Therapeutic Drug Monitoring Market

Market Overview

The global therapeutic drug monitoring market size was valued at USD 2.0 billion in 2023 and is projected to reach a value of USD 5.0 billion by 2032, registering a CAGR of 10.2% during the forecast period (2024-2032). The therapeutic drug monitoring market share is predicted to grow as organ transplant surgeries increase.

Therapeutic Drug Monitoring (TDM) is a clinical procedure that involves determining drug concentrations in a patient's blood or other biological fluids to optimize drug dose and assure therapeutic efficacy while minimizing side effects. TDM is especially critical for medicines with short therapeutic windows, unpredictable pharmacokinetics, or high interpatient variability in drug metabolism.

The therapeutic drug monitoring market is expanding due to the rising prevalence of chronic diseases, increased awareness of therapeutic drug monitoring, and increased demand for therapeutic drug monitoring services in emerging economies. The increasing frequency of chronic diseases such as cardiovascular disease, cancer, and neurological disorders, which necessitate long-term treatment with medications with a limited therapeutic window, is driving demand for therapeutic drug monitoring services. 

However, more competent experts are needed to ensure the expansion of the therapeutic drug monitoring market by limiting the availability of certified staff to run tests and interpret data. This can lead to diagnostic and treatment delays, increased drug mistakes, and poor patient outcomes. Furthermore, a shortage of trained individuals may result in limited access to cutting-edge technology required for successful test execution. Thus, more educated specialists may be needed to reduce the demand for therapeutic drug monitoring services since fewer people can afford the tests or obtain the results. These significant issues may impede the therapeutic drug monitoring market's growth in the coming years.

Highlights

• Immunoassays led the market based on technology.
• Consumables are a significant contributor to the market by product.
• Antiepileptic generates the highest revenue share by drug class.
• Hospitals dominate the market by end-users.

Market Dynamics

Global Therapeutic Drug Monitoring Market Drivers

Increasing Prevalence of Chronic Diseases

The increasing prevalence of chronic ailments such as cardiovascular disease, diabetes, cancer, autoimmune disorders, and infectious diseases demands long-term medication. TDM is crucial in optimizing drug dose and guaranteeing therapeutic efficacy while reducing side effects, particularly for drugs used in the treatment of chronic disorders. According to the International Diabetes Federation (IDF), diabetes affects 10.5% of individuals aged 20 to 79, or over 537 million people globally. According to the IDF Diabetes Atlas, a repository for global diabetes statistics, 46% of people with diabetes are unaware of their condition. Diabetes requires lifelong management, which frequently includes many medications to regulate blood glucose levels and prevent consequences like cardiovascular disease, neuropathy, and blindness. TDM is needed in diabetes care for medications such as insulin and oral hypoglycemic agents to ensure accurate dosing, limit the risk of hypoglycemia, and maintain glycemic control.

According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the leading cause of death worldwide, accounting for an estimated 17.9 million deaths each year. In 2021, CVD killed 20.5 million people, accounting for over a third of all deaths worldwide. This represents a 60% increase from the 12.1 million deaths from CVDs in 1990. TDM is useful in CVD care for medications such as anticoagulants (e.g., warfarin), antiplatelet agents (e.g., clopidogrel), and lipid-lowering agents (e.g., statins) because it ensures therapeutic efficacy, reduces bleeding or thrombotic events, and improves cardiovascular outcomes.

As a result, TDM plays a vital role in chronic illness management by assuring customized dosage regimens, increasing therapeutic efficacy, minimizing treatment-related hazards, and improving medication safety, adherence, and quality of care across varied patient groups. 

Global Therapeutic Drug Monitoring Market Restraints

Limited Reimbursement Policies

Limited or uneven reimbursement rules for TDM services and assays might stymie market expansion and adoption by putting financial obstacles between healthcare providers and patients. With proper reimbursement, healthcare institutions may be able to engage in TDM infrastructure, implement TDM procedures, or provide TDM services, especially when TDM is viewed as a cost burden rather than a value-added service. In the United States, funding for TDM services varies by payer, including Medicare, Medicaid, private insurance companies, and managed care organizations. While certain insurers may offer partial reimbursement for TDM assays in certain circumstances or as part of bundled payment arrangements, coverage criteria, coding requirements, and reimbursement rates may vary, resulting in inconsistencies in reimbursement for TDM-related expenses.

According to an American Society for Clinical Pharmacology and Therapeutics (ASCPT) survey, approximately 40% of clinical pharmacologists and pharmacometricians reported reimbursement challenges for TDM services and assays, such as low reimbursement rates, coverage denials, and administrative burdens related to billing and documentation requirements.

Thus, limited payment for TDM services may limit patient access to TDM testing, especially for uninsured or underinsured patients who may incur out-of-pocket expenses or coverage denials for TDM assays. Inadequate remuneration may encourage healthcare providers to provide TDM services or invest in TDM infrastructure, reducing the availability of TDM testing and expertise in specific healthcare settings or geographic regions.

Global Therapeutic Drug Monitoring Market Opportunity

Expansion of Point of Care Testing

Using point-of-care testing (POCT) technologies in TDM allows one to decentralize testing, shorten turnaround times, and increase patient access to TDM services. Patients using warfarin anticoagulation therapy must have their international normalized ratio (INR) levels monitored often to ensure therapeutic anticoagulation and reduce the risk of bleeding or thrombosis.

Traditionally, INR testing was done in centralized laboratories using venous blood samples, which caused delays in receiving findings and making medication adjustments. With the introduction of POCT devices such as handheld coagulometers, patients can now perform INR testing at home with a fingerstick blood sample, allowing for real-time monitoring, immediate dose modifications, and increased patient engagement in self-management of anticoagulant medication.

As a result, POCT allows for decentralized testing and brings TDM services closer to patients, improving access to timely monitoring and tailored dose adjustments, especially in underserved or distant areas with limited access to centralized laboratories. The growth of point-of-care testing (POCT) for Therapeutic Drug Monitoring (TDM) presents a huge opportunity to alter healthcare service delivery, improve patient-centered care, and drive personalized medicine innovation. POCT technology can help players in the TDM ecosystem overcome access constraints, improve clinical outcomes, and capitalize on market development potential in various healthcare settings and patient demographics.

Regional Analysis

The global therapeutic drug monitoring market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global therapeutic drug monitoring market shareholder and is estimated to grow at a CAGR of 9.6% over the forecast period. The North American therapeutic drug monitoring market produced over half of global revenue. The rising prevalence of organ transplantation and the widespread acceptance and gradual use of these metabolite measurement methodologies are primary drivers of the significant market share. The United States contributes the most revenue to the regional market. The country has essential industry participants, a growing need for innovative technology and tailored pharmaceuticals, and an increase in private labs.

Furthermore, by 2023, more than 750,000 Canadians will be living with heart failure, with over 106,000 new cases diagnosed each year. This indicates that one-third of Canadians suffer from heart failure. These estimates will drive market expansion in this region over the next several years. Some factors driving the growth of the therapeutic drug monitoring market in the United States include key product launches, a high concentration of market players or manufacturer presence, acquisitions and partnerships among significant players, and an increase in chronic diseases. For example, on June 29, 2022, Bamboo Health, previously Appriss Health and PatientPing, announced a collaboration with the Wyoming Board of Pharmacy to build a solution for their Prescription Drug Monitoring Program (PDMP). 

Asia-Pacific is anticipated to exhibit a CAGR of 10.5% over the forecast period. The region's growth can be attributed to factors such as a large patient population, economic development in China, India, Japan, and South Korea, rising consumer spending and per capita income, increased government and private market participation, advancements in drug profiling, system engineering, and automation, and an increase in hospital and medical care institutions. China, Japan, India, and South Korea account for the majority of income in the regional market. This is due to increased knowledge of drug monitoring during surgical procedures, a growing older population with chronic illnesses, expanding healthcare infrastructure, and increased R&D spending by corporations seeking cost-effective monitoring systems. 

The European region generates significant revenue for the business. The region's healthcare sector is growing due to increased manufacturing of modern healthcare devices, increased spending on healthcare services, and government investment.

Segmental Analysis

The global therapeutic drug monitoring market is segmented based on technology, drug class, product, and end-users.

The market is further segmented by technology into Immunoassays and chromatography-spectrometry.

The Immunoassay category led the market in 2023 due to the availability of highly specific and reliable immunoassays, the increasing acceptance rate of new techniques, and the need for minimum training to use the equipment. Immunoassays are an analytical technique used in Therapeutic Drug Monitoring (TDM) to determine the concentration of medicines or metabolites in biological samples such as blood, serum, or urine. Immunoassays identify and quantify target molecules by exploiting particular binding interactions between antigens and antibodies. Common immunoassay formats include ELISA, CLIA, and FIA. Immunoassays have several advantages, including high sensitivity, short assay times, and simplicity of automation, making them ideal for high-throughput TDM testing in clinical laboratories. 

However, immunoassays may have limitations regarding cross-reactivity, assay interference, and the measurement of drug metabolites that share structural similarities with the original substance.

Chromatography-spectrometry techniques, such as liquid chromatography (LC), gas chromatography (GC), and mass spectrometry (MS), are commonly employed in TDM to separate, identify, and quantify pharmaceuticals and their metabolites in complicated biological matrices. Chromatography separates drug molecules based on their physicochemical properties, such as size, polarity, and charge. In contrast, spectrometry detects and quantifies the separated analytes using mass-to-charge ratios (m/z) and fragmentation patterns. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) are widely used in TDM because of their high specificity, selectivity, and sensitivity for drug analysis.

Based on product, the market is fragmented into Consumables and equipment.

The consumables segment accounted for the most significant market share in 2023 and is predicted to increase at the quickest CAGR over the forecast period. Consumables are the disposable components or reagents used in TDM testing methods. These comprise assay kits, reagent cartridges, calibration standards, quality control materials, sample collecting tubes, pipette tips, and other disposable laboratory supplies. Consumables are vital in TDM processes, enabling sample preparation, assay execution, and result interpretation. High-quality consumables assure accuracy, precision, and dependability in TDM testing, which improves the overall performance of TDM assays and laboratory operations. The increasing need for innovative, technology-based, cost-effective kits and the widespread usage of these reagents in R&D drive its profitable expansion.

Equipment refers to the instruments, devices, and systems utilized in TDM laboratories to execute analytical procedures, data analysis, and result reporting. Instruments in this category include LC-MS, GC-MS, immunoassay analyzers, automated pipetting systems, laboratory balances, centrifuges, and other lab equipment. TDM testing relies heavily on equipment to perform sample processing, separation, detection, quantification, and data analysis with high precision, sensitivity, and throughput. Modern technology improves laboratory efficiency, productivity, and capacity for TDM testing, allowing for faster turnaround times, more accurate measurements, and seamless connection with laboratory information systems (LIS) or LIMS.

The market can be further bifurcated by drug class into Antiepileptic, Antiarrhythmic, Immunosuppressant, and Antibiotic Drugs.

The anti-epileptics sector retained the most significant market share in 2023, owing to the rising prevalence of epilepsy and seizures, as well as the explosive growth in the number of antiepileptic medications. Antiepileptic medicines (AEDs) treat epilepsy and seizure disorders by regulating electrical activity in the brain. Phenytoin, carbamazepine, valproic acid, and phenobarbital are among the most widely monitored AEDs. TDM for AEDs is required to keep therapeutic drug concentrations within the therapeutic range, maximizing seizure control while limiting the risk of harm. 

Immunosuppressive drugs are pharmaceuticals that suppress the immune system's activity to prevent organ rejection in transplant recipients and treat autoimmune illnesses. TDM is commonly used to monitor immunosuppressive drugs such as tacrolimus, cyclosporine, sirolimus, and mycophenolic acid. TDM for immunosuppressants is essential for achieving adequate immunosuppression while reducing the risk of rejection and drug-related consequences. The immunosuppressant segment has seen higher penetration; nonetheless, the tiny margin for the therapeutic index of these medications and the inter-individual variability reported in immunosuppressant blood concentrations need TDM for these drugs.

The market is classified into Hospitals, Diagnostic Labs, Research, and Academic Institutes based on end-users.

TDM programs in hospitals are incorporated into clinical workflows to monitor medication concentrations, improve dosage regimens, and assure therapeutic efficacy while reducing the risk of adverse drug responses or toxicity. Hospital TDM testing is often done in centralized clinical laboratories outfitted with specific equipment and staffed by qualified laboratory technicians. Hospital-based TDM services serve a vast spectrum of patient demographics, including inpatients, outpatients, and emergency department patients, as well as therapeutic areas such as cardiology, neurology, oncology, and infectious diseases. 

Additionally, with accurate patient information such as age, metabolism, ethnicity, and drug performance history, hospitals handle more than half of all therapeutic drug monitoring. The need for accurate patient history to develop effective treatment plans has prompted many hospitals to design request forms for drug metabolite monitoring; the increasing use of computerized entry of patient history and information records is expected to improve hospital TDS services even further.

Diagnostic laboratories, which include commercial reference laboratories and independent clinical laboratories, play an essential role in providing TDM testing services to healthcare professionals, patients, and other end users. Diagnostic labs provide diverse TDM tests, leveraging cutting-edge instrumentation, validated techniques, and quality assurance measures to provide accurate and trustworthy outcomes. Diagnostic labs act as outsourcing partners for hospitals, clinics, physician offices, and other healthcare organizations that lack the necessary infrastructure or expertise to conduct TDM testing in-house. By collaborating with diagnostic labs, healthcare providers can access a wide range of TDM tests, shorten turnaround times, and maximize resource use while maintaining high-quality testing and regulatory compliance.

Recent Developments

• April 2024- Roche earned the FDA Breakthrough Device Designation for a blood test to enable earlier Alzheimer's disease diagnosis.
• April 2024- Abbott (NYSE: ABT) received FDA approval for its TriClip™ transcatheter edge-to-edge repair (TEER) device, which is intended to treat tricuspid regurgitation (TR) or a leaking tricuspid valve.
• February 2024- Danaher partnered with Cincinnati Children's Hospital Medical Center to improve patient safety in early drug development.