Analysis of the US Clinical Laboratories Market

Decentralization will Significantly Increase Retail Setting Test Volume by 2017

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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.

Table of Contents

1. Executive Summary
Key Findings
Scope and Segmentation
Total Clinical Laboratories Market: Market Engineering Measurements, US, 2014
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
2. Market Overview
Clinical Laboratories Landscape
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
3. Competitive Playbook
New Market Opportunities
Merger, Acquisition, and Partnership Assessment
Number of Closed Deals
Acquisition Highlights
Laboratory Transaction Trends
4. Drivers, Restraints, and Trends—Total Clinical Laboratories Market
Market Drivers
Companion Diagnostics and Personalized Medicine will Help Increase Valuation of Diagnostics
Effects of ACA (Early Screening And Detection) Coupled with Aging Population to Increase Test Utilization
Explosion of Genomic Testing Companies to Offer Attractive Acquisition Targets
Technology Adoption Such as Digital Pathology and Liquid Biopsy to Boost the Market Valuation of Modern Testing
Market Restraints
Direct-to-consumer Testing Promotes Retail Setting Delivery, Decreasing Test Volume for Many Core and Independent Laboratories
FDA Oversight of LDTs Can Negatively Impact the High Growth Rates Observed
Impact on Clinical Laboratories
Delayed and decreased Medicare Payments to Hamper Revenue for Clinical Laboratories
Market Impact of Top 10 Trends
5. Forecasts and Trends
Market Engineering Measurements
Revenue Forecast
Revenue Forecast by Segment
Growth Rate by Segment
6. LDTs and FDA Tests—Comparison by Therapeutic Area
LDTs vs. FDA Tests
7. Competitive Environment
Market Share Analysis
Specialty Diagnostic LDT Companies
Routine Testing Laboratories
8. Competitor SWOT Analysis
Reference Laboratories
Specialized Laboratories
Hospital Laboratories
9. The Last Word
3 Big Predictions
Legal Disclaimer
10. Appendix
Market Engineering Methodology


List of Figures & Charts

1. Clinical Laboratories Market: Summary of Major Competition, US, 2015
2. Key Companies to Watch in 2015
3. Key Companies to Watch in 2017 and Beyond
4. Predicted Implications and Opportunities for Diagnostic Manufacturers
5. Clinical Laboratories Market: Test Volume by Facility Type, US, 2014
6. Clinical Laboratories—Current Business Model
7. Patient-centric Solutions
8. Clinical Laboratories Market: Partnership Types, US, 2015
9. Total Clinical Laboratories Market: Market Outlook, US, 2014 and 2024
10. Total Clinical Laboratories Market: Game-changing Strategies, US, 2015
11. Total Clinical Laboratories Market: Notable Deals and Market Impact, US, 2013–2015
12. Clinical Laboratories Market: Quest/LabCorp Acquisition Highlights, US, 2013–2015
13. Total Clinical Laboratories Market: Key Market Drivers, US, 2015–2018
14. Clinical Laboratory Market: New Developments in Companion Diagnostics, US, 2014–2015
15. Total Clinical Laboratories Market: Key Market Restraints, US, 2015–2018
16. Clinical Laboratories Market: Direct-to-consumer Test Price Comparison, US, 2015
17. Clinical Laboratories Market: Proposed LDT Regulation Oversight, US
18. Concerns for a Clinical Laboratory
19. Impact on Clinical Laboratories
20. Clinical Laboratories Market: Public Reaction to LDT Regulations, US, 2015
21. Clinical Laboratories Market: Selected Laboratory Debt Scenario, US, 2013
22. Clinical Laboratories Market: Market Revenue by Company, US, 2014
23. Specialty Diagnostic LDT Companies
24. Routine Testing Laboratories

1. Total Clinical Laboratories Market: Customer Opportunities, US, 2015
2. Total Clinical Laboratories Market: Market Engineering Measurements, US, 2014
3. Clinical Laboratories Market: Healthcare Spending, US, 2013
4. Clinical Laboratories Market: Laboratories by Facility Type, US, 2014
5. Clinical Laboratories Market: Test Volume by Specialty, US, 2014
6. Clinical Laboratories Market: Closed Deals, US, 2009–2015
7. Clinical Laboratories Market: 65 and Older Population, US, 1900–2060
8. Clinical Laboratories Market: Adoption of Liquid Biopsy Survey, Global, 2015
9. Clinical Laboratories Market: Retail Clinic Expansion, US, 2008–2016
10. Clinical Laboratories Market: Projected Payments Based on CLFS Cuts, US, 2010–2015
11. Clinical Laboratories Market: ACA Projected CLFS Reductions, US, 2010–2022
12. Clinical Laboratories Market: Biomarker Test Annual 510(k) Clearance, US, 2003–2014
13. Clinical Laboratories Market: Average Biomarker Test Review Time, US, 2003–2014
14. Total Clinical Laboratories Market: Impact of Top 10 Trends, US, 2015
15. Clinical Laboratories Market: Revenue Forecast, US, 2012–2018
16. Clinical Laboratories Market: Revenue Forecast by Segment, United States, 2012–2018
17. Clinical Laboratories Market: Percent Revenue Contribution, US, 2014
18. Clinical Laboratories Market: LDTs vs. FDA Tests by Therapeutic Area, US, 2015
19. Clinical Laboratories Market: LDTs vs. FDA Tests by Therapeutic Area, US, 2015
20. Clinical Laboratories Market: Market Share Analysis, US, 2014
21. Clinical Laboratories Market: Independent Lab Market Share Analysis, US, 2014
22. Clinical Laboratories Market: Reference Laboratory SWOT Analysis, US, 2015
23. Clinical Laboratories Market: Specialty Laboratory SWOT Analysis, US, 2015
24. Clinical Laboratories Market: Hospital Laboratory SWOT Analysis, US, 2015
25. Clinical Laboratories Market: POL SWOT Analysis, US, 2015
26. Market Engineering Methodology




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