Global Clinical Lab Market - Market Research, Industry Trends, Market Share


Published: 04/27/2017
Pages: 200
Full Study Price: US$ 3,995

Global Clinical Laboratory Market provides an in-depth and comprehensive overview of the clinical laboratory industry and the major trends driving market growth. The clinical laboratory market is experiencing growth, and this report discusses the key regions wherein market growth is most prevalent. Regions include: North America; Europe; Middle East and Africa; Asia Pacific; and Latin America. The clinical laboratory market is highly competitive and incorporates different companies which Kalorama considers to be industry leaders.

Global Clinical Laboratory Market covers market trends which are inclusive of population statistics, emergent issues, regulatory environment, laboratory regulation, reimbursement, payer types, and developments in personalized medicine. Information gathered for this report was consolidated from both primary and secondary research, which includes interviews conducted with more than 50 key industry officials, consultants, healthcare providers, and government personnel.

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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)