The Transplant Diagnostics Market, estimated at USD 1,130.9 Mn in 2025, is expected to exhibit a CAGR of 8.2% and reach USD 1,963.4 Mn by 2032.
The industry is witnessing significant growth driven by rising demand for advanced, reliable, and cost-effective medical devices across diagnostic, therapeutic, and monitoring applications. Rapid advancements in device design, digital health integration, and adoption of minimally invasive technologies are reshaping the competitive landscape. Furthermore, supportive regulatory frameworks, increasing healthcare investments, and the growing focus on patient-centric care are expected to create new growth avenues for market players.
Key market players are focusing on research and development activities in order to get product approvals from the regulatory authorities, which is driving the global transplant diagnostics market’s growth. For instance, in December 2025, Thermo Fisher Scientific Inc., the world leader in serving science, announced its SeCore CDx HLA Sequencing System was granted De Novo Classification by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic with KIMMTRAK (tebentafusp-tebn), Immunocore’s T cell receptor therapy for HLA-A 02:01-positive adults with metastatic or unresectable uveal melanoma, a rare but deadly cancer of the eye.
Global Transplant Diagnostics Market– Impact of Coronavirus (COVID-19) Pandemic
The World Health Organization (WHO) designated the illness caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which first appeared in Wuhan (province of Hubei, China) in the last months of 2025, as "coronavirus disease 2025" or COVID-19. This virus spreads quickly and had a serious negative impact on the economies, social behaviors, and healthcare of every country in the world.
COVID-19 affected the economy in three main ways: by directly affecting production and demand, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to the lockdown, several countries, such as India, China, Brazil, and others, faced problems regarding the transportation of things from one place to another.
COVID-19 also had a negative impact on the global transplant diagnostics market. For instance, the study "Diagnostic Testing of COVID-19 in Solid Organ Transplantation: Current Clinical Application and Future Strategies," published in October 2025, states that the COVID-19 pandemic has affected several aspects of solid organ transplantation, including donor and recipient appropriateness and infection and transmission prevention after transplantation. Growing understanding of SARS-CoV-2 transmissibility and diagnostic fidelity in immunocompromised patients during the COVID-19 pandemic continued to inform best practices for solid organ donation.
Global Transplant Diagnostics Market: Key Developments
On May 25, 2025, GenDx, a Eurobio Scientific Company, announced it had obtained a worldwide license from the Università degli Studi di Torino (UNITO) for their method to detect donor specific cell free DNA (cfDNA) in patients that have undergone a lung transplant.
In March 2025, Immucor, Inc., a company that provides transfusion and transplantation diagnostic products, announced two additions to its transplant diagnostics portfolio, demonstrating its ongoing commitment to new advancements in the field of histocompatibility.
Browse 53 Market Data Tables and 44 Figures spread through 180 Pages and in-depth TOC on “Global Transplant Diagnostics Market”- Forecast to 2032, Global Transplant Diagnostics Market, By Product Type (Instrument, Reagents & Kits, and Software), By Technology (Molecular Assay, and Non-Molecular Assay), By Application (Tissue Typing, Infectious Disease Testing, Serum-Cross Matching, and Blood Profiling), By Organ Type (Kidney, Liver, Heart, Lungs, Pancreas, and Others), By End User (Hospitals & Transplant Centers, Research Laboratories & Academic Institutes, and Commercial Service Providers), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa).
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Key Takeaways of the Global Transplant Diagnostics Market:
- The global transplant diagnostics market is expected to exhibit a CAGR of 8.2% during the forecast period. The merger with emerging economies offers lucrative growth opportunities for players in the global transplant diagnostics market .
- Among product type segment, the reagents & kits segment is expected to hold a dominant position in the global transplant diagnostics market during the forecast period due to the increasing product launches. For instance, on October 17, 2025, GenDx announced the launch of their newly developed product, NGS-Turbo, designed for Human leukocyte antigen (HLA) typing using Oxford Nanopore Technologies sequencing devices. NGS-Turbo represents a significant leap forward in the field of HLA typing, offering unparalleled speed and efficiency when time is of the essence.
- Among region, North America is expected to be the dominant region in the global transplant diagnostics Countries in North America, such as the U.S. and Canada, have infrastructure, government support, and financed organizations to help raise money and awareness for organ transplantation for patients. For instance, the National Institute of Health reported in May 2025 that funding for transplant research was US$ 721 million in 2025, US$ 702 million in 2025, and US$ 735 million in 2025 (expected), respectively. Consequently, the growing use of transplant diagnostics will fuel market expansion in this region and result in higher financing for transplantation research.
- Major players operating in the global transplant diagnostics market are Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Qiagen N.V., F. Hoffman-La Roche Ltd., Immucor, Inc., Becton Dickinson and Company, bioMérieux S.A., Illumina, Inc., CareDx, Inc., and GenDx.
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