Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
INDUSTRY AT A GLANCE
SCOPE AND METHODOLOGY
GLOBAL MARKET OVERVIEW
Table 1-1: Global Clinical Laboratory Market Analysis, 2010-2021 (in millions of dollars at the manufacturer’s level)
Figure 1-1: Global Clinical Laboratory Market Analysis: 2010-2021
MARKET CONCLUSIONS
KEY ISSUES AND TRENDS AFFECTING THE MARKET
LEADING MARKET PARTICIPANTS
CHAPTER TWO: INDUSTRY OVERVIEW
CLINICAL LABORATORY DESCRIPTION
TESTING AND SERVICES
Routine Testing
Table 2-1: Laboratory Reference Parameters for Complete Blood Count (CBC)
Table 2-2: High Cholesterol Risk Categories (Desirable levels, Borderline high, High risk)
Table 2-3: Raised or At-Risk Total Cholesterol (> = 190 mg/dL), Age Standardized Estimates, 2008 data (Iceland, Germany, Denmark,
United Kingdom, Ireland, Italy, France, Netherlands, Switzerland, United Arab Emirates, Singapore, Japan, Poland, Thailand, Australia,
United States, Israel, Canada, Mexico, Russian Federation, Argentina, Brazil, Philippines, Republic of Korea, Turkey, Saudi Arabia,
Venezuela, China, India)
Table 2-4: Number of Reported HIV Testing and Counseling Services by Country, 2014 (India, Ethiopia, Uganda, Kenya, Nigeria,
Mozambique, South Africa, Rwanda, United Republic of Tanzania, Zambia, Mexico, Kazakhstan, Malawi, Viet Nam, Côte d’Ivoire,
Democratic Republic of the Congo, Zimbabwe, Malaysia, Thailand, Haiti, Peru, Belarus, Indonesia, Burundi, Cuba)
Table 2-5: Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2015 (Afghanistan, Argentina,
Australia, Belgium, Brazil, Canada, China, Democratic People’s Republic of Korea, Denmark, France, Germany, India, Indonesia, Iran
[Islamic Republic of], Iraq, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian
Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom
of Great Britain and Northern Ireland, United States of America, Venezuela [Bolivarian Republic of], Viet Nam)
Table 2-6: HCG Levels in Pregnant Women by Days Past Ovulation
Table 2-7: Substance Detection Periods by Test Method (Alcohol, Cocaine, Morphine, Phenobarbital, Methadone, PCP, LSD, Heroin,
Methamphetamine; Urine, Blood, Hair)
Table 2-8: Screening and Brief Interventions for Substance Abuse by Select Country, 2008 Data (Afghanistan, Australia, Austria,
Belgium, Canada, China, Denmark, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iran [Islamic Republic of], Iraq,
Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Republic of Korea, Russian
Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Venezuela [Bolivarian Republic of])
Table 2-9: Normal Reference Levels in a Medical Urinalysis
Specialty Testing
GLOBAL CLINICAL LABORATORY STRUCTURE
Global Hospital/Acute Care Data
Table 2-10: Hospital Density per 100,000 Population by Country, 2013 (Afghanistan, Brazil, Canada, China, France, Finland, Germany,
Iceland, Indonesia, Iraq, Israel, Italy, Japan, Korea [Republic of], Malaysia, Mexico, Netherlands, Pakistan, Philippines, Poland, Saudi
Arabia, Singapore, South Africa, Thailand, Turkey, United Kingdom, United States)
Figure 2-1: Hospitals per 100,000 Population by Country, 2013 (Afghanistan, Brazil, Canada, China, France, Finland, Germany, Iceland,
Indonesia, Iraq, Israel, Italy, Japan, Korea [Republic of], Malaysia, Mexico, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia,
Singapore, South Africa, Thailand, Turkey, United Kingdom, United States)
Global Access to Physicians
Table 2-11: Medical Doctors per 1,000 Population by Country, 2013 (Afghanistan, Argentina, Australia, Brazil, Canada, China, France,
Germany, India, Ireland, Israel, Italy, Japan, Mexico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United
Kingdom, United States, Vietnam)
Figure 2-2: Medical Doctors per 1,000 Population by Country, 2013 (Afghanistan, Argentina, Australia, Brazil, Canada, China, France,
Germany, India, Ireland, Israel, Italy, Japan, Mexico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United
Kingdom, United States, Vietnam)
CLIA Laboratory Registration, Laboratories by Type
Figure 2-6: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: 1/2017 (Physician Office, Skilled Nursing / Nursing
Facility, Home Health Agency, Hospital, Pharmacy, Community Clinic, ESRD Clinic, Independent, Others)
Table 2-13: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined), January 2017 (Ambulance, Ambulatory
Surgery Center, Ancillary Test Site, Assisted Living Facility, Blood Bank, Community Clinic, Comprehensive Outpatient Rehab, End Stage
Renal Disease Dialysis, Federally Qualified Health Center, Health Fair, Health Maintenance Organization, Home Health Agency, Hospice,
Hospital, Independent, Industrial, Insurance, Intermediate Care Facility for Mentally Retarded, Mobile Laboratory, Pharmacy, Physician
Office, Other Practitioner, Prison, Public Health Laboratory, Rural Health Clinic, School/Student Health Service, Skilled Nursing/Nursing
Facility, Tissue Bank/Repository, Other, Total)
Figure 2-7: Change in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2013, July 2015 and
January 2017 (Ambulance, Ambulatory Surgery Center, Ancillary Test Site, Assisted Living Facility, Blood Banks, Community Clinic,
Comprehensive Outpatient Rehab, End Stage Renal Disease Dialysis, Federally Qualified Health Center, Health Fair, Health Maintenance
Organization, Home Health Agency, Hospice, Hospital, Independent, Industrial, Insurance, Intermediate Care – Mentally Retarded, Mobile
Laboratory, Pharmacy, Physician Office, Other Practitioner, Prison, Public Health Laboratory, Rural Health Clinic, School/Student Health
Service, Skilled Nursing, Tissue Bank/Repositories, Other)
Independent Clinical Laboratories
Table 2-14: Leading U.S. Independent Laboratory Groups, as of January 2017
Figure 2-8: Leading U.S. Independent Laboratory Groups, Distribution of Centers, as of January 2017
Figure 2-9: Growth in U.S. Independent Laboratory Facilities, mid-2011 through January 2017
Laboratory Health Workers by Country, 2010-2014 Average (United States, China, Brazil, Korea, Mexico, Canada)
CHAPTER THREE: ISSUES AND TRENDS IN THE CLINICAL LABORATORY INDUSTRY
ISSUES AND TRENDS OVERVIEW
DEMOGRAPHICS
Global Demographics
Table 3-1: The Global Population, 1980-2050
Figure 3-1: The Global Population, 1980-2050 (in millions)
Regional Population Overview
Table 3-2: World Population by Major Geographic Region, 2010 – 2050 (Asia Pacific, Europe, Northern America, Latin America, Rest of
World, World)
Figure 3-2: World Population by Major Geographic Region, 2010–2050 (Asia Pacific, Europe, Northern America, Latin America, Rest of
World)
Aging Populations
Table 3-3: Global Population Trends Age 65+, 2000-2050
Figure 3-3: Global Population Trends Age 65+, 2000-2050 (Millions)
INCIDENCE OF CHRONIC DISEASES AND CONDITIONS
Figure 3-4: Global Causes of Death, 2014 and 2015
SURGICAL PROCEDURE VOLUMES
Table 3-4: Global Surgical Procedure Volume Forecast by Region, 2015-2030*
(procedures in thousands) (Northern America, Europe, Asia Pacific, Latin America, Rest of World, Total) .. 69
REGULATORY OVERVIEW
Certificate of Waiver
Table 3-5: Selected CLIA Waived Laboratory Tests
Certificate of Provider-Performed Microscopy Procedures (PPMP)
Table 3-6: Provider-Performed Microscopy Procedures
Certificate of Compliance and Certificate of Accreditation
Figure 3-5: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), January 2017
Table 3-7: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), January 2017
States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988
Table 3-8: CLIA Exempt States, Number of Laboratories, January 2017 (New York, Washington)
PAYERS AND REIMBURSEMENT
Laboratory Service Payer Types
Table 3-9: U.S. Clinical Laboratory Clients and Payers by Type (%) (Medicare and Medicaid, Private Patient, Commercial Insurance,
Managed Care)
Figure 3-6: Clinical Laboratory Clients and Payers by Type (Medicare/Medicaid, Private, Commercial, Managed Care)
Trends in Medicare Reimbursement
Table 3-10: Medicare Reimbursement Trends, 2009 vs. 2013 vs. 2015 vs. 2016
Health Care Reform
Protecting Access to Medicare Act (PAMA) of 2014
Bundled Insurance Payments for ESRD Patients
Table 3-11: Laboratory Tests Subject to ESRD Consolidated Billing (CY 2017)
Table 3-12: Comparison between New Bundled and Composite Medicare Reimbursement Program (1983-2010 and 2011+)
Commercial Insurance Providers
NEW DEVELOPMENTS IN INFORMATION TECHNOLOGY
CHAPTER FOUR: LEADING MARKET PARTICIPANTS
SUMMARY
Figure 4-1: Leading Market Participants, Global Service Revenues, 2014, 2015 and 2016 ($millions)
U.S. COMPETITIVE ANALYSIS
Table 4-1: Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2016
Figure 4-2: Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2016
Figure 4-3: Estimated U.S. Laboratory Service Revenues for Leading Clinical Laboratory Providers, 2010 vs. 2016
ALERE, INC.
Company Overview
Table 4-2: Alere Corporate Details
Performance Review
Figure 4-4: Alere Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
BIO-REFERENCE LABORATORIES – OPKO
Company Overview
Table 4-3: Bio-Reference Laboratories Corporate Details
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
DAVITA HEALTHCARE PARTNERS, INC.
Company Overview
Table 4-4: DaVita Healthcare Corporate Details
Performance Review
Figure 4-5: DaVita Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
GENOMIC HEALTH, INC.
Company Overview
Table 4-5: Genomic Health Corporate Details
Performance Review
Figure 4-6: Genomic Health Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
LABORATORY CORPORATION OF AMERICA
Company Overview
Table 4-6: Laboratory Corporation of America Corporate Details
Performance Review
Figure 4-7: Laboratory Corporation of America Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
MYRIAD GENETICS, INC.
Company Overview
Table 4-7: Myriad Genetics Corporate Details
Performance Review
Figure 4-8: Myriad Genetics Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
NEOGENOMICS, INC.
Company Overview
Table 4-8: NeoGenomics, Inc. Corporate Details
Performance Review
Figure 4-9: NeoGenomics Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
QUEST DIAGNOSTICS, INC.
Company Overview
Table 4-9: Quest Diagnostics Corporate Details
Performance Review
Figure 4-10: Quest Diagnostics Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
SIEMENS HEALTHINEERS
Company Overview
Table 4-10: Siemens Healthineers Corporate Details
Performance Review
Figure 4-11: Siemens’ Healthineers Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
SONIC HEALTHCARE LIMITED
Company Overview
Table 4-11: Sonic Healthcare Corporate Details
Performance Review
Figure 4-12: Sonic Healthcare Revenue Summary, 2010-2016 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
SPECTRA LABORATORIES: A FRESENIUS COMPANY
Company Overview
Table 4-12: Spectra Laboratories Corporate Details
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
SYNLAB INTERNATIONAL GMBH
Company Overview
Table 4-13: SYNLAB International Corporate Details
Performance Review
Table 4-14: SYNLAB International Business Combination Details
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
CHAPTER FIVE: MARKET TRENDS AND SUMMARY
GLOBAL MARKET OVERVIEW
Table 5-1: Global Clinical Laboratory Market Analysis, 2010-2021 (in millions of dollars at the manufacturer’s level)
Figure 5-1: Global Clinical Laboratory Market Analysis: 2010-2021
SERVICE MARKETS BY TEST SEGMENT
Figure 5-2: Global Clinical Laboratory Revenue Share by General Test Segment, 2016 (%)
Table 5-2: Global Clinical Laboratory Market Analysis by Test Segment (Routine vs. Specialty), 2010-2021 (in millions of dollars at the
manufacturers’ level)
Routine Testing
Table 5-3: Most Common Performed Routine Tests by Order Request, 2016
Figure 5-3: Global Clinical Laboratory Market Analysis: Routine Testing Market Trend, 2010-2021
Specialty Testing
Table 5-4: Most Common Performed Specialty Tests by Order Request, 2016
Figure 5-4: Global Clinical Laboratory Market Analysis: Specialty Testing Market Trend, 2010-2021
CHAPTER SIX: REGIONAL MARKETS AND TRENDS
OVERVIEW
Table 6-1: Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2016 (Northern America; Europe, Middle East,
Africa; Asia Pacific; Latin America; Total)
Figure 6-1: Global Clinical Laboratory Market Analysis, Revenues by Region, 2016 (Northern America; Europe, Middle East, Africa; Asia
Pacific; Latin America)
NORTHERN AMERICAN MARKET OVERVIEW
Table 6-2: Northern America Market Value by Country, 2016 (in millions of dollars at the manufacturers’ level) (Canada, United States,
Rest of Northern America)
U.S. Clinical Laboratory Market
Table 6-3: U.S. Clinical Laboratory Market Analysis, 2010-2021 (in millions of dollars at the manufacturer’s level)
Figure 6-2: U.S. Clinical Laboratory Market Analysis: 2010-2021
Market Analysis by Laboratory Type
Table 6-4: U.S. Clinical Laboratory Market Analysis by Laboratory Type, 2010-2021 (in millions of dollars at the manufacturers’ level)
(Hospital-based, Physician-office, Independent, Total)
EUROPE AND MIDDLE EAST MARKET OVERVIEW
Table 6-5: Europe/Middle East and Africa Market Value by Country, 2016 (in millions of dollars at the manufacturers’ level) (Germany,
France, Italy, Spain, United Kingdom, Switzerland, Rest of EMEA, Total)
ASIA PACIFIC MARKET OVERVIEW
Table 6-6: Asia Pacific Market Value by Country, 2016 (in millions of dollars at the manufacturers’ level) (China, Japan, India, South
Korea, Australia, Rest of Asia Pacific, Total)
LATIN AMERICA MARKET OVERVIEW
Table 6-7: Latin America Market Value by Country, 2016 (in millions of dollars at the manufacturers’ level) (Brazil, Mexico, Rest of Latin
America, Total)
