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Analysis of the US Clinical Laboratories Market

Analysis of the US Clinical Laboratories Market

The majority of the quantitative and qualitative information contained in this research service was acquired through primary research conducted with individuals from clinical laboratories. Several consultations were conducted with vice presidents of business units and marketing, product managers, marketing managers, marketing directors, and business development directors from competitors in reference and specialty laboratories. Industry-specific information obtained includes:

Revenue breakdowns by customer segments: hospital-based labs, independent labs, and physician office laboratories (POLs)

Revenues, market share estimates, and projected growth rates of competitors

Top-level understanding of market drivers, restraints, laboratory counts, and test volume by specialty Supplementary research was conducted utilizing secondary sources including scientific journals, online media, Frost & Sullivan databases and research services, and publicly available corporate filings. Forecasts are based on the data and analyses regarding industry challenges, market drivers and restraints, and market trends. If specific revenues or market sizes were unavailable, estimates were derived through consultations with industry experts, augmented by secondary research. Growth trends specific to certain market participants are based on consultations, past growth rates, and regulatory governance.

About this report

This research service evaluates the US clinical laboratories market. The analysis provides extensive understanding of test distribution in independent laboratories (reference and specialized), physician office laboratories, hospital-based labs, and others including retail clinics and mobile diagnostic centers. The study covers the potential impact of the Food and Drug Administration’s laboratory-developed test (LDT) regulation guideline on clinical laboratories and the effects of the physician fee schedules (PFS) and clinical laboratory fee schedules (CLFS) on the price of tests. Key companies to watch for high-complexity testing and home health monitoring have been assessed. The study period is from 2012 to 2018; the base year is 2014.


  • Methodology
  • Executive Summary
    • Key Findings
    • Scope and Segmentation
    • Key Questions this Study will Answer
    • Market Engineering Measurements
    • Key Companies to Watch in 2015
    • Key Companies to Watch in 2017 and Beyond
    • 3 Big Predictions
    • Decentralization of Healthcare
    • Preference of Higher-deductible Plans
    • Predicted Implications and Opportunities for Diagnostic Manufacturers
  • Market Overview
    • Clinical Laboratories Landscape
      • Table Clinical Laboratories Market: Test Volume by Facility Type, US, 2014
      • Table Clinical Laboratories Market: Test Volume by Specialty, US, 2014
    • Clinical Laboratories-Current Business Model
    • Patient-centric Solutions
    • Laboratory Information Service Model
    • Partnership Models Between Commercial Labs and Hospital Labs
    • Defining Healthcare Trends in the Future
  • Competitive Playbook
    • New Market Opportunities
    • Merger, Acquisition, and Partnership Assessment
    • Number of Closed Deals
    • Acquisition Highlights
    • Laboratory Transaction Trends
  • Drivers, Restraints, and Trends-Total Clinical Laboratories Market
    • Market Drivers
    • Drivers Explained
    • Market Restraints
    • Restraints Explained
      • Table Clinical Laboratories Market: Direct-to-consumer Test Price Comparison, US, 2015
      • Table Clinical Laboratories Market: Selected Laboratory Debt Scenario, US, 2013
      • Table Clinical Laboratories Market: ACA Projected CLFS Reductions, US, 2010-2022
    • Market Impact of Top 10 Trends
  • Forecasts and Trends
    • Market Engineering Measurements
      • Table Clinical Laboratories Market: Market Engineering Measurements, US, 2014
    • Forecast Assumptions
    • Revenue Forecast
      • Table Clinical Laboratories Market: Revenue Forecast, US, 2012-2018
    • Revenue Forecast by Segment
      • Table Clinical Laboratories Market: Revenue Forecast by Segment, United States, 2012-2018
    • Growth Rate by Segment
      • Table Clinical Laboratories Market: Growth Rate by Segment, US, 2013-2018
    • Revenue Forecast Discussion
  • LDTs and FDA Tests-Comparison by Therapeutic Area
    • LDTs vs. FDA Tests
    • Competitive Environment
    • Market Share Analysis
      • Table Clinical Laboratories Market: Market Revenue by Company, US, 2014
    • Specialty Diagnostic LDT Companies
      • Table Specialty Diagnostic LDT Companies
    • Routine Testing Laboratories
      • Table Routine Testing Laboratories
  • Competitor SWOT Analysis
    • Reference Laboratories
    • Specialized Laboratories
    • Hospital Laboratories
    • POLs
  • The Last Word
    • The Last Word-3 Big Predictions
  • Appendix
    • Market Engineering Methodology

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