U.S. Fusion Biopsy Market Size, Share & Trends Analysis Report By Biopsy Route (Transrectal, Transperineal), By End-use (Hospitals, Diagnostic Centers, Ambulatory Care Centers), By Region, And Segment) - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2024-2033

U.S. Fusion Biopsy Market Size and Growth

The U.S. fusion biopsy market size was valued at USD 301.19 million in 2023 and is projected to surpass around USD 603.65 million by 2033, registering a CAGR of 7.2% over the forecast period of 2024 to 2033. 

U.S. Fusion Biopsy Market Key Takeaways

• Based on product, the transrectal biopsy route dominated the market with the largest share of 84.11% in 2023.
• The transperineal biopsy segment is expected to grow at the fastest rate at 10.1% CAGR from 2024 to 2033.
• Based on end-use, hospitals held the largest share of 59.19% in 2023
• The ambulatory care centers segment is projected to expand at the fastest CAGR from 2024 to 2033

Market Overview

The U.S. fusion biopsy market is a rapidly evolving segment of the diagnostic imaging and oncology landscape, primarily driven by advancements in precision diagnostics for prostate cancer. Fusion biopsy, also known as MRI/ultrasound fusion biopsy, combines real-time ultrasound imaging with pre-acquired magnetic resonance imaging (MRI) data to guide biopsy needles to areas of concern within the prostate more accurately than conventional biopsy techniques. This integration significantly improves the detection rate of clinically significant prostate cancers while minimizing overdiagnosis and unnecessary treatments for indolent tumors.

In recent years, prostate cancer has remained one of the most diagnosed cancers among men in the United States. According to the American Cancer Society, approximately 288,300 new cases of prostate cancer were expected in 2023, with numbers continuing to climb due to increased awareness, widespread screening programs, and an aging population. Amidst these developments, the limitations of traditional transrectal ultrasound (TRUS)-guided biopsies have become evident, particularly their inability to consistently detect tumors located in the anterior or apical zones of the prostate. This diagnostic gap has created an urgent need for more accurate, image-guided biopsy systems.

Fusion biopsy has quickly emerged as a preferred diagnostic tool, particularly in urologic and oncology centers. With its ability to overlay high-resolution MRI data over ultrasound images in real time, it enables targeted sampling from suspicious lesions identified on MRI scans. This not only reduces the likelihood of false negatives but also supports risk stratification and treatment planning. Furthermore, the growing application of fusion biopsy in active surveillance protocols and repeat biopsy scenarios underscores its importance in the continuum of prostate cancer management.

As technology becomes more accessible, and payers adopt favorable reimbursement frameworks, the U.S. fusion biopsy market is witnessing increased penetration in hospitals, ambulatory surgical centers, and diagnostic imaging networks. Moreover, collaborations between software developers, device manufacturers, and medical institutions are accelerating the development of next-generation fusion systems with improved accuracy, automation, and user-friendly interfaces.

Major Trends in the Market

• Shift from Random to Targeted Biopsy Techniques: Clinicians and patients alike are increasingly favoring fusion biopsy due to its superior detection rates and reduced sampling errors.

• Rising Adoption of Transperineal Biopsy Approach: This route is gaining momentum for its reduced infection risks and enhanced anterior zone access.

• Integration of Artificial Intelligence (AI) in Image Analysis: AI tools are enhancing lesion segmentation, registration accuracy, and biopsy planning.

• Growing Role in Active Surveillance Programs: Fusion biopsy is increasingly used to monitor patients with low-grade prostate cancer, minimizing overtreatment.

• Expansion into Outpatient Settings: Diagnostic and ambulatory centers are adopting compact, portable fusion biopsy systems to expand patient access.

• Improved Reimbursement Policies: CMS and private insurers are gradually providing coverage for MRI-targeted biopsies, boosting hospital adoption.

• Surge in Training and Credentialing Programs: Medical institutions are offering certifications in fusion biopsy techniques, expanding the skilled workforce.

• Cloud-Based Imaging Platforms: Remote collaboration and image sharing are facilitating second opinions and multidisciplinary case reviews.

• Combination with Genomic Testing: Tissue obtained through fusion biopsy is often used for genomic profiling, aiding precision medicine.

• Commercial Collaborations and Device Launches: Companies are entering strategic partnerships to launch integrated MRI-ultrasound systems for prostate diagnostics.

U.S. Fusion Biopsy Market Report Scope

U.S. Fusion Biopsy Market By Biopsy Route Insights

Transrectal fusion biopsy has dominated the U.S. market historically, owing to its simplicity, shorter learning curve, and minimal procedural setup. This route has been the standard in urology practices for decades and continues to be widely used in both inpatient and outpatient settings. With extensive physician familiarity and established clinical workflows, transrectal procedures remain the default choice in many high-volume practices. The use of real-time ultrasound guidance overlaid with MRI-defined targets has made transrectal fusion biopsies highly efficient for posterior prostate lesions.

However, the transperineal route is emerging as the fastest-growing segment, propelled by its superior safety profile and enhanced access to anterior and apex lesions. With growing concerns about post-biopsy sepsis and antibiotic resistance, clinicians are increasingly opting for this method. Advances in equipment, such as stepper systems and robotic-assisted needle guidance, have made transperineal biopsies more precise and less invasive. Furthermore, the transperineal approach is gaining favor in academic centers and tertiary hospitals, where comprehensive prostate mapping and anterior zone targeting are essential. Its widespread adoption is expected to accelerate with the launch of compact and mobile fusion systems tailored for office-based use.

U.S. Fusion Biopsy Market By End-use Insights

Hospitals currently dominate the fusion biopsy market by end-use, driven by their access to advanced imaging infrastructure, skilled personnel, and integrated pathology services. Large hospitals and academic medical centers are often early adopters of innovative diagnostics and invest heavily in precision medicine tools. Most hospitals also have in-house MRI capabilities, enabling seamless scheduling of pre-biopsy imaging. Additionally, reimbursement processes are streamlined in hospital environments, where fusion biopsy is offered as part of a comprehensive prostate cancer evaluation package.

Meanwhile, ambulatory care centers are the fastest-growing end-use segment, owing to their cost-efficiency, convenience, and quick turnaround times. With the healthcare system shifting toward outpatient care, ambulatory centers are embracing fusion biopsy systems to provide advanced diagnostics outside the traditional hospital setting. These centers often cater to patients seeking shorter wait times and more personalized care. Newer compact fusion biopsy platforms that don’t require complex MRI environments are also facilitating adoption in these settings. The rise of specialty urology clinics operating within ambulatory frameworks is further contributing to this trend, positioning it as a high-growth segment in the coming years.

Country-Level Analysis

The United States represents one of the most technologically advanced and innovation-driven healthcare markets globally. In the context of fusion biopsy, this advantage manifests in widespread availability of MRI technology, highly trained urologists and radiologists, and institutional readiness to adopt new imaging tools. States like California, New York, Texas, and Florida lead in the number of fusion biopsy installations and case volumes, partly due to their high population density, prevalence of cancer centers, and higher patient awareness.

Medicare coverage and favorable policies by private insurers are also playing a pivotal role in expanding market access across different states. Moreover, major academic centers such as the Mayo Clinic, Cleveland Clinic, and Johns Hopkins are actively conducting research on fusion biopsy outcomes and contributing to evidence-based clinical pathways. Training programs and fellowships in prostate MRI interpretation and fusion techniques are expanding nationwide, especially in teaching hospitals.

Mobile imaging units and cloud-based data sharing platforms are helping bridge geographic disparities, allowing patients in rural or underserved areas to access cutting-edge fusion biopsy services. Overall, the U.S. market is positioned at the forefront of fusion biopsy adoption, supported by a confluence of technology, policy, and clinical expertise.

U.S. Fusion Biopsy Market Recent Developments

• March 2025: Koelis announced the U.S. launch of Trinity® 3D MRI/ultrasound fusion biopsy system, designed to enable both transrectal and transperineal procedures in outpatient settings.

• February 2025: Exact Imaging partnered with leading academic institutions to initiate clinical trials assessing the performance of their EV29 Fusion Biopsy Platform in community practice settings.

• January 2025: BK Medical, a subsidiary of GE HealthCare, released an upgraded version of its transperineal biopsy navigation system with AI-guided targeting tools.

• December 2024: UC San Diego Health implemented a pilot program integrating fusion biopsy with genomic risk scoring to personalize prostate cancer treatment plans.

• November 2024: BiopSee launched a new grid-based transperineal system compatible with in-office fusion biopsy workflows, aiming to expand access in small clinics.

U.S. Fusion Biopsy Market Top Key Companies:

• Artemis
• Koelis
• Eigen Health
• MedCom
• Focal Healthcare
• BK Medical
• Agiliti Health
• Penn Medicine
• Cleveland Diagnostics
• PanGIA Biotech
• miR Scientific, Inc.

U.S. Fusion Biopsy Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Fusion Biopsy market.

By Route 

• Transrectal
• Transperineal

By End-use

• Hospitals
• Diagnostic Centers
• Ambulatory care Centers