In Vitro Diagnostics (IVD) Quality Control Market worth $2.15 billion by 2030 with 5.5% CAGR | MarketsandMarkets™
DELRAY BEACH, Fla., Sept. 19, 2025 /PRNewswire/ -- The global In Vitro Diagnostics Quality Control Market, valued at US$1.58 billion in 2024, stood at US$1.65 billion in 2025 and is projected to advance at a resilient CAGR of 5.5% from 2025 to 2030, culminating in a forecasted valuation of US$2.15 billion by the end of the 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.
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Based on product & service, the IVD quality control market is segmented into quality control products, data management solutions, and quality assurance services. Among these, the quality control products segment is projected to register the highest growth rate during the forecast period. This growth is primarily driven by the growing number of IVD tests performed globally and the need to ensure accuracy, reliability, and reproducibility of diagnostic outcomes. The rising incidence of chronic and infectious diseases, coupled with the growing adoption of advanced diagnostic technologies such as molecular assays, has heightened the demand for quality control products. Regulatory requirements mandating the use of control materials for compliance and performance validation further add to this growth. Additionally, laboratories are increasingly preferring third-party controls over instrument-specific ones, as they provide unbiased performance evaluation, broader applicability across platforms, and enhanced flexibility. These dynamics position the quality control products segment as the fastest-growing area of the IVD quality control market.
Based on technology, the IVD quality control market is categorized into immunoassays, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation & hemostasis, and other technologies. During the forecast period, the molecular diagnostics segment is expected to register the fastest growth. This expansion is primarily driven by the rising global burden of infectious diseases, genetic disorders, and cancer, which has accelerated the adoption of molecular testing techniques such as PCR, NGS, and isothermal amplification. The growing demand for personalized medicine, companion diagnostics, and rapid detection of emerging pathogens has further intensified the reliance on molecular assays, underscoring the critical need for stringent quality controls to ensure accuracy and reliability. Additionally, increasing regulatory scrutiny and the push for standardized testing practices are compelling laboratories to adopt robust molecular quality control solutions. Collectively, these factors position molecular diagnostics as the fastest-growing technology segment in the IVD quality controls market.
North America holds the leading position in the IVD quality controls market, supported by a highly developed healthcare infrastructure, advanced diagnostic networks, and strong regulatory standards that prioritize accuracy and reliability in testing. The region conducts a large volume of diagnostic procedures annually, driven by the high prevalence of chronic and infectious diseases, as well as a growing emphasis on early detection and personalized medicine. This creates consistent demand for quality controls to ensure dependable and reproducible diagnostic results. The market is further strengthened by the presence of several global leaders in IVD quality control manufacturing, many of whom are headquartered or have significant operations in the region. These players invest heavily in innovation, developing advanced QC solutions that integrate automation, digital platforms, and data management systems. Such advancements reduce human error, streamline workflows, and enhance laboratory efficiency, which are critical factors in meeting the growing testing demand. Regulatory bodies in North America impose stringent requirements for laboratory accreditation and quality assurance. These frameworks necessitate the use of reliable QC products across diagnostic applications, thereby reinforcing the market's strong foundation. Additionally, high healthcare spending and robust investment in research and development contribute to ongoing market expansion. Laboratories and diagnostic service providers are quick to adopt new QC technologies, including software-driven quality management systems and integrated control platforms, reflecting the region's focus on innovation and efficiency. Collectively, these factors ensure North America's strong leadership position in the global IVD quality controls market, with growth driven by technology adoption, regulatory rigor, and the region's commitment to maintaining the highest standards in diagnostic accuracy.
The IVD quality controls market is witnessing strong opportunities with the rising adoption of advanced diagnostics and the shift toward decentralized and point-of-care testing. One of the key trends creating opportunity is the increasing use of multianalyte controls, which allow laboratories to streamline processes, reduce costs, and enhance efficiency by consolidating multiple assays into a single control material. Market players can tap into this by developing comprehensive multianalyte solutions tailored for automated platforms and molecular assays. Additionally, expanding into emerging regions, forming strategic collaborations for distribution, and integrating digital tools for real-time QC data monitoring can further strengthen their market position and customer engagement.
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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).
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.
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