Therapeutic Drug Monitoring - Technologies, Markets, and Companies

  • ID: 2074117
  • Report
  • 208 Pages
  • Jain PharmaBiotech
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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 outcome. 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 of 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. TDM market is analyzed from 2016 to 2026 according to technologies as well as geographical distribution. Global market for DoA testing was also analyzed from 2016 to 2026 and divided according to the area of application. Unmet needs and strategies for 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 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 2017-2027/
  • 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 development of personalized medicine

The report covers the following areas:

  • 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
  • References
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0. 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
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 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 treatment of Alzheimer disease
Donepezil
Galantamine
Memantine
Drugs used for 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
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 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

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 2017-2027
Table 8-2: Global markets for TDM according to tests in drug categories 2017-2027
Table 8-3: Global markets for TDM according to point of application 2017-2027
Table 8-4: Markets for TDM and DoA testing equipment 2017-2027
Table 8-5: Geographical distribution of markets for TDM tests 2017-2027
Table 8-6: Drivers for growth of TDM markets
Table 8-7: Global markets for DoA testing 2016-2026
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
 
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

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