IVD Quality Control Market, By Type (Quality Control, Data Management Solutions, Quality Assurance Services), Product (Control, Calibrator), Application (Immunochemistry, Molecular Diagnostics), Manufacturer Type, End-use, – Global Forecast (2024 – 2032)

IVD Quality Control Market, By Type (Quality Control, Data Management Solutions, Quality Assurance Services), Product (Control, Calibrator), Application (Immunochemistry, Molecular Diagnostics), Manufacturer Type, End-use, – Global Forecast (2024 – 2032)


The IVD Quality Control Market size will record 5.7% CAGR during 2024-2032, driven by the rising prevalence of chronic diseases and genetic disorders. According to WHO, noncommunicable diseases (NCDs) account for 41 million deaths annually, representing 74% of all global deaths. These conditions often require ongoing monitoring and precise diagnosis, necessitating stringent quality control measures to ensure test accuracy and patient safety. The growing emphasis on early disease detection and preventive healthcare is spurring the development of advanced quality control solutions that can support a wide range of diagnostic tests

Innovations in diagnostic technologies, including next-generation sequencing, high-throughput screening, and automated testing systems, are enhancing the accuracy and efficiency of diagnostic procedures. These advancements enable more precise detection of diseases and conditions, leading to better patient outcomes. The integration of cutting-edge technologies into quality control processes and the rising adoption of automated systems in laboratories are further fueling market expansion

The IVD (in-vitro diagnostics) quality control industry is classified based on type, product, application, manufacturer type, end-use, and region.

The data management solutions segment will grow rapidly through 2032, as these solutions encompass various technologies and platforms designed to manage, analyze, and secure large volumes of diagnostic data. By offering real-time monitoring and comprehensive data analytics, these solutions facilitate improved decision-making and ensure adherence to quality standards. The implementation of effective data management systems enables healthcare providers and diagnostic labs to handle complex data sets with greater accuracy, thereby enhancing the overall quality of diagnostic outcomes.

The molecular diagnostics segment will witness decent growth through 2032, driven by the growing prevalence of genetic disorders, infectious diseases, and cancer. These tests require rigorous quality control measures to ensure their accuracy and reliability. As the field of molecular diagnostics continues to evolve with new technological innovations, the emphasis on maintaining high-quality standards in testing processes will drive the market growth.

Asia Pacific IVD quality control industry will register significant gains over 2024-2032, driven by rapid advancements in healthcare infrastructure, increasing investments in medical research, and a rising focus on improving diagnostic accuracy. Countries such as China, India, and Japan are leading the way in adopting advanced diagnostic technologies and quality control measures. The growing prevalence of chronic diseases and the expanding healthcare sector in these countries are contributing to the rising demand for high-quality diagnostic solutions.


Chapter 1 Methodology & Scope
1.1 Market scope & definitions
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 Technological landscape
3.5 Regulatory landscape
3.6 Porter’s analysis
3.7 PESTEL analysis
Chapter 4 Competitive Landscape, 2023
4.1 Introduction
4.2 Company market share analysis
4.3 Competitive positioning matrix
4.4 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
5.4 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 Other products
Chapter 7 Market Estimates and Forecast, By Application, 2021 – 2032 ($ Mn)
7.1 Key trends
7.2 Immunochemistry
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 Instruments 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-users
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
10.3.7 Rest of Europe
10.4 Asia Pacific
10.4.1 Japan
10.4.2 China
10.4.3 India
10.4.4 Australia
10.4.5 South Korea
10.4.6 Rest of Asia Pacific
10.5 Latin America
10.5.1 Brazil
10.5.2 Mexico
10.5.3 Argentina
10.5.4 Rest of Latin America
10.6 Middle East and Africa
10.6.1 Saudi Arabia
10.6.2 South Africa
10.6.3 UAE
10.6.4 Rest of Middle East and Africa
Chapter 11 Company Profiles
11.1 Abbott Laboratories
11.2 Bio-Rad Laboratories, Inc.
11.3 Becton, Dickinson and Company
11.4 BIO-TECHNE CORPORATION
11.5 CINVEN LIMITED
11.6 Danaher Corporation
11.7 F. Hoffmann-La Roche Ltd.
11.8 Hologic, Inc.
11.9 Helena Laboratories Corporation
11.10 Merck KGaA
11.11 QIAGEN N.V.
11.12 QuidelOrtho Corporation
11.13 Randox Laboratories Ltd
11.14 Sysmex Corporation
11.15 Siemens Healthineers AG
11.16 Thermo Fisher Scientific, Inc.

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