Minimal Residual Disease Testing Market is expected to reach US$2.55 billion to grow at a strong CAGR of 12.2%, Market Size, Share Analysis, Growth Trends, Forecast.

The global minimal residual disease testing market was worth US$1.27 billion in 2023, US$1.43 billion in 2024 and is estimated to grow at a strong CAGR of 12.2% during the period 2024-2031, reaching a forecasted value of US$2.55 billion by the end of this period.

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The driving forces behind the minimal residual disease testing market are the rising cancer and hematological malignancies prevalence, the government initiatives for the public awareness campaigns of the disease, and the growing partnerships. The aging population, increasing hematological disorders that need MRD testing, higher health spending, and better healthcare facilities are some future opportunities that will be large enough to attract the market players.The high frequency ventilators market is growing due to the rising prevalence of chronic respiratory diseases (like COPD and ARDS), an expanding geriatric population susceptible to respiratory issues, and continuous technological advancements that offer better patient outcomes and enable use in diverse settings like home care.

United States: Key Industry Developments
✅ November 2025: Adaptive Biotechnologies launched an enhanced MRD assay for early detection of hematologic cancers, featuring improved sensitivity for better patient monitoring.​

✅ October 2025: FDA approved new companion diagnostic tests integrating MRD monitoring to support personalized leukemia treatment plans.​

✅ September 2025: Leading diagnostic labs expanded NGS-based MRD testing services, enhancing prognosis tracking and accessibility for oncology patients.

Japan: Key Industry Developments
✅ June 2025: QIAGEN expanded MRD testing through partnerships, including co-development of blood-based assays for solid tumors on digital PCR platforms.​

✅ January 2025: Datar Cancer Genetics unveiled Target-MRD, a blood test combining ddPCR and NGS for ultra-sensitive MRD detection in solid organ cancers.

Recent FDA Approval:-
→ On August 25, 2025, the FDA granted Breakthrough Device Designation to the Haystack MRD test, a circulating tumor DNA (ctDNA) assay developed by Quest Diagnostics. This designation is intended to expedite the development and review of devices that provide more effective treatment or diagnosis for life-threatening conditions. The test is designed to identify MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy. This is a significant regulatory milestone for the minimal residual disease testing market.

→ An article published in October 2025 mentioned that the FDA approved new companion diagnostic tests in October that integrate MRD monitoring for personalized leukemia treatment, though specific details of the company and test name were not provided in the snippet.

→ On November 13, 2025, the FDA approved ziftomenib (Komzifti, Kura Oncology, Inc.) for adults with relapsed or refractory acute myeloid leukemia (AML) with a specific mutation. While this is a drug approval, the management of AML often involves MRD testing, demonstrating the integration of MRD concepts into general oncology care and related regulatory activities

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Market Segmentation-

Segmentation by Technology
→ Flow Cytometry:
This segment involves using flow cytometry techniques to detect residual cancer cells at a high sensitivity. It is the dominant technology segment with an estimated market share of 40% in 2025, driven by its widespread availability, rapid results, and adoption in hematological malignancy monitoring.

→ Polymerase Chain Reaction (PCR)-based Assays:
This includes real-time PCR, quantitative PCR, and allele-specific PCR methods for detecting MRD. It accounts for roughly 35% of the market, as PCR provides high sensitivity and specificity, particularly in leukemia and lymphoid malignancies.

→ Next-Generation Sequencing (NGS):
NGS-based MRD testing is a newer technology for detecting genetic mutations at ultra-low levels. It holds approximately 20% of the market, growing rapidly due to its precision and ability to detect a wide spectrum of mutations across hematologic cancers.

→ Other Technologies:
This includes digital PCR, microfluidics, and emerging molecular assays. It represents around 5% of the market, currently limited by high costs and specialized expertise, but with potential for growth as technology matures.

Segmentation by End-User
→ Hospitals & Clinics:
Hospitals and oncology clinics use MRD testing for patient monitoring and treatment planning. This is the dominant end-user segment with a market share of about 55% in 2025, driven by the increasing adoption of personalized medicine and hematology-focused cancer care.

→ Diagnostic Laboratories:
Independent and commercial labs provide MRD testing services for hospitals and research institutions. They account for roughly 30% of the market, supported by increasing outsourcing of specialized diagnostics and rising demand for high-throughput testing.

→ Research & Academic Institutes:
These institutes use MRD testing for clinical research and trial monitoring. This segment holds around 15% of the market, driven by rising investment in oncology research and clinical trials focused on minimal residual disease.

Regional insights:-
→ North America holds the largest market share with approximately 35.0%. This dominance is driven by the presence of leading pharmaceutical and biotechnology companies, advanced healthcare infrastructure, and high adoption of MRD testing in clinical trials and patient monitoring in the U.S.

→ Asia Pacific is the fastest-growing region and holds a significant share estimated around 30%, propelled by improving healthcare infrastructure, increasing hematological cancer cases, and robust government initiatives in countries like Japan, China, and India.

→ Europe, Middle East, and Africa collectively represent around 25-30% of the market, supported by stringent regulatory frameworks and growing emphasis on precision medicine.

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Competitive Landscape:-
→ The major players in the minimal residual disease testing market include Adaptive Biotechnologies Corp., ARUP Laboratories., Myriad Genetics, Inc., Guardant Health, Natera, Inc., HematoLogics, Inc., Laboratory Corporation of America® Holdings., Twist Bioscience., Invivoscribe, Inc. and Cytognos among others.

Key Developments
→ Foresight Diagnostics, Inc a U.S.-based company received funding of $58.75 million for the commercialization of its novel MRD testing portfolio "PhasED-Seq" which is based on ultrasensitive liquid biopsy. The company aims to use the funding for commercial-level development and launch in the region.

→ Adela, Inc. received $48 million in funding for its proprietary MRD testing technology called genome-wide methylation used for the early detection of cancers. Adela plans to use the funding for commercial development of its MRD testing product.

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