North America Therapeutic Drug Monitoring Market, by Technology (Immunoassays, Chromatography Spectrometry, and Others), Product (Consumables and Equipment), Drug Class, (Antiepileptic Drugs, Antiarrhythmic Drugs, Immunosuppressant Drugs, Antibiotic Drugs, Antipsychotics, and Others), and End User, (Hospitals, Diagnostic Labs, and Research & Academic Institutes): Global Opportunity Analysis and Industry Forecast, 2024 -2035

North America Therapeutic Drug Monitoring Market Research, 2035

The global North America therapeutic drug monitoring market size was valued at $0.9 billion in 2023 and is projected to reach $2.1 billion by 2035, registering a CAGR of 7.3% from 2024 to 2035.

The growth of the North America therapeutic drug monitoring market is driven by rise in prevalence of chronic diseases. For instance, Centers for Disease Control and Prevention (CDC) estimated that around 129 million people in the U.S. had at least 1 major chronic disease. In addition, Canadian Diabetes Association estimated that around 5,883,000 people were affected with diabetes in 2023 and the number is estimated to reach 7,417,000 in 2033 in Canada.

Therapeutic drug monitoring (TDM) is a clinical practice that involves the measurement of drug concentrations in a patient's bloodstream at specific intervals. TDM ensures that drug levels remain within a targeted therapeutic range, optimizing treatment efficacy while minimizing the risk of adverse effects. Therapeutic drug monitoring is particularly important for drugs with a narrow therapeutic index, where small changes in drug concentration can result in significant clinical effects. The process involves collecting blood samples from patients at various time points after medication administration.

Key Takeaways

• By technology, the immunoassays segment dominated the market in terms of revenue in 2023.
• By product, the consumables segment dominated the market in terms of revenue in 2023 and is expected to grow at the fastest CAGR during the forecast period.
• By drug class, the antiepileptic drugs segment dominated the market in terms of revenue in 2023. 
• By end user, the hospitals segment dominated the market in terms of revenue in 2023 and is expected to grow at the fastest CAGR during the forecast period. 
• By country, the U.S. dominated the market in terms of revenue in 2023. However, Mexico is anticipated to grow at the highest CAGR during the forecast period.

Market Dynamics

The North America therapeutic drug monitoring market trends such as rise in technological advancements in TDM methodologies have significantly impacted the market growth. The integration of novel technologies, such as immunoassays, chromatography, and mass spectrometry, has enhanced the precision and accuracy of drug level monitoring. These technological advancements have enabled healthcare professionals to achieve more precise therapeutic outcomes, thus driving the market growth. The increase in geriatric population in North America is also driving the growth of the therapeutic drug monitoring market. Elderly individuals often have multiple comorbidities and are more susceptible to adverse drug reactions. Therapeutic drug monitoring helps healthcare providers optimize drug therapy for elderly patients, thereby improving treatment outcomes and reducing the risk of adverse effects. As the geriatric population continues to grow, the demand for therapeutic drug monitoring is expected to increase, thus driving the market growth in North America.

In addition, rise in prevalence of chronic diseases, including cardiovascular diseases, neurological disorders, and autoimmune diseases, has boosted the demand for therapeutic drug monitoring. As the population ages, the incidence of chronic diseases increases, necessitating the use of TDM to optimize treatment outcomes. Moreover, the rise in demand for personalized medicine and individualized treatment regimens has further propelled the adoption of therapeutic drug monitoring techniques. Further, increase in adoption of TDM in the field of psychiatry and mental health has significantly contributed to the market growth. With rise in incidence of psychiatric disorders, such as depression, schizophrenia, and bipolar disorder, there is a growing need to monitor drug levels to ensure optimal therapeutic outcomes and prevent adverse effects.

Furthermore, the expanding applications of TDM beyond traditional drug classes to include immunosuppressants, antibiotics, and anti-epileptic drugs have broadened the market scope. This expansion has created new opportunities for market players to innovate and develop advanced TDM solutions. Additionally, supportive government initiatives, favorable reimbursement policies, and the presence of well-established healthcare infrastructure in North America have also fueled the market growth. These factors have encouraged the adoption of therapeutic drug monitoring, thereby driving the expansion of the market in the region.

Moreover, the growing adoption of personalized medicine is another significant driving factor for the North American therapeutic drug monitoring market. Personalized medicine aims to tailor medical treatment to the individual characteristics of each patient, including their genetic makeup, lifestyle, and environment. Therapeutic drug monitoring plays a crucial role in personalized medicine by optimizing drug dosages according to the specific needs of each patient. By monitoring drug concentrations in the blood or plasma, healthcare providers can adjust medication doses to achieve the desired therapeutic outcomes while minimizing the risk of adverse effects. The increasing focus on personalized medicine is expected to drive the demand for therapeutic drug monitoring in North America.

However, the cost associated with implementing therapeutic drug monitoring (TDM) services, including the purchase of equipment, consumables, and training of staff, is expected to be prohibitive. This high initial investment may deter some healthcare providers from adopting TDM, especially in smaller clinics and healthcare facilities, which is expected to restrain the market growth. However, the integration of therapeutic drug monitoring into routine clinical practice is driving market growth in North America. Healthcare providers are increasingly incorporating TDM into their treatment protocols to optimize drug therapy for better patient outcomes. The availability of TDM services in hospitals, clinics, and other healthcare facilities is expanding, making drug monitoring more accessible to patients. The seamless integration of TDM into clinical practice is expected to drive the market growth in North America.

Rise in drug development activities in North America is driving the growth of the North America therapeutic drug monitoring market. Pharmaceutical companies are investing heavily in R&D to bring new drugs to the market. Therapeutic drug monitoring plays a crucial role in the clinical development of drugs by providing valuable data on drug concentrations, pharmacokinetics, and pharmacodynamics. Drug developers use this data to optimize dosing regimens, assess drug efficacy, and ensure patient safety. The growing focus on precision medicine and the development of targeted therapies are expected to further boost the demand for therapeutic drug monitoring in North America. Further, high healthcare expenditure in North America contributes to the growth of the therapeutic drug monitoring market. Governments and private organizations are investing heavily in healthcare infrastructure, research, and development. The availability of funds for healthcare initiatives, including TDM, is expected to drive the market growth in the region. In addition, the expansion of healthcare insurance coverage and reimbursement policies for TDM services is expected to fuel the market growth in North America.

Segmental Overview

The North America therapeutic drug monitoring market analysis is segmented into technology, product, drug class, end user, and country. On the basis of technology, it is segmented into immunoassays, chromatography spectrometry, and others. On the basis of product, the market is bifurcated into consumables and equipment. On the basis of drug class, it is segmented into antiepileptic drugs, antiarrhythmic drugs, immunosuppressant drugs, antibiotic drugs, antipsychotics, and others. On the basis of end user, the market is classified into hospitals, diagnostic labs, and research & academic institutes. Country-wise, the market is studied across the U.S., Canada, and Mexico.

By Technology

The immunoassays segment held the largest North America therapeutic drug monitoring market share in 2023 and is expected to register the highest CAGR during the forecast period, owing to high sensitivity and specificity of immunoassay techniques, the rise in prevalence of chronic diseases, expanding applications, ongoing technological advancements, and supportive government initiatives.

By Product

The consumables segment held the largest North America therapeutic drug monitoring market share in 2023 and is expected to register the highest CAGR during the forecast period, owing to increase in prevalence of chronic diseases and expanding applications of consumables in therapeutic drug monitoring.

By Drug Class

The antiepileptic drugs segment held the largest North America therapeutic drug monitoring market share in 2023 and is expected to register the highest CAGR during the forecast period, owing to increase in prevalence of epilepsy and rise in adoption of antiepileptic drugs (AEDs). Epilepsy is a chronic neurological disorder, and AEDs are the primary treatment option. The need for regular monitoring of AED levels to optimize treatment outcomes and minimize adverse effects is driving the demand for TDM services in North America.

By End User

The hospital segment held the largest North America therapeutic drug monitoring market share in 2023 and is expected to register the highest CAGR during the forecast period, as hospitals have the infrastructure, resources, and expertise required to perform therapeutic drug monitoring effectively. They have well-equipped laboratories and highly skilled healthcare professionals who can conduct TDM tests and interpret the results accurately. Rise in adoption of personalized medicine and individualized treatment regimens in hospitals has further support the segment growth.

By Country

The North America therapeutic drug monitoring market is analyzed across the U.S. Canada and Mexico. The U.S. accounted for a major share of the North America therapeutic drug monitoring market in 2023 and is expected to maintain its dominance during the forecast period. This is attributed to the advanced healthcare infrastructure and well-established regulatory framework that have facilitated the widespread adoption of therapeutic drug monitoring. Availability of skilled healthcare professionals, state-of-the-art medical facilities, and advanced technologies has contributed to the dominance of North America in the therapeutic drug monitoring market.

Mexico offers profitable opportunities for key players operating in the North America therapeutic drug monitoring market, thereby registering the fastest growth rate during the forecast period, owing to increase in prevalence of chronic diseases in Mexico. Rise in incidence of cardiovascular diseases, neurological disorders, autoimmune diseases, and other chronic conditions has necessitated the use of TDM to optimize treatment outcomes. As the population in Asia-Pacific continues to age, the burden of chronic diseases is expected to increase, further driving the demand for TDM.

Competition Analysis

Competitive analysis and profiles of the major players in the North America therapeutic drug monitoring market, such as F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc, Bio-Rad Laboratories, Inc, Siemens, Danaher Corporation, Exagen Inc, Agilent Technologies, Waters Corporation, and SEKISUI CHEMICAL CO., LTD are provided in this report. Major key players have adopted expansion as a key developmental strategy to improve the product portfolio of the North America therapeutic drug monitoring market.

Recent Developments in North America Therapeutic Drug Monitoring Industry

• In November 2022, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostic products, announced an expanded portfolio of independent quality controls (QC) products, now including InteliQ and Liquichek compact vials, for the Abbott Alinity ci-series integrated clinical chemistry and immunoassay testing instruments.

  North America Therapeutic Drug Monitoring Market, by Technology Report Highlights