Therapeutic Drug Monitoring Market

The global therapeutic drug monitoring market in terms of revenue was estimated to be worth $1.8 billion in 2022 and is poised to reach $2.9 billion by 2027, growing at a CAGR of 9.6% from 2022 to 2027. The growth of this market is primarily driven by an amplifying focus on research experimentation associated with therapeutic drug monitoring and an increase in severe diseases. However, the requirement for massive capital investments and the hesitancy of compact hospitals to offer therapeutic drug monitoring services may restrain the growth of this market.

Attractive Opportunities in the Therapeutic Drug Monitoring Market

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Recession Impact on the Therapeutic Drug Monitoring Market

Market growth is anticipated to slow due to concerns about a possible recession. According to an article published in the Wall Street Journal in 2022, the fear of recession has driven a 9% gain for the NYSE Arca Pharmaceutical Index over the past year and a 13.1% decline for the S&P 500. Trends are expected to be like the COVID-19 recession, wherein procedural volumes and routine testing in a particular country or region depended on the spread of COVID-19 and actions taken by regional authorities. For instance, global cardiovascular and neuromodulation procedural volumes dropped during COVID-19, directly affecting the demand for Abbott's medical devices 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.
• The primaries also confirmed the impact of the recession.
• The company's volume analysis for 2020–2021 further aided the recession impact analysis.

Therapeutic Drug Monitoring Market Dynamics

Driver: Importance of therapeutic drug monitoring in organ transplant procedures

Conducting therapeutic drug monitoring for immunosuppressive medications is essential in managing patients undergoing solid-organ transplantation. A person receiving an organ transplant is prescribed immunosuppressants so the body does not reject the organ. When administering immunosuppressants, clinicians need to individualise a patient's drug therapy and ensure an optimal balance between therapeutic efficacy and the probability of adverse effects. Patients present different pharmacodynamics and pharmacokinetics, so achieving this goal with immunosuppressant therapy monitoring can be challenging.

Therapeutic drug monitoring is used before administering immunosuppressants as it minimises the pharmacokinetic component of variability. Improper drug concentrations in immunosuppressants can lead to adverse effects in transplant patients. Supra-therapeutic drug concentrations can put the patient at risk of over-immunosuppression, which may cause infection. On the other hand, sub-therapeutic drug concentrations can cause the recipient's body to reject an allograft. This inter-individual variability in drug concentrations creates the need for therapeutic drug monitoring.

The importance of therapeutic drug monitoring has grown due to the rising number of organ transplant procedures being performed. In 2020, 39,000 transplants will be performed in the US, and 106,771 children, women, and men are on the national transplant waiting list (source: HRSA).

Opportunity: increasing prevalence of autoimmune diseases.

Autoimmune diseases affect approximately 3% of the US population (10 million people) (Johns Hopkins University, 2022). Similarly, around 4% of the world's population is affected by one of more than 80 different autoimmune diseases. The most common autoimmune disorders include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, lupus, Crohn's disease, psoriasis, and scleroderma. It is also estimated by the American Autoimmune Related Diseases Association (AARDA) that as many as 50 million Americans are living with an autoimmune disease, at a cost of USD 86 billion a year. According to the US Department of Health and Human Services (HHS), these diseases represent the fourth-largest cause of disability among women in the US. They are the eighth-leading cause of death for women between the ages of 15 and 64. As a result, the introduction of new therapeutics for treating inflammatory autoimmune diseases has increased rapidly in the last decade. For instance, tacrolimus is a widely used immunosuppressive drug in patients with autoimmune diseases.

Challenge: Alternatives to conventional therapeutic drug monitoring

In therapeutic drug monitoring, many patients require regular blood testing to monitor their health and progress. After specific procedures, such as renal transplants, physicians must monitor the patient's condition frequently through blood analysis to help ensure consistent drug concentrations in the patient's bloodstream. Generally, therapeutic drug monitoring is challenging to maintain in this process without compromising the specimen quality and accuracy or the patient's comfort and convenience, if not both. It becomes significantly more challenging when it requires participation from children, the elderly, or those who live in rural or isolated areas.

To reduce drawbacks, dried blood spot (DBS) sampling for therapeutic drug monitoring can be an alternative to conventional blood sampling, especially in children. As per a research article, switching to DBS for therapeutic drug monitoring offered easy results and improved cost-effectiveness. For instance, for children with renal transplants treated with immunosuppressants, the total societal costs for conventional sampling were USD 287.5 (EUR 259) for one sample. In contrast, home sampling costs were $113.2 (EUR 102) for a sample.

Companies have also adopted the benefits offered by DBS to provide ease in therapeutic drug monitoring compared to the conventional method. For instance, Neoteryx, LLC, provides the Mitra Device, a single-use, non-sterile device that enables easy at-home sampling for therapeutic drug monitoring in paediatric patients.

chemiluminescence immunoassays (CLIAs) in the product's immunoassay therapeutic drug monitoring segment to witness the highest growth as well as the largest share in the therapeutic drug monitoring market during the forecast period.

The market is divided into chemiluminescence immunoassays, colorimetric immunoassays, fluorescence immunoassays, radioimmunoassays, and other immunoassays based on the immunoassay. The chemiluminescence immunoassays segment is projected to grow at the highest CAGR during the forecast period because these assays are commonly used in TDM in either enzyme-amplified or direct chemiluminescence measurements.

In 2021, the US accounted for the largest share of the North American therapeutic drug monitoring market.

Based on the region, the North American Therapeutic Drug Monitoring market is segmented into the US and Canada. In 2021, the US accounted for the largest share of the North American therapeutic drug monitoring market. Growth in this market can be attributed to rising awareness and adoption of precision medicine, the rising number of drug development activities or launches, and the well-established reimbursement framework for clinical diagnostics.

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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.

Frequently Asked Questions (FAQ):

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