Transplant Drug Monitoring Assay Market Size Trends Growth Value Forecast to 2031

Transplant Drug Monitoring Assay Market Outlook 2031
• The global transplant drug monitoring assay market was valued at US$ 198.0 Mn in 2021
• The global market is projected to advance at a CAGR of 11.0% from 2022 to 2031
• The global transplant drug monitoring assay market is anticipated to reach more than US$ 542 Mn by the end of 2031
Analysts' Viewpoint on Transplant Drug Monitoring Assay Market Scenario
Therapeutic drug monitoring (TDM) of transplant medicine plays a crucial role in helping health care professionals maintain plasma and blood levels of immunosuppressants within their respective therapeutic ranges. TDM ensures that concentrations are not too low or too high, thereby minimizing the risks of rejection or toxicity, respectively. Leading players operating in the healthcare industry offer a full line of Immunosuppressant Drug Monitoring (ISD) assays, such as mycophenolic acid, cyclosporine, everolimus, and tacrolimus, to aid in patient monitoring. Rise in healthcare expenditure, improvement in healthcare infrastructure, increase in global per capita income, and government reimbursement programs are likely to create lucrative opportunities for companies operating in the transplant drug monitoring assay market in the next few years.
Overview of Transplant Drug Monitoring Assay Market
The global transplant drug monitoring assay market is expected to grow at a rapid pace during the forecast period from 2022 to 2031, owing to the increase in need for organ transplantation, surge in R&D funding, and rise in prevalence of chronic liver and kidney diseases. Increase in need for point-of-care therapeutic drug monitoring and home-based therapeutic drug monitoring is likely to create lucrative opportunities for players operating in the global transplant drug monitoring assay market during the forecast period.

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Rise in Geriatric Population and Increase in Incidence of Chronic Diseases to Drive Market
Rise in incidence of chronic diseases of the liver, heart, kidney, and pancreas along with blood disorders such as leukemia and aplastic anemia are driving the demand for organ transplants/replacements. This is expected to boost the global transplant drug monitoring assay market. According to the Health Resources & Services Administration (HRSA), around 40,000+ transplants were performed across the globe in 2021. According to the World Health Organization (WHO), the global geriatric population stood at around 524 million in 2010 and is anticipated to reach 1.5 billion by 2050. The world is aging at a rapid pace, especially in developed countries such as the U.S., Germany, and Japan. For instance, the U.S. Census Bureau stated in 2010 that people older than 65 years represented around 12.4% of the total population in 2000, and the percentage is expected to reach 19% in the U.S. by 2030. Surge in geriatric population directly affects the growth and demand for organ transplants, primarily due to their higher susceptibility to kidney and heart diseases.
Government Support for Organ Donation to Augment Transplant Drug Monitoring Assay Market
The number of organ donors across the globe has been rising due to the initiatives by government organizations. Various government authorities across developed and developing countries support organ donation through awareness programs, financial assistance, and effective schemes and policies. In April 2022, the Government of Canada announced the investment of US$ 2 Mn for research in innovative organ and tissue donation.
In November 2019, the Spanish Ministry of Health, Consumer Affairs and Social Welfare and the World Health Organization (WHO) signed an agreement for fostering cooperation in the field of donation and transplantation of organs, cells, and tissues. This technical agreement will lead to the creation of the Global Observatory on Donation and Transplantation 'GODT', which will collect and manage global data on clinical and regulatory information regarding organ transplants. Thus, government support for organ donation is expected to create significant opportunities in the global transplant drug monitoring assay market.
Field-proven Reliability and Efficiency to Drive Equipment Segment
In terms of product, the global transplant drug monitoring assay market has been bifurcated into equipment and consumables. The equipment segment held major share of the global market in 2021. The segment is projected to grow at a rapid pace during the forecast period. Clinical chemistry analyzers and immunoassay analyzers provide mid-to high-volume laboratories the flexibility to improve efficiencies and economics. With a throughput of excellent onboard parameters, this equipment delivers field-proven reliability and efficiency to laboratories worldwide. Additionally, leading players such as Thermo Scientific are coming up with innovative solutions such as 'QMS Everolimus'. This analyzer carries the CE mark for usage in the European Union for liver transplant drug monitoring.
Growth in Need for Organ Transplantation Globally to Propel Chromatography-MS Segment
Based on technology, the global transplant drug monitoring assay market has been classified into chromatography-MS and immunoassays. Chromatography-MS is a rapidly growing segment of the global transplant drug monitoring assay market. The segment is expected to advance at a CAGR of 12.2% during the forecast period. Growth of the segment can be ascribed to the rise in demand for organ transplantation across the globe. Currently, 121,678 people are waiting for lifesaving organ transplants in the U.S.
FDA Approval as Transplantation Drug to Augment Tacrolimus Segment
Based on drug, the global transplant drug monitoring assay market has been split into tacrolimus, cyclosporin, methotrexate, and others. The tacrolimus segment held major share of the global market in 2021. Recent FDA approval for tacrolimus as a transplantation drug is projected to drive the segment during the forecast period. In July 2021, the U.S. Food and Drug Administration (FDA) approved the usage of the transplant drug tacrolimus for the prevention of organ rejection in pediatric and adult patients receiving lung transplants. Furthermore, nearly 85% of kidney transplant recipients have been prescribed tacrolimus as a maintenance immunosuppressive regimen, primarily due to its higher potency, and lower rejection and nephrotoxicity compared to cyclosporine.

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Provision of Transplant Drug Monitoring Services to Drive Hospital Laboratories Segment
Based on end-user, the global transplant drug monitoring assay market has been divided into hospital laboratories, commercial & private laboratories, and others. The hospital laboratories segment held prominent share of the global market in 2021. The segment is likely to expand at the fastest CAGR during the forecast period. TDM assays are increasingly provided in hospitals and ambulatory surgical centers with multiple medical specialties. These services are managed entirely by hospital pharmacists. Hence, these pharmacists assume a crucial role in ensuring the optimal use of TDM assays. Additionally, rise in number of government and private hospital laboratories in emerging economies, such as China and India, and increase in incidence of cardiovascular and chronic liver diseases are driving the segment. Surge in patient base is encouraging hospital laboratories to form alliances and strategic partnerships. This is also likely to propel the segment.
Regional Outlook of Global Transplant Drug Monitoring Assay Market
North America accounted for major share of around 35% of the global transplant drug monitoring assay market in 2021. North America's dominance can be ascribed to improvements in technology, surgical techniques, and immunosuppressive drugs along with rise in success rate of organ transfer procedures. Additionally, rapid adoption of advanced treatments, increase in R&D activities, high affordability, and rise in prevalence of chronic diseases, including chronic kidney diseases and CVDs, are driving the demand for organ transplantation. This is likely to boost the transplant drug monitoring assay market in North America.
Europe and Asia Pacific are also large markets for transplant drug monitoring assays. These regions held the second and third largest share, respectively, of the global market in 2021. The transplant drug monitoring assay market in Asia Pacific is driven by the rise in focus on organ donation. Strong presence of Siemens Healthineers AG, Hologic, Inc., Danaher Corporation, and Bio-Rad Laboratories, Inc., specifically in China, India, and South Korea, is also expected to augment the market in Asia Pacific. The market in Latin America is projected to grow at a faster pace than that in Middle East & Africa.

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Analysis of Key Players in Global Transplant Drug Monitoring Assay Market
The global transplant drug monitoring assay market is consolidated, with the presence of a small number of leading players. Most of the companies are investing significantly in research & development activities, primarily to introduce innovative assays. Furthermore, diversification of product portfolios and mergers & acquisitions are the key strategies adopted by the leading players. Abbott, Thermo Fisher Scientific Inc., H.U. Group Holdings, Inc. (Fujirebio Holdings, Inc.), Hoffmann-La Roche Ltd., Siemens Healthineers AG, Hologic, Inc., Danaher Corporation, and Bio-Rad Laboratories, Inc. are the key players in the transplant drug monitoring assay market.

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