NEW YORK, Dec. 18, 2014 /PRNewswire/ -- Although the market
for IVD products sold in physician office labs (POLs) is expected
to show minimal growth, certain test categories will perform above
average in terms of revenues, according to Kalorama
Information. Kalorama found that the market grows at a little
more than 3% per year, but that certain tests will see faster
revenue growth. The finding was made in Kalorama
Information's recent report, Physician Office Laboratory
Markets.
Kalorama last conducted a survey of physician office labs in
2010. Its updated physician office report is available
at: http://www.kaloramainformation.com/Physician-Office-Laboratory-8339073/.
The POL market encompasses a variety of institutions beyond
physician practices, including specialty and multispecialty
clinics; other primary care and urgent care clinics; and outpatient
clinics not located or associated with a hospital (or hospital lab)
or outpatient surgical services. Physician office
laboratories are diverse in their capabilities and setting.
Individual practitioners may simply perform reimbursable, in-office
pregnancy and glucose tests. Some specialty practices and clinics
run CBCs and chemistry panels using small lab and benchtop
automated analyzers requiring moderate complexity CLIA compliance.
Medicare physician filings also indicate POLs perform moderate
complexity infectious disease tests using plate immunoassays and
molecular assays as well as in-situ hybridization tests using
tissue samples.
According to the report the following tests will demonstrate
faster-than-average revenue growth in the global POL
market.
- Anemia tests and markers including B12/folate, serum
iron, total iron binding capacity (TIBC) and ferritin largely round
out the POL market for anemia tests Test demand remains high due to
demographic aging as well as the clinical prevalence of anemia and
available remedial treatments able to be initiated by primary care
practitioners.
- Microalbumin is an important marker of kidney function
in diabetics that has seen increased usage by physicians worldwide.
With increasing standards of diabetic care and intervention in the
developing world and still rising usage of the test in North America and Europe, the POL microalbumin test market is
expected to demonstrate revenue growth of 10% per year.
- Cardiac Markers (CK-MB, other assays of creatine kinase
[CK], troponins, myoglobin and BNPs) on laboratory medicine and
rapid tests are used for the early detection of CVD risk in at risk
individuals.
- CRP –a known marker of chronic inflammation and can be
used to detect infections and differentiate between bacterial
(significantly elevated CRP) and viral infections. High-sensitivity
CRP (hsCRP) is an assay form increasingly present on POC analyzers
and is used to determine if slightly elevated CRP levels are
present, an indicator of CVD risk. CRP tests are much more widely
used in European POLs, especially German and Swiss markets, than in
U.S. POLs.
- HbA1c –usually checked on diabetics during their routine
visits, Glycated hemoglobin (HbA1c) is a hemoglobin variant with
attached glucose that is clinically significant as a measure of
long-term blood sugar levels (or hemoglobin's exposure to glucose)
and as an evaluation tool for patient glucose control. Ideally,
insulin-dependent diabetics should have their HbA1c fraction tested
every 3 months. The HbA1c test market does not depend upon
frequent consumer testing to generate volume, but rather has
delivered growth through more regular patient screening, the
limited introduction of self-testing, and rising application in
healthcare systems worldwide.
In addition to these areas, Kalorama sees the possibility that
molecular tests will reach the POL. Routine infectious
disease testing has invited the first forays of molecular
diagnostics into the space. Several molecular platforms already
support ease-of-use, moderately complex flu assays that can be
performed outside of central labs. While CLIA waivers for such
molecular assays would assuredly boost their market potential,
regulators' concerns over CLIA-waived test QA/QC measures among POC
users will likely delay the first such milestone waiver for
molecular POC. Moderate-complexity molecular systems' penetration
among CLIA-certified POLs is expected to represent only a minor
paradigm of growth for the overall POL market.
Kalorama Information's Physician Office Laboratory
Markets presents readers not only the leading
opportunities for IVD sales growth in the POL channel, but is also
a valuable resource for determining competitive positioning within
the channel vis-à-vis its leading players. Find this report in
addition to other industry leading research from Kalorama
Information at: http://www.kaloramainformation.com/.
About Kalorama Information -- Kalorama Information, a
division of MarketResearch.com, supplies the latest in independent
medical market research in diagnostics, biotech, pharmaceuticals,
medical devices and healthcare; as well as a full range of custom
research services. We routinely assist the media with healthcare
topics. Follow us on Twitter, LinkedIn and our blog.
Contact:
Bruce Carlson
(212) 807-2622
bcarlson@kaloramainformation.com
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SOURCE Kalorama Information