In Vitro Diagnostics (IVD) Quality Control Market Size & Forecast Report, 2013 - 2024

Industry Insights

The global In-Vitro Diagnostics (IVD) Quality Control Market is anticipated to reach USD 1.13 billion by 2024. The rising number of certified clinical laboratories requires quality control (QC) services to maintain their standards, associated with the increasing acceptance of third-party providers of quality control services, to ensure accurate and reproducible test results and better outcomes which are anticipated to drive the growth. 

For the establishment of definite standards of quality, the internal Quality Control (QC) programs and the external QAS (Quality Assurance Schemes) is very important to ensure validity and reliability of the test results obtained by the IVD devices. These programs are essential in confirming the delivery of patient diagnostic outcomes, which are reliable and without errors, such as misdiagnosis because of device-related errors, which can impact the health of the patient.

The regulation of these In vitro diagnostics devices are controlled by the respective regulatory bodies, which includes the U.S. FDA (Food and Drug Administration), the International Medical Device Regulators Forum (IMDRF), the European Commission, the Australian Therapeutic Goods Administration (TGA), the Eurasian Economic Union (EEU) and the Brazilian National Health Surveillance Agency (ANVISA).

The currently undergoing, extensive R&D-related activities besides the introduction of new laws to improve the efficacy and safety levels of the IVD services are anticipated to drive market growth. For example, in September 2012, a new regulation for IVD devices was published by the European Commission targeted to enhance transparency, safety, and traceability without constraining innovation. These new regulatory inclusions are anticipated to drive market growth.

Type Insights

On the type basis, the IVD quality control market is categorized into quality assurance services quality control (QC), and data management. The QC schemes are appropriate to plasma-based, whole blood-based, and serum-based products. In 2016, the QC market was one of the largest segments because of the rapidly developing IVD technologies and the existence of numerous internal QC programs for the different features of the IVD device-based procedures of testing

Application Insights

There are numerous applications of the IVDs, which include hematology, immunology, coagulation, clinical chemistry, molecular diagnostics, and microbiology. Amongst these all, molecular diagnostics is anticipated to be the fastest-growing market segment with a 4.88% CAGR. The frequent usage of the technologies in molecular diagnostics, such as gene expression and PCR, high accuracy, and specificity are some of the responsible factors associated with its high growth.

End-use Insights

The hospitals market segment was valued as the largest market segment of over 46.0% in 2016 owing to the high application of IVD tests in hospitals and the necessity of obedience with the IVD directives for product traceability. The home care market segment is anticipated to observe a lucrative progression owing to the persistent increase in the usage of devices for point-of-care testing. The rise in adoption of microchip technology which is used to handle fluids in IVD equipment, as well as the enhanced production processes and the miniaturization technology are creating efficient point-of-care devices, which are very less susceptible to errors.

Regional Insights

In 2016, the largest market share of the IVD quality control market was found to be in North America with revenue of approximately USD over 400.0 million. The existence of a huge number of qualified clinical laboratories, a good distribution network and the rising number of IVD products approvals having assured safety and quality from the regulatory authorities are some of the major driving factors.

The Asia Pacific region had the highest CAGR of over 4.8% owing to the rising government efforts for the standardization of the testing procedures of the clinical laboratory to improve the accuracy of results.

Competitive Market Share Insights

Some major key players of the IVD quality control market include Siemens Healthcare GmbH, Alere, Inc., Roche Diagnostics, Abbott Laboratories, Inc., Qiagen N.V., Hologic, Inc. (Gen-Probe), Bio-Rad Laboratories, Inc., Becton, Dickinson and Company(BD), Quidel Corporation, bioMerieux, Inc., Thermo Fisher Scientific, Inc., Sero AS and Sysmex Corporation.

Market Segments

IVD Quality Control Market Application Outlook, by Revenue (USD Million, 2013 - 2024)
    • Clinical Chemistry
    • Immunochemistry
    • Hematology
    • Molecular Diagnostics
    • Coagulation
    • Microbiology
    • Others

IVD Quality Control Market Type Outlook, by Revenue (USD Million), 2013 - 2024
    • Quality Controls
        • Plasma-based Controls
        • Serum-based Controls
        • Whole Blood-based Controls
        • Other IVD Quality Controls
    • Data Management
    • Quality Assurance Services

IVD Quality Control Market End-use Outlook, by Revenue (USD Million), 2013 - 2024
    • Home-care
    • Laboratory
    • Hospitals
    • Others

IVD Quality Control Market Regional Outlook, by Revenue (USD Million), 2013 - 2024
    • North America
        • the U.S.
        • Canada
    • Europe
        • Germany
        • the UK
    • the Asia Pacific
        • Japan
        • China
    • Latin America
        • Brazil
        • MEA
    • South Africa