Clinical Laboratory Services

Markets, Growth Opportunities, Competitive Analysis and Competitor Profiles

Publication Date	November 2008
Publisher	Kalorama Information
Product Type	Report
Pages	250
ISBN Number	not applicable
Product Code	KAL00141

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Summary

Dominated by Lab Corp and Quest, the clinical laboratory services market is growing as new competitors enter. An essential part of the health industry, it is estimated that approximately 80% of physicians diagnoses are a result of laboratory tests. In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

Those seeking to enter this business or to know more about it will benefit from Clinical Laboratory Services (Markets, Growth Opportunities, Competitive Analysis and Competitor Profiles), an overview of the clinical laboratory industry and the trends driving growth. Included in the report are statistics influencing the industry, incidence of diseases in the U.S., demographics; life expectancy, and company strategies. Information is presented as a U.S. market, with a section on key international markets. A market summary includes a total market analysis, analysis by laboratory type, and an analysis for routine and specialty testing.

Also included is a competitive analysis of leading clinical laboratory providers.

Several leading market participants are discussed in this report.

Some of these include:

Quest Diagnostics, Inc.
Laboratory Corporation of America
Genzyme Corporation
DaVita
Clarient, Inc.
Spectra Laboratories
Bio-Reference Laboratories

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information.

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
Market Breakdown by Type (Hospital, Physician, Independent)
Market Share of Competitors

For the purpose of this study, Kalorama Information conducted interviews with more than 50 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

Content

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
- 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
- Commercial Insurance Providers
- New Developments
- 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
- 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
Chapter Four: Market Trends and Summary
- Market Overview
- Market Analysis by Laboratory Type
- Market Analysis by Test Type
- Competitive Analysis
Chapter Five: List of Major Companies and Organizations
List of Tables
- 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: U.S. Registered Hospitals by Type, 2006
- Table 2-7: Leading for-Profit U.S. Hospital Chains, 2006
- Table 2-8: Physicians in the US by Specialty, 1970-2000
- Table 2-9: Leading U.S. Independent Laboratory Groups, 2007
- Table 2-10: U.S. Prevalence of Selected Medical Conditions
- Table 2-11: The U.S. Population, 1980-2020
- Table 2-12: Percent U.S. Population over Age 65 by Year
- Table 2-13: Average U.S. Life Expectancy in Years 1980, 2004 and 2006
- Table 2-14: Selected CLIA Waived Laboratory Tests
- Table 2-15: Provider-Performed Microscopy Procedures
- Table 2-16: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2007
- Table 2-17: CLIA Exempt States, Number of Laboratories, 2007
- Table 2-18: Health Insurance Trends in the United States, Estimated 2007 (millions)
- Table 2-19: Clinical Laboratory Clients and Payers by Type
- Table 2-20: Leadting Commercial Insurance Providers, 2007
- Table 2-21: Quest and LabCorp Service Contracts for Leading Insurance Providers
- Table 3-1: Corporate Details of Quest Diagnostics
- Table 3-2: Corporate Details of Laboratory Corporation of America
- Table 3-3: Corporate Details of Genzyme Corporation
- Table 3-4: Corporate Details of DaVita
- Table 3-5: Corporate Details of Clarient
- Table 3-6: Corporate Details of Fresenius Medical Care AG
- Table 3-7: Corporate Details of Bio-Reference Laboratories
- Table 4-1: U.S. Clinical Laboratory Market Analysis, 2005-2007
- Table 4-2: Forecasted U.S. Clinical Laboratory Market Analysis: 2008-2012
- Table 4-3: U.S. Clinical Laboratory Market Analysis by Type, 2005-2007
- Table 4-4: Forecasted U.S. Clinical Laboratory Market Analysis by Type, 2008-2012
- Table 4-5: U.S. Clinical Laboratory Market Analysis by General Test Type, 2007
- Table 4-6: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2007
List of Figures
- Figure 1-1: U.S. Clinical Laboratory Market Analysis: 2005-2012
- Figure 2-1: Growth in Clinical Laboratories, 1997-2007
- Figure 2-2: U.S. Prevalence of Selected Medical Conditions
- Figure 2-3: The US Population, 1980-2020
- Figure 2-4: Estimated Population by Age Group, 2000 and 2050
- Figure 2-5: Average U.S. Life Expectancy in Years 1980 and 2006
- Figure 2-6: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), December 2007
- Figure 2-7: Clinical Laboratory Certificates Issued by Selected State (non-exempt laboratories only), December 2007
- Figure 2-8: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2007
- Figure 2-9: Clinical Laboratory Clients and Payers by Type
- Figure 3-1: Quest Diagnostics Clinical Testing Sales to Third Parties, 2005-2007 ($millions)
- Figure 3: : Laboratory Corporation of Americas Sales to Third Parties, 2005-2007 ($millions)
- Figure 3-3: Genzyme Corporation Genetics/Diagnostics Sales to Third Parties, 2005-2007 ($millions)
- Figure 3-4: DaVitas Laboratory Service Revenues, 2006 and 2007
- Figure 3-5: Clarients Sales to Third Parties, 2005-2007
- Figure 3-6: Bio-References Sales to Third Parties, 2005-2007
- Figure 4-1: U.S. Clinical Laboratory Market Analysis: 2005-2012
- Figure 4-2: U.S. Clinical Laboratory Market Analysis by Type, 2005-2012
- Figure 4-3: U.S. Clinical Laboratory Market Share by Type, 2007
- Figure 4-4: U.S. Clinical Laboratory Market Share by Type, 2012
- Figure 4-5: U.S. Clinical Laboratory Market Analysis by General Test Type, 2007
- Figure 4-6: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2007