The U.S. clinical laboratory market is on the cusp of radical changes, but it is unclear if these transitions will bring greater prosperity to the market or dampen its growth prospects. The market is assessing the impact of developments like Accountable Care Organizations (ACOs) and Food and Drug Administration (FDA) oversight on laboratory developed tests (LDTs). Further, the market is witnessing physician migration to hospitals, continued consolidation of laboratories and hospitals, increased connectivity among all healthcare providers, and changes to current procedural terminology (CPT) coding in molecular pathology.
New analysis from Frost & Sullivan's (drugdiscovery.frost.com) Analysis of the U.S. Clinical Laboratory Market research finds that the market generated revenues of $63.92 billion in 2011 and estimates this to reach $89.31 billion in 2017. The most significant revenue growth in the forecast model will occur in 2014 due to the Affordable Care Act, which will expand healthcare coverage to 19.5 million people. After 2014 in this forecast model, falling reimbursement rates for laboratory testing will cause market growth to lag behind the national health expenditure.
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The unceasing need for testing of transmittable disease will remain a key driver for diagnostics, as new pathogen strains (seasonal influenza, H1N1, etc.) develop each year. Clinical laboratories will also address the rising incidence of hospital-acquired infections, such as methicillin-resistant staphylococcus aureus (MRSA) and sexually transmitted diseases (STDs) like human papillomavirus (HPV) and HPV-positive head and neck cancers.
"The infectious disease segment is the predominant application for molecular pathology and accounts for 60 percent of the market," said Frost & Sullivan Industry Analyst Winny Tan, Ph.D. "The tremendous need and rapid technological development guarantee higher volumes of molecular diagnostic tests for infectious disease."
While opportunities are abundant, laboratories are feeling the pinch of a 1.75 percent cut to the Medicare lab fee for the next five years. Furthermore, with new American Medical Association (AMA) codes that are analyte-specific, substituting stacked procedure codes, the high-growth molecular pathology segment will likely follow the trend of falling reimbursement rates observed across healthcare.
Traditionally, the pathology practice has not been patient interfacing; however, pathologists will have to become more than just interpreters of laboratory results to help reverse the diminishing reimbursement trend. By being ambassadors for the laboratory, pathologists can help publicize the value of laboratory testing, which will in turn influence patient care.
"Laboratories must empower pathologists with continuous development and leadership training," said Tan. "Additional efforts to increase the pathologist's role would involve establishing patient case reviews with other healthcare professionals, such as physicians and radiologists. Once they are adequately prepared for their expanded roles, they can begin to integrate the patients' total laboratory testing history with the current diagnosis."
The market can help patients save costs and simultaneously increase test volumes by advocating early detection of diseases. The introduction of ACOs that rely on value-based medical care will also reinforce the use of screening tests and, thereby, generate higher revenues for the market.
Analysis of the U.S. Clinical Laboratory Market is part of the Life Sciences Growth Partnership Services program, which also includes research in the following markets: Vital Signs - Extending Diagnostic Testing from the Clinical Laboratory and Physician Office to the Retail Clinic; Vital Signs - Molecular Diagnostics Market Review: Opportunities in Infectious Diseases, Oncology, Carrier Screening, and Prenatal Testing; Strategic Analysis of Central and Eastern European IVD Market; and U.S. Hospital EHR Market 2009-2016. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.
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Analysis of the U.S. Clinical Laboratory Market / NA84-55