• +353-1-416-8900(GMT OFFICE HOURS)
  • 1-800-526-8630(US/CAN TOLL FREE)
  • 1-917-300-0470(EST OFFICE HOURS)
Therapeutic Drug Monitoring Markets - Product Image

Therapeutic Drug Monitoring Markets

  • ID: 2497107
  • March 2013
  • Region: Global
  • 173 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Abbott Laboratories
  • Bayer AG
  • Beckman Coulter
  • BioChem Pharmaceuticals
  • BioRad
  • OraSure Technologies
  • MORE

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.

FEATURED COMPANIES

  • Abbott Laboratories
  • Bayer AG
  • Beckman Coulter
  • BioChem Pharmaceuticals
  • BioRad
  • OraSure Technologies
  • MORE

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

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

3. Commonly Monitored Therapeutic Drugs
3.1 Antiepileptics
3.2 Antiarrhythmics
3.3 Antimanics
3.4 Antineoplastic Drugs (Anticancer Drugs)
3.5 Bronchodilators
3.6 Antibiotics
3.7 Immunosupressants
3.7.1 Interference in Immunosuppressant Drug Immunoassays1
3.8 Antiretrovirals
3.9 Antimycotic Agents
3.9.1 Flucytosine
3.9.2 Triazoles
3.9.3 Itraconazole
3.9.4 Voriconazole
3.9.5 Posaconazole

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

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

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

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

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

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

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

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

INDEX OF TABLES

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

INDEX OF FIGURES

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

- Abbott Laboratories
- Alere/ Inverness Medical Innovations
- Bayer AG
- Beckman Coulter
- BioChem Pharmaceuticals
- BioRad
- OraSure Technologies
- Roche Diagnostics
- Siemens Healthcare
- Thermo Fisher

Note: Product cover images may vary from those shown

RELATED PRODUCTS

Our Clients

Our clients' logos