DELRAY BEACH, Fla., Dec. 18, 2024 /PRNewswire/ -- The global therapeutic drug monitoring market would expand at a compound annual growth rate (CAGR) of 8.4% from USD 2.30 billion in 2024 to USD 3.44 billion by 2029. The main cause of this increase is the rising incidence of lifestyle-related and chronic illnesses including cancer and heart disease, which require careful medication control. The market's growth is also being driven using AI-powered diagnostic solutions and technological advancements like chromatography and immunoassays. Furthermore, the market is being driven by increasing expenditures in healthcare infrastructure, the focus on increasing transplant success rates, and precision medicine regulatory measures.
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The major technical development is the use of machine learning and AI to TDM. Such AI-powered solutions foster better treatment planning and improved medication concentration predicts through real-time assessment of patient data. Advances in non-invasive sample methods, such saliva-based TDM, have transformed the field by increasing patient compliance and convenience. From a regulatory viewpoint, too, the broader applicability of TDM would further rise along with growing companion diagnostics regulations in the space of precision medicine-immunotherapies, especially for cancer. These listed factors are going to spur competition and, thereby, innovation while accelerating the adoption of advanced TDM solutions.
Based on technology, the therapeutic drug monitoring market can be segregated based on immunoassays and chromatography-MS technologies. Immunoassays would capture the largest market share in the year 2023 for the high sensitivity, efficiency, and speed, along with competent facility of offering inexpensive results within no time. They find wider applicability in clinical practices for routine purposes due to ease of integration with automated systems and their interaction with high-throughput platforms. Businesses are, therefore, investing heavily in the development of immunoassay technology to fully exploit these benefits. For instance, Beckman Coulter Diagnostics introduced the DxC 5001 Clinical Analyzer in July 2024, which combines immunoassay and clinical chemistry capabilities. Abbott has also improved the precision of its tests for the Alinity and ARCHITECT platforms, ensuring reliable medication monitoring. These expenditures show a strong commitment to fulfilling the rising need for reliable and expandable diagnostics.
By Drug Class, the therapeutic drug monitoring market can be divided into several medication classes, including immunosuppressive drugs, bronchodilator drugs, psychoactive drugs, anti-epileptic drugs, anti-arrhythmic drugs, and antibiotics. In the therapeutic drug monitoring market, the anti-epileptic drug segment is the one with the highest rate of growth in 2023. Since anti-epileptic medications (AEDs) have a limited therapeutic index and require correct dosage to avoid toxicity or subtherapeutic effects, they are one of the TDM market sectors with the highest rate of growth. This growth, spurred by the increasing prevalence of epilepsy, particularly in an aging population and in poverty-stricken regions, propels the need for TDM so that the optimum response in patients is realized. Companies take advantage of this growth to invest in automated instruments targeted for AED monitoring, along with specific immunoassays. For example, Abbott is upgrading its point-of-care TDM systems to accelerate the results during clinical practice, while Roche Diagnostics provides very sensitive tests for a variety of medications, including valproate and carbamazepine.
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Some of the prominent players operating in the market include Abbott (US), Thermo Fisher Scientific Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher Corporation (US), Bio-Rad Laboratories, Inc. (US), bioMérieux SA (France), Biosynex SA (France), Grifols, S.A. (Spain), Exagen Inc. (US), ARK Diagnostics, Inc. (US), R-Biopharm AG (Germany), and Randox Laboratories Ltd. (UK).
F. Hoffmann-La Roche Ltd. (Switzerland)
Pharmaceuticals and Diagnostics are the two primary business sectors of Roche Diagnostics, a part of F. Hoffmann-La Roche Ltd. that produces and sells diagnostic goods. Roche provides a wide range of assays, kits, and systems/analyzers for therapeutic drug monitoring under the Diagnostics business. In 2023, it invested USD 15.40 billion in R&D, compared to USD 14.90 billion in 2021. Similarly, it focuses on developing and updating its product portfolio. Its extensive portfolio of therapeutic drug monitoring instruments (including immunoassay analyzers) and wide geographic reach are the key factors contributing to its large market share.
Abbott (US)
Abbott is a well-known and established company in the market for therapeutic drug monitoring. Because of its great distribution system, it has a significant global presence and offers a wide selection of items. To keep its place in this industry, the corporation mostly uses organic methods, such new product introductions. As a result, the company has more than 100 products in its pipeline. The company also has a well-developed supply chain and distribution networks. In 2023, Abbott strategically prioritized cost efficiency by approving restructuring plans across its medical devices, diagnostics, and established pharmaceutical segments.
Thermo Fisher Scientific Inc. (US)
It is one of the leading players in the therapeutic drug monitoring market. Its Specialty Diagnostics segment offers a wide range of diagnostic test kits, reagents, culture media, instruments, and associated products for customers in healthcare, clinical, pharmaceutical, industrial, and food safety laboratories. It has a strong global distribution network, both direct and indirect, and is well-established in over 150 countries in North America, Europe, Asia, and Latin America. By acquiring related technologies and companies, Thermo Fisher continues to broaden its product line and capabilities as part of its strategic focus. On October 17, 2023, the company entered into a definitive agreement to acquire all outstanding shares of Olink Holding AB. Earlier, on January 3, 2023, it completed the acquisition of the UK-based Binding Site Group, now part of its Specialty Diagnostics division. The Binding Site Group is recognized as a key provider of innovative diagnostic assays and solutions, aimed at improving the detection and management of blood cancers and immune system disorders.
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