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Sep 15, 2013 (Vol. 33, No. 16)

The Rising Star of the Clinical Diagnostic Industry

Point-of-Care Testing Can Change Therapy Decisions, Improve Outcomes, and Lower Costs

  • Click Image To Enlarge +
    Impact mapping of drivers and restraints, U.S. and Western Europe, 2013–2019

    The global point-of-care testing (POCT) market sales revenue was $5.32 billion in 2012 and is expected to reach $9.03 billion in 2019, expanding at a compound annual growth rate (CAGR) of 7.9% between 2012 and 2019. This includes professional-use POCT only (hospitals, physician office laboratories, primary care centers, etc.). Frost & Sullivan’s recent analysis shows that the POCT market is expected to grow steadily.

    Manufacturers globally continue to focus on areas in which near-patient diagnosis and monitoring can profoundly change therapy decisions, improve outcomes, and lower costs. Companies are strengthening their R&D focus for the development of highly sensitive biosensors, less expensive optical systems, and noninvasive systems to integrate into POCT instruments for better performance. Microfluidic systems based on the lab-on-chip concept, along with increased biomarker discoveries of equipment, may witness a paradigm shift in the clinical diagnostics industry.

    Point-of-care molecular diagnostic testing is under development, concentrating on viral load and infectious diseases. Infectious disease testing continues to expand in emerging countries, while cardiovascular and diabetes testing is growing in developed countries.

    In the United States, the overall adoption of POCT is gradually increasing, and this will have a significant impact on the traditional means by which clinical diagnostic tests are performed. POCT has been well supported in Western Europe despite reimbursement issues for certain types of tests. However, the high cost of POCT on a cost-per-test basis, when compared to central laboratory tests, is a challenge.

  • Click Image To Enlarge +
    Impact mapping of drivers and restraints, emerging countries, 2013–2019

    While most parts of Western Europe and the United States are well-versed with automated POCT, in developing markets such as India, Taiwan, and South Korea, physicians are reluctant to adopt POCT because quality standards are still a major concern. The growing trend toward automation and modernization of laboratories and hospitals in emerging countries will lead to future opportunities in the POCT market. Point of care is expected to gain importance in emerging countries in Asia, Africa, and parts of Central and Eastern Europe as well.

  • Part of Every Major Hospital Unit

    The frequency, type, and scale of diagnostic sensing and testing will increase at the patient’s bedside. Hospital laboratories will carry out additional functions such as quality control studies and cross-checking evaluations of the functional efficacy of POCT systems.

    There is a shift from concepts such as mobile laboratories and in-house testing to lab-on-chips (LOCs) and noninvasive diagnostics. Advancements in molecular diagnostics and microfluidics technology will expand the market. Though it will be difficult to perform sample testing using noninvasive modes because of their technical barriers, they will definitely improve vital signs monitoring and disease diagnostics in different settings.

    The perception of POCT changes with technological advances by improving the quality of tests and lowering the costs. The impact will be directly visible on the reduction in the volume of laboratory-based sensing. POCT will get incubated as a ubiquitous part of every major hospital unit.

    However, the perception of facilitating home and hospital-based tests differs for various regions:

    • In the United States and United Kingdom, there is a high level of retail with major pharmacy chains, which will be a booster to drive sales of POCT kits.
    • Modernization of pathology services in emerging countries will increase the uptake of POCT, leading to increased patient awareness of diagnostics.
  • POCT Integration with Healthcare IT

    To facilitate enhanced POCT data management, manufacturers may look to partner with IT vendors. This will facilitate automated systems for discrete time-bound or continuous monitoring. This would require no supervision and would automatically sort critical patients needing immediate attention, notifying the concerned medical caregiver.

    However, such continuous sampling or automated discrete time-bound sampling may hugely increase test costs for a patient. This issue needs to be resolved. Possibly, if such continuous testing devices are available, some sort of packaged testing subscription can be levied instead of charging per test. This would increase and promote equipment usage.

    However, such automated diagnostics and therapies in a conjoint loop are increasingly becoming a requirement. For instance, researchers found that maintenance of normal glucose levels during surgery allows a patient to recover faster, have fewer complications, and spend fewer days in a hospital as an in-patient.

    POCT enhances value propositions through the adoption of e-Health techniques of wireless transfer and networked data storage and integration. This will not only enhance data-management capabilities, but also boost easy and safe integration of POCT within hospital set-ups.

  • Diversifying Product Portfolios

    As the capabilities of POCT grow, so does the potential addressable market. This is in relation to new diseases or mutations that arise and novel areas where POCT has yet to be utilized.

    POCT is expanding to other areas such as oncology, gastrointestinal diseases, bone health, and women’s health. A few companies, such as Augurix Diagnostics, have ventured into under-diagnosed medical conditions. Similarly, Alere has ventured into bladder cancer and tests for placental growth factor to aid in the prediction of preeclampsia.

    New opportunities continue to emerge as new infectious diseases emerge. In the future, rapid diagnostic tests will continually be needed to diagnose and screen for outbreaks and mutations of known diseases.



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