Wilmington, Delaware, United States, July 20, 2023 (GLOBE NEWSWIRE) -- The global therapeutic drug monitoring assay market was valued at US$ 198.0 Mn in 2021 and is projected to expand at a CAGR of 11.0% from 2022 to 2031.
Most immunosuppressants need therapeutic drug monitoring (TDM) as a guide therapy, and the assays are used to assess concentrations of narrow-therapeutic index drugs in whole blood or plasma. TDM helps in the individualization of drug dosage for solid organ transplant recipients.
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Surge in demand for immunosuppressive drugs after a range of solid organ transplantations is projected to offer significant opportunities for companies in the market. Introduction of point-of-care therapeutic drug monitoring is projected to broaden the market outlook. Additionally, rise in R&D activities in novel biological matrices used in TDM in recent years has fueled the therapeutic drug monitoring assay industry growth.
Key Findings of Study
Increase in Adoption of Advanced TDM Assay Equipment
Based on product, the equipment segment accounted for the leading market share in 2021. The segment is projected to expand at a significant rate during the forecast period. Increase in adoption of advanced clinical chemistry analyzers and immunoassays is expected to bolster the segment. Significant demand for TDM for liver, kidney, and heart transplants presents substantial growth opportunities for companies in the therapeutic drug monitoring assay market.
Rise in Demand for Chromatography Mass Spectrometry
Increase in adoption of novel mass spectrometry techniques in TDM is expected to augment the market size. High-performance liquid chromatography with tandem mass-spectrometry is a widely used technique. Based on technology, the chromatography MS segment is projected to expand at a CAGR of 12.2% during the forecast period.
Significant Usage of Tacrolimus as Immunosuppressive Drugs for Organ Transplantations to Bolster Market Growth
Usage of tacrolimus as a transplant drug is increasing rapidly. In terms of segment, the tacrolimus segment accounted for the leading market share in 2021. Considerable demand for tacrolimus as a liver transplantation treatment is expected to accelerate market growth. Ease of measurement of the tacrolimus concentration, in contrast to several other pharmacodynamic biomarkers, is one of the factors that is increasing preference for TDM of tacrolimus.
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Key Growth Drivers of Therapeutic Drug Monitoring Assay Market
- Rise in incidence of chronic diseases that lead to organ failure is a key driver of the global therapeutic drug monitoring assay market. High global prevalence of chronic renal disease and chronic liver disease is likely to lead to chronic organ failure, which is anticipated to spur demand for global therapeutic drug monitoring assays.
- Significant initiatives by the governments of several countries to promote organ donation and transplantation are expected to strengthen the therapeutic drug monitoring assay market. Governments around the world are launching several programs to encourage organ donation; an instance is the National Organ Transplant Program (NOTP) by the Government of India to promote organ transplantation in the country.
Regional Landscape
North America accounted for the leading share of nearly 35% of the global market in 2021. Significant usage of immunosuppressive therapy is strengthening demand for TDM monitoring assays. Rapid adoption of therapeutic monitoring of immunosuppressive therapy with cyclosporine, tacrolimus, mycophenolic acid, and sirolimus is expected to accelerate market development in the region over the next few years. Rise in the number of kidney and liver transplant procedures in North America is expected to augment market value in the near future.
Europe accounted for the second largest market share in the same year. Asia Pacific trailed Europe by accounting for the third largest share. The market in both regions is projected to expand at a rapid pace, driven by a rise in demand for organ transplants for the treatment of chronic kidney disease. Increase in usage of immunosuppressants among kidney and liver transplant patients is expected to create significant opportunities for market players in these regions.
Competition Landscape
The business landscape is consolidated, with the presence of only a few players accounting for the majority stake in the market. Leading players are introducing novel assays and therapeutic drug monitoring techniques to stay ahead of the competition. For instance, they are focusing on the development of algorithm-based/computer-assisted immunosuppressant dosing technology.
Key companies in the global therapeutic drug monitoring assay market are:
- Abbott
- Thermo Fisher Scientific Inc.
- H.U. Group Holdings, Inc. (Fujirebio Holdings, Inc.)
- Hoffmann-La Roche Ltd.
- Siemens Healthineers AG
- Hologic, Inc.
- Danaher Corporation
- Bio-Rad Laboratories
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Segmentation
The global therapeutic drug monitoring assay market is segmented based on:
Product
- Equipment
- Consumables
- Chromatography & MS Detectors
- Immunoassay Analyzers
- Clinical Chemistry Analyzers
Technology
- Chromatography-MS
- Immunoassays
Drug
- Tacrolimus
- Methotrexate
- Cyclosporin
- Others
End-user
- Hospital Laboratories
- Commercial & Private Laboratories
- Others
Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- Latin America
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