Organ Transplant Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 - By Offering (Kits and Assays, Consumables, and Services), By Application (Donor Testing (Pre-transplantation testing (Histocompatibility Testing, Blood Profiling Testing, and Other Testing), Post-transplantation testing (Post-Infection Testing, Risk of Disorder Testing, and Other Testing)), Recipient Testing (Pre-transplantation testing (Histocompatibility Testing, Blood Profiling Testing, and Other Testing), Post-transplantation Testing (Post-Infection Testing, Risk of Disorder Testing, and Other Testing)), By Transplant Type (Solid Organ Transplant (Kidney, Liver, Lung, Pancreas, and Other Organs Transplant), Stem Cell Transplant), By Technology (Molecular Technologies (PCR, Sanger Sequencing, Next-Generation Sequencing (NGS), Other Molecular Technologies), Non-molecular Technologies (Serology, Flow Cytometry), Other Technologies), By End User (Hospitals and Transplant Centers, Academic and Research Institutions, Reference Laboratories, and Other End Users), and By Region and Competition 2021-2031F

Market Overview

The Global Organ Transplant Diagnostics Market will grow from USD 6.47 Billion in 2025 to USD 9.87 Billion by 2031 at a 7.29% CAGR. The Global Organ Transplant Diagnostics Market comprises assays, reagents, and instrument systems utilized for histocompatibility testing, pathogen screening, and immune monitoring across the pre-transplant to post-transplant continuum. The primary drivers propelling this sector include the rising global prevalence of chronic diseases leading to organ failure and an aging demographic that necessitates advanced therapeutic interventions. This increasing clinical need translates directly into higher procedural volumes and a corresponding demand for rigorous compatibility profiling. According to the Global Observatory on Donation and Transplantation, in its international report released in December 2024, the global volume of solid organ transplants reached 172,397 procedures, representing a 9.5% increase compared to the previous assessment cycle.

Despite this growth trajectory, the market faces a significant challenge due to the persistent global shortage of donor organs. This disparity between the high number of patients on waitlists and the limited supply of viable organs restricts the total number of surgeries performed, effectively capping the addressable market for pre-surgical cross-matching and confirmatory diagnostics. Furthermore, the substantial costs associated with molecular testing technologies and variable reimbursement policies in emerging economies may further impede the broader accessibility and expansion of these diagnostic solutions.

Key Market Drivers

The surge in demand for non-invasive post-transplant monitoring is fundamentally reshaping the Global Organ Transplant Diagnostics Market by establishing new standards for patient surveillance and allograft protection. Clinicians are increasingly adopting liquid biopsy solutions that utilize donor-derived cell-free DNA (dd-cfDNA) to identify potential rejection events earlier and with greater sensitivity than traditional tissue biopsies. This technological shift significantly reduces the physical burden on patients while enabling more frequent and accurate immune monitoring, thereby driving substantial volume growth for diagnostic providers. According to CareDx, November 2025, in the 'Third Quarter 2025 Financial Results', the company reported a testing services volume of 50,300 tests, representing a 13% increase compared to the same period in the prior year, highlighting the rapid clinical integration of these advanced monitoring modalities.

Simultaneously, the rising prevalence of chronic diseases leading to organ failure acts as a primary catalyst for the sustained expansion of pre-transplant compatibility testing. Conditions such as end-stage renal disease and cardiovascular failure are accelerating the size of patient waitlists, creating an urgent and expanding need for rigorous histocompatibility profiling and HLA typing to ensure equitable and successful organ allocation. According to the Health Resources and Services Administration's OrganDonor.gov, updated in May 2025, there were over 103,000 men, women, and children listed on the national transplant waiting list. This elevated clinical demand directly supports procedural throughput; according to the Organ Procurement and Transplantation Network, in January 2025, the United States performed a record 48,149 organ transplants during 2024, underscoring the critical dependence of the transplant ecosystem on robust diagnostic infrastructure.

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Key Market Challenges

The persistent shortage of donor organs acts as a primary restraint on the commercial expansion of the global organ transplant diagnostics market. Since the utilization of diagnostic assays is directly proportional to the volume of surgical procedures, the scarcity of available organs creates a hard ceiling on market revenue. This limitation reduces the frequency of presurgical compatibility testing and restricts the number of patients entering the monitoring phase after transplantation. Consequently, the market cannot fully capitalize on the clinical demand because the number of addressable patients is physically limited by the stagnant supply of donors.

This structural bottleneck creates a widening gap between potential demand and actual testing volumes. According to the Organ Procurement and Transplantation Network, in 2024, there were more than 103,000 candidates waiting for a transplant on the national waiting list in the United States. This substantial disparity highlights how the lack of donors prevents a large segment of the patient population from accessing the full range of diagnostic services, thereby hampering the recurring revenue streams derived from routine profiling.

Key Market Trends

The integration of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing predictive risk stratification, addressing inefficiencies in organ procurement that traditional methods cannot resolve. These technologies are increasingly deployed to analyze complex donor variables, optimizing the critical decision-making window between life support withdrawal and organ retrieval. By accurately predicting donor progression, AI tools minimize the discarding of viable organs, directly counteracting the persistent supply shortage. According to The Guardian, November 2025, in the article 'New AI tool could cut wasted efforts to transplant organs by 60%', a machine learning model developed by researchers at Stanford University demonstrated a 60% reduction in futile procurement attempts compared to standard clinical predictions, highlighting the operational efficacy of computational diagnostics.

Simultaneously, the market is experiencing a shift toward personalized transplant medicine through the adoption of novel RNA-based biomarkers that offer granular insights beyond standard liquid biopsies. Clinicians are moving toward transcriptomic profiling to assess rejection risk with higher specificity, allowing for tailored immunosuppression regimens that mitigate long-term graft toxicity. This demand for precision diagnostics is evidenced by the rapid commercial uptake of next-generation assays designed for individualized risk assessment. According to Verici Dx, July 2025, in a corporate update regarding its trading performance, the company reported 299 orders for its Tutivia diagnostic test in the second quarter of 2025, reflecting a growing clinical reliance on advanced genomic signatures for patient-specific management.

Segmental Insights

Next-Generation Sequencing (NGS) stands as the fastest-growing segment within the global organ transplant diagnostics market primarily due to its capability for high-resolution Human Leukocyte Antigen typing. This technology enhances donor-recipient matching accuracy significantly more than traditional serological methods, which directly aids in mitigating the risk of organ rejection. The expansion is further supported by the increasing implementation of high-throughput workflows in laboratories, allowing for the simultaneous processing of multiple samples. As a result, healthcare institutions are rapidly adopting NGS to ensure precise compatibility assessment and improve patient outcomes.

Regional Insights

North America leads the Global Organ Transplant Diagnostics Market, supported by established healthcare infrastructure and a high volume of transplant procedures. The region benefits from a structured regulatory environment and initiatives by organizations such as the United Network for Organ Sharing (UNOS) that improve organ allocation efficiency. Furthermore, favorable reimbursement policies and the concentration of major diagnostic manufacturers within the region drive the adoption of testing solutions. This ecosystem ensures consistent demand for diagnostics, cementing North America as the primary market for transplant-related technologies.

Recent Developments

• In October 2024, CareDx, Inc. announced a strategic partnership with Dovetail Genomics to advance human leukocyte antigen (HLA) genotyping for organ and stem cell transplant matching. This collaboration involved integrating Dovetail’s Hi-C LinkPrep technology into CareDx’s next-generation sequencing-based AlloSeq Tx 17 solution. The integration enabled high-resolution genotyping and haplotyping across the entire HLA region without the need for separate family studies. The President and Chief Executive Officer of CareDx highlighted that this development provided the transplant community with an important tool for optimizing donor-recipient matching, potentially improving the likelihood of long-term transplant success through more precise genetic analysis.
• In July 2024, Thermo Fisher Scientific introduced a new pre-transplant risk assessment assay designed to evaluate the probability of early acute rejection in kidney transplant recipients. Launched through the company’s CLIA-certified laboratory, this diagnostic tool utilizes proprietary markers to generate data that can inform personalized immunosuppression management. The President of Transplant Diagnostics at Thermo Fisher Scientific reported that the assay demonstrated improved prognostic accuracy compared to traditional risk factors such as panel-reactive antibodies. By identifying high-risk patients prior to surgery, the test aims to improve long-term graft outcomes and assist medical professionals in reducing rejection-related complications.
• In June 2024, Natera, Inc. launched a new feature for its Prospera Heart test known as the Donor Quantity Score. This product enhancement was designed to improve the detection of rejection in heart transplant patients by measuring the absolute amount of donor-derived cell-free DNA, rather than relying solely on the donor fraction. Data presented at an industry meeting indicated that the new scoring method increased test specificity to 84.2% and reduced false positive results by over 37%. The company noted that this advancement provided clinicians with a clearer assessment of rejection risk, complementing existing diagnostic metrics for better patient management.
• In April 2024, Eurofins Scientific completed the acquisition of Ascend Clinical, LLC, a large independent laboratory specializing in kidney dialysis testing in the United States. This acquisition significantly expanded Eurofins' operational footprint in the transplant diagnostics and renal care sectors. By integrating Ascend’s specialized testing services with its own extensive bioanalytical network, Eurofins aimed to enhance its support for transplant networks and dialysis clinics nationwide. The Chief Executive Officer of Eurofins stated that the transaction reinforced the company's commitment to providing high-quality testing solutions for patients in the renal and transplantation fields, thereby broadening their service offerings to a more extensive client base.

Key Market Players

• 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, in addition to the industry trends which have also been detailed below:

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

• Organ Transplant Diagnostics Market, By Transplant Type:

• Solid Organ Transplant (Kidney, Liver, Lung, Pancreas, and 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE