Therapeutic Drug Monitoring Market
The global therapeutic drug monitoring market in terms of revenue was estimated to be worth $1.8 billion in 2023 and is poised to reach $2.9 billion by 2030, growing at a CAGR of 9.6% from 2023 to 2030. This market's expansion is being driven mostly by an increased emphasis on research experiments connected with therapeutic medication monitoring and an increase in severe illnesses. However, the need for large capital expenditures and the reluctance of small hospitals to provide therapeutic medication monitoring services may limit the market's growth.
The Effect of the Recession on the Therapeutic Drug Monitoring Market
Concerns about a possible recession are projected to stifle market growth. Fear of a recession, according to a Wall Street Journal piece published in 2022, has spurred a 9% gain in the NYSE Arca Pharmaceutical Index over the last year and a 13.1% decline in the S&P 500. Trends are expected to be similar to the COVID-19 recession, in which procedure volumes and routine testing in a single country or region were determined by the spread of COVID-19 and the activity of regional authorities. During COVID-19, for example, global cardiovascular and neuromodulation operation volumes dropped, reducing demand for Abbott's medical equipment and diagnostic tests.The recession has had an impact on the quarterly revenue of companies such as Abbott Laboratories (US) and may have an impact on capital spending.
Market Dynamics for Therapeutic Drug Monitoring
Driver: Therapeutic medication monitoring is critical in organ transplant operations.
Therapeutic drug monitoring for immunosuppressive drugs is critical in the treatment of patients undergoing solid-organ transplantation. Immunosuppressants are given to transplant recipients so that their bodies do not reject the organ. When giving immunosuppressants, doctors must personalise the medication therapy for each patient and strike an ideal balance between therapeutic efficacy and the possibility of unwanted effects. Because patients have variable pharmacodynamics and pharmacokinetics, reaching this aim with immunosuppressive treatment monitoring might be difficult.
Therapeutic drug monitoring is done before giving immunosuppressants to reduce pharmacokinetic variability. Improper immunosuppressant medication doses can have negative consequences in transplant patients. Supratherapeutic medication doses can cause over-immunosuppression, which can lead to infection. Sub-therapeutic medication concentrations, on the other hand, can cause the recipient's body to reject an allograft. Because of this inter-individual heterogeneity in medication concentrations, therapeutic drug monitoring is required.
The increasing frequency of organ transplant surgeries has increased the need of therapeutic medication monitoring. 39,000 transplants will be done in the United States in 2020, with 106,771 children, women, and men on the national transplant waiting list (source: HRSA).
Opportunity: Rising prevalence of autoimmune illnesses.
Autoimmune illnesses impact around 3% of the population in the United States (10 million individuals) (Johns Hopkins University, 2022). Similarly, one of over 80 distinct autoimmune diseases affects around 4% of the world population. Type 1 diabetes, multiple sclerosis, rheumatoid arthritis, lupus, Crohn's disease, psoriasis, and scleroderma are the most prevalent autoimmune illnesses. According to the American Autoimmune illness Association (AARDA), up to 50 million Americans have an autoimmune illness, which costs the country $86 billion per year. These diseases are the fourth biggest cause of disability among women in the United States, according to the US Department of Health and Human Services (HHS).
They are the sixth biggest cause of mortality in women between the ages of 15 and 64. As a result, the development of novel medicines for the treatment of inflammatory autoimmune disorders has accelerated during the last decade. Tacrolimus, for example, is an immunosuppressive medication commonly used in individuals with autoimmune illnesses.
Challenge: Various alternatives to traditional therapeutic drug monitoring.
Many patients in therapeutic medication monitoring require regular blood tests to assess their health and development. Following some surgeries, such as kidney transplants, physicians must often check the patient's status by blood analysis to assist guarantee consistent medication concentrations in the patient's circulation. In general, therapeutic drug monitoring is difficult to maintain in this procedure without jeopardising specimen quality and accuracy, or, more likely, the patient's comfort and convenience, if not both. It becomes substantially more difficult when youngsters, the elderly, or individuals living in rural or distant locations are required to participate.
DBS sampling for therapeutic medication monitoring can provide an alternative to standard blood sample to lessen downsides, particularly in youngsters. According to a study, switching to DBS for therapeutic medication monitoring provided simple findings and enhanced cost-effectiveness. For example, the total societal expenses for traditional sampling for children with kidney transplants treated with immunosuppressants were USD 287.5 (EUR 259) for one sample. In comparison, home sampling costs $113.2 (EUR 102) per sample.
Companies have also exploited DBS benefits to simplify therapeutic drug monitoring as compared to the old method. For example, Neoteryx, LLC provides the Mitra Device, a single-use, non-sterile device that enables for convenient at-home sample collection for therapeutic drug monitoring in paediatric patients.
Chemiluminescence immunoassays (CLIAs) in the product's immunoassay therapeutic drug monitoring category will see the most increase and market share in the therapeutic drug monitoring market during the forecast period.
Based on the immunoassay, the market is split into chemiluminescence immunoassays, colorimetric immunoassays, fluorescence immunoassays, radioimmunoassays, and other immunoassays. Because these assays are extensively employed in TDM in either enzyme-amplified or direct chemiluminescence measurements, the chemiluminescence immunoassays sector is expected to develop at the fastest CAGR throughout the projection period.
The United States will hold the highest proportion of the North American therapeutic drug monitoring market in 2021.
North America's Therapeutic Drug Monitoring market is divided into two regions: the United States and Canada. The United States will control the majority of the North American therapeutic drug monitoring market in 2021. Growing precision medicine understanding and acceptability, increased drug development activities or releases, and a well-established payment mechanism for clinical diagnostics are all driving expansion in this market.
Some of the major players operating in this market are Abbott (US), F. Hoffmann-La Roche (Switzerland), Siemens Healthineers AG. (Germany), Thermo Fisher Scientific (US), Danaher Corporation (US), and Bio-Rad Laboratories (US). In 2021, Abbott (US held the leading position in the market. The company has a strong geographic presence across North America, Europe, and Asia Pacific. Thermo Fisher Scientific (US) held the second position in the therapeutic drug monitoring market in 2021.
Therapeutic Drug Monitoring Market Report Scope
This research report categorizes the Therapeutic Drug Monitoring market into the following segments and subsegments:
Product Split
- Consumables
- Equipment
- Immunoassay Analyzers
- Chromatography & MS Detectors
- Clinical Chemistry Analyzers
Technology Split
- Immunoassays.
- Chemiluminescence Immunoassays
- Chemiluminescence Immunoassays
- Colorimetric Immunoassays
- Fluorescence Immunoassays
- Radioimmunoassay
- Other Immunoassays
- Chromatography-MS
- LC-MS
- GC-MS
Class of drug Split
- Antiepileptic Drugs
- Antibiotic Drugs
- Immunosuppressant Drugs
- Antiarrhythmic Drugs
- Bronchodilator Drugs
- Psychoactive Drugs
- Other Drugs
End user Split
- Hospital Laboratories
- Commercial & Private Laboratories
- Other End Users
Recent Developments:
- In May 2012, Theradiag (France) announced the launch of ez-Track1, a point-of-care testing solution for therapeutic drug monitoring.
In January 2021, Theradiag (France) announced CE marking for four new i-Tracker test kits for biotherapy monitoring.