IVD Quality Control Market To Reach $1.13 Billion By 2024

July 2016 | Report Format: Electronic (PDF)

The global IVD quality control market is expected to reach over USD 1.13 billion by 2024 according to a new report by Grand View Research, Inc.

The continually evolving technology-oriented changes in the diagnostics field and the growing requirement to ensure patient safety necessitate the implementation of quality assurance programs in various medical disciplines including radiology and point-of-care devices.

The patients rely on self-testing IVD devices for long-term disease management and hence it is important for such IVD devices to be checked for quality in terms of result reproducibility and validity in order to guarantee patient safety. The rising number of certified clinical laboratories offering dependable IVD-based diagnostic services directly correlates with increased patient confidence, thus driving the quality control market.

In addition to quality assessments, amendments to the regulatory framework are made intermittently to enhance the present quality standards with the main objective of safeguarding qualitative superiority of the diagnostic services rendered to patients.

In May 2016, the European Union passed an agreement to update the pre-existing regulations pertaining to IVD devices wherein the updates were in concern with raising the patient safety levels, particularly for disabled persons. Furthermore, the presence of third party quality control agencies for independent assessment of the IVD devices is expected to elevate the current safety standards, which is expected to further propel the market growth.

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Further key findings from the study suggest:

  • In 2015, the clinical chemistry segment dominated the IVD quality control market with a share of over 35%. The increasing demand for preventive medicine and the rapid transformation of clinical laboratories into highly automated and efficient businesses are some of the factors for its large market share.

  • The molecular diagnostics is one of the fastest growing segments during the forecast period owing to the increasing technical complexity of molecular diagnostic testing coupled with the constant need for quality evaluation to ensure standards. The molecular diagnostics tests are of prime importance as the test outcomes enable healthcare practitioners make critical treatment decisions.

  • The hospital segment held the largest share in 2015 due to the presence of highly advanced technology-based devices, such as Next Generation Sequencing (NGS), mass spectrophotometry, and microarrays, and the rising applications of the optimized quality-control procedures

  • The North America contributed over 43% of the market share in 2015 attributable to the presence of over 150,000 registered diagnostics laboratories. The clinical laboratories are required to provide accurate results and maintain the accuracy standards in order to retain their license to operate.

  • Many pharmaceutical companies are implementing the new draft guidance enforced by the U.S. FDA for data integrity on current Good Manufacturing Practices (cGMP).It provides information in relation to establishing robust operating procedures and strong quality management systems, obtaining high-quality raw materials, investigating quality deviations, and maintaining reliable diagnostic laboratories

Grand View Research has segmented the IVD quality control market on the basis of application, type, end-use, and region:

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

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • MEA

    • South Africa

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