Fusion Biopsy Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Biopsy Route (Transrectal, Transperineal), By End-User (Hospitals, Diagnostic Centers, Ambulatory Care Centers), By Region, Competition, 2020-2030F

Market Overview

The Global Fusion Biopsy Market, valued at USD 618.92 Million in 2024, is projected to experience a CAGR of 8.60% to reach USD 1015.34 Million by 2030. Fusion biopsy is an advanced diagnostic technique that integrates magnetic resonance imaging with real-time ultrasound to precisely target suspicious lesions for tissue sampling, predominantly within the prostate. This method enhances diagnostic accuracy by guiding the biopsy needle to specific abnormal areas, a considerable improvement over traditional random sampling. The market for fusion biopsy is significantly driven by the increasing global prevalence of prostate cancer and continuous advancements in imaging technologies that improve detection and procedural precision. According to the American Cancer Society, an estimated 313,780 new cases of prostate cancer are projected for the United States in 2025, underscoring the persistent demand for effective diagnostic solutions.

Despite these drivers, a significant impediment to market expansion is the elevated cost associated with fusion biopsy systems and procedures, alongside challenges in securing comprehensive reimbursement in various regions. This financial burden can limit widespread adoption, particularly in healthcare systems with constrained budgets or in developing economies. Furthermore, the specialized training required for proficient operation of these advanced systems contributes to a scarcity of skilled professionals, which can also hinder broader implementation.

Key Market Drivers

The increasing global prevalence of prostate cancer is a primary market driver, fueling demand for precise diagnostic tools. With new diagnoses consistently rising, advanced detection methods are critical for improved patient outcomes. According to the International Agency for Research on Cancer's Global Cancer Observatory, in 2022, approximately 1.5 million new cases of prostate cancer were reported globally, underscoring this persistent demand. Simultaneously, continuous advancements in medical imaging technologies significantly impact market expansion. Improvements in MRI and ultrasound systems, with sophisticated software, enhance fusion biopsy precision. These technological evolutions enable more accurate lesion identification. For example, according to Philips, in July 2025, the FDA granted 510(k) clearance for its latest UroNav version, which demonstrated a 30% improvement in high-risk prostate cancer diagnosis compared to standard biopsy approaches.

This integration of advanced imaging not only improves diagnostic accuracy but also contributes to more judicious patient management, often reducing the need for unnecessary invasive procedures. An MRI-first strategy, facilitated by these technological enhancements, allows for better risk stratification before biopsy. According to a study published by ScienceDaily in December 2024, an MRI-first approach in prostate cancer detection found that 96 percent of patients with a normal MRI result did not develop aggressive prostate cancer within three years, reducing the need for immediate biopsies. Such evidence of improved patient pathways, driven by more precise imaging, actively supports the broader adoption and sustained growth of the global fusion biopsy market by demonstrating tangible clinical benefits and a more targeted diagnostic workflow.

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Key Market Challenges

The elevated cost associated with fusion biopsy systems and procedures, alongside challenges in securing comprehensive reimbursement, significantly impedes market expansion. The high capital investment required for these advanced diagnostic platforms creates a substantial financial burden for healthcare providers. This limitation particularly affects institutions with restricted budgets and healthcare systems in developing economies, curtailing their ability to acquire and implement fusion biopsy technology.

Difficulties in obtaining comprehensive reimbursement for these specialized procedures further exacerbate the financial strain. The absence of adequate coverage can deter both healthcare facilities from offering the service and patients from accessing it, even when clinically indicated. This financial barrier directly hampers broader adoption of fusion biopsy, despite the persistent demand for effective diagnostic solutions for prostate cancer. According to the American Society of Clinical Oncology, in March 2023, approximately 288,300 men were estimated to be diagnosed with prostate cancer, underscoring the significant unmet need that current financial constraints prevent from being fully addressed.

Key Market Trends

The integration of Artificial Intelligence and Machine Learning is a significant trend transforming the global fusion biopsy market by enhancing diagnostic accuracy and procedural efficiency. AI algorithms analyze complex imaging data, such as MRI, to identify suspicious lesions with greater precision, reducing inter-operator variability and potentially lowering healthcare costs. This technological advancement also facilitates more efficient workflows, with AI systems capable of optimizing lesion segmentation and image texture analysis. According to Vention, a technology company, as of May 2024, the FDA approved 882 devices powered by artificial intelligence and machine learning, with 13 of these devices specifically for gastroenterology-urology applications. Furthermore, a randomized controlled trial discussed in EMJ in December 2024 demonstrated that AI-guided cognitive fusion-targeted biopsy significantly improved detection rates for clinically significant prostate cancer. This capability supports more targeted biopsies and contributes to better patient stratification for personalized treatment.

The growing adoption of the transperineal biopsy route is another impactful trend in the global fusion biopsy market, driven primarily by improved patient safety and enhanced diagnostic yield. Unlike the transrectal approach, the transperineal route avoids passing the biopsy needle through the rectum, substantially reducing the risk of infectious complications. This procedural shift represents a move towards safer and often more comfortable patient experiences, which encourages broader acceptance among both clinicians and patients. European guidelines, as reported by Medscape in March 2025, call transperineal biopsy the preferred approach based on infection concerns. Additionally, the TRANSLATE study, presented at the European Association of Urology congress in March 2025 and published in The Lancet Oncology, found that transperineal prostate biopsies identified 5.7% more cases of clinically significant prostate cancer than transrectal biopsies among over 1100 patients. This improvement in cancer detection, coupled with reduced infection risk, underscores the clinical advantages fueling its increased adoption.

Segmental Insights

The Transrectal segment maintains a dominant position within the Global Fusion Biopsy Market, primarily attributed to its established record of accuracy and its recognized role in clinical practice. This approach has historically been considered a standard for prostate biopsies, benefiting from a mature technological foundation and the widespread commercial availability of compatible systems. The ability of transrectal fusion biopsy to precisely target suspicious lesions identified through multi-parametric MRI for accurate tissue sampling remains critical for effective prostate cancer diagnosis and treatment planning, thereby ensuring its continued and significant adoption by healthcare providers prioritizing diagnostic reliability.

Regional Insights

North America holds a prominent position in the Global Fusion Biopsy Market, driven by its well-established healthcare infrastructure and the considerable prevalence of prostate cancer. The region's leadership is further solidified by the high adoption rate of advanced diagnostic technologies, including MRI-ultrasound fusion, which enables more accurate and targeted biopsies. Favorable reimbursement policies, alongside a robust regulatory framework and strong government support for research and development activities, particularly from entities like the U. S. Food and Drug Administration, significantly contribute to market expansion. Additionally, a heightened awareness among both healthcare providers and patients regarding precision diagnostics, coupled with the presence of key industry innovators, reinforces North America's market dominance.

Recent Developments

• In July 2025, Royal Philips obtained FDA 510(k) clearance for the latest iteration of its UroNav system, which is an advanced image-guided navigation technology specifically designed for prostate cancer care. This updated system incorporates an advanced annotation workflow intended to assist clinicians during focal therapy procedures. The enhancement supports delivering more precise, minimally invasive care. The technology integrates pre-procedural MRI imaging with real-time ultrasound, a method clinically shown to improve high-risk prostate cancer diagnosis by 30% compared to standard biopsy approaches.

• In December 2024, Avenda Health, a University of California Los Angeles (UCLA) spinoff company, developed an artificial intelligence (AI) tool named Unfold AI. This software was designed to enhance the accuracy of prostate cancer diagnosis by processing imaging scans and clinical laboratory data. Unfold AI assists oncologists and anatomic pathologists in visualizing the extent of a tumor, which is critical for precise diagnostic and treatment planning within the global fusion biopsy market. The development represents a breakthrough in utilizing AI for advanced prostate cancer evaluation.

• In September 2024, Koelis, a prominent innovator in prostate care, announced a collaboration with DeepHealth. This partnership focused on integrating DeepHealth's artificial intelligence-powered Prostate software with the Koelis Trinity 3D Ultrasound Platform. The objective of this collaboration was to enhance the streamlining of prostate MRI interpretation and facilitate seamless MRI-ultrasound fusion for targeted prostate biopsy and subsequent treatment. This initiative aimed to improve diagnostic accuracy and workflow efficiencies for urologists and radiologists in the global fusion biopsy market.

• In 2024, Focal Healthcare, a developer of image-guided prostate cancer technology, announced that its Fusion Bx 2.0 prostate fusion biopsy solution received CE Mark approval. This regulatory clearance allows the company to offer its technology across Europe. The Fusion Bx 2.0 system integrates data from multiparametric MRI with a semi-robotic arm and an intuitive interface, enabling urologists to perform targeted transrectal and transperineal prostate biopsies. This development supports the adoption of updated guidelines that recommend MRI prior to biopsy for improved diagnostic accuracy.

Key Market Players

• Eigen Health Ltd
• Koninklijke Philips N.V.
• Hitachi, Ltd.
• MedCom Inc
• Esaoate SpA
• KOELIS SAS
• Focal Healthcare Inc
• UC-Care Medical Systems Ltd.
• GeoScan Medical

Report Scope:

In this report, the Global Fusion Biopsy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fusion Biopsy Market, By Biopsy Route:

o   Transrectal

o   Transperineal

• Fusion Biopsy Market, By End-User:

o   Hospitals

o   Diagnostic Centers

o   Ambulatory Care Centers

• Fusion Biopsy Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Fusion Biopsy Market.

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Global Fusion Biopsy Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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