Market Overview

Global In Vitro Diagnostics Quality Control Market size and share is currently valued at USD 1.26 Billion in 2024 and is anticipated to generate an estimated revenue of USD 1.87 Billion by 2032, according to the latest study by Polaris Market Research. Besides, the report notes that the market exhibits a robust 5.1% Compound Annual Growth Rate (CAGR) over the forecasted timeframe, 2024 - 2032

In vitro diagnostics quality control refers to the processes and materials used to monitor and verify the accuracy and precision of diagnostic tests performed outside the human body—such as blood, urine, and tissue analyses. These controls are essential for maintaining the integrity of laboratory workflows, ensuring compliance with international standards, and minimizing false positives or negatives. Common applications include clinical chemistry, immunoassays, hematology, molecular diagnostics, and point-of-care testing.

The market encompasses a wide range of control materials, including liquid controls, lyophilized (freeze-dried) controls, and third-party controls that are compatible with multiple instrument platforms. These products are used across hospital laboratories, independent diagnostic centers, research institutions, and pharmaceutical companies. As diagnostic technologies advance especially in genomics, proteomics, and personalized medicine the demand for robust, standardized quality control solutions continues to rise.

Growth Drivers

A key factor fueling market expansion is the increasing emphasis on regulatory compliance and accreditation. Organizations such as the Clinical and Laboratory Standards Institute (CLSI), College of American Pathologists (CAP), and International Organization for Standardization (ISO) have established rigorous guidelines for laboratory quality management. Compliance with these standards necessitates the routine use of quality control materials, driving adoption across both developed and emerging economies.

Another major driver is the growing prevalence of chronic and infectious diseases. Conditions such as diabetes, cardiovascular disorders, cancer, and infectious agents like HIV, hepatitis, and emerging pathogens require frequent and accurate diagnostic monitoring. As testing volumes increase, so does the need for reliable control mechanisms to ensure consistent performance across high-throughput environments.

Technological innovation in diagnostic platforms—such as automated analyzers, next-generation sequencing, and rapid antigen tests—has also contributed to market growth. These advanced systems require equally sophisticated control materials that can simulate real patient samples and detect subtle instrument variations. The shift toward digital pathology and laboratory information management systems (LIMS) further enhances the integration of quality control into routine operations.

Additionally, the expansion of decentralized testing, including point-of-care and at-home diagnostics, has introduced new challenges in result consistency. Quality control solutions tailored for portable devices are becoming essential to maintain trust in rapid testing outcomes, especially in remote or resource-limited settings.

Key Companies in Global In Vitro Diagnostics Quality Control Market

• Abbott Laboratories
• Alpha-Tec Systems
• Bio-Rad Laboratories, Inc.
• Bio-Techne Corporation
• CleanNA
• Danaher Corporation
• Fortress Diagnostics
• Grifols, S.A.
• Newland EMEA
• Helena Laboratories Corporation
• Maine Molecular Quality Controls, Inc.
• Microbiologics
• Microbix Biosystems
• Ortho-Clinical Dia

Market Segmentation

The in vitro diagnostics quality control market can be segmented by product type, application, end user, and technology. By product, the market includes liquid-based controls, lyophilized controls, and specialty controls such as those designed for molecular or genetic testing. Liquid controls are gaining preference due to their convenience, reduced reconstitution time, and longer stability.

In terms of application, the market spans clinical chemistry, hematology, coagulation, immunoassay, microbiology, and molecular diagnostics. Immunoassay and molecular diagnostics segments are experiencing notable growth, driven by the rising use of biomarkers and genetic screening in disease management.

End users include hospital laboratories, reference laboratories, research institutions, and point-of-care testing facilities. Reference laboratories, which handle large volumes of complex tests, represent a dominant segment due to their stringent quality assurance requirements. Meanwhile, point-of-care settings are increasingly adopting third-party controls to validate portable diagnostic devices.

By technology, the market supports a range of platforms, including enzyme-linked immunosorbent assays (ELISA), polymerase chain reaction (PCR), flow cytometry, and mass spectrometry. The integration of multiplex controls capable of monitoring multiple analytes simultaneously is a growing trend, improving efficiency and reducing operational costs.

Regional Analysis

North America holds a leading position in the market, supported by a well-established healthcare infrastructure, high healthcare spending, and strict regulatory frameworks. The United States, in particular, has a dense network of accredited laboratories that routinely use quality control materials to meet federal and professional standards.

Europe follows closely, with strong adoption in countries like Germany, the United Kingdom, and France. The European Union’s In Vitro Diagnostic Regulation (IVDR) has heightened the need for standardized quality control, prompting laboratories to upgrade their validation protocols.

The Asia-Pacific region is projected to register the fastest growth over the coming years. Rising healthcare investments, expanding diagnostic services, and growing awareness of laboratory quality in nations such as China, India, and Japan are key contributors. Government initiatives to improve healthcare access and diagnostic accuracy are further stimulating market demand.

Latin America and the Middle East & Africa are also showing gradual but steady progress. Increasing collaborations between global diagnostic firms and local providers, along with efforts to strengthen public health systems, are creating new opportunities for quality control product deployment.

Future Outlook

The future of the in vitro diagnostics quality control market is shaped by the ongoing pursuit of diagnostic excellence. As precision medicine and personalized healthcare gain traction, the need for highly accurate and reproducible test results will only intensify. Manufacturers are expected to focus on developing multi-analyte controls, automation-compatible formats, and digital solutions that enable real-time monitoring and data analytics.

Integration with artificial intelligence and cloud-based platforms may revolutionize how laboratories manage quality control, allowing for predictive maintenance and remote oversight. Furthermore, the development of universal controls compatible with diverse instruments could reduce costs and simplify supply chains.

With global health security remaining a priority, the role of quality control in ensuring trustworthy diagnostic outcomes will remain indispensable. As the market evolves, it will continue to support safer, more reliable healthcare delivery across every stage of disease detection and management.

More Trending Latest Reports By Polaris Market Research:

Drag Reducing Agent Market

Drug Discount Card Market

Distribution Transformer Market

Curcumin Market

U.S. Garden Planter Market

Myasthenia Gravis Disease Treatment Market

Air Separation Plant Market

Marine And Marine Management Software Market

Curcumin Market