IVD品管市場規模、佔有率及成長分析（按產品/服務、技術、製造商類型、最終用戶和地區）－2025 年至 2032 年產業預測

2023 年全球 IVD品管市場規模為 11.1 億美元，預計將從 2024 年的 11.6 億美元成長到 2032 年的 15.9 億美元，預測期內（2025-2032 年）的複合年成長率為 4.1%。

由於老年人口不斷成長、對外部品質評估計劃的需求不斷增加以及已開發地區採用照護現場(POC) 設備等因素，全球 IVD（體外診斷）品管市場正在經歷顯著成長。感染疾病、愛滋病毒和癌症的增多需要創新的診斷方法以實現有效治療和嚴格的品質監測。例如，截至 2019 年，約有 2,450 萬人正在接受愛滋病毒抗逆轉錄病毒治療，凸顯了快速診斷系統的需求。然而，挑戰依然存在，包括實驗室負擔增加、IVD測試的報銷情況不利以及許多新興市場缺乏強制性法規認證，這些都可能阻礙市場的發展。

目錄

介紹

• 調查目的
• 研究範圍
• 定義

調查方法

• 資訊採購
• 二次資料和一次資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機會
  • 限制與挑戰
• 波特的分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 市場吸引力指數（2024年）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 定價分析

IVD品管市場規模（依產品/服務）及複合年成長率（2025-2032）

• 市場概覽
• 品管產品
  • 基於血清/血漿的對照
  • 全血對照
  • 尿液檢查
  • 其他控制Other control
• 資料管理解決方案
  • 實驗室資訊管理系統（LIMS）
  • 獨立軟體
• 品質保證服務

IVD品管市場規模：依技術及複合年成長率（2025-2032）

• 市場概覽
• 免疫化學
• 臨床化學
  • 電解質和礦物質
  • 腎功能
  • 肝功能
  • 蛋白質和酵素
  • 心臟標記物
  • 其他
• 分子診斷
  • 核酸增幅檢查
  • DNA序列分析
  • 基因檢測
  • 其他
• 微生物學
• 血液學
• 凝血/止血
• 其他技術

IVD品管市場規模（按製造商類型和複合年成長率） (2025-2032)

• 市場概覽
• 第三方控制
  • 獨立控制
  • 儀器特定控制
• 由原始設備製造商管理

IVD品管市場規模（依最終用戶和複合年成長率）(2025-2032)

• 市場概覽
• 醫院
• 臨床實驗室
• 學術研究所
• 其他最終用戶

IVD品管市場規模：按地區及複合年成長率（2025-2032）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業市場定位（2024年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市場佔有率分析（2024年）
• 主要企業簡介
  • 公司詳情
  • 產品系列分析
  • 公司分部佔有率分析
  • 收益與前一年同期比較對比（2022-2024 年）

主要企業簡介

• 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）

結論和建議

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