The global therapeutic drug monitoring market was valued USD 1.77 billion in 2015. The growing need to perform drug profiling for various medications, such as anti-epileptics, immunosuppressants, and antibiotics, is one of the foremost factors responsible for the market growth. Drug monitoring aids the healthcare practitioners to monitor and maintain the drug concentration range in blood or plasma, within the defined therapeutic window, which is specific to a drug. TDM is the primary diagnostic tool employed to deliver an optimized dose of the drugs that are known to cause adverse drug reactions (ADRs) to define the drug concentration-response relationship, and the pharmacokinetic parameters of the drug entities that influence the drug metabolism patterns, with the aim of achieving better therapy outcomes in patients.
U.S. therapeutic drug monitoring market, by product, 2013 - 2024 (USD Million)
Therapeutic drug monitoring applications include the diagnosis of unexpected complications, such as toxicity, and the identification and subsequent tailoring of the optimal drug dose specific to the genetic profile of the concerned patient. In addition, TDM finds its application in diagnosing the root cause of failed therapy outcomes in a precise manner as it enables physicians to draw distinctions between the following confounding outcomes: ineffectual drug treatments, patient medication non-compliance, and adverse drug reactions that may be synonymous with the effects of the underlying condition. The increasing demand for the administration of personalized dosage patterns is expected to favor the emergence of the TDM market during the forecast period.
The introduction of novel devices with marked technological advancements facilitates rapid throughput operations with increased accuracy and specificity. The new range of the automated devices, such as IMMULITE 2000 XPiimmunoassay system, is expected to further drive the market growth.
The product portfolio of the therapeutic drug monitoring market is segmented into consumables and equipment. The consumables segment held the largest market share in 2015 with revenue generation of over USD 1,102 million and is expected to grow at the fastest CAGR during the forecast period. The increasing demand for new technology-based, cost-effective kits and the extensive use of these reagents in the R&D area are some of the factors responsible for its lucrative growth.
Immunoassays, proteomic technologies, and other technologies, such as thin-layer chromatography, spectrophotometry, polarimetry, and electrophoresis, are the technology segments of the market. The Immunoassay segment dominated the market in 2015 owing to the availability of highly specific and reliable immunoassays, the rising adoption rate of the advanced techniques, and the requirement of minimal training to handle the equipment.
The proteomics segment is expected to grow at a profitable CAGR during the forecast period due largely to the capacity of this technology to interrogate a variety of biospecimens for their proteome, the rising private and government funding for proteomics-related research activities, and the increasing adoption rates of these products in the areas of drug discovery, clinical research, and biomarker validation.
Drug class based segmentation includes anti-epileptics, antibiotics, immunosuppressants, psychoactives, and anti-arrhythmic drugs. The anti-epileptics segment held the largest market share in 2015as a consequence of the increasing prevalence of epilepsy and seizures and the resultant explosive growth in the number of Anti-epileptic drugs. It has been observed that the immunosuppressants segment has witnessed a higher penetration; the small margin for the therapeutic index of these drugs and the inter-individual differences observed in the blood concentrations of the immunosuppressants necessitate TDM for these drugs.
The end-use segment includes hospital labs, private labs, and others (research institutes, academic institutes, and pharmaceutical companies). Over 50% of the therapeutic drug monitoring is carried out in hospitals due to the availability of accurate patient information, such as age, metabolism, ethnicity, and drug performance history. The need for accurate patient history required to devise effective treatment plans has led many hospitals to design request forms for drug metabolite monitoring; the increasing use of computerized entry of patient history and information records is expected to further improve the TDS service in the hospitals.
In 2015, the North America therapeutic drug monitoring market generated approximately half of the global revenue. High rate of organ transplantation coupled with the high acceptance and gradual adoption of these metabolite measuring procedures is one of the major drivers for the large market share.
Lucrative growth in the Asia Pacific region is enumerated at a CAGR of over 8.5% over the forecast period attributable to the presence of unmet needs and the continuous efforts of the government to provide low-cost services with the aim of promoting individualized dosage patterns for organ transplantation cases as well as to support personalized medicine initiatives.
Some prominent players of the therapeutic drug monitoring market include Roche AG, Siemens Healthcare GmbH, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Beckman Coulter, Inc., Abbott Laboratories, Inc., Agilent Technologies, Inc., bioMérieux, Inc., and Alere, Inc. Companies are introducing new-generation, clinically-effective drug monitoring devices that are portable and miniaturized so as to gain a competitive edge in the market. For instance, Probe Scientific Ltd. has developed a novel point-of-care therapeutic monitoring device, MicroEye, used in determining the concentration of immunosuppressants in the transplanted patients.
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