Therapeutic Drug Monitoring Market Assessment, By Product [Equipment, Consumables], By Technology [Immunoassays, Chromatography-Mass Spectrometry, Electrophoresis, Proteomic Technology, Others], By Drug Class [Antiepileptic Drugs, Antiarrhythmic Drugs, Im

Therapeutic Drug Monitoring Market Assessment, By Product [Equipment, Consumables], By Technology [Immunoassays, Chromatography-Mass Spectrometry, Electrophoresis, Proteomic Technology, Others], By Drug Class [Antiepileptic Drugs, Antiarrhythmic Drugs, Immunosuppressant Drugs, Antibiotic Drugs, Psychoactive Drugs, Bronchodilator Drugs, Others], By End-user [Hospitals, Diagnostic Laboratories, Research and Academic Institutes], By Region, Opportunities and Forecast, 2017-2031F

Global therapeutic drug monitoring market is projected to witness a CAGR of 9.56% during the forecast period 2024-2031F, growing from USD 1.77 billion in 2023 to USD 3.67 billion in 2031F. The market’s growth is augmented by the expansion of the healthcare sector, increasing requirement for personalized medication regime, and growing prevalence of chronic diseases.

The growing prevalence of various chronic diseases, such as cancer, across the globe is one of the major factors supporting the market’s expansion as therapeutic drug monitoring helps in optimizing drug efficacy, assessing toxicity, and monitoring compliance with treatment regimen. According to the estimates of the American Cancer Society, 2,001,140 new cases of cancer and 611,720 related deaths are expected to occur in the United States in 2024.

Additionally, increasing investments by various companies towards the expansion of their intellectual property portfolio is bolstering the global therapeutic drug monitoring market size. In October 2023, ProciseDx Inc. announced that they had purchased two US patents from W. Health LP. The two patents, US Patent No. 11,085,931 and US Patent No. 11,119,096 coupled with the existing intellectual property of the company, expected to allow them in expanding their footprint in the therapeutic drug monitoring of biological drugs sector. The monitoring of biologics aids healthcare professionals in optimizing the care provided to patients suffering from inflammatory bowel disease (IBD) by providing personalized dosing of biologics. The investment is expected to aid the company in expanding their portfolio and offer monitoring solutions to a wider range of customers.

Meanwhile, novel products launched by various companies is one of the major global therapeutic drug monitoring market trends. In December 2023, lifespin GmbH launched their therapeutic drug monitoring software that will aid the laboratories to use algorithms for receiving antibiotic measurements of the patients. The company’s product utilizes nuclear magnetic resonance (NMR) for testing antibiotics that are commonly used, such as Ceftriaxon, Cefuroxim, and Ceftazidim. The test rollout will happen with the help of the company’s cloud system and the laboratories that will be in possession of the necessary hardware will be able to deploy the company’s algorithm.

Increasing Organ Transplantation Boosts Market Demand

The rising requirement for organ transplantation due to the increasing prevalence of different chronic conditions such as cystic fibrosis, cancer, and acute and chronic hepatitis, among others is bolstering the global therapeutic drug monitoring market demand. According to the estimates of the Organ Procurement and Transplantation Network (OPTN), approximately 46,632 organ transplants were performed in 2023 from both deceased and living donors, representing an 8.7% increase from 2022 and 12.7% increase from 2021. The increase is propelling the global therapeutic drug monitoring market demand as various immunosuppressive medications are provided to the patient at different times to prevent the rejection of the transplanted organ by the recipient’s body. To ensure that these medications are provided to the patient in a balance, therapeutic drug monitoring is deployed. One of the most common immunosuppressive agents, Tacrolimus is administered in both outpatient and inpatient settings in cases of solid organ transplant as a key immunosuppressive agent. Such agents require monitoring as it is essential to ensure that the serum levels of the patient remain stable over the course of treatment.

Increasing Investments Support Market Expansion

The growth of the market is supported by the rise in investments towards therapeutic drug monitoring platforms. In September 2023, Ghent University and Imec spin-offs, Axithra secured USD 10.7 million (EUR 10 million) in seed funding for developing a therapeutic drug monitoring platform that is able to measure the drug concentration in blood in an accurate and time efficient manner. Initially, Axithra is expected to deploy their technology for measuring beta-lactam antibiotic concentration in the blood of the patients. The class of antibiotics is administered to millions of patients every year that are in intensive care for prevent and treat bacterial infections. The therapeutic drug monitoring platform offered by Axithra will allow for tailored treatments for individual patients. The technology draws company’s expertise in photonic wafer processing, in the field of silicon nitride in particular. The prototype is expected to be released in 2025. Such investments are expected to provide lucrative growth opportunities for the market as they allow the development of advanced technologies.

North America Holds a Significant Market Share

The growth of the market in North America is propelled by the presence of a well-established healthcare sector, expansion of geriatric population, increasing provision of approvals from different regulatory bodies in the region, and rising prevalence of infectious and chronic diseases. In May 2024, Saladax Biomedical, Inc., a leading biotechnology research company known for marketing, manufacturing, and developing assays responsible for providing rapid therapeutic drug levels for medicines, received approval from Health Canada for 5-Fluorouracil (5-FU) therapeutic drug monitoring (TDM) test. The 5-FU TDM test, known as My5-FU Assay aims to ensure accurate drug dosage to reduce toxicity and improve efficacy, thus optimizing patient care. The traditional dosing methods for 5-FU, that are body surface area (BSA) based are not known to account for individual patient difference. Saladax’s assay allows healthcare professionals to adjust and measure 5-FU levels during a chemotherapy cycle, with the help of a single blood sample. Such approvals are expected to provide lucrative growth opportunities to the market in North America in the forecast period.

Antiepileptic Drugs Account for a Significant Market Share

The increase in the number of cases of epilepsy across the globe is propelling the segment’s expansion by bolstering the requirement for antiepileptic drugs. According to the estimates of the World Health Organization (WHO), approximately 50 million individuals across the globe suffer from epilepsy. The optimal implementation of therapeutic drug monitoring can aid in enhancing clinical care for antiepileptic drugs with complex pharmacokinetics and complement clinical decision making in the management of the condition.

Meanwhile, immunosuppressant drugs are expected to witness significant growth in the coming years due to the rising requirement of organ transplant and increase in the number of cases of autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. According to the estimates of WHO, in 2023, over 1.8 million individuals suffered from multiple sclerosis, globally.

Future Market Scenario (2024 – 2031F)

Therapeutic drug monitoring technologies are expected to aid in optimizing personalized dosing and determining the clinical efficacy of drugs in patients, thus enabling precision medicine strategies. The rapid evolutions in nanomaterials coupled with preparation and manufacturing of optical and electrochemical biosensors along with their integration in wearables is expected to provide several advantages in therapeutic drug monitoring. Therapeutic drug monitoring analyses are expected to shed light on determining the correct method of prescribing drugs to improve clinical outcomes. Due to costly nature of therapeutic drug monitoring, the sector is expected to benefit through investments from therapeutic developers and organizations. The integration of therapeutic drug monitoring in precision medicine has the potential to improve patient outcomes. The requirement for therapeutic drug monitoring is expected to propel due to the rising prevalence of autoimmune diseases, epilepsy, cardiovascular diseases, fungal infections, bacterial infections, and psychiatric diseases.

Key Players Landscape and Outlook

Strategic collaborations by key market players are expected to bolster the global therapeutic drug monitoring market growth. In July 2021, Thermo Fisher Scientific Inc. announced partnership with Mindray to develop reliable biochemistry solutions for testing drug abuse. The two chemistry analyzers will be available for drug screening in court and clinical laboratories in Canada and the United States. With its partnership, the companies aim to address the requirements of their customers in criminal justice, hospitals, and commercial settings. To provide access to drug testing, both companies have entered in an agreement to offer the Health Canada–approved and FDA-cleared BA-800M (800 tests/hour) and BS-480 (400 tests/hour) analyzers to toxicology laboratories. Such partnerships are expected to aid the market players in strengthening their position and expanding their customer base.