| Study Period | 2021 - 2030 |
| Market Size (2025) | USD 1.36 Billion |
| Market Size (2030) | USD 2.11 Billion |
| CAGR (2025 - 2030) | 9.12 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Therapeutic Drug Monitoring Market Analysis
The Therapeutic Drug Monitoring Market size is estimated at USD 1.36 billion in 2025, and is expected to reach USD 2.11 billion by 2030, at a CAGR of 9.12% during the forecast period (2025-2030).
Globally, the COVID-19 pandemic put enormous pressure on the healthcare system. Hospitals were understaffed and overworked. The urgent need for an accurate and rapid diagnosis of SARS-CoV-2 infection was critical as global healthcare systems continue to operate during the COVID-19 pandemic. In particular, serological and immunological testing of infected asymptomatic and symptomatic individuals was in high demand. Thus, COVID-19 impacted the market profoundly. As per the study published in Expert Review of Clinical Immunology in June 2021, enzyme-linked immunosorbent assays (ELISAs), chemiluminescent immunoassays (CLIAs), and lateral flow immunoassays (LFIAs) were the principal methodologies of serology-based tests for the detection of SARS-CoV-2.
Furthermore, according to the study titled "Rapid chromatographic immunoassay-based evaluation of COVID-19," published in February 2021, rapid chromatographic immunoassay-based test offered quick and accurate detection of COVID-19 and possessed excellent specificity and moderate sensitivity. Thus, the COVID-19 pandemic had a favorable impact on the market initially. As the pandemic has subsided, the market has lost some traction. However, it is expected to have stable growth during the forecast period of the study.
Increasing prevalence of cancers, neurological conditions, HIV, autoimmune and cardiac diseases, and growing R&D activities and clinical trials to expand the application of technologies in various indications. In August 2021, the Journal of Clinical Neurology cited epilepsy as the third most common neurological disorder after stroke and dementia, affecting approximately 70 million patients worldwide. According to WHO's 2021 data, more than 55 million people will live with dementia worldwide. Nearly 10 million new cases will be reported every year. Alzheimer's disease is the most common form of dementia and may contribute to 60-70% of the cases. Therefore, increasing chances of such diseases are anticipated to propel the market growth over the forecast period.
Moreover, various initiatives by the market players, such as product launches and mergers and acquisitions, are expected to propel the market's growth. For instance, in May 2022, THERADIAG, a company specializing in vitro diagnostics and theragnostic, reported the launch of ez-Track1, an accurate Point-of-Care Testing (POCT) solution for therapeutic drug monitoring. Such advancement in drug monitoring technology is expected to boost the market over the forecast period.
However, the reluctance of healthcare providers to implement therapeutic drug monitoring services in emerging nations is likely to hinder market growth over the forecast period.
Therapeutic Drug Monitoring Market Trends
Immunoassays Expected to Hold a Significant Market Share
Immunoassays are widely used in many vital areas of pharmaceutical analysis, such as diagnosis of diseases, therapeutic drug monitoring, clinical pharmacokinetics, and bioequivalence studies in drug discovery and pharmaceutical industries. The importance and widespread of immunoassay methods in pharmaceutical analysis are attributed to their inherent specificity, high throughput, and high sensitivity for analyzing a wide range of analytes in biological samples.
The continuous research work and requirements for drug developments in pharmaceutical industries are the major factors contributing to the segment's growth. For instance, according to the study published by the National Library of Medicine in March 2021, researchers developed a reliable and specific radioimmunoassay method for the measurement of dodecapeptide angiotensin in human plasma and urine using an affinity-purified antibody fraction directed towards the C-terminus of the human Ang-(1-12) sequence. The radioimmunoassay method was applied to quantify the Ang-(1-12) in plasma and urine.
The growing technological advancement in the product is expected to propel the segment's growth. For instance, in November 2021, Boditech Med launched its new automated immunoassay analyzer with a blood collection tube, including an all-in-one cartridge system, at MEDICA 2021.
Thus, the segment will likely expand over the forecast period due to the aforementioned factors.
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North America Holds a Significant Market Share and is Expected to do the Same during the Forecast Period
North America is expected to witness a significant share in the overall therapeutic drug monitoring market over the forecast period. The major market drivers are the increasing incidence rates of chronic disorders and infectious diseases, the rising geriatric population, and the well-developed healthcare infrastructure in the region.
Additionally, according to an article published by the Heart and Stroke Foundation of Canada in February 2022, over 750,000 people in the nation are living with heart failure, and over 100,000 people are diagnosed with a heart condition every year. Such figures are anticipated to propel the market growth over the forecast period in this region.
Key product launches, high concentration of market players or manufacturer's presence, acquisitions & partnerships among significant players, and increasing cases of chronic diseases in the United States are some of the factors driving the growth of the therapeutic drug monitoring market in the country. For instance, in May 2022, Bamboo Health, formerly Appriss Health and PatientPing, announced a partnership with the Wyoming Board of Pharmacy on June 29 to develop a solution for its Prescription Drug Monitoring Program (PDMP).
Therefore, owing to the aforesaid factors, the growth of the studied market is anticipated in the North American region.
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Therapeutic Drug Monitoring Industry Overview
The therapeutic drug monitoring market is moderately competitive and consists of several major players. Some companies are expanding their market position by adopting various strategies, such as acquisitions and mergers, while others are developing new techniques for treating multiple disease indications and introducing new products to maintain their market share. The competitive landscape includes an analysis of a few international and local companies that hold market shares and are well known, including F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Danaher Corporation (Beckman Coulter Inc.), and Siemens Healthcare GmbH, among others.
Therapeutic Drug Monitoring Market Leaders
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Thermo Fisher Scientific
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Bio-Rad Laboratories
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F. Hoffmann-La Roche Ltd
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Danaher Corporation (Beckman Coulter, Inc.)
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Siemens Healthcare GmbH
- *Disclaimer: Major Players sorted in no particular order
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Therapeutic Drug Monitoring Market News
- March 2022: Biognosys launched its expanded suite of proteomics platforms that provide pharmaceutical and diagnostics customers with deep biological insights across the entire R&D pipeline, from early-stage discovery to clinical settings.
- January 2022: Seer launched a next-generation proteomics research platform. The system can be used for categorizing the tens of thousands of proteins within the human body that drive the biological functions of both life and disease.
Therapeutic Drug Monitoring Industry Segmentation
Therapeutic drug monitoring is the clinical practice of measuring the concentration of specific drugs with a narrow therapeutic index and/or their breakdown products (metabolites) at timed intervals in a patient's bloodstream. These systems help to maintain a relatively constant concentration of the drug in the blood required to show therapeutic effects and, thus, assist in assessing individual dosage regimens.
Therapeutic Drug Monitoring Market is Segmented by Technology (Immunoassays and Proteomic Technologies), Drug Class (Antiarrhythmic Drugs, Immunosuppressants, Antiepileptic Drugs, and Other Drug Classes), End-user (Hospitals, Diagnostic Centers, and Other End-users), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across significant global regions. The report offers the value (in USD million) for the above segments.
| By Technology | Immunoassays | ||
| Proteomic Technologies | |||
| By Drug Class | Antiarrhythmic Drugs | ||
| Immunosuppressants | |||
| Antiepileptic Drugs | |||
| Other Drug Classes | |||
| By End-user | Hospitals | ||
| Diagnostic Centres | |||
| Other End-users | |||
| By Geography | North America | United states | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Therapeutic Drug Monitoring Market Research FAQs
How big is the Therapeutic Drug Monitoring Market?
The Therapeutic Drug Monitoring Market size is expected to reach USD 1.36 billion in 2025 and grow at a CAGR of 9.12% to reach USD 2.11 billion by 2030.
What is the current Therapeutic Drug Monitoring Market size?
In 2025, the Therapeutic Drug Monitoring Market size is expected to reach USD 1.36 billion.
Who are the key players in Therapeutic Drug Monitoring Market?
Thermo Fisher Scientific, Bio-Rad Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corporation (Beckman Coulter, Inc.) and Siemens Healthcare GmbH are the major companies operating in the Therapeutic Drug Monitoring Market.
Which is the fastest growing region in Therapeutic Drug Monitoring Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Therapeutic Drug Monitoring Market?
In 2025, the North America accounts for the largest market share in Therapeutic Drug Monitoring Market.
What years does this Therapeutic Drug Monitoring Market cover, and what was the market size in 2024?
In 2024, the Therapeutic Drug Monitoring Market size was estimated at USD 1.24 billion. The report covers the Therapeutic Drug Monitoring Market historical market size for years: 2021, 2022, 2023 and 2024. The report also forecasts the Therapeutic Drug Monitoring Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Therapeutic Drug Monitoring Industry Report
The Therapeutic Drug Monitoring Market is a rapidly evolving field, segmented by various technologies such as immunoassays and proteomic technologies. This market encompasses a wide range of drug classes, including antiarrhythmic drugs, immunosuppressants, and antiepileptic drugs, among others. The end-users of these technologies primarily include hospitals and diagnostic centers, with other end-users also contributing to the market dynamics.
The market forecast indicates a significant growth rate, driven by advancements in industry research and the increasing adoption of therapeutic drug monitoring in clinical settings. The industry outlook remains positive, with market leaders continuously innovating to improve the accuracy and efficiency of drug monitoring techniques. Industry reports highlight the growing market size and the expanding market value, which are key indicators of the market's robust health.
Market segmentation is crucial for understanding the diverse applications and regional variations within the therapeutic drug monitoring market. North America, Europe, Asia-Pacific, the Middle East, Africa, and South America each present unique opportunities and challenges, contributing to the overall market trends. Industry statistics and market data provide valuable insights into these regional differences, helping stakeholders make informed decisions.
The market analysis reveals that the integration of advanced technologies and the rising demand for personalized medicine are significant drivers of market growth. The industry review underscores the importance of continuous market research to stay abreast of the latest market trends and predictions. This comprehensive market overview serves as an essential resource for understanding the current state and future potential of the therapeutic drug monitoring market.
For a detailed examination of the market, including historical data and future projections, refer to the industry reports and market forecast documents. These resources offer in-depth industry information, including market leaders, industry sales, and market growth patterns. The report example and report PDF provide a snapshot of the extensive research conducted by leading research companies, ensuring that stakeholders have access to the most reliable and up-to-date market information.
