體外診斷（IVD）品管市場規模、佔有率和成長分析（按產品/服務、技術、製造商類型、最終用戶和地區分類）－2026-2033年產業預測

全球體外診斷（IVD）品管市場規模預計在 2024 年達到 11.6 億美元，從 2025 年的 12.1 億美元成長到 2033 年的 16.7 億美元，在預測期（2026-2033 年）內複合年成長率為 4.1%。

推動全球體外診斷（IVD）品管市場成長要素包括臨床檢查室數量的增加、人口老化以及對外部品質評估項目需求的不斷成長。已開發地區照護現場（POC​​）設備的日益普及以及第三方品管舉措的激增，進一步推動了市場擴張。此外，包括愛滋病和各種癌症在內的感染疾病的增加，也需要創新的診斷解決方案和強力的品管措施，以進行有效的治療監測。然而，品管對實驗室帶來的額外負擔、IVD檢測報銷政策不合理以及許多開發中國家缺乏嚴格的臨床檢查室認證法規等挑戰，可能會阻礙市場發展。總體而言，這些趨勢為體外診斷（IVD）品管帶來了複雜但充滿希望的前景。

全球體外診斷（IVD）品管市場促進因素

各種疾病的日益普及導致檢查室檢測數量激增，顯著提升了全球體外診斷（IVD）市場對品管的需求。為滿足這一不斷成長的需求，公立和私立實驗室都在擴建，尤其在多種健康問題方面，診斷檢測數量的激增尤為顯著。此外，政府機構也在新建實驗室以提升檢測能力，進一步推動了市場成長。對維持高標準和高準確性的日益重視凸顯了有效品管解決方案的重要性，從而推動了行業內的創新和投資。

限制全球體外診斷（IVD）品管市場的因素

全球體外診斷（IVD）品管市場面臨的主要挑戰之一是，醫院建立有效的品管流程需要大量的投資和專業知識。對於採用低通量品管流程的臨床檢查室，實施這些流程的經濟負擔可能相當沉重。此外，許多醫療機構的預算限制進一步阻礙了這些關鍵品管流程的廣泛應用。這些因素共同導致醫院和檢查室不願意實施嚴格的品管措施，阻礙了整個市場的成長和效率。

全球體外診斷（IVD）品管市場趨勢

全球體外診斷（IVD）品管市場呈現強勁成長勢頭，主要受疾病盛行率上升和對診斷設備技術進步日益重視的推動。醫療設備製造商正加速創新，以提高檢測的準確性和效率。此外，醫院和檢查室對能夠提供快速且準確結果的就地檢驗解決方案表現出顯著的偏好，進一步推動了市場需求。這種對快速診斷能力的追求不僅改善了患者照護，也推動了整個體外診斷（IVD）品管行業的成長，使其成為現代醫療保健基礎設施的關鍵組成部分。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 二手資料和一手資料方法
• 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
• 細分市場機會分析

市場動態與展望

• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場吸引力指數（2025）
• PESTEL 分析
• 總體經濟指標
• 價值鏈分析
• 定價分析

全球體外診斷（IVD）品管市場規模（依產品/服務分類）及複合年成長率（2026-2033）

• 品管產品
  • 血清/血漿對照品
  • 全血對照
  • 尿液對照
  • 其他控制
• 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

全球體外診斷（IVD）品管市場規模（依技術及複合年成長率分類）（2026-2033 年）

• 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定序
  • 基因檢測
  • 其他
• 微生物學
• 血液學
• 凝血/止血
• 其他技術

全球體外診斷（IVD）品管市場規模（按製造商類型和複合年成長率分類）（2026-2033 年）

• 第三方控制
  • 獨立控制
  • 設備特定控制
• OEM（原始設備製造商）控制

全球體外診斷（IVD）品管市場規模（按最終用戶分類）及複合年成長率（2026-2033 年）

• 醫院
• 臨床檢查室
• 學術研究機構
• 其他最終用戶

全球體外診斷（IVD）品管市場規模（按地區分類）及複合年成長率（2026-2033）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 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
• 主要企業的市場定位（2025 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2025 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2023-2025年營收年比比較

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）

結論與建議

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