Summary

Market Analysis of MRD Testing Facility in the U.S.

BIS research is engaged in a study focusing on U.S. MRD ((Minimal Residual Disease) Testing Facilities Market. The report is focused on an overview of MRD testing in U.S., profiles of MRD testing facilities, market size, 2020-2030, technology landscape and key dynamics of the market.

MRD testing plays a crucial role in tracking certain cancers, particularly leukaemia and lymphoma. Many laboratories and medical institutions across the U.S. provide MRD testing services. This type of testing has evolved into an indispensable component of oncology diagnostics and treatment monitoring. Its transformative capabilities, including high sensitivity in detecting residual cancer cells, have propelled the adoption of advanced technologies such as Next-Generation Sequencing (NGS), digital PCR, and flow cytometry.

Objective of the Study

This study aims to systematically profile approximately 200 Minimal Residual Disease (MRD) Testing Facilities across the United States, encompassing the following categories:

• MRD Testing Laboratories
• MRD Testing Hospitals
• MRD Testing Companies
• MRD Testing Centers
• MRD Testing Volume
• MRD Market

The study is focused on profiling about 200 testing facilities in U.S. providing valuable insights for strategic planning, market analysis, and benchmarking. Stakeholders can compare operational metrics, identify underserved regions, and explore partnership opportunities. The detailed test data helps optimize clinical workflows, adopt advanced technologies, and align with industry standards. It also supports compliance with regulatory requirements and enhances funding advocacy. Overall, the report is a comprehensive resource for driving innovation and competitiveness in the MRD testing landscape.

Insights on Geographical Distribution of Facilities in U.S.

Geographical Distribution and Facility Insights

• The distribution of MRD testing facilities across the U.S. highlights regional disparities in access and utilization. States like California, New York, and Texas lead in MRD test volumes, driven by robust healthcare infrastructure and a high incidence of cancer.
• Conversely, states with smaller populations, such as Kansas and Nevada, exhibit lower test volumes but maintain competitive per capita utilization rates. Accredited facilities with CAP and CLIA certifications dominate the landscape, ensuring high-quality testing and compliance with stringent regulatory standards.

The current study also highlights the number of diagnostic laboratories in US testing MRD. California reported the highest number of MRD testing facilities in 2022 with a test volume of 156,658 and test per Capita 401. New York and Texas also followed California in testing facilities. However, Missouri and Utah reported the lowest test volume i.e. 2,554 and 2,720 respectively.

Moreover, companies are also carrying out MRD testing at a higher volume. For instance, Adaptive Biotechnologies carried out 36,871 NGS-based MRD clonoSEQ tests in 2022 as compared to 22,516 NGS-based MRD clonoSEQ tests in 2021. Company reported 51% Y-o-Y growth. Hence, this rising volume of MRD testing is anticipated to boost the overall market growth.

Market Size Estimates, 2020-2030

The U.S. MRD testing market is poised to reach $1,667.5 million by 2030, with a CAGR of 14.18% during the forecast period 2024 and 2030. U.S. testing facilities market accounted for a substantial 39.53% share in 2023 in the overall global MRD testing facilities. In the U.S., several facilities offer MRD testing, with factors such as technology used, test accuracy, and clinical expertise driving the choice of where to get tested.

Report also focuses on the market dynamics, technology landscape and challenges of the market

• The robust growth of the MRD testing market in the U.S. can be attributed to a confluence of factors, including increasing cancer incidence, rising demand for personalized treatment, and rapid advancements in molecular diagnostics. According to the American Cancer Society, leukemia accounted for 13% of adolescent cancer diagnoses in 2022, while myeloma diagnoses exceeded 34,000 cases in the same year. Furthermore, based on the findings of the study. hospitals and specialty clinics dominate the end-user segment, comprising 44.01% of the market in 2023. This sector’s strategic integration of MRD testing into oncology services reflects the growing emphasis on personalized medicine. Research institutions and diagnostic laboratories also contribute significantly, with anticipated CAGRs of 14.1% and 13.3%, respectively, during the forecast period. These segments highlight the expanding role of MRD testing in clinical trials and routine diagnostics.

Conclusion

The increasing adoption of these advanced technologies is revolutionizing MRD testing, making it more precise, accessible, and essential for shaping cancer treatment approaches. As the field evolves, there is a growing emphasis on developing personalized treatment plans informed by the in-depth genetic data obtained through MRD testing.

The U.S. MRD testing market is at the forefront of oncology diagnostics, characterized by continuous innovation, strategic collaborations, and a growing emphasis on personalized medicine. While challenges such as cost barriers and sensitivity limitations persist, advancements in companion diagnostics, Medicare coverage expansion, and clinical trials offer promising solutions. By addressing these hurdles and leveraging emerging opportunities, the MRD testing market is well-positioned to enhance cancer care and improve patient outcomes in the years to come.

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Table of Contents

Overview of MRD Testing in the U.S.
U.S. MRD Testing Market Size, 2020-2030
U.S. MRD Testing Market Technology Landscape
U.S. MRD Testing Market End-User Stats
U.S. MRD Testing Market Dynamics: Key Drivers
U.S. MRD Testing Market Dynamics: Key Challenges
U.S. MRD Testing Market Dynamics: Market Opportunities
U.S. MRD Testing Facility Profiles

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