Cell-Free DNA Testing Transplant Market : Global Industry Analysis and Opportunity Assessment, 2036

How big is Cell-Free DNA Testing Transplant Market in 2026?

USD 466.3 million in 2026 and USD 934.6 million by 2036 at a 7.2% CAGR.

Demand for the cell-free DNA testing transplant market is forecast to expand at 7.2% CAGR between 2026 and 2036, increasing valuation from USD 466.3 million in 2026 to USD 934.6 million by 2036. Transplant programs purchase these assays to add a repeatable blood-based signal between routine laboratory surveillance and invasive biopsy decisions. The American Society of Transplant Surgeons stated in October 2024 that kidney programs rely heavily on serum creatinine plus urine protein and donor-specific antibody monitoring. Conventional measures can identify injury late or leave uncertain cases dependent on invasive tissue sampling for clarification. Cell-free DNA testing creates commercial value through validated results inside a defined clinical escalation protocol. Related transplant diagnostics research helps laboratories compare post-transplant services with broader compatibility testing across the transplant pathway. Comparable liquid biopsy workflows clarify specimen handling requirements and sample-processing economics without proving transplant-specific clinical adoption. Contracts gain value through predictable testing cadence plus interpretation and reimbursement support with sample logistics.

Commercial routes differ between centralized reference testing and in-house laboratory models across national health systems. United States transplant centers can order covered laboratory-developed tests through national service networks without installing sequencing equipment. European hospitals can evaluate regulated assay kits that place testing inside qualified molecular laboratories with local validation and trained staff. The United Kingdom route depends on public-service evidence and laboratory commissioning across a centralized transplant system. Germany offers strong transplant-center infrastructure but in-house adoption requires instrument compatibility and documented quality procedures. Japan and South Korea have concentrated tertiary transplant networks that support specialized testing despite unresolved local authorization and reimbursement routes. Broader molecular diagnostics research provides useful technology context for laboratory investment without establishing a transplant-specific purchasing route. Related clinical NGS analysis research helps transplant laboratories assess data-processing requirements across complex sequencing workflows and reporting systems. Purchasing decisions therefore separate assay performance from service distance plus report turnaround and training burden with payer coverage.

Summary of the Cell-Free DNA Testing Transplant Market

Market Signal	Commercial Impact
Demand and Growth Drivers	Transplant programs create measurable demand through recurring blood-based surveillance that reduces uncertainty between routine laboratory monitoring and invasive biopsy decisions. Kidney transplant volume supports frequent monitoring needs across a large recipient population with long follow-up periods. Coverage policies improve purchasing confidence when test indications and permitted surveillance cadence remain clearly defined for clinicians. Centralized services lower installation requirements while decentralized kits give qualified hospitals greater control over turnaround and sample custody. Specialist interpretation and rapid sample logistics convert each assay result into a clinically usable service rather than an isolated laboratory measurement.
Product and Segment View	The product architecture combines donor-derived cell-free DNA measurement with laboratory processing and clinically interpretable reporting. Platform choice changes capital requirements and operational responsibility across transplant centers using centralized services or qualified local laboratories. Kidney transplant is projected to hold 31.7% share in 2026 driven by its large recipient base and longitudinal monitoring requirements. Next-generation sequencing is estimated to hold 36.5% share in 2026 owing to standardized high-marker laboratory workflows and coordinated quality controls. Acute rejection monitoring is projected at 36.8% share supported by its direct role in time-sensitive clinical investigation and treatment escalation. Hospitals are likely to account for 44.3% share in 2026, internal testing requires validation investment and sustained sample volume.
Geography and Growth Outlook	National growth differs through transplant volume plus reimbursement and laboratory authorization with dependable local service access and trained personnel. South Korea is forecast to record 8.8% CAGR through 2036 with registry infrastructure and concentrated tertiary transplant care supporting implementation. Germany and Japan form a close growth cluster although their transplant volumes and local approval routes differ materially. The USA requires coverage evidence plus service integration despite established transplant programs and broad national specimen logistics. The UK depends on public commissioning plus laboratory access despite national coordination across specialist transplant centers.
Competitive Landscape	Competition separates centralized testing services from decentralized assay kits and instrument partnerships with different ownership of validation responsibilities. Clinical breadth matters alongside regulatory authorization and laboratory support because transplant programs need evidence for each covered organ pathway. CareDx and Natera operate centralized multi-organ testing services with national specimen logistics across the United States. Eurofins Viracor provides a specialized reference-laboratory service that supports kidney transplant monitoring through centralized processing. Insight Molecular Diagnostics and Devyser develop decentralized assays that place validation responsibility inside qualified molecular laboratories. Thermo Fisher Scientific and Bio-Rad support instrument access while Eurobio Scientific manages laboratory assay channels outside North America.
Analyst Perspective	Executives should treat donor-derived cell-free DNA as a decision-support service rather than an isolated reagent purchase. Clinical value depends on protocol fit and accountable follow-up through clearly assigned interpretation and treatment-escalation responsibilities. Transplant programs should verify each organ indication and define how results change biopsy or treatment decisions. Laboratory leaders should compare sample turnaround with internal validation cost plus technical support and quality responsibility. Financial review should test reimbursement stability and utilization thresholds across the complete post-transplant follow-up pathway. - Anurag Sharma, Principal Analyst at Future Market Insights

Source: FMI's proprietary forecasting model and primary research

How is the cell-free DNA testing transplant market segmented?

The cell-free DNA testing transplant industry is segmented by transplant type, technology, application, end user, and region.

Transplant type separates kidney plus heart and lung pathways from liver and other organ transplants because each graft has different injury patterns and monitoring protocols. Technology distinguishes next-generation sequencing from PCR-based assays plus digital PCR and other methods that quantify donor-derived genetic material. Application analysis separates acute rejection monitoring from graft surveillance plus broader post-transplant monitoring and diagnostic support. End-user categories distinguish hospitals from dedicated transplant centers plus diagnostic laboratories and academic research institutes according to testing ownership and clinical responsibility. Regional analysis compares national systems through approval routes plus payer coverage and laboratory capacity with transplant activity and service access. The classification excludes pre-transplant histocompatibility testing and unrelated oncology liquid biopsy revenue because neither belongs to post-transplant donor-derived cell-free DNA monitoring.

How does Kidney Transplant influence monitoring design within the Transplant Type category?

Kidney recipients form the broadest recurring monitoring population because graft function requires years of laboratory follow-up. The Health Resources and Services Administration reported 27,759 kidney transplants in the United States during 2024. The documented procedure volume establishes a substantial clinical monitoring workload without proving that transplant centers purchased any specific assay. Transplant programs assess cell-free DNA testing through monitoring frequency plus reimbursement and turnaround with the ability to reduce unnecessary biopsies. Related organ preservation solutions research provides adjacent context for graft management without replacing transplant-specific evidence.

• Within transplant type, kidney transplant is projected to account for 31.7% share in 2026 attributed to its large recipient base and established surveillance schedules. Long follow-up periods create recurring testing occasions that support sustained service revenue beyond the initial transplant episode.
• Kidney-focused assay adoption is expanding among nephrologists and transplant coordinators who investigate graft injury alongside creatinine and donor-specific antibody results. A defined escalation plan remains necessary because positive molecular signals can require selective tissue confirmation and careful multidisciplinary treatment review.

What drives adoption of Next-Generation Sequencing within the Technology category?

Sequencing platforms estimate donor-derived fractions across many genetic markers without requiring donor genotyping in several commercial workflows. Hospitals require validated instruments plus contamination controls and trained molecular staff capable of maintaining reproducible analytical performance. CareDx reported in February 2025 that a decentralized AlloSeq-cfDNA study included 580 kidney recipients across three European centers. The announcement described strong consistency with its centralized assay, and sequencing quality control research clarifies the operational burden without independently proving commercial adoption.

• Multiplexed marker coverage supports standardized centralized testing across large sample networks through consistent analytical pipelines and coordinated quality controls. Next-generation sequencing is likely to capture 36.5% share within technology in 2026 through established commercial service platforms and mature laboratory workflows.
• Sufficient national sample volume supports efficient batched processing and consistent analytical quality across centralized reference laboratory networks. Smaller transplant centers may prefer outsourced next-generation sequencing services because local ownership adds capital expense and specialized quality-management responsibility across sustained daily operations.

What makes Acute Rejection Monitoring central to the Application category?

Acute rejection monitoring requires a timely signal that can guide biopsy decisions during clinically uncertain episodes. Natera reported in April 2024 that its prospective ProActive analysis covered 1,631 kidney recipients with at least eighteen months of follow-up. Donor-derived cell-free DNA increased before biopsy-proven antibody-mediated and T-cell-mediated rejection among participants included in the prospective study. The reported timing supports earlier clinical investigation through an additional biomarker signal rather than independent rejection diagnosis. Genomic risk stratification research offers related clinical decision-framework context without independently proving transplant-specific outcomes or purchasing behavior.

• Application is forecast to be led by acute rejection monitoring at 36.8% share in 2026 supported by its direct connection with urgent clinical decisions. The use case supports premium interpretation and rapid reporting whenever clinicians must distinguish possible rejection from other graft injuries.
• Purchases of acute rejection monitoring services are anticipated to rise among transplant physicians facing uncertain conventional markers and practical biopsy risks. Utilization remains strongest inside protocols that define sampling triggers and clearly establish how results change immunosuppression or tissue evaluation.

How do hospitals evaluate cell-free DNA testing within the End User category?

Hospitals coordinate transplant surgery and graft management through multidisciplinary teams that control test ordering and treatment escalation. Hospital laboratories must align assay performance with accreditation requirements and clinical reporting systems plus quality controls. Analytical laboratory services research helps administrators compare internal molecular capacity with outsourced processing and support. Devyser announced in April 2024 that Advyser Solid organs received IVDR approval as software used with the One Lambda Devyser Accept cfDNA kidney-monitoring assay. The approval supports regulated decentralized testing in Europe while local authorization and hospital validation remain necessary for use.

• Hospital teams control transplant care pathways and laboratory governance across recurring recipient monitoring and treatment escalation. Hospitals are expected to represent 44.3% of end user in 2026 driven by integrated clinical responsibility. Shared clinical records help multidisciplinary teams connect molecular results with medication changes and selective biopsy planning.
• Recurring test volume can justify local assay validation and quality-control costs for hospital laboratory directors with qualified molecular teams. Lower-volume transplant programs often prefer outsourced services that provide broader organ coverage without maintaining specialized molecular infrastructure and dedicated sequencing personnel.

What are the drivers, restraints, and opportunities in the cell-free DNA testing transplant market?

High transplant-monitoring workload supports recurring testing; limited standalone diagnostic certainty constrains use; decentralized platforms create an opening for qualified hospital laboratories.

• Driver: Recurring surveillance and clinically uncertain graft injury create demand for repeatable blood-based information between routine laboratory tests and biopsy.
• Restraint: Donor-derived cell-free DNA cannot identify every rejection phenotype reliably without supporting clinical data and validated escalation rules.
• Opportunity: Decentralized kits can shorten result ownership for qualified hospitals that maintain appropriate instruments and molecular quality systems.

Recurring surveillance creates demand as transplant teams need repeated evidence between routine laboratory changes and biopsy decisions. CareDx reported in August 2025 that the Kidney Allograft Outcomes AlloSure Registry included 1,743 recipients across 56 United States transplant centers. The registry protocol prescribed seven tests during year one and four annual tests during years two and three, creating recurring service revenue across several post-transplant years. Related clinical diagnostics research helps laboratories compare operating models, but explicit testing schedules determine budget responsibility and clinical escalation without functioning as reimbursement evidence.

Clinical interpretation remains the main restraint because elevated donor-derived cell-free DNA can reflect graft injury without identifying one definitive cause. The European Society for Organ Transplantation consensus concluded that serial testing may help exclude subclinical antibody-mediated rejection in stable kidney recipients. The same consensus found weaker support for identifying subclinical T-cell-mediated rejection through the biomarker alone. Transplant teams therefore combine results with graft function and antibody findings plus imaging or biopsy evidence. Adoption slows whenever commercial materials imply diagnostic certainty beyond the validated clinical population and documented rejection use case.

Decentralized testing creates a commercial opening for transplant centers that already operate qualified molecular laboratories. In August 2024, Oncocyte described initial GraftAssure shipments to sites in the United States and Southeast Asia with instrument validation and staff training. Local processing reduces specimen transport and improves turnaround control, but the hospital accepts assay validation plus equipment maintenance and proficiency-testing responsibilities. Commercial expansion depends on support packages covering onboarding and quality controls plus software updates and technical response.

Which country CAGRs are profiled in the cell-free DNA testing transplant market?

Country	CAGR
USA	5.8%
UK	6.3%
Germany	7.8%
Japan	7.4%
South Korea	8.8%

How do country-level CAGRs compare in the cell-free DNA testing transplant market?

The country forecasts span 3.0 percentage points from the USA at 5.8% to South Korea at 8.8%. Germany and Japan form a close upper-middle cluster with four-tenths of a percentage point separating their modeled rates. The UK occupies the measured space between the USA and the Germany-Japan pair without joining either close cluster. South Korea remains one percentage point above Germany within the same five-country forecast comparison presented here. Forecast spacing describes modeled market momentum rather than current revenue scale or installed testing volume in each country.

• South Korea’s separated rate requires faster conversion from clinical evaluation into recurring orders than the middle cluster requires.
• Germany and Japan need separate launch economics because their narrow percentage gap can conceal different pricing and validation timelines.
• The UK’s intermediate rate supports phased milestones that distinguish initial hospital acceptance from sustained testing cadence across annual budgets.
• The USA’s lower modeled pace places greater commercial weight on account retention and repeat utilization than rapid greenfield expansion.
• Every country figure remains a forecast output and cannot establish legal availability or present company access by itself.

Comparable growth rates do not create identical entry conditions because regulation and service responsibility differ across national systems. Manufacturers must match authorization and training with financing plus laboratory economics inside each country-specific launch plan. The full report provides country-level CAGR analysis across North America, Latin America, Europe, East Asia, South Asia, Oceania and the Middle East and Africa.

Country-wise Analysis

• United States transplant centers can order several Medicare-recognized donor-derived cell-free DNA services through national reference laboratories. Demand for the cell-free DNA testing transplant market in the USA is forecast to rise at 5.8% CAGR over the assessment period through established testing networks and defined coverage routes. The Centers for Medicare & Medicaid Services posted the final MolDX LCD notice on July 16, 2026. The policy is scheduled to take effect on August 30, 2026 and covers qualifying for-cause or surveillance uses under organ-specific criteria. Commercial payer variation and detailed documentation remain material frictions that prevent uniform utilization across eligible recipient populations. Hospital contracts should define covered indications and turnaround requirements while assigning responsibility for claims denied by individual payers.
• NHS Blood and Transplant coordinates national organ allocation through the NHS Organ Donor Register and National Transplant Register. The UK cell-free DNA testing transplant market is projected to record 6.3% CAGR during the assessment period through public-service evaluation and centralized clinical pathways. Public commissioning requires transplant programs to establish service impact and laboratory ownership before recurring testing enters annual budgets. NHS Blood and Transplant reports that it facilitated nearly 4,600 transplants across the United Kingdom during 2024/25. National coordination supports multicenter protocol review but public commissioning can delay adoption without clear budget ownership and evidence that results change biopsy or treatment decisions within NHS pathways.
• Germany concentrates specialist transplantation within nationally coordinated centers and university hospitals linked to the Eurotransplant allocation framework. The German cell-free DNA testing transplant market is estimated to post 7.8% CAGR over the assessment period through specialist capacity and established molecular laboratories. The German Organ Transplantation Foundation reported 985 deceased donors and 3,020 distributed organs during 2025. Concentrated transplant activity supports recurring molecular surveillance programs at major university hospitals with established specialist laboratory infrastructure. Reimbursement pathways and decentralized assay validation remain material barriers across statutory insurance and regional laboratory operations. Commercial entry requires German-language training and documented instrument compatibility plus reliable technical support for qualified laboratories.
• Japan’s national post-transplant survey requires transplant facilities to submit recipient follow-up information through the TRACER registry or an approved paper route. Sales of cell-free DNA transplant testing in Japan are forecast to expand at 7.4% CAGR by 2036 through structured recipient follow-up and specialist hospital care. Structured reporting supports longitudinal follow-up but does not create automatic access to commercially available donor-derived cell-free DNA assays. Japan Organ Transplant Network data dated June 30, 2026 listed 14,983 registered kidney candidates in the official national waiting list. Extended waiting periods increase the value of graft preservation, yet local authorization and laboratory governance require Japanese validation plus distribution and technical service aligned with national reporting.
• South Korea maintains a multicenter national transplant cohort across kidney and four other solid organs. The South Korean cell-free DNA testing transplant market is anticipated to advance at 8.8% CAGR over the assessment period through registry infrastructure and concentrated tertiary hospitals. The Korea National Institute of Health reported in November 2024 that 86 centers participate across five organ cohorts and register more than 2,000 new recipients annually. The national registry supports longitudinal evidence development and protocol comparison across participating Korean transplant institutions. Local reimbursement and regulatory authorization remain material constraints, so companies need Korean clinical partnerships and qualified specimen-processing or in-house testing routes.

Who are the notable companies in the cell-free DNA testing transplant market?

CareDx, Natera, Eurofins Viracor, Insight Molecular Diagnostics, Devyser Diagnostics, Thermo Fisher Scientific, Bio-Rad Laboratories, and Eurobio Scientific are notable companies shaping this market.

Competition combines centralized clinical testing with decentralized kits and instrument partnerships that assign different laboratory responsibilities. CareDx and Natera operate United States services across kidney plus heart and lung recipients while Eurofins Viracor provides TRAC through a specialized reference laboratory. Insight Molecular Diagnostics develops a covered kidney service and digital PCR kit while Devyser owns a sequencing-based laboratory assay. Thermo Fisher Scientific supports assay distribution through One Lambda and Bio-Rad supplies the digital PCR platform used during GraftAssure development. Eurobio Scientific commercializes transplant monitoring assay products through laboratory channels outside North America and selected international territories. Related organ perfusion products research gives executives adjacent transplant-system context without proving competitive capability in this testing category.

• CareDx and Natera compete through national testing logistics plus multi-organ clinical services and integrated physician reporting. Their selection value rests on validated organ indications and reimbursement access rather than instrument ownership or local laboratory validation capacity.
• Eurofins Viracor addresses centralized reference testing while Eurobio Scientific serves laboratory assay channels outside North America. Customers must verify service geography plus assay authorization because corporate scale does not guarantee local access or dependable technical support.
• Insight Molecular Diagnostics and Devyser pursue decentralized testing through digital PCR or sequencing kits designed for qualified molecular laboratories. Thermo Fisher Scientific and Bio-Rad strengthen instrument access plus technical distribution while laboratories retain validation and quality responsibility.

Competitive Benchmarking: Cell-Free DNA Testing Transplant Market

Company	Clinical Testing Services	Decentralized Assay Platform	Multi-Organ Coverage	Geographic Reach
CareDx	High	Low	High	United States
Natera	High	Low	High	United States
Eurofins Viracor	Medium	Low	Low	United States
Insight Molecular Diagnostics	Medium	Medium	Low	United States and selected international centers
Devyser Diagnostics	Low	High	Low	Europe and selected international markets
Thermo Fisher Scientific	Low	Medium	Low	Europe and selected international markets
Bio-Rad Laboratories	Low	Medium	Low	Global partner markets
Eurobio Scientific	Low	High	Low	Europe and selected international markets

Scoring basis: Clinical Testing Services is High for commercial multi-organ patient testing and Medium for one-organ clinical testing whereas Low indicates verified participation without a patient-testing service. Decentralized Assay Platform is High for an owned regulated kit with software and Medium for a research kit or verified distribution role. Low applies to documented service participation without a deployable kit and related laboratory software for qualified transplant centers. Multi-Organ Coverage is High for three or more solid organs and Medium for two organs. A current kidney-specific offering receives Low under the documented single-organ threshold for commercial coverage assessment.

Key Developments in the Cell-Free DNA Testing Transplant Market

• In June 2024, Natera launched Donor Quantity Score as a new feature for Prospera Heart. Natera stated that the method combines donor-derived fraction with absolute donor-derived quantity to improve rejection detection across acute cellular and antibody-mediated rejection. The development broadened the test’s clinical reporting proposition without changing the continuing need for qualified physician interpretation.
• In March 2025, CareDx expanded AlloSure testing to pediatric heart recipients of every age and simultaneous pancreas-kidney recipients. CareDx stated that both expanded indications received New York State Clinical Laboratory Evaluation Program approval for clinical testing. The expansion widened the addressable recipient populations for CareDx centralized testing services across two specialized transplant pathways.
• In March 2026, Insight Molecular Diagnostics submitted GraftAssureDx for United States Food and Drug Administration review as a kidney transplant rejection testing kit. The filing followed ISO 13485 certification and included analytical data plus clinical evidence that the company presented for regulatory review. Commercial clinical use remains dependent on regulatory authorization and launch execution rather than completion of the filing alone.
• In June 2026, CareDx completed the sale of its Lab Products business to Eurobio Scientific for USD 171.2 million in cash consideration. The transferred business included NGS-based monitoring assays for solid organ and stem cell recipients outside North America. The closing changed product ownership while CareDx retained its core United States precision medicine testing focus.

Key Players in the Cell-Free DNA Testing Transplant Market

Centralized Testing Services

• CareDx
• Natera
• Eurofins Viracor

Decentralized Assay Developers

• Insight Molecular Diagnostics
• Devyser Diagnostics
• Eurobio Scientific

Platform and Distribution Partners

• Thermo Fisher Scientific
• Bio-Rad Laboratories

Cell-Free DNA Testing Transplant Market - Report Scope

Coverage field	Report scope
Market breakdown	Transplant type, technology, application, end user, and region.
Quantitative Units	USD million
Market Definition	Blood-based donor-derived cell-free DNA tests plus assay kits and laboratory services with directly associated software and interpretation used for post-transplant graft surveillance and rejection assessment.
Regions Covered	North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia and Pacific, and Middle East and Africa.
Countries Covered	USA, UK, Germany, Japan, and South Korea.
Key Companies Profiled	CareDx, Natera, Eurofins Viracor, Insight Molecular Diagnostics, Devyser Diagnostics, Thermo Fisher Scientific, Bio-Rad Laboratories, and Eurobio Scientific.
Forecast Period	2026 to 2036.
Approach	Hybrid bottom-up and top-down market sizing supported by market-specific primary interviews and authoritative official desk research.

Cell-Free DNA Testing Transplant Market - Research Methodology

Method	Approach
Primary Research	FMI analysts gathered input from manufacturers, service providers, technology developers, distributors, end users, procurement teams, and subject-matter experts. Interviews examined purchasing decisions, product or service evaluation, adoption barriers, approval requirements, pricing considerations, and expectations for technical or commercial support. Respondents were also asked what evidence is required before a trial, pilot, or initial order develops into regular purchasing.
Desk Research	Desk research covered government statistics, regulatory publications, trade data, industry associations, technical literature, standards, company filings, product information, and official corporate announcements. Sources were reviewed for relevance, publication date, geographic coverage, and consistency with the defined market scope. Claims relating to performance, applications, approvals, capacity, investment, and commercial activity were retained only when supported by credible public evidence.
Market Sizing and Forecasting	The market model combined the baseline value with historical performance, segment structure, pricing and volume indicators, adoption levels, company participation, and country-level demand conditions. Forecast assumptions considered economic activity, investment trends, regulatory developments, technology adoption, purchasing cycles, supply availability, and barriers to wider market use. Segment and regional estimates were reconciled before the final market total was calculated.
Data Validation	Estimates were checked against multiple independent indicators, including public data, company activity, trade patterns, industry developments, and findings from primary interviews. Validation also tested whether products, services, applications, and company revenues fell within the defined market boundaries. Adjacent categories, unsupported claims, overlapping revenues, and activities without direct market relevance were excluded to reduce double counting and maintain consistency across segments and countries.

Cell-Free DNA Testing Transplant Market by Segments

Cell-Free DNA Testing Transplant Market segmented by Transplant Type:

• Kidney Transplant
• Heart Transplant
• Lung Transplant
• Liver Transplant
• Other Organ Transplants

Cell-Free DNA Testing Transplant Market segmented by Technology:

• Next-Generation Sequencing
• PCR-based Assays
• Digital PCR
• Other Technologies

Cell-Free DNA Testing Transplant Market segmented by Application:

• Acute Rejection Monitoring
• Graft Surveillance
• Post-transplant Monitoring
• Diagnostic Support

Cell-Free DNA Testing Transplant Market segmented by End User:

• Hospitals
• Transplant Centers
• Diagnostic Laboratories
• Academic Research Institutes

Cell-Free DNA Testing Transplant Market by Region:

• North America
  • United States
  • Canada
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Chile
• Western Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Benelux
  • Nordics
• Eastern Europe
  • Poland
  • Czech Republic
  • Romania
  • Hungary
• East Asia
  • China
  • Japan
  • South Korea
• South Asia and Pacific
  • India
  • ASEAN
  • Australia and New Zealand
• Middle East and Africa
  • GCC Countries
  • South Africa
  • Türkiye
  • Israel

Research Sources and Bibliography

• American Society of Transplant Surgeons. (2024, October). ASTS Statement on donor-derived cell-free DNA (dd-cf-DNA).
• Health Resources and Services Administration. (2025, January 15). Organ Transplants Exceeded 48,000 in 2024; a 3.3 Percent Increase From the Transplants Performed in 2023.
• CareDx, Inc. (2025, February 20). CareDx Announces Study Showing AlloSeq cfDNA Highly Accurate in Detecting Rejection in Organ Transplant Patients.
• Natera, Inc. (2024, April 11). Natera Announces Publication of Largest Prospective dd-cfDNA Study in Kidney Transplantation.
• Thermo Fisher Scientific. (n.d.). One Lambda Devyser Accept cfDNA Assay.
• CareDx, Inc. (2025, August 6). CareDx Announces Landmark KOAR Study Published in the American Journal of Transplantation.
• Park, S., Sellares, J., Tinel, C., Anglicheau, D., Bestard, O., & Friedewald, J. J. (2024, January 4). European Society of Organ Transplantation Consensus Statement on Testing for Non-Invasive Diagnosis of Kidney Allograft Rejection. Transplant International, 36, Article 12115.
• Oncocyte Corporation. (2024, August 8). Oncocyte Announces Successful GraftAssure™ Beta Launch and Q2 2024 Results.
• Centers for Medicare & Medicaid Services. (2026, July 16). MolDX: Molecular Testing for Solid Organ Allograft Rejection (L40062).
• NHS Blood and Transplant. (n.d.). Organ donation and transplantation.
• Deutsche Stiftung Organtransplantation. (2026, January 13). Organspendezahlen 2025 auf höchstem Stand seit 2012, dennoch weiterhin großer Bedarf.
• Japan Organ Transplant Network. (2026, June 30). [Number of registered transplant candidates].
• Japan Organ Transplant Network. (2026, January 5). 2025[Implementation of the fiscal 2025 post-organ-transplant survey (request)].
• Korea National Institute of Health. (2024, November 21).[Organ transplantation cohort].
• Centers for Medicare & Medicaid Services. (2026, January 12). Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection (A58019).
• Insight Molecular Diagnostics Inc. (n.d.). iMDx Company Profile.
• Devyser Diagnostics AB. (n.d.). One Lambda Devyser Accept cfDNA.
• Natera, Inc. (2024, June 17). Natera Launches Differentiated New Feature for Prospera™ Heart Test, Enhancing Detection of Rejection for Transplant Patients.
• CareDx, Inc. (2025, March 11). CareDx Launches Two Expanded Indications for AlloSure Testing Services.
• Insight Molecular Diagnostics Inc. (2026, March 26). IMDX Submits GraftAssureDx for FDA Review and Reports Q4 2025 Results.
• CareDx, Inc. (2026, June 30). CareDx Announces Completion of Sale of Lab Products Business to Eurobio Scientific.
• Devyser Diagnostics AB. (2024, April 25). Devyser receives IVDR approval for post-transplant monitoring software.

This bibliography is provided for reader reference and is not exhaustive. The full report contains the complete reference list and detailed citations.

This Report Answers

• How large is the cell-free DNA testing transplant market in 2026 and 2036?
• Which clinical pressures support recurring donor-derived cell-free DNA testing after transplantation?
• Why does Kidney Transplant hold the main Transplant Type share in 2026?
• How does Next-Generation Sequencing support centralized and decentralized testing models?
• What limits standalone interpretation of donor-derived cell-free DNA results?
• How do country growth rates differ across the USA, UK, Germany, Japan, and South Korea?
• Which companies provide testing services plus assay kits and enabling platforms?
• How can decentralized testing change laboratory ownership and turnaround responsibility?
• What should hospital leaders evaluate before adopting transplant cell-free DNA testing?