- CHAPTER ONE: EXECUTIVE SUMMARY
- Industry at a Glance
- Scope and Methodology
- Size and Growth of the Market
- Key Issues and Trends Affecting the Market
- Leading Market Participants
- CHAPTER TWO: INDUSTRY OVERVIEW, REGULATION AND TRENDS
- Clinical Laboratory Description
- Testing and Services
- Routine Testing
- Blood Cell Count
- Cholesterol Level Testing
- HIV Testing
- Anti-HIV-1 Oral Specimen Collection Device
- Anti-HIV-1 Testing Service
- Nucleic Acid Testing
- Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
- Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
- 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
- Physician-office Laboratories
- Independent Clinical Laboratories
Incidence of Diseases
Demographics
- Population Over Age 65
- Life Expectancy
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
- Commercial Insurance Providers
New Developments in Information Technology
International Markets and Trends
CHAPTER THREE: LEADING MARKET PARTICIPANTS
Summary
Quest Diagnostics, Inc.
- Company Overview
- Performance Review
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Business Locations
Laboratory Corporation of America
- Company Overview
- Performance Review
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
Genzyme Corporation
- Company Overview
- Performance Review
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
DaVita, Inc.
- Company Overview
- Performance Review
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
Clarient, Inc.
- Company Overview
- Performance Review
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
Spectra Laboratories
- Company Overview
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
Bio-Reference Laboratories
- 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
- Key Acquisitions, Alliances, and Partnerships
- Products and Services
- Growth Strategy
- Locations
CHAPTER FIVE: MARKET ANALYSIS
Market Overview
Market Analysis by Laboratory Type
Market Analysis by Test Type
Competitive Analysis
APPENDIX: COMPANY DIRECTORY
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Figure 1-1: U.S. Clinical Laboratory Market Analysis: 2006-2013
CHAPTER TWO: INDUSTRY OVERVIEW
Table 2-1: Laboratory Reference Parameters for CBC
Table 2-2: High Cholesterol Risk Categories
Table 2-3: HIV Testing Products/Services Approved by the FDA
Table 2-4: HCG Levels in Pregnant Women by Days Past Ovulation
Table 2-5: Substance Detection Periods by Test Method
Table 2-6: Normal Reference Levels in a Medical Urinalysis
Figure 2-1: Growth in Clinical Laboratories, 1997-2008
Table 2-7: U.S. Registered Hospitals by Type, 2006 compared to 2008
Table 2-8: Leading For-Profit U.S. Hospital Chains, 2006, 2007, 2008
Figure 2-2: Trend in For-Profit U.S. Hospital Facilities, 2006-2008
Figure 2-3: Trend in For-Profit U.S. Hospital Licensed Beds, 2006-2008
Figure 2-4: Trend in For-Profit U.S. Hospital Inpatient Admissions, 2006-2008
Table 2-9: Physicians in the US by Specialty, 1970-2008
Table 2-10: Leading U.S. Independent Laboratory Groups, 2008
Table 2-11: U.S. Prevalence of Selected Medical Conditions
Figure 2-5: U.S. Prevalence of Selected Medical Conditions
Table 2-12: The U.S. Population, 1980-2020
Figure 2-6: The US Population, 1980-2020
Table 2-13: Percent U.S. Population Over Age 65 by Year
Figure 2-7: Estimated Population by Age Group, 2000 and 2050
Table 2-14: Average U.S. Life Expectancy in Years 1980, 2004, 2006 and 2008
Figure 2-8: Average U.S. Life Expectancy in Years 1980 and 2008
Table 2-15: Selected CLIA Waived Laboratory Tests
Table 2-16: Provider-Performed Microscopy Procedures
Figure 2-9: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), December 2008
Table 2-17: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2008
Figure 2-10: Clinical Laboratory Certificates Issued by Selected State (non-exempt laboratories only), December 2008
Figure 2-11: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2008
Table 2-18: CLIA Exempt States, Number of Laboratories, 2008
Table 2-19: Health Insurance Trends in the United States, Estimated 2007*
Table 2-20: Clinical Laboratory Clients and Payers by Type
Figure 2-12: Clinical Laboratory Clients and Payers by Type
Table 2-21: Laboratory Fee Schedule for Common CPT Codes in Specialty Testing, 2007-2009
Table 2-21: Leading Commercial Insurance Providers, 2008
Table 2-22: Quest and LabCorp Service Contracts for Leading Insurance Providers
CHAPTER THREE: LEADING MARKET PARTICIPANTS
Table 3-1: Corporate Details of Quest Diagnostics
Figure 3-1: Quest Diagnostics’ Clinical Testing Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)
Table 3-2: Corporate Details of Laboratory Corporation of America
Figure 3-2: Laboratory Corporation of America’s Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)
Table 3-3: Corporate Details of Genzyme Corporation
Figure 3-3: Genzyme Corporation Testing Service Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)
Table 3-4: Corporate Details of DaVita
Figure 3-4: DaVita’s Laboratory Service Revenues, 2006-2008 and Estimated 2009 ($millions)
Table 3-5: Corporate Details of Clarient
Figure 3-5: Clarient’s Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)
Table 3-6: Corporate Details of Fresenius Medical Care AG
Table 3-7: Corporate Details of Bio-Reference Laboratories
Figure 3-6: Bio-Reference’s Sales to Third Parties, 2006-2009 ($millions)
Table 3-8: Corporate Details of Genomic Health, Inc.
Figure 3-7: Genomic Health’s Sales to Third Parties, 2006-2008 and estimated 2009 ($millions)
Table 3-9: Corporate Details of Genoptix, Inc.
Figure 3-8: Genoptix Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)
CHAPTER FOUR: ANALYSIS
Table 4-1: U.S. Clinical Laboratory Market Analysis, 2006-2013
Figure 4-1: U.S. Clinical Laboratory Market Analysis: 2006-2013
Table 4-2: U.S. Clinical Laboratory Market Analysis by Type, (Hospital-Based, Physician, Other) 2006-2013
Figure 4-2: U.S. Clinical Laboratory Market Analysis by Type, (Hopsital-Based, Phyisican, Other) 2006-2013
Figure 4-3: U.S. Clinical Laboratory Market Share by Type, (Hopsital-Based, Phyisican, Other) 2009
Figure 4-4: U.S. Clinical Laboratory Market Share by Type, (Hopsital-Based, Phyisican, Other) 2013
Table 4-3: U.S. Clinical Laboratory Market Analysis by General Test Type, (Routine vs. Specialty) 2009
Figure 4-5: U.S. Clinical Laboratory Market Analysis by General Test Type, (Routine vs. Specialty) 2009
Table 4-4: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2007 and 2009
Figure 4-6: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2009
Figure 4-7: Estimated Laboratory Service Revenues for Leading Clinical Laboratory Providers 2007 and 2009
Figure 4-7: Rate of Growth: Lab Corp and Quest Diagnostics 2007 and 2009