The Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)
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Clinical laboratories are an essential part of the health industry. It is estimated that approximately 80% of physician's diagnoses are a result of laboratory tests. 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 this market 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:
The issues and trends which are fueling growth:
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:
A competitive analysis of leading clinical laboratory providers includes:
Our methodology:
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.
All market data pertains to the world market at the manufacturers' level. The base year for data was 2009. Historical data was provided for the years 2006, 2007 and 2008, with forecast data provided for 2010 through 2014. Compound annual growth rates (CAGRs) are provided for the 2006-2009 and 2009-2014 periods for each segment covered. A competitive analysis is provided for the year 2009. The forecasted market analysis for 2010-2014 was largely based on demographic trends, new developments, company performance trends, mergers and acquisitions, and national expansion.
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, (Hospital-Based, Physician, Other) 2006-2013
Figure 4-3: U.S. Clinical Laboratory Market Share by Type, (Hospital-Based, Physician, Other) 2009
Figure 4-4: U.S. Clinical Laboratory Market Share by Type, (Hospital-Based, Physician, 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
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Medical Facility Industry: The Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)
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-- Hospital, Physician and Independent Lab Statistics
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