Global Clinical Laboratory Services Industry

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Global Clinical Laboratory Services Industry Published on January 2014

Report Summary This report analyzes the worldwide markets for Clinical Laboratory Services in US$ Million by the following Product Segments: Hospital-Based Laboratories, and Others. 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 2012 through 2020. Also, a six-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 profiles164 companies including many key and niche players such as ADICON Clinical Laboratories, Inc. ARUP Laboratories Asuragen, Inc. Atherotech Diagnostics Lab Bio-Reference Laboratories, Inc. Clarient, Inc.

Table of Content

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers

I-1 I-2

Data Interpretation & Reporting Level

I-2

Quantitative Techniques & Analytics

I-3

Product Definitions and Scope of Study

I-3

Hospital-Based Medical Laboratories

I-3

Others

I-4

Physician's Office-Based Medical Labs

I-4

Independent Laboratories

I-4

II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW Prelude

II-1 II-1

Despite Challenges, Emerging Markets Provide Growth Opportunities II-2 Developed Nations: Cost Pressures Necessitate New Strategies

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II-3

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II-3

II-3

Rising Healthcare Needs of Aging Global Population

II-4

Table 1: Over-65 Years Population as a % of Total Population (2010 & 2020P) (includes corresponding Graph/Chart)

II-5

Table 2: Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart)

II-5

Table 3: Global Population Statistics for the 65+ Age Group (2012) (includes corresponding Graph/Chart)

II-6

Table 4: Life Expectancy Rates at Birth by Geographic Region (1990 & 2011) (includes corresponding Graph/Chart)

II-7

Increase in Healthcare Spending in Emerging Markets

II-7

Table 5: Healthcare Spending as % of GDP in Select Countries (2011) (includes corresponding Graph/Chart)

II-8

Increasing Awareness Levels

II-8

Need to Cut Healthcare Costs

II-8

Rising Incidence of Diseases

II-8

World Cancer Statistics: Incidence and Mortality Data

II-8

Table 6: 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)

II-9

Table 7: 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)

II-9

Table 8: New Cancer Cases in the World by Affected Site (2012) (In Thousands) (includes corresponding Graph/Chart)

II-10

Table 9: 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)

II-10

Table 10: 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)

II-11

Table 11: Global Cancer Mortality in Men for Select Cancers

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II-11

Table 12: 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)

II-12

Cancer Prone Sites based on Age

II-12

Global HIV Statistics

II-12

Table 13: Global Summary of the AIDS Epidemic in 2011 (includes corresponding Graph/Chart)

II-12

Some Significant HIV Statistics by Region (2011)

II-13

Increasing Role of Clinical Labs in Testing of Infectious Diseases

II-13

Table 14: Reported Cases of Major Infectious by Geographic Region (2011)

II-14

Esoteric Testing Market: Faster Growth than Routine Testing Segment

II-15

Increasing Role of Advanced Tests in Clinical Treatment Decision Making

II-15

Opportunities in Personalized Medicine and Clinical Trial Services

II-15

Clinical Labs Opt for Reagent Rental Contracts to Sustain Operations

II-16

Cancer Testing Market: Opportunity for Clinical Labs

II-16

Shortened Hospitalization Enhances Significance of Medical Labs II-16 Lab Automation Speeds Up

II-17

Heightened Use of IT Systems in Clinical Laboratories Laboratory Outsourcing Trend Gains Strength

II-17 II-17

Autoimmune Disease Testing: Labs Seek Cost-Effective & High Productivity Options

II-18

Assessing the Impact of Point-of-Care Testing on Clinical Labs II-18 IVD Market Growth: An Indication of Growth in Clinical Labs Market

II-19

Laboratory Budget Allocations Affected by Prevailing Economic Environment

II-20

POLs: Reducing Turnaround Times for Testing

II-20

Challenges Facing Lab Testing Market

II-21

2. COMPETITIVE LANDSCAPE Introduction

II-22 II-22

Quest Diagnostics & LabCorp: The Leading Independent Labs Consolidation Activity Continues to Strengthen

II-23

Major Clinical Laboratory Transactions (2011-2013) 3. CLINICAL LABORATORY SERVICES - AN INTRODUCTION Clinical Laboratory Services

Global Clinical Laboratory Services Industry (From Issuu)

II-22

II-23 II-25

II-25

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II-25

Laboratory Medicine

II-25

Anatomic Pathology

II-26

Clinical Pathology

II-26

Types of Tests Conducted in Medical Labs

II-28

Routine Tests

II-28

Esoteric Tests

II-28

Anatomic Pathology Services

II-28

Types of Clinical Laboratories

II-29

Hospital-Based Laboratories

II-29

Physician's Office-Based Medical Labs

II-29

Reference Laboratories

II-29

Potential Customers for Medical Laboratories

II-30

Work Process in Clinical Labs

II-30

Specimen Processing & Result Analysis in Clinical Labs Laboratory Information Systems

II-30

II-31

Conducting Lab Tests

II-31

Key Personnel in Medical Labs

II-31

Role of Medical Technologists

II-32

Role of Medical Technicians

II-33

Analysis, Validation and Interpretation of Results Testing Equipment

II-33

II-33

Bio-Safety Hazards and Equipment Design

II-33

Essential Bio-safety Equipment in Clinical Laboratories

II-34

Personal Protection Equipment in Medical Labs

II-34

Economic Model Followed By Testing Laboratories Revenues

II-35

Expenses

II-35

II-34

Dichotomy between Customers and Payers in Medical Lab Industry II-35 Impact of Environmental Factors on Lab Tests

II-35

Regulatory Overview

II-36

Legislative & Regulatory Environment Worldwide GCLP

II-36

ISO 15189:2003

II-37

ISO 15189 Accreditation ILAC

II-36

II-37 II-37

4. PRODUCT INNOVATIONS/INTRODUCTIONS

II-38

Genomic Health Launches Oncotype DX Prostate Cancer Test Clarient Rolls Out Next-Generation Sequencing Assay

II-38 II-38

SilverStaff Clinical Laboratories to Provide BGM Galectin-3速 Test of BG Medicine

II-38

Quest Diagnostics Unveils Dementia Clinical Diagnostic Panel Psychemedics Unveils Hair Alcohol Test

II-39

II-39

Prometheus Laboratories Introduces PROMETHEUS速 Anser' ADA NeoGenomics Launches Clinical Molecular Tests for MDS

II-40

II-40

LipoScience Introduces Vantera Clinical Analyzer for Cardiovascular Disease Management

Global Clinical Laboratory Services Industry (From Issuu)

II-40

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II-41

GeneDx to Introduce Comprehensive Genetic Tests Suite for Ovarian and Breast Cancers

II-41

Enzo Clinical Labs Collaborates with Oncimmune to Launch Novel Diagnostic Test

II-41

Myriad RBM Introduces Oncology® v. 2.0 Test

II-42

NeoGenomics Introduces NeoSITE' Barrett's Esophagus FISH Test

II-42

diaDexus Introduces CE marked PLAC Test for Lp-PLA(2) Activity 5. RECENT INDUSTRY ACTIVITY

II-42

II-43

Quest Diagnostics Acquires Dignity Health's Clinical Operations II-43 Quest Diagnostics Takes Over Laboratory Operations of Concentra II-43 LifeLabs Acquires BC Biomedical

II-43

JLL Takes Over BioClinica and CoreLab

II-44

Quest Diagnostics Takes Over ConVerge Diagnostic Services

II-44

Spectra Laboratories Acquires Shiel Medical Laboratory

II-44

Gamma-Dynacare Medical Acquires Controlling Stake in Impact Genetics

II-45

Proove Biosciences Takes Over Colwell Clinical Labs

II-45

BioReference to Acquire Laboratory Business of Edge BioSystems

II-45

Cleveland Clinic Laboratories Signs Agreement with ACL for Specialized Testing Services

II-46

Cancer Genetics and Mayo Clinic Establish JV, Oncospire Genomics II-46 HDL to Form Joint Venture with GeneNews for ColonSentry Test Gamma-Dynacare Collaborates with OSR Medical

II-46

II-46

Mayo Medical and Mayo Clinic in Collaboration Agreement with bioTheranostics

II-47

MACL & Oncimmune® Offer EarlyCDT®-Lung Blood Test

II-47

Luminex and NMTC Collaborate for Lab-Developed Panel ARUP Partners with Predictive Biosciences

II-47 II-47

PrimeraDx and Quest Diagnostics Ink Co-Development Agreement

II-48

DaVita Labs Inks Research Collaboration Agreement with Myriad RBM II-48 Rochester General Health System Inks Partnership Agreement with Mayo Medical Laboratories

II-48

Corgenix Medical Inks Agreement with Atherotech Diagnostics Lab II-49 MDxHealth Inks Marketing Partnership with Bostwick Laboratories II-49 ARUP Laboratories Inks Agreement with Oncimmune®

II-49

Instituto Hermes Pardini Takes Over Diagnostika - Unidade de Patologia e Citologia

II-50

LifeLabs Medical Laboratory Acquires CML HealthCare

II-50

Mayo Medical Conducts NMR Lipoprotein Particle Testing with LipoScience Vantera® Clinical Analyzer

II-50

Bio-Reference Signs Agreement with Natera to Commercialize Panorama' NIPT

II-51

Myriad Genetics Signs Companion Diagnostic Deal with TESARO

II-51

OpGen Establishes CLIA-Certified Clinical Services Laboratory and Introduces Microbial Genetic Tests for HAIs

II-51

Echevarne to Distribute Natera's Panorama' Prenatal Test

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II-51

AccelPath Acquires DigiPath

II-52

OPKO Health Takes Over Prost-Data

II-52

Ampersand Takes Over Willow Laboratories

II-52

LabCorp Takes Over MEDTOX

II-53

WCP Takes Over Sterling Reference Laboratories

II-53

Gamma-Dynacare to Take Over LifeLabs Quebec

II-53

Quest Diagnostics Takes Over S.E.D. Medical Laboratories

II-54

TrovaGene Acquires MultiGEN Diagnostics Clinical Laboratory Business

II-54

Bode Technology Group Takes Over Chromosomal Laboratories

II-54

Becton, Dickinson and Company Takes Over KIESTRA Lab Automation II-54 CD Diagnostics Acquires Stake in CML

II-55

Quest Diagnostics to Acquire UMass' Clinical Laboratory Outreach Business

II-55

AmperSand Capital to Acquire Calloway

II-55

Genova Diagnostics and Metametrix Merge Operations

II-55

Al Borg to Merge Operations with Al Mokhtabar

II-56

InCyte Pathology Signs Preliminary Merger Deal with Eastside Pathology

II-56

Gamma-Dynacare Acquires Alcohol and Drug Testing Business of Maxxam Analytics

II-56

ADICON Inks Strategic Collaboration Framework Contract with Siemens

II-57

Myriad RBM Signs Collaboration Agreement with Sanofi and PHRI for Protein Bio-marker Research

II-57

DLMP and MML Collaborate with Kindstar for Esoteric Tests

II-58

Qiagen Signs Co-Marketing Pact with KingMed Diagnostics

II-58

WuXi PharmaTech Enters into JV Agreement with PRA

II-58

AKUH Establishes High-Tech Stat Laboratory in Rawalpindi

II-59

Warburg Pincus Collaborates with Lab Industry Veterans to Launch RDL

II-59

Covance and BML Expand CB Trial Lab

II-60

Bio-Reference Laboratories to Establish Laboratorio Buena Salud II-60 The University of Western Australia Establishes Translational Cancer Pathology Laboratory

II-60

Khandelwal Laboratories Establishes KLab in Nepal

II-60

6. FOCUS ON SELECT PLAYERS

II-61

ADICON Clinical Laboratories, Inc. (China)

II-61

ARUP Laboratories (US) Asuragen, Inc. (US)

II-61 II-61

Atherotech Diagnostics Lab (US)

II-62

Bio-Reference Laboratories, Inc. (US)

II-62

Bioscientia Institut f端r Medizinische Diagnostik GmbH (Germany) II-62 Clarient, Inc. (US)

II-62

DaVita, Inc. (US)

II-63

Enzo Clinical Labs (US)

Global Clinical Laboratory Services Industry (From Issuu)

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II-64

Gamma-Dynacare Medical Laboratories (Canada)

II-64

Genoptix Medical Laboratory (US)

II-65

Genova Diagnostics, Inc. (US)

II-65

Kingmed Diagnostics (China)

II-65

Healthscope Ltd. (Australia)

II-66

Laboratory Corporation of America Holdings (US) Labco S.A. (France)

II-66 II-67

Mayo Medical Laboratories (US) Myriad Genetic, Inc. (US) Pathology, Inc. (US)

II-67 II-68 II-68

Prometheus Laboratories, Inc. (US)

II-68

Quest Diagnostics, Inc. (US)

II-69

Sonic Healthcare Limited (Australia)

II-69

American Esoteric Laboratories (US)

II-69

Spectra Laboratories, Inc. (US)

II-70

Thyrocare Technologies Limited (India)

II-70

The National Health Laboratory Service (South Africa) Unilabs SA (Switzerland)

II-70

II-71

7. GLOBAL MARKET PERSPECTIVE

II-72

Table 15: World Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

II-72

Table 16: World Historic Review for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

II-73

Table 17: World 15-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

II-74

Table 18: World Recent Past, Current and Future Analysis for Hospital-based Medical Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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>> Get this Report Now by email! Table 19: World Historic Review for Hospital-based Medical Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

II-76

Table 20: World 15-Year Perspective for Hospital-based Medical Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

II-77

Table 21: World Recent Past, Current and Future Analysis for Other Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

II-78

Table 22: World Historic Review for Other Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

II-79

Table 23: World 15-Year Perspective for Other Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

II-80

III. MARKET 1. THE UNITED STATES A.Market Analysis

III-1 III-1

Clinical Laboratories: A Small Yet Vital Constituent of Healthcare Industry

III-1

Table 24: US Healthcare Spending (2012): Percentage Share Breakdown of Spending by Segment - Hospitals, Professional Services, Prescriptions, Medical Products, Laboratory Testing, and Others (includes corresponding Graph/Chart)

III-1

Changing Healthcare Industry Dynamics Affect Clinical Lab Testing Market

III-1

Table 25: Healthcare Spending as a % of GDP (includes corresponding Graph/Chart)

III-2

Positive Outlook for Clinical Laboratory Services Market

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III-3

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III-4

A Glance at Major Growth Drivers

III-5

Unmet Diagnostic Needs of Aging Population

III-5

Table 26: North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart)

III-6

Table 27: US Population Breakdown by Age Group (2012) (includes corresponding Graph/Chart)

III-7

Increasing Burden of Chronic Diseases Drives Focus onto Early Detection & Prevention

III-7

Cancer Statistics in the US

III-7

Table 28: New Cancer Cases by Gender and Affected Site in the US (2013)

III-8

Prevalence of Diabetes Mellitus in North America

III-9

Table 29: Prevalence of Diabetes Mellitus in North America (2012) (includes corresponding Graph/Chart)

III-9

Opportunities in Personalized Medicine and Clinical Trial Services

III-9

Increasing Reimbursement Pressures - Opportunities for Testing Services

III-10

Growing Focus on Early Diagnosis

III-10

Impact of Scientific Advances & Role of Healthcare IT Solutions

III-10

Need to Reduce Healthcare Costs

III-10

Legislative, Regulatory and Policy Environment

III-11

Opportunities for Individual Testing

III-11

Population Screening Initiatives

III-11

Challenges Facing Clinical Labs Market

III-11

Product-Related Trends

III-13

Table 30: Clinical Laboratory Testing Market in the US (2010): Percentage Share Breakdown of Revenues by Segment (includes corresponding Graph/Chart)

III-13

Routine Tests: The Largest Product Category

III-13

Anatomic Pathology & Cytology Testing: Personalized Medicine Presents Positive Future

III-13

Table 31: US Market for Outpatient Anatomic Pathology Testing (2010): Percentage Share Breakdown of Revenues by Test Type - Pap Smears, Skin Biopsies, Gynecology Biopsies, Prostate, Gastrointestinal, and Others (includes corresponding Graph/Chart)

III-14

Esoteric Testing Market: Faster Growth than Routine Testing Segment

III-14

Molecular Diagnostics: Promising Growth Opportunities

III-15

Drugs of Abuse Testing: Prospects Linked to Employment Levels III-16 Future Holds Promise for Specialty Testing Market

III-16

Impact of Healthcare Spending Cuts on Routine & Specialty Lab Tests

III-16

Increasing Role of Advanced Tests in Clinical Treatment

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III-16

Tissue-based Diagnostics Market to Expand

III-17

Toxicology Laboratories Market: An Insight

III-17

Genetic and Genomic Clinical Lab Testing Market: Promising Prospects

III-17

Shift towards Managed Care - A Challenge for Independent Clinical Labs'

III-19

Evolving ACO Business Model: A Challenge for Independent Labs III-19 Integration of Clinical Care: Impact on Clinical Labs & Anatomic Pathology Groups

III-20

Hospital Laboratory Outreach Programs: On the Rise

III-21

Physician Practices: The New Acquisition Targets

III-21

Table 32: % of Independent Physicians in the US (2005-2013) (includes corresponding Graph/Chart)

III-22

Cost Cutting Measures to Hit Lab Outreach Testing Business' III-22 Hospitals Foray into Health Insurance Market: Opportunities for Hospital Labs

III-22

FDA to Regulate Laboratory Developed Tests (LDTs)

III-23

Shortened Hospital Stay Enhances Significance of Medical Labs III-23 Lab Automation: A Key Trend in the Clinical Laboratory Testing Market

III-23

Health Plans Interpose Between Clinical Labs and Physicians POCT Segment Withstands Cost Pressures

III-24

III-24

Dealing with Regulatory Changes: A Tough Ask for Clinical Labs III-24 CMS Proposes to Slash Payment for Lab Tests

III-25

Providers of Clinical Laboratory Service in the US: A Review Hospital-Based Labs

III-25

III-25

Table 33: Hospital Lab Test Market in the US (2012): Percentage Share Breakdown of Revenues by Payer (includes corresponding Graph/Chart)

III-26

Table 34: Registered Hospitals in the US (2012): Percentage Share Breakdown of Number of Hospitals by Type of Hospital (includes corresponding Graph/Chart) Independent Labs

III-27

III-27

Table 35: Independent Labs Market in the US (2012): Percentage Share Breakdown of Revenues for Quest Diagnostics, LabCorp, Small Independent Labs, Niche Labs, and Tier 2 Labs (includes corresponding Graph/Chart) Physician Office-Based Labs and Others Competitive Landscape

III-28 III-28

III-29

Consolidation Activity Gathers Pace in Clinical Laboratory Testing Market

III-30

Table 36: Number of Closed M&A Transactions in the US Clinical Labs Market (2005-2012) (includes corresponding Graph/Chart)

III-31

Table 37: Closed M&A Transactions in the US Clinical Labs

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III-31

Major Clinical Laboratory Transactions (2011-2013) Regulatory Landscape A2LA

III-34 III-34

ASCLS CAP

III-32

III-34 III-34

Clinical Laboratory Improvement Amendments (CLIA)

III-35

Table 38: CLIA-Certified Laboratories in the US (2013): Percentage Share Breakdown of Number of Laboratories by Certificate Type (includes corresponding Graph/Chart)

III-36

Table 39: CLIA-Certified Laboratories in the US (2013): Percentage Share Breakdown of Number of Labs by Lab Type (includes corresponding Graph/Chart)

III-36

Health Insurance Portability and Accountability Act of 1996

III-37

Substance Abuse and Mental Health Services Administration (SAMHSA) Regulation

III-37

Reimbursement Scenario for Clinical Laboratory Tests

III-37

Impact on Funding Changes on Clinical Labs Testing Market Medicare Coverage for Screening Tests

III-38

Medicare Clinical Laboratory Fee Schedule (CLFS)

III-39

Medicare Physician Fee Schedule (MPFS) Medicaid

III-38

III-39 III-40

Payment and Coding for Clinical Laboratory Testing Services

III-40

Table 40: Medicare Spending in the US (2012): Percentage Share Breakdown of Spending by Category - Inpatient Hospital, Managed Care, Prescription Drugs, Physician Fee Schedule, SNF, Home Health, Hospice, Clinical Laboratory, and Others (includes corresponding Graph/Chart)

III-41

Product Innovations/Introductions

III-42

Strategic Corporate Developments Key Players B.Market Analytics

III-48 III-64 III-71

Table 41: US Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

III-71

Table 42: US Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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III-72

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III-73

2. CANADA

III-74

A.Market Analysis Outlook

III-74 III-74

Rising Incidence of Chronic Diseases Spurs Need for Testing

III-74

Table 44: New Cancer Cases in Canada by Gender and Affected Site (2012) (includes corresponding Graph/Chart)

III-75

Table 45: New Cancer Cases in Canada by Province (2012) (includes corresponding Graph/Chart)

III-76

Table 46: New Cancer Cases in Canada by Age Group and Gender (2012) (includes corresponding Graph/Chart)

III-77

Table 47: Prevalence of Diabetes Mellitus in Canada (2012) (includes corresponding Graph/Chart)

III-78

Funding Crunch Bolsters Consolidation Activity among Independent Labs

III-78

Regulatory Scenario in Canada Accreditation Canada

III-78 III-78

Standards Council of Canada

III-80

Strategic Corporate Developments

III-82

Gamma-Dynacare Medical Laboratories - A Key Player B.Market Analytics

III-85

III-86

Table 48: Canadian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

III-86

Table 49: Canadian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

III-87

Table 50: Canadian 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

Global Clinical Laboratory Services Industry (From Issuu)

III-88

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III-89

A.Market Analysis Outlook

III-89 III-89

Demographics Drive Market Growth

III-89

Table 51: Percentage Breakdown of Japanese Population by Age Group (2012) (includes corresponding Graph/Chart)

III-89

Table 52: Over 65 Years Population in Japan (1950-2010) (includes corresponding Graph/Chart)

III-90

Table 53: Prevalence of Diabetes Mellitus in Japan (2012 & 2030) (includes corresponding Graph/Chart)

III-90

Strategic Corporate Development

III-91

B.Market Analytics

III-92

Table 54: Japanese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

III-92

Table 55: Japanese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

III-93

Table 56: Japanese 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart) 4. EUROPE A.Market Analysis Outlook Overview

III-94 III-95 III-95 III-95 III-95

Table 57: Diagnostics Market in Europe (2012): Percentage Share Breakdown of Revenues by Medical Imaging, Laboratory Testing, and Anatomic Pathology (includes corresponding Graph/Chart)

III-95

Debt Crisis in Europe Affects Healthcare Industry

III-96

European Healthcare System: In a State of Transition'

III-96

Aging Population to Drive Demand for Medical Laboratory Services

III-97

Table 58: Population Breakup by Age Group for Select European Countries: 2012 (As a % of Total Population) (includes corresponding Graph/Chart) Accreditation and Regulatory Scenario in the EU

Global Clinical Laboratory Services Industry (From Issuu)

III-98 III-99

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III-100

Table 59: 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 2012 through 2020 (includes corresponding Graph/Chart)

III-100

Table 60: 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 2006 through 2011 (includes corresponding Graph/Chart)

III-101

Table 61: European 15-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 2006, 2014 & 2020 (includes corresponding Graph/Chart)

III-102

Table 62: European Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 63: European Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

III-104

Table 64: European 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart) 4a. FRANCE A.Market Analysis Outlook Overview

III-105 III-106 III-106 III-106 III-106

Table 65: 65+ Population as % of Total Population (includes corresponding Graph/Chart)

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Table 66: Clinical Testing Laboratories in France (2012): Percentage Share Breakdown of Number of Labs by Type

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Labco S.A. - A Key Player

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B.Market Analytics

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Table 67: French Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 68: French Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 69: French 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

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4b. GERMANY

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A.Market Analysis Outlook

III-111 III-111

Privatization: A Visible Trend in the Labs Market Regulatory Scenario in Germany

III-111 III-111

DAkkS GmbH - Germany's National Accreditation Body

III-111

Bioscientia Institut f端r Medizinische Diagnostik GmbH - A Key Player B.Market Analytics

III-112 III-112

Table 70: German Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 71: German Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 72: German 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding

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III-114

4c. ITALY

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A.Market Analysis Outlook

III-115 III-115

ACCREDIA - The Italian Accreditation Body B.Market Analytics

III-115 III-116

Table 73: Italian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 74: Italian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 75: Italian 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

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4d. THE UNITED KINGDOM A.Market Analysis Outlook

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UKAS - The Sole National Accreditation Body in the UK B.Market Analytics

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III-120

Table 76: UK Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 77: UK Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 78: UK 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

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A.Market Analysis Outlook

III-123 III-123

Strategic Corporate Development

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B.Market Analytics

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Table 79: Spanish Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 80: Spanish Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 81: Spanish 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

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4f. RUSSIA

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Market Analysis

III-127

Table 82: Russian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 83: Russian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 84: Russian 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

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4g. REST OF EUROPE A.Market Analysis Outlook

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Switzerland Ukraine

III-130 III-130

Strategic Corporate Developments

III-131

Unilabs SA (Switzerland) - A Key Player B.Market Analytics

III-131 III-132

Table 85: Rest of Europe Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 86: Rest of Europe Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 87: Rest of Europe 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart) 5. ASIA-PACIFIC A.Market Analysis Overview

III-134 III-135 III-135 III-135

Healthcare Spending in Asia-Pacific: On the Rise

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China and India: Two Fast-Growing Markets

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APLAC - A Regional Accreditation Body in Asia-Pacific B.Market Analytics

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Table 88: 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 2012 through 2020 (includes corresponding Graph/Chart)

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Table 89: 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 2006 through 2011 (includes corresponding Graph/Chart)

III-138

Table 90: Asia-Pacific 15-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for China and Rest of Asia-Pacific

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Table 91: Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

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Table 92: Asia-Pacific Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2006 through 2011 (includes corresponding Graph/Chart)

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Table 93: Asia-Pacific 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

III-142

5a. CHINA

III-143

A.Market Analysis Outlook

III-143 III-143

Medical Labs Market: An Overview

III-143

Healthcare Reforms: Opportunities for Clinical Labs Market Independent Clinical Labs - A Nascent Market

III-143

III-144

Table 94: Leading Independent Medical Labs in China (2013): Percentage Share Breakdown of Revenues for KingMed Diagnostics, DiAn Diagnostics, Adicon Clinical Laboratories Inc., DaAn Health, and Others (includes corresponding Graph/Chart)

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CNAL - The National Accreditation Body in China

III-146

HKAS - An Accreditation Body in Hong Kong

III-146

Strategic Corporate Developments Key Players B.Market Analytics

III-147 III-149 III-151

Table 95: Chinese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

III-151

Table 96: Chinese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with

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III-152

Table 97: Chinese 15-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, and Other Laboratories Markets for Years 2006, 2014 & 2020 (includes corresponding Graph/Chart)

III-153

5b. REST OF ASIA-PACIFIC

III-154

A.Market Analysis

III-154

Outlook

III-154

Review of Select Regional Markets

III-154

Australia

III-154

Strong Growth in Lab Testing Leads to Increased Private Health Insurance Premiums

III-154

NATA - An Australian Regulatory Agency India

III-154

III-155

Clinical Laboratory Market: Overview Growth Drivers Challenges

III-155 III-156 III-156

Table 98: Indian Medical Laboratories Market (2010): Percentage Share Breakdown of Revenues by Type of Lab High-End Labs, Regional Labs, and Manual Labs (includes corresponding Graph/Chart)

III-157

Table 99: Indian Clinical Laboratory Market (2013E): Percentage Share Breakdown of Revenues by Segment Biochemistry, Immunology, Hematology, Microbiology, Histopathology, Molecular, and Genetics (includes corresponding Graph/Chart)

III-158

Biochemistry Analysis: An Important Clinical Lab Segment Competitive Landscape

III-158

III-158

Business Model of Medical Labs

III-159

Table 100: Indian Medical Laboratories Market (2013)): Number of Labs and Collection Centers Operated by Metropolis, SRL Diagnostics, and Dr. Lal Path Labs Regulatory Scenario in India Indonesia Korea

III-160

III-160 III-160 III-160

Rapidly Aging Population Spurs Demand for Clinical Lab Testing

III-160

Table 101: South Korean Medical Laboratories Market (2010): Percentage Share Breakdown of Medical Laboratories by Healthcare Segment - Immunochemistry, Infectious Disease, Clinical Chemistry, Microbiology, Hematology, Molecular Biology, and Others (includes corresponding Graph/Chart)

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Regulatory Scenario in Philippines Singapore

III-161

III-162 III-162

SAC - The National Agency for Accreditation in Singapore Thailand

BLQS - A Designated Accreditation Authority in Thailand Strategic Corporate Developments Key Players B.Market Analytics

III-162

III-162 III-162

III-163 III-164 III-165

Table 102: Rest of Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location Hospital-Based Laboratories, and Other Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2012 through 2020 (includes corresponding Graph/Chart)

III-165

Table 103: Rest of Asia-Pacific Historic Rev

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