IVD Quality Control Market, By Type (Quality Control, Data Management Solutions, Quality Assurance Services), Product (Control, Calibrator), Application (Immunochemistry, Molecular Diagnostics), Manufacturer Type, End-use, – Global Forecast (2024 – 2032)

IVD Quality Control Market, By Type (Quality Control, Data Management Solutions, Quality Assurance Services), Product (Control, Calibrator), Application (Immunochemistry, Molecular Diagnostics), Manufacturer Type, End-use, – Global Forecast (2024 – 2032)

IVD Quality Control Market Size

IVD Quality Control Market size was valued at around USD 1.3 billion in 2023 and is estimated to grow at 5.7% CAGR from 2024 to 2032. IVD quality control refers to the processes and procedures used to ensure the accuracy, reliability, and consistency of in vitro diagnostic tests and instruments.

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IVD quality control involves the use of specific materials, known as controls, and protocols to monitor and verify the performance of diagnostic assays. These controls are tested alongside patient samples to detect any deviations from expected results, allowing laboratories to identify and correct errors in their testing processes.
 

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The rising demand for point-of-care testing (POCT) in the in vitro diagnostics (IVD) quality control market is driven by the need for rapid, accessible, and reliable diagnostic solutions that enhance patient care and streamline healthcare delivery. It enables immediate clinical decisions in emergency situations such as acute infections or cardiac events by providing quick results at the patient's bedside or in remote areas where traditional lab facilities are unavailable. Additionally, POCT is vital in chronic disease management, such as blood glucose monitoring for diabetes patients, allowing for timely treatment adjustments and improved patient outcomes.

Furthermore, increasing demand for accurate diagnostic testing, advancements in diagnostic technologies, and stringent regulatory requirements, are the promoting factors advancing the growth of the market.

IVD Quality Control Market Trends

The landscape of in vitro diagnostics (IVD) quality control is evolving rapidly due to significant advancements in diagnostic technologies. These innovations are enhancing the precision, speed, and reliability of diagnostic tests, are crucial for accurate disease detection, monitoring, and management. The integration of cutting-edge technologies such as next-generation sequencing, which is estimated to reach USD 47 billion by 2032, digital PCR, and artificial intelligence is transforming the IVD industry, driving improvements in patient care and expanding the scope of diagnostic capabilities.

• Next-generation sequencing (NGS) allows for the rapid sequencing of large sections of DNA or RNA, providing detailed genetic information that was previously unattainable with traditional sequencing methods.
• Digital PCR enhances the precision of nucleic acid quantification by partitioning samples into thousands of individual reactions, allowing for absolute quantification of target molecules.
• Biosensors are analytical devices that utilize biological recognition elements such as antibodies, enzymes, nucleic acids (DNA or RNA), or whole cells, to detect and quantify specific biological molecules, often referred to as analytes. These biological recognition elements exhibit high specificity and affinity towards their target molecules, allowing biosensors to selectively capture and bind the analytes of interest, thereby increasing the growth of the market.

IVD Quality Control Market Analysis

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Based on type, the IVD quality control market is classified into quality control, data management solutions, and quality assurance services. Further, quality control is segmented into serum/plasma-based controls, whole blood-based controls, urine-based controls, and other quality controls. The quality control segment is estimated to account for USD 907.6 million by the end of 2032.

• Quality control involves regular monitoring of various aspects of the diagnostic process, including instrument performance, reagent quality, and assay procedures. This monitoring ensures that all components of the testing process are functioning correctly and consistently.
• Protocols include the use of control materials with known values to validate test accuracy and precision. These control materials mimic patient samples and are run alongside patient samples to verify that the test system is performing within acceptable limits.
• Further, quality control measures help reduce analytical variability in diagnostic testing by standardizing procedures and minimizing sources of error. This improves the comparability of test results across different laboratories and testing platforms, promoting consistency in patient care, thereby leading the segmental growth

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Based on product, the IVD quality control market is divided into control, calibrators, and other products. Further, control is segmented into total protein, albumin, blood urea nitrogen, uric acid, creatinine, sodium, potassium, chloride, calcium, magnesium, aspartate transaminase, creatine kinase, gamma glutamyl transferase, total bilirubin, and other controls. The control segment accounted for USD 641.3 million in 2023.

• Controls serve as benchmarks for evaluating the performance of diagnostic tests and instruments. By running control materials with known values alongside patient samples, laboratories can assess the accuracy and precision of their testing procedures.
• It provides a means of verifying the accuracy of test results by comparing them to expected values. Deviations from the expected values indicate potential issues with the testing process, such as instrument malfunction or reagent degradation, prompting further investigation and corrective actions.
• Moreover, control materials help detect systematic errors or biases in testing procedures that may affect the accuracy of results. Monitoring control results over time allows laboratories to identify trends or shifts in performance and take corrective actions to address underlying issues.
• They are used to monitor the performance of diagnostic instruments, ensuring that they are functioning within acceptable limits. Regular testing with control materials helps detect instrument drift or inconsistencies, enabling timely maintenance or recalibration to maintain accuracy.
• Thus, such aforementioned factors are expected to augment the segmental growth.

Based on application, the IVD quality control market is classified into immunochemistry, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation and hemostasis, and other applications. Further, clinical chemistry is divided into electrolytes and minerals, renal function, liver function, proteins and enzymes, cardiac markers, and other clinical chemistry. The clinical chemistry segment is estimated to account for USD 567.6 million by the end of 2032.

• Clinical chemistry encompasses a broad array of tests to analyze various analytes in biological samples, including blood, serum, and urine. This comprehensive approach allows for a thorough assessment of metabolic functions, organ health, and disease markers, providing valuable insights into a patient's overall health status.
• Through the analysis of biomarkers, enzymes, electrolytes, and other substances, clinical chemistry tests can detect abnormalities indicative of underlying health conditions at an early stage. Early detection enables prompt intervention and treatment, potentially preventing the progression of diseases and improving patient outcomes.
• Further, clinical chemistry tests are instrumental in monitoring the effectiveness of medical treatments and interventions. By tracking changes in biomarker levels or metabolic parameters over time, healthcare providers can evaluate the response to therapy, adjust treatment regimens as necessary, and optimize patient care. Thus, driving the growth of the market.

Based on manufacturer type, the IVD quality control market is segmented third-party controls and original equipment manufacturer controls. Further, third party controls is divided into independent controls and instruments specific controls. The third-party controls segment held a market share of 61.7% in the year 2023.

• Third-party controls are manufactured by independent suppliers separate from the diagnostic test or instrument manufacturer. This independence ensures impartiality in control material production and reduces the risk of bias or conflicts of interest, providing greater confidence in the reliability of control materials.
• It often covers a wide range of analytes, including common biomarkers, enzymes, electrolytes, and specialty assays. This diversity allows laboratories to monitor the performance of multiple tests and instruments simultaneously, optimizing workflow efficiency and reducing the need for multiple control materials.
• Further, third-party controls are manufactured according to standardized processes and reference materials, ensuring consistency and traceability across different batches and lots. Standardization facilitates comparability of control results between laboratories and over time, promoting harmonization in diagnostic testing practices. Thus, stimulating the growth of the market.

Based on end use, the IVD quality control market is segmented into hospital, clinical laboratories, academic and research institutes, and other end-users. The hospitals segment accounted for USD 453.2 million in 2023.

• Hospitals typically have well-equipped clinical laboratories capable of performing a wide range of diagnostic tests. This on-site testing capability allows hospitals to conduct quality control measures directly within their facilities, ensuring prompt assessment and maintenance of test accuracy and reliability.
• They have immediate access to patient samples, allowing for real-time quality control testing alongside routine diagnostic procedures. This enables rapid detection and correction of any issues related to test performance, minimizing the risk of reporting inaccurate or unreliable results to healthcare providers and patients.
• Additionally, hospitals often have established quality management systems (QMS) to ensure compliance with regulatory requirements and accreditation standards, such as those set forth by organizations like the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP), thereby escalating the growth of the market.

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The U.S. market is anticipated to grow at CAGR of 5.6% during the analysis timeframe.

• The U.S. is home to numerous leading IVD companies and research institutions that continuously drive technological advancements and innovations in the field. This results in high-quality, cutting-edge diagnostic tools and quality control measures.
• The country has a robust regulatory framework governed by the Food and Drug Administration (FDA). This ensures that IVD products meet stringent quality and safety standards, which enhances the credibility and reliability of U.S.-manufactured IVD quality control products.

Germany IVD quality control market is anticipated to witness lucrative growth between 2024 – 2032.

• Germany is renowned for its engineering excellence and high-quality manufacturing processes. This reputation extends to the production of IVD quality control products, ensuring they meet rigorous standards of precision and reliability.
• Additionally, Germany invests significantly in R&D within the life sciences and healthcare sectors. This investment supports the continuous innovation and improvement of IVD quality control technologies.

Japan IVD quality control industry is expected to grow significantly over the years.

• Japan is renowned for its cutting-edge technology and innovation across various industries, including healthcare. Japanese companies continually develop advanced IVD quality control solutions that incorporate the latest technological advancements.
• Japanese products are often associated with reliability, precision, and durability. This reputation enhances the competitiveness of Japanese IVD quality control products in both domestic and international market.

UAE market is anticipated to witness lucrative growth between 2024 – 2032.

• The UAE government has launched various initiatives to enhance healthcare services and infrastructure, including the promotion of preventive care and the development of healthcare innovation hubs. These initiatives create opportunities for IVD quality control companies to contribute to the advancement of healthcare standards.

IVD Quality Control Market Share

The IVD quality control industry is highly competitive, marked by several players striving for market dominance. Providers offer comprehensive storage and analysis with improved efficiency and affordability. This includes advancements in processing, precision, automation, and customization. Competition is driven by factors such as the quality, reliability, and ease of usage along with integration capabilities with existing technologies, and compliance with regulatory standards. Strategic partnerships with companies and healthcare networks play a crucial role in market positioning.

IVD Quality Control Market Companies

Some of the eminent market participants operating in the IVD quality control industry include

• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Becton, Dickinson and Company
• BIO-TECHNE CORPORATION
• CINVEN LIMITED
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Hologic, Inc.
• Helena Laboratories Corporation
• Merck KGaA
• QIAGEN N.V.
• QuidelOrtho Corporation
• Randox Laboratories Ltd.
• Sysmex Corporation
• Siemens Healthineers AG
• Thermo Fisher Scientific, Inc.

IVD Quality Control Industry News

• In November 2023 Merck, launched ChemisTwin, the first digital reference materials platform. It performed automatic analysis of samples’ purity, identification, and degradation of compounds through calibrated algorithm-based digital references. The platform benefited the company by streamlining analysis processes, enhancing accuracy, and facilitating quicker decision-making in research and development.
• In April 2021, Thermo Fisher Scientific Inc. acquired PPD, Inc., a provider of clinical research services to the pharma and biotech industry. This acquisition enhanced Thermo Fisher's IVD quality control capabilities by integrating PPD's expertise in clinical research, enabling more robust clinical validation of diagnostic tests.

The IVD quality control market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Type

• Quality control
  • Serum/plasma-based controls
  • Whole blood-based controls
  • Urine-based controls
  • Other quality controls
• Data management solutions
• Quality assurance services

Market, By Product

• Control
  • Total protein
  • Albumin
  • Blood urea nitrogen
  • Uric acid
  • Creatinine
  • Sodium
  • Potassium
  • Chloride
  • Calcium
  • Magnesium
  • Aspartate transaminase
  • Creatine kinase
  • Gamma glutamyl transferase
  • Total bilirubin
  • Other controls
• Calibrators
• Other products

Market, By Application

• Immunochemistry
• Clinical chemistry
  • Electrolytes and minerals
  • Renal function
  • Liver function
  • Proteins and enzymes
  • Cardiac markers
  • Other clinical chemistry applications
• Molecular diagnostics
  • Nucleic acid amplification tests
  • DNA sequencing
  • Genetic testing
  • Other molecular diagnostic applications
• Microbiology
• Hematology
• Coagulation and hemostasis
• Other applications

Market, By Manufacturer Type

• Third-party controls
  • Independent controls
  • Instruments specific controls
• Original equipment manufacturer controls

Market, By End-use

• Hospitals
• Clinical laboratories
• Academic and research institutes
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa