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Impact of US Healthcare Reform on the In Vitro Diagnostics Market

  • June 2014
  • 87 pages
  • Frost & Sullivan
Report ID: 2212022


Table of Contents

Patient Influx and Increased Testing Will Steer Clinical Labs toward ACO Models

This Market Insight highlights the effects of the US Patient Protection and Affordable Care Act on the in vitro diagnostics (IVD) market, diagnostic test service providers, and IVD manufacturers. The deliverable also focuses on global trends and the outlook for the IVD market. Estimates and trends for all IVD segments—immunochemistry, point-of-care testing, molecular diagnostics, clinical microbiology, tissue diagnostics, hematology, hemostasis, and self-monitoring blood glucose—are provided. Key market drivers and restraints and the competitive landscape for the global market are discussed. The base year is 2013.

Executive Summary
-The US healthcare reform act, commonly called the Affordable Care Act (ACA), has created both challenges and opportunities for clinical laboratories and manufacturers of in vitro diagnostics (IVD). Negative effects include reimbursement reductions and cost containment measures due to decreased operating margins; positive effects include increased prevention and wellness services that will increase test volumes for labs.
-Home care, healthcare information technology (HCIT), pharmaceuticals, and wellness services are expected to benefit as a result of healthcare reform.
-As a result of reimbursement issues and greater awareness, laboratory-based testing is becoming decentralized, which will result in the growth of point-of-care testing (POCT) and molecular diagnostics segments of the IVD industry.
-Next-generation sequencing and digital polymerase chain reaction (dPCR) remain popular molecular diagnostic technologies.
-Clinical microbiology, tissue diagnostics, hemostasis, hematology, and immunochemistry are moving toward automation. These are well-established, mature segments dominated by IVD market leaders. Competition between market participants is stiff.
-With personalized medicine on the horizon, more pharmaceutical and IVD industry partnerships are being observed to develop companion diagnostic products.

Opportunities for IVD Manufacturers and Clinical Labs
The following are macro-level trends for the IVD industry:
-Decentralization: The move to reduce costs and perform diagnosis during single patient visits generate more demand for point-of-care testing (POCT) applications.
-Molecular testing: Technologies and tests based on genetic material and protein composition that facilitate early detection and a personalized approach are on the horizon. As of 2013, the National Institutes of Health (NIH) Genetic Testing Repository had about tests available for conditions for genes.
-Automation: New testing methods are coupled with laboratory information management systems to suit growing demand and staffing shortages.

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