Clinical laboratory testing is one of the most important sectors of
medical care. Although it is generally involved in over 70% of medical
diagnoses, it accounts for less than 5% of overall healthcare
expenditures. The term clinical laboratory testing usually refers to
determining the concentration or activity of a protein, carbohydrate,
lipid, electrolyte, enzyme or small molecule in easily collected body
fluids such as blood, serum, plasma, urine and saliva. This TriMark
Publications report describes the specific segments of the clinical
laboratory testing business and the strategies used by laboratory
companies to develop new business opportunities. The study presents
emerging business practices and analyzes the partnerships and alliances
that various key sector players have forged or could forge in the near
future. New clinical laboratory business methods are also examined to
identify lead positions and potential future growth areas. Moreover, the
report profiles leading companies in the clinical laboratory industry,
with a primary focus on companies that actively analyze and market
laboratory data.
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Table of Contents
1. Overview 6
1.1 Objectives of the Report 6
1.2 Methodology 7
1.3 Scope of the Report 8
1.4 Executive Summary 9
2. IVD Clinical Laboratory Testing Market 15
2.1 Introduction 15
2.2 Independent Clinical Labs 16
2.2.1 Key Players for Independent Clinical Labs 16
2.3 Medical Expenditures 18
2.4 Medicare Clinical Lab Services Spending Trends 20
3. The Clinical Laboratory Testing Market 24
3.1 U.S. Market 24
3.1.1 Hospital-based Clinical Laboratories 27
3.1.2 Commercial Clinical Laboratory Testing 27
3.1.3 Physician Office Laboratories (POLs) 28
3.2 Clinical Lab Testing Key Players 31
3.2.1 Commercial Clinical Labs 31
3.2.2 Hospital Lab Collaborative Ventures 32
3.2.3 Specialty Labs 33
3.3 Revenue and Reimbursement 34
3.4 Outlook for Clinical Laboratory Testing 38
3.4.1 Long-term Changes 38
3.4.2 Market Drivers 40
3.4.3 Barriers to Successful Clinical Laboratory Operations 40
3.4.4 Key Technologies 44
3.4.5 Conclusion 44
4. Hot Sectors in the Clinical Lab Testing Market 46
4.1 Workplace Drugs-of-Abuse Testing 46
4.2 Clinical Toxicology 47
4.3 Clinical Testing for the Pharmaceutical Industry 47
4.4 Vitamin D Testing 47
4.5 Diabetes (Glucose) Testing 48
4.6 Molecular Diagnostic Testing 48
4.7 Cardiac Markers 50
4.8 Blood Bank Screening 51
4.9 Genetic Testing 51
4.10 Predictive Medicine Testing 51
4.11 Personalized Medicine 53
4.12 Cancer Testing 54
4.13 Point of Care Testing 55
4.14 Monitoring Testing 55
4.15 Anatomic Pathology 55
4.16 Immunodiagnostics 56
4.17 Opiate Testing 56
5. Important Clinical Lab Testing Technology Trends 57
5.1 Technology Platform Innovations in Clinical Lab Testing 57
5.2 The New Paradigm 57
5.3 Consolidated Workstations 57
5.4 Automation in the Laboratory 59
5.5 Laboratory Information Systems 59
5.6 New User-friendly Interface 60
5.7 Data-Management Issues 61
5.7.1 Wireless LANs 61
5.7.2 Data and Workflow Management Systems 62
5.7.3 Beckman Central Command 62
5.7.4 Clinical IT More Widely Available in Physician Practices 63
5.7.5 Physician Electronic Health Records (EHRs) 64
5.7.6 Specimen Tracking and Processing 64
6. Business Trends in the Clinical Laboratory Testing Sector 65
6.1 Key Developments 65
6.2 Sector Consolidation 65
6.3 Acquisition Pricing 65
6.4 Hospital Lab Competition Threats 67
6.5 Acquisition, License Agreements, Internal Development and Partnerships 68
6.6 Merger, Acquisition and Partnering Activities in the Clinical Lab Testing Industry 68
6.7 Comparison of Quest and LabCorp 71
6.7.1 Acquisitions 72
6.7.2 Quest’s Growth 72
6.7.3 Laboratory Corporation of America 73
6.7.4 LabCorp’s Growth 74
6.7.5 Competitive Advantages of National Labs like Quest and LabCorp 75
6.7.6 National Managed Care Companies 76
6.7.7 Billing and Collection Management 78
6.7.8 Lower Reagent and Supply Costs 79
6.7.9 Esoteric Testing Capabilities 79
6.7.10 Ability to Invest in Web-based Connectivity Solutions 79
6.7.11 Competitive Disadvantages of Quest and LabCorp 79
6.7.12 Difficulties with Turnaround Times and Stat Services 79
6.7.13 Physician-Laboratory Communication 79
6.7.14 Specimen Pickup Scheduling Inflexibility 80
6.8 Regulation of Clinical Laboratory Operations 81
6.8.1 CLIA and State Regulations 82
6.8.2 Drug Testing 82
6.8.3 Controlled Substances 82
6.8.4 Medical Waste, Hazardous Waste and Radioactive Materials 83
6.8.5 FDA 83
6.8.6 Occupational Safety 83
6.8.7 Specimen Transportation 83
6.8.8 Corporate Practice of Medicine 83
6.9 Hospital Outreach Programs 83
6.10 Supply Chain and GPO Contracting 84
6.11 Specialty Labs 84
6.12 Expansion of Hospital-based Labs and Hospital Outreach Programs 85
6.13 Managed Care 85
7. Company Profiles 86
7.1 ACM Medical Laboratory 86
7.2 Alere 86
7.3 American Esoteric Laboratories (Sonic Healthcare) 87
7.4 American Pathology Partners 87
7.5 AmeriPath (Quest) 87
7.6 ARUP Laboratories 87
7.7 Athena Diagnostics 88
7.8 Aurora Diagnostics 89
7.9 Bio-Reference Laboratories, Inc. 89
7.10 BioTech MedLab 90
7.11 Caris Diagnostics 90
7.12 CBLPath 90
7.13 Centrex Clinical Laboratories 90
7.14 Clarient, Inc. 90
7.15 Clinical Reference Laboratory 91
7.16 Clongen Laboratories, LLC 91
7.17 CompuNet Clinical Laboratories 92
7.18 EndoChoice Pathways 92
7.19 Enzo Biochem, Inc. 92
7.20 Esoterix (LabCorp) 92
7.21 Exagen Diagnostics 93
7.22 Geneva Laboratories 93
7.23 Genomic Health, Inc. 93
7.24 Genzyme 94
7.25 IBT Laboratories 94
7.26 Integrated Regional Laboratories (IRL) 94
7.27 LabCorp 94
7.28 MEDTOX Scientific, Inc. 96
7.29 Meriter Health Services 96
7.30 Mid America Clinical Laboratories (MACL) 97
7.31 Monogram Biosciences, Inc. 97
7.32 Myriad Genetics, Inc. 97
7.33 National Jewish Medical and Research Center 98
7.34 Parkway Clinical Laboratories 99
7.35 Pathology, Inc. 99
7.36 Predictive Biosciences 99
7.37 Psychemedics Corporation 100
7.38 Quest Diagnostics, Inc. 100
7.39 RDL Reference Laboratory 100
7.40 Satellite Laboratory Services 101
7.41 Signal Genetics 101
7.42 Solstas Lab Partners 101
7.43 Sonic Healthcare 102
7.44 Spectra 102
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Report Details:
Published: July 2012
No. of Pages: 134
Price: Single User License – US$3400
Corporate User License – US$6800
Table of Contents
1. Overview 6
1.1 Objectives of the Report 6
1.2 Methodology 7
1.3 Scope of the Report 8
1.4 Executive Summary 9
2. IVD Clinical Laboratory Testing Market 15
2.1 Introduction 15
2.2 Independent Clinical Labs 16
2.2.1 Key Players for Independent Clinical Labs 16
2.3 Medical Expenditures 18
2.4 Medicare Clinical Lab Services Spending Trends 20
3. The Clinical Laboratory Testing Market 24
3.1 U.S. Market 24
3.1.1 Hospital-based Clinical Laboratories 27
3.1.2 Commercial Clinical Laboratory Testing 27
3.1.3 Physician Office Laboratories (POLs) 28
3.2 Clinical Lab Testing Key Players 31
3.2.1 Commercial Clinical Labs 31
3.2.2 Hospital Lab Collaborative Ventures 32
3.2.3 Specialty Labs 33
3.3 Revenue and Reimbursement 34
3.4 Outlook for Clinical Laboratory Testing 38
3.4.1 Long-term Changes 38
3.4.2 Market Drivers 40
3.4.3 Barriers to Successful Clinical Laboratory Operations 40
3.4.4 Key Technologies 44
3.4.5 Conclusion 44
4. Hot Sectors in the Clinical Lab Testing Market 46
4.1 Workplace Drugs-of-Abuse Testing 46
4.2 Clinical Toxicology 47
4.3 Clinical Testing for the Pharmaceutical Industry 47
4.4 Vitamin D Testing 47
4.5 Diabetes (Glucose) Testing 48
4.6 Molecular Diagnostic Testing 48
4.7 Cardiac Markers 50
4.8 Blood Bank Screening 51
4.9 Genetic Testing 51
4.10 Predictive Medicine Testing 51
4.11 Personalized Medicine 53
4.12 Cancer Testing 54
4.13 Point of Care Testing 55
4.14 Monitoring Testing 55
4.15 Anatomic Pathology 55
4.16 Immunodiagnostics 56
4.17 Opiate Testing 56
5. Important Clinical Lab Testing Technology Trends 57
5.1 Technology Platform Innovations in Clinical Lab Testing 57
5.2 The New Paradigm 57
5.3 Consolidated Workstations 57
5.4 Automation in the Laboratory 59
5.5 Laboratory Information Systems 59
5.6 New User-friendly Interface 60
5.7 Data-Management Issues 61
5.7.1 Wireless LANs 61
5.7.2 Data and Workflow Management Systems 62
5.7.3 Beckman Central Command 62
5.7.4 Clinical IT More Widely Available in Physician Practices 63
5.7.5 Physician Electronic Health Records (EHRs) 64
5.7.6 Specimen Tracking and Processing 64
6. Business Trends in the Clinical Laboratory Testing Sector 65
6.1 Key Developments 65
6.2 Sector Consolidation 65
6.3 Acquisition Pricing 65
6.4 Hospital Lab Competition Threats 67
6.5 Acquisition, License Agreements, Internal Development and Partnerships 68
6.6 Merger, Acquisition and Partnering Activities in the Clinical Lab Testing Industry 68
6.7 Comparison of Quest and LabCorp 71
6.7.1 Acquisitions 72
6.7.2 Quest’s Growth 72
6.7.3 Laboratory Corporation of America 73
6.7.4 LabCorp’s Growth 74
6.7.5 Competitive Advantages of National Labs like Quest and LabCorp 75
6.7.6 National Managed Care Companies 76
6.7.7 Billing and Collection Management 78
6.7.8 Lower Reagent and Supply Costs 79
6.7.9 Esoteric Testing Capabilities 79
6.7.10 Ability to Invest in Web-based Connectivity Solutions 79
6.7.11 Competitive Disadvantages of Quest and LabCorp 79
6.7.12 Difficulties with Turnaround Times and Stat Services 79
6.7.13 Physician-Laboratory Communication 79
6.7.14 Specimen Pickup Scheduling Inflexibility 80
6.8 Regulation of Clinical Laboratory Operations 81
6.8.1 CLIA and State Regulations 82
6.8.2 Drug Testing 82
6.8.3 Controlled Substances 82
6.8.4 Medical Waste, Hazardous Waste and Radioactive Materials 83
6.8.5 FDA 83
6.8.6 Occupational Safety 83
6.8.7 Specimen Transportation 83
6.8.8 Corporate Practice of Medicine 83
6.9 Hospital Outreach Programs 83
6.10 Supply Chain and GPO Contracting 84
6.11 Specialty Labs 84
6.12 Expansion of Hospital-based Labs and Hospital Outreach Programs 85
6.13 Managed Care 85
7. Company Profiles 86
7.1 ACM Medical Laboratory 86
7.2 Alere 86
7.3 American Esoteric Laboratories (Sonic Healthcare) 87
7.4 American Pathology Partners 87
7.5 AmeriPath (Quest) 87
7.6 ARUP Laboratories 87
7.7 Athena Diagnostics 88
7.8 Aurora Diagnostics 89
7.9 Bio-Reference Laboratories, Inc. 89
7.10 BioTech MedLab 90
7.11 Caris Diagnostics 90
7.12 CBLPath 90
7.13 Centrex Clinical Laboratories 90
7.14 Clarient, Inc. 90
7.15 Clinical Reference Laboratory 91
7.16 Clongen Laboratories, LLC 91
7.17 CompuNet Clinical Laboratories 92
7.18 EndoChoice Pathways 92
7.19 Enzo Biochem, Inc. 92
7.20 Esoterix (LabCorp) 92
7.21 Exagen Diagnostics 93
7.22 Geneva Laboratories 93
7.23 Genomic Health, Inc. 93
7.24 Genzyme 94
7.25 IBT Laboratories 94
7.26 Integrated Regional Laboratories (IRL) 94
7.27 LabCorp 94
7.28 MEDTOX Scientific, Inc. 96
7.29 Meriter Health Services 96
7.30 Mid America Clinical Laboratories (MACL) 97
7.31 Monogram Biosciences, Inc. 97
7.32 Myriad Genetics, Inc. 97
7.33 National Jewish Medical and Research Center 98
7.34 Parkway Clinical Laboratories 99
7.35 Pathology, Inc. 99
7.36 Predictive Biosciences 99
7.37 Psychemedics Corporation 100
7.38 Quest Diagnostics, Inc. 100
7.39 RDL Reference Laboratory 100
7.40 Satellite Laboratory Services 101
7.41 Signal Genetics 101
7.42 Solstas Lab Partners 101
7.43 Sonic Healthcare 102
7.44 Spectra 102
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