U.S. market projected to grow from USD 1.57 billion in 2025 to USD 2.67 billion by 2035, while Europe market expected to reach USD 3.58 billion driven by expanding transplant networks and advanced diagnostic technologies
Austin, United States, May 25, 2026 (GLOBE NEWSWIRE) — Transplant Diagnostics Market Size & Growth Analysis:
“According to SNS Insider, the global Transplant Diagnostics Market was valued at USD 6.23 billion in 2025 and is expected to reach USD 12.70 billion by 2035, expanding at a CAGR of 7.39% during the forecast period from 2026 to 2035.”
Growth in the Global Transplant Diagnostics Market is expected to be fueled by an increasing number of people suffering from various kinds of chronic diseases requiring organ transplant procedures. These include kidney, liver, heart, and lung diseases. The need for accurate and sophisticated transplant diagnostic tools is also being spurred by the need to achieve better results through precise matching of donor organs with patients and minimize cases of rejections.
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The U.S. Transplant Diagnostics Market was valued at USD 1.57 Billion in 2025 and is expected to reach USD 2.67 Billion by 2035, growing at a CAGR of 5.46%.
Being one of the most advanced transplant diagnostics markets globally, the United States market is propelled by favorable factors such as clinical facilities, higher volume of transplant procedures performed, and increased adoption of molecular diagnostic tools. Besides that, the adoption of artificial intelligence-based compatibility prediction systems, dd-cfDNA monitoring, and high-resolution HLA typing are other drivers bolstering the country’s leadership.
The Europe Transplant Diagnostics Market is estimated to be USD 1.82 Billion in 2025 and is projected to reach USD 3.58 Billion by 2035, growing at a CAGR of 6.98% during 2026–2035.
The Europe Transplant Diagnostics market will continue to experience growth due to the extensive deceased donor transplant network present within the EU which includes the use of Eurotrans plant (which serves 8 European countries) and the UK Transplant system where the large number of transplants performed require diagnostic testing.
Rising Organ Transplant Volumes and Molecular Diagnostic Advancements Globally
Key factors that drive the market growth include an increase in the number of organ transplant surgeries taking place all around the world and the rising demand for detecting graft rejection at an early stage. Increase in the number of individuals suffering from chronic diseases has expanded the patient population requiring kidney, liver, heart, and lung transplant surgeries. Additionally, technological developments in the field of molecular diagnostics, such as high-resolution HLA typing, multiplex crossmatch assays, and liquid biopsy-derived dd-cfDNA testing, have improved the accuracy of donor-recipient compatibility and help intervene at an early stage in the case of rejection.
Leading Market Players Listed in this Report are:
- CareDx Inc.
- Thermo Fisher Scientific Inc. (One Lambda)
- Bio-Rad Laboratories Inc.
- Immucor Inc. (Werfen)
- Luminex Corporation (DiaSorin)
- Bio-Techne Corporation
- F. Hoffmann-La Roche AG
- Abbott Laboratories
- Illumina Inc.
- Pacific Biosciences (PacBio)
- GenDx BV
- Inno-Train Diagnostik GmbH
- Grifols SA
- Transmedics Group Inc.
- Beckman Coulter Life Sciences
- QIAGEN NV
- Miltenyi Biotec GmbH
- Hemacare Corporation
- Hologic Inc.
- Agena Bioscience Inc.
Segmentation Analysis
By Product
In 2025, the Reagents & Consumables segment accounted for the largest market share due to their constant use in transplant diagnosis involving the HLA typing kit, antibody test, and dd-cfDNA assay consumption processes. The Software & Services segment is forecasted to have the highest CAGR since there is an increasing use of advanced AI technologies and sophisticated online HLA databases.
By Technique
The largest segment in 2025 was the Molecular Assay due to the necessity of the molecular technique for HLA typing, antibody identification, and analysis of genetic compatibility in transplant cases. There is also the growth of non-molecular methods that are used for diagnostic and transplant screening purposes within developing healthcare systems.
By Transplant Type
In 2025, the largest segment was the Solid Organ Transplant as the kidney transplant accounted for the most substantial share due to its wide global availability and proven diagnosis. The liver, heart, and lung transplant diagnostics also continued to evolve as the number of transplantations was gradually increasing. Another growing segment of this market was the Stem Cell and Bone Marrow Transplantation.
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Regional Insights
In 2025, North America held nearly 45% market share in the Transplant Diagnostics Market because of sophisticated transplant infrastructure, better reimbursement policies, and early adoption of diagnostic innovations. Leading this market is the USA on account of higher volumes of transplants, an advanced laboratory system, and use of AI-based diagnostic tools and platforms. Ongoing research activities in diagnostics and close collaboration between transplant facilities and biotechnology companies enhance their regional dominance in the market.
The fastest growing region in the market is likely to be Asia Pacific because of the rapidly growing number of transplant programs, increasing expenditure on healthcare services, and adoption of advanced molecular diagnostic systems. There is strong growth in the number of transplant cases in countries like China, India, Japan, and South Korea due to improvements in their healthcare infrastructure and increased awareness about organ transplantation.
Recent Developments
- In 2026, CareDx launched AlloSeq cfDNA 2.0, integrating donor-derived cell-free DNA monitoring with HLA antibody and viral infection markers to provide a comprehensive post-transplant diagnostic solution.
- In 2025, Thermo Fisher Scientific introduced the VeriFlex HLA Typing System, a fully automated NGS-based platform enabling high-resolution, high-throughput HLA typing with reduced processing time and improved laboratory efficiency.
Exclusive Sections of the Report (The USPs):
- NGS-BASED HLA TYPING ADOPTION ANALYSIS – helps you understand the shift toward high-resolution genetic matching systems improving donor-recipient compatibility and transplant success rates globally.
- LIQUID BIOPSY REJECTION MONITORING INSIGHTS – helps you evaluate the growing role of donor-derived cell-free DNA (dd-cfDNA) in early detection of transplant rejection and post-operative monitoring.
- AI-POWERED COMPATIBILITY PREDICTION LANDSCAPE – helps you assess how machine learning models are improving donor matching accuracy and reducing transplant waiting times.
- POST-TRANSPLANT SURVEILLANCE EVOLUTION – helps you identify advancements in multiplex assays, antibody detection systems, and integrated diagnostic workflows for long-term patient monitoring.
- TRANSPLANT INFRASTRUCTURE EXPANSION TRACKING – helps you analyze the impact of expanding transplant centers, laboratory networks, and organ procurement systems on diagnostic demand.
- REGIONAL TRANSPLANT VOLUME AND DIAGNOSTIC ADOPTION OUTLOOK – helps you evaluate transplant activity levels, regulatory frameworks, and diagnostic penetration across key global regions.
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Transplant Diagnostics Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 6.23 Billion |
| Market Size by 2035 | USD 12.70 Billion |
| CAGR | CAGR of 7.39% From 2026 to 2035 |
| Base Year | 2025 |
| Forecast Period | 2026-2035 |
| Historical Data | 2022-2024 |
| Key Segments | • By Product (Reagents & Consumables, Instruments, Software & Services) • By Technique (Molecular Assay, Non-Molecular Assay) • By Transplant Type (Solid Organ Transplant [Kidney, Liver, Heart, Lung], Stem Cell/Bone Marrow Transplant) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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