In Vitro Diagnostics (IVD) Quality Control Companies

The IVD quality controls market 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. The growth of the IVD quality controls market is supported by several key factors. The increasing number of accredited clinical laboratories worldwide is creating greater demand for reliable and standardized quality controls. At the same time, laboratories are steadily shifting toward the use of third-party quality controls to ensure unbiased performance monitoring and compliance with regulatory requirements. The need for external quality assessment programs is also on the rise, as laboratories seek to validate their testing processes against independent benchmarks. Furthermore, the higher incidence of chronic and infectious diseases is leading to an increase in the overall volume of diagnostic testing. In addition, the growing adoption of point-of-care instruments, particularly in developed regions, is further contributing to the need for robust and versatile quality control solutions.

In December 2024, LGC Limited (UK) acquired DiaMex GmbH (Germany), a leading manufacturer of third-party serology and molecular quality controls, to expand its clinical diagnostics and genomics portfolio. The acquisition strengthens LGC’s offerings with DiaMex’s Optitrol product range, enhancing innovation and providing laboratories and blood banks worldwide with greater choice from a single supplier.

In November 2024, Bio-Techne Corporation (US) obtained 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.

The key players in the IVD quality controls market are Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott (US), LGC Limited (UK), F. Hoffmann-La Roche Ltd. (Switzerland), Randox Laboratories Ltd. (UK), 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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Bio-Rad Laboratories, Inc. (US) holds a leading position in the IVD quality controls market with one of the broadest portfolios of independent and instrument-specific controls across clinical chemistry, immunoassays, hematology, molecular diagnostics, and microbiology. The company’s global presence, combined with continuous product innovation, enables it to meet the evolving needs of diagnostic laboratories and healthcare providers. Bio-Rad focuses on enhancing laboratory standardization, accuracy, and regulatory compliance while supporting multi-instrument compatibility, which has made its controls widely adopted across diverse clinical settings. Its strong R&D investments, extensive distribution network, and customer-focused approach further reinforce its dominance in the quality controls space.

Thermo Fisher Scientific Inc. (US) maintains a strong foothold in the IVD quality controls market, supported by its wide-ranging product offerings and integrated diagnostic solutions. The company provides quality control materials tailored for clinical chemistry, molecular diagnostics, and specialized testing, ensuring reliability and consistency across diverse laboratory applications. Leveraging its global reach and advanced manufacturing capabilities, Thermo Fisher emphasizes precision, scalability, and regulatory compliance to address the stringent needs of clinical laboratories. Its strategic focus on innovation and customer-centric solutions positions it as a key partner for labs aiming to achieve high-quality standards and dependable test results.

Abbott (US) is a prominent player in the IVD quality controls market, recognized for integrating quality controls across its broad portfolio of diagnostic instruments and assays. The company emphasizes delivering reliable, system-specific controls that ensure optimal performance of its clinical chemistry, immunoassay, and molecular testing platforms. Abbott’s strength lies in its ability to combine innovation with scalability, leveraging its global presence and advanced R&D capabilities to address the growing demand for accurate and standardized diagnostic testing. The company continues to enhance its portfolio through continuous product development and integrated solutions that streamline laboratory operations. Its strong brand reputation, extensive distribution network, and focus on customer-centric innovation further reinforce Abbott’s position as a trusted leader in the IVD quality controls market.

Market Ranking

The top five players in the IVD quality controls market are Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott (US), LGC Limited (UK), and F. Hoffmann-La Roche Ltd. (Switzerland), each contributing to market growth through innovation, global presence, and broad product offerings. Bio-Rad Laboratories is widely recognized for its comprehensive third-party quality control portfolio, supporting a broad range of laboratory platforms. Thermo Fisher Scientific emphasizes ready-to-use, barcoded solutions that streamline workflows and ensure traceability across multiple diagnostic disciplines. Abbott integrates quality controls tightly within its diagnostic platforms, offering system-specific reliability and global scalability. LGC Limited has built its reputation around independent third-party controls, combining scientific excellence with targeted acquisitions to expand reach and technical expertise. F. Hoffmann-La Roche Ltd., leveraging its deep expertise in clinical chemistry and immunoassays, provides robust quality controls aligned with its extensive instrument portfolio and strong innovation pipeline. Collectively, these companies set the benchmark for quality, reliability, and innovation, driving the continued advancement of the IVD quality controls market.

Related Reports:

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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