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    In Vitro Diagnostics Quality Control market

    ID: MRFR/HC/30925-HCR
    128 Pages
    Kinjoll Dey
    October 2025

    IVD Quality Control Market Research Report By Application (Clinical Diagnostics, Blood Testing, Microbiology, Molecular Diagnostics, Quality Control in Laboratories), By Product Type (Control Sera, Control Plasma, Control Urine, Control For Blood Gases, Control For Coagulation), By End User (Hospitals, Diagnostic Laboratories, Research Laboratories, Pharmaceutical Companies, Blood Banks), By Technology (Chemistry, Immunoassay, Nucleic Acid Amplification, Mass Spectrometry, Microarray) and By Regional (North America, Europe, South America, A...

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    In Vitro Diagnostics Quality Control market Summary

    As per MRFR analysis, the IVD Quality Control Market Size was estimated at 4.73 USD Billion in 2024. The IVD Quality Control industry is projected to grow from 4.905 USD Billion in 2025 to 7.063 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 3.71 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The IVD Quality Control Market is poised for substantial growth driven by technological advancements and increasing regulatory compliance.

    • Technological advancements are enhancing the accuracy and efficiency of quality control processes in the IVD sector.
    • North America remains the largest market for IVD quality control, while Asia-Pacific is emerging as the fastest-growing region.
    • Clinical diagnostics continues to dominate the market, whereas blood testing is witnessing rapid growth due to rising demand.
    • The rising demand for accurate diagnostics and increasing regulatory requirements are key drivers propelling market expansion.

    Market Size & Forecast

    2024 Market Size 4.73 (USD Billion)
    2035 Market Size 7.063 (USD Billion)
    CAGR (2025 - 2035) 3.71%

    Major Players

    Roche Diagnostics (CH), Abbott Laboratories (US), Siemens Healthineers (DE), Thermo Fisher Scientific (US), bioMerieux (FR), Ortho Clinical Diagnostics (US), Danaher Corporation (US), Sysmex Corporation (JP), Hologic, Inc. (US)

    In Vitro Diagnostics Quality Control market Trends

    The IVD Quality Control Market is currently experiencing a dynamic evolution, driven by the increasing demand for accurate and reliable diagnostic testing. As healthcare systems worldwide prioritize patient safety and treatment efficacy, the emphasis on quality control measures in vitro diagnostics has intensified. This market appears to be influenced by advancements in technology, regulatory changes, and the growing awareness of the importance of quality assurance in laboratory settings. Furthermore, the integration of automation and digital solutions into quality control processes seems to enhance efficiency and reduce human error, thereby fostering a more robust market environment. In addition, the IVD Quality Control Market is likely to witness a shift towards personalized medicine, which necessitates stringent quality control protocols to ensure the reliability of diagnostic results. The rising prevalence of chronic diseases and the need for timely diagnosis may further propel the demand for innovative quality control solutions. As stakeholders in the healthcare sector continue to invest in research and development, the market is poised for substantial growth, reflecting a commitment to improving patient outcomes through enhanced diagnostic accuracy and reliability.

    Technological Advancements

    The IVD Quality Control Market is increasingly shaped by technological innovations that enhance the precision and reliability of diagnostic tests. Automation and digitalization are becoming integral, streamlining quality control processes and minimizing human error. These advancements not only improve efficiency but also facilitate real-time monitoring and data analysis, which are crucial for maintaining high standards in laboratory practices.

    Regulatory Compliance

    Regulatory frameworks governing the IVD Quality Control Market are evolving, reflecting a heightened focus on patient safety and product efficacy. Stricter compliance requirements are compelling manufacturers to adopt more rigorous quality control measures. This trend indicates a shift towards ensuring that diagnostic products meet stringent standards, thereby fostering trust among healthcare providers and patients alike.

    Personalized Medicine

    The growing trend towards personalized medicine is significantly impacting the IVD Quality Control Market. As treatments become more tailored to individual patient needs, the demand for precise and reliable diagnostic tools increases. This necessitates robust quality control protocols to ensure that diagnostic results are accurate, ultimately enhancing patient care and treatment outcomes.

    The ongoing evolution of quality control measures in the in vitro diagnostics sector appears to be driven by a growing emphasis on regulatory compliance and patient safety, suggesting a robust future for innovation in this field.

    U.S. Food and Drug Administration (FDA)

    In Vitro Diagnostics Quality Control market Drivers

    Growth of Point-of-Care Testing

    The growth of point-of-care testing (POCT) is emerging as a significant driver for the IVD Quality Control Market. POCT allows for rapid diagnostic results at the site of patient care, which is increasingly preferred in various healthcare settings. This trend is particularly relevant in emergency care and remote locations where timely decision-making is critical. As the demand for POCT rises, the need for stringent quality control measures becomes paramount to ensure the accuracy and reliability of these tests. The IVD Quality Control Market must adapt to support the unique challenges posed by POCT, including the need for portable quality control solutions. This shift is likely to stimulate innovation and investment in quality control technologies tailored for point-of-care applications, thereby expanding the market.

    Increasing Regulatory Requirements

    The IVD Quality Control Market is significantly influenced by the increasing regulatory requirements imposed by health authorities. Regulatory bodies are continuously updating guidelines to ensure the safety and efficacy of in vitro diagnostic products. Compliance with these regulations is essential for manufacturers to maintain market access and avoid penalties. The IVD Quality Control Market must adapt to these evolving standards, which often necessitate enhanced quality control measures. For example, the introduction of stricter quality assurance protocols can lead to increased operational costs for manufacturers. However, this also presents an opportunity for growth, as companies that invest in robust quality control systems are likely to gain a competitive edge. The market is expected to expand as organizations prioritize compliance and seek innovative solutions to meet regulatory demands.

    Rising Demand for Accurate Diagnostics

    The increasing emphasis on accurate diagnostics is a primary driver for the IVD Quality Control Market. As healthcare systems strive for improved patient outcomes, the need for reliable and precise diagnostic tools has surged. This demand is reflected in the projected growth of the IVD market, which is expected to reach approximately 100 billion USD by 2025. The IVD Quality Control Market plays a crucial role in ensuring that diagnostic tests meet stringent accuracy standards, thereby enhancing the overall reliability of healthcare services. Furthermore, the rise in chronic diseases necessitates frequent testing, further propelling the need for robust quality control measures in IVD products. As a result, manufacturers are increasingly investing in quality control solutions to maintain compliance and meet the expectations of healthcare providers and patients alike.

    Technological Innovations in Quality Control

    Technological innovations are significantly influencing the IVD Quality Control Market. Advancements in automation, artificial intelligence, and data analytics are transforming quality control processes, making them more efficient and effective. For instance, automated quality control systems can reduce human error and enhance the speed of testing, which is vital in clinical settings. The integration of AI in quality control allows for real-time monitoring and predictive analytics, enabling proactive measures to be taken before issues arise. This shift towards technology-driven solutions is expected to contribute to the growth of the IVD Quality Control Market, as organizations seek to leverage these innovations to improve their operational efficiency and product reliability. As a result, the market is likely to witness an influx of new players offering cutting-edge quality control technologies.

    Focus on Patient Safety and Quality Assurance

    The focus on patient safety and quality assurance is a driving force behind the IVD Quality Control Market. As healthcare providers increasingly prioritize patient outcomes, the demand for high-quality diagnostic tests has intensified. This focus is reflected in the growing adoption of quality management systems that ensure the reliability of IVD products. The IVD Quality Control Market is responding to this trend by developing comprehensive quality assurance protocols that align with best practices in patient safety. Furthermore, the emphasis on quality assurance is likely to lead to increased collaboration between manufacturers and healthcare providers, fostering a culture of continuous improvement. As a result, the market is expected to grow as stakeholders recognize the importance of quality control in enhancing patient safety and overall healthcare quality.

    Market Segment Insights

    By Application: Clinical Diagnostics (Largest) vs. Blood Testing (Fastest-Growing)

    The IVD Quality Control Market showcases a diverse application landscape with significant market share distribution across various segments. Clinical diagnostics hold the largest share, reflecting a consistent demand for accurate and reliable results in patient care. Blood testing is also a major component of this market, driven by the rising incidence of blood-related disorders and the escalating need for precise diagnostic methods. Microbiology testing and molecular diagnostics, although smaller in size, are instrumental in addressing specific healthcare challenges, thus carving out their niche in the market. Growth trends in the IVD Quality Control Market are favoring blood testing as one of the fastest-growing segments, propelled by advancements in technology and an increasing focus on personalized medicine. The push for regulatory compliance in laboratories enhances the importance of quality control solutions across all applications. Microbiology testing and molecular diagnostics are experiencing upward momentum due to their role in infectious disease detection and genetic testing, respectively. This growth is further supported by an expanding patient population and heightened awareness of the significance of quality in diagnostics.

    Clinical Diagnostics (Dominant) vs. Microbiology Testing (Emerging)

    Clinical diagnostics continue to dominate the IVD Quality Control Market, driven by their vital role in patient care and diagnostics. This segment encompasses a wide range of tests that guide medical decisions, ensuring the quality and reliability of testing processes. Microbiology testing, while emerging, plays a crucial role in infection control and disease management. It focuses on identifying pathogens and antimicrobial susceptibility, becoming increasingly relevant with the rise of antibiotic resistance. Both segments complement each other, as quality control in clinical diagnostics enhances the accuracy of microbiology testing. As the healthcare landscape evolves, both clinical diagnostics and microbiology testing will continue to adapt, emphasizing precision and efficacy in laboratory services.

    By Product Type: Control Sera (Largest) vs. Control Plasma (Fastest-Growing)

    In the IVD Quality Control Market, Control Sera holds the largest market share among the different product types, reflecting its vital role in ensuring accurate diagnostic testing. Control Plasma follows closely as a significant component, while Control Urine, Control for Blood Gases, and Control for Coagulation contribute to a diverse portfolio catering to various diagnostic needs. The distribution of market share indicates a strong preference for Control Sera in laboratories, highlighting its established presence in quality assurance practices. The growth trends in the IVD Quality Control Market show a robust increase in demand for Control Plasma, which is quickly becoming the fastest-growing segment. This rise can be attributed to advancements in diagnostics and the increasing complexity of testing methods, which necessitate reliable quality control solutions. Additionally, the growing awareness of the importance of quality assurance in laboratories is driving the adoption of various controls, particularly Control Urine and Control for Coagulation, which are gaining traction in specialized testing environments.

    Control Sera (Dominant) vs. Control Plasma (Emerging)

    Control Sera remains the dominant product type within the IVD Quality Control Market due to its longstanding application in validating test results across a wide range of diagnostic procedures. It provides critical reference points for assays and panel tests, ensuring precision and accuracy in results. Meanwhile, Control Plasma is emerging as a significant competitor, driven by innovations in clinical testing and an increased focus on hematology. As laboratories seek to enhance their quality assurance protocols, both Control Sera and Control Plasma are poised for continued growth, each serving unique roles—Control Sera as a primary standard for routine testing, and Control Plasma expanding its reach in specialized and high-throughput diagnostic settings.

    By End User: Diagnostic Laboratories (Largest) vs. Hospitals (Fastest-Growing)

    In the IVD Quality Control Market, the distribution of market share among end users is notably diverse. Diagnostic Laboratories hold the largest share, attributed to their pivotal role in performing extensive tests and ensuring quality assurance across numerous diagnostic procedures. Hospitals follow closely, leveraging advanced IVD technologies to enhance patient care. Research Laboratories, Pharmaceutical Companies, and Blood Banks also contribute significantly, focusing on specialized applications, although their market presence is comparatively smaller. Growth trends in this segment reveal that Hospitals are emerging as the fastest-growing end user, driven by rising investments in healthcare infrastructure and increasing patient volumes. Furthermore, Diagnostic Laboratories continue to expand their market share, fueled by the demand for precise diagnostic tools and quality control measures. Research Laboratories are expected to grow steadily as they focus on innovation, while Pharmaceutical Companies and Blood Banks aim to enhance their quality assurance protocols to meet regulatory standards.

    Diagnostic Laboratories (Dominant) vs. Hospitals (Emerging)

    Diagnostic Laboratories act as the backbone of the IVD Quality Control Market due to their established infrastructure and expertise in testing services, positioning them as the dominant force. They implement stringent quality control measures to maintain accuracy and reliability, which is critical for patient outcomes. On the other hand, Hospitals are emerging rapidly within this market, propelled by increasing investments in diagnostic technology and the growing emphasis on patient-centric care. The integration of advanced IVD solutions within hospital settings enhances their ability to provide swift and reliable diagnosis, reflecting a shift towards more proactive healthcare management. As hospitals prioritize quality control in diagnostic processes, they are likely to experience significant growth, potentially narrowing the gap with their dominant counterparts.

    By Technology: Immunoassay (Largest) vs. Mass Spectrometry (Fastest-Growing)

    The IVD Quality Control Market displays a diverse distribution in technology segments, with Immunoassay leading the way due to its widespread acceptance and utility across various diagnostics applications. This segment is followed by Chemistry and Nucleic Acid Amplification, which also contribute significantly to the market. Mass Spectrometry and Microarray, while currently smaller, are making notable strides in their respective niches, displaying promising potential as the market evolves.

    Immunoassay (Dominant) vs. Mass Spectrometry (Emerging)

    Immunoassay technology stands out as the dominant force in the IVD Quality Control market, offering reliable and sensitive detection of various biomarkers, thus ensuring accuracy in quality control processes. Its established market position is supported by a broad range of applications in clinical laboratories. Conversely, Mass Spectrometry is emerging rapidly, gaining traction due to its advanced analytical capabilities, precision, and ability to handle complex biological matrices. While initially seen as niche, its rapid advancement and adaptability are positioning it as a critical component in quality control protocols, vital for meeting the increasing demand for accurate diagnostic solutions.

    Get more detailed insights about In Vitro Diagnostics Quality Control market

    Regional Insights

    The IVD Quality Control Market exhibited a diverse regional segmentation, with North America leading the charge, generating a revenue of 1.8 USD Billion in 2023 and projected to grow to 2.5 USD Billion by 2032, primarily due to advanced healthcare infrastructure and a focus on diagnostics. Europe follows with a significant valuation of 1.2 USD Billion in 2023, increasing to 1.7 USD Billion by 2032, reflecting strong regulations and a growing demand for accurate diagnostics.

    The APAC region, while smaller at 0.9 USD Billion in 2023, is expected to reach 1.2 USD Billion by 2032, driven by expanding healthcare investments and a rising population.Meanwhile, South America and MEA hold lower valuations at 0.3 USD Billion and 0.2 USD Billion, respectively, in 2023, with South America projected to grow to 0.4 USD Billion and MEA to 0.3 USD Billion by 2032, showcasing potential growth opportunities in these emerging markets. The majority holding in North America showcases technological advancements that dominate the market, while the growth in APAC illustrates an increasing focus on improving healthcare systems.

    Overall, these insights provide a comprehensive view of the IVD Quality Control Market segmentation within regional boundaries.

    IVD Quality Control Market By Regional

    Source Primary Research, Secondary Research, MRFR Database and Analyst Review

    Key Players and Competitive Insights

    The IVD Quality Control Market is characterized by substantial competition among various key players, each aiming to innovate and deliver superior quality control solutions for in vitro diagnostics. As the demand for accurate and reliable diagnostic testing expands, companies are increasingly focused on enhancing their product offerings through research and development. The market is influenced by technological advancements, regulatory frameworks, and evolving healthcare needs, leading to a dynamic landscape where players must constantly adapt to maintain their competitive edge. Companies are also investing in strategic collaborations, mergers, and acquisitions to strengthen their market presence and expand their geographical reach. 

    The integration of automation and digital technologies into quality control processes is becoming a critical differentiator among competitors, allowing for improved efficiency, accuracy, and compliance in laboratory settings.Siemens Healthineers holds a prominent position in the IVD Quality Control Market thanks to its extensive range of quality control products and solutions that cater to various diagnostic applications. The company's commitment to innovation and robust R&D has led to the development of highly accurate quality control systems that enhance laboratory performance and ensure reliable test results.

    Siemens Healthineers leverages its strong reputation in the healthcare industry, built upon years of experience and expertise, to provide advanced analytics and tailored services that address the unique needs of laboratories worldwide. 

    Its focus on customer-centric solutions and ability to deliver comprehensive service offerings provides a tangible advantage in a competitive market, enabling healthcare providers to achieve optimal operational efficiency and patient outcomes.Sysmex Corporation is another key player in the IVD Quality Control Market, known for its specialization in hematology and other diagnostic areas. The company combines cutting-edge technology with innovative quality control solutions that enhance laboratory workflows and ensure accurate diagnostic results.

    Sysmex Corporation's strong commitment to research and development has led to the introduction of state-of-the-art quality control products that comply with international standards, thereby reinforcing its position in the market.

    Key Companies in the In Vitro Diagnostics Quality Control market market include

    Industry Developments

    • Q2 2024: Bio-Rad Launches New InteliQ Quality Controls for Immunoassay Testing Bio-Rad Laboratories announced the launch of its InteliQ Immunoassay quality controls, designed to streamline laboratory workflow and improve the accuracy of immunoassay testing in clinical laboratories.
    • Q2 2024: Siemens Healthineers Receives FDA Clearance for Atellica Solution Quality Control Module Siemens Healthineers received FDA clearance for its Atellica Solution Quality Control Module, which automates quality control processes for in vitro diagnostic testing, aiming to enhance laboratory efficiency and compliance.
    • Q2 2024: Roche Launches New Multi-Analyte Quality Control Panel for Molecular Diagnostics Roche announced the commercial launch of a new multi-analyte quality control panel for molecular diagnostics, supporting laboratories in ensuring the reliability of their molecular testing platforms.
    • Q3 2024: Randox Laboratories Opens New Quality Control Manufacturing Facility in the UK Randox Laboratories opened a new manufacturing facility dedicated to the production of in vitro diagnostics quality control materials, expanding its capacity to meet growing global demand.
    • Q3 2024: Thermo Fisher Scientific Announces Partnership with Beckman Coulter for Quality Control Solutions Thermo Fisher Scientific entered into a partnership with Beckman Coulter to co-develop and distribute advanced quality control solutions for clinical laboratories, aiming to improve diagnostic accuracy and workflow.
    • Q3 2024: Bio-Techne Acquires QC Diagnostics to Expand Quality Control Portfolio Bio-Techne completed the acquisition of QC Diagnostics, a company specializing in quality control materials for in vitro diagnostics, to broaden its product offerings and strengthen its market position.
    • Q4 2024: Abbott Receives CE Mark for Alinity Quality Control System Abbott announced it has received CE Mark approval for its Alinity Quality Control System, enabling the company to market the product across the European Union for use in clinical laboratories.
    • Q4 2024: QuidelOrtho Launches New Quality Control Software for Point-of-Care Diagnostics QuidelOrtho launched a new software platform designed to automate and manage quality control processes for its point-of-care diagnostic devices, aiming to enhance compliance and reduce manual errors.
    • Q1 2025: Bio-Rad Laboratories Appoints New Vice President of Quality Control Division Bio-Rad Laboratories announced the appointment of a new Vice President to lead its Quality Control Division, focusing on strategic growth and innovation in the in vitro diagnostics quality control market.
    • Q1 2025: Siemens Healthineers Expands Quality Control Product Line with New Hematology Controls Siemens Healthineers expanded its quality control product line by launching new hematology controls, designed to support laboratories in maintaining high standards of accuracy in blood analysis.
    • Q2 2025: Randox Laboratories Secures Major Contract to Supply Quality Control Materials to NHS Randox Laboratories secured a significant contract to supply in vitro diagnostics quality control materials to the UK National Health Service, supporting the quality assurance of diagnostic testing across NHS laboratories.
    • Q2 2025: Roche Receives FDA Clearance for Next-Generation Quality Control Solution Roche received FDA clearance for its next-generation quality control solution, designed to improve the reliability and efficiency of in vitro diagnostic testing in clinical laboratories.

    Future Outlook

    In Vitro Diagnostics Quality Control market Future Outlook

    The IVD Quality Control Market is projected to grow at a 3.71% CAGR from 2024 to 2035, driven by technological advancements, regulatory changes, and increasing demand for accurate diagnostics.

    New opportunities lie in:

    • Development of integrated quality control software solutions for laboratories.
    • Expansion of remote quality monitoring services for IVD devices.
    • Investment in AI-driven analytics for predictive quality control.

    By 2035, the IVD Quality Control Market is expected to be robust, reflecting sustained growth and innovation.

    Market Segmentation

    In Vitro Diagnostics Quality Control market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Laboratories
    • Pharmaceutical Companies
    • Blood Banks

    In Vitro Diagnostics Quality Control market Technology Outlook

    • Chemistry
    • Immunoassay
    • Nucleic Acid Amplification
    • Mass Spectrometry
    • Microarray

    In Vitro Diagnostics Quality Control market Application Outlook

    • Clinical Diagnostics
    • Blood Testing
    • Microbiology Testing
    • Molecular Diagnostics
    • Quality Control in Laboratories

    In Vitro Diagnostics Quality Control market Product Type Outlook

    • Control Sera
    • Control Plasma
    • Control Urine
    • Control For Blood Gases
    • Control For Coagulation

    Report Scope

    MARKET SIZE 20244.73(USD Billion)
    MARKET SIZE 20254.905(USD Billion)
    MARKET SIZE 20357.063(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)3.71% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesIntegration of artificial intelligence in IVD Quality Control processes enhances accuracy and efficiency.
    Key Market DynamicsRising regulatory scrutiny and technological advancements drive innovation in the IVD Quality Control Market.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the projected growth of the In Vitro Diagnostics Quality Control market?

    The In Vitro Diagnostics Quality Control market is the expected increase in total market value of 7.06 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the In Vitro Diagnostics Quality Control market?

    In Vitro Diagnostics Quality Control market size was valued at approximately 4.73 billion USD in 2024. This figure will reach 7.06 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the In Vitro Diagnostics Quality Control market?

    In Vitro Diagnostics Quality Control market is expected to grow at a CAGR of 3.71% between 2025 and 2035.

    How much will the In Vitro Diagnostics Quality Control market be worth by 2035?

    In Vitro Diagnostics Quality Control market is expected to be worth of 7.06 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the In Vitro Diagnostics Quality Control market perform over the next 10 years?

    Over the next 10 years the In Vitro Diagnostics Quality Control market is expected to shift from usd billion 4.73 to 7.06 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

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