In Vitro Diagnostics (IVD) Quality Control Market Analysis and Forecast to 2035: Type, Product, Services, Technology, Component, Application, End User, Process, Functionality, Mode

Description

The In Vitro Diagnostics (IVD) Quality Control Market is anticipated to expand from $4.3 billion in 2025 to $7.9 billion by 2035, with a CAGR of approximately 6.4%. In 2025, the In Vitro Diagnostics (IVD) Quality Control Market exhibited a robust volume, with projections indicating significant growth by 2035. The clinical chemistry segment holds a commanding 35% market share, closely followed by immunoassay at 30%, and molecular diagnostics at 25%. The hematology segment accounts for the remaining 10%. This distribution underscores the pivotal role of clinical chemistry in diagnostic applications, driven by advancements in technology and increased demand for accurate diagnostics. Key market players include Bio-Rad Laboratories, Thermo Fisher Scientific, and Randox Laboratories, each leveraging innovation to maintain competitive advantage.\n\nThe competitive landscape is shaped by stringent regulatory frameworks such as the FDA's Quality System Regulation and the EU's In Vitro Diagnostic Regulation, which influence market dynamics and compliance costs. Future projections highlight a 6.4% annual growth rate, propelled by technological advancements and increased healthcare expenditure. Investment in R&D and strategic partnerships are expected to further drive market expansion. Despite challenges like regulatory compliance and intense competition, the market outlook remains positive, with substantial opportunities in emerging regions and personalized medicine.

Segment Overview

The In Vitro Diagnostics (IVD) Quality Control Market is witnessing robust growth, driven by technological advancements and the increasing need for accurate diagnostic results. Immunoassay controls are the top-performing sub-segment, owing to their critical role in ensuring the reliability of immunoassays, which are widely used in disease detection. Molecular diagnostics controls follow closely, benefiting from the rising prevalence of infectious diseases and genetic disorders that demand precise molecular testing.\n\nGeographically, North America leads the market, supported by a well-established healthcare infrastructure and a high adoption rate of advanced diagnostic technologies. Europe is the second-highest performing region, attributed to its strong regulatory framework and increasing healthcare expenditure. Within these regions, the United States and Germany stand out as key contributors, driven by ongoing innovations and a strong emphasis on quality assurance in clinical laboratories. The market's trajectory is further bolstered by strategic collaborations and continuous investments in research and development.

Market Segmentation
Type	Internal Quality Control, External Quality Assessment, Instrument Specific Control, Data Management Solutions, Others
Product	Serum-Based Controls, Whole Blood-Based Controls, Urine-Based Controls, Plasma-Based Controls, Others
Services	Third-Party Quality Control Services, Laboratory Accreditation, Proficiency Testing, Consulting Services, Others
Technology	Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation, Others
Component	Analyzers, Software, Reagents, Consumables, Others
Application	Clinical Laboratories, Hospitals, Academic and Research Institutes, Home Care, Others
Process	Pre-Analytical, Analytical, Post-Analytical, Others
End User	Diagnostic Laboratories, Point-of-Care Testing, Research Laboratories, Pharmaceutical Companies, Others
Functionality	Automated, Semi-Automated, Manual, Others
Mode	Online Quality Control, Offline Quality Control, Others

Geographical Overview

The North American In Vitro Diagnostics (IVD) Quality Control Market is robust. The United States is the key driver. Its technological advancements and healthcare infrastructure are unmatched. This region benefits from high healthcare expenditure. Regulatory frameworks are stringent, ensuring quality and reliability. Canada complements this growth with its own investments in healthcare.\n\nEurope follows closely, characterized by its rigorous regulatory standards. Germany, the United Kingdom, and France are pivotal. They are investing in innovative diagnostic solutions. The region's aging population increases demand. This necessitates reliable diagnostics, boosting market growth.\n\nAsia-Pacific is experiencing rapid expansion. China and India lead due to their large populations. Increasing healthcare awareness fuels demand for quality diagnostics. Government initiatives in healthcare infrastructure are significant. Japan also contributes with its technological expertise.\n\nIn Latin America, Brazil and Mexico are prominent players. They are focusing on healthcare improvements. Economic growth supports investment in diagnostics. The Middle East and Africa region shows potential. South Africa and the UAE are key contributors. Their healthcare sectors are evolving, driving demand for IVD quality control.

Key Trends and Drivers

The In Vitro Diagnostics (IVD) Quality Control Market is experiencing robust growth, propelled by technological advancements in diagnostic testing and increasing demand for accurate and reliable test results. A key trend is the integration of artificial intelligence and machine learning in quality control processes, enhancing precision and efficiency in diagnostics. Moreover, the shift towards personalized medicine is driving the need for stringent quality control measures to ensure test accuracy and patient safety.\n\nRegulatory bodies are increasingly emphasizing stringent quality standards, which is another critical driver for market expansion. This regulatory focus ensures compliance and boosts consumer confidence in diagnostic outcomes. Additionally, the rising prevalence of chronic and infectious diseases necessitates frequent and reliable diagnostic testing, further fueling market demand. Opportunities are abundant in emerging economies where healthcare infrastructure is rapidly developing, offering fertile ground for market penetration.\n\nFurthermore, the trend towards automation in laboratories is streamlining workflows and reducing human error, thereby enhancing the reliability of diagnostic results. Companies investing in innovative quality control solutions and expanding their presence in untapped markets are poised to capitalize on these trends. As healthcare systems worldwide prioritize precision and reliability, the IVD Quality Control Market is set for sustained growth and innovation.

Research Scope

Estimates and forecasts the overall market size across type, application, and region.
Provides detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling.
Identifies factors influencing market growth and challenges, opportunities, drivers, and restraints.
Identifies factors that could limit company participation in international markets to help calibrate market share expectations and growth rates.
Evaluates key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities.
Analyzes smaller market segments strategically, focusing on their potential, growth patterns, and impact on the overall market.
Outlines the competitive landscape, assessing business and corporate strategies to monitor and dissect competitive advancements.

Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.

Product Code: GIS10301

1 Executive Summary

1.1 Market Size and Forecast
1.2 Market Overview
1.3 Market Snapshot
1.4 Regional Snapshot
1.5 Strategic Recommendations
1.6 Analyst Notes

2 Market Highlights

2.1 Key Market Highlights by Type
2.2 Key Market Highlights by Product
2.3 Key Market Highlights by Services
2.4 Key Market Highlights by Technology
2.5 Key Market Highlights by Component
2.6 Key Market Highlights by Application
2.7 Key Market Highlights by End User
2.8 Key Market Highlights by Process
2.9 Key Market Highlights by Functionality
2.10 Key Market Highlights by Mode

3 Market Dynamics

3.1 Macroeconomic Analysis
3.2 Market Trends
3.3 Market Drivers
3.4 Market Opportunities
3.5 Market Restraints
3.6 CAGR Growth Analysis
3.7 Impact Analysis
3.8 Emerging Markets
3.9 Technology Roadmap
3.10 Strategic Frameworks
- 3.10.1 PORTER's 5 Forces Model
- 3.10.2 ANSOFF Matrix
- 3.10.3 4P's Model
- 3.10.4 PESTEL Analysis

4 Segment Analysis

4.1 Market Size & Forecast by Type (2020-2035)
- 4.1.1 Internal Quality Control
- 4.1.2 External Quality Assessment
- 4.1.3 Instrument Specific Control
- 4.1.4 Data Management Solutions
- 4.1.5 Others
4.2 Market Size & Forecast by Product (2020-2035)
- 4.2.1 Serum-Based Controls
- 4.2.2 Whole Blood-Based Controls
- 4.2.3 Urine-Based Controls
- 4.2.4 Plasma-Based Controls
- 4.2.5 Others
4.3 Market Size & Forecast by Services (2020-2035)
- 4.3.1 Third-Party Quality Control Services
- 4.3.2 Laboratory Accreditation
- 4.3.3 Proficiency Testing
- 4.3.4 Consulting Services
- 4.3.5 Others
4.4 Market Size & Forecast by Technology (2020-2035)
- 4.4.1 Immunoassay
- 4.4.2 Clinical Chemistry
- 4.4.3 Molecular Diagnostics
- 4.4.4 Microbiology
- 4.4.5 Hematology
- 4.4.6 Coagulation
- 4.4.7 Others
4.5 Market Size & Forecast by Component (2020-2035)
- 4.5.1 Analyzers
- 4.5.2 Software
- 4.5.3 Reagents
- 4.5.4 Consumables
- 4.5.5 Others
4.6 Market Size & Forecast by Application (2020-2035)
- 4.6.1 Clinical Laboratories
- 4.6.2 Hospitals
- 4.6.3 Academic and Research Institutes
- 4.6.4 Home Care
- 4.6.5 Others
4.7 Market Size & Forecast by End User (2020-2035)
- 4.7.1 Diagnostic Laboratories
- 4.7.2 Point-of-Care Testing
- 4.7.3 Research Laboratories
- 4.7.4 Pharmaceutical Companies
- 4.7.5 Others
4.8 Market Size & Forecast by Process (2020-2035)
- 4.8.1 Pre-Analytical
- 4.8.2 Analytical
- 4.8.3 Post-Analytical
- 4.8.4 Others
4.9 Market Size & Forecast by Functionality (2020-2035)
- 4.9.1 Automated
- 4.9.2 Semi-Automated
- 4.9.3 Manual
- 4.9.4 Others
4.10 Market Size & Forecast by Mode (2020-2035)
- 4.10.1 Online Quality Control
- 4.10.2 Offline Quality Control
- 4.10.3 Others5 Regional Analysis
5.1 Global Market Overview
5.2 North America Market Size (2020-2035)
- 5.2.1 United States
  - 5.2.1.1 Type
  - 5.2.1.2 Product
  - 5.2.1.3 Services
  - 5.2.1.4 Technology
  - 5.2.1.5 Component
  - 5.2.1.6 Application
  - 5.2.1.7 End User
  - 5.2.1.8 Process
  - 5.2.1.9 Functionality
  - 5.2.1.10 Mode
- 5.2.2 Canada
  - 5.2.2.1 Type
  - 5.2.2.2 Product
  - 5.2.2.3 Services
  - 5.2.2.4 Technology
  - 5.2.2.5 Component
  - 5.2.2.6 Application
  - 5.2.2.7 End User
  - 5.2.2.8 Process
  - 5.2.2.9 Functionality
  - 5.2.2.10 Mode
- 5.2.3 Mexico
  - 5.2.3.1 Type
  - 5.2.3.2 Product
  - 5.2.3.3 Services
  - 5.2.3.4 Technology
  - 5.2.3.5 Component
  - 5.2.3.6 Application
  - 5.2.3.7 End User
  - 5.2.3.8 Process
  - 5.2.3.9 Functionality
  - 5.2.3.10 Mode
5.3 Latin America Market Size (2020-2035)
- 5.3.1 Brazil
  - 5.3.1.1 Type
  - 5.3.1.2 Product
  - 5.3.1.3 Services
  - 5.3.1.4 Technology
  - 5.3.1.5 Component
  - 5.3.1.6 Application
  - 5.3.1.7 End User
  - 5.3.1.8 Process
  - 5.3.1.9 Functionality
  - 5.3.1.10 Mode
- 5.3.2 Argentina
  - 5.3.2.1 Type
  - 5.3.2.2 Product
  - 5.3.2.3 Services
  - 5.3.2.4 Technology
  - 5.3.2.5 Component
  - 5.3.2.6 Application
  - 5.3.2.7 End User
  - 5.3.2.8 Process
  - 5.3.2.9 Functionality
  - 5.3.2.10 Mode
- 5.3.3 Rest of Latin America
  - 5.3.3.1 Type
  - 5.3.3.2 Product
  - 5.3.3.3 Services
  - 5.3.3.4 Technology
  - 5.3.3.5 Component
  - 5.3.3.6 Application
  - 5.3.3.7 End User
  - 5.3.3.8 Process
  - 5.3.3.9 Functionality
  - 5.3.3.10 Mode
5.4 Asia-Pacific Market Size (2020-2035)
- 5.4.1 China
  - 5.4.1.1 Type
  - 5.4.1.2 Product
  - 5.4.1.3 Services
  - 5.4.1.4 Technology
  - 5.4.1.5 Component
  - 5.4.1.6 Application
  - 5.4.1.7 End User
  - 5.4.1.8 Process
  - 5.4.1.9 Functionality
  - 5.4.1.10 Mode
- 5.4.2 India
  - 5.4.2.1 Type
  - 5.4.2.2 Product
  - 5.4.2.3 Services
  - 5.4.2.4 Technology
  - 5.4.2.5 Component
  - 5.4.2.6 Application
  - 5.4.2.7 End User
  - 5.4.2.8 Process
  - 5.4.2.9 Functionality
  - 5.4.2.10 Mode
- 5.4.3 South Korea
  - 5.4.3.1 Type
  - 5.4.3.2 Product
  - 5.4.3.3 Services
  - 5.4.3.4 Technology
  - 5.4.3.5 Component
  - 5.4.3.6 Application
  - 5.4.3.7 End User
  - 5.4.3.8 Process
  - 5.4.3.9 Functionality
  - 5.4.3.10 Mode
- 5.4.4 Japan
  - 5.4.4.1 Type
  - 5.4.4.2 Product
  - 5.4.4.3 Services
  - 5.4.4.4 Technology
  - 5.4.4.5 Component
  - 5.4.4.6 Application
  - 5.4.4.7 End User
  - 5.4.4.8 Process
  - 5.4.4.9 Functionality
  - 5.4.4.10 Mode
- 5.4.5 Australia
  - 5.4.5.1 Type
  - 5.4.5.2 Product
  - 5.4.5.3 Services
  - 5.4.5.4 Technology
  - 5.4.5.5 Component
  - 5.4.5.6 Application
  - 5.4.5.7 End User
  - 5.4.5.8 Process
  - 5.4.5.9 Functionality
  - 5.4.5.10 Mode
- 5.4.6 Taiwan
  - 5.4.6.1 Type
  - 5.4.6.2 Product
  - 5.4.6.3 Services
  - 5.4.6.4 Technology
  - 5.4.6.5 Component
  - 5.4.6.6 Application
  - 5.4.6.7 End User
  - 5.4.6.8 Process
  - 5.4.6.9 Functionality
  - 5.4.6.10 Mode
- 5.4.7 Rest of APAC
  - 5.4.7.1 Type
  - 5.4.7.2 Product
  - 5.4.7.3 Services
  - 5.4.7.4 Technology
  - 5.4.7.5 Component
  - 5.4.7.6 Application
  - 5.4.7.7 End User
  - 5.4.7.8 Process
  - 5.4.7.9 Functionality
  - 5.4.7.10 Mode
5.5 Europe Market Size (2020-2035)
- 5.5.1 Germany
  - 5.5.1.1 Type
  - 5.5.1.2 Product
  - 5.5.1.3 Services
  - 5.5.1.4 Technology
  - 5.5.1.5 Component
  - 5.5.1.6 Application
  - 5.5.1.7 End User
  - 5.5.1.8 Process
  - 5.5.1.9 Functionality
  - 5.5.1.10 Mode
- 5.5.2 France
  - 5.5.2.1 Type
  - 5.5.2.2 Product
  - 5.5.2.3 Services
  - 5.5.2.4 Technology
  - 5.5.2.5 Component
  - 5.5.2.6 Application
  - 5.5.2.7 End User
  - 5.5.2.8 Process
  - 5.5.2.9 Functionality
  - 5.5.2.10 Mode
- 5.5.3 United Kingdom
  - 5.5.3.1 Type
  - 5.5.3.2 Product
  - 5.5.3.3 Services
  - 5.5.3.4 Technology
  - 5.5.3.5 Component
  - 5.5.3.6 Application
  - 5.5.3.7 End User
  - 5.5.3.8 Process
  - 5.5.3.9 Functionality
  - 5.5.3.10 Mode
- 5.5.4 Spain
  - 5.5.4.1 Type
  - 5.5.4.2 Product
  - 5.5.4.3 Services
  - 5.5.4.4 Technology
  - 5.5.4.5 Component
  - 5.5.4.6 Application
  - 5.5.4.7 End User
  - 5.5.4.8 Process
  - 5.5.4.9 Functionality
  - 5.5.4.10 Mode
- 5.5.5 Italy
  - 5.5.5.1 Type
  - 5.5.5.2 Product
  - 5.5.5.3 Services
  - 5.5.5.4 Technology
  - 5.5.5.5 Component
  - 5.5.5.6 Application
  - 5.5.5.7 End User
  - 5.5.5.8 Process
  - 5.5.5.9 Functionality
  - 5.5.5.10 Mode
- 5.5.6 Rest of Europe
  - 5.5.6.1 Type
  - 5.5.6.2 Product
  - 5.5.6.3 Services
  - 5.5.6.4 Technology
  - 5.5.6.5 Component
  - 5.5.6.6 Application
  - 5.5.6.7 End User
  - 5.5.6.8 Process
  - 5.5.6.9 Functionality
  - 5.5.6.10 Mode
5.6 Middle East & Africa Market Size (2020-2035)
- 5.6.1 Saudi Arabia
  - 5.6.1.1 Type
  - 5.6.1.2 Product
  - 5.6.1.3 Services
  - 5.6.1.4 Technology
  - 5.6.1.5 Component
  - 5.6.1.6 Application
  - 5.6.1.7 End User
  - 5.6.1.8 Process
  - 5.6.1.9 Functionality
  - 5.6.1.10 Mode
- 5.6.2 United Arab Emirates
  - 5.6.2.1 Type
  - 5.6.2.2 Product
  - 5.6.2.3 Services
  - 5.6.2.4 Technology
  - 5.6.2.5 Component
  - 5.6.2.6 Application
  - 5.6.2.7 End User
  - 5.6.2.8 Process
  - 5.6.2.9 Functionality
  - 5.6.2.10 Mode
- 5.6.3 South Africa
  - 5.6.3.1 Type
  - 5.6.3.2 Product
  - 5.6.3.3 Services
  - 5.6.3.4 Technology
  - 5.6.3.5 Component
  - 5.6.3.6 Application
  - 5.6.3.7 End User
  - 5.6.3.8 Process
  - 5.6.3.9 Functionality
  - 5.6.3.10 Mode
- 5.6.4 Sub-Saharan Africa
  - 5.6.4.1 Type
  - 5.6.4.2 Product
  - 5.6.4.3 Services
  - 5.6.4.4 Technology
  - 5.6.4.5 Component
  - 5.6.4.6 Application
  - 5.6.4.7 End User
  - 5.6.4.8 Process
  - 5.6.4.9 Functionality
  - 5.6.4.10 Mode
- 5.6.5 Rest of MEA
  - 5.6.5.1 Type
  - 5.6.5.2 Product
  - 5.6.5.3 Services
  - 5.6.5.4 Technology
  - 5.6.5.5 Component
  - 5.6.5.6 Application
  - 5.6.5.7 End User
  - 5.6.5.8 Process
  - 5.6.5.9 Functionality
  - 5.6.5.10 Mode6 Market Strategy
6.1 Demand-Supply Gap Analysis
6.2 Trade & Logistics Constraints
6.3 Price-Cost-Margin Trends
6.4 Market Penetration
6.5 Consumer Analysis
6.6 Regulatory Snapshot

7 Competitive Intelligence

7.1 Market Positioning
7.2 Market Share
7.3 Competition Benchmarking
7.4 Top Company Strategies

8 Company Profiles

8.1 Honeywell International
- 8.1.1 Overview
- 8.1.2 Product Summary
- 8.1.3 Financial Performance
- 8.1.4 SWOT Analysis
8.2 Siemens
- 8.2.1 Overview
- 8.2.2 Product Summary
- 8.2.3 Financial Performance
- 8.2.4 SWOT Analysis
8.3 Schneider Electric
- 8.3.1 Overview
- 8.3.2 Product Summary
- 8.3.3 Financial Performance
- 8.3.4 SWOT Analysis
8.4 ABB
- 8.4.1 Overview
- 8.4.2 Product Summary
- 8.4.3 Financial Performance
- 8.4.4 SWOT Analysis
8.5 Rockwell Automation
- 8.5.1 Overview
- 8.5.2 Product Summary
- 8.5.3 Financial Performance
- 8.5.4 SWOT Analysis
8.6 Fortinet
- 8.6.1 Overview
- 8.6.2 Product Summary
- 8.6.3 Financial Performance
- 8.6.4 SWOT Analysis
8.7 Palo Alto Networks
- 8.7.1 Overview
- 8.7.2 Product Summary
- 8.7.3 Financial Performance
- 8.7.4 SWOT Analysis
8.8 Check Point Software Technologies
- 8.8.1 Overview
- 8.8.2 Product Summary
- 8.8.3 Financial Performance
- 8.8.4 SWOT Analysis
8.9 Trend Micro
- 8.9.1 Overview
- 8.9.2 Product Summary
- 8.9.3 Financial Performance
- 8.9.4 SWOT Analysis
8.10 CyberArk
- 8.10.1 Overview
- 8.10.2 Product Summary
- 8.10.3 Financial Performance
- 8.10.4 SWOT Analysis
8.11 Dragos
- 8.11.1 Overview
- 8.11.2 Product Summary
- 8.11.3 Financial Performance
- 8.11.4 SWOT Analysis
8.12 Nozomi Networks
- 8.12.1 Overview
- 8.12.2 Product Summary
- 8.12.3 Financial Performance
- 8.12.4 SWOT Analysis
8.13 Claroty
- 8.13.1 Overview
- 8.13.2 Product Summary
- 8.13.3 Financial Performance
- 8.13.4 SWOT Analysis
8.14 Kaspersky
- 8.14.1 Overview
- 8.14.2 Product Summary
- 8.14.3 Financial Performance
- 8.14.4 SWOT Analysis
8.15 FireEye
- 8.15.1 Overview
- 8.15.2 Product Summary
- 8.15.3 Financial Performance
- 8.15.4 SWOT Analysis
8.16 McAfee
- 8.16.1 Overview
- 8.16.2 Product Summary
- 8.16.3 Financial Performance
- 8.16.4 SWOT Analysis
8.17 Belden
- 8.17.1 Overview
- 8.17.2 Product Summary
- 8.17.3 Financial Performance
- 8.17.4 SWOT Analysis
8.18 Forescout Technologies
- 8.18.1 Overview
- 8.18.2 Product Summary
- 8.18.3 Financial Performance
- 8.18.4 SWOT Analysis
8.19 Tenable
- 8.19.1 Overview
- 8.19.2 Product Summary
- 8.19.3 Financial Performance
- 8.19.4 SWOT Analysis
8.20 Radiflow
- 8.20.1 Overview
- 8.20.2 Product Summary
- 8.20.3 Financial Performance
- 8.20.4 SWOT Analysis

9 About Us

9.1 About Us
9.2 Research Methodology
9.3 Research Workflow
9.4 Consulting Services
9.5 Our Clients
9.6 Client Testimonials
9.7 Contact Us