Minimal Residual Disease Testing Market (2026-2036)
The global minimal residual disease testing market is projected to reach USD 13.6 billion by 2036 from an estimated USD 2.7 billion in 2026, growing at a CAGR of 17.5% during the forecast period from 2026 to 2036. The market stood at USD 2.3 billion in 2025.
- Published
- Sep 2026
- Pages
- 218
- Format
- PDF + Excel
- Report ID
- MRHC - 1041385
- Base year
- 2025
- 2025 · BASELINE
- $2.30B
- 2036
- $13.60B
- CAGR 2026–2036
- 17.5%
2025 baseline · 2026–2036 forecast at 17.5% CAGR · hover a bar for the value
Key highlights
The global minimal residual disease testing market is projected to reach USD 13.6 billion by 2036, growing at a CAGR of 17.5% during 2026 to 2036, driven by the establishment of MRD as a regulatory endpoint, rising cancer incidence, and expanding Medicare coverage for molecular diagnostics.
On April 12, 2024, the U.S. FDA's Oncologic Drugs Advisory Committee voted 12 to 0 that available data support the use of MRD as an intermediate clinical endpoint for accelerated approval in multiple myeloma, drawing on meta analyses covering 42 clinical trials and 21,006 patients.
On January 20, 2026, the FDA issued draft guidance under docket FDA 2025 D 2616 defining the MRD endpoint as MRD negativity rate assessed in the bone marrow by either flow cytometry based or sequencing based methods, with public comment open until March 23, 2026.
The Medicare Clinical Laboratory Fee Schedule gapfill determination for next generation sequencing based MRD testing has been set at USD 2,007 per test, an increase of 17% on the previous implied rate under the episode based billing structure.
Adaptive Biotechnologies generated MRD revenue of USD 212 million in 2025, an increase of 46%, on 105,587 clonoSEQ tests, an increase of 39%, and recognized USD 9.0 million in MRD pharma regulatory milestone revenue in the first quarter of 2026, described as the first U.S. primary endpoint milestone.
Natera processed approximately 800, 800 oncology tests in 2025 and reported clinical MRD unit growth of approximately 34,000 sequentially between the first and second quarters of 2026, the largest sequential increase the company has recorded.
NeoGenomics received a third Medicare covered indication for its RaDaR ST assay, for monitoring response to immune checkpoint inhibitors in late stage solid tumors, and Guardant Health obtained MolDX coverage for Guardant Reveal in colorectal cancer surveillance using a tissue free methylation approach.
Bio Rad Laboratories acquired and integrated Stilla Technologies to expand its Droplet Digital PCR portfolio, while Adaptive Biotechnologies implemented the Illumina NovaSeq X Plus platform for clonoSEQ clinical sequencing.
In 2026, next generation sequencing is expected to hold the largest technology share, the highest among all technology segments.
North America is expected to account for the largest regional share in 2026, supported by the Molecular Diagnostic Services Program, the only assay specific reimbursement framework for MRD testing among the regions studied, while Asia Pacific is projected to register the fastest CAGR.
Report summary
| Particulars | Details |
|---|---|
| Forecast Period | 2026 to 2036 |
| Base Year | 2025 |
| Estimated Year | 2026 |
| CAGR (Value) | 17.5% |
| Format | PDF, Excel & Cloud Portal · 218 pages |
| Market Size (Value) in 2026 | USD 2.7 Billion |
| Market Size (Value) in 2036 | USD 13.6 Billion |
| Segments Covered | By Offering: Assays & Reagents; Instruments; Software & Services. By Technology: Flow Cytometry; Polymerase Chain Reaction; Next Generation Sequencing; Other Technologies. By Application: Blood Cancers (Lymphoma, Leukemia, Multiple Myeloma, Other Blood Cancers); Solid Tumors. By Sample Type: Blood; Bone Marrow; Other Sample Types. By Customer Type: Pharmaceutical & Biopharmaceutical Companies; Hospitals; Diagnostic Laboratories; Academic & Research Organizations/Institutions |
| Countries Covered | North America (U.S., Canada), Europe (Germany, U.K., France, Italy, Spain, Switzerland, Netherlands, Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, Rest of Asia Pacific), Latin America (Brazil, Mexico, Rest of Latin America), and Middle East & Africa |
| Key Companies | Natera, Inc. (U.S.), Adaptive Biotechnologies Corporation (U.S.), F. Hoffmann La Roche Ltd. (Switzerland), Bio Rad Laboratories, Inc. (U.S.), Illumina, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), QIAGEN N.V. (Netherlands), Guardant Health, Inc. (U.S.), NeoGenomics Laboratories, Inc. (U.S.), Myriad Genetics, Inc. (U.S.), Exact Sciences Corporation (U.S.), Integrated DNA Technologies, Inc. (U.S.), Twist Bioscience Corporation (U.S.), Sysmex Corporation (Japan), Invivoscribe, Inc. (U.S.) |
| Primary Reference Sources | U.S. Food and Drug Administration (draft guidance FDA 2025 D 2616, Oncologic Drugs Advisory Committee proceedings); Centers for Medicare & Medicaid Services and MolDX Local Coverage Determinations; company annual reports, earnings releases, and investor presentations from Natera, Adaptive Biotechnologies, Bio Rad Laboratories, Illumina, Thermo Fisher Scientific, QIAGEN, Guardant Health, NeoGenomics, and Myriad Genetics; New York State Department of Health Clinical Laboratory Evaluation Program; European Commission In Vitro Diagnostic Regulation documentation; peer reviewed clinical literature on MRD methodology |
Report overview
Segments covered: offering, type, technology, application, end user. Regions: North America, Europe, Asia-Pacific, Latin America.
Assays and reagents account for the largest share of market value through most of the forecast period, reflecting the recurring reagent consumption inherent to serial MRD monitoring, while next generation sequencing based testing and demand from pharmaceutical and biopharmaceutical companies represent the fastest growing categories as MRD assessment becomes embedded in oncology drug development.
Minimal residual disease testing is performed to detect the small numbers of cancerous cells that remain in a patient after treatment and clinical remission. Because these cells are present at very low concentrations, their detection depends on high accuracy, high sensitivity technologies including flow cytometry, polymerase chain reaction, and next generation sequencing. Oncologists rely on MRD testing to gauge the risk of cancer recurrence, and while the approach is well established for blood cancers such as leukemia, lymphoma, and multiple myeloma, its use in solid tumors is expanding as circulating tumor DNA based methods mature and reimbursement broadens.
The defining development shaping this market is the establishment of MRD as a regulatory endpoint capable of supporting accelerated drug approval. The FDA's Oncologic Drugs Advisory Committee voted unanimously in April 2024 that MRD supports accelerated approval in multiple myeloma, and the agency's January 2026 draft guidance formalizes MRD negativity, assessed in bone marrow by flow cytometry based or sequencing based methods, as an endpoint sponsors can use in registrational trials. This shift has moved MRD testing beyond clinical monitoring into a required component of oncology drug development, funded from pharmaceutical development budgets rather than clinical reimbursement alone, and it has broadened the customer base for MRD testing to include sponsors running trials in addition to hospitals, diagnostic laboratories, and academic centers.
Market dynamics
6 factors across 3 forcesGrowing Incidence of Cancer and Rising Survival Rates
The growing cancer burden and expanding survivor population are increasing the need for sensitive disease monitoring. The U.S. recorded an estimated 2.04 million new cancer cases in 2025, while the number of people living with a history of cancer reached 18.6 million and is projected to exceed 22 million by 2035. As more patients achieve remission following treatment, monitoring for residual disease and early signs of relapse is becoming increasingly important. In multiple myeloma, MRD status is also demonstrating strong prognostic value, with recent studies reporting substantially longer progression-free survival among MRD-negative patients.
Establishment Of MRD As A Regulatory Endpoint Supporting Accelerated Approval
Regulatory acceptance of MRD is creating an additional source of demand beyond routine clinical monitoring. In January 2026, the FDA issued draft guidance specifically supporting MRD negativity as an endpoint for accelerated approval in multiple myeloma, following unanimous acceptance by its Oncology Drugs Advisory Committee. Commercial activity is already reflecting this shift: Adaptive Biotechnologies reported $9.0 million in MRD pharma regulatory milestone revenue in Q1 2026, while MRD revenue increased 53% year over year to $67.1 million and clonoSEQ test volume rose 41% to 32,595 tests.
Table of contents
13 chapters · 143 sections · 218 pages · click to expandSegmental analysis
| Segment | Largest share (2026) | Fastest growth (2026–2036) |
|---|---|---|
| By Offering | Assays and reagents | Software And Services |
| By Technology | Next generation sequencing | — |
| By Application | — | Solid Tumors |
| By Sample Type | Blood | — |
| By Customer Type | Pharmaceutical and biopharmaceutical companies | Pharmaceutical and biopharmaceutical companies |
By Offering
- Assays And Reagents Lead In 2026, Software And Services Grow Fastest
- Assays and reagents are expected to account for the largest share of the market, reflecting the serial nature of MRD monitoring in which reagents are consumed at every timepoint.
- Software and services are projected to register the highest growth, supported by the interpretive demands of classifying low signal results against reference datasets.
By Technology
- Next Generation Sequencing Dominates And Grows Fastest
- Next generation sequencing is expected to hold the largest technology share in 2026, the highest among all technology segments.
- Flow cytometry dominate the market reinforced by its naming alongside sequencing based methods in the FDA's draft guidance as a qualifying method for the regulatory endpoint.
By Application
- Blood Cancers Lead In 2026, Solid Tumors Grow Fastest
- Blood cancers are expected to hold the larger application share in 2026.
- Solid tumors are projected to register the higher CAGR at 18.7%, as coverage determinations extend from post surgical surveillance into treatment response monitoring during active systemic therapy.
By Sample Type
- Blood Leads And Grows Fastest
- Blood is expected to account for the largest sample type share in 2026, reflecting its suitability for serial monitoring at frequencies bone marrow aspiration cannot support and its role as the practical sample for solid tumor MRD assessment.
- Bone marrow holds 36.0% share, reinforced by the FDA draft guidance specifying bone marrow for assessment of the regulatory endpoint.
By Customer Type
- Pharmaceutical and biopharmaceutical companies are expected to account for the largest customer share at 38.0% in 2026 and to register the highest growth, as MRD assessment becomes a required component of registrational trial design in multiple myeloma.
- Academic and research organizations register the lowest CAGR, reflecting sustained pressure on public research funding.
Geographic analysis
North America
Largest shareNorth America is expected to account for the largest regional share in 2026. The region operates the Molecular Diagnostic Services Program, the only assay specific reimbursement framework for MRD testing among the geographies studied, and hosts the two largest laboratory service providers, Natera and Adaptive Biotechnologies. The Medicare Clinical Laboratory Fee Schedule gapfill rate of USD 2,007 per test for next generation sequencing based MRD testing establishes a published price anchor unique to this market.
Europe
Europe is shaped by the In Vitro Diagnostic Regulation, under which manufacturers of legacy Class C devices must lodge a formal conformity assessment application with a notified body by May 26, 2026, and hold a signed written agreement by September 26, 2026, to retain market access. Standardization across European centers is supported by the Euro MRD quality control program for PCR based reporting and by the EuroFlow Consortium for flow cytometry based assessment, both of which originated substantially from German, Dutch, and Spanish institutions.
Asia-Pacific
Fastest growthAsia Pacific is expected to register the fastest CAGR among all regions during the forecast period. No assay specific coverage framework equivalent to the Molecular Diagnostic Services Program operates anywhere in the region, and a materially higher proportion of testing is paid for directly by patients, which makes realized price per test a stronger determinant of volume than in North America. China's National Medical Products Administration has issued specific technical review points addressing next generation sequencing based reagents for tumor gene variation detection in plasma specimens, establishing the regulatory basis on which circulating tumor DNA based MRD assays are assessed domestically.
Competitive landscape
Major companies operating in the global minimal residual disease testing market have pursued regulatory approvals, coverage expansion, platform partnerships, and acquisitions to strengthen their positions. Laboratory service providers operating proprietary assays at scale compete on clinical evidence and covered indications, while platform and reagent suppliers compete on portfolio breadth and installed base.
Some of the prominent players operating in the global minimal residual disease testing market include Natera, Inc. (U.S.), Adaptive Biotechnologies Corporation (U.S.), F. Hoffmann La Roche Ltd. (Switzerland), Bio Rad Laboratories, Inc. (U.S.), Illumina, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), QIAGEN N.V. (Netherlands), Guardant Health, Inc. (U.S.), NeoGenomics Laboratories, Inc. (U.S.), Myriad Genetics, Inc. (U.S.), Exact Sciences Corporation (U.S.), Integrated DNA Technologies, Inc. (U.S.), Twist Bioscience Corporation (U.S.), Sysmex Corporation (Japan), and Invivoscribe, Inc. (U.S.).
- —
Adaptive Biotechnologies recognized USD 9.0 million in MRD pharma regulatory milestone revenue in the first quarter of 2026, described as the first U.S. primary endpoint milestone, and obtained expanded Medicare coverage for clonoSEQ in recurrence monitoring for mantle cell lymphoma.
- —
Natera raised its full year 2026 revenue guidance twice, most recently to USD 2.85 billion to USD 2.91 billion, and reported that clinical MRD units grew by approximately 34,000 sequentially in the second quarter of 2026.
- —
NeoGenomics received a third Medicare covered indication for RaDaR ST, for monitoring response to immune checkpoint inhibitors in late stage solid tumors, with two further submissions pending with MolDX.
- —
Guardant Health received Medicare coverage under the Molecular Diagnostic Services Program for Guardant Reveal in surveillance following curative intent therapy in colorectal cancer.
- —
Bio Rad Laboratories acquired and integrated Stilla Technologies, expanding its Droplet Digital PCR portfolio, and entered distribution and development partnerships with Gencurix and Biodesix.
- —
Adaptive Biotechnologies implemented the Illumina NovaSeq X Plus platform for clonoSEQ clinical sequencing and launched integration of clonoSEQ into Flatiron Health's OncoEMR electronic medical record platform.
- —
Myriad Genetics presented pan cancer data from its Precise MRD whole genome sequencing based assay, reporting 97% baseline detection with 16% of samples detected in the ultrasensitive range.
- —
Invivoscribe's Laboratory for Personalized Molecular Medicine received New York State Department of Health approval for its FLT3 ITD MRD Assay in April 2025 and its NPM1 MRD Assay approximately two months later.
- —
The FDA issued draft guidance on January 20, 2026, under docket FDA 2025 D 2616, defining the MRD endpoint for accelerated approval in multiple myeloma, with public comment open until March 23, 2026.
- Natera, Inc. (U.S.)
- Adaptive Biotechnologies Corporation (U.S.)
- F. Hoffmann La Roche Ltd. · Switzerland
- Bio Rad Laboratories, Inc. (U.S.)
- Illumina, Inc. (U.S.)
- Thermo Fisher Scientific, Inc. (U.S.)
- QIAGEN N.V. · Netherlands
- Guardant Health, Inc. (U.S.)
- NeoGenomics Laboratories, Inc. (U.S.)
- Myriad Genetics, Inc. (U.S.)
- Exact Sciences Corporation (U.S.)
- Integrated DNA Technologies, Inc. (U.S.)
- Twist Bioscience Corporation (U.S.)
- Sysmex Corporation · Japan
- Invivoscribe, Inc. (U.S.)
Frequently asked questions
The global minimal residual disease testing market size is estimated at USD 2.7 billion in 2026.
Cite this report
Meticulous Research. (2026). Minimal Residual Disease (MRD) Testing Market - Opportunity Analysis and Industry Forecast (2026-2036) (Report No. MRHC - 1041385). Meticulous Market Research Pvt. Ltd. https://www.meticulousresearch.com/product/minimal-residual-disease-testing-market-6068