This report deals with therapeutic drug monitoring, a multi-disciplinary clinical specialty, aimed at improving patient care by monitoring drug levels in the blood to individually adjust the dose of drugs for improving outcomes. TDM is viewed as a component of personalized medicine that interacts with several other disciplines including pharmacokinetics and pharmacogenetics. One chapter is devoted to monitoring drugs of abuse (DoA). Various technologies used for well-known DoA are described. A section on drug abuse describes methods of detection of performance-enhancing drugs.
The TDM market is analyzed from 2020 to 2030 according to technologies as well as geographical distribution. The global market for DoA testing was also analyzed from 2020 to 2030 and divided according to the area of application. Unmet needs and strategies for the development of markets for TDM are discussed. The report contains profiles of 35 companies involved in developing tests and equipment for drug monitoring along with their collaborations. The text is supplemented with 21 tables, 9 figures and 210 selected references from the literature.
Benefits of this report
- Up-to-date one-stop information on therapeutic drug monitoring
- Description of 35 companies involved with their collaborations in this area
- Market analysis 2020-2030
- Market values in major regions
- Strategies for developing markets for therapeutic drug monitoring
- A selected bibliography of 210 publications
- Text is supplemented by 21 tables and 9 figures
Who should read this report?
- Biotechnology companies developing assays and equipment for drug monitoring
- Reference laboratories providing drug monitoring services
- Pharmaceutical companies interested in companion tests for monitoring their drugs
- Clinical pharmacologists interested in integrating therapeutic drug monitoring with pharmacogenetics for the development of personalized medicine
The report contains information on the following:
- Introduction to TDM
- Technologies for TDM
- Drug Monitoring Instruments
- Applications of TDM
- Drugs Requiring Monitoring
- Monitoring of Biological Therapies
- Monitoring of Drug Abuse
- Markets for TDM
- Companies
Table of Contents
Executive Summary
1. Introduction
- Definitions
- Historical Landmarks in the development of TDM
- Pharmacology relevant to TDM
- Pharmacokinetics
- Pharmacodynamics
- Pharmacogenetics
- Pharmacogenomics
- Pharmacoproteomics
- Drug receptors
- Protein binding
- Therapeutic range of a drug
- Variables that affect TDM
- Indications for TDM
- Multidisciplinary nature of TDM
- Role of TDM in personalized medicine
2. Technologies for TDM
- Introduction
- Sample preparation
- Proteomic technologies
- Mass spectrometry
- Liquid chromatography MS
- Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry
- Combining capillary electrophoresis with MS
- Gas-liquid chromatography
- Tissue imaging mass spectrometry
- New trends in sample preparation
- Pressure Cycling Technology
- Desorption electrospray ionization imaging
- High Performance Liquid Chromatography (HPLC)
- Ultra performance LC
- Application of HPLC and MS for separation of drug molecules
- TDM using dry blood spots
- Analysis of dried blood spots for drugs using DESI
- Quantitative analysis of drugs in dried blood spot by paper spray MS
- TDM in sweat
- Immunoassays
- Enzyme-linked immunosorbent assay
- Cloned Enzyme Donor Immunoassay
- Enzyme Multiplied Immunoassay Technique
- Fluorescence Polarization Immunoassay
- Particle Enhanced Turbidimetric Inhibition Immunoassay
- Radioimmunometric assays
- Biosensors
- Biochips & Microarrays
- Introduction
- Microchip capillary electrophoresis
- Phototransistor biochip biosensor
- Microchip-based fluorescence polarization immunoassay for TDM
- Cellular microarrays
- Microfluidics for TDM
- Lab-on-a-chip
- Micronics' microfluidic technology
- Rheonix CARD technology
- Nano-interface in a microfluidic chip
- Levitation of nanofluidic drops with physical forces
- Nanoarrays
- Nanobiotechology
- NanoDx™
- Biomarkers
- Applications of biomarkers in drug safety studies
- Genomic technologies for toxicology biomarkers
- Proteomic technologies for toxicology biomarkers
- Metabonomic technologies for toxicology biomarkers
- Integration of genomic and metabonomic data to develop toxicity biomarkers
- Toxicology studies based on biomarkers
- Biomarkers of hepatotoxicity
- Biomarkers of nephrotoxicity
- Cardiotoxicity
- Neurotoxicity
- Biomarkers in clinical trials
- Molecular diagnostics
- Novel technologies for TDM at point-of-care
- NanoEye
- Nanobiosensors
3. Drug Monitoring Instruments
- Introduction
- Description of important instruments
- Abbott instruments
- ARCHITECT c16000
- ARCHITECT c4000
- ARCHITECT c8000
- ARCHITECT ci16200 Integrated System
- ARCHITECT ci4100 Integrated System
- ARCHITECT ci8200 integrated with the ARCHITECT i2000SR
- ARCHITECT i1000SR
- ARCHITECT i4000SR
- AxSYM
- Agilent’s 6400 Series Triple Quadrupole LC/MS
- Alfa Wassermann’s ACE Alera
- AMS Diagnostics’ LIASYS
- Beckman Coulter instruments
- Beckman Coulter Unicel Series
- AU5800 automated chemistry systems
- AU480
- Binding Site ESP600
- bioMerieux Mini Vidas
- Carolina BioLis 24i
- Chromsystems’ HPLC instruments
- Grifols Triturus
- ABX Pentra 400
- Medica EasyRA
- Nova Biomedical Critical Care Xpress
- Ortho Clinical Diagnostics’ VITROS® family of systems
- Immunodiagnostic systems
- Randox intruments
- Randox RX Imola
- Roche instruments
- Cobas® 8000
- COBAS INTEGRA® Systems
- SCIEX instruments
- SCIEX LC/MS/MS
- Siemens instruments
- ADVIA 1200
- ADVIA Centaur XP immunoassay system
- CLINITEK® AUWi System
- Dimension® Xpand® Plus Integrated Chemistry System
- EMIT® II Plus Syva®
- Viva® Drug Testing Systems
- Thermo Scientific instruments
- Indiko
- Tosoh AIA-Series
4. Applications of TDM
- Introduction
- Pharmaceutical research and drug development
- Clinical trials
- Computerized clinical decision support systems for TDM and dosing
- Medication-related interferences with measurements of catecholamines
- Polymorphisms of genes affecting drug metabolism
- TDM for drug safety
- TDM in special groups
- The aged
- Children
- Pregnancy
- TDM of prophylactic therapy
- Monitoring of vitamin D levels
- Monitoring of RBC folic acid levels during pregancy
- Applications according to various conditions
- Anesthesia and critical care
- Optimizing antimicrobial dosing for critically ill patients
- TDM monitoring of thiopental continuous infusion in critical care
- Role of TDM in critical care cardiac patients.
- Cancer
- Epilepsy
- Personalized approach to use of AEDs
- Infections
- Virus infections
- Fungal infections
- Pain management
- Role of TDM in pain management
- Monitoring of analgesic drugs in urine samples
- AEDs as analgesics
- Triptans for migraine
- Psychiatric disorders
- Guidelines for use of TDM in psychiatric patients
- TDM of psychotropic drugs
- Emergency toxicology
- Future of TDM
5. Drugs Requiring Monitoring
- Introduction
- Anticoagulants
- Dabigatran
- Analgesics
- Monitoring of opioid use
- TDM of morphine
- TDM of oxycodone
- TDM of codeine
- Antiepileptics
- Carbamazepine
- TDM of carbamazepine
- Gabapentin
- Lacosamide
- Lamotrigine
- TDM of lamotrigine
- Levetiracetam
- TDM of levetiracetam
- Phenobarbital
- TDM of phenobarbital
- Phenytoin
- TDM of phenytoin
- Primidone
- TDM of primidone
- Topiramate
- TDM of topiramate
- Valproic acid
- TDM of valproic acid
- TDM of multiple antiepileptic drugs in plasma/serum
- Antiinflammatory agents
- Infliximab
- Antimicrobials
- Antibiotics
- Amikacin
- Anti-tuberculosis drugs
- Chloramphenicol
- Gentamicin
- Tobramycin
- Vancomycin
- Norvancomycin
- Antiviral agents
- Anti-HIV drugs
- Antifungal agents
- Voriconazole
- Antidepressants
- TDM of selective serotonin reuptake inhibitors
- Citalopram
- Antipsychotics
- Aripiprazole
- Clozapine
- Quetiapine
- Risperidone
- TDM of AEDs in psychiatric disorders
- TDM of lithium in psychiatric disorders
- TDM of multiple drugs in psychiatry
- Bronchodilators
- Theophylline
- Cardiovascular drugs
- Antiarrhythmic drugs
- Antihypertensive drugs
- β-blockers
- Cardiotonic drugs
- Digoxin
- TDM of statins for hypercholesterolemia
- Chemotherapy for cancer
- TDM of 5-FU
- TDM of imitanib
- TDM of Methotrexate
- TDM of paclitaxel
- Drugs used for the treatment of Alzheimer disease
- Donepezil
- Galantamine
- Memantine
- Drugs used for the treatment of Parkinson disease
- Monitoring of levodopa and carbidopa therapy
- Catechol-O-methyltransferase inhibitors
- Drugs for treatment of attention-deficit hyperactivity disorder
- Atomoxetine
- Methylphenidate
- Hypnotic-sedative drugs
- Benzodiazepines
- Propofol
- Immunosuppressive drugs
- Immunosuppressants used for the treatment of various diseases
- Azathioprine
- Hydroxychloroquine for patients with systemic lupus erythematosus
- Methotrexate for rheumatoid arthritis
- Mycophenolic acid for the treatment of lupus nephritis
- Immunosuppressants used for prevention of organ rejection in transplantation
- TDM of Tacrolismus in transplantation
- TDM of cyclosporine A in transplantation
- Monitoring of immunosuppression with mycophenolate mofetil
- Steroids
- Prednisone
- Miscellaneous drugs
- Nimodipine
- Sildenafil
6. Monitoring of Biological Therapies
- Introduction
- Cell therapy
- In vivo tracking of cells
- Molecular imaging for tracking cells
- MRI technologies for tracking cells
- Superparamagnetic iron oxide nanoparticles as MRI contrast agents
- Visualization of gene expression in vivo by MRI
- Gene therapy
- Application of molecular diagnostic methods in gene therapy
- Use of PCR to study biodistribution of gene therapy vector
- PCR for verification of the transcription of DNA
- In situ PCR for direct quantification of gene transfer into cells
- Detection of retroviruses by reverse transcriptase (RT)-PCR
- Confirmation of viral vector integration
- Monitoring of gene expression
- Monitoring of gene expression by green fluorescent protein
- Monitoring in vivo gene expression by molecular imaging
- Monoclonal antibodies
- Natalizumab
7. Monitoring of Drug Abuse
- Introduction
- Tests used for detection of drug abuse
- Forensic applications of detection of illicit drugs in fingerprints by MALDI MS
- MS for doping control
- Randox assays for DoA
- Drugs of Abuse Array V
- Urine drug testing
- TDM of drugs for treatment of substance abuse-related disorders
- Drug testing to monitor treatment of drug abuse
- Minimum requirement for drug testing in patients
- Analgesic abuse
- Fentanyl abuse
- Β-blockers as doping agents
- Detection of β-blockers in urine
- Chronic alcohol abuse
- Cocaine
- CEDIA for cocaine in human serum
- Detection of cocaine molecules by nanoparticle-labeled aptasensors
- Infrared spectroscopy for detection of cocaine in saliva
- Marijuana
- Use of marijuana and synthetic cannabinoids
- Detection of cannabinoids
- ELISA for detection of synthetic cannabinoids
- Fluorescence spectral fingerprinting of synthetic cannabinoids
- Drug abuse for performance enhancement in sports
- Historical aspects of drug abuse in sports
- Drugs used by athletes for performance enhancement
- Techniques used for detection of drug abuse by athletes
- Mass spectrometry for detection of peptide hormones
- miRNAs for the detection of erythropoiesis-stimulating agents
- Detection of anabolic steroids
- Body fluids and tissues used for detection of drug abuse in sports
- Urine drug testing
- Spray (sweat) drug test kits
- Hair drug testing
- Gene doping in sports
- Gene transfer methods used for enhancing physical performance
- Misuse of cell therapy in sport
- Challenges of detecting genetic manipulations in athletes
- Drug abuse testing in race horses
- Limitations and future
- Role of the pharmaceutical industry in anti-doping testing
8. Markets for TDM
- Introduction
- Methods for market estimation and future forecasts
- Global markets for TDM tests
- Global markets for TDM according to technologies
- Global TDM markets according to drug categories
- Agents used for treatment of Alzheimer disease
- Analgesics
- Anticancer agents
- Anticoagulants
- Antidepressants
- Antiepileptics
- Antimicrobials
- Antipsychotics
- Biological therapies
- Bronchodilators
- Cardiovascular drugs
- Corticosteroids/antihistaminics/antiinflammatory agents
- Hypnotic-sedatives
- Immunosuppressants
- Parkinson disease drugs
- Breakdown of global markets according to point of application of tests
- Markets for TDM and DoA testing equipment
- Geographical distribution of markets for TDM tests
- Drivers for growth of TDM markets
- Markets for DoA testing
- Unmet needs in TDM
- Cost-benefit studies
- Simplifying assays and reducing time and cost
- Strategies for developing markets
- Physician education
- Supporting research on TDM
- Biomarker patents for drug monitoring
9. Companies
- Profiles of companies
- Collaborations
10. References
List of Tables
Table 1-1: Historical landmarks in the development of therapeutic drug monitoring
Table 4-1: Psychotropic drugs requiring TDM
Table 5-1: Drugs requiring TDM
Table 5-2: Indications and therapeutic ranges of various AEDs
Table 6-1: Molecular imaging methods for tracking cells in vivo
Table 6-2: Applications of molecular diagnostics in gene therapy
Table 7-1: Commonly tested drugs of abuse and recreational drugs
Table 7-2: Testing and confirmation cutoff concentrations/detection times for DoA
Table 7-3: Historical landmarks of drug abuse in sports
Table 7-4: Drugs used by athletes for performance enhancement
Table 7-5: Genes that may be used for performance enhancement
Table 8-1: Global markets for TDM according to technologies from 2020-2030
Table 8-2: Global markets for TDM according to tests in drug categories 2020-2030
Table 8-3: Global markets for TDM according to point of application 2020-2030
Table 8-4: Markets for TDM and DoA testing equipment 2020-2030
Table 8-5: Geographical distribution of markets for TDM tests 2020-2030
Table 8-6: Drivers for growth of TDM markets
Table 8-7: Global markets for DoA testing 2020-2030
Table 9-1: Major players in therapeutic drug monitoring
Table 9-2: Drugs for which monitoring and detection tests are provided by LabCorp
Table 9-3: Collaborations of companies involved in TDM
List of Figures
Figure 1-1: Therapeutic window of a drug
Figure 1-2: Therapeutic range of a drug
Figure 1-3: Flow chart of TDM
Figure 1-4: Interrelationships of TDM
Figure 2-1: Separation of structurally similar drug molecules by HPLC
Figure 2-2: Determination of the identity of a target substance by mass spectrometry
Figure 2-3: Basic principle of a biosensor
Figure 8-1: Unmet needs in TDM
Figure 8-2: Metabolism of azathioprine and biomarkers for TDM
