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IVD Quality Control Market

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from $4,850 218 Pages Global Market Insights November, 2024 GMI19407263
Best Price Guarantee
Price from $4,850
Length 218 Pages
Publisher Global Market Insights
Published Date November, 2024
SKU GMI19407263

IVD Quality Control Market


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.


Chapter 1 Methodology
1.1 Market segmentation
1.2 Market definitions
1.3 Research design
1.4 Market size estimates and calculations
1.4.1 Approach 1: Company share analysis
1.4.2 Approach 2: Investor presentation approach
1.4.3 Approach 3: Secondary-based approach
1.5 Key trends for market estimates
1.6 Forecast model
1.7 Primary research & validation
1.7.1 Primary sources
1.7.2 Data mining sources
1.7.2.1 Paid sources
1.7.2.2 Public sources
Chapter 2 Executive Summary
2.1 Global market 360° synopsis, 2021 - 2032
2.2 Type trends
2.3 Product trends
2.4 Application trends
2.5 Manufacturer type trends
2.6 End-use trends
2.7 Regional trends
Chapter 3 IVD Quality Control 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 (POC)testing
3.2.1.4 Stringent regulatory requirement
3.2.2 Industry pitfalls & challenges
3.2.2.1 Limited reimbursement policies
3.3 Growth potential analysis
3.3.1 By type
3.3.2 By product
3.3.3 By application
3.3.4 By manufacturer type
3.3.5 By end-use
3.4 Technology landscape
3.5 Regulatory landscape
3.6 Market size assessment of calibration verifiers for modern cardiac markers analysed by immunoassay methods, 2021 - 2032 (USD Million)
3.7 Pricing analysis
3.8 Porter's analysis
3.9 PESTEL analysis
Chapter 4 Competitive Landscape, 2023
4.1 Introduction
4.1.1. Bio-Rad Laboratories, Inc.
4.1.2. Randox Laboratories Ltd.
4.1.3. Bio-Techne Corporation
4.2 Company market share analysis
4.3 Product revenue analysis for major players
4.4 Competitive positioning matrix
4.5 Strategy outlook matrix
Chapter 5 IVD Quality Control Market, By Type
5.1 Quality control
5.1.1 Serum/plasma-based controls
5.1.2 Whole blood-based controls
5.1.3 Urine-based controls
5.1.4 Other quality controls
5.2 Data management solutions
5.2.1 Laboratory information management systems (LIMS)
5.2.1.1 Without peer reporting system
5.2.1.2 With integrated peer reporting system
5.2.2 Standalone software
5.2.2.1 Standalone peer reporting system
5.2.2.2 Data analysis and visualization
5.2.2.3 Regulatory compliance
5.2.2.4 Automated data integration
5.2.2.5 Other standalone software add-ons
5.3 Quality assurance services
5.3.1 Quality control monitoring
5.3.2 Standalone operating procedures (SOPs)
5.3.3 Regulatory compliance support
5.3.4 Training and competency assessment
5.3.5 Internal audits and inspections
5.3.6 Documentation and record keeping
5.3.7 Other quality assurance services
Chapter 6 IVD Quality Control Market, By Product
6.1 Controls
6.1.1 Total protein
6.1.2 Albumin
6.1.3 Blood urea nitrogen
6.1.4 Uric acid
6.1.5 Creatinine
6.1.6 Sodium
6.1.7 Potassium
6.1.8 Chloride
6.1.9 Calcium
6.1.10 Magnesium
6.1.11 Aspartate transaminase
6.1.12 Creatine kinase
6.1.13 Gamma glutamyl transferase
6.1.14 Total bilirubin
6.1.15 Other controls
6.2 Calibrators
6.3 Calibration verifiers
6.4 Other products
Chapter 7 IVD Quality Control Market, By Application
7.1 Immunoassay
7.1.1 By manufacturer type
7.1.1.1 Third party controls
7.1.1.1.1 Independent controls
7.1.1.1.2 Instrument-specific controls
7.1.1.2 Original equipment manufacturer controls
7.1.2 By instrument type
7.1.2.1 Point of care instruments
7.1.2.1.1 Third party controls
7.1.2.1.1.1 Independent controls
7.1.2.1.1.2 Instrument-specific controls
7.1.2.1.2 Original equipment manufacturer controls
7.1.2.2 Non-point-of-care instruments
7.1.2.2.1 Third party controls
7.1.2.2.1.1 Independent controls
7.1.2.2.1.2 Instrument specific controls
7.1.2.2.2 Original equipment manufacturer controls
7.2 Clinical chemistry
7.2.1 Electrolytes and minerals
7.2.2 Renal function
7.2.3 Liver function
7.2.4 Proteins and enzymes
7.2.5 Cardiac markers
7.2.5.1 By manufacturer type
7.2.5.1.1 Third party controls
7.2.5.1.1.1 Independent controls
7.2.5.1.1.2 Instrument specific controls
7.2.5.1.2 Original equipment manufacturer (OEM) controls
7.2.5.2 By instrument type
7.2.5.2.1 Point of care instruments
7.2.5.2.1.1 Third party controls
7.2.5.2.1.1.1 Independent controls
7.2.5.2.1.1.2 Instrument-specific controls
7.2.5.2.1.2 Original equipment manufacturer controls
7.2.5.2.2 Non-point of care instruments
7.2.5.2.2.1 Third party controls
7.2.5.2.2.1.1 Independent controls
7.2.5.2.2.1.2 Instrument-specific controls
7.2.5.2.2.2 Original equipment manufacturer controls
7.2.6 Other clinical chemistry
7.3 Molecular diagnostics
7.3.1 Nucleic acid amplification tests
7.3.2 DNA sequencing
7.3.3 Genetic testing
7.3.4 Other molecular diagnostics
7.4 Microbiology
7.5 Hematology
7.6 Coagulation and hemostasis
7.7 Other applications
Chapter 8 IVD Quality Control Market, By Manufacturer Type
8.1 Third party controls
8.1.1 Independent controls
8.1.2 Instrument specific controls
8.2 Original equipment manufacturer controls
Chapter 9 IVD Quality Control Market, By End-use
9.1 Hospitals
9.2 Clinical laboratories
9.3 Academic and research institutes
9.4 Other end-users
Chapter 10 IVD Quality Control Market, By Region
10.1 North America
10.2 Europe
10.3 Asia Pacific
10.4 Latin America
10.5 Middle East and Africa
Chapter 11 Company Profiles
11.1 Abbott Laboratories
11.1.1 Global overview
11.1.2 Business overview
11.1.3 Financial data
11.1.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.1.4 Product landscape
11.1.5 SWOT analysis
11.2 Bio-Rad Laboratories, Inc.
11.2.1 Global overview
11.2.2 Business overview
11.2.3 Financial data
11.2.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.2.4 Product landscape
11.2.5 Strategic outlook
11.2.6 SWOT analysis
11.3 Becton, Dickinson and Company
11.3.1 Global overview
11.3.2 Business overview
11.3.3 Financial data
11.3.3.1 Annual sales revenue, 2020 - 2023 (USD Million)
11.3.4 Product landscape
11.3.5 SWOT analysis
11.4 Bio-Techne Corporation
11.4.1 Global overview
11.4.2 Business overview
11.4.3 Financial data
11.4.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.4.4 Product landscape
11.4.5 Strategic outlook
11.4.6 SWOT analysis
11.5 Agilent Technologies, Inc.
11.5.1 Global overview
11.5.2 Business overview
11.5.3 Financial data
11.5.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.5.4 Product landscape
11.5.5 SWOT analysis
11.6 Danaher Corporation
11.6.1 Global overview
11.6.2 Business overview
11.6.3 Financial data
11.6.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.6.4 Product landscape
11.6.5 Strategic outlook
11.6.6 SWOT analysis
11.7 F. Hoffmann-La Roche Ltd.
11.7.1 Global overview
11.7.2 Business overview
11.7.3 Financial data
11.7.3.1 Annual sales revenue, 2023 - 2020 (USD Million)
11.7.4 Product landscape
11.7.5 Strategic outlook
11.7.6 SWOT analysis
11.8 Hologic, Inc.
11.8.1 Global overview
11.8.2 Business overview
11.8.3 Financial data
11.8.3.1 Annual sales revenue, 2020-2023 (USD Million)
11.8.4 Product landscape
11.8.5 Strategic outlook
11.8.6 SWOT analysis
11.9 Helena Laboratories Corporation
11.9.1 Global overview
11.9.2 Business overview
11.9.3 Financial data
11.9.4 Product landscape
11.9.5 SWOT analysis
11.10 Merck KGaA
11.10.1 Global overview
11.10.2 Business overview
11.10.3 Financial data
11.10.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.10.4 Product landscape
11.10.5 SWOT analysis
11.11 QIAGEN N.V.
11.11.1 Global overview
11.11.2 Business overview
11.11.3 Financial data
11.11.3.1 Annual sales revenue, 2023 - 2020 (USD Million)
11.11.4 Product landscape
11.11.5 Strategic outlook
11.11.6 SWOT analysis
11.12 QuidelOrtho Corporation
11.12.1 Global overview
11.12.2 Business overview
11.12.3 Financial data
11.12.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.12.4 Product landscape
11.12.5 Strategic outlook
11.12.6 SWOT analysis
11.13 Randox Laboratories Ltd
11.13.1 Global overview
11.13.2 Business overview
11.13.3 Financial data
11.13.4 Product landscape
11.13.5 Strategic outlook
11.13.6 SWOT analysis
11.14 Sysmex Corporation
11.14.1 Global overview
11.14.2 Business overview
11.14.3 Financial data
11.14.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.14.4 Product landscape
11.14.5 SWOT analysis
11.15 Siemens Healthineers AG
11.15.1 Global overview
11.15.2 Business overview
11.15.3 Financial data
11.15.3.1 Annual sales revenue, 2023-2020 (USD Million)
11.15.4 Product landscape
11.15.5 Strategic outlook
11.15.6 SWOT analysis
11.16 Thermo Fisher Scientific Inc.
11.16.1 Global overview
11.16.2 Business overview
11.16.3 Financial data
11.16.3.1 Annual sales revenue, 2023 - 2020 (USD Million)
11.16.4 Product landscape
11.16.5 Strategic outlook
11.16.6 SWOT analysis
11.17 Technopath Manufacturing Ltd.
11.17.1 Global overview
11.17.2 Business overview
11.17.3 Financial data
11.17.4 Product landscape
11.17.5 Strategic outlook
11.17.6 SWOT analysis

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