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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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.

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.

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.

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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.

Key Market Players:

The significant players in the Therapeutic Drug Monitoring industry 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), Exagen Inc. (US), R-Biopharm AG (Germany), ARK Diagnostics, Inc. (US), apDia Group (Belgium), Immundiagnostik AG (Germany), and Sekisui Medical Co. Ltd. (Japan).

Recent Developments:

• In May 22, Theradiag (France) Announced the launch of ez-Track1, a Point-of-Care Testing solution for TDM.
• In Jan 2021, Theradiag (France) Announced CE marking for four new i-Tracker test kits for biotherapy monitoring.

Report Objectives

• To define, describe, and forecast the global Therapeutic Drug Monitoring market based on product, and region
• To provide detailed information regarding the major factors influencing the growth of the market (drivers, opportunities, and industry-specific challenges)
• To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the total market
• To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
• To forecast the size of market segments with respect to four main regions—North America, Europe, Asia Pacific, and the Rest of the World (RoW)2
• To strategically profile key players and comprehensively analyze their product portfolios, market shares, and core competencies3
• To track and analyze competitive developments such as acquisitions, expansions, new product launches, and partnerships in the Therapeutic Drug Monitoring market

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