Transplant Diagnostics Market (2025 - 2033) Size, Share & Trends Analysis Report By Test (Molecular Assays, Sequencing-based Molecular Assays, Non-molecular Assays), By Product, By Application, By Transplant Area, By End-use, By Region, And Segment Forecasts

Transplant Diagnostics Market Summary

For instance, in October 2025, UBC enzyme technology introduced the first human test toward universal donor organs for transplantation. It has developed enzymes that successfully convert a kidney to universal type O for transplant, marking a significant step toward faster, more compatible organ donations. Further, the results show that the kidney functioned normally for two days without evidence of hyperacute rejection. This quick immune reaction can destroy an incompatible organ in minutes. By the third day, some blood-type markers resurfaced, causing a moderate response. Still, the damage was significantly less severe than in a usual mismatch, and researchers noticed signals that the body was starting to tolerate the organ.

Furthermore, the aging population, the prevalence of chronic disease, and advances in transplantation techniques are all driving market growth. For example, in October 2025, the World Health Organization claimed that in 2020, individuals aged 60 and older outnumbered children under five. Between 2015 and 2050, the worldwide population over 60 will almost double, from 12% to 22%. Furthermore, by 2050, 80% of older people will reside in low- and middle-income countries. The pace of population ageing is much faster than in the past. As chronic diseases such as heart failure, kidney disease, and liver disorders continue to rise, the need for organ transplantation as a life-saving treatment is also increasing. This rise in transplant procedures highlights the importance of accurate and advanced diagnostic tools to ensure donor-recipient compatibility, reduce the risk of organ rejection, and improve transplantation success rates.

Consequently, the transplant diagnostics industry’s growth is driven by the rising incidence of organ-related diseases, leading to the continuous development of innovative transplant diagnostic technologies and improved medical devices to meet the growing demand from hospitals and specialized clinics, ultimately enhancing patient outcomes. Moreover, innovative transplant technologies include 3D bioprinting of organs, robotic surgery for increased precision, and AI-powered diagnostics to improve organ selection and patient outcomes.

For instance, in April 2025, NewYork-Presbyterian performed the first fully robotic liver transplant in New York, U.S., saving a 59-year-old man in a procedure that advances the field of organ transplantation. This was the only three programs in the U.S. to perform this surgery. Robotic liver transplant surgery improves accuracy in a complex and challenging process that involves bleeding from the body's largest internal organ. Traditional "open" liver transplant surgery necessitates a big abdominal incision, 8 to 10 hours of operation, blood transfusions, a 10-day hospital stay, and a six-month rehabilitation period. Other advancements involve xenotransplantation, converting donor organs to a universal blood type, and using nanotechnology to reduce transplant rejection.

Furthermore, the market growth is heavily driven by government programs and funding for transplantation, raising awareness about organ donation, technological breakthroughs in HLA typing, and crossmatching. For instance, in October 2023, GenDx (U.S.) launched NGS-Turbo, revolutionizing high-resolution HLA typing with Oxford Nanopore Technologies sequencing devices. NGS-Turbo represents a significant leap forward in HLA typing, offering unparalleled speed and efficiency when time is of the essence. Moreover, with the release of this new product, GenDx continues to push the boundaries of innovation in the field of HLA typing, and NGS-Turbo demonstrates its commitment to providing cutting-edge solutions for the transplantation community.

However, the market growth is restrained owing to the high cost of advanced technologies like Next-Generation Sequencing (NGS), which limits adoption in lower-resource settings and the complexity of HLA sequencing. Further, other growth retarder factors include data privacy concerns, especially with AI-driven solutions, a shortage of skilled personnel, and the lack of consistent reimbursement policies globally.

Market Concentration & Characteristics

Noninvasive diagnostic methods, such as donor-derived cell-free DNA tests and enhanced molecular assays, drive market innovation. The integration of AI and machine learning improves diagnostic precision and patient-specific monitoring. For instance, in July 2025, CareDx (U.S.) launched AlloSure Plus (formerly AlloView), an AI-driven diagnostic platform that integrates AlloSure donor-derived cell-free DNA (dd-cfDNA) analysis with traditional tools in order to provide a personalized risk of rejection. In addition, an international, prospective study led by the Paris Transplant Group validated that AlloSure Plus can identify organ rejection using over 2,700 renal transplant biopsies.

Mergers and acquisitions are increasing as businesses seek to broaden their technological portfolios and worldwide reach. Strategic alliances and acquisitions enable enterprises to acquire access to breakthrough diagnostic platforms while also strengthening their position in critical areas.

Regulatory organizations are strengthening rules to guarantee transplant diagnostics are safe, accurate, and clinically valid. Compliance with changing standards and data privacy legislation is vital for market participants to retain acceptance and trust.

Companies are working to broaden their product offerings by creating advanced biomarker tests, quick testing kits, and point-of-care devices. Continuous innovation aims to improve early identification, minimize intrusive therapies, and improve patient outcomes. For instance, in October 2024, QIAGEN (Germany) expanded its automated liquid biopsy portfolio in order to enhance organ transplant applications. These innovations not only broaden the company's portfolio to fulfill its clients' different needs but also demonstrate its leadership in providing high-quality, automated solutions in organ transplantation.

Adoption is increasing in emerging regions such as Asia Pacific and Latin America due to increasing awareness and the development of healthcare infrastructure. Moreover, regional growth strategies concentrate on adapting solutions to fit local regulatory and clinical requirements.

Test Insights

The molecular assays segment led the transplant diagnostics market with the largest revenue share of 41.37% in 2024, owing to its better accuracy, sensitivity, and clinical value in diagnosing graft rejection and guaranteeing donor-recipient compatibility. These assays, which include PCR-based testing, NGS, and quantitative real-time PCR (qPCR), allow for the detection of specific genetic markers, as well as HLA type, and donor-derived cell-free DNA, all of which are important for monitoring transplant status. The need for early detection, improved prediction capacities, and more customized immunosuppressive medication drives molecular-based diagnostics testing demand. Furthermore, molecular assays provide faster turnaround times and higher scalability for high-throughput testing, which is particularly useful in transplant centers and specialized laboratories. Their expanding incorporation into ordinary clinical practice, backed by regulatory approvals and rising clinician awareness, has strengthened their position in transplant diagnostics.

The sequencing-based molecular assays segment is expected to witness the fastest CAGR during the forecast period. The current research and development in transplant diagnostics prioritize more accurate and highly sensitive tests. This focus on improved diagnostics has the potential to enhance patient outcomes and drive the future demand for sequencing-based molecular assays.

Product Insights

The reagents and consumables segment dominated the market and accounted for largest revenue share in 2024, owing to the growing demand for effective and early profiling during organ transportation. This segment generates consistent revenue as consumables and reagents are constantly used and replenished in pre- and post-transplant screening. Furthermore, the growing number of organ transplants worldwide, the increased use of high throughput testing platforms and advancements in molecular diagnostic techniques have all contributed to demand. The segment also has immense advantages from increased laboratory infrastructure and investment in transplant diagnostics in emerging markets.

The software and services segment is expected to witness the fastest CAGR during the forecast period, owing to the latest developments in the software industry and improved services offered by the market players. For instance, 4bases (Switzerland) provides an innovative genetic diagnostic solution for next generation sequencing (NGS), launched InnoGraft; a non-invasive, cost-effective, and highly sensitive platform for longitudinal monitoring of solid organ transplant recipients. Furthermore, InnoGraft detects donor-derived cell-free DNA (dd-cfDNA) in a recipient’s plasma that offers molecular evidence of graft injury days, or routine test abnormalities appear or even weeks before clinical symptoms. Moreover, the recent development in software technology and with the induction of artificial intelligence (AI) and machine learning (ML) are giving more efficient output.

Application Insights

Diagnostics dominated the transplant diagnostics industry with the largest revenue share of 70.93% in 2024. Diagnostics enables matching the recipient and organ donor by evaluating compatibility primarily via Human Leukocyte Antigen (HLA) testing. Transplant diagnostics include screening of both recipients & donors for viral infections, ensuring that infections are detected before transplantation to prevent their transmission. Research application, on the other hand, is expected to witness significant growth during the forecast period.

Research application is expected to witness significant growth during the forecast period, owing to the increasing focus on understanding transplant rejection mechanisms and improving patient outcomes. Advancements in genomics, biomarker discovery, and proteomics are driving the use of transplant diagnostics in research settings to develop novel therapeutic strategies and personalized medicine approaches. Additionally, the rising investment by pharmaceutical and biotechnology companies in transplant-related research, coupled with growing collaborations between academic institutions and industry players, is accelerating innovation. This surge in research activities is also supported by the availability of advanced molecular diagnostic tools that enable detailed monitoring of immune responses and early detection of complications, paving the way for more effective and targeted transplant therapies.

Transplant Area Insights

The solid organ transplantation segment dominated the global transplant diagnostics market in 2024, accounting for a revenue share of 45.63%, primarily due to the increasing prevalence of chronic and life-threatening conditions such as cardiovascular diseases, liver cirrhosis, chronic kidney disease, and pulmonary disorders. The growing global burden of organ failure, driven by geriatric populations, lifestyle-related risk factors, and a rise in non-communicable diseases, has led to a surge in demand for organ transplants. Technological advancements in transplant diagnostics, such as improved crossmatch testing, HLA typing, and molecular assays, have enhanced solid organ transplants' success rates and safety, further boosting market growth.

In addition, expanding organ donation programs and awareness initiatives have contributed to a higher number of transplant procedures, particularly in developed regions. For instance, in 2023, the Securing the U.S. Organ Procurement and Transplantation Network (OPTN) Act, a program, was signed into law, allowing the Health Resources and Services Administration, which oversees the OPTN, to modernize the current system. Modernization plans include changing the system's management structure from a single federal contractor to a multi-vendor, multi-contract model.

Meanwhile, the stem cell transplantation segment is projected to register the fastest CAGR during the forecast period. This growth is driven by the expanding clinical applications of stem cells in treating a wide range of diseases, such as hematologic malignancies, autoimmune disorders, and cardiovascular conditions. Stem cell transplants are also increasingly explored in regenerative medicine and immune system reconstitution therapies. Ongoing research, favorable regulatory frameworks, and increasing investment in cell-based therapies are accelerating the adoption of stem cell transplantation. Furthermore, advancements in genetic profiling, transplant compatibility testing, and cell characterization are enhancing the safety and effectiveness of these procedures, further driving the demand in this segment.

End-use Insights

The hospitals and transplant centers segment dominated the transplant diagnostics market in 2024, owing to the rising healthcare expenditure and use of advanced medical devices in these settings. Hospitals are the integral components of the organ transplantation process. In addition, several countries are focusing more on the development of hospitals and specialized centers that focus on organ transplantation.

The research and academic institutes segment is expected to witness the fastest CAGR during the forecast period. Government and private institutes are focusing more on efficient solutions for organ transplantation and diagnostics. Moreover, the HRSA, an agency of the U.S. Government, in March 2023, announced an organ procurement and transplantation network modernization initiative to strengthen accountability and transparency in the organ procurement and transplantation network (OPTN).

Regional Insights

The North America transplant diagnostics market held a considerable revenue share of 32.52% in 2024, owing to the availability of well-developed health infrastructure and a high adoption of advanced medical technologies. Furthermore, a rise in investment in research and development for organ transplantation is driving the market. According to the Health Resources & Services Administration (HRSA), as of March 2024, more than 46,000 organ transplants were performed in the U.S.

U.S. Transplant Diagnostics Market Trends

In 2024, the U.S. transplant diagnostics industry captured a significant market share, owing to advanced healthcare infrastructure, advanced medical technology & devices, and rising awareness among citizens about organ transplantation. For instance, the Human Resources and Services Administration, every 8 minutes, another person is added to the transplant waiting list in 2024. Below is the chart representation of the different organ waiting lists for the 2024.

Europe Transplant Diagnostics Market Trends

The Europe transplant diagnostics industry’s growth is attributed to an increase in the region's healthcare budget as well as the availability of professional surgeons and advanced healthcare technologies. Strong government support for organ donation programs and transplant registries has helped to improve access and outcomes. The presence of leading research institutions and diagnostic companies in major countries such as the UK, Germany, and France promotes the development and implementation of novel testing methods for the transplant diagnostics. Furthermore, stringent regulatory requirements and favorable reimbursement schemes have improved the overall quality and consistency of transplant diagnostic procedures throughout Europe.

The UK transplant diagnostics market held the largest revenue share of Europe in 2024, owing to the availability of skilled surgeons, growing healthcare expenditure, and a highly developed healthcare infrastructure. The country has a well-established organ donation and transplant framework supported by organizations such as NHS Blood and Transplant (NHSBT), which enhances operational efficiency and accessibility. For instance, in November 2024, each year in the UK, nearly 3,000 organs are transplanted, and over 2,000 sight-saving corneal transplants are carried out. Further, continuous investment in research and development, along with the early adoption of advanced molecular diagnostic technologies, has strengthened the UK’s position in the market. Additionally, strong collaborations between academic institutions, hospitals, and biotechnology firms support innovation and the integration of cutting-edge transplant diagnostics into clinical practice.

The transplant diagnostics market in Germany is expected to grow at a significant pace, due to the increasing healthcare expenditure and adoption of advanced medical devices. Germany's strong clinical research infrastructure and hospital network facilitate the integration of next-generation transplant diagnostic tools, such as sequencing platforms and molecular assays. Moreover, favorable government policies, an increasing number of transplant procedures, and increased organ donation awareness drive market growth. The presence of key industry players and ongoing investments in precision medicine and laboratory automation are helping to accelerate the adoption of high-quality transplant diagnostics.

Asia Pacific Transplant Diagnostics Market Trends

The transplant diagnostics industry in Asia Pacific is projected to witness the fastest CAGR of 10.15% during the forecast period. Advancements in healthcare infrastructure drive the growth, increasing healthcare expenditure, and rising disposable income. Also, there has been a significant increase in the prevalence of chronic disease in middle age and geriatric population, especially in countries such as China, Japan, and India.

The Japan transplant diagnostics market is expected to witness steady growth during the forecast period, owing to increasing healthcare investment, a growing geriatric population, and rising incidence of chronic diseases leading to organ failure. For instance, as per the World Economic Forum, more than 1 in 10 people in the country are now aged 80 or older, and almost a third of its population is over 65, an estimated 36.23 million in 2023. Further, the country’s highly advanced healthcare infrastructure and strong emphasis on precision medicine are driving the adoption of molecular diagnostics and next-generation sequencing (NGS) in transplant care. Government initiatives to promote organ donation and streamline transplant procedures, along with the presence of technologically sophisticated laboratories, are further supporting market expansion. Additionally, collaborations between academic institutions, hospitals, and diagnostic companies are accelerating research and the clinical adoption of innovative transplant testing solutions.

The transplant diagnostics market in China held the largest revenue share in 2024. This can be attributed to the significant improvements in healthcare infrastructure and rising public awareness about the importance of organ transplantation. Furthermore, government-led measures to upgrade hospitals and provide access to new diagnostic technology have helped drive market expansion.

Latin America Transplant Diagnostics Market Trends

The Latin America transplant diagnostics industry is steadily advancing, fueled by rising awareness of genetic disorders and improvements in healthcare infrastructure. Countries across the region are recognizing the importance of early detection to reduce the burden of inherited diseases and improve patient outcomes. In Brazil, for example, the National Center for Biotechnology Information (NCBI) published a study in January 2023 analyzing 70 cystic fibrosis care centers (CFCCs), which revealed gaps in multidisciplinary teams and access to treatments like CFTR modulators, highlighting the need for broader carrier screening programs.

Middle East and Africa Transplant Diagnostics Market Trends

In the Middle East transplant diagnostics industry, countries such as Saudi Arabia, the UAE, and Qatar are investing considerably in updating their healthcare systems and implementing new molecular diagnostic techniques in transplant medicine. Furthermore, growing kidney failures are also driving up demand for organ transplants and diagnostics. The market growth in Africa has been slower due to insufficient healthcare infrastructure and funding. Overall, the region holds untapped potential that may be unlocked through continued investment and policy support.

Key Transplant Diagnostics Company Insights

The transplant diagnostics market features several key players driving innovation and adoption. Leading companies are heavily investing, rapidly evolving with continuous product innovation, geographic expansion, and strategic collaboration.

Recent Developments

• February 2025: Pirche AG (Germany) partnered with leading transplant diagnostics provider, Devyser AB (Sweden). The collaboration intends to demonstrate how Pirche's TxPredictor Platform, an AI-based technology that provides powerful immune profiling and risk prediction capabilities to enhance clinical decision-making, can allow more tailored monitoring through a portfolio of novel biomarkers developed by Devyser.

• June 2024, Devyser Diagnostics AB (Sweden) expanded its exclusive collaboration and distribution agreement with Thermo Fisher Scientific (U.S.), giving Thermo Fisher exclusive rights to commercialize, under combined brands, Devyser’s post-transplant portfolio of NGS products globally.

• May 2024: Thermo Fisher launched CXCL10 testing service. It is designed for kidney transplant patients and can detect CXCL10 chemokine faster in comparison to the currently used tests.

Transplant Diagnostics Market Report Scope

Global Transplant Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global transplant diagnostics market report based on test, product, application, transplant area, end-use, and region:

• Test Outlook (Revenue, USD Million, 2021 - 2033)

  • Molecular Assays

    • PCR-based Molecular Assays

    • Real-time PCR

    • Sequence-based Primer-PCR

    • Sequence-specific Oligonucleotide-PCR

    • Other PCR-based Molecular Assays

  • Sequencing-based Molecular Assays

    • Sanger Sequencing

    • Next Generation Sequencing

    • Other Sequencing-based Molecular Assays

  • Non-molecular Assays

    • Serological Assays

    • Mixed Lymphocyte Culture Assays

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Reagents & Consumables

  • Instruments

  • Software and Services

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Diagnostic Application

    • Infectious Disease Testing

    • Histocompatibility Testing

    • Blood Profiling

  • Research Application

• Transplant Area Outlook (Revenue, USD Million, 2021 - 2033)

  • Solid Area Transplantation

    • Kidney Transplantation

    • Liver Transplantation

    • Heart Transplantation

    • Lung Transplantation

    • Pancreas Transplantation

    • Other Organs Transplantation

  • Stem Cell Transplantation

  • Soft Tissue Transplantation

  • Bone Marrow Transplantation

• End-use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals and Transplant Centers

  • Research and Academic Institutes

  • Independent Reference Laboratories

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  •  North America

    • U.S.

      • Canada

      • Mexico 

    • Europe

      • UK

      • Germany

      • France

      • Italy

      • Spain

      • Denmark

      • Sweden

      • Norway

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

      • Thailand

    • Latin America

      • Brazil

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

      • Kuwait