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:

  • 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


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:

  • 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


A competitive analysis of leading clinical laboratory providers includes:

  • Quest Diagnostics, Inc.

  • Laboratory Corporation of America (LabCorp)

  • Genomic Health

  • Genoptix, Inc.

  • Genzyme Corporation

  • DaVita

  • Clarient, Inc.

  • Spectra Laboratories

  • Bio-Reference Laboratories


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.

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 and 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

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