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Analysis of the US Clinical Laboratories Market 

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

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.

Table Of Contents

Analysis of the US Clinical Laboratories Market 
Table Of Contents
1 EXECUTIVE SUMMARY

Executive Summary
1. Key Findings
2. Key Findings
3. Key Findings
4. Scope and Segmentation
5. Scope and Segmentation
6. Key Questions this Study will Answer
7. Measurements
8. Key Companies to Watch in 2015
9. Key Companies to Watch in 2017 and Beyond
10. 3 Big Predictions
11. Decentralization of Healthcare
12. Preference of Higher-deductible Plans
13. Predicted Implications and Opportunities for Diagnostic Manufacturers

2 MARKET OVERVIEW

Market Overview
1. Clinical Laboratories Landscape
2. Clinical Laboratories Landscape
3. Clinical Laboratories Landscape
4. Clinical Laboratories—Current Business Model
5. Patient-centric Solutions
6. Laboratory Information Service Model
7. Laboratory Information Service Model
8. Partnership Models Between Commercial Labs and Hospital Labs
9. Defining Healthcare Trends in the Future
10. Defining Healthcare Trends in the Future

3 COMPETITIVE PLAYBOOK

Competitive Playbook
1. New Market Opportunities
2. New Market Opportunities
3. Merger, Acquisition, and Partnership Assessment
4. Merger, Acquisition, and Partnership Assessment
5. Merger, Acquisition, and Partnership Assessment
6. Merger, Acquisition, and Partnership Assessment
7. Merger, Acquisition, and Partnership Assessment
8. Merger, Acquisition, and Partnership Assessment
9. Merger, Acquisition, and Partnership Assessment
10. Number of Closed Deals
11. Acquisition Highlights
12. Laboratory Transaction Trends

4 DRIVERS, RESTRAINTS, AND TRENDS—TOTAL CLINICAL LABORATORIES MARKET

Drivers, Restraints, and Trends—Total Clinical Laboratories Market
1. Market Drivers
2. Drivers Explained
3. Drivers Explained
4. Drivers Explained
5. Drivers Explained
6. Drivers Explained
7. Market Restraints
8. Restraints Explained
9. Restraints Explained
10. Restraints Explained
11. Restraints Explained
12. Restraints Explained
13. Restraints Explained
14. Restraints Explained
15. Restraints Explained
16. Restraints Explained
17. Restraints Explained
18. Restraints Explained
19. Restraints Explained
20. Restraints Explained
21. Restraints Explained
22. Restraints Explained
23. Market Impact of Top 10 Trends

5 FORECASTS AND TRENDS

Forecasts and Trends
1. Measurements
2. Forecast Assumptions
3. Revenue Forecast
4. Revenue Forecast by Segment
5. Growth Rate by Segment
6. Revenue Forecast Discussion
7. Revenue Forecast Discussion

6 LDTS AND FDA TESTS—COMPARISON BY THERAPEUTIC AREA

LDTs and FDA Tests—Comparison by Therapeutic Area
1. LDTs vs. FDA Tests
2. LDTs vs. FDA Tests

7 COMPETITIVE ENVIRONMENT

Competitive Environment
1. Market Share Analysis
2. Market Share Analysis
3. Market Share Analysis
4. Specialty Diagnostic LDT Companies
5. Routine Testing Laboratories

8 COMPETITOR SWOT ANALYSIS

Competitor SWOT Analysis
1. Reference Laboratories
2. Specialized Laboratories
3. Hospital Laboratories
4. POLs

9 THE LAST WORD

The Last Word
1. The Last Word—3 Big Predictions
2. Legal Disclaimer

10 APPENDIX

Appendix
1. Methodology
2. List of Exhibits
3. List of Exhibits
4. List of Exhibits

List of Exhibits


Clinical Laboratories Market: Customer Opportunities, US, 2014
Clinical Laboratories Market: Summary of Major Competition, US, 2014
Total Clinical Laboratories Market: Market Engineering Measurements, US, 2014
Clinical Laboratories Market: Healthcare Spending, US, 2013
Clinical Laboratories Market: Laboratories by Facility Type, US, 2014
Clinical Laboratories Market: Test Volume by Specialty, US, 2014
Clinical Laboratories Market: Partnership Types, US, 2014
Total Clinical Laboratories Market: Market Outlook, US, 2014 and 2024
Total Clinical Laboratories Market: Game-changing Strategies, US, 2014-2015
Total Clinical Laboratories Market: Notable Deals and Market Impact, US, 2013-2014
Clinical Laboratories Market: Closed Deals, 2009-2015
Total Clinical Laboratories Market: Key Market Drivers, US, 2015-2018
Clinical Laboratories Market: New Developments in Companion Diagnostics, US,
2014-2015
Clinical Laboratories Market: Adoption of Liquid Biopsy Survey, Global, 2015
Total Clinical Laboratories Market: Key Market Restraints, US, 2015-2018
Clinical Laboratories Market: Retail Clinic Expansion, US, 2008-2016
Clinical Laboratories Market: Projected Payments Based on CLFS Cuts, US, 2010-2015
CLFS Payment Cuts, 2011-2012
Clinical Laboratories Market: ACA Projected CLFS Reductions, US, 2010-2022
Clinical Laboratories Market: Biomarker Test Annual 510(k) Clearance, 2003-2014
Clinical Laboratories Market: Average Biomarker Test Review Time, US, 2003-2014
Total Clinical Laboratories Market: Impact of Top 10 Trends, US, 2014
Clinical Laboratories Market: Market Engineering Measurements, US, 2014
Clinical Laboratories Market: Revenue Forecast, US, 2012-2018
Clinical Laboratories Market: Revenue Forecast by Segment, US, 2012-2018
Clinical Laboratories Market: Growth Rate by Segment, US, 2013-2018
Clinical Laboratories Market: Percent Revenue Contribution, US, 2014
Clinical Laboratories Market: LDT vs. FDA Test by Therapeutic Area, US, 2015
Clinical Laboratories Market: Market Share Analysis, US, 2015
Clinical Laboratories Market: Reference Laboratory SWOT Analysis, US, 2015
Clinical Laboratories Market: Specialty Laboratory SWOT Analysis, US, 2015
Clinical Laboratories Market: Hospital Laboratory SWOT Analysis, US, 2015
Clinical Laboratories Market: POL SWOT Analysis, US, 2015

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