Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles)

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