United States In Vitro Diagnostics (IVD) Quality Control Market was valued at USD 0.9 Billion in 2022 and is projected to reach USD 1.5 Billion by 2030, growing at a CAGR of 7.0% from 2024 to 2030.
The In Vitro Diagnostics (IVD) Quality Control Market has seen significant growth in recent years due to an increasing demand for accurate and reliable diagnostic tests. This market plays a critical role in ensuring the accuracy of diagnostic results, which directly impacts patient care and treatment. In particular, quality control systems are used to ensure that diagnostic devices maintain high standards of performance and reliability, minimizing errors in testing.
The primary types of quality control products in the In Vitro Diagnostics (IVD) Quality Control Market include control materials, reagents, and calibration standards. These products are necessary for labs and diagnostic centers to maintain the precision of their equipment, offering consistent and reproducible results. For example, control materials are used to monitor the accuracy and precision of test results, helping to detect any potential discrepancies in the equipment's performance.
Industries across the healthcare and medical diagnostics sectors require stringent quality control measures to meet regulatory standards and maintain trust in their results. Laboratories, hospitals, and clinical research facilities rely heavily on IVD quality control to ensure compliance with global regulations such as ISO 13485 and FDA guidelines. These regulatory requirements are designed to ensure that diagnostic devices and equipment perform to the highest standards, ultimately safeguarding patient health.
One of the primary drivers of the In Vitro Diagnostics (IVD) Quality Control Market is the growing number of diagnostic tests conducted annually. As healthcare continues to advance, there is an increasing demand for efficient, precise, and cost-effective diagnostic solutions. The IVD market is expected to grow substantially in the coming years, fueled by technological advancements in testing equipment, increased awareness of healthcare quality, and the expanding global population.
Furthermore, industries involved in the development and manufacturing of diagnostic devices face increasing pressure to comply with stringent quality control requirements. This has led to a surge in the demand for quality control products and services that ensure the reliability and safety of diagnostic tools and equipment. As a result, companies are continually investing in quality control technologies to stay competitive in the rapidly evolving market.
Overall, the In Vitro Diagnostics (IVD) Quality Control Market is integral to ensuring accurate and reliable results in diagnostic testing. With the continuous advancements in healthcare technology, the need for robust quality control measures will only increase, further driving the growth of this market in the years to come.
Get an In-Depth Research Analysis of the US In Vitro Diagnostics (IVD) Quality Control Market Size And Forecast [2025-2032]
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Siemens Healthcare GmbH
Roche Diagnostics
Abbott
Abbott Laboratories Inc
Bio-Techne
Hologic Inc
Qiagen N.V.
Bio-Rad Laboratories Inc
Quidel Corporation
Becton
Dickinson and Company(BD)
BioMerieux Inc
Sysmex Corporation
Sero AS
Thermo Fisher Scientific Inc
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By the year 2030, the scale for growth in the market research industry is reported to be above 120 billion which further indicates its projected compound annual growth rate (CAGR), of more than 5.8% from 2023 to 2030. There have also been disruptions in the industry due to advancements in machine learning, artificial intelligence and data analytics There is predictive analysis and real time information about consumers which such technologies provide to the companies enabling them to make better and precise decisions. The Asia-Pacific region is expected to be a key driver of growth, accounting for more than 35% of total revenue growth. In addition, new innovative techniques such as mobile surveys, social listening, and online panels, which emphasize speed, precision, and customization, are also transforming this particular sector.
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Growing demand for below applications around the world has had a direct impact on the growth of the US In Vitro Diagnostics (IVD) Quality Control Market
Instruments
Reagents & Consumables
Quality Control Software
Clinical Diagnostics
Laboratory Research
Point-of-Care Testing
Hospitals
Diagnostic Laboratories
Research & Academic Institutes
Others (e.g., Homecare, Point-of-Care Facilities)
Polymerase Chain Reaction (PCR)
Immunoassays
Flow Cytometry
Microarrays
Whole Blood-based Control
Plasma-based Control
Serum-based Control
Urine-based Control
US (United States, US and Mexico)
Europe (Germany, UK, France, Italy, Russia, Turkey, etc.)
Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)
South America (Brazil, Argentina, Columbia, etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
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1. Introduction of the US In Vitro Diagnostics (IVD) Quality Control Market
Overview of the Market
Scope of Report
Assumptions
2. Executive Summary
3. Research Methodology of Verified Market Reports
Data Mining
Validation
Primary Interviews
List of Data Sources
4. US In Vitro Diagnostics (IVD) Quality Control Market Outlook
Overview
Market Dynamics
Drivers
Restraints
Opportunities
Porters Five Force Model
Value Chain Analysis
5. US In Vitro Diagnostics (IVD) Quality Control Market, By Type
6. US In Vitro Diagnostics (IVD) Quality Control Market, By Application
7. US In Vitro Diagnostics (IVD) Quality Control Market, By Geography
US
Europe
Asia Pacific
Rest of the World
8. US In Vitro Diagnostics (IVD) Quality Control Market Competitive Landscape
Overview
Company Market Ranking
Key Development Strategies
9. Company Profiles
10. Appendix
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