Clinical Laboratory Services Market, 6th Edition

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, 2010-2025 (in millions of dollars at the manufacturer’s level)
• • Figure 1-1: Global Clinical Laboratory Market Analysis: 2010-2025

Market Conclusions

• The United States and China are the most attractive clinical laboratory markets for growth and new opportunities
• The U.S. is the largest market for clinical laboratory revenues
• Emerging markets are becoming increasingly competitive
• Specialty testing services will be primary drivers for the global market
• Pricing, and to a lesser extent test exclusion, will likely impact industry performance and participation in future years
• Diversifying geographic participation and payer groups are a growing strategy to remain competitive
• Newer technologies, molecular testing services, shifting test volume to less conventional areas
• COVID-19 Future Impact

KEY ISSUES AND TRENDS AFFECTING THE MARKET
LEADING MARKET PARTICIPANTS

CHAPTER TWO: INDUSTRY OVERVIEW

CLINICAL LABORATORY DESCRIPTION

• • Figure 2-1: Hospital Length of Stay in Days (2018-2019 Average)

NUMBER OF LABORATORY HEALTH WORKERS BY COUNTRY

• • Figure 2-2: Laboratory Health Workers by Country, 2010-2019 Average

THE LARGEST CLINICAL LABORATORY MARKET: THE UNITED STATES
Structure and Regulation in the U.S.

• Certificate of Waiver
  • Table 2-1: Selected CLIA Waived Laboratory Tests
• Certificate of Provider-Performed Microscopy Procedures (PPMP)
  • Table 2-2: Provider-Performed Microscopy Procedures
• Certificate of Compliance and Certificate of Accreditation
  • Figure 2-3: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), March 2020
  • Table 2-3: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), as of March 2020
  • Figure 2-4: Laboratory Certificate Trends by Application Type, July 2010- March 2020
• States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988
  • Table 2-4: CLIA Exempt States, Number of Laboratories, as of March 2020

LABORATORY DEVELOPED TEST REGULATIONS

• Directive 98/79/EC
• Health Canada Changes and Forecasted Action

PAYERS AND REIMBURSEMENT
Laboratory Service Payer Types

• • Table 2-5: U.S. Clinical Laboratory Revenues by Client and Payer Type (%), 2020
• • Figure 2-5: Clinical Laboratory Revenues by Client and Payer Type, 2020 Estimates

Trends in Medicare Reimbursement

• • Figure 2-6: Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009 through 2020

Health Care Reform
Protecting Access to Medicare Act (PAMA) of 2014

• • Table 2-6: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2023
• Impact of CARES Act on PAMA

Advanced Laboratory Tests (ADLT)

• • Table 2-7: List of Approved ADLTs, March 2021

Bundled Insurance Payments for ESRD Patients

• • Table 2-8: Laboratory Tests Subject to ESRD Consolidated Billing (CY 2019)

Commercial Insurance Providers

• • Table 2-9: National Commercial Insurance Provider List, 2020
• • Figure 2-7: National Commercial Insurance Providers by Membership and Total Revenues, 2020

TRANSPARENCY IN PRICING

• • Figure 2-8: Revenue and Test Volume Trends, Quest Diagnostics

DIRECT-TO-CONSUMER TESTING

• • Table 2-10: Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Pixel LabCorp) 2019 (in US $)

DTC in Genetic Testing
EXPANDING CANCER TEST UTILIZATION AND TECHNOLOGIES
LabCorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy
Foundation Medicine signs $111M contract with Department of Veterans Affairs
Quest Diagnostics Attention to Oncology
THE ROLE OF INFORMATION TECHNOLOGY

• • Table 2-11: Selected Laboratory Information Management System Providers, 2020 Vendor List

INDUSTRY DRIVERS
Global Demographics

• • Table 2-12: The Global Population, 1980-2050
• • Figure 2-9: The Global Population, 1980-2050 (in millions)
• Regional Population Overview
  • Table 2-13: World Population by Major Geographic Region, 2010 – 2050
  • Figure 2-10: World Population by Major Geographic Region, 2010–2050
• Aging Populations
  • Table 2-14: Global Population Trends Age 65+, 2000-2050
  • Figure 2-11: Global Population Trends Age 65+, 2000-2050 (Millions)

Chronic Diseases and Conditions

• • Figure 2-12: Global Prevalence of Disease, 2000, 2015 and Projected 2030
• • Figure 2-13: Global Causes of Death, 2000, 2010 and 2016
• • Figure 2-14: Change in Mortality Over 2000-2016 Period

Economic Performance

• Health Expenditures
  • Figure 2-15: Global Health Spending as a Percentage of GDP, by Country, 2019 estimates (%)

CHAPTER THREE: TESTING SERVICES BY SPECIALTY

TEST AND SERVICES OVERVIEW

• • Figure 3-1: Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2010-2025 ($millions)
• • Table 3-1: Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2010-2025 (in millions of dollars at the manufacturers’ level)
• • Figure 3-2: Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2020-2025 (excluding COVID-19)
• • Figure 3-3: Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2020 (%)

CLINICAL CHEMISTRY – ROUTINE AND ESSENTIAL TESTING

• • Figure 3-4: Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2010-2025
• • Table 3-2: Market Overview – Routine and Essential Testing, 2020

Routine Clinical Chemistry
Cholesterol Level Testing

• • Table 3-3: High Cholesterol Risk Categories
• • Table 3-4: Raised or At-Risk Total Cholesterol (> = 190 mg/dL) age standardized estimates, 2008 data

Urinalysis

• • Table 3-5: Normal Reference Levels in a Medical Urinalysis

Hematology

• Blood Cell Count
  • Table 3-6: Laboratory Reference Parameters for CBC

Coagulation
Endocrinology

• Thyroid Function Tests
• Pregnancy Testing
  • Table 3-7: HCG Levels in Pregnant Women by Days Past Ovulation

IMMUNOLOGY AND MICROBIOLOGY

• • Figure 3-5: Global Clinical Laboratory Market Analysis: Immunology & Microbiology Testing Service Market Trend, 2010-2025
• • Table 3-8: Market Overview – Immunology & Microbiology Testing, 2020

Allergy and Food Intolerance
Tumor Markers
Cardiac Markers
HIV Testing

• • Table 3-9: Number of Reported HIV Tests Performed by Country, 2018
• • Figure 3-6: Number of HIV Testing/Counseling Facilities per 100,000 Adult Populations and HIV Positive Population per 1,000 by Select Country (2017)

CYTOLOGY AND HISTOLOGY TESTING

• • Figure 3-7: Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2010-2025
• • Table 3-10: Market Overview – Cytology & Histology Testing, 2020
• Pap Test
  • Figure 3-8: Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country 2016/2017 Estimates

GENETIC TESTING

• • Figure 3-9: Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2010-2025
• • Table 3-11: Market Overview – Genetic Testing, 2020

TOXICOLOGY TESTING

• • Figure 3-10: Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2010-2025
• • Table 3-12: Substance Detection Periods by Test Method

COVID-19 VIRUS TESTING

• • Figure 3-11: Global Distribution of COVID-19 Test Services: Volume, 2020
• • Figure 3-12: Factors Affecting COVID-19 Clinical Testing Market, 2021 and Beyond

CHAPTER FOUR: GLOBAL CLINICAL LABORATORY MARKET BY PROVIDER GROUP

CLINICAL LABORATORY MARKET: PROVIDER OVERVIEW

• • Table 4-1: Global Clinical Laboratory Market Analysis by Provider Segment, 2020, 2025 (Hospitals, Physician Offices/Outpatient Clinics, Independent)
• • Figure 4-1: Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2020-2025
• • Figure 4-2: Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2020 (%)

HOSPITALS AND ACUTE CARE PROVIDERS

• • Figure 4-3: COVID-19 Impact on Hospital-based Laboratory Testing Markets, $millions
• • Table 4-2: Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)
• • Figure 4-4: Hospital Beds per 1,000 Population by Country, 2020

PHYSICIANS AND OUTPATIENT CARE PROVIDERS

• • Figure 4-5: COVID-19 Impact on Physician-based Laboratory Testing Markets, $millions
  • Table 4-3: Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)

Physician Offices

• • Figure 4-6: Medical Doctors per 1,000 Population by Country, 2019/2020

Global Nursing Establishments and Assisted Living Facilities
Global Dialysis Clinics
INDEPENDENT LABORATORY PROVIDERS

• • Figure 4-7: COVID-19 Impact on Independent Laboratory Testing Markets, $millions
• • Table 4-4: Revenues for Selected U.S.-based Reference Labs 2015-2020 ($million, estimated)
• • Table 4-5: Estimated Clinical Test Volume by Select Independent Laboratory, 2020 (millions of units)
• • Table 4-6: Estimated COVID-19 Test Volume by Select Independent Laboratory, 2020 (millions of units)
• • Table 4-7: Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)

CHAPTER FIVE: NORTH AMERICA MARKET

OVERVIEW

• • Table 5-1: North America Market Value by Country, 2020 (in millions of dollars at the manufacturers’ level)

UNITED STATES

• • Table 5-2: The United States Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
• • Figure 5-1: The United States Clinical Laboratory Service Market, Performance 2010-2025 ($millions)

U.S. Market by Test Type

• • Table 5-3: The United States Clinical Laboratory Service Market by Testing Services, Estimates and Forecast 2020 and 2025 ($millions)
• • Figure 5-2: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues by Type, 2020
• • Figure 5-3: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Type, 2010-2025 ($millions)

U.S. Market by Laboratory Provider Type

• • Table 5-4: The United States Clinical Laboratory Service Market by Laboratory Type, Estimates and Forecast 2020 and 2025 ($millions)
• • Figure 5-4: U.S. Clinical Laboratory Market Share by Laboratory Type, 2020
• • Figure 5-5: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Laboratory Type, 2010-2025 ($millions)

U.S. Clinical Laboratory Industry Structure

• • Figure 5-6: Growth in Clinical Laboratories, 1997-2020
• CLIA Laboratory Registration, Laboratories by Type
  • Figure 5-7: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: March 2020
  • Table 5-5: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) March 2020
  • Figure 5-8: Growth Trends in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2011 and March 2020
  • Figure 5-9: Change in CLIA Registered Laboratories by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2011-2020

Independent Clinical Laboratories

• • Table 5-6: Leading U.S. Independent Laboratory Groups, as of March 2020
• • Figure 5-10: Leading U.S. Independent Laboratory Groups, Distribution of Centers, as of March 2020
• Growth in Independent Clinical Laboratories
  • Figure 5-11: Growth in U.S. Independent Laboratory Facilities, June 2011 through March 2020

Hospital-based Laboratories

• U.S. Hospital Data
  • Figure 5-12: Number of Hospitals in the U.S., 1975-2019
  • Table 5-7: U.S. Hospital Types
  • Table 5-8: AHA Statistics – U.S. Registered Hospitals by Type, 2010 through 2019
  • Table 5-9: AHA Statistics for U.S. Hospitals, 2012-2019
• U.S. Hospital Stay Stats
  • Figure 5-13: U.S. Hospital Length of Stay, Average by Broad Age Group, 2016
• Growth in Hospital Clinical Laboratories
  • Figure 5-14: Growth in U.S. Hospital Laboratory Locations, June 2011 through March 2020

Physician-office and Clinic Laboratories

• Number of U.S. Physicians
  • Figure 5-15: Number of Physician Offices, United States, 2000-2017, Estimated 2018
• Growth in Clinical Laboratories in the Physician Office
  • Figure 5-16: Growth in U.S. Physician Office Laboratory Locations, June 2011 through March 2020

Nursing Facility and Home Health

• U.S. Nursing Home Establishments
  • Figure 5-17: Number of Nursing Homes (United States), 2000-2017, Estimated 2018
• U.S. Home Health Facilities
• Growth in Clinical Laboratories in the Nursing Facility and Home Health Segment
  • Figure 5-18: Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through March 2020

Pharmacy-based Laboratories

• Growth in Pharmacy-Based Clinical Laboratories
  • Figure 5-19: Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through March 2020

Dialysis Clinics

• Growth in U.S. Dialysis Clinics and Affiliated Laboratories
  • Figure 5-20: Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through March 2020

CANADA

• • Table 5-10: Canada Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
• • Figure 5-21: Canada Clinical Laboratory Service Market, Performance 2010-2025 ($millions)

CHAPTER SIX: EMEA MARKET

OVERVIEW

• • Table 6-1: EMEA Market Value by Country, 2020 (in millions of dollars at the manufacturers’ level)
• • Figure 6-1: EMEA Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020-2025

GERMANY

• • Table 6-2: Germany Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
• • Figure 6-2: Leading Laboratory Service Suppliers by Estimated Distribution of Revenues, Germany, 2020

FRANCE

• • Table 6-3: France Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

ITALY

• • Table 6-4: Italy Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

SPAIN

• • Table 6-5: Spain Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

UNITED KINGDOM

• • Table 6-6: United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

SWITZERLAND

• • Table 6-7: Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

REST OF EMEA
Middle East
Turkey

CHAPTER SEVEN: ASIA PACIFIC MARKET

OVERVIEW

• • Table 7-1: Asia Pacific Clinical Laboratory Service Market Value by Country, 2020 (in millions of dollars at the manufacturers’ level)
• • Figure 7-1: Asia Pacific Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020-2025

JAPAN

• • Table 7-2: Japan Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

Japan Clinical Laboratory Industry Structure

• • Figure 7-2: Japan Clinical Laboratory Industry by Type, 2020
• • Figure 7-3: Japan Clinical Laboratory Industry by Test Classification, 2020
• • Figure 7-4: Japan Clinical Laboratory Industry, Number of Laboratories by Prefecture, 2020

CHINA

• • Table 7-3: China Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

China Clinical Laboratory Industry Structure

• • Figure 7-5: China Clinical Laboratory Industry by Type, 2020

INDIA

• • Table 7-4: India Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

SOUTH KOREA

• • Table 7-5: South Korea Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

AUSTRALIA

• • Table 7-6: Australia Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

REST OF ASIA PACIFIC
Singapore
Indonesia
Philippines
Taiwan

CHAPTER EIGHT: LATIN AMERICA MARKET

OVERVIEW

• • Table 8-1: Latin America Market Value by Country, 2020 (in millions of dollars at the manufacturers’ level)
• • Figure 8-1: Latin America Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020-2025

BRAZIL

• • Table 8-2: Brazil Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

MEXICO

• • Table 8-3: Mexico Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)

REST OF LATIN AMERICA
Argentina
Chile

• • Table 8-4: Estimated Clinical Labs in Chile (Average Tests/Year, Number of Labs, Private Sector, Public Sector) – 2019

Colombia

• • Table 8-5: Classification of Laboratories by Test Complexity

Peru
Venezuela

CHAPTER NINE: LEADING MARKET PARTICIPANTS

GLOBAL COMPETITOR SUMMARY

• • Figure 9-1: Top 10 Market Participants, Global Service Revenues, Estimated 2019 and 2020 ($millions)
• • Figure 9-2: Market Contribution by Clinical Laboratory Service Providers, 2020

U.S. COMPETITIVE ANALYSIS

• • Table 9-1: Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2020
• • Figure 9-2: Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2020

#1: QUEST DIAGNOSTICS, INC.
Company Overview

• • Table 9-3: Quest Diagnostics Corporate Details

Performance Review

• • Figure 9-3: Quest Diagnostics Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#2: LABORATORY CORPORATION OF AMERICA
Company Overview

• • Table 9-4: Laboratory Corporation of America Corporate Details

Performance Review

• • Figure 9-4: Laboratory Corporation of America Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#3: SONIC HEALTHCARE LIMITED
Company Overview

• • Table 9-5: Sonic Healthcare Corporate Details

Performance Review

• • Figure 9-5: Sonic Healthcare Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#4: SYNLAB INTERNATIONAL GMBH (SYNLAB BONDCO PLC)
Company Overview

• • Table 9-6: SYNLAB Corporate Details

Performance Review

• • Figure 9-6: SYNLAB Revenue Summary, 2016-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#5: EXACT SCIENCES CORP.
Company Overview

• • Table 9-7: Exact Sciences Corporate Details

Performance Review

• • Figure 9-7: Exact Sciences Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#6: EUROFINS SCIENTIFIC SE
Company Overview

• • Table 9-8: Eurofins Scientific Corporate Details

Performance Review

• • Figure 9-8: Eurofins Scientific Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#7: MIRACA HOLDINGS, INC.
Company Overview

• • Table 9-9: Miraca – H.U. Group Holdings, Inc. Corporate Details

Performance Review

• • Figure 9-9: Miraca Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

#8: BIOREFERENCE LABORATORIES – AN OPKO HEALTH SUBSIDIARY
Company Overview

• • Table 9-10: BioReference Laboratories Corporate Details

Key Acquisitions, Alliances, and Partnerships
Performance Review

• • Figure 9-10: BioReference Laboratories Revenue Summary, 2010-2020 ($millions)

Products and Services

• COVID-19 Events and Impact

#9: UNILABS
Company Overview

• • Table 9-11: Unilabs Corporate Details

Performance Review
Products and Services

• COVID-19 Events and Impact

#10: SIEMENS HEALTHINEERS
Company Overview

• • Table 9-12: Siemens Healthineers Corporate Details

Performance Review

• • Figure 9-11: Siemens Healthineers’ Revenue Summary, 2010-2020 ($millions)

Key Acquisitions, Alliances, and Partnerships
Products and Services

• COVID-19 Events and Impact

CHAPTER TEN: MARKET TRENDS AND SUMMARY

GLOBAL MARKET OVERVIEW

• • Table 10-1: Global Clinical Laboratory Market Analysis, 2010-2025 (in millions of dollars at the manufacturer’s level)
• • Figure 10-1: Global Clinical Laboratory Market Analysis: 2010-2025

REGIONAL OVERVIEW

• • Table 10-2: Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2020
• • Figure 10-2: Global Clinical Laboratory Market Analysis, Revenues by Region, 2020
• • Figure 10-3: Global Clinical Laboratory Market Analysis: Regional Growth Forecast, CAGR 2020-2025
• • Figure 10-4: Estimated COVID-19 Market Performance by Region, 2020

Population growth
Aging populations
Increasing disease burden
Economic growth in developing regions
Stabilizing economies in developed regions
Pricing pressures
Focusing on Efficient health systems
Overall growth in demand for health care services
COVID-19

APPENDIX I: ACCREDITATION ORGANIZATIONS UNDER CLIA
AABB
AMERICAN ASSOCIATION FOR LABORATORY ACCREDITATION
ACCREDITATION ASSOCIATION FOR HOSPITALS AND HEALTH SYSTEMS/HEALTHCARE FACILITIES ACCREDITATION PROGRAM (AAHHS/HFAP) (FORMERLY KNOWN AS THE AMERICAN OSTEOPATHIC ASSOCIATION/HEALTHCARE FACILITIES ACCREDITATION PROGRAM (AOA/HFAP))
AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS
COLA
COLLEGE OF AMERICAN PATHOLOGISTS