Market overview
The global transplant biomarker risk stratification market is worth USD 616 mn in 2026 and is forecast to reach USD 1.4 bn by 2036, growing at a 8.5% CAGR. United States is the largest country market and Donor-derived cell-free DNA is the largest by assay segment.
| Scope | Blood and urine tests that detect rejection and injury in transplanted organs by measuring donor-derived cell-free DNA, gene expression and other biomarkers, sold as laboratory services. |
|---|---|
| Industry | Healthcare |
| Value 2025 | USD 560 mn |
| Value 2026 | USD 616 mn |
| Value 2036 | USD 1.4 bn |
| CAGR 2026-2036 | 8.5% |
| Volume 2026 | 495,000 tests |
| Volume 2036 | 1,119,187 tests |
| Average price 2026 | USD 1,244 per test |
| Report price | Starts from USD 1,999 |
| Published | November 2026 |
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Transplant Biomarker Risk Stratification market size and forecast, 2026-2036
Source: Compare Market Research analysis.
© 2026 Compare Market Research. All rights reserved.
| Year | Market value |
|---|---|
| 2026 | USD 616 mn |
| 2027 | USD 668 mn |
| 2028 | USD 725 mn |
| 2029 | USD 787 mn |
| 2030 | USD 854 mn |
| 2031 | USD 926 mn |
| 2032 | USD 1.0 bn |
| 2033 | USD 1.1 bn |
| 2034 | USD 1.2 bn |
| 2035 | USD 1.3 bn |
| 2036 | USD 1.4 bn |
Transplant Biomarker Risk Stratification market segmentation
By assay
Source: Compare Market Research analysis.
© 2026 Compare Market Research. All rights reserved.
| Segment | Share 2026 | Share 2036 | Value 2026 | CAGR 2026-36 |
|---|---|---|---|---|
| Donor-derived cell-free DNA | 62.0% | 69.3% | USD 382 mn | 9.7% |
| Gene expression profiling | 20.0% | 15.4% | USD 123 mn | 5.7% |
| Other biomarker assays | 18.0% | 15.3% | USD 111 mn | 6.7% |
By organ
Source: Compare Market Research analysis.
© 2026 Compare Market Research. All rights reserved.
| Segment | Share 2026 | Share 2036 | Value 2026 | CAGR 2026-36 |
|---|---|---|---|---|
| Kidney | 62.0% | 63.0% | USD 382 mn | 8.7% |
| Heart | 20.0% | 16.9% | USD 123 mn | 6.7% |
| Liver, lung and other | 18.0% | 20.1% | USD 111 mn | 9.7% |
By use
| Segment | Share 2026 | Share 2036 | Value 2026 | CAGR 2026-36 |
|---|---|---|---|---|
| Rejection monitoring | 48.0% | 44.0% | USD 296 mn | 7.6% |
| Immunosuppression guidance | 30.0% | 30.0% | USD 185 mn | 8.5% |
| Infection risk | 22.0% | 26.0% | USD 136 mn | 10.3% |
By platform
| Segment | Share 2026 | Share 2036 | Value 2026 | CAGR 2026-36 |
|---|---|---|---|---|
| NGS and digital PCR | 44.0% | 52.0% | USD 271 mn | 10.3% |
| PCR and microarray | 34.0% | 28.0% | USD 209 mn | 6.4% |
| Immunoassay and others | 22.0% | 20.0% | USD 136 mn | 7.5% |
By lab
| Segment | Share 2026 | Share 2036 | Value 2026 | CAGR 2026-36 |
|---|---|---|---|---|
| Reference labs | 56.0% | 54.0% | USD 345 mn | 8.1% |
| Hospital labs | 32.0% | 32.0% | USD 197 mn | 8.5% |
| Transplant centres | 12.0% | 14.0% | USD 74 mn | 10.2% |
Top 25 countries for transplant biomarker risk stratification by revenue
Countries are ranked by revenue earned from sales in the country, not by where the product is made. The ten largest hold 98.5% of 2026 revenue and the 25 countries below together hold 99.4%.
Source: Compare Market Research analysis.
© 2026 Compare Market Research. All rights reserved.
| # | Country | Value 2026 | Share 2026 | Value 2036 | CAGR 2026-36 |
|---|---|---|---|---|---|
| 1 | United States | USD 493 mn | 80.0% | USD 1.1 bn | 8.4% |
| 2 | Germany | USD 25 mn | 4.0% | USD 58 mn | 9.0% |
| 3 | United Kingdom | USD 18 mn | 3.0% | USD 43 mn | 8.9% |
| 4 | France | USD 15 mn | 2.5% | USD 36 mn | 8.9% |
| 5 | Italy | USD 12 mn | 2.0% | USD 29 mn | 9.0% |
| 6 | Spain | USD 12 mn | 2.0% | USD 29 mn | 9.0% |
| 7 | Japan | USD 9.2 mn | 1.5% | USD 22 mn | 9.2% |
| 8 | Canada | USD 9.2 mn | 1.5% | USD 22 mn | 9.2% |
| 9 | Australia | USD 6.2 mn | 1.0% | USD 14 mn | 8.5% |
| 10 | Netherlands | USD 6.2 mn | 1.0% | USD 14 mn | 8.5% |
| 11 | Switzerland | USD 1.2 mn | 0.2% | USD 2.6 mn | 7.9% |
| 12 | Austria | USD 0.74 mn | 0.1% | USD 1.5 mn | 7.6% |
| 13 | Belgium | USD 0.55 mn | 0.09% | USD 1.1 mn | 7.2% |
| 14 | Sweden | USD 0.43 mn | 0.07% | USD 0.97 mn | 8.5% |
| 15 | Denmark | USD 0.37 mn | 0.06% | USD 0.84 mn | 8.5% |
| 16 | South Korea | USD 0.31 mn | 0.05% | USD 0.70 mn | 8.5% |
| 17 | Israel | USD 0.31 mn | 0.05% | USD 0.84 mn | 10.5% |
| 18 | Brazil | USD 0.25 mn | 0.04% | USD 0.84 mn | 13.0% |
| 19 | Poland | USD 0.25 mn | 0.04% | USD 0.70 mn | 10.9% |
| 20 | Mexico | USD 0.25 mn | 0.04% | USD 0.70 mn | 10.9% |
| 21 | Taiwan | USD 0.18 mn | 0.03% | USD 0.42 mn | 8.5% |
| 22 | Norway | USD 0.18 mn | 0.03% | USD 0.42 mn | 8.5% |
| 23 | India | USD 0.18 mn | 0.03% | USD 0.56 mn | 11.7% |
| 24 | Singapore | USD 0.18 mn | 0.03% | USD 0.56 mn | 11.7% |
| 25 | Turkey | USD 0.18 mn | 0.03% | USD 0.42 mn | 8.5% |
| Rest of world | USD 3.6 mn | 0.6% | USD 6.3 mn | 5.6% |
Source: Compare Market Research analysis.
© 2026 Compare Market Research. All rights reserved.
Competitive landscape
Group 1: Global leaders
- CareDx
- Natera
Group 2: Regional and specialist players
- Eurofins Viracor
- Oncocyte
Group 3: Emerging and niche players
- Verici Dx
- Quest Diagnostics
Research methodology
Every figure on this page comes from the research framework that we apply to all of the markets we cover. The 2025 base for the transplant biomarker risk stratification market is built from the volume sold and the price that buyers pay, and is cross-checked against the size of the wider industry the market belongs to. Where a market can be sized in more than one way, the routes are compared before a figure is set.
The forecast runs year by year from the 2025 base to 2036. Growth in each year reflects demand from the industries that buy the product, adoption of new technology, pricing, regulation and replacement cycles. Volume and price are modelled together, so revenue in each year equals volume multiplied by average price. The 2026 to 2036 compound annual growth rate of 8.5% is calculated from the resulting values.
The market is divided by assay, by organ, by use, by platform, by lab. The 25 largest countries are ranked by revenue earned from sales to buyers in each country, not by where the product is made. Segment values and country values add up to the market total in every year, and every report is checked for consistency before it is published.
Companies are placed in three groups: global leaders, regional and specialist players, and emerging and niche players. The groups describe how companies compete in the market. They are not a ranking and they are not market shares.
Our analysts also carry out primary research. Customized reports add interviews with key opinion leaders, such as senior executives, technical specialists and buyers, to test the assumptions behind the numbers for the question being asked.
Frequently asked questions
How big is the transplant biomarker risk stratification market?
The global transplant biomarker risk stratification market is estimated at USD 560 mn in 2025 and USD 616 mn in 2026.
How fast will the transplant biomarker risk stratification market grow?
It is forecast to reach USD 1.4 bn by 2036, a compound annual growth rate of 8.5% from 2026, an increase of USD 777 mn.
Which country is the largest market for transplant biomarker risk stratification?
United States is the largest market by revenue at USD 493 mn in 2026, 80.0% of the global total. The three largest countries together hold 87.0%.
Which country is growing fastest?
Among the ten largest markets, Japan is growing fastest at 9.2% a year from 2026 to 2036.
Which transplant biomarker risk stratification segment is largest?
In the by assay split, Donor-derived cell-free DNA is the largest segment with 62.0% of 2026 revenue.
Who are the leading transplant biomarker risk stratification companies?
Global leaders include CareDx, Natera.
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