IVD品管市场规模、份额及成长分析（按产品/服务、技术、製造商类型、最终用户和地区）－2025 年至 2032 年产业预测

2023 年全球 IVD品管市场规模为 11.1 亿美元，预计将从 2024 年的 11.6 亿美元成长到 2032 年的 15.9 亿美元，预测期内（2025-2032 年）的复合年增长率为 4.1%。

由于老年人口不断增长、对外部品质评估计划的需求不断增加以及已开发地区采用照护现场(POC) 设备等因素，全球 IVD（体外诊断）品管市场正在经历显着增长。感染疾病、爱滋病毒和癌症的增多需要创新的诊断方法以实现有效治疗和严格的品质监测。例如，截至 2019 年，约有 2,450 万人正在接受爱滋病毒抗逆转录病毒治疗，凸显了快速诊断系统的需求。然而，挑战依然存在，包括实验室负担增加、IVD测试的报销情况不利以及许多新兴市场缺乏强制性法规认证，这些都可能阻碍市场的发展。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 二次资料和一次资料方法
• 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
• 细分机会分析

市场动态与展望

• 市场概览
• 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

关键市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024年）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 定价分析

IVD品管市场规模（依产品/服务）及复合年增长率（2025-2032）

• 市场概览
• 品管产品
  • 基于血清/血浆的对照
  • 全血对照
  • 尿液检查
  • 其他控制Other control
• 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

IVD品管市场规模：依技术及复合年增长率（2025-2032）

• 市场概览
• 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序列分析
  • 基因检测
  • 其他的
• 微生物学
• 血液学
• 凝血/止血
• 其他技术

IVD品管市场规模（按製造商类型和复合年增长率） (2025-2032)

• 市场概览
• 第三方控制
  • 独立控制
  • 仪器特定控制
• 由原始设备製造商管理

IVD品管市场规模（依最终用户和复合年增长率）(2025-2032)

• 市场概览
• 医院
• 临床实验室
• 学术研究所
• 其他最终用户

IVD品管市场规模：按地区及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 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
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司详情
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

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）

结论和建议

Global IVD Quality Control Market size was valued at USD 1.11 billion in 2023 and is poised to grow from USD 1.16 billion in 2024 to USD 1.59 billion by 2032, growing at a CAGR of 4.1% during the forecast period (2025-2032).

The global in vitro diagnostics (IVD) quality control market is experiencing significant growth, driven by factors such as the rising elderly population, an uptick in demand for external quality assessment programs, and the adoption of point-of-care (POC) instruments in developed regions. The increase in infectious diseases, HIV, and cancers necessitates innovative diagnostics for effective treatment and stringent quality monitoring. For instance, as of 2019, approximately 24.5 million individuals were receiving antiretroviral therapy for HIV, highlighting the need for rapid diagnostic systems. Nevertheless, challenges remain, including added burdens on laboratories, unfavorable reimbursement scenarios for IVD tests, and a lack of mandatory accreditation regulations in many emerging markets, which may hinder market progression.

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 rise in the prevalence of various diseases has led to an increase in laboratory testing, driving growth in the global IVD quality control market. With the surge in demand for diagnostic testing due to the COVID-19 pandemic that began in December 2019, both public and private laboratories have expanded significantly. Governments around the world have responded by establishing additional laboratories to enhance testing capacity and meet the growing need for accurate diagnostics. This increase in laboratory infrastructure and testing capabilities has been a key factor propelling the market forward, as the demand for reliable quality control in diagnostics continues to escalate.

Restraints in the Global Ivd Quality Control Market

The global IVD quality control market faces significant restraints due to the high costs associated with establishing quality control (QC) procedures in hospitals and clinical laboratories. Implementing effective QC requires both substantial investment and specialized expertise, which can be a barrier, especially for clinical laboratories that operate with low volume QC processes. Additionally, many hospitals and laboratories are constrained by tight budgets, which further hampers the implementation and adoption of these crucial QC procedures. Consequently, these financial and resource challenges can lead to slower growth and limited utilization of quality control systems in the IVD market.

Market Trends of the Global Ivd Quality Control Market

The Global IVD Quality Control market is experiencing significant growth, driven by the rising prevalence of chronic diseases and an increased focus on precision medicine. Medical device companies are investing in the development of innovative, technologically advanced diagnostic devices to enhance testing accuracy and efficiency. Concurrently, hospitals and laboratories are increasingly adopting point-of-care testing solutions, facilitating immediate access to real-time data for better clinical decision-making. This shift towards rapid diagnostics, combined with stringent regulatory standards for quality control, is propelling market expansion. As healthcare's demand for reliability and speed continues to rise, the IVD quality control sector is poised for robust growth.

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, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global IVD Quality Control Market Size by Product and Service & CAGR (2025-2032)

• 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 (2025-2032)

• 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 (2025-2032)

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

Global IVD Quality Control Market Size by End User & CAGR (2025-2032)

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

Global IVD Quality Control Market Size & CAGR (2025-2032)

• 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, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

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