The global therapeutic drug monitoring market was valued at USD 1.4 Billion in 2021 and it is anticipated to grow up to USD 4.5 Billion by 2031, at a CAGR of 12.3% during the forecast period.
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Therapeutic Drug Monitoring is a medical practice which is used for determining the concentration of particular drug in the bloodstream of the patient at different time interval. It is used in sustaining constant volume drug in the bloodstream without any toxic effect. Therapeutic drug monitoring is not used in majority of drugs but only the drugs which have narrow therapeutic window. It is also used in drugs with marked pharmacokinetic variability.
Market Trends and Drivers
Rising preference for precision medicine will boost the overall market growth. Precision medicine is an evolving approach for disease treatment and prevention that considers individual variability in genes, environments, and lifestyles. Precision medicine involves selecting drugs wholly tailored to a patient based on disease condition and history. Although this practice is expanding into all disease areas, oncology has seen the most progress. Recently, cancer patients are being provided treatment through combination drugs, based on studies conducted on the patient’s parameters such as systems biology, analysis of the tumor, and gene expression data in the absence and presence of pharmacological perturbation. This approach, which is currently being tested in various settings, aims to revolutionize pharmacotherapy in oncology and other disease areas. TDM can be of immense value to advance this novel way of treating patients.
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Market Restraints and Challenges
Operational barriers faced in conducting TDM tests may hampers the market growth. Clinical laboratories across major markets are still evolving. As a result, technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as chemiluminescence immunoassays, HPLC, and multiplex flow immunoassays (MFI). Laboratory space also needs to be reconfigured to meet the requirements of conducting specific immunoassay tests for pathogen detection to avoid cross-contamination and ensure efficient time management. The need to maintain and operate advanced immunoassay instruments, particularly those capable of handling a single sample type, is highly expensive. Due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, a shortage of skilled laboratory technicians to operate advanced immunoassay diagnostic products limits their overall adoption, particularly in emerging markets. Also, the reluctance to move from manual operations toward automation is another major challenge for market growth. This is because many providers find it difficult to transition to IT-based approaches from manual or traditional approaches and may not prefer to make the shift at all.
Major Players in the Global Therapeutic Drug Monitoring Market
The key players in the market are Abbott (US), Thermo Fisher Scientific (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher Corporation (US), Bio-Rad Laboratories (US), bioMérieux SA (France), Theradiag SA (France), Grifols S.A. (Spain), Randox Laboratories Ltd. (Ireland) among others.
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COVID-19 Impact
A worldwide emergency has been caused by the COVID-19 pandemic. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a drop in TDM testing since pandemic onset. For instance, in April 2020, a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing was noticed, mainly due to a large number of cancellations of outpatient. Likewise, it is also believed that disruption to normal patterns of care and disease monitoring of patients on biologics could increase the threat of disease and adverse clinical reactions. Research associations and other medical bodies are making various attempts to conduct clinical trials to develop a suitable anti-COVID drug, which is anticipated to fuel the growth of the TDM market. Moreover, the Pharmacology group – AC43 of the National Agency for Research on AIDS and Viral Hepatitis and the Therapeutic Drug Monitoring Group of the French Society of Pharmacology and Therapeutics proposed, at the end of March 2020, that a TDM evaluation be performed 48 hours after the start of treatment to check the early attainment of an adequate residual concentration.
Global Therapeutic Drug Monitoring Market Segmentation
By Product
- Consumables
- Equipment
- Data Management Services
By Technology
- Immunoassays
- Proteomic Technologies
By Drug Class
- Anti-epileptics
- Antibiotics
- Immunosuppressants
- Anti-arrhythmics
By End-use
- Hospital Labs
- Private Labs
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