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Analysis of the US Clinical Laboratories Market 

  • October 2015
  • -
  • Frost & Sullivan
  • -
  • 96 pages

Summary

Table of Contents

Analysis of the US Clinical Laboratories Market : Decentralization will Significantly Increase Retail Setting Test Volume by 2017

Key Findings

The clinical laboratories market in the United States was valued at $ Billion in 2015. Value is expected to rise to $ Billion by 2018 at a compound annual growth rate (CAGR) of %.

Market Drivers:

Factors propelling growth include increased medical innovation in companion diagnostics and personalized medicine, uptake of newer technologies providing faster turnaround time (e.g., digital pathology and liquid biopsy), and increased test utilization due to emphasis on early detection and screening.

Market Restraints:

Factors restraining growth include increased Food and Drug Administration (FDA) regulatory oversight of laboratory-developed tests (LDTs), delayed (k) review periods that affect entry of new tests into the market, reimbursement pressures because of cuts in physician fee schedules (PFS) and clinical laboratory fee schedules (CLFS) that result in market consolidation, and a test volume shift from laboratories to retail clinics.

Future Trends

- Decentralized testing will promote the healthy growth of retail clinics and easier access to low-cost healthcare.

- Manufacturers will see high growth in the point-of-care (POC) testing sales of reagents and analyzers as there activity increases in walk-in clinics. Manufacturers will also offer disruptive technologies based on microfluidics and cheaper disposable cartridges for near-site testing.

- By 2020, Frost & Sullivan predicts about a % reduction in the CLFS based on the current imposed laws. As a result, many fee-for-service models and outreach practices will be in jeopardy, paving the way for value-based healthcare delivery.

Specialty laboratories will remain acquisition targets for bigger reference laboratories because of their strong growth in genetic and molecular testing. These laboratories perform high-value testing; as a result, healthy growth is projected.

- Pricing transparency in the healthcare marketplace will be a trend. Laboratories will disclose test prices, encouraging customers to shop around.

- The FDA’s LDT guidance, if implemented, would affect several high-risk tests and restrain revenue for several specialty diagnostic companies.

- Use of customer relationship management (CRM) and other informatics tools to support data availability and enable physicians to make guided reimbursements will become the norm. Laboratories will also embrace interoperability standards.

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