Organ Transplant Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Organ Transplant Diagnostics Market is projected to expand from USD 6.47 Billion in 2025 to USD 9.87 Billion by 2031, reflecting a compound annual growth rate of 7.29%. This market encompasses a broad range of assays, reagents, and instrument systems essential for histocompatibility testing, pathogen screening, and immune monitoring throughout the transplant continuum. The primary catalysts for this growth are the increasing global prevalence of chronic diseases causing organ failure and an aging population requiring advanced medical interventions, which collectively drive the demand for rigorous compatibility profiling. As evidence of this rising clinical need, the Global Observatory on Donation and Transplantation reported in December 2024 that global solid organ transplant volumes reached 172,397 procedures, marking a 9.5% increase over the prior assessment cycle.

Despite the positive growth trajectory, the sector encounters significant hurdles stemming from the chronic global shortage of donor organs. This imbalance between the extensive waitlists of patients and the scarce supply of viable organs limits the number of surgeries performed, thereby placing a ceiling on the addressable market for pre-surgical cross-matching and confirmatory diagnostics. Additionally, the high costs associated with molecular testing technologies, combined with inconsistent reimbursement policies in emerging economies, pose further barriers that may hinder the widespread accessibility and expansion of these essential diagnostic solutions.

Market Drivers

The escalating demand for non-invasive post-transplant monitoring is transforming the Global Organ Transplant Diagnostics Market by setting new benchmarks for patient surveillance and allograft protection. Medical professionals are increasingly utilizing liquid biopsy solutions that detect donor-derived cell-free DNA (dd-cfDNA) to spot potential rejection events with greater speed and sensitivity than traditional tissue biopsies, reducing patient burden while enhancing immune monitoring accuracy. This shift is driving significant volume growth for diagnostic providers; for instance, CareDx reported in its 'Third Quarter 2025 Financial Results' in November 2025 that testing services volume reached 50,300 tests, a 13% increase from the previous year, underscoring the rapid clinical adoption of these advanced modalities.

Concurrently, the increasing prevalence of chronic conditions leading to organ failure serves as a major driver for the continued expansion of pre-transplant compatibility testing. Diseases such as end-stage renal disease and cardiovascular failure are expanding patient waitlists, thereby necessitating rigorous histocompatibility profiling and HLA typing to facilitate successful organ allocation. Data from the Health Resources and Services Administration's OrganDonor.gov, updated in May 2025, indicates that over 103,000 individuals were listed on the national transplant waiting list. This intense clinical demand supports procedural throughput, as evidenced by the Organ Procurement and Transplantation Network's January 2025 report, which noted a record 48,149 organ transplants performed in the United States during 2024, highlighting the ecosystem's reliance on robust diagnostic infrastructure.

Market Challenges

The enduring scarcity of donor organs serves as a primary constraint on the commercial growth of the global organ transplant diagnostics market. Because the use of diagnostic assays is intrinsically linked to the volume of surgical procedures, the limited availability of organs effectively places a hard cap on market revenue potential. This restriction diminishes the frequency of pre-surgical compatibility testing and limits the number of patients who can transition into the post-transplantation monitoring phase. Consequently, the industry is unable to fully meet clinical demand, as the addressable patient population is physically constrained by the stagnant supply of donors.

This structural bottleneck results in a widening disparity between potential demand and actual testing volumes. According to data from the Organ Procurement and Transplantation Network, there were more than 103,000 candidates awaiting a transplant on the national waiting list in the United States in 2024. This significant gap illustrates how the shortage of donors precludes a large portion of the patient population from utilizing the full spectrum of diagnostic services, thereby impeding the generation of recurring revenue streams that would otherwise arise from routine profiling.

Market Trends

The incorporation of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing predictive risk stratification, targeting inefficiencies in organ procurement that conventional methods fail to address. These advanced technologies are being utilized to interpret complex donor variables, thereby optimizing the crucial decision-making period between the withdrawal of life support and organ retrieval. By offering accurate predictions of donor progression, AI tools help minimize the discard rate of viable organs, directly mitigating the ongoing supply shortage; for example, The Guardian reported in November 2025 that a machine learning model developed by Stanford University researchers achieved a 60% reduction in futile procurement attempts compared to standard predictions.

In parallel, the market is witnessing a transition toward personalized transplant medicine driven by the adoption of novel RNA-based biomarkers that provide deeper insights than standard liquid biopsies. Clinicians are increasingly relying on transcriptomic profiling to evaluate rejection risks with greater specificity, enabling the customization of immunosuppression regimens to reduce long-term graft toxicity. This shift toward precision diagnostics is reflected in the commercial success of next-generation assays; Verici Dx reported in a July 2025 corporate update that it received 299 orders for its Tutivia diagnostic test in the second quarter of 2025, demonstrating a growing reliance on advanced genomic signatures for individualized patient management.

Key Players Profiled in the Organ Transplant Diagnostics Market

• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• F. Hoffmann La-Roche Ltd.
• Abbott
• QIAGEN
• Bruker
• Becton, Dickinson and Company
• Immucor, Inc.
• Bio-Rad Laboratories, Inc.
• Omixon Inc.

Report Scope

In this report, the Global Organ Transplant Diagnostics Market has been segmented into the following categories:

Organ Transplant Diagnostics Market, by Offering:

• Kits and Assays
• Consumables
• Services

Organ Transplant Diagnostics Market, by Application:

• Donor Testing (Pre-transplantation testing (Histocompatibility Testing
• Blood Profiling Testing
• Other Testing)
• Post-transplantation testing (Post-Infection Testing
• Risk of Disorder Testing
• Other Testing))
• Recipient Testing (Pre-transplantation testing (Histocompatibility Testing
• Blood Profiling Testing
• Other Testing)
• Post-transplantation Testing (Post-Infection Testing
• Risk of Disorder Testing,
• Other Testing))

Organ Transplant Diagnostics Market, by Transplant Type:

• Solid Organ Transplant (Kidney
• Liver
• Lung
• Pancreas
• Other Organs Transplant)
• Stem Cell Transplant

Organ Transplant Diagnostics Market, by Technology:

• Molecular Technologies (PCR
• Sanger Sequencing
• Next-Generation Sequencing (NGS)
• Other Molecular Technologies)
• Non-molecular Technologies (Serology
• Flow Cytometry)
• Other Technologies

Organ Transplant Diagnostics Market, by End User:

• Hospitals and Transplant Centers
• Academic and Research Institutions
• Reference Laboratories
• Other End Users

Organ Transplant Diagnostics Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Organ Transplant Diagnostics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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