The North America therapeutic drug monitoring market was valued for $885.29 million in 2023 and is estimated to reach$2.06 billion by 2035, exhibiting a CAGR of 7.30% from 2024 to 2035.
Therapeutic drug monitoring (TDM) is a clinical practice aimed at optimizing medication dosing and ensuring safe and effective therapy. It involves measuring drug concentrations in a patient's blood or other bodily fluids at specific intervals to maintain drug levels within a therapeutic range. By monitoring drug levels, healthcare providers can adjust dosage regimens to achieve the desired therapeutic effect while minimizing the risk of adverse effects or toxicity. TDM is commonly used for drugs with a narrow therapeutic index, where small changes in concentration can lead to significant clinical outcomes, or for medications with unpredictable pharmacokinetics or potential for drug-drug interactions.
The major factors that drive the growth of the North America therapeutic drug monitoring market include rise in prevalence of chronic diseases and complex medical conditions that contribute to the demand for TDM products. Chronic conditions such as cardiovascular diseases, diabetes, cancer, and psychiatric disorders often require long-term medication management, making precise dosing and therapeutic monitoring essential for patient safety and treatment efficacy. For instance, according to American Psychiatric Association in 2022, nearly one in five (19%) U.S. adults experiences some form of mental illness. Thus, rise in prevalence of chronic conditions led to increased medication use, necessitating complex treatment regimens, addressing drug resistance and treatment failure, supporting personalized medicine initiatives, and minimizing adverse effects, which drives the market growth.
In addition, advancements in analytical techniques and laboratory technologies have enhanced the accuracy and efficiency of TDM assays, making them more accessible and cost-effective for healthcare providers, which is expected to drive the market growth. Availability of automated platforms, rapid turnaround times, and improved sensitivity of drug assays enable timely monitoring of drug levels and adjustment of treatment regimens as needed.
However, technical errors in sample collection and stringent regulatory process requirements and approval processes for new monitoring assays can limit the adoption of therapeutic drug monitoring products, which, in turn, hinders the growth of the market. On the other hand, increase in focus on R&D activities for therapeutic drug monitoring and rise in technological advancements are expected to create immense opportunities for the growth of the North America therapeutic drug monitoring market during the forecast period.
The North America therapeutic drug monitoring market is categorized 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.
The major companies profiled in the report include 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. Key players operating in the market have adopted expansion as their key strategy to expand their product portfolio
Therapeutic drug monitoring (TDM) is a clinical practice aimed at optimizing medication dosing and ensuring safe and effective therapy. It involves measuring drug concentrations in a patient's blood or other bodily fluids at specific intervals to maintain drug levels within a therapeutic range. By monitoring drug levels, healthcare providers can adjust dosage regimens to achieve the desired therapeutic effect while minimizing the risk of adverse effects or toxicity. TDM is commonly used for drugs with a narrow therapeutic index, where small changes in concentration can lead to significant clinical outcomes, or for medications with unpredictable pharmacokinetics or potential for drug-drug interactions.
The major factors that drive the growth of the North America therapeutic drug monitoring market include rise in prevalence of chronic diseases and complex medical conditions that contribute to the demand for TDM products. Chronic conditions such as cardiovascular diseases, diabetes, cancer, and psychiatric disorders often require long-term medication management, making precise dosing and therapeutic monitoring essential for patient safety and treatment efficacy. For instance, according to American Psychiatric Association in 2022, nearly one in five (19%) U.S. adults experiences some form of mental illness. Thus, rise in prevalence of chronic conditions led to increased medication use, necessitating complex treatment regimens, addressing drug resistance and treatment failure, supporting personalized medicine initiatives, and minimizing adverse effects, which drives the market growth.
In addition, advancements in analytical techniques and laboratory technologies have enhanced the accuracy and efficiency of TDM assays, making them more accessible and cost-effective for healthcare providers, which is expected to drive the market growth. Availability of automated platforms, rapid turnaround times, and improved sensitivity of drug assays enable timely monitoring of drug levels and adjustment of treatment regimens as needed.
However, technical errors in sample collection and stringent regulatory process requirements and approval processes for new monitoring assays can limit the adoption of therapeutic drug monitoring products, which, in turn, hinders the growth of the market. On the other hand, increase in focus on R&D activities for therapeutic drug monitoring and rise in technological advancements are expected to create immense opportunities for the growth of the North America therapeutic drug monitoring market during the forecast period.
The North America therapeutic drug monitoring market is categorized 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.
The major companies profiled in the report include 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. Key players operating in the market have adopted expansion as their key strategy to expand their product portfolio
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Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: NORTH AMERICA THERAPEUTIC DRUG MONITORING MARKET, BY TECHNOLOGY
CHAPTER 5: NORTH AMERICA THERAPEUTIC DRUG MONITORING MARKET, BY PRODUCT
CHAPTER 6: NORTH AMERICA THERAPEUTIC DRUG MONITORING MARKET, BY DRUG CLASS
CHAPTER 7: NORTH AMERICA THERAPEUTIC DRUG MONITORING MARKET, BY END USER
CHAPTER 8: THERAPEUTIC DRUG MONITORING MARKET, BY REGION
CHAPTER 9: COMPETITIVE LANDSCAPE
CHAPTER 10: COMPANY PROFILES
