The global transplant diagnostics market size is estimated to reach USD 12.15 billion by 2033, registering a CAGR of 7.45% from 2025 to 2033, according to a new report by Grand View Research, Inc. An increasing number of patients suffering from chronic diseases frequently leading to organ failure is creating an upsurge in demand for transplant procedures. In addition, the adoption of stem cell therapy and personalized medicine is escalating, thereby influencing demand for transplant diagnostics.
Risks and complexities associated with organ transplants necessitate the need for improved and sophisticated diagnostic tools. Next-Generation Sequencing (NGS) technology is rapidly replacing traditional diagnostic methods, such as serological techniques employed in Human Leukocyte Antigen (HLA) typing, owing to the growing demand for high-throughput diagnostic tools with enhanced accuracy.
Market growth is expected to be restrained by factors such as reimbursement controversies and ethical issues in some parts of the world. In addition, the high cost of performing HLA matching using Polymerase Chain Reaction (PCR) and NGS devices is challenging the growth of the transplant diagnostics market in developing countries.
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Based on test, the molecular assays segment led the market with the 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.
Based on application, the diagnostics dominated the transplant diagnostics industry with the largest revenue share of 70.93% in 2024.
Based on transplant area, the solid organ transplantation segment dominated the market with a revenue share of 45.63% in 2024, due to the increasing prevalence of chronic and life-threatening conditions such as cardiovascular diseases, liver cirrhosis, chronic kidney disease, and pulmonary disorders.
Based on end-use, 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.
The North America transplant diagnostics market held a dominant revenue share of 32.52% in 2024, owing to the availability of well-developed health infrastructure and a high adoption of advanced medical technologies.
Grand View Research has segmented the global transplant diagnostics market based on test, product, application, transplant area, end-use, and region:
Transplant Diagnostics 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
Transplant Diagnostics Product Outlook (Revenue, USD Million, 2021 - 2033)
Reagents & Consumables
Instruments
Software and Services
Transplant Diagnostics Application Outlook (Revenue, USD Million, 2021 - 2033)
Diagnostic Application
Infectious Disease Testing
Histocompatibility Testing
Blood Profiling
Research Application
Transplant Diagnostics 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
Transplant Diagnostics End-use Outlook (Revenue, USD Million, 2021 - 2033)
Hospitals and Transplant Centers
Research and Academic Institutes
Independent Reference Laboratories
Transplant Diagnostics 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
List of Key Players in the Transplant Diagnostics Market
Thermo Fisher Scientific, Inc.
Illumina, Inc.
F. Hoffmann La-Roche Ltd
Abbott
QIAGEN
Bruker
BD (Becton, Dickinson and Company)
Werfen (Immucor, Inc.)
Bio-Rad Laboratories, Inc.
Omixon Inc.
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