Global In Vitro Diagnostics (IVD) Quality Control Product Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In November 2023, Merck KGaA launched ChemisTwin to analyze the sample’s purity, identification, and degradation of compounds through calibrated algorithm-based digital references.

• In June 2023, Randox Laboratories Ltd acquired Cellix Limited to expand its market footprint in personalized medicine and improve preventative healthcare.

The global in vitro diagnostics (IVD) quality control product market can be segmented based on product type, application, and end-user. In terms of product type, the market includes quality control materials, calibrators, and proficiency testing materials. Quality control materials serve as reference materials that mimic patient specimens and contain known concentrations of analytes, allowing laboratories to assess the accuracy and precision of their testing systems. Calibrators are used to standardize assay results by establishing a calibration curve and ensuring consistency across different testing runs. Proficiency testing materials, also known as external quality assessment (EQA) materials, are distributed by external proficiency testing providers to assess the performance of clinical laboratories and compare their results with those of other laboratories.

The application segment of the IVD quality control product market encompasses various diagnostic disciplines, including clinical chemistry, immunoassay, hematology, microbiology, molecular diagnostics, and others. Each diagnostic discipline requires specific quality control products tailored to the analytes and testing methods used in that discipline. For example, clinical chemistry quality control products may include serum-based materials containing analytes such as glucose, cholesterol, and electrolytes, while molecular diagnostics quality control products may include nucleic acid-based materials for assessing the accuracy of nucleic acid amplification assays. The diversity of diagnostic disciplines and testing methodologies within the IVD market necessitates a wide range of quality control products to meet the unique needs of different laboratories and testing environments.

End-users of IVD quality control products include clinical laboratories, hospitals, academic and research institutions, and contract research organizations. Clinical laboratories represent the largest end-user segment, driven by the high volume of diagnostic testing performed in healthcare settings to support patient care and disease management. These laboratories rely on quality control products to ensure the accuracy, reliability, and traceability of their testing processes, enabling them to deliver high-quality diagnostic results to healthcare providers and patients. Hospitals and healthcare facilities also play a significant role in the adoption and utilization of quality control products, as they strive to maintain quality assurance and accreditation standards to meet regulatory requirements and ensure patient safety. Academic and research institutions utilize quality control products in laboratory research and development activities to validate assay performance, troubleshoot technical issues, and advance scientific knowledge in the field of in vitro diagnostics.

Global In Vitro Diagnostics (IVD) Quality Control Product Segment Analysis

In this report, the Global In Vitro Diagnostics (IVD) Quality Control Product Market has been segmented by Application, End User and Geography.

Global In Vitro Diagnostics (IVD) Quality Control Product Market, Segmentation by Application

The Global In Vitro Diagnostics (IVD) Quality Control Product Market has been segmented by Application into Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, Microbiology and Others.

The clinical chemistry represents a significant segment within the IVD quality control product market, focusing on the analysis of biochemical markers in bodily fluids such as blood, serum, and urine. Quality control products for clinical chemistry applications include reference materials containing analytes such as glucose, cholesterol, electrolytes, and enzymes, allowing laboratories to assess the accuracy and precision of their chemistry assays. These quality control materials play a vital role in ensuring the reliability of clinical chemistry testing results, enabling healthcare providers to make informed decisions regarding patient diagnosis and treatment.

Immunochemistry is another key application segment in the global IVD quality control product market, involving the measurement of antigens, antibodies, and immune complexes in biological specimens. Immunoassays play a crucial role in diagnosing infectious diseases, autoimmune disorders, allergies, and hormonal imbalances, among other conditions. Quality control products for immunochemistry applications include serum-based materials containing analytes such as hormones, tumor markers, infectious disease antigens, and therapeutic drugs, enabling laboratories to validate the accuracy and precision of their immunoassay methods. These quality control materials ensure the reliability of immunoassay results, supporting timely and accurate patient diagnosis and management.

Hematology is another important application segment in the IVD quality control product market, focusing on the analysis of blood cells and clotting factors to assess hematological disorders and coagulation abnormalities. Quality control products for hematology applications include whole blood-based materials containing red blood cells, white blood cells, platelets, and hemoglobin, as well as plasma-based materials containing clotting factors and coagulation proteins. These quality control materials enable laboratories to monitor the performance of their hematology analyzers and coagulation assays, ensuring the accuracy and precision of blood cell counts, differential leukocyte counts, and coagulation tests. By maintaining the quality and reliability of hematology testing results, these quality control products support healthcare providers in diagnosing and managing hematological disorders, bleeding disorders, and thrombotic conditions effectively.

Global In Vitro Diagnostics (IVD) Quality Control Product Market, Segmentation by End User

The Global In Vitro Diagnostics (IVD) Quality Control Product Market has been segmented by End User into Clinical Laboratories, Hospitals, Research and Academic Institudes and Others.

The clinical laboratories represent a primary end-user segment, encompassing a variety of settings such as independent clinical laboratories, reference laboratories, and diagnostic testing facilities within healthcare institutions. These laboratories perform a wide range of diagnostic tests, including clinical chemistry, hematology, microbiology, and molecular diagnostics, to support patient care and disease management. Quality control products are integral to maintaining the accuracy and precision of test results, enabling laboratories to meet regulatory requirements, adhere to quality standards, and ensure the reliability of diagnostic testing.

Hospitals constitute another significant end-user segment in the Global IVD Quality Control Product Market, as they rely on diagnostic testing services to support patient diagnosis, treatment, and monitoring across various medical specialties. Hospital laboratories conduct a diverse array of diagnostic tests, ranging from routine screenings to specialized assays for complex medical conditions. Quality control products play a critical role in hospital laboratories by helping to monitor and verify the performance of analytical instruments, reagents, and testing procedures, ensuring consistent and reliable test results for patient care. By implementing quality control measures, hospitals can enhance the accuracy of diagnoses, reduce the risk of errors, and improve overall patient outcomes.

Research and academic institutes represent a distinct end-user segment in the Global IVD Quality Control Product Market, encompassing academic research laboratories, biotechnology companies, and government research institutions engaged in biomedical research and development. These institutes utilize diagnostic tests and quality control products for a variety of purposes, including basic research, preclinical studies, and clinical trials. Quality control products enable researchers to validate assay performance, troubleshoot experimental protocols, and ensure the reproducibility of experimental results, contributing to the advancement of scientific knowledge and the development of innovative diagnostic technologies. By supporting rigorous quality assurance practices, research and academic institutes play a vital role in driving progress in the field of in vitro diagnostics and improving healthcare outcomes globally.

Global In Vitro Diagnostics (IVD) Quality Control Product Market, Segmentation by Geography

In this report, the Global In Vitro Diagnostics (IVD) Quality Control Product Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global In Vitro Diagnostics (IVD) Quality Control Product Market Share (%), by Geographical Region, 2024

North America, comprising the United States and Canada primarily, holds a significant share in the global IVD quality control product market. This dominance is attributed to factors such as advanced healthcare infrastructure, a large number of clinical laboratories, and stringent regulatory standards. North America is home to several leading IVD manufacturers and research institutions, driving innovation and market growth in the region.

Europe represents another prominent region in the global IVD quality control product market, encompassing countries such as the United Kingdom, Germany, France, and Italy. The region benefits from a well-established healthcare system, extensive laboratory network, and emphasis on quality assurance and accreditation. European countries have robust regulatory frameworks governing the use of quality control products in clinical laboratories, ensuring the accuracy and reliability of diagnostic testing procedures. Europe is witnessing increasing adoption of point-of-care testing and molecular diagnostics, further driving demand for high-quality quality control products.

The Asia Pacific region, including countries like China, India, Japan, and Australia, is experiencing rapid growth in the IVD quality control product market. Factors such as improving healthcare infrastructure, rising healthcare expenditure, and growing awareness about the importance of diagnostic accuracy are driving market expansion in this region. Increasing prevalence of infectious diseases, chronic conditions, and cancer in Asia Pacific countries is fueling demand for diagnostic testing services and quality control products. As healthcare systems continue to evolve and healthcare access improves across Asia Pacific, the demand for high-quality IVD quality control products is expected to rise, presenting significant opportunities for market growth and development in the region.

This report provides an in depth analysis of various factors that impact the dynamics of Global In Vitro Diagnostics (IVD) Quality Control Product Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Regulatory Compliance
• Quality Assurance

• Diagnostic Accuracy : Diagnostic accuracy is a paramount concern in the global in vitro diagnostics (IVD) quality control product market, as it directly impacts patient care and treatment decisions. Quality control products play a vital role in ensuring the accuracy and reliability of diagnostic testing procedures by providing laboratories with reference materials that mimic patient specimens. These control materials enable laboratories to monitor the performance of their testing systems, detect errors or deviations in test results, and verify the accuracy of assay results against known reference values. By incorporating quality control practices into their testing protocols, laboratories can enhance diagnostic accuracy, minimize false-positive and false-negative results, and improve patient outcomes.

  The use of high-quality quality control products is essential for maintaining diagnostic accuracy across various diagnostic disciplines, including clinical chemistry, immunoassay, hematology, microbiology, and molecular diagnostics. Each diagnostic discipline requires specific quality control materials tailored to the analytes and testing methods used in that discipline. For example, clinical chemistry quality control products may include serum-based materials containing analytes such as glucose, cholesterol, and electrolytes, while molecular diagnostics quality control products may include nucleic acid-based materials for assessing the accuracy of nucleic acid amplification assays. By selecting appropriate quality control products and monitoring assay performance regularly, laboratories can ensure the accuracy and reliability of their diagnostic tests, thereby providing clinicians with confidence in the diagnostic results and supporting optimal patient care.

  Adherence to regulatory standards and accreditation requirements is essential for maintaining diagnostic accuracy and quality assurance in clinical laboratories. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) establish guidelines and performance standards for IVD quality control products to ensure their effectiveness and safety. Accreditation bodies such as the College of American Pathologists (CAP) and the International Organization for Standardization (ISO) require laboratories to implement quality control practices and participate in proficiency testing programs to maintain accreditation status. By complying with regulatory and accreditation requirements, laboratories can demonstrate their commitment to diagnostic accuracy, quality assurance, and patient safety, ultimately contributing to improved healthcare outcomes and public health.

Restraints

• Cost constraints
• Regulatory hurdles

• Limited adoption : Limited adoption of In Vitro Diagnostics (IVD) Quality Control Products poses a significant challenge in the global market, affecting the accuracy, reliability, and reproducibility of diagnostic testing across various healthcare settings. Despite the importance of quality control measures in ensuring the accuracy and precision of test results, some healthcare facilities may face barriers to adopting IVD quality control products. These barriers may include cost constraints, limited awareness of quality control best practices, and resource limitations in terms of personnel, infrastructure, and training. Inadequate investment in quality assurance programs and insufficient regulatory oversight may also contribute to the limited adoption of IVD quality control products, particularly in resource-limited settings and underserved regions.

  Variations in regulatory requirements and quality standards across different countries and healthcare systems may complicate the adoption of IVD quality control products on a global scale. Healthcare facilities operating in regions with less stringent regulatory oversight or limited enforcement of quality standards may perceive quality control measures as optional rather than essential components of diagnostic testing protocols. Cultural and organizational factors within healthcare institutions, such as resistance to change, competing priorities, and perceived workflow disruptions, may hinder the integration of quality control practices into routine laboratory operations. As a result, some healthcare providers may prioritize cost considerations or operational efficiency over the implementation of comprehensive quality assurance programs, leading to suboptimal testing practices and potential risks to patient safety.

  Addressing the limited adoption of IVD quality control products requires concerted efforts from healthcare stakeholders, regulatory authorities, industry partners, and professional organizations to promote awareness, education, and best practices in quality assurance. Strategies to enhance adoption may include providing targeted training and educational resources to healthcare personnel, raising awareness of the importance of quality control in diagnostic testing, and advocating for regulatory policies that prioritize patient safety and quality outcomes. By fostering a culture of quality excellence and promoting the adoption of evidence-based quality control practices, stakeholders can mitigate barriers to adoption and ensure the widespread implementation of effective quality assurance measures in in vitro diagnostics, ultimately improving the reliability and accuracy of diagnostic testing worldwide.

Opportunities

• Innovation Opportunities
• Market Expansion

• Regulatory Compliance : Regulatory compliance is a paramount consideration in the global in vitro diagnostics (IVD) quality control product market, ensuring that quality control products meet stringent standards for safety, efficacy, and performance. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional regulatory bodies, enforce regulations and guidelines to govern the development, manufacturing, and distribution of IVD quality control products. These regulations aim to safeguard patient health and ensure the accuracy and reliability of diagnostic testing procedures by establishing requirements for product quality, labeling, documentation, and post-market surveillance.

  Manufacturers of IVD quality control products must adhere to regulatory requirements specific to each market in which their products are sold, navigating complex regulatory landscapes and obtaining necessary approvals or clearances before marketing their products. Regulatory compliance involves rigorous testing and validation of quality control products to demonstrate their safety, efficacy, and performance characteristics. Manufacturers are required to conduct analytical and clinical studies to evaluate the accuracy, precision, and stability of quality control materials, as well as to establish reference ranges and establish traceability to reference standards.

  Ongoing regulatory oversight and compliance are essential throughout the product lifecycle, including post-market surveillance, adverse event reporting, and quality management system audits. Regulatory agencies monitor the safety and performance of IVD quality control products through surveillance mechanisms such as adverse event reporting systems, inspections of manufacturing facilities, and periodic review of product documentation. Manufacturers are required to maintain comprehensive quality management systems and adhere to good manufacturing practices (GMP) to ensure the consistency and reliability of their products. By complying with regulatory requirements and implementing robust quality assurance measures, manufacturers contribute to the overall safety and effectiveness of diagnostic testing procedures, thereby safeguarding patient health and promoting confidence in the IVD quality control product market.

Key players in Global In Vitro Diagnostics (IVD) Quality Control Product Market include:

• Siemens Healthineers AG
• Abbott
• Bio-Rad Laboratories
• Danaher
• F. Hoffmann-La Roche Ltd
• Sysmex Corporation
• QuidelOrtho Corporation
• Randox Laboratories Ltd
• Helena Laboratories Corporation
• Thermo Fisher Scientific Inc

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis