Consumerism and a Test Volume Shift to the Retail Setting will Increase Significantly by 2017

Once the US shifts from a fee-for-service model to a value-based one, clinical laboratories will see considerable demand for preventative testing
Frost & Sullivan
2016-01-12 22:35 2169

MOUNTAIN VIEW, Calif., Jan. 12, 2016 /PRNewswire/ -- Although diagnostic testing constitutes only about three percent of healthcare expenses, it determines 70 to 80 percent of diagnostic decisions. Due to its influential role in delivering high-quality healthcare, the U.S. clinical laboratories market will stay buoyant in the coming years.

Frost & Sullivan
Frost & Sullivan

Analysis from Frost & Sullivan, Analysis of the US Clinical Laboratories Market (, finds the market earned revenues of $77.56 billion in 2015 and estimates this to reach $90.21 billion in 2018.

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"Increased innovation in companion diagnostics and personalized medicine is boosting the value of diagnostics in the total healthcare industry," said Frost & Sullivan Transformational Health Senior Industry Analyst Divyaa Ravishankar. "Additionally, the uptake of new technologies such as digital pathology and liquid biopsy capable of providing faster turnaround times is propelling the U.S. clinical laboratories market."

Once the move from a fee-for-service model to a value-based healthcare takes effect, precision medicine will strengthen and preventative testing will grow in popularity. However, in the process traditional laboratory testing demand at high-volume centers such as hospitals and health centers will witness a downtrend.

Furthermore, with direct-to-consumer testing promoting the retail setting delivery, many core and independent laboratories could see their test volumes decrease. This will remain a restraint for laboratories as several companies are propagating Internet-based testing.

In line with regulations, community pharmacies will sell point-of-care tests for low blood volume qualitative tests for electrolytes, renal function, thyroid stimulating hormones and liver function as well as STD panels, viral hepatitis panels, respiratory panels and opioid panels.

However, the Food and Drug Administration's oversight of laboratory-developed test (LDT) regulations to ensure quality, safety and validity while developing these tests will continue to challenge specialty laboratories focused on niche types of testing. Reimbursement pressures due to cuts in physician lab fee schedules and clinical lab fee schedules will also negatively affect the U.S. clinical laboratories market.

"From a reimbursement standpoint, molecular testing is an attractive segment for U.S. clinical laboratories. Most companies focusing on molecular testing show double-digit revenue growth, in contrast to single-digit growth in laboratories performing clinical chemistry panels, immunoassays or culture tests," pointed out Ravishankar. "Investing in startups or established firms pioneering molecular testing could be a means to generate value adds for larger reference laboratories."

Analysis of the US Clinical Laboratories Market is part of the Life Sciences ( Growth Partnership Service program. Frost & Sullivan's related studies include: Analysis of the Cardiac Biomarker Diagnostics Market, US Nucleic Acid Purification and Isolation Markets, Analysis of the Global Flow Cytometry Market, and Analysis of the US and European Diabetes Diagnostics Market. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

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Analysis of the US Clinical Laboratories Market

Kayla Belcher
Corporate Communications – North America
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Source: Frost & Sullivan
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