Cost-benefit outcomes and novel anti-thrombotics are having an impact on future development of this industry segment, says market analyst
Substantial growth is expected in the European market for point-of-care (POC) coagulation testing, as an increasing number of outpatient anticoagulation clinics show impressive clinical and cost results for POC testing.
New analysis from international growth consultant Frost and Sullivan reveals that the POC testing market in Europe, including near testing and self testing devices, will grow dramatically from €140 million in 2003 to over €350 million in 2009.
POC coagulation analysers are gaining preference in the critical care, surgery, and home testing environments since they provide healthcare professionals rapid and accurate information for improved patient monitoring. "The biggest advantage of POC testing is the decrease in turn-around time because most POC analyses are performed on whole blood, minimising any transport and logistical handovers that normally occur within laboratory testing," explains research analyst Shree Viswadia, from Frost and Sullivan.
Coagulation testing looks at end-point measurements between bleeding and clotting (thrombosis) and the new technological developments are expected to allow a comprehensive assessment of the complex interactions between various blood clotting factors.
"The high portability of POC instruments means that they are available at near patient sites along with an extensive breadth of menu for tests," observes Viswadia.
Currently, near patient testing (NPT) - patient bedside, emergency room, critical care room, intensive care unit, immediate care wards and operating room - forms the bulk of POC coagulation tests.
However, the self-testing segment, where patients monitor themselves at home, away from the sites of professional patient care, is expected to grow in the near future.
Manufacturers are focusing on technological advancement to strengthen their hold in this competitive market, offering easy to operate and fast working analysers.
The incorporation of dosing software allows healthcare personnel to save and download test results for quick reference. Along with audit trail facilities that link hospital intranet systems and share data, this is an attractive value addition to traditional POC testing.
While rapid turn-around time and timely dosage adjustments allowed by POC testing shortens patient stay in hospitals, such decentralised testing also helps in dealing with the dearth of trained health personnel.
Although benefits including advances in connectivity are driving POC instrument adoption; quality control issues, attitudes of physicians, and reimbursement policies could restrain uptake.
"Concerns over quality control for patients monitoring their own International Normalised Ratio (INR) for blood clotting time have not yet been addressed," notes Viswadia.
"Also, the results derived from one coagulation technique to the next are significantly different and physicians might prefer traditional laboratory tests to home monitors".
The slow implementation of insurance policies providing reimbursement for off-site testing is another market dampener.
Without clear reimbursement schedules, apprehensions about purchasing and utilising home testing monitors are likely to hold back sales.
Another market concern is the development of new thrombin inhibitor drugs such as Ximelagatran.
Their approval and marketing could gradually eliminate the need for routine blood coagulation monitoring. Manufacturers are working towards a new generation of monitors that provide rapid quantitative data and have low operating costs to the patient and healthcare institution.
"The future in POC coagulation monitors will include instruments that have expanding test menus and smaller sample sizes making them more suitable for alternate site testing," statesViswadia.
POC testing is finding increasing acceptance across Europe with Germany, Italy and the United Kingdom having the largest number of users.
With the number of elderly patients increasing, self-testing is also expected to help lighten the laboratory workload on hospitals and physicians' offices.
Frost and Sullivan will hold a conference call at 14:30hrs GMT (15:30 CET) on Tuesday 9 December 2003, which will provide industry participants with an outlook for the European point-of-care coagulation testing market, including an introduction to the market, the discussion of market drivers and restraints as well as regional aspects.
To participate, please email to reports@frost.com with your name, company, title, telephone number, and e-mail.
Upon receipt of the above information, a confirmation/pass code will be e-mailed to you.