Clinical Laboratory Services: Market Research Report

December 2018 | 470 pages | ID: CB981A04153EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Clinical Laboratory Services in US$ Million by the following Segments: Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World.

Annual estimates and forecasts are provided for the period 2016 through 2024. Also, a five-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research.

Company profiles are primarily based on public domain information including company URLs.

The report profiles 133 companies including many key and niche players such as -

• ADICON Clinical Laboratories, Inc.
• ARUP Laboratories
• Bio-Reference Laboratories, Inc.
• DaVita, Inc.
• Enzo Clinical Labs
• Genova Diagnostics, Inc.

Contents

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
Hospital-Based Medical Laboratories
Independent Laboratories
Physician Office-Based Laboratories

2. INDUSTRY OVERVIEW

Clinical Laboratory Services – An Overview
Growth of Specialty Labs
Outlook
Developed Nations: Cost Pressures Necessitate New Strategies
Despite Challenges, Emerging Markets Provide Growth Opportunities
Routine Testing Takes the Lead; Esoteric Testing Services Drive Growth
Common Routine and Esoteric Tests
Key Market Drivers
Growth Contributing Factors in a Gist
Rising Healthcare Needs of Aging Global Population

Table 1. Global Aging Population (in Thousands) by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Table 2. Global Aging Population in Select Regions/Countries: Population of 60+ Individuals as a Percentage of Total Population for 2015 & 2050 (includes corresponding Graph/Chart)

Table 3. Elderly Population (60+ Years) as a Percentage of Total Population (2015 & 2050) (includes corresponding Graph/Chart)

Table 4. Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart)

Table 5. Life Expectancy for Select Countries in Number of Years: 2015 (includes corresponding Graph/Chart)

Increase in Healthcare Spending in Emerging Markets

Table 6. Healthcare Spending as a Percentage of GDP by Region (2016) (includes corresponding Graph/Chart)

Table 7. Per Capita Healthcare Spending (in US$) in Select Developed Countries for the Year 2016 (includes corresponding Graph/Chart)

Increasing Awareness Levels
Need to Cut Healthcare Costs
Rising Incidence of Diseases
Major Causes of Fatalities Worldwide – A Statistical Overview

Table 8. Fatalities in High Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD, Cancer, Injury, and Others (includes corresponding Graph/Chart)

Table 9. Fatalities in Mid Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD; Cancer; Injury; HIV, TB & Malaria; Malnutrition; and Others (includes corresponding Graph/Chart)

Table 10. Fatalities in Low Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD; Cancer; Injury; HIV, TB & Malaria; Malnutrition; and Others (includes corresponding Graph/Chart)

World Cancer Statistics: Incidence and Mortality Data

Table 11. World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart)

Table 12. World Cancer Mortality by Geographic Region and Gender (2012): Number of Cancer-Related Deaths (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart)

Table 13. New Cancer Cases in the World by Affected Site (2012) (In Thousands) (includes corresponding Graph/Chart)

Table 14. Global Incidence of Common Cancers in Men (2012): Number of New Cases Reported in Thousands for Lung & Bronchus, Prostate, Colorectal and Liver Cancers (includes corresponding Graph/Chart)

Table 15. Global Incidence of Common Cancers in Women (2012): Number of New Cases Reported in Thousands for Breast, Colorectal, Lung & Bronchus and Liver Cancers (includes corresponding Graph/Chart)

Table 16. Global Cancer Mortality in Men for Select Cancers (2012): Number of Deaths in Thousands for Lung & Bronchus, Liver, Colorectal and Prostate Cancers (includes corresponding Graph/Chart)

Table 17. Global Cancer Mortality in Women for Select Cancers (2012): Number of Deaths in Thousands for Breast, Lung & Bronchus, Colorectal and Liver (includes corresponding Graph/Chart)

Cancer Prone Sites based on Age
Global HIV Statistics

Table 18. HIV Infection Statistics Worldwide: 2017 (in Million) (includes corresponding Graph/Chart)

Table 19. Worldwide HIV Prevalence and Incidence (in Million) by Region: 2017 (includes corresponding Graph/Chart)

Table 20. Worldwide AIDS Related Deaths by Geographic Region: 2017 (includes corresponding Graph/Chart)

Cardiovascular Disease Statistics

Table 21. Fatalities by Heart Conditions - Estimated Percentage Breakdown for Cardiovascular Disease, Ischemic Heart Disease, Stroke, and Others (includes corresponding Graph/Chart)

Table 22. Prevalence of Heart Failure in Select Countries (includes corresponding Graph/Chart)

Table 23. Global Annual Medical Cost of CVD in US$ Billion: 2010, 2015, 2020, 2025, and 2030 (includes corresponding Graph/Chart)

Increasing Role of Clinical Labs in Testing Infectious Diseases

3. MARKET TRENDS & ISSUES

Need for Clinical Laboratories to Reinvent Business Models
Laboratory Informatics Offers Opportunities to Streamline Operations
Transforming Hospital Laboratory into a Profit Center
Laboratory Specific IT Platforms Provide a Business Case for Outreach Programs
Hospital Outreach Laboratories Deliver Better Value to Larger Organizations
Managing and Measuring Value
Manufacturers Leveraging Expertise to Address Requirements of Laboratories
Factors Impacting Laboratories
Moving Towards Value Driven Healthcare
Maximizing ROI in a Low Cost Environment
Making Most of Global Best Practices
Advent of Novel Devices Fuel growth for Clinical Laboratory Services Market
Biobanks Gain Prominence
Home Based Systems Go Digital
Drones Emerging as Cost Effective and Efficient Mode for Transporting Samples
Innovative Strategies of Clinical Laboratories at Health Systems
Creation of Standardized Medical Laboratory Services
Standardization of Test Methodologies and Menus
Laboratory Testing Industry Faces Unique Investor Led Disruption
Divergent Paths for Independent Labs and Health System Labs
Factors Affecting Divergence
Supporting ACO Requirements
Transformations in Healthcare
Integrated Care Support
Population Health Initiatives
Home-Field Benefits
Evolving Clinical Laboratory Sector to Drive Diverse Lab Test Segment Market Share
Key Market Differentiators
Real-Time Lab Data Access
IVD Market Growth: An Indication of Growth in Clinical Labs Market
New Technologies and Tests Drive Demand for Specific Testing
Increasing Role of Advanced Tests in Clinical Treatment Decision Making
Increasing Opportunities in Personalized Medicine and Clinical Trial Services
Cancer Testing Market: Opportunity for Clinical Labs
Shortened Hospitalization Enhances Significance of Medical Labs
Lab Automation Speeds Up
Standardization Gains Precedence in the Hunt for Automation
Heightened Use of IT Systems in Clinical Laboratories
Assessing the Impact of Point-of-Care Testing on Clinical Labs
Autoimmune Disease Testing: Labs Seek Cost-Effective & High Productivity Options
POLs: Reducing Turnaround Times for Testing
POL Market Succumbs to Cost Pressures
Laboratory Outsourcing Trend Gains Strength
Value-Based Outsourcing of Services to Take Center Stage
Challenges Facing Lab Testing Market
Dependence on Third Parties
Lack of Skilled Workers

4. CLINICAL LABORATORY SERVICES - AN INTRODUCTION

Clinical Laboratory Services
Laboratory Medicine
Anatomic Pathology
Histology
Histopathology
Physiology
Pathology
Surgical Pathology
Electron Microscopy
Pathophysiology
Clinical Pathology
Microbiology
Bacteriology
Parasitology
Virology
Mycology
Immunology/Serology
Hematology
Clinical Chemistry
Genetics
Toxicology
Urinalysis
Cytogenetics
Reproduction Biology
Clinical Biochemistry
Types of Tests Conducted in Medical Labs
Routine Tests
Esoteric Tests
Anatomic Pathology Services
Types of Clinical Laboratories
Hospital-Based Laboratories
Physician Office-Based Laboratories
Reference Laboratories
Potential Customers for Medical Laboratories
Work Process in Clinical Labs
Specimen Processing & Result Analysis in Clinical Labs
Laboratory Information Systems
Conducting Lab Tests
Key Personnel in Medical Labs
Role of Medical Technologists
Role of Medical Technicians
Analysis, Validation and Interpretation of Results
Testing Equipment
Bio-Safety Hazards and Equipment Design
Essential Bio-safety Equipment in Clinical Laboratories
Personal Protection Equipment in Medical Labs
Economic Model Followed By Testing Laboratories
Revenues
Test Volume
Price
Expenses
Dichotomy between Customers and Payers in Medical Lab Industry
Impact of Environmental Factors on Lab Tests
Cleanliness
Dust
Humidity
Temperature
Light
Regulatory Overview
Legislative & Regulatory Environment Worldwide
GCLP
ISO 15189:2003
ISO 15189 Accreditation
ILAC

5. COMPETITIVE LANDSCAPE

A Preview
Quest Diagnostics & LabCorp: The Leading Independent Labs
Consolidation Activity Continues to Soar
Select Major Clinical Laboratory Transactions in the Recent Past
Industry Giants Tread on Different Paths in Consolidation Activity
5.1 Focus on Select Players
ADICON Clinical Laboratories, Inc. (China)
ARUP Laboratories (USA)
Bio-Reference Laboratories, Inc. (USA)
DaVita, Inc. (USA)
Enzo Clinical Labs (USA)
Genova Diagnostics, Inc. (USA)
Kingmed Diagnostics (China)
Laboratory Corporation of America Holdings (USA)
Dynacare (Canada)
Mayo Clinic Laboratories (USA)
NeoGenomics Laboratories (USA)
Genoptix, Inc. (USA)
Quest Diagnostics, Inc. (USA)
Sonic Healthcare Limited (Australia)
Bioscientia Institut für Medizinische Diagnostik GmbH (Germany)
American Esoteric Laboratories (USA)
Spectra Laboratories, Inc. (USA)
SYNLAB International GmbH (Germany)
The National Health Laboratory Service (South Africa)
Thyrocare Technologies Limited (India)
Unilabs SA (Switzerland)
5.2 Service/Product Introductions
LabCorp Introduces Pixel by LabCorpSM
Genoptix Introduces BCR-ABL MRDx TFR Monitoring Test
Ortho and Diazyme Launch Three New Microtip Partnership Assays
LabCorp Receives FDA Approval for UltraQual Multiplex PCR Assay
Enzo Introduces AMPIPROBE
LabCorp Introduces PD-L1 IHC 28-8 pharmDx Assay in the US
Quest Diagnostics Introduces QHerit
LabCorp Unveils ADAMTS13 Test
LabCorp Introduces PreTRM Test
GenPath Women’s Health Introduces ClariTest
Quest Diagnostics Introduces Test to Assess Response to Antiviral Therapy for HBV
Quest Diagnostics Introduces Antibody Test for Zika Virus
Mayo Clinic Launches Zika Antibody Test
Quest Diagnostics Introduces CogniSense Cognitive Assessment Tool
Great Basin Scientific Launches Shiga Toxin Direct Test
Laboratory Corporation of America Launches Zika Virus Testing
Quest Diagnostics Introduces New Cancer Test Services
Laboratory Corporation of America Launches Epi proColon Colorectal Cancer Test
Immunetics to Launch New Services for Invasive Fungal Infections
5.3 Recent Industry Activity
NeoGenomics Acquires Genoptix
Quest Diagnostics to Establish Flagship Laboratory in the US
Quest Diagnostics to Take Over Clinical Laboratory Services Business of BBPL
Mayo Medical Laboratories Changes Name to Mayo Clinic Laboratories
LabCorp Renews Partnership with Horizon Blue Cross Blue Shield of New Jersey
Quest Diagnostics Extends Supply Agreement with Clinical Genomics
Quest Diagnostics to Acquire Laboratory Services Operations of Marin General Hospital
Quest Diagnostics Takes Over Select Laboratory Services Operations of Hurley Medical Center
Jinyu Medical Joins Global Strategic Alliance for Medical Diagnostic Services
BioIVT Takes Over Clinical Trials Laboratory Services
Quest Diagnostics to Divest Indian Diagnostics Business
Quest Diagnostics Takes Over PhenoPath
Quest Diagnostics to Take Over US Business of Oxford Immunotec
Quest Diagnostics Takes Over ReproSource
SYNLAB Takes Over Yhtyneet Medix Laboratoriot
Zhejiang Dian Diagnostics and Agena Bioscience Sign Commercial Partnership
Genoptix and MolecularMD Sign Marketing and Testing Services Agreement for MRDx BCR-ABL Test
LabCorp and Unilabs Enter into Strategic Partnership
LabCorp and Mount Sinai Health System Embark onStandardization of Laboratory Services
ACM Global Acquires DrugScan and DSI Medical Services
KingMed and llumina Partner to Develop New Testing Applications
Quest Diagnostics Acquires Shiel Medical Laboratory Business of Fresenius
NeoGenomics Joins COEP Program of Thermo Fisher
Eurofins Scientific Acquires EAG Laboratories
Quest Diagnostics Acquires Cleveland HeartLab
Quest Diagnostics and Clinical Genomics Announce FDA Approval for InSure ONE
LabCorp Enters into Laboratory Partnership with Capital Health
Quest Diagnostics Acquires Select Assets of California Laboratory Associates
Quest Diagnostics Takes Over Laboratory Services Operations of Two Hospitals in Connecticut
Unilabs to Take Over Blufstein
Unilabs to Acquire to Stake in Scientific Clinical Laboratories
Quest Diagnostics Acquires Med Fusion and Clear Point
LabCorp Extends Laboratory Services Agreement with Novant Health
Sysmex Inks Agreement with Myanmar’s NHL for Improving Clinical Testing
BioPharma Services Acquires Assays from Bioanalytical Laboratory Services
Quest Diagnostics Joins Hands with AncestryDNA for Genotyping Test Services
LabCorp Inks Definitive Deal to Acquire and Merge with Sequenom
MDxHealth and Cerba Ink European Distribution Deal for MDxHealth’s Prostate Cancer Test
Schryver Medical Takes Over Professional Clinical Laboratory
Oxford Immunotec Inks Definitive Deal to Acquire Imugen
Zora Biosciences and Mayo Medical Team Up for New Plasma Ceramide Tests
Quest Diagnostics Introduces New Hepatitis C Testing Capabilities
Aurora Diagnostics Takes Over Pacific Pathology
Meridian Bioscience Acquires Magellan Biosciences and Magellan Diagnostics
Laboratory Corporation of America Acquires Pathology
Clinical Research Laboratories Takes Over Suncare Research Laboratories

6. GLOBAL MARKET PERSPECTIVE

Table 24. World Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 25. World Historic Review for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 26. World 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

Table 27. World Recent Past, Current and Future Analysis for Hospital-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 28. World Historic Review for Hospital-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 29. World 14-Year Perspective for Hospital-Based Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

Table 30. World Recent Past, Current and Future Analysis for Independent Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 31. World Historic Review for Independent Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 32. World 14-Year Perspective for Independent Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

Table 33. World Recent Past, Current and Future Analysis for Physician Office-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 34. World Historic Review for Physician Office-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 35. World 14-Year Perspective for Physician Office-Based Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America, and Rest of World Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7. REGIONAL MARKET PERSPECTIVE

7.1 The United States
A. Market Analysis
Current and Future Analysis
Clinical Laboratories: A Vital Constituent of Healthcare Industry
Impact of PAMA on Clinical Laboratories
Smaller Labs Embrace Digital Pathology Technology
Physician Office Laboratories Losing Sheen in the US
New Legislation Pushes Hospitals to Explore Cost Cutting Options
Genetic Testing Costs Concern Health Insurers
Emerging Trends in Clinical Laboratory Market
PAMA 2014 Kicks in Rate Cuts
Laboratory Benefit Management Program
Accountable Care Organizations
Increasing Demand for Personalized Medicine
Clinical Laboratory Services: Systemic Challenges
Number and Type of Laboratories
Detecting Frauds in Low Cost Tests
Technical Complexity of Clinical Laboratory Services
Strategies in the Dramatically Evolving Economic Environment
Decline in Medicare Payments
Increasing Market Competitiveness
Laboratories-of-Choice Option
Increased Cost Sharing by Patients
Increase in Bundled Payment Options
Options for Clinical Laboratories
Partnering with Other Health Systems or Area Hospitals for Building Lab Business
Perform Tests on Behalf of Large Laboratories Attempting Entry into New Markets
Affiliate with Larger Labs having the Ability to Manage the Lab Business of Hospitals
Selling of Outreach Lab Businesses to Large National Laboratory Companies
Entering into JVs with National Labs for Expanding Outreach Business
Changing Healthcare Industry Dynamics Affect Clinical Lab Testing Market

Table 36. Healthcare Spending as a % of GDP: 2006-2017 (includes corresponding Graph/Chart)

A Glance at Major Growth Drivers
Unmet Diagnostic Needs of Aging Population

Table 37. US Elderly Population by Age Group (2000-2050) (includes corresponding Graph/Chart)

Increasing Burden of Chronic Diseases Drives Focus onto Early Detection & Prevention
Cancer Statistics in the US

Table 38. The US Cancer Incidence by Gender (2017): No. of Reported New Cases for Men and Women (includes corresponding Graph/Chart)

Table 39. Cancer Incidence in the US by Affected Site (2017): Number of New Cancer Cases (includes corresponding Graph/Chart)

Prevalence of Diabetes Mellitus in the US

Table 40. Prevalence of Diabetes Mellitus in the US (2013 & 2035): Number of People with DM (in Thousands) in the 20-79 Age Group for the US (includes corresponding Graph/Chart)

Opportunities in Personalized Medicine and Clinical Trial Services
Growing Focus on Early Diagnosis
Impact of Scientific Advances & Role of Healthcare IT Solutions
Need to Reduce Healthcare Costs
Legislative, Regulatory and Policy Environment
Opportunities for Individual Testing
Population Screening Initiatives
Challenges Facing Clinical Labs Market
Key Trends & Issues
Product-Related Trends
Anatomic Pathology & Cytology Testing: Personalized Medicine Presents Positive Future
Esoteric Testing Market: Faster Growth than Routine Testing Segment
Molecular Diagnostics: Promising Growth Opportunities
Drugs of Abuse Testing: Prospects Linked to Employment Levels
Future Holds Promise for Specialty Testing Market
Impact of Healthcare Spending Cuts on Routine & Specialty Lab Tests
Increasing Role of Advanced Tests in Clinical Treatment Decision Making
Tissue-based Diagnostics Market to Expand
Toxicology Laboratories Market: An Insight
Genetic and Genomic Clinical Lab Testing Market: Promising Prospects
Shift towards Managed Care – A Challenge for Independent Clinical Labs?
Evolving ACO Business Model: A Challenge for Independent Labs
Integration of Clinical Care: Impact on Clinical Labs & Anatomic Pathology Groups
Hospital Laboratory Outreach Programs: On the Rise
Physician Practices: The New Acquisition Targets

Table 41. % of Independent Physicians in the US (2000, 2005 & 2016) (includes corresponding Graph/Chart)

Cost Cutting Measures to Hit Lab Outreach Testing Business?
Hospitals Foray into Health Insurance Market: Opportunities for Hospital Labs
Shortened Hospital Stay Enhances Significance of Medical Labs
Lab Automation: A Key Trend in the Clinical Laboratory Testing Market
Health Plans Interpose Between Clinical Labs and Physicians
POCT Segment Withstands Cost Pressures
Quality Concerns Bring Information Technologies to the Fore
Move towards IQCP Remains Lethargic
Dealing with Regulatory Changes: A Tough Ask for Clinical Labs
A Peek into Reimbursement Environment for Clinical Lab Services
Regulation of LDTs Hangs in Balance
Competitive Landscape
Providers of Clinical Laboratory Service in the US: A Review
Hospital-Based Labs

Table 42. Registered Hospitals in the US by Type: 2017 (includes corresponding Graph/Chart)

Independent Labs

Table 43. Independent Labs Market in the US (2017): Percentage Share Breakdown of Revenues for Quest Diagnostics, LabCorp, Small Independent Labs and Others (includes corresponding Graph/Chart)

Physician Office-Based Labs and Others
Consolidation Activity Gathers Pace in Clinical Laboratory Testing Market
Regulatory Landscape
Select Major Regulations
A2LA
ASCLS
CAP
Clinical Laboratory Improvement Amendments (CLIA)

Table 44. CLIA-Certified Laboratories in the US (2017): Percentage Share Breakdown of Number of Labs by Lab Type (includes corresponding Graph/Chart)

Health Insurance Portability and Accountability Act of 1996
FDA Regulations
Substance Abuse and Mental Health Services Administration (SAMHSA) Regulation
Medicare Coverage for Screening Tests
Medicare Clinical Laboratory Fee Schedule (CLFS)
Medicare Physician Fee Schedule (MPFS)
Medicaid

Table 45. Medicare Spending in the US (2017): Percentage Share Breakdown of Spending by Category - Medicare Advantage, Inpatient Hospital, Prescription Drugs, Physician Fee Schedule, Outpatient Hospital and Others (includes corresponding Graph/Chart)

B. Market Analytics

Table 46. US Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 47. US Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 48. US 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.2 Canada
A. Market Analysis
Current and Future Analysis
Rising Incidence of Chronic Diseases Spurs Need for Testing

Table 49. New Cancer Cases in Canada by Gender and Affected Site (2017) (includes corresponding Graph/Chart)

Table 50. New Cancer Cases in Canada by Province (2017) (includes corresponding Graph/Chart)

Table 51. Cancer Incidence in Canada by Age Group and Gender: Age Standardized Incidence Rate per 100,000 People (2015) (includes corresponding Graph/Chart)

Diabetes Prevalence in Canada – A Statistical Overview

Table 52. Prevalence of Diabetes Mellitus in Canada (2013 & 2035): Number of People with DM (in Thousands) in the 20-79 Age Group (includes corresponding Graph/Chart)

Regulatory Scenario in Canada
Accreditation Canada
Standards Council of Canada
B. Market Analytics

Table 53. Canadian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 54. Canadian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 55. Canadian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.3 Japan
A. Market Analysis
Current and Future Analysis
Physician Office Labs Play Limited Role in Lab Services
Demographics Drive Market Growth

Table 56. Japanese Elderly (65+ Years) Population: 2000-2050 (in Thousands) (includes corresponding Graph/Chart)

Table 57. Percentage Distribution of Japanese Population by Age Group: 2015 (includes corresponding Graph/Chart)

Table 58. Prevalence of Diabetes Mellitus in Japan (2012 & 2030) (includes corresponding Graph/Chart)

B. Market Analytics

Table 59. Japanese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 60. Japanese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 61. Japanese 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.4 Europe
A. Market Analysis
Current and Future Analysis
Favorable Demographics and Technological Evolutions to Drive the Market
Economic Woes and their Effect on the Market

Table 62. Diagnostics Market in Europe (2017): Percentage Share Breakdown of Revenues by Medical Imaging, Laboratory Testing, and Anatomic Pathology (includes corresponding Graph/Chart)

European Healthcare System: In a State of Transition?
Aging Population to Drive Demand for Medical Laboratory Services

Table 63. European Country-wise Statistics of 60+ Population as % of Total Population: 2015 (includes corresponding Graph/Chart)

Increasing Incidence of Cancer Drives Demand for Testing

Table 64. Cancer Incidence in Europe by Site: 2012 (in Thousands) (includes corresponding Graph/Chart)

A Peek into the Competitive Landscape
Select Leading Players
Cerba
Unilabs
Labco
Synlab
LabCorp
Sonic Healthcare
Synlab-Labco Combination Alters Market Landscape
Accreditation and Regulatory Scenario in the EU
B. Market Analytics

Table 65. European Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 66. European Historic Review for Clinical Laboratory Services by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 67. European 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

Table 68. European Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 69. European Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 70. European 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.1 France
A. Market Analysis
Current and Future Analysis
Market Overview

Table 71. Percentage Distribution of French Population by Age Group: 2015 (includes corresponding Graph/Chart)

Complex Regulations Slow Down Industry Consolidation

Table 72. Leading Players in the French Clinical Laboratory Services Market (2017): Percentage Breakdown of Revenues for Cerba/Novescia, Eurofins, Labco, Unilabs and Others (includes corresponding Graph/Chart)

B. Market Analytics

Table 73. French Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 74. French Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 75. French 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.2 Germany
A. Market Analysis
Current and Future Analysis
Clinical Laboratory Services in Germany – An Overview
Policy Restrictions Stifle the Market
Privatization: A Visible Trend in the Lab Market
Regulatory Scenario in Germany
DAkkS GmbH – Germany’s National Accreditation Body
B. Market Analytics

Table 76. German Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 77. German Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 78. German 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.3 Italy
A. Market Analysis
Current and Future Analysis
ACCREDIA – The Italian Accreditation Body
B. Market Analytics

Table 79. Italian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 80. Italian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 81. Italian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.4 The United Kingdom
A. Market Analysis
Current and Future Analysis
UKAS – The Sole National Accreditation Body in the UK
B. Market Analytics

Table 82. UK Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 83. UK Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 84. UK 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.5 Spain
Market Analysis

Table 85. Spanish Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 86. Spanish Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 87. Spanish 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.6 Russia
Market Analysis

Table 88. Russian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 89. Russian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 90. Russian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.4.7 Rest of Europe
A. Market Analysis
Current and Future Analysis
Focus on Select Regional Markets
Switzerland
Overview
Physician Office Labs Market Goes Strong in Swiss
Poland
Ukraine
B. Market Analytics

Table 91. Rest of Europe Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 92. Rest of Europe Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 93. Rest of Europe 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.5 Asia-Pacific
A. Market Analysis
Current and Future Analysis
Overview
Healthcare Spending in Asia-Pacific on the Rise
China and India: Two Fast-Growing Markets
APLAC – A Regional Accreditation Body in Asia-Pacific
B. Market Analytics

Table 94. Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 95. Asia-Pacific Historic Review for Clinical Laboratory Services by Geographic Region - China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 96. Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for China and Rest of Asia-Pacific Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

Table 97. Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 98. Asia-Pacific Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 99. Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.5.1 China
A. Market Analysis
Current and Future Analysis
Medical Labs Market: An Overview
Healthcare Reforms: Opportunities for Clinical Labs Market
Drive to Improve Access to Healthcare Fuels Growth in Independent Clinical Laboratories

Table 100. Leading Independent Medical Labs in China (2017): Percentage Breakdown of Revenues for Leading Players (includes corresponding Graph/Chart)

Industry Leaders Look to Expand Beyond Clinical Services
CNAL – The National Accreditation Body in China
B. Market Analytics

Table 101. Chinese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 102. Chinese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 103. Chinese 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

  7.5.2 Rest of Asia-Pacific
A. Market Analysis
Current and Future Analysis
Review of Select Regional Markets
Australia
NATA – An Australian Regulatory Agency
Hong Kong
HKAS – An Accreditation Body in Hong Kong
India
Clinical Laboratory Market: Overview
Growth Drivers
Challenges
Levels of Medical Laboratories
Primary Level
Secondary Level
Tertiary Level
Biochemistry Analysis: An Important Clinical Lab Segment

Table 104. Indian Clinical Laboratory Market (2018E): Percentage Share Breakdown of Revenues by Segment - Biochemistry, Immunology, Hematology, Microbiology, Histopathology and Others (includes corresponding Graph/Chart)

Competitive Landscape
Business Model of Medical Labs

Table 105. Indian Medical Laboratories Market (2018)): Number of Labs and Collection Centers Operated by Metropolis, SRL Diagnostics, and Dr. Lal Path Labs (includes corresponding Graph/Chart)

Regulatory Scenario in India
Indonesia
Overview
Novel Technologies Fuel Demand for Clinical Laboratory Testing
South Korea
Rapidly Aging Population Spurs Demand for Clinical Lab Testing
KOLAS – The National Accreditation Agency of Korea
Philippines
Regulatory Scenario in Philippines
Singapore
Clinical Laboratories Market in Singapore – An Overview
SAC – The National Agency for Accreditation in Singapore
Thailand
BLQS – A Designated Accreditation Authority in Thailand
Vietnam
Rising Incidence of Diseases Fuels Clinical Laboratory Market in Vietnam
B. Market Analytics

Table 106. Rest of Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 107. Rest of Asia-Pacific Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 108. Rest of Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.6 Latin America
A. Market Analysis
Current and Future Analysis
Latin America Emerges as Promising Central Lab Market
Market Drivers
Impact of Macro Economic Factors
Service Provider Landscape
Industry Best Practices
Cost Saving Strategies
Focus on Select Regional Markets
Brazil
Overview
INMETRO – The National Accreditation Body of Brazil
Diagnostic Lab Market in Brazil to Remain Highly Dynamic
Expansion of Healthcare Sector Fuels Growth
Market Outlook
Chile
B. Market Analytics

Table 109. Latin American Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 110. Latin American Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 111. Latin American 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

7.7 Rest of World
A. Market Analysis
Current and Future Analysis
Focus on Select Regional Markets
Medical Laboratories in Sub-Saharan Africa
East Africa
West Africa
Nigeria
State of Medical Diagnostics in Nigeria
South Africa
Regulatory Environment in South Africa
B. Market Analytics

Table 112. Rest of World Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 113. Rest of World Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 114. Rest of World 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2011, 2018 & 2024 (includes corresponding Graph/Chart)

8. COMPANY PROFILES

Total Companies Profiled: 133 (including Divisions/Subsidiaries - 148)
The United States (102)
Canada (11)
Japan (1)
Europe (15)
  France (2)
  Germany (2)
  The United Kingdom (5)
  Rest of Europe (6)
Asia-Pacific (Excluding Japan) (13)
Middle East & Africa (5)
Latin America (1)