The In Vitro Diagnostic (IVD) quality controls market is poised for steady growth, valued at an estimated USD 1.65 billion in 2025 and projected to reach USD 2.15 billion by 2030, growing at a CAGR of 5.5% during the forecast period. Several factors are fueling this expansion, reflecting both the evolving needs of clinical laboratories and the broader trends in global healthcare diagnostics.
Key Drivers of Market Growth
- Rise of Accredited Clinical Laboratories
The increasing number of accredited laboratories worldwide is driving demand for reliable and standardized quality controls. Accreditation requires strict adherence to testing protocols, making quality control solutions indispensable. - Shift Toward Third-Party Quality Controls
Laboratories are progressively adopting third-party controls to ensure unbiased performance monitoring and regulatory compliance. Independent quality assessments help validate results and foster confidence in diagnostic outcomes. - External Quality Assessment Programs (EQAPs)
The growing need for external benchmarking is pushing labs to participate in EQAPs. These programs help laboratories compare their performance against independent standards, further highlighting the importance of robust quality control measures. - Increase in Diagnostic Testing Volume
The rising incidence of chronic and infectious diseases worldwide has led to higher diagnostic testing volumes. This trend, combined with the adoption of point-of-care instruments, particularly in developed regions, is boosting demand for versatile quality control solutions.
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Recent Developments in the IVD Quality Controls Market
- LGC Limited Acquires DiaMex GmbH (December 2024)
UK-based LGC Limited expanded its clinical diagnostics and genomics portfolio by acquiring Germany’s DiaMex GmbH, a leading manufacturer of third-party serology and molecular quality controls. The acquisition adds DiaMex’s Optitrol product range to LGC’s offerings, enhancing innovation and providing laboratories and blood banks worldwide with a broader selection from a single supplier. - Bio-Techne Corporation Secures IVDR Certification (November 2024)
US-based Bio-Techne Corporation received In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators, confirming compliance with European Union standards for in vitro diagnostic devices.
Leading Players in the Market
The IVD quality controls market features several global leaders driving innovation, standardization, and regulatory compliance:
- Bio-Rad Laboratories, Inc. (US)
Known for its comprehensive portfolio of independent and instrument-specific controls across clinical chemistry, immunoassays, hematology, molecular diagnostics, and microbiology. Bio-Rad emphasizes laboratory standardization, multi-instrument compatibility, and regulatory compliance, reinforced by strong R&D investments and a global distribution network. - Thermo Fisher Scientific Inc. (US)
Offers a wide range of quality control materials for clinical chemistry, molecular diagnostics, and specialized testing. Thermo Fisher focuses on precision, scalability, and regulatory compliance, providing labs with integrated solutions and ready-to-use barcoded controls to streamline workflows. - Abbott (US)
Delivers system-specific quality controls across clinical chemistry, immunoassay, and molecular testing platforms. Abbott integrates innovation with scalability and global reach, offering reliable, standardized solutions that enhance laboratory efficiency. - LGC Limited (UK)
Specializes in independent third-party quality controls, strengthening its position through acquisitions such as DiaMex GmbH. - F. Hoffmann-La Roche Ltd. (Switzerland)
Leverages expertise in clinical chemistry and immunoassays, providing robust controls that complement its extensive instrument portfolio and innovation pipeline.
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Market Outlook
The top five players—Bio-Rad Laboratories, Thermo Fisher Scientific, Abbott, LGC Limited, and F. Hoffmann-La Roche—set the benchmark for quality, reliability, and innovation in the IVD quality controls space. Their contributions are pivotal in supporting laboratory standardization, ensuring accurate diagnostic results, and fostering global trust in clinical testing.
As the IVD quality controls market continues to expand, laboratories worldwide will benefit from greater product choice, enhanced accuracy, and compliance with stringent regulatory standards, ultimately improving patient care and diagnostic confidence.
Conclusion
The growth of the IVD quality controls market is a reflection of the healthcare industry’s commitment to accuracy, reliability, and standardization. With increasing global demand, rising chronic and infectious disease prevalence, and continued innovation from market leaders, quality control solutions are becoming an indispensable part of modern clinical diagnostics.
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