Therapeutic drug monitoring is a multidisciplinary practice of measuring drug amount in bloodstream to maintain its effective concentration. It is used to maximize efficacy of drug, avoid toxicity and adverse drug reactions (ADR), facilitate dose adjustment according patient requirement, and to identify therapeutic failure. It is used especially for drugs characterized by narrow therapeutic window, drugs that are highly protein bound and those in which the metabolite might be toxic. Physicians and hospitals use therapeutic drug monitoring to maximize the clinical benefits of the drug by minimizing the toxic side effects thereby improving the quality of life for the patients.
North America dominates the global therapeutic drug monitoring market
North America holds the dominant position in therapeutic drug monitoring (TDM) market, owing to robust health care infrastructure, high awareness for treatment regime and increasing patient awareness regarding adverse drug reaction (ADR). According to 2013 survey by Medical Expenditure Panel published in Scientific American, 1 in 7 American adult consume Anti-Psychotic drug, a class of drugs which requires TDM. Stringent government regulations regarding safe medication practices especially with drugs having narrow therapeutic range would propel growth therapeutic drug monitoring. Moreover, increasing adoption of instruments such as monitors and analytic equipment, reagents, and diagnostics tools for drug monitoring is driving the growth of therapeutic drug monitoring market.
However, difficulty in reimbursement bars the widespread usage of TDM, as often the cost associated with TDM is high. Furthermore, insufficient infrastructure and skilled manpower is restraining the growth of the market in emerging economies.
Therapeutic Drug Monitoring Market Taxonomy
On the basis of product type:
- Consumables (Assay kits)
On the basis of technology:
- Enzyme Immunoassay
- Fluorescence Polarization Immunoassay
- Mass Spectrometry
On the basis of end user:
- Hospitals (Clinical Pharmacology departments)
- Pathological labs
- Research and Academic Institutions
- Pharmaceutical and Biotech firms
Personalized medicine and advanced technologies such as assay performance and drug monitoring to fuel the growth of therapeutic drug monitoring market
Personalized medicine is driving the growth of therapeutic drug monitoring market, owing to increasing demand for better treatment outcome with minimum side effects from the medication. For instance, TDM is majorly used for anti-cancer drugs monitoring for which standard guidelines are recommended by many oncology Journal and associations, one of them being the European Journal of Oncology. Moreover, advanced treatment therapies such pharmacogenomics, gene testing, and proteomics is further expected to boost the growth of market. Increasing antimicrobial resistance is one of the key factor driving the growth of TDM market. According to WHO Factsheet 2017, antimicrobial resistance is one of the leading cause of death. For instance, according to WHO factsheet, around 4,80,000 multi-drug resistance TB cases were reported, which is creating an opportunity for physicians to optimize or monitor the drug therapies through TDM.
Organ transplant procedures are also propelling the growth of therapeutic drug monitoring market. Immunosuppressant drugs are basic treatment for organ transplant to avoid rejection of transplanted organ by body, which requires TDM to avoid ADR and side effects. Asia Pacific is a promising region for organ transplant due to increased awareness and infrastructure availability. According to Waters Corporation Blog, China witnessed 35% y-o-y increase in organ transplant in the first 4 months of 2017. There is a growing trend of clinical research organizations being shifted to cost effective Asia Pacific region for bioequivalence study of generic drugs on account of low cost of processes in this region. Moreover, advances in the field of biomedical technology such as nano biosensors and implantable devices are expected to boost the growth of therapeutic drug monitoring market. Advancement in tools for TDM such as assay kits, chromatography columns, spectrometry, and alternative matrices such as interstitial fluid provide continuous real time monitoring of the therapeutic drug through Probe Scientific’s new MicroEye Technology.
Key players in the global therapeutic drug monitoring market include Roche Diagnostics, Thermo Fisher Scientific, Bio Rad Laboratories, Siemens Healthcare Diagnostics, Beckmann Coulter, and Abbott Diagnostics. In 2016, Danaher Corporation, parent company for Beckman Coulter acquired Cepheid at US$ 4 billion to strengthen company’s diagnostic portfolio.