체외진단(IVD) 품질관리 시장 규모, 점유율, 성장 분석 : 제품 및 서비스별, 기술별, 제조업체 유형별, 최종사용자별, 지역별 - 업계 예측(2026-2033년)

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