Therapeutic Drug Monitoring Markets

  • March 2013
  • -
  • TriMark Publications
  • -
  • 173 pages

Therapeutic drug monitoring (TDM) is an important clinical assessment of drug plasma concentrations that also yields information regarding the efficacy, toxicity levels and potential drug-drug interactions of agents with a narrow therapeutic index. Ultimately, therapeutic drug monitoring testing provides clinical information to optimize dosage regimes and prevent adverse reactions and lack of treatment compliance. This TriMark Publications report analyzes the therapeutic drug monitoring market and the various market segments within it, e.g., antiepileptics, antiarrhythmics, antibiotics, antineoplastics, bronchodilators, immunosuppressives and HIV/AIDS drugs. The report also examines drug analysis technology platforms, clinical applications of therapeutic drug testing and the market for quantitative diagnostic drug tests. Moreover, the study analyzes almost all of the companies known to be marketing, manufacturing or developing therapeutic drug monitoring products in the U.S. and worldwide. Detailed tables and charts with sales forecasts and marketshare data are also included.

Table Of Contents

TABLE OF CONTENTS

1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 10
1.4 Objectives 10
1.5 Methodology 11
1.6 Executive Summary 12

2. Therapeutic Drug Monitoring 16
2.1 Introduction 16
2.2 Function of Therapeutic Drug Monitoring 18
2.3 Drug Screening Boom 20
2.3.1 Pain Management Drug Testing in Europe 22
2.3.2 Neonate Patients and Patients of Old Age 22
2.3.3 Therapeutic Drug Monitoring and Immunosuppressive Drugs 23
2.3.4 Antiretroviral Usage and TDM Monitoring 23
2.4 The Process of Therapeutic Drug Monitoring 25

3. Commonly Monitored Therapeutic Drugs 29
3.1 Antiepileptics 30
3.2 Antiarrhythmics 32
3.3 Antimanics 35
3.4 Antineoplastic Drugs (Anticancer Drugs) 37
3.5 Bronchodilators 39
3.6 Antibiotics 40
3.7 Immunosupressants 41
3.7.1 Interference in Immunosuppressant Drug Immunoassays1 42
3.8 Antiretrovirals 43
3.9 Antimycotic Agents 47
3.9.1 Flucytosine 47
3.9.2 Triazoles 47
3.9.3 Itraconazole 47
3.9.4 Voriconazole 48
3.9.5 Posaconazole 48

4. Therapeutic Drug Testing Market Analysis 49
4.1 Therapeutic Drug Monitoring - Market Revenue Analysis 49
4.2 Therapeutic Drug Monitoring - Market Share Analysis 52
4.3 Therapeutic Drug Monitoring - Market Dynamics 54
4.4 Quality Control and Accreditation 55
4.5 Common Drugs Analyzed by Therapeutic Drug Monitoring in the Developing World
55
4.6 Pitfalls of Therapeutic Drug Monitoring in the Developing World 55
4.7 Diagnostic Testing in the Future 56

5. Company Specific Instrumentation and Test Kit Review 57
5.1 Biosite Diagnostics (Inverness, Now Called Alere) 57
5.2 Abbott Diagnostics 58
5.3 Roche Diagnostics 59
5.4 American Bio Medica Corp. 60
5.5 Phamatech, Inc. 64
5.6 First Check Medical 64
5.7 OraSure 65
5.8 Concateno 65
5.9 Alfa Scientific Designs, Inc. 65
5.11 Beckman Coulter 68
5.12 Bio-Rad 70
5.13 Siemens Healthcare Diagnostics 70
5.14 Thermo Fisher Scientific 71
5.15 Agilent Technologies 71
5.16 Randox 72
5.17 Awareness Technology 74
5.18 Carolina Chemistries 74
5.19 Horiba Medical 75
5.20 Ortho Clinical Diagnostics (Johnson andamp; Johnson) 75
5.21 Medica Corporation, Inc. 76
5.22 Tecan 76

6. Instrumentation/Analyzer Evaluation 77
6.1 Abaxis 77
6.2 Abaxis Picolo Express 77
6.3 Abbott AxSYM 78
6.4 Abbott ARCHITECH c4000 78
6.5 Abbott ARCHITECH i2000 Series 79
6.6 Abbott iSTAT 80
6.7 Alfa Wassermann ACE Alera 81
6.8 AMS Liasys 83
6.9 AMS SAT 450 85
6.10 AMS VEGASYS 86
6.11 AMS NEPHYS 87
6.12 AMS ELLIPSE 89
6.13 Beckman Coulter AU Range 90
6.14 Beckman Coulter UniCel Dx 91
6.15 Beckman Coulter Access 2 91
6.16 BioMerieux VIDAS 92
6.17 BioMerieux MiniVIDAS 95
6.18 Carolina Chemistries BioLis 24i 95
6.19 DiaSorin ETI-MAX 3000 96
6.20 DiaSorin LIAISON 97
6.21 DiaSorin LIAISON XL 98
6.22 Grifols TRITURU.S. 98
6.23 Horiba ABX Pentra 400 99
6.24 Alere/Inverness Medical DS2 99
6.25 Ortho Clinical Diagnostics VITROS 5600 99
6.26 Ortho Clinical Diagnostics VITROS 4600 100
6.27 Ortho Clinical Diagnostics VITROS 5, IFS 102
6.28 Ortho Clinical Diagnostics VITROS 350 104
6.29 Ortho Clinical Diagnostics VITROS ECiQ 104
6.30 Medica EasyRA 106
6.31 Nova Biomedical Critical Care Xpress 106
6.32 Polymedico Poly-Chem 106
6.33 Polymedico Spotchem EZ Analyzer 106
6.34 RandoxRX Imola 107
6.35 Randox RX Daytona Plus 109
6.36 Randox Daytona 110
6.37 Randox RX Monza 110
6.38 Randox RX Suzuka 112
6.39 Roche Cobas c701 113
6.40 Roche Cobas c502 113
6.41 Roche Total Lab Automation Platform 113
6.42 Roche Cobas 6000 113
6.43 Siemens Dimension Vista 3000T 114
6.44 Siemens Dimension Vista 1500 116
6.45 Siemens Dimension Vista 1000T 117
6.46 Siemens Dimension Vista 500 118
6.47 Siemens Dimension RxL Max 118
6.48 Siemens Dimension Expand Plus 120
6.49 Siemens Dimension EXL with LM integrated Chemistry System 121
6.50 Siemens Dimension EXL200 integrated Chemistry System 122
6.51 Siemens CLINITEK Novus Automated Urine Clinical Chemical Analyzer 123

7. In Vitro Diagnostic Technologies and Potential Applications 124
7.1 Performance Characteristics Required for Implementation of
FDA-Approved/Cleared Tests 124
7.2 Immunoassays 124
7.2.1 Technology Principle 125
7.2.2 Enzyme Immunoassays 125
7.2.3 Enzyme-Linked Immunosorbant Assay 126
7.2.4 Enzyme Multiplied Immunoassay Technique 126
7.2.5 Cloned Enzyme Donor Immunoassay 127
7.2.6 Radio Immunoassay 127
7.2.7 Fluorescence Polarization Immunoassay 127
7.2.8 Lateral Flow Immunoassays 128
7.2.9 Particle Enhanced Turbidimetric Inhibition Immunoassay 128
7.2.10 Affinity Chrome Mediated Immunoassay 128
7.2.11 Future Trends of Immunoassays 128
7.3 Chemiluminescence 128
7.4 High Pressure Liquid Chromatography (HPLC) 128
7.5 Gas Chromatography/Mass Spectrometry 129
7.6 Liquid Chromatography/Mass Spectrometry 130

8. Chemical Analyzer Market Analysis 131
8.1 Ultra-Large Clinical Chemistry Analyzer Market Analysis 131
8.2 High Volume Clinical Chemistry Market 132
8.3 Mid-Size Clinical Chemistry Analyzers 133
8.4 Small-Volume Chemical Analyzer Market 134
8.5 Competitive Analysis 135

9. SWOT Analysis 139
9.1 Main Drivers of Therapeutic Drug Analysis Market 139
9.2 Potential Threats and Restraints of the Therapeutic Drug Testing Market 141
9.3 Challenges of this Market Place Going Forward 142
9.4 Opportunities of the Therapeutic Drug Analysis Test Market 144
9.5 Summary of Market Strengths, Weaknesses, Opportunities and Threats 144

10. Company Profiles and TDM Market Position Analysis 146
10.1 Main Players in the Industry - Market Leaders 146
10.2 Roche Diagnostics Market Analysis 146
10.3 Abbott Laboratories Market Analysis 149
10.4 Siemens Healthcare Market Analysis 151
10.5 Thermo Fisher Market Analysis 152
10.6 Beckman Coulter Market Analysis 153
10.7 OraSure Technologies Market Analysis 156
10.8 Alere/ Inverness Medical Innovations Market Analysis 158
10.9 Bayer AG Market Analysis 159
10.10 BioChem Pharmaceuticals Market Analysis 162
10.11 BioRad Market Analysis 162

Appendix 1: Analysis of Plasma Drug Concentrations in Therapeutic Drug
Monitoring 166


INDEX OF TABLES

Table 2.1: Conditions Under Which Therapeutic Drug Monitoring is Performed 16
Table 2.2: Conditions Where Therapeutic Drug Monitoring is not Required 17
Table 2.3: Key Attributes of Therapeutic Drug Monitoring 17
Table 2.4: Process of Therapeutic Drug Monitoring 26
Table 2.5: Information required to correctly interpret TDM concentration 27
Table 3.1: Monitored Therapeutic Drugs by Category and Indications 29
Table 3.2: Commonly Monitored Drugs 30
Table 3.3: Common Antiepileptic Drugs that undergo Therapeutic Drug Monitoring
30
Table 3.4: Proposed Therapeutic Range for newer Antiepileptics 31
Table 3.5: Antiepileptic Drug Monitoring Indications 31
Table 3.6: Application of Therapeutic Ranges for Antiepileptic Therapies 31
Table 3.7: Classification and examples of Antiarrhythmic Agents 33
Table 3.8 Antiarrhythmic Drugs, Indication and Therapeutic Range 33
Table 3.9: Commonly Prescribed Antiarrhythmic Drugs 33
Table 3.10: Recommended Collection Logistics and Sampling times for
Antiarrhythmic Therapeutic
Monitoring 34
Table 3.11: Analytical Issues in Monitoring Cardiac Drugs 34
Table 3.12: Drug Interactions Observed for Cardiac Drugs 34
Table 3.13: Short Term Side Effects of Lithium 36
Table 3.14: Long Term Side Effects of Lithium 36
Table 3.15: Classification of Antineoplastic agents 37
Table 3.16: General Toxicities of Antineoplastic Drugs 38
Table 3.17: Toxic effects of Methotrexate 38
Table 3.18: Therapeutic Range of Common Bronchodilators 39
Table 3.19: Toxic effects of Theophylline 39
Table 3.20: Toxic effects of Caffeine 39
Table 3.21: Common Antibiotics and their Therapeutic Ranges used in Therapeutic
Drug Monitoring 40
Table 3.22: Types of Immunosuppressant Therapeutics 41
Table 3.23: Non-steady State Kinetics of Immunosuppressant’s in Therapeutic Drug
Monitoring 42
Table 3.24: Common Immunosuppressant Agents in Therapeutic Drug Monitoring 42
Table 3.25: European and U.S. Guidelines for Therapeutic Drug Monitoring of
Antiretroviral Drugs 44
Table 3.26: Antiretroviral Therapy in Children in Low- and Middle-Income
Countries 45
Table 3.27: Antiretroviral Therapy Coverage in Low- and Middle-Income Countries
45
Table 3.28: Suggested Minimum Trough Plasma Concentrations for Individuals with
Wild-Type HIV 46
Table 3.29: Guidelines for Therapeutic Management of Antiretroviral Drugs 47
Table 3.30: Justification for Therapeutic Drug Monitoring of Antifungals 48
Table 3.31: Recommendation for Therapeutic Drug Monitoring of Antifungals 48
Table 4.1: Global Market Revenue Forecast for Therapeutic Drug Testing,
2009-2019 49
Table 4.2: U.S. Market Revenue Forecast for Therapeutic Drug Testing, 2009-2019
50
Table 4.3: Europe Market Revenue Forecast for Therapeutic Drug Testing,
2009-2019 51
Table 4.4: Japan Market Revenue Forecast for Therapeutic Drug Testing, 2009-2019
51
Table 4.5: Asia Excluding Japan Market Revenue Forecast - Therapeutic Drug
Testing, 2009-2019 51
Table 4.6: Central and Latin America Market Revenue Forecast - Therapeutic Drug
Testing, 2009-2019 52
Table 4.7: Middle East/Africa Market Revenue Forecast - Therapeutic Drug
Testing, 2009-2019 52
Table 4.8: Global Market Share Analysis for Therapeutic Drug Testing, 2012 53
Table 4.9: U.S. Market Share Analysis for Therapeutic Drug Testing, 2012 54
Table 4.10: Therapeutic Drug Monitoring Market Growth Drivers 55
Table 4.11: Therapeutic Drug Monitoring Market Entry Barriers and Risks 55
Table 4.12: Pitfalls of Therapeutic Drug Monitoring in Developing Countries 56
Table 5.1: Therapeutic Drug Monitoring Panel Available for Abbott Diagnostic
ARCHITECT Range
of Analyzers 58
Table 5.2: OraSure Portfolio of Drug Detection Methodologies 65
Table 5.3: Alpha Scientific Designs Drug of Abuse Testing Cut-Off Level 66
Table 5.4: Regulatory Clearance of Alpha Scientific Products for Drug Testing 67
Table 5.5: Available 510K Cleared Analytes for the Visionâ„¢ Integrated Drug Test
Cup 68
Table 6.1: Specifications of Abaxis Picolo Express 77
Table 6.2: Panel of Metabolites Detected by the Abaxis Picolo Express 77
Table 6.3: Panel of Assays Available for Abbott AxSYM System 78
Table 6.4: Panel of Assays Available for the Abbott ARCHITECH c4000 79
Table 6.5: Panel of Assays Available for the Abbott ARCHITECH i2000SR 80
Table 6.6: Specifications of Alfa Wassermann ACE Alera 82
Table 6.7: Test Panel for Alfa Wassermann ACE Alera 82
Table 6.8: Analyzer Medical Systems Clinical Analyzer Range and Throughput
Capacity 83
Table 6.9: Specifications and Features of AMS Lysis 84
Table 6.10: Specifications and Features of AMS SAT 450 85
Table 6.11: Specifications and Features of AMS VEGASYS 86
Table 6.12: Specifications and Features of AMS NEPHYS 87
Table 6.13: Specifications and Tables of AMS ELLIPSE 89
Table 6.14: Beckman Coulter’s AU Range of Chemical Analyzers and Throughput
Capacity 90
Table 6.15: Beckman Coulter’s UniCel Dx Range of Chemical Analyzers and
Throughput Capacity 91
Table 6.16: Features of Beckman Coulter Access 2 Immunoassay System 91
Table 6.17: Beckman Coulter Test Panel for Chemical Analyzers 92
Table 6.18: Features of the BioMerieux VIDAS System 93
Table 6.19: Test Panel Available for BioMerieux VIDAS System 94
Table 6.20: Specifications of BioMerieux MiniVIDAS Analyzer 95
Table 6.21: Test Panel for Carolina Chemistries BioLis 24i 96
Table 6.22: Features of DiaSorin ETI-MAX 3000 Analyzer 97
Table 6.23: Features of DiaSorin LIAISON Analyzer 97
Table 6.24: Sample Management of DiaSorin LIAISON Analyzer 98
Table 6.25: Specifications of Gilfols TRITURU.S. Immunoanalyzer 98
Table 6.26: Reagents Available for the Horiba Medical ABX PENTRA 400 99
Table 6.27: Reagents Available for the Horiba Medical PENTRA 200 99
Table 6.28: Features of Ortho Clinical Diagnostics VITROS 5600 Analyzer 100
Table 6.29: Specifications and Features of Ortho Clinical Diagnostics VITROS
4600 Analyzer 100
Table 6.30: Specifications of Ortho Clinical Diagnostics VITROS 5, IFS 102
Table 6.31: Specifications of Ortho Clinical Diagnostics VITROS 350 Analyzer 104
Table 6.32 Specifications of Ortho Clinical Diagnostics VITROS ECiQ Analyzer 104
Table 6.33: Features of Polymedico Poly-Chem Analyzer 106
Table 6.34: Features of Polymedico Spotchem EZ Analyzer 106
Table 6.35: Test Kits Available for PolyMedico Analyzers 107
Table 6.36: Features of Randox Laboratories RX Imola 108
Table 6.37: Test Menu for Randox Laboratories RX Imola Analyzer 108
Table 6.38: Features of Randox Laboratories RX Daytona Plus Analyzer 109
Table 6.39: Therapeutic Drug Monitoring Panel of Randox Laboratories RX Daytona
plus 109
Table 6.40: Features of Randox Laboratories Daytona Analyzer 110
Table 6.41: Test Menu for Randox Laboratories Daytona Analyzer 110
Table 6.42: Features of Randox Laboratories RX Monza Anayzer 110
Table 6.43: Test Panel of Randox Laboratories RX Monza Analyzer 111
Table 6.44: Features of Randox Laboratories RX Suzuka 112
Table 6.45: Therapeutic Drug Monitoring Test Panel of Randox Laboratories RX
Suzuka Analyzer 113
Table 6.46: Features of Siemens Dimension Vista 3000T Analyzer 114
Table 6.47: Assays available for Siemens Dimension Analyzers 114
Table 6.48: Features of Siemens Dimension Vista 1500 Analyzer 116
Table 6.49: Features of Siemens Dimension Vista 1000T 117
Table 6.50: Features of Siemens Dimension Vista 500 118
Table 6.51: Features of Siemens Dimension RxL Max Analyzer 118
Table 6.52: Assay Panel for Siemens Dimension RxL Max Analyzer 119
Table 6.53: Features of Siemens Dimension Expand Plus 120
Table 6.54: Features of Siemens Dimension EXL with LM Integrated Chemistry
System 121
Table 6.55: Features of Siemens Dimension EXL 200 Integrated Chemistry System
122
Table 6.56: Features of Siemens CLINITEK Novus Automated Urine Clinical Chemical
Analyzer 123
Table 7.1: Performance Characteristics Required Before Implementation of
FDA-Approved/Cleared Tests 124
Table 7.2: Comparison of Monoclonal and Polyclonal Antibody Characteristics 125
Table 7.3: Advantages and Disadvantages of Gas Chromatography/Mass Spectrometry
130
Table 9.1: Potential Challenges of Therapeutic Drug Testing Market 142
Table 9.2: Timeline of Legislative Changes from the Health Care and Education
Reconciliation Act,
2010 to 2013 143
Table 10.1: Market Leaders in the Therapeutic Drug Monitoring Testing Industry
146
Table 10.2: Beckman Coulter Chemistry Systems Available for Ultra High, High,
Moderate and Small Volume Laboratories 155
Table 10.3: Forensic Toxicology Therapeutic Portfolio of OraSure 156
Table 10.4: OraSure Portfolio of Drug Detection Methodologies 156
Table 10.5: Top-Selling Pharmaceutical Products by Bayer Healthcare
Pharmaceuticals 161
Table 10.6: Selected Bayer Products undergoing Registration 161
Table 10.7: Bayer -Top Selling Pharmaceutical Products by Sales, 2010-2011 162
Table 10.8: Life Science Product Portfolio - BioRad 163
Table 10.9: Customer Profile of BioRad 163
Table 10.10: Panel of BioRads Life Science Industry Competitors 163
Table 10.11: Panel of BioRads Clinical Diagnostic Industry Competitors 164
Table App 1.1: Variables that Contribute to Therapeutic Drug Monitoring Analysis
166
Table App 1.2: Common Drug Administration Routes 168
Table App 1.3: CYP Enzyme Metabolism of Clinically Relevant Therapeutic Agents
170
Table App 1.4: Major Sources of Pharmacokinetic Variability 170
Table App 1.5: Common Drug Groups involved in Therapeutic Drug Monitoring 172
Table App 1.6: Interpretative Criteria for a number of common drugs during
Therapeutic Drug Monitoring 173


INDEX OF FIGURES

Figure 2.1: Pharmacokinetics and TDM Relationship 18
Figure 2.2: Process for Reaching Dosage Decisions with Therapeutic Drug
Monitoring 19
Figure 2.3: Individualized Drug Treatment using Therapeutic Drug Monitoring 19
Figure 2.4: Pharmacokinetics and Pharmacodynamics Contribute to Variability in
the Relationship Between Therapeutic Dose and Effect 20
Figure 2.5: Concept of Therapeutic Range 20
Figure 2.6: Antiretroviral Coverage in Low and Middle Income Countries 24
Figure 2.7: Scenarios for Incremental Expansion of Antiretroviral Provision to
Treat and Prevent HIV 25
Figure 3.1: Number of Depression Sufferers in the U.S. 2005-2010 36
Figure 3.2: The Requirement for Immunosuppressant Drug Monitoring 42
Figure 3.3 Global Summary of the AIDS Epidemic 44
Figure 3.4: Number of People receiving Antiretroviral Therapy 44
Figure 4.1: Global Revenue of Therapeutic Drug Testing Market Forecast,
2009-2017 49
Figure 4.2 Geographic Market Share of the Therapeutic Drug Test Market 50
Figure 4.3: Global Market Share Analysis for Therapeutic Drug Testing (2012) 53
Figure 4.4: U.S. Market Share Analysis - Therapeutic Drug Testing (2012) 54
Figure 6.1: Panel of Assays Available for the Abbott iSTAT 81
Figure 7.1: Principle of ELISA 126
Figure 7.2: Enzyme Multiplied Immunoassay Technique (EMIT) 127
Figure 7.3: Flow Diagram of High Pressure Liquid Chromatography 129
Figure 8.1: Market Share Ultra-Large Clinical Chemistry Analyzers U.S. 131
Figure 8.2: Market Share Ultra-Large Clinical Chemistry Analyzers Non-U.S. 131
Figure 8.3: Global Sales of Chemical Analyzers from Roche Diagnostics, 2010 136
Figure 9.1: Summary of Strengths, Weaknesses, Opportunities and Threats of
Therapeutic Drug
Test Market 145
Figure 10.1: Roche Diagnostics Sales Volume, 2008-2012 146
Figure 10.2: Roche Diagnostics Core Operating Profit, 2010-2012 147
Figure 10.3: Roche Diagnostics Sales by Global Region, 2012 148
Figure 10.4: Abbott’s Two New Companies in 2012 - Diversified Medical Products
and Research-Based Pharmaceuticals 149
Figure 10.5: Abbott Diversified Medical Product Portfolio 150
Figure 10.6: Abbott Laboratories Global Annual Sales, 2008-2012 150
Figure 10.7: Abbott Laboratories Net Earnings, 2010-2012 150
Figure 10.8: Abbott Laboratories Net Sales - Diagnostics Division, 2010-2012 151
Figure 10.9: Siemens Market Share by Geographic Region, 2012 152
Figure 10.10: Thermo Fisher Revenue Generated by Geographic Region, 2011 152
Figure 10.11: Beckman Coulter Revenue by Geographic Region, 2010 154
Figure 10.12: Beckman Coulter Revenue by Segment, 2010 155
Figure 10.13: Revenue Generated by OraSure’s Oral Fluid Collection Devices,
2010-2011 157
Figure 10.14: Bayer Company Structure - Health Care, Crop Science and Material
Science 160
Figure 10.15: Bayer Global Sales by Geographic Market, 2011 162
Figure 10.16: BioRad Global Net Sales, 2007-2011 164
Figure 10.17: BioRad Geographical Breakdown of Sales, 2011 164
Figure 10.18: Research and Development Expenditure, BioRad 2007-2011 165
Figure App 1.1: Volume of Distribution of Various Therapeutic Drugs 167
Figure App 1.2: Major Pharmacokinetic Processes Affecting Drug Concentration 168
Figure App 1.3: Role of Cytochrome P450 Enzymes in Hepatic Metabolism - Relative
Hepatic Content
of CYP Enzyme 169
Figure App 1.4: Role of Cytochrome P450 Enzymes in Hepatic Metabolism -
Percentage Drugs Metabolized
by CYP Enzymes 169
Figure App 1.5: Variability of Pharmacokinetics 171
Figure App 1.6: Steady State Kinetics of Therapeutic Drug Monitoring 172

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5 Companies

Company Profiles

Roche Holding AG

Switzerland

BD Biosciences

United States

Life Technologies Corp.

United States

Beckman Coulter Inc.

United States

Promega Corp.

United States

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