TRANSPLANT DIAGNOSTICS MARKET ANALYSIS

The global transplant diagnostics market size is expected to reach US$ 1,677 Mn by 2030, from US$ 966.3 Mn in 2023, at a CAGR of 8.2% during the forecast period. The global transplant diagnostics market is witnessing significant growth due to the increasing prevalence of chronic diseases such as cancer and the rising geriatric population globally. Transplant diagnostics help determine the compatibility between the donor and recipient, enabling effective organ transplantation. Advancements in transplantation therapies and the development of novel diagnostic technologies such as next-generation sequencing (NGS) are expanding the applications of transplant diagnostics. Moreover, the growing public awareness about organ donation and transplantation is creating strong demand. However, high costs associated with procedures and stringent regulations can hinder market growth to some extent.

Global Transplant Diagnostics Market Regional Insights:

• North America is expected to be the largest market for transplant diagnostics during the forecast period, accounting for over 35% of the market share in 2023. The growth of the market in North America is attributed to the rising prevalence of chronic diseases, an increasing elderly population base, and the growing number of organ transplantation procedures.
• Europe is expected to be the second-largest market for transplant diagnostics, accounting for over 25% of the market share in 2023. The growth of the market in Europe is attributed to the increasing organ failure cases and expanding healthcare expenditures across major countries.
• Asia Pacific is expected to be the fastest-growing market for transplant diagnostics, which is expected to grow at a CAGR of over 10% during the forecast period. The growth of the market in The Asia Pacific region has experienced a significant increase in demand for kidney transplants due to the rising incidence of chronic renal illnesses brought on by changing food and lifestyle choices.

Figure 1. Global Transplant Diagnostics Market Share (%), by Region, 2023

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Analyst’s Views:

The global transplant diagnostics market is poised to grow significantly over the forecast period owing to rising organ transplantation procedures worldwide. The increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases requiring organ transplantation will drive market growth. Moreover, technological advancements in diagnostics tests such as next-generation sequencing and molecular assays for better accuracy in detecting infections and screening transplant recipients and donors are expected to boost market revenues.

On the other hand, a stringent regulatory environment is a major challenge for market players. Lack of awareness regarding organ donation and the high costs associated with transplantation procedures and diagnostic testing in developing nations may hamper market growth to some extent. However, increasing research and development (R&D) investments by key players to develop cost-effective and high-throughput tests with rapid turnaround times will create new opportunities for market expansion over the forecast period.

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 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.

Global Transplant Diagnostics Market Trends:

• Adoption of solid organ transplantation: The global trends of solid organ transplantation have significantly influenced the growth of the global transplant diagnostics market in recent years. As the number of organ transplant procedures increases globally due to growing acceptance, success rates, and demand for transplantation as a treatment option, it has led to greater focus on precision diagnostics needed pre and post transplantation.
• Growth in living donor transplantation: The growth of living donor transplantation is having a significant influence on the global transplant diagnostics market. With living donor transplants on the rise, the need for more advanced diagnostic tools and precision medicine approaches is increasing. In certain situations, preemptive transplants and shorter wait times are made possible by living donor transplants. This reduces the health risks for patients and the financial burden on healthcare systems compared to traditional deceased donor transplants. As a result, many countries are pushing to expand their living donor programs and educate more of the public about living donation options.
• Shift towards immunosuppressant minimization regimens: The shift towards immunosuppressant minimization regimens is having a significant influence on the global transplant diagnostics market. By reducing the dosage or duration of immunosuppressive drugs post-transplant, the risk of side effects in patients can be lowered. This requires closer monitoring of transplant recipients to detect any early signs of rejection. As a result, there is greater demand for diagnostic tools that can accurately assess the status of the transplant and immune system activity.

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.

Figure 2. Global Transplant Diagnostics Market Share (%), by Product Type, 2023

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Recent Developments:

New product launches:

• On March 22, 2023, Quest Diagnostics, the nation's leading provider of diagnostic information services, unveiled a comprehensive suite of advanced diagnostics and support services, Quest Advanced Specialized Transplant Services, which is designed to broaden access to laboratory tests for transplanting solid organ, human cells and tissue.
• In March 2022, Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced two additions to its transplant diagnostics portfolio, demonstrating their ongoing commitment to new advancements in the field of histocompatibility. The company announced the global launch of MIA FORA NGS EXPRESS HLA Typing Software. This new software offering gives users of MIA FORA NGS MFlex HLA Typing assays a faster and easier NGS analysis experience.
• In May 2022, Hologic, Inc., a medical technology company, announced the U.S. Food and Drug Administration (FDA) had approved its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus (CMV) in patients who have had solid organ or stem cell transplants. The test is the first to be introduced in the U.S. by Hologic for post-transplant pathogen detection and monitoring on Hologic’s fully automated Panther system, and joins the existing portfolio of diagnostic and viral load testing for HIV-1, Hepatitis C and Hepatitis B.

Collaboration and Acquisitions:

• On November 21, 2023, GenDx, a Eurobio Scientific Company, announced it had entered into a collaboration with OSE Immunotherapeutics, a biotech company dedicated to developing first-in-class assets in immuno-oncology, to develop and validate a companion diagnostic (CDx) test for high resolution typing of HLA-A*02 based on their IVDR registered NGSgo kit and NGSengine software.
• In November 2022, Werfen, a worldwide leader in specialized diagnostics in the specialties of hemostasis, acute care diagnostics, transfusion, autoimmunity and transplant, announced it had agreed to acquire Immucor, Inc., from TPG. Immucor is a privately held corporation with a strong global presence in transfusion and transplant in vitro diagnostics. This acquisition will allow Werfen to expand its portfolio of Specialized Diagnostics solutions for hospitals and clinical laboratories.
• In October 2022, Immucor, Inc., and Pirche AG, the global leader in artificial intelligence (AI)-powered molecular matching and prediction analysis, announced a multi-year partnership to expand Immucor’s transplant diagnostic software, representing a continued contribution of novel approaches to innovate in the field of histocompatibility. Immucor will also make an investment in Pirche as part of this partnership.

Top Companies in the Global Transplant Diagnostics Market

• Thermo Fisher Scientific, Inc.
• Bio-Rad Laboratories, Inc.
• Qiagen N.V.
• Hoffman-La Roche Ltd.
• Immucor, Inc.
• Becton Dickinson and Company
• bioMérieux S.A.
• Illumina, Inc.
• CareDx, Inc.

Definition: Transplant diagnostics are medical tests that are performed before and after a transplant procedure to ensure the compatibility between the donor and recipient of an organ or tissue. These diagnostics are crucial in determining the success of the transplantation, minimizing the risk of organ rejection, and ensuring the recipient's immune system can accept the new organ.