Clinical Lab Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)
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. The constant pressure to reduce healthcare spending is shifting healthcare utilization in favor of the laboratory, making it an ever more valuable part of the treatment plan. As hospital stays are shortened, contact between the physician and patient is reduced, which places a larger role on labs to gather, interpret, and deliver accurate information to the physician in a timely manner. We can expect to see an increase in the number of clinical labs, particularly in the independent sector, as these trends continue to influence the industry.
Since the last time Kalorama Information studied the U.S. market for clinical lab services two years ago, there have been substantial changes in the industry, including changes in market share as major companies eat into regional labs, new competitors enter the marketplace, and new specialty tests are developed and priced. 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 presented are for the U.S. market. Key international markets are discussed as well.
Key market data provided includes:
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:
Since the last time Kalorama Information studied the U.S. market for clinical lab services two years ago, there have been substantial changes in the industry, including changes in market share as major companies eat into regional labs, new competitors enter the marketplace, and new specialty tests are developed and priced. 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 presented are for the U.S. market. Key international markets are discussed as well.
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 2014
- Market Breakdown by Lab Type (Hospital, Physician, Independent)
- Market Breakdown by Test Type (Specialty, Routine)
- 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
- Quest Diagnostics, Inc.
- Laboratory Corporation of America (LabCorp)
- Genomic Health
- Genoptix, Inc.
- Genzyme Corporation
- DaVita
- Clarient, Inc.
- Spectra Laboratories
- Bio-Reference Laboratories
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
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
Physician-office Laboratories
Independent Clinical Laboratories
CLIA Laboratory Registration, Laboratories by Type
Incidence of Diseases
Demographics
Population Over Age
World Demographics
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
Insurance and Reimbursement
Laboratory Service Payer Types
Trends in Medicare Reimbursement
Commercial Insurance Providers
Health Care Reform Issues
New Developments in Information Technology
International Markets and Trends
Asia Pacific
Europe
Latin America
Middle East
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
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
Locations
Myriad Genetics, 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
Products and Services
Growth Strategy
Locations
CHAPTER FOUR: MARKET TRENDS AND SUMMARY
Market Overview
Market Analysis by Laboratory Type
Market Analysis by Test Type
Competitive Analysis
International Market Overview
APPENDIX I: LIST OF MAJOR COMPANIES AND ORGANIZATIONS
APPENDIX II: STATE CLIA OFFICES
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
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
Physician-office Laboratories
Independent Clinical Laboratories
CLIA Laboratory Registration, Laboratories by Type
Incidence of Diseases
Demographics
Population Over Age
World Demographics
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
Insurance and Reimbursement
Laboratory Service Payer Types
Trends in Medicare Reimbursement
Commercial Insurance Providers
Health Care Reform Issues
New Developments in Information Technology
International Markets and Trends
Asia Pacific
Europe
Latin America
Middle East
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
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
Locations
Myriad Genetics, 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
Products and Services
Growth Strategy
Locations
CHAPTER FOUR: MARKET TRENDS AND SUMMARY
Market Overview
Market Analysis by Laboratory Type
Market Analysis by Test Type
Competitive Analysis
International Market Overview
APPENDIX I: LIST OF MAJOR COMPANIES AND ORGANIZATIONS
APPENDIX II: STATE CLIA OFFICES
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: U.S. Clinical Laboratory Market Analysis, 2008-2015
CHAPTER TWO: 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, 1997-2011
Table 2-6 : U.S. Registered Hospitals by Type, 2008 compared to 2010
Figure 2-2: Number of Hospitals in the US, 1975-2005, Estimated 2015
Table 2-7 : Leading For-Profit U.S. Hospital Chains, 2008 and 2010
Table 2-8 : Physicians in the U.S. by Specialty, 1970-2008
Figure 2-3 : Number of Physician Offices, 2000-2009
Table 2-9 : Leading U.S. Independent Laboratory Groups, mid-2011
Figure 2-4: U.S. CLIA Clinical Laboratory Registration by Laboratory Type: 6/2011
Table 2-10: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2011
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 U.S. 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: The World Population, 1980-2020
Figure 2-8: The World Population, 1980-2020
Table 2-15: Average Life Expectancy in Years by Country 1980, 2004 and 2011
Figure 2-9: Average Life Expectancy in Years by Country 1980 and 2011
Table 2-16: Selected CLIA Waived Laboratory Tests
Table 2-17: Provider-Performed Microscopy Procedures
Figure 2-10 : Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), June 2011
Table 2-18: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2011
Figure 2-11: Clinical Laboratory Certificates Issued by Selected State (non-exempt laboratories only), June 2011
Figure 2-12: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2011
Table 2-19: CLIA Exempt States, Number of Laboratories, June 2011
Table 2-20: Health Insurance Trends in the United States, Estimated 2010* (millions)
Table 2-21: Clinical Laboratory Clients and Payers by Type
Figure 2-13: Clinical Laboratory Clients and Payers by Type
Table 2-22: Leading Commercial Insurance Providers, 2011
Table 2-23: Release of Laboratory Test Results Directly to Patients, by State
CHAPTER THREE: LEADING MARKET PARTICIPANTS
Table 3-1: Corporate Details of Quest Diagnostics
Figure 3-1: Quest Diagnostics’ Clinical Testing Sales to Third Parties, 2008-2011 ($millions)
Table 3-2: Corporate Details of Laboratory Corporation of America
Figure 3-2: Laboratory Corporation of America’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-2: Corporate Details of DaVita
Figure 3-3 : DaVita’s Laboratory Service Revenues, 2008-2011 ($millions)
Table 3-4 : Company Details for Clarient
Figure 3-4 : Clarient’s Sales to Third Parties, 2008 and 2009 and Estimated 2010 and 2011 ($millions)
Table 3-5 : Corporate Details for Myriad Genetics
Figure 3-5 : Myriad Genetics’ Sales to Third Parties, 2008-2011 ($millions)
Table 3-6: Company Details for Spectra Laboratories
Table 3-7 : Corporate Details of Bio-Reference Laboratories
Figure 3-6 : Bio-Reference’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-8 : Corporate Details of Genomic Health, Inc.
Figure 3-7: Genomic Health’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-9 : Company Details for Genoptix, Inc.
CHAPTER FOUR: MARKET TRENDS AND SUMMARY
Table 4-1: U.S. Clinical Laboratory Market Analysis, 2008-2015
Figure 4-1: U.S. Clinical Laboratory Market Analysis: 2008-2015
Table 4-2: U.S. Clinical Laboratory Market Analysis by Type, 2008-2015
Figure 4-2: U.S. Clinical Laboratory Market Analysis by Type, 2008-2015
Figure 4-3: U.S. Clinical Laboratory Market Share by Type, 2011
Figure 4-4: U.S. Clinical Laboratory Market Share by Type, 2015 :
Table 4-3: U.S. Clinical Laboratory Market Analysis by General Test Type, 2011
Figure 4-5 : U.S. Clinical Laboratory Market Analysis by General Test Type, 2011
Table 4-4 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2008 and 2011
Figure 4-6 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2008
Figure 4-7 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2011
Figure 4-8 : Estimated Laboratory Service Revenues for Leading Clinical Laboratory Providers 2008 and 2011
Table 4-5 : Global Clinical Laboratory Market Analysis, Revenues by Region, 2011
Figure 4-9 : Global Clinical Laboratory Market Analysis, Revenues by Region, 2011
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: U.S. Clinical Laboratory Market Analysis, 2008-2015
CHAPTER TWO: 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, 1997-2011
Table 2-6 : U.S. Registered Hospitals by Type, 2008 compared to 2010
Figure 2-2: Number of Hospitals in the US, 1975-2005, Estimated 2015
Table 2-7 : Leading For-Profit U.S. Hospital Chains, 2008 and 2010
Table 2-8 : Physicians in the U.S. by Specialty, 1970-2008
Figure 2-3 : Number of Physician Offices, 2000-2009
Table 2-9 : Leading U.S. Independent Laboratory Groups, mid-2011
Figure 2-4: U.S. CLIA Clinical Laboratory Registration by Laboratory Type: 6/2011
Table 2-10: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2011
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 U.S. 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: The World Population, 1980-2020
Figure 2-8: The World Population, 1980-2020
Table 2-15: Average Life Expectancy in Years by Country 1980, 2004 and 2011
Figure 2-9: Average Life Expectancy in Years by Country 1980 and 2011
Table 2-16: Selected CLIA Waived Laboratory Tests
Table 2-17: Provider-Performed Microscopy Procedures
Figure 2-10 : Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), June 2011
Table 2-18: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2011
Figure 2-11: Clinical Laboratory Certificates Issued by Selected State (non-exempt laboratories only), June 2011
Figure 2-12: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), June 2011
Table 2-19: CLIA Exempt States, Number of Laboratories, June 2011
Table 2-20: Health Insurance Trends in the United States, Estimated 2010* (millions)
Table 2-21: Clinical Laboratory Clients and Payers by Type
Figure 2-13: Clinical Laboratory Clients and Payers by Type
Table 2-22: Leading Commercial Insurance Providers, 2011
Table 2-23: Release of Laboratory Test Results Directly to Patients, by State
CHAPTER THREE: LEADING MARKET PARTICIPANTS
Table 3-1: Corporate Details of Quest Diagnostics
Figure 3-1: Quest Diagnostics’ Clinical Testing Sales to Third Parties, 2008-2011 ($millions)
Table 3-2: Corporate Details of Laboratory Corporation of America
Figure 3-2: Laboratory Corporation of America’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-2: Corporate Details of DaVita
Figure 3-3 : DaVita’s Laboratory Service Revenues, 2008-2011 ($millions)
Table 3-4 : Company Details for Clarient
Figure 3-4 : Clarient’s Sales to Third Parties, 2008 and 2009 and Estimated 2010 and 2011 ($millions)
Table 3-5 : Corporate Details for Myriad Genetics
Figure 3-5 : Myriad Genetics’ Sales to Third Parties, 2008-2011 ($millions)
Table 3-6: Company Details for Spectra Laboratories
Table 3-7 : Corporate Details of Bio-Reference Laboratories
Figure 3-6 : Bio-Reference’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-8 : Corporate Details of Genomic Health, Inc.
Figure 3-7: Genomic Health’s Sales to Third Parties, 2008-2011 ($millions)
Table 3-9 : Company Details for Genoptix, Inc.
CHAPTER FOUR: MARKET TRENDS AND SUMMARY
Table 4-1: U.S. Clinical Laboratory Market Analysis, 2008-2015
Figure 4-1: U.S. Clinical Laboratory Market Analysis: 2008-2015
Table 4-2: U.S. Clinical Laboratory Market Analysis by Type, 2008-2015
Figure 4-2: U.S. Clinical Laboratory Market Analysis by Type, 2008-2015
Figure 4-3: U.S. Clinical Laboratory Market Share by Type, 2011
Figure 4-4: U.S. Clinical Laboratory Market Share by Type, 2015 :
Table 4-3: U.S. Clinical Laboratory Market Analysis by General Test Type, 2011
Figure 4-5 : U.S. Clinical Laboratory Market Analysis by General Test Type, 2011
Table 4-4 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2008 and 2011
Figure 4-6 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2008
Figure 4-7 : Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2011
Figure 4-8 : Estimated Laboratory Service Revenues for Leading Clinical Laboratory Providers 2008 and 2011
Table 4-5 : Global Clinical Laboratory Market Analysis, Revenues by Region, 2011
Figure 4-9 : Global Clinical Laboratory Market Analysis, Revenues by Region, 2011
