IVD quality control market

The report "In Vitro Diagnostics (IVD) Quality Control Market by Product & Service (QC (Plasma, Serum, Blood), Solutions), Technology (Immunoassay, MDx, Microbiology, Hematology), Manufacturer (Third-party, OEM), End User (Hospitals, Labs) - Global Forecast to 2030", is valued at an estimated USD 1.65 billion in 2025 and is projected to reach USD 2.15 billion by 2030, at a CAGR of 5.5% during the forecast period.

Browse 422 market data Tables and 55 Figures spread through 378 Pages and in-depth TOC on "In Vitro Diagnostics (IVD) Quality Control Market by Product & Service (QC (Plasma, Serum, Blood), Solutions), Technology (Immunoassay, MDx, Microbiology, Hematology), Manufacturer (Third-party, OEM), End User (Hospitals, Labs) - Global Forecast to 2030"
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The growth of the IVD quality controls market is strongly supported by the increasing number of accredited clinical laboratories and the rising demand for external quality assessment (EQA) support. As more laboratories seek and maintain accreditation from regulatory and standardization bodies such as ISO, CAP, and CLIA, the adoption of robust quality control measures becomes essential to ensure compliance and testing accuracy. At the same time, the emphasis on participating in EQA programs is driving laboratories to rely on third-party controls and advanced QC solutions that enable performance benchmarking and gap identification. Together, these factors are reinforcing the importance of reliable quality controls, creating sustained momentum for market growth.

By manufacturer type, the third-party controls segment accounted for the largest share of the IVD quality controls market in 2024.

Based on manufacturer type, the IVD quality controls market is segmented into third-party controls and original equipment manufacturer (OEM) controls. In 2024, third-party controls accounted for the largest share of the market. Their strong adoption is driven by their compatibility across multiple instruments and reagent lots, providing laboratories with greater operational flexibility and cost efficiency. These controls also offer longer shelf life, consistent analyte stability, and clinically relevant concentration ranges, ensuring reliable and reproducible test results. Being independent of instrument manufacturers, third-party controls provide an unbiased assessment of laboratory performance, which is particularly valuable for accreditation and regulatory compliance. As laboratories increasingly focus on standardization and quality assurance, the preference for third-party solutions continues to grow, solidifying their leading position in the IVD quality controls market.

By end user, the clinical laboratories segment is projected to be the fastest-growing segment during the forecast period.

Based on end users, the IVD quality controls market is segmented into hospitals, clinical laboratories, academic & research institutes, and other end users. Among these, clinical laboratories are expected to register the fastest growth during the forecast period. This growth is driven by the increasing volume of diagnostic tests performed in independent and specialized laboratories, coupled with their rising adoption of advanced diagnostic technologies. Clinical laboratories are focusing on improving test accuracy, reproducibility, and regulatory compliance, which has heightened the demand for robust quality control products, data management solutions, and quality assurance services. The preference for third-party controls and multianalyte solutions further supports their rapid adoption of QC systems. In addition, the expansion of high-throughput testing in these settings is creating additional opportunities for market players to provide flexible and reliable QC solutions tailored to clinical laboratory workflows.

North America represents the largest regional segment in the IVD quality controls market.

The IVD quality controls market has been segmented into five geographical regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America holds the largest share of the IVD quality controls market, supported by a highly developed healthcare system, extensive diagnostic infrastructure, and strong regulatory frameworks that emphasize accuracy and quality in laboratory testing. The region has a high volume of diagnostic procedures due to the rising prevalence of chronic and infectious diseases, which drives demand for reliable quality control solutions. Advanced adoption of automated diagnostic platforms, molecular testing, and point-of-care instruments further fuels market growth. Laboratories in the region prioritize compliance, reproducibility, and efficiency, increasing the reliance on third-party and multianalyte QC products. In addition, the presence of major global players and their continuous investment in innovation and distribution networks reinforce North America’s leadership position. The combination of technological advancement, stringent regulations, and high healthcare expenditure ensures that North America remains the dominant market for IVD quality controls.

The major players operating in the IVD quality controls market are Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific, Inc. (US), Randox Laboratories Ltd. (UK), LGC Limited (UK), Abbott (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), QuidelOrtho Corporation (US), Danaher Corporation (US), Sysmex Corporation (Japan), Bio-Techne Corporation (US), Microbix Biosystems Inc. (Canada), Microbiologics, Inc. (US), ZeptoMetrix (US), Fortress Diagnostics (UK), Helena Laboratories Corporation (US), Streck, Inc. (US), SERO AS (Norway), Maine Molecular Quality Controls, Inc. (US), Sun Diagnostics, LLC (US), Alpha-Tec (US), Grifols, S.A. (Spain), ConeBioproducts (US), Eurotrol B.V. (Netherlands), and Biorex Diagnostics (UK).

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