipment Manufacturer controls

Global IVD Quality Control Market Size by End User & CAGR (2026-2033)

• Market Overview
• Hospitals
• Clinical Laboratories
• Academic and Research Institutes
• Other End users

Global IVD Quality Control Market Size & CAGR (2026-2033)

• North America (Product and Service, Technology, Manufacturer Type, End User)
  • US
  • Canada
• Europe (Product and Service, Technology, Manufacturer Type, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product and Service, Technology, Manufacturer Type, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product and Service, Technology, Manufacturer Type, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product and Service, Technology, Manufacturer 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 (2023-2025)

Key Company Profiles

• Thermo Fisher Scientific (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tecan Group Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Diagnostics (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Becton, Dickinson and Company (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PerkinElmer (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DiaSorin (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ortho Clinical Diagnostics (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quidel Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hologic, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Qiagen N.V. (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations