세계의 IVD 품질 관리 시장 기회, 성장 촉진요인, 산업 동향 분석 예측(2024-2032년)

The Global IVD Quality Control Market was valued at USD 1.3 billion in 2023 and is expected to grow at a CAGR of 4.2% over the coming years. This growth is primarily fueled by the advancements in diagnostic technologies, escalating demand for precise diagnostic testing, rising interest in point-of-care testing, and strict regulatory requirements. Additionally, growing healthcare expenditure and improved access to advanced diagnostic tools in emerging markets are further contributing to the market's expansion. As the healthcare industry continues to evolve, the need for precise diagnostics to guide medical decisions is rising, driving the demand for quality control systems that ensure the accuracy and reliability of diagnostic tests.

The global rise in chronic and infectious diseases is also pushing the need for continuous and accurate diagnostics. IVD quality control involves processes that validate the accuracy, precision, and consistency of tests performed in controlled laboratory settings. These tests, typically conducted on samples such as blood, urine, or tissue, are crucial in ensuring that diagnostic devices provide reliable results. This is essential for accurate diagnosis, treatment, and patient care.

The market is segmented by type, with the quality control segment leading in 2023, accounting for USD 859.6 million. Quality control plays a critical role in monitoring the performance of diagnostic tests and ensuring they meet established standards. This is essential for maintaining patient safety, achieving regulatory compliance, and ensuring the reliability of diagnostic laboratories. By product type, the control segment held the largest market share in 2023 at 50.6%, driven by increasing expenditure on in vitro diagnostic procedures.

Technological advancements in control materials are expected to drive growth in this segment. In terms of application, the immunoassay segment led the market in 2023 and is expected to grow at a CAGR of 4.4% due to its importance in early disease detection. Geographically, North America dominated the market in 2023, with revenue of USD 493.2 million. The region's leadership is attributed to a growing elderly population, rising demand for diagnostic testing, and advanced healthcare infrastructure.As diagnostic needs increase, so does the demand for IVD quality control products.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing demand for accurate diagnostic testing
    • 3.2.1.2 Advancements in diagnostic technologies
    • 3.2.1.3 Rising demand for point-of-care testing
    • 3.2.1.4 Stringent regulatory requirements
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 High cost of IVD quality control services
    • 3.2.2.2 Limited reimbursement policies
• 3.3 Growth potential analysis
• 3.4 Technology landscape
• 3.5 Regulatory landscape
• 3.6 Pricing analysis
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Competitive analysis of major market players
• 4.4 Competitive positioning matrix
• 4.5 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Quality control
  • 5.2.1 Serum/plasma-based controls
  • 5.2.2 Whole blood-based controls
  • 5.2.3 Urine-based controls
  • 5.2.4 Other quality controls
• 5.3 Data management solutions
  • 5.3.1 Laboratory information management systems (LIMS)
  • 5.3.2 Standalone software
• 5.4 Quality assurance services

Chapter 6 Market Estimates and Forecast, By Product, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Control
  • 6.2.1 Total protein
  • 6.2.2 Albumin
  • 6.2.3 Blood urea nitrogen
  • 6.2.4 Uric acid
  • 6.2.5 Creatinine
  • 6.2.6 Sodium
  • 6.2.7 Potassium
  • 6.2.8 Chloride
  • 6.2.9 Calcium
  • 6.2.10 Magnesium
  • 6.2.11 Aspartate transaminase
  • 6.2.12 Creatine kinase
  • 6.2.13 Gamma glutamyl transferase
  • 6.2.14 Total bilirubin
  • 6.2.15 Other controls
• 6.3 Calibrators
• 6.4 Calibration verifiers
• 6.5 Other products

Chapter 7 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Immunoassay
• 7.3 Clinical chemistry
  • 7.3.1 Electrolytes and minerals
  • 7.3.2 Renal function
  • 7.3.3 Liver function
  • 7.3.4 Proteins and enzymes
  • 7.3.5 Cardiac markers
  • 7.3.6 Other clinical chemistry applications
• 7.4 Molecular diagnostics
  • 7.4.1 Nucleic acid amplification tests
  • 7.4.2 DNA sequencing
  • 7.4.3 Genetic testing
  • 7.4.4 Other molecular diagnostic applications
• 7.5 Microbiology
• 7.6 Hematology
• 7.7 Coagulation and hemostasis
• 7.8 Other applications

Chapter 8 Market Estimates and Forecast, By Manufacturer Type, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 Third party controls
  • 8.2.1 Independent controls
  • 8.2.2 Instrument specific controls
• 8.3 Original equipment manufacturer controls

Chapter 9 Market Estimates and Forecast, By End Use , 2021 - 2032 ($ Mn)

• 9.1 Key trends
• 9.2 Hospitals
• 9.3 Clinical laboratories
• 9.4 Academic and research institutes
• 9.5 Other End Use

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
• 10.4 Asia Pacific
  • 10.4.1 China
  • 10.4.2 Japan
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 South Korea
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Argentina
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 UAE

Chapter 11 Company Profiles

• 11.1 Abbott
• 11.2 Agilent Technologies
• 11.3 Becton, Dickinson and Company
• 11.4 Bio-Rad Laboratories
• 11.5 Bio-Techne Corporation
• 11.6 Danaher Corporation
• 11.7 F. Hoffmann-La Roche
• 11.8 Helena Laboratories Corporation
• 11.9 Hologic
• 11.10 Merck
• 11.11 QIAGEN
• 11.12 QuidelOrtho Corporation
• 11.13 Randox Laboratories
• 11.14 Siemens Healthineers
• 11.15 Sysmex Corporation
• 11.16 Technopath Manufacturing
• 11.17 Thermo Fisher Scientific