Therapeutic Drug Monitoring Market Report 2025

The therapeutic drug monitoring market size has grown strongly in recent years. It will grow from $2.23 billion in 2024 to $2.43 billion in 2025 at a compound annual growth rate (CAGR) of 8.9%. The growth in the historic period can be attributed to rising incidence of chronic diseases, drug safety concerns, pharmacogenomics integration, increasing drug development, regulatory emphasis on precision medicine.

The therapeutic drug monitoring market size is expected to see rapid growth in the next few years. It will grow to $3.72 billion in 2029 at a compound annual growth rate (CAGR) of 11.3%. The growth in the forecast period can be attributed to expanding applications in oncology, rise in personalized medicine practices, global increase in aging population, expanded point-of-care testing, growing pharmaceutical r&d expenditure. Major trends in the forecast period include personalized medicine, technological advancements, increased drug development and usage, point-of-care testing (poct), emerging biomarkers and assay technologies.

The growth of the therapeutic drug monitoring market is expected to be propelled by the increasing prevalence of organ transplant surgeries. Organ transplantation involves the surgical transfer of an organ from a donor to a recipient. Therapeutic drug monitoring (TDM) of immunosuppressive medications has proven effective in managing patients undergoing solid organ transplantation. Optimizing TDM may help avoid toxic or insufficiently low-dose therapy, which could lead to organ rejection. For example, a January 2023 article from the United Network for Organ Sharing, a non-profit organization managing organ transplants in the US, reported a 3.7% increase in organ transplants in 2022 compared to 2021, totaling 42,887 procedures. Hence, the surge in organ transplant surgeries is a driving factor for the therapeutic drug monitoring market.

The anticipated growth of the therapeutic drug monitoring market is also attributed to the increasing consumption of drugs. Drugs, substances used for medical purposes to diagnose, treat, or prevent diseases in humans or animals, are subject to therapeutic drug monitoring to optimize dosage regimens. This involves measuring and adjusting drug concentrations in the bloodstream to ensure efficacy while minimizing side effects. According to the United Nations Office on Drugs and Crime in June 2023, the global estimate of people who inject drugs was 13.2 million in 2021, marking an 18% increase from previous estimates. Additionally, the global drug usage estimate was over 296 million people in 2021, showing a 23% increase over the previous decade. Therefore, the rising consumption of drugs is a key driver for the therapeutic drug monitoring market.

Major companies in the therapeutic drug monitoring market are concentrating on developing anti-idiotypic antibody technology to improve the sensitivity and specificity of assays for accurately measuring biologic drug levels and evaluating patient immune responses. This technology is instrumental in therapeutic drug monitoring as it allows for precise detection and measurement of biologic drug levels, ensuring accurate dosing and effective tracking of patient immune responses. For example, in June 2024, Bio-Rad Laboratories, a U.S.-based biotechnology company, introduced new anti-idiotypic and anti-monomethyl auristatin E (MMAE) antibodies designed for bioanalytical assays, enhancing pharmacokinetic (PK) and antidrug-antibody (ADA) monitoring. These innovative antibodies improve the reliability of assays for antibody-drug conjugates (ADCs) and play a crucial role in the therapeutic drug monitoring market by enabling accurate assessments of drug levels and immune responses, ultimately facilitating optimal patient dosing.

Prominent companies in the therapeutic drug monitoring market are directing their efforts toward developing testing solutions, including Point-of-Care Testing (POCT) solutions, to address the need for prompt decision-making. Point-of-Care Testing (POCT) involves a medical diagnostic approach that enables rapid testing and analysis of patient samples. For example, in May 2022, THERADIAG, a French company specializing in biological diagnostic tools, unveiled ez-Track1, a Point-of-Care Testing (POCT) solution tailored for therapeutic drug monitoring. This addresses the escalating demand for patient-centric diagnostics in the global healthcare sector. Initially launched in Europe, ez-Track1 conducts tests with whole blood samples, yielding results within 10 minutes and facilitating swift decision-making in implementing biotherapies. The CE-marked system's initial menu includes tests for Infliximab, anti-Infliximab, Adalimumab, and anti-adalimumab, with plans to expand rapidly to cover a broader range of chronic inflammatory diseases and other conditions.

In February 2023, Sentinel Diagnostics, an Italian in vitro diagnostic company, completed the acquisition of Eureka S.r.l. for an undisclosed amount. This strategic move positions Sentinel Diagnostics to emerge as a significant producer and developer of IVD tests. The expanded capabilities resulting from this acquisition will empower Sentinel Diagnostics to offer clinical laboratories a broader selection of assays, spanning from high-throughput core lab tests to the most cutting-edge, specialized second-level assays. EUREKA S.r.l. is an Italian IVD chromatographic company providing ready-to-use diagnostic kits for HPLC, GC, GC-MS, and LC-MS/MS applications, serving special clinical chemistry, therapeutic drug monitoring, occupational toxicology, and forensic toxicology purposes.

Major companies operating in the therapeutic drug monitoring market include Abbott Laboratories Inc., F. Hoffmann-La Roche AG, Siemens Healthineers AG, Thermo Fisher Scientific Inc., Sekisui Medical Co., Buehlmann Laboratories AG, Danaher Corporation, Bio-Rad Laboratories Inc., bioMérieux SA, Randox Laboratories Limited, Chromsystems Instruments & Chemicals GmbH, Grifols SA, Merck KGaA, BioChem Pharmaceuticals, Beckman Coulter Inc., DiaSorin S.p.A., Hologic Inc., Immunodiagnostic Systems Holdings plc, Kronus Inc., QuidelOrtho Corporation, Sysmex Corporation, TDM Solutions Inc., Theradiag, Tosoh Bioscience LLC, Trinity Biotech plc, Associated Regional and University Pathologists Inc., Mayo Clinic Laboratories, Quest Diagnostics.

North America was the largest region in the therapeutic drug monitoring market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global therapeutic drug monitoring market report during the forecast period. The regions covered in the therapeutic drug monitoring market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the therapeutic drug monitoring market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Therapeutic drug monitoring (TDM) is a clinical procedure that involves continuous monitoring of a patient's bloodstream to assess the concentration of a specific medicine, ensuring the effectiveness of their dose regimens. TDM is employed for pharmaceuticals that have challenging target concentrations to monitor, medications exhibiting significant pharmacokinetic variability, drugs with established therapeutic effects and notable side effects, and medications with narrow therapeutic ranges.

The primary product types within therapeutic drug monitoring encompass consumables, equipment, immunoassay analyzers, chromatography, and detectors. Consumables for therapeutic drug monitoring include reagents and supplies utilized alongside TDM assays. Various technologies are employed, such as immunoassays, chemiluminescence immunoassays, colorimetric immunoassays, fluorescence immunoassays, radioimmunoassay, other immunoassays, chromatography-ms, lc-ms, and gc-mc. These technologies cover different drug classes, including antiseptic drugs, antibiotic drugs, immunosuppressant drugs, antiarrhythmic drugs, bronchodilator drugs, psychoactive drugs, and other drugs. Therapeutic drug monitoring is applicable in diverse settings, including hospital laboratories, commercial and private laboratories, and other end-users.

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The therapeutic drug monitoring market includes revenues earned by entities by providing drug monitoring, urine drug testing, drug efficacy testing, and drug toxicology. The market value includes the value of related goods sold by the service provider or included within the service offering. The therapeutic drug monitoring market also includes sales of Immunoassay kits, Mass spectrometry instruments, and Chromatography systems. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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