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
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About
Grand View Research:
Grand View Research, Inc. is a U.S.
based market research and consulting company, registered in the State of
California and headquartered in San Francisco. The company provides syndicated
research reports, customized research reports, and consulting services. To help
clients make informed business decisions, we offer market intelligence studies
ensuring relevant and fact-based research across a range of industries, from
technology to chemicals, materials and healthcare.
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