TRANSPLANT DIAGNOSTICS MARKET ANALYSIS

Market Challenges And Opportunities

Global Transplant Diagnostics Market Drivers:

• Increasing prevalence of organ failure and organ transplantation procedures: The increasing prevalence of organ failure and demand for organ transplantation is one of the major factors driving the growth of the global transplant diagnostics market. For instance, in February 2022, the Health Resources and Services Administration reported that the number of individuals waiting for solid organ transplants in the U.S. was over 106,000. Solid organ transplant recipients include those in need of kidneys (83%), livers (11%), pancreas (1%), hearts (3%), and other organs (2%).
• Technological advancements in transplant diagnostics: Advancements in molecular diagnostic techniques and assays are revolutionizing transplant diagnostics. Technologies like next-generation sequencing (NGS), digital polymerase chain reaction (PCR), and microarray-based assays are enabling high-throughput, automated testing with unprecedented accuracy and speed. Compared to conventional methods, these new techniques can detect genetic variations and predict compatibility at a much finer level. NGS-based human leukocyte antigen (HLA) typing, for instance, can determine if donors and recipients match at the allele level, hence enhancing results. As such, many top hospitals worldwide have now incorporated NGS and digital PCR into their evaluation processes for pre-transplant donor-recipient matching and post-transplant monitoring.
• Rising awareness about organ donation and transplantation: With increased life expectancy and rising incidence of organ failure due to chronic diseases and medical conditions, the demand for organ transplantation has grown significantly over the years. More people are now aware about the process of organ donation and its importance in saving lives of patients suffering from organ failure. This rising awareness about organ donation and transplantation is one of the key factors fueling the expansion of global transplant diagnostics.

Global Transplant Diagnostics Market Restraints:

• High cost of transplant diagnostic test: The high cost of transplant diagnostic products is significantly restraining the growth of the global transplant diagnostics market. Transplant diagnostics help in determining the compatibility between an organ donor and recipient before transplantation. However, the diagnostic tools and technologies used for transplant compatibility testing are extremely expensive. For instance, Illumina’s Trusight HLA V2, an amplicon based NGS HLA typing kit, costs around US$ 5000 for 11 HLA genes of 24 samples; this amounts to US$ 208 per sample. This is further loaded with additional sequencing costs of around US$ 5 (0.3 M, pair-end 100 bp on Illumina X 10 platform) per sample.
• Stringent regulatory frameworks: Stringent regulatory frameworks around the world are putting brakes on the growth of the global transplant diagnostics market. Complying with regulations involves lengthy approval processes and high compliance costs for companies. This deters many players from entering this market or launching new products.
• Limited reimbursement policies: Limited reimbursement policies across various countries are posing a major challenge for the growth of the global transplant diagnostics market. Stringent regulations around the reimbursement of transplant diagnostic tests are restricting patients' access to important diagnostic procedures. Since organ transplantation is an extremely expensive procedure involving heavy costs for donor selection, immunological testing, immunosuppressant drugs, post-transplant care, and monitoring, a lack of adequate insurance coverage makes it unaffordable for many patients.

Global Transplant Diagnostics Market Opportunities:

• Increasing healthcare expenditure: Increasing healthcare expenditure can present a major opportunity for growth in the global transplant diagnostics market. As more countries strive to expand access to quality healthcare, greater funding is being directed towards important areas such as organ transplantation. For instance, by 2040, according to the estimates by Deloitte, a multinational professional services network, U.S. health care spending could reach US$ 8.3 trillion—US$ 3.5 trillion lower than projections based on numbers from the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) focused on traditional health care.
• Government initiatives to promote organ donation: Government initiatives to promote organ donation present a major opportunity for the global transplant diagnostics market. By encouraging more people to become organ donors, governments can significantly boost the number of organ transplants performed each year. This will drive up demand for diagnostic testing procedures and technologies that are crucial for transplant success.
• Increasing R&D investments in transplant diagnostics: Increasing investments in research and development for transplant diagnostics presents a great opportunity to drive growth in the global transplant diagnostics market. As the number of organ transplantation procedures increases every year due to the rising prevalence of chronic diseases, there is a growing clinical need for advanced diagnostic tools that help facilitate the organ matching and allocation process.