The Worldwide Market for Clinical Laboratory Services, 9th Edition

Table of Contents

Chapter One: Executive Summary

Industry at a Glance

• Figure 1-1: Clinical Laboratory Service Market Overview, 2024

Scope and Methodology

Global Market Overview

• Figure 1-2: Factors Driving Demand in Clinical Laboratory Service Market, 2024
• Table 1-1: Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions at the manufacturers’ level)
• Figure 1-3: Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions)

Key Issues and Trends Affecting the Market

Leading Market Participants

Chapter Two: Industry Overview

Clinical Laboratory Description

• Figure 2-1: Clinical Laboratory Order (Diagnosis, Treatment, Monitoring)
• Figure 2-2: Global Hospital Length of Stay in Days, by Country, 2021 Average

Number of Laboratory Health Workers by Country

• Figure 2-3: Global Laboratory Health Workers, by Country, 2010-2021 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 2-4: Clinical Laboratory Certificate of Accreditation Issued, by Organization (non-exempt laboratories only), March 2024
• Table 2-3: Clinical Laboratory Certificates Issued, by Type (non-exempt laboratories only), as of April 2023
• Figure 2-5: Laboratory Certificate Trends, by Application Type, July 2010 – March 2024
• States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988
• Table 2-4: CLIA Exempt States, Number of Laboratories, as of March 2024

Laboratory Developed Test Regulations

• FDA
• Directive 98/79/EC

Payers and Reimbursement

• Figure 2-6: Positive Forces and Negative Forces for Payers and Reimbursement

Laboratory Service Payer Types

• Table 2-5: U.S. Clinical Laboratory Revenues, by Client and Payer Type, 2023 (%)
• Figure 2-7: Clinical Laboratory Revenues, by Client and Payer Type, 2023 Estimates (%)

Trends in Medicare Reimbursement

• Figure 2-8: Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009-2024

Health Care Reform

Protecting Access to Medicare Act (PAMA) of 2014

• Table 2-6: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
• Impact of CARES Act on PAMA
• Saving Access to Laboratory Service Act (SALSA)

Advanced Laboratory Tests (ADLT)

• Table 2-7: List of Approved ADLTs, 2018-March 2024

Bundled Insurance Payments for ESRD Patients

• Table 2-8: Laboratory Tests Subject to ESRD Consolidated Billing (CY 2022)

Commercial Insurance Providers

• Table 2-9: National Commercial Insurance Provider List, 2023
• Figure 2-9: National Commercial Insurance Providers, by Membership and Total Revenues, 2023 ($ billions)

Transparency in Pricing

• Figure 2-10: Revenue and Test Volume Trends, Quest Diagnostics, 2010-2023 ($ millions)

Direct-to-Consumer Testing

• Table 2-10: Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Labcorp On Demand) 2023 (in US $)

DTC in Genetic Testing

Expanding Cancer Test Utilization and Technologies

Labcorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy

Labcorp Launches New Test for NSCLC

Labcorp Offers First FDA Test for Monitoring Residual Blood Cancer Cells

Labcorp Launches New Test for Skin Cancer

Labcorp Acquires Select Assets of Invitae

Labcorp Launches Plasma Detect

Quest Diagnostics Attention to Oncology

Quest Collaborates with GRAIL on Oncology

Quest Releases Companion Diagnostic

Quest Offers Biocept’s Liquid Biopsy Test for Lung Cancer

Quest Acquires Haystack Oncology

Quest Launches MelaNodal Predict Test

The Role of Information Technology

• Table 2-11: Selected Laboratory Information Management System Providers, 2023 Vendor List

Industry Drivers

Global Demographics

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

Chronic Diseases and Conditions

• Figure 2-14: Global Prevalence of Disease, 2000, 2015, and Projected 2030 (in millions)
• Figure 2-15: Global Causes of Death, 2000, 2010, and 2020 (in millions)
• Figure 2-16: Change in Mortality by Disease Type, Over 2000-2020 Period (%)

Economic Performance

• Health Expenditures
• Figure 2-17: Global Health Spending as a Percentage of GDP, by Country, 2022 estimates (%)

Chapter Three: Testing Services by Specialty

Test and Services Overview

• Figure 3-1: Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2018-2028 ($ millions)
• Table 3-1: Global Clinical Laboratory Market Analysis, by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2018-2028 ($ millions at the manufacturers’ level)
• Figure 3-2: Global Clinical Laboratory Market Analysis, Segment Growth Forecast, by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), CAGR 2023-2028 (%)
• Figure 3-3: Global Clinical Laboratory Market Analysis, by Testing Service (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), Distribution of Revenues, 2023 (%)

Clinical Chemistry – Routine and Essential Testing

• Figure 3-4: Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2018-2028 ($ millions)
• Table 3-2: Market Overview – Routine and Essential Testing, 2023 ($ millions)

Routine Clinical Chemistry

Cholesterol Level Testing

• Table 3-3: High Cholesterol Risk Categories

Urinalysis

• Table 3-4: Normal Reference Levels in a Medical Urinalysis

Hematology

• Blood Cell Count
• Table 3-5: Laboratory Reference Parameters for CBC

Coagulation

Endocrinology

• Thyroid Function Tests
• Pregnancy Testing
• Table 3-6: 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, 2018-2028 ($ millions)
• Table 3-7: Market Overview – Immunology & Microbiology Testing, 2023 ($ millions)

Allergy and Food Intolerance

Tumor Markers

Cardiac Markers

HIV Testing

Cytology and Histology Testing

• Figure 3-6: Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2018-2028 ($ millions)
• Table 3-8: Market Overview – Cytology & Histology Testing, 2023 ($ millions)
• Pap Test
• Figure 3-7: Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country 2019 Estimates

Genetic Testing

• Figure 3-8: Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2018-2028 ($ millions)
• Table 3-9: Market Overview – Genetic Testing, 2023 ($ millions)

Toxicology Testing

• Figure 3-9: Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2018-2028 ($ millions)
• Table 3-10: Substance Detection Periods by Selected Test Method

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 (Hospitals, Physician Offices/Outpatient Clinics, Independent), 2023-2028 ($ millions at the manufacturers’ level)
• Figure 4-1: Global Clinical Laboratory Market Analysis, Provider Segment Growth Forecast, CAGR 2023-2028 (%)
• Figure 4-2: Global Clinical Laboratory Market Analysis, by Provider Group, Distribution of Revenues, 2023 (%)

Hospitals and Acute Care Providers

• Figure 4-3: COVID-19 Impact on Hospital-based Laboratory Testing Markets, 2021-2023 ($ millions)
• Table 4-2: Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)
• Figure 4-4: Hospital Beds per 1,000 Population, by Country, 2021/2022

Physicians and Outpatient Care Providers

• Figure 4-5: COVID-19 Impact on Physician-based Laboratory Testing Markets, 2021-2023 ($ millions)
• Table 4-3: Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)

Physician Offices

• Figure 4-6: Medical Doctors per 1,000 Population, by Country, 2021/2022

Global Nursing Establishments and Assisted Living Facilities

Global Dialysis Clinics

Independent Laboratory Providers

• Figure 4-7: COVID-19 Impact on Independent Laboratory Testing Markets, 2021-2023 ($ millions)
• Table 4-4: Revenues for Selected U.S.-based Reference Labs 2018-2023 ($ millions, estimated)
• Table 4-5: Estimated Clinical Test Volume by Select Independent Laboratory, 2023 (millions of units)
• Table 4-6: Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)

Chapter Five: North America Market

Overview

• Table 5-1: North America Market Value, by Country, 2023 ($ millions at the manufacturers’ level)

United States

• Table 5-2: The United States Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
• Figure 5-1: The United States Clinical Laboratory Service Market, Performance 2018-2028 ($ millions)

U.S. Market by Test Type

• Table 5-3: The United States Clinical Laboratory Service Market, by Testing Services, Estimates and Forecast 2023 and 2028 ($ millions)
• Figure 5-2: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues, by Type, 2023 (%)
• Figure 5-3: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time, by Type, 2018-2028 ($ millions)

U.S. Market by Laboratory Provider Type

• Table 5-4: The United States Clinical Laboratory Service Market, by Laboratory Type, Estimates and Forecast 2023 and 2028 ($ millions)
• Figure 5-4: U.S. Clinical Laboratory Market Share, by Laboratory Type, 2023 (%)
• Figure 5-5: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time, by Laboratory Type, 2018-2028 ($ millions)

U.S. Clinical Laboratory Industry Structure

• Figure 5-6: Growth in Clinical Laboratories, 2000-2023
• CLIA Laboratory Registration, Laboratories by Type
• Figure 5-7: U.S. CLIA Clinical Laboratory Registration, by Primary Laboratory Type, April 2024
• Table 5-5: CLIA Registered Laboratories, by Type of Facility (Exempt/Non-Exempt Combined), April 2024
• Figure 5-8: Growth Trends in CLIA Registered Laboratories, by Type of Facility (Exempt/Non-Exempt Combined) June 2020 and April 2024
• Figure 5-9: Change in CLIA Registered Laboratories, by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2020-2024

Independent Clinical Laboratories

• Figure 5-10: Leading U.S. Independent Laboratory Groups, Distribution of Centers, December 2023 (%)
• Growth in Independent Clinical Laboratories
• Figure 5-11: Growth in U.S. Independent Laboratory Facilities, June 2011 through April 2024

Hospital-based Laboratories

• S. Hospital Data
• Table 5-6: U.S. Hospital Types
• Table 5-7: AHA Statistics – U.S. Registered Hospitals, by Type, 2010-2022
• Table 5-8: AHA Statistics for U.S. Hospitals, 2014-2022
• S. Hospital Stay Stats
• Figure 5-12: U.S. Hospital Length of Stay, Average by Broad Age Group, 2021
• Growth in Hospital Clinical Laboratories
• Figure 5-13: Growth in U.S. Hospital Laboratory Locations, June 2011 through April 2024

Physician-office and Clinic Laboratories

• Number of U.S. Physicians
• Growth in Clinical Laboratories in the Physician Office
• Figure 5-14: Growth in U.S. Physician Office Laboratory Locations, June 2011 through April 2024

Nursing Facility and Home Health

• S. Nursing Home Establishments
• S. Home Health Facilities
• Growth in Clinical Laboratories in the Nursing Facility and Home Health Segment
• Figure 5-15: Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through April 2024

Pharmacy-based Laboratories

• Growth in Pharmacy-Based Clinical Laboratories
• Figure 5-16: Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through April 2024

Dialysis Clinics

• Growth in U.S. Dialysis Clinics and Affiliated Laboratories
• Figure 5-17: Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through April 2024

Canada

• Table 5-9: Canada Clinical Laboratory Service Market, Estimates and Forecast 2023-2028 ($ millions)
• Figure 5-18: Canada Clinical Laboratory Service Market, Performance 2018-2028 ($ millions)

Chapter Six: EMEA Market

Overview

• Table 6-1: EMEA Market Value, by Country, 2023 ($ millions at the manufacturers’ level)
• Figure 6-1: EMEA Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028

Germany

• Table 6-2: Germany Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
• Figure 6-2: Leading Laboratory Service Suppliers, by Estimated Distribution of Revenues, Germany, 2023 (%)

France

• Table 6-3: France Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Italy

• Table 6-4: Italy Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Spain

• Table 6-5: Spain Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

United Kingdom

• Table 6-6: United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Switzerland

• Table 6-7: Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Chapter Seven: Asia Pacific Market

Overview

• Table 7-1: Asia Pacific Clinical Laboratory Service Market Value, by Country, 2023 ($ millions at the manufacturers’ level)
• Figure 7-1: Asia Pacific Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028 (%)

Japan

• Table 7-2: Japan Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Japan Clinical Laboratory Industry Structure

• Figure 7-2: Japan Clinical Laboratory Industry, by Type, 2023 (%)
• Figure 7-3: Japan Clinical Laboratory Industry, by Test Classification, 2022-2023 (%)
• Figure 7-4: Japan Clinical Laboratory Industry, Number of Laboratories, by Prefecture, 2023 (%)

China

• Table 7-3: China Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

China Clinical Laboratory Industry Structure

• Figure 7-5: China Clinical Laboratory Industry, by Type, 2023 (%)

India

• Table 7-4: India Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

South Korea

• Table 7-5: South Korea Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Australia

• Table 7-6: Australia Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Chapter Eight: Latin America Market

Overview

• Table 8-1: Latin America Market Value, by Country, 2023 ($ millions at the manufacturers’ level)
• Figure 8-1: Latin America Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028

Brazil

• Table 8-2: Brazil Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Mexico

• Table 8-3: Mexico Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)

Chapter Nine: Leading Market Participants

Global Competitor Summary

• Figure 9-1: Market Participants, Global Service Revenues, Estimated 2022 and 2023 ($ millions)

U.S. Competitive Analysis

• Table 9-1: Top Ten Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2023 ($ millions)
• Figure 9-2: Top 10 Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2023 (%)

Select Company Profiles

Quest Diagnostics, Inc.

Company Overview

• Table 9-2: Quest Diagnostics Corporate Details

Performance Review

• Figure 9-3: Quest Diagnostics Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

• COVID-19 Events and Impact

Laboratory Corporation of America

Company Overview

• Table 9-3: Laboratory Corporation of America Corporate Details

Performance Review

• Figure 9-4: Laboratory Corporation of America Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

• COVID-19 Events and Impact

Exact Sciences Corp.

Company Overview

• Table 9-4: Exact Sciences Corporate Details

Performance Review

• Figure 9-5: Exact Sciences Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

• COVID-19 Events and Impact

Sonic Healthcare Limited

Company Overview

• Table 9-5: Sonic Healthcare Corporate Details

Performance Review

• Figure 9-6: Sonic Healthcare Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

BioReference Laboratories – An OPKO Health Subsidiary

Company Overview

• Table 9-6: BioReference Laboratories Corporate Details

Key Acquisitions, Alliances, and Partnerships

Performance Review

• Figure 9-7: BioReference Laboratories Revenue Summary, 2010-2023 ($ millions)

Products and Services

Myriad Genetics, Inc.

Company Overview

• Table 9-7: Myriad Genetics Corporate Details

Key Acquisitions, Alliances, and Partnerships

Performance Review

• Figure 9-8: Myriad Genetics Revenue Summary, 2010-2023 ($ millions)

Products and Services

SYNLAB International GmbH (SYNLAB Bondco PLC)

Company Overview

• Table 9-8: SYNLAB Corporate Details

Performance Review

• Figure 9-9: SYNLAB Revenue Summary, 2015-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

• COVID-19 Events and Impact

Eurofins Scientific SE

Company Overview

• Table 9-11: Eurofins Scientific Corporate Details

Performance Review

• Figure 9-10: Eurofins Scientific Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

• COVID-19 Events and Impact

H.U. Group Holdings Miraca

Company Overview

• Table 9-10: H.U. Group Holdings, Inc. Corporate Details

Performance Review

• Figure 9-11: H.U. Holdings Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

Siemens Healthineers

Company Overview

• Table 9-11: Siemens Healthineers Corporate Details

Performance Review

• Figure 9-12: Siemens Healthineers’ Revenue Summary, 2010-2023 ($ millions)

Key Acquisitions, Alliances, and Partnerships

Products and Services

Unilabs

Company Overview

• Table 9-12: Unilabs Corporate Details

Performance Review

Products and Services

• COVID-19 Events and Impact

Medicover AB

Company Overview

• Table 9-13: Medicover Corporate Details

Key Acquisitions, Alliances, and Partnerships

Performance Review

• Figure 9-13: Medicover Revenue Summary, 2010-2023 ($ millions)

Products and Services

Chapter Ten: Market Trends and Summary

Global Market Overview

• Table 10-1: Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions at the manufacturers’ level)
• Figure 10-1: Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions)

Regional Overview

• Table 10-2: Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2023 ($ millions)
• Figure 10-2: Global Clinical Laboratory Market Analysis, Revenues by Region, 2023 (%)
• Figure 10-3: Global Clinical Laboratory Market Analysis, Regional Growth Forecast, CAGR 2023-2028 (%)
• Figure 10-4: Estimated COVID-19 Market Performance, by Region, 2023 ($ millions)

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

Multiplex Testing

AI and Machine Learning Laboratory Trends

Molecular Testing and Other Advanced Testing Will Open New Avenues

Digital Pathology Trends

Staffing Shortages