Clinical Lab Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)

Dec 20, 2013
200 Pages - Pub ID: KLI5167692
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The market for clinical lab services is dynamic. It is estimated that approximately 80% of physician's diagnoses are a result of laboratory tests, and a fair number of these tests are sent to clinical lab service providers. There is constant pressure to reduce healthcare spending, and that in turn is shifting healthcare utilization in favor of the laboratory. This has not escaped the attention of major competitors who operate in the industry, and those planning to enter.

Clinical Laboratory Services (Markets, Growth Opportunities, Competitive Analysis and Competitor Profiles), provides an in-depth market overview, a total market analysis, analysis by laboratory type, and by routine and specialty testing and a review of the latest trends driving growth. Revenues and forecasts, segment breakouts and market share presented are for the U.S. market, but international clinical lab service markets are estimated and forecasted in this report. Key market data provided includes:
  • Hospital, Physician and Independent Lab Statistics
  • Major Tests Performed by Clinical Lab Companies
  • Disease Incidence and Trends Driving Lab Business
  • Market Forecast to 2018
  • Geographic Breakout of Clinical Lab Services Market (includes US, Europe Asia with specific breakouts for Germany, Japan, China, India and Brazil)
  • Market Breakdown by Lab Type (Hospital, Physician, Independent)
  • Market Breakdown by Test Type (Specialty, Routine)
  • US Market Share of Competitors
  • Competitive Analysis of Leading clinical Lab Providers
A trend towards preventive and risk factor testing has been noted in several disciplines, particularly in the areas of oncology, endocrinology, and gynecology. Physicians in these areas are taking full advantage of testing for early detection and disease prevention. Some of the other issues and trends explored in this study include:
  • U.S. Demographics
  • Types of Specialty Tests
  • Growing Competition
  • Increasing Life Expectancy
  • Growing Incidence of Disease
  • New Product Offerings
  • Regulatory Environment
  • Insurance and Reimbursement
  • Payer Types
  • Developments in Personalized Medicine


  • A competitive analysis of leading clinical laboratory providers includes:
  • Quest Diagnostics, Inc.
  • Laboratory Corporation of America (LabCorp)
  • Genomic Health
  • Genoptix, Inc.
  • Genzyme Corporation
  • DaVita
  • Clarient, Inc.
  • Spectra Laboratories
  • Bio-Reference Laboratories
The information in this report is the result of interviews with executives and market experts, as well as thorough research of secondary sources such as company literature, trade publications and medical and business journals. The emphasis Kalorama puts on primary research guarantees that new insights will be uncovered that are not available from any other source. The most important part of Kalorama's efforts is its superior analysis of company activities and their true significance in the marketplace.

 Historical data was provided for the years 2008- 2012, with forecast data provided for 2013 through 2017. A competitive analysis is provided for the year 2013. The forecasted market analysis for 2013-2017 was largely based on demographic trends, new developments, company performance trends, mergers and acquisitions, and national expansion.
EXECUTIVE SUMMARY
Industry at a Glance
Scope and Methodology
World Market Summary
The U.S. Clinical Laboratory Market
Key Issues and Trends Affecting the Market
Leading Market Participants
INDUSTRY OVERVIEW
Clinical Laboratory Description
Testing and Services
Routine Testing
Blood Cell Count
Cholesterol Level Testing
HIV Testing
Pap Testing
Pregnancy Testing
Substance Abuse Testing
Urinalysis
Specialty Testing
Endocrinology
Esoteric Testing
Genetics
Immunology and Molecular Microbiology
Oncology
Serology
Toxicology
Industry Structure
Hospital-based Laboratories
U.S. Hospital Data
U.S. Hospital Stay Stats
International Hospital/Acute Care Data
International Hospital Stay Stats
Physician-office Laboratories
Number of U.S. Physicians
Independent Clinical Laboratories
CLIA Laboratory Registration, Laboratories by Type
ISSUES AND TRENDS IN THE CLINICAL LABORATORY INDUSTRY
Issues and Trends Overview
Demographics
Global Demographics
Global Population Over Age 65
U.S. Demographics
U.S. Population Over Age 65
Life Expectancy
Incidence of Diseases
Surgical Procedure Volumes
Regulatory Overview
Certificate of Waiver
Certificate of Provider-Performed Microscopy Procedures (PPMP)
Certificate of Compliance and Certificate of Accreditation
States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988
Insurance and Reimbursement
Laboratory Service Payer Types
Trends in Medicare Reimbursement
Health Care Reform
Bundled Insurance Payments for ESRD Patients
HIPPA
Commercial Insurance Providers
New Developments in Information Technology
LEADING MARKET PARTICIPANTS
Summary
Bio-Reference Laboratories
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Clarient, Inc. (A GE Healthcare Company)
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Locations
DaVita Healthcare Partners, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Genomic Health, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Genoptix, Inc.
Company Overview
Performance Review
Products and Services
Growth Strategy
Locations
Laboratory Corporation of America
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Myriad Genetics, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
Quest Diagnostics, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Business Locations
Spectra Laboratories
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
MARKET TRENDS AND SUMMARY
World Market Overview
U.S. Market Overview
Market Analysis by Laboratory Type
Hospital-based Clinical Laboratory Segment
Independent Laboratory Segment
Physician-Office Laboratory Segment
Market Analysis by Test Type
Routine Testing
Specialty Testing
U.S. Competitive Analysis
International Market Overview
International Markets and Trends
Asia Pacific
Europe and Middle East
Latin America
LIST OF MAJOR COMPANIES AND ORGANIZATIONS
STATE CLIA OFFICES
LIST OF EXHIBITS
EXECUTIVE SUMMARY
Table 1-1
World Clinical Laboratory Market Analysis, 2008-2018
Figure 1-1
World Clinical Laboratory Market Analysis: 2008-2018
Table 1-2
U.S. Clinical Laboratory Market Analysis, 2008-2018
Figure 1-2
U.S. Clinical Laboratory Market Analysis: 2008-2018
Figure 1-3
Leading Market Participant Revenues, 2012* ($millions)
INDUSTRY OVERVIEW
Table 2-1
Laboratory Reference Parameters for CBC
Table 2-2
High Cholesterol Risk Categories
Table 2-3
HCG Levels in Pregnant Women by Days Past Ovulation
Table 2-4
Substance Detection Periods by Test Method
Table 2-5
Normal Reference Levels in a Medical Urinalysis
Figure 2-1
Growth in Clinical Laboratories, 1997-2013
Table 2-6
U.S. Registered Hospitals by Type, 2008 through 2011
Figure 2-2
Distribution of U.S. Registered Hospitals by Type, 2011
Figure 2-3
Number of Hospitals in the U.S., 1975-2005, Estimated 2015
Table 2-7
Statistics for U.S. Hospitals, 2011
Table 2-8
Leading For-Profit U.S. Hospital Chains, 2010 and 2012
Table 2-9
U.S. Hospital Length of Stay, Average by Age Group
Figure 2-4
U.S. Hospital Length of Stay, Average by Age Group
Table 2-10
Registered Hospitals and Acute Care Centers by Country
Figure 2-5
Registered Hospitals and Acute Care Centers by Country
Table 2-11
Average International Length of Stay for Acute Care Centers, by Country 2011
Figure 2-6
Average International Length of Stay, by Country 2011
Table 2-12
Physicians in the U.S. by Specialty, 1970-2010
Figure 2-7
Number of Physician Offices, United States, 2000-2009
Table 2-13
Medical Doctors per 1,000 Population by Country, 2011
Figure 2-8
Medical Doctors per 1,000 Population by Country, 2011
Table 2-14
Leading U.S. Independent Laboratory Groups, mid-2013
Figure 2-9
Leading U.S. Independent Laboratory Groups, Distribution of Centers, mid-2013
Figure 2-10
U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: 6/2013
Table 2-15
CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2013
Figure 2-11
Change in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt
Combined) June 2011 versus June 2013
ISSUES AND TRENDS IN THE CLINICAL LABORATORY INDUSTRY
Table 3-1
The Global Population, 1980-2050
Figure 3-1
The Global Population, 1980-2050
Table 3-2
Global Population Trends Age 65+, 2000-2050
Figure 3-2
Global Population Trends Age 65+, 2000-2050
Table 3-3
The U.S. Population, 1980-2050
Figure 3-3
The U.S. Population, 1980-2050
Table 3-4
Percent U.S. Population Over Age 65 by Year, 2000-2050
Figure 3-4
United States Population Trend Age 65+, 2000-2050
Table 3-5
Average Life Expectancy in Years by Country 1980 and 2012
Figure 3-5
Average Life Expectancy in Years by Country 1980 and 2012
Table 3-6
U.S. Prevalence of Selected Medical Conditions
Figure 3-6
U.S. Prevalence of Selected Medical Conditions
Table 3-7
Surgical Procedures in the United States, by Procedure Category, 2010
Table 3-8
Selected CLIA Waived Laboratory Tests
Table 3-9
Provider-Performed Microscopy Procedures
Figure 3-7
Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), June 2013
Table 3-10
Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2013
Figure 3-8
Clinical Laboratory Certificates Issued by Selected State (non-exempt laboratories only), June 2013
Figure 3-9
Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2013
Table 3-11
CLIA Exempt States, Number of Laboratories, June 2013
Table 3-12
Health Insurance Trends in the United States, Estimated 2010* (millions)
Figure 3-10
Health Insurance Coverage in the United States by Type, Estimated 2010*
Table 3-13
U.S. Clinical Laboratory Clients and Payers by Type, 2013 (%)
Figure 3-11
Clinical Laboratory Clients and Payers by Type
Table 3-14
Medicare Reimbursement Trends, 2009 vs. 2013
Table 3-14 (continued)
Medicare Reimbursement Trends, 2009 vs. 2013
Table 3-15
ESRD-Related Laboratory Tests Included in New Bundle Payment Structure
Table 3-16
Comparison Between New Bundled and Composite Medicare Reimbursement Program (1983-2010 and 2011+)
Table 3-17
Leading Commercial Insurance Providers, 2012
Table 3-18
Leading Laboratory Information Management System Providers
Table 3-19
Release of Laboratory Test Results Directly to Patients, by State
Table 3-19 (continued)
Release of Laboratory Test Results Directly to Patients, by State
LEADING MARKET PARTICIPANTS
Figure 4-1
Leading Market Participant Revenues, 2012* ($millions)
Table 4-1
Corporate Details of Bio-Reference Laboratories
Figure 4-2
Bio-Reference’s Sales to Third Parties, 2008-2012 ($millions)
Table 4-2
Company Details for Clarient
Figure 4-3
Clarient’s Sales to Third Parties, 2008 and 2009 and Estimated 2010, 2011, and 2012 ($millions)
Table 4-3
Corporate Details of DaVita
Figure 4-4
DaVita’s Revenues, 2008-2012 ($millions)
Table 4-4
Corporate Details of Genomic Health
Figure 4-5
Genomic Health’s Sales to Third Parties, 2008-2012 ($millions)
Table 4-5
Company Details for Genoptix
Figure 4-6
Novartis' Sales to Third Parties, 2008-2012 ($millions)
Table 4-6
Corporate Details of Laboratory Corporation of America
Figure 4-7
Laboratory Corporation of America’s Sales to Third Parties, 2008-2012 ($millions)
Table 4-7
Corporate Details for Myriad Genetics
Figure 4-8
Myriad Genetics’ Sales to Third Parties, 2008-2012 ($millions)
Table 4-8
Corporate Details of Quest Diagnostics
Figure 4-9
Quest Diagnostics’ Clinical Testing Sales to Third Parties, 2008-2012 ($millions)
Table 4-9
Company Details for Spectra Laboratories
Figure 4-10
Fresenius Medical Care Revenues and Estimated Spectra Clinical Testing Sales to Third Parties, 2008-2012 ($millions)
MARKET TRENDS AND SUMMARY
Table 5-1
World Clinical Laboratory Market Analysis, 2008-2018
Figure 5-1
World Clinical Laboratory Market Analysis: 2008-2018
Table 5-2
U.S. Clinical Laboratory Market Analysis, 2008-2018
Figure 5-2
U.S. Clinical Laboratory Market Analysis: 2008-2018
Table 5-3
U.S. Clinical Laboratory Market Analysis by Laboratory Type, 2008-2018
Figure 5-3
U.S. Clinical Laboratory Market Analysis by Laboratory Type, 2008-2018
Figure 5-4
U.S. Clinical Laboratory Market Share by Laboratory Type, 2013
Figure 5-5
U.S. Clinical Laboratory Market Share by Laboratory Type, 2018
Figure 5-6
U.S. Clinical Laboratory Market Share by Test Type, 2013
Table 5-4
U.S. Clinical Laboratory Market Analysis by Test Type, 2008-2018
Figure 5-7
U.S. Clinical Laboratory Market Analysis by Test Type, 2008-2018
Figure 5-8
U.S. Clinical Laboratory Market Analysis: Routine Testing Market Trend, 2008-2018149
Figure 5-9
U.S. Clinical Laboratory Market Analysis: Specialty Testing by Type, 2013
Figure 5-10
U.S. Clinical Laboratory Market Analysis: Specialty Testing Market Trend, 2008-2018152
Table 5-5
Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical
Laboratory Providers 2013
Figure 5-11
Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical
Laboratory Providers 2013
Figure 5-12
Estimated U.S. Laboratory Service Revenues for Leading Clinical Laboratory Providers 2010 vs. 2013
Table 5-6
Global Clinical Laboratory Market Analysis, Revenues by Region, 2013
Figure 5-13
Global Clinical Laboratory Market Analysis, Revenues by Region, 2013
LIST OF MAJOR COMPANIES AND ORGANIZATIONS
STATE CLIA OFFICES

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