Description
The Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)
Clinical laboratories are an essential part of the health industry. Kalorama Information estimates that approximately 80% of physicians’ diagnoses are a result of laboratory tests.he 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 Clinical Laboratory Services Market Data
- 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
Clinical Laboratory Services Market Issues and Trends
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
Leading Clinical Laboratory Services Providers Analysis:
- Quest Diagnostics, Inc.
- Laboratory Corporation of America (LabCorp)
- Genomic Health
- Genoptix, Inc.
- Genzyme Corporation
- DaVita
- Clarient, Inc.
- Spectra Laboratories
- Bio-Reference Laboratories
Scope & 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.
Table of Contents
TABLE OF CONTENTS
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 FOUR: 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
