IVD Quality Control Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2024 - 2032
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.
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.
Report Content
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
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
