Fusion Biopsy Market Size and Share
| Study Period | 2020 - 2030 |
| Market Size (2025) | USD 0.82 Billion |
| Market Size (2030) | USD 1.21 Billion |
| CAGR (2025 - 2030) | 8.06% |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Fusion Biopsy Market Analysis by Mordor Intelligence
The Fusion Biopsy Market size is estimated at USD 0.82 billion in 2025, and is expected to reach USD 1.21 billion by 2030, at a CAGR of 8.06% during the forecast period (2025-2030).
The growth of the global fusion biopsy market is primarily fueled by the rising global incidence of prostate cancer and the increasing demand for precise, minimally invasive diagnostic solutions. Fusion biopsy systems, which combine MRI and real-time ultrasound for targeted sampling, offer enhanced diagnostic accuracy and significantly reduce false-negative rates—key factors for detecting and staging clinically significant prostate malignancies.
The World Health Organization’s Cancer Report (October 2024) projects a 39% global rise in prostate cancer cases by 2040, reflecting a significant public health concern. In Europe, the European Association of Urology’s 2024 Annual Report states that prostate cancer accounts for 27% of all new male cancer diagnoses, underscoring its significant burden on healthcare systems across the continent. According to GLOBOCAN 2024, prostate cancer ranks as the leading male cancer diagnosis in 118 countries worldwide, reflecting the widespread and growing need for accurate diagnostic tools in both developed and emerging economies.
Earlier, in December 2023, NHS Digital Statistics (UK) reported 55,033 new cases of prostate cancer in England, a 25% increase since 2019, further emphasizing the escalating disease burden. This pronounced uptick in prostate cancer incidence—driven by an aging global population, greater disease awareness, and strengthened healthcare infrastructure—is directly influencing the demand for fusion biopsy systems. These systems are increasingly being integrated into urology practices worldwide to improve diagnostic precision, enable early intervention, and ultimately enhance patient outcomes.
Despite the momentum, high costs associated with fusion biopsy systems and procedures remain a significant barrier to broader market penetration, especially in low-resource and price-sensitive settings. Nevertheless, ongoing technological advancements, expanding reimbursement support, and focused efforts to enhance accessibility are expected to overcome these challenges. As stakeholders work to scale adoption and drive down costs, the global fusion biopsy market is poised for robust growth over the forecast period.
Global Fusion Biopsy Market Trends and Insights
Equipment Product Segment Poised for Major Growth in Fusion Biopsy Market
The equipment segment commands a significant share of the fusion biopsy market. This segment's prominence stems from the escalating global prostate cancer burden and the rising demand for advanced diagnostic systems. These systems not only enhance precision and reduce diagnostic errors but also facilitate early disease detection. By merging multiparametric MRI with real-time transrectal ultrasound (TRUS), fusion biopsy equipment targets suspicious lesions, often overlooked by traditional systematic biopsies.
The healthcare providers are increasingly adopting advanced fusion biopsy platforms, enhancing lesion detection accuracy and streamlining procedures. Manufacturers are innovating, introducing ergonomic MRI machines tailored for prostate interventions, and providing continuous hardware and software upgrades. Modern MRI systems boast workflow-optimized coils and sequences designed explicitly for prostate mpMRI, leading to reduced scan times and enhanced lesion visualization.
A key growth driver for the equipment segment is the infusion of artificial intelligence into fusion biopsy workflows. MRI/ultrasound fusion platforms are increasingly integrating artificial intelligence (AI)—driven software, aiding radiologists in mpMRI scan interpretations. Current algorithms can automatically score prostate lesions using the PI-RADS v2.1 criteria, prioritizing suspicious regions and minimizing inter-reader variability. A 2024 study in European Radiology highlights the efficacy of AI, noting a 14% boost in diagnostic sensitivity and a 17% drop in false-negative rates when compared to radiologist-only assessments.
AI's influence extends to refining the fusion process, significantly reducing spatial registration errors between pre-acquired MRI images and live ultrasound. Such advancements ensure precise needle guidance and shorter procedure times. Clinical studies showcased at the RSNA 2024 annual meeting revealed AI's prowess: targeting systems achieved 89–92% accuracy in pinpointing clinically significant prostate cancer, a notable leap from the 70–75% accuracy of traditional TRUS-guided biopsies.
With a growing global emphasis on prostate health and the deepening integration of AI in diagnostics, the equipment segment is poised to maintain its leadership in the fusion biopsy market. The advancement of imaging precision, AI-driven targeting, and the escalating incidence of prostate cancer worldwide underscores the pivotal role of equipment in enhancing prostate cancer diagnostics.
North America is Expected to Dominate the Fusion Biopsy Market
North America hold the largest share of the global fusion biopsy market, driven by its advanced healthcare infrastructure, swift tech adoption, and a strong focus on early cancer detection. The region enjoys a robust reimbursement framework and increased awareness among both healthcare professionals and patients about the benefits of precision diagnostics, notably the MRI/ultrasound fusion biopsy for prostate cancer.
Specifically, the United States propels the North American market, bolstered by major diagnostic device manufacturers, cutting-edge imaging centers, and a significant volume of prostate cancer screenings. In the United States, the American Cancer Society’s Cancer Facts & Figures 2025 highlights prostate cancer as the most frequently diagnosed cancer in men, with 313,780 new cases expected in 2025. Further, the National Cancer Institute’s SEER database (September 2024) indicates a 3% annual increase in incidence rates since 2014, along with a 4–5% yearly rise in regional and distant-stage diagnoses, signaling a shift toward more aggressive disease presentations and reinforcing the urgency for advanced diagnostic modalities like fusion biopsy.
In response to these trends, healthcare providers across North America are increasingly turning to multiparametric MRI (mpMRI) and fusion-guided biopsy techniques. This shift aligns with endorsements from the American Urological Association (AUA) and the National Comprehensive Cancer Network (NCCN), both advocating for image-guided, targeted biopsies to mitigate overdiagnosis and enhance the detection of significant cancers.
North America also leads in clinical research and innovation within the fusion biopsy realm. Numerous academic medical centers and cancer institutes in the region are delving into trials that integrate artificial intelligence (AI) into imaging workflows. This integration aims to bolster lesion detection, refine biopsy targeting, and diminish interpretation variability. Institutions like Johns Hopkins University and the University of Toronto are at the forefront, pioneering AI-based image registration and real-time fusion technology validation.
With a robust research ecosystem, ongoing medical training, substantial healthcare tech investments, and high patient throughput, North America solidifies its position as a leader in the adoption and evolution of fusion biopsy systems. The region consistently sets the gold standard for innovation, precision, and best practices in prostate cancer diagnostics.
Competitive Landscape
The fusion biopsy market is moderately consolidated, with a few key players accounting for a significant share of the market. Intense competition among these market players is driven by the need to innovate and meet the growing demand for advanced diagnostic tools in prostate cancer management. This competitive landscape also creates opportunities for new entrants to establish their presence.
To bolster their market stance, companies pursue strategies like mergers, product launches, collaborations, expanding distribution networks, and venturing into developing regions. Additionally, investments in research and development to enhance biopsy accuracy and efficiency are gaining traction. These efforts aim to cater to the rising demand for minimally invasive diagnostic solutions, further intensifying competition in the market.
Key international players—including Canon, Inc., FUJIFILM Holdings Corporation, GE Healthcare, Koninklijke Philips N.V., and Koelis command significant market shares due to their strong portfolios in imaging equipment. This competitive landscape fosters innovation and ensures a dynamic market environment, driven by the global rise in prostate cancer.
Fusion Biopsy Industry Leaders
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Canon Inc.
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FUJIFILM Holdings Corporation
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GE Healthcare
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Koninklijke Philips N.V.
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Koelis
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- September 2024: Koelis SAS introduced a compact 3D transducer for transperineal fusion biopsy and treatment. The device integrates with major high-level disinfection systems, improving safety and usability in clinical environments.
- July 2024: In a pioneering move, Sir HN Reliance Foundation Hospital has introduced Indian state Maharashtra's inaugural MR fusion biopsy machine. This advanced equipment, leveraging MRI guidance, enhances the precision of prostate treatments. The MR Fusion Biopsy machine seamlessly integrates MRI visuals with ultrasound technology, harnessing artificial intelligence (AI) to pinpoint cancerous regions within a patient's body.
- January 2024: Quibim introduced QP-Prostate, an AI-driven tool for prostate cancer detection. The product received CE and UKCA certifications, enhancing its credibility and adoption in European markets. Its AI algorithm identifies and stratifies intermediate and high-grade aggressive prostate cancer lesions, while also segmenting the prostate to enhance diagnostic accuracy and fusion biopsy planning. The results can be directly exported for fusion biopsy procedures.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Our study defines the fusion biopsy market as revenue generated from dedicated MRI-ultrasound image-fusion consoles, associated software, compatible probes, guidance accessories, and single-use biopsy disposables used mainly for prostate cancer diagnosis.
All service revenues, conventional ultrasound-only or MRI-only biopsies, and fusion systems sold exclusively for renal or breast applications are excluded.
Segmentation Overview
- By Product Type
- Equipment
- Consumables
- By Route
- Transrectal
- Transperineal
- By End-User
- Hospitals
- Diagnostic Centers
- Ambulatory Surgical Centers
- Others
- Geography
- North America
- United States
- Canada
- Mexico
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Middle East and Africa
- GCC
- South Africa
- Rest of Middle East and Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Multiple interviews were conducted with urologists, interventional radiologists, OR managers, and purchasing heads spread across North America, Europe, and key Asia-Pacific markets. These discussions clarified real-world procedure volumes, consumable pull-through, transperineal adoption rates, and average selling prices, and they helped us stress-test early AI-enabled workflow assumptions surfaced during desk research.
Desk Research
Mordor analysts began with public datasets such as WHO GLOBOCAN incidence curves, American Cancer Society patient statistics, and EU-27 prostate screening registries, which map procedure demand across 40 countries. Regulatory filings from the US FDA MAUDE database and European CE-mark dossiers helped us list every cleared fusion platform, while reimbursement fee schedules released by the US CMS and Germany's DRG catalog clarified billing dynamics. Trade association briefs from the European Association of Urology, peer-reviewed articles in European Radiology, and company 10-K filings supplied technical efficacy, pricing bands, and installed-base trends. Paid repositories, D&B Hoovers for company financials, Dow Jones Factiva for deal tracking, and Questel for recent patent families, rounded out competitive intelligence. The sources cited here are illustrative; many additional datasets were reviewed to validate figures and close information gaps.
Market-Sizing & Forecasting
We built a top-down incidence-to-procedure model that starts with country-level prostate cancer caseloads, applies screening penetration and biopsy conversion factors, and then layers route-specific shares (transrectal vs transperineal) before multiplying by weighted average spend per procedure. Selected bottom-up checks, annual console shipments from supplier disclosures, sampled hospital installed bases, and ASP × unit triangulation, were used to tune totals. Key variables include MRI availability per million population, reimbursement code coverage expansion, average console ASP erosion, shift toward single-use needles, and the percent of biopsies migrating to fusion guidance each year. A multivariate regression, supported by scenario analysis where reimbursement reforms are pending, drives forecasts through 2030, while missing datapoints are interpolated using three-year moving averages aligned to regional growth proxies.
Data Validation & Update Cycle
Outputs pass a three-layer review: automated variance scans against historical series, peer review by a senior medical-devices analyst, and final sign-off from the healthcare research lead. Models refresh annually; mid-cycle updates are triggered when material events, major regulatory approvals, guideline changes, or >10 % price shifts, occur. A fresh data sweep is completed just before each publication to ensure clients receive the latest view.
Why Mordor's Fusion Biopsy Baseline Earns Trust
Published estimates often diverge because firms choose different product mixes, pricing bases, and refresh cadences.
By aligning scope to the complete procedure wallet and by validating each assumption with field interviews, Mordor delivers a balanced baseline that decision-makers can trace back to transparent variables.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 0.82 B (2025) | Mordor Intelligence | - |
| USD 0.80 B (2025) | Global Consultancy A | Omits single-use disposables and uses static incidence-based demand without technology migration factors |
| USD 0.65 B (2024) | Industry Insights Firm B | Counts equipment revenue only and applies conservative ASPs from mixed ultrasound segments |
| USD 0.83 B (2024) | Trade Journal C | Applies aggressive price normalization and assumes all procedures remain transrectal, inflating unit volumes |
The comparison shows that figures swing when consumables, hybrid routes, or price trajectories are treated differently.
Mordor's disciplined scope definition, dual-path validation, and annual refresh ensure our numbers remain the most dependable starting point for strategic planning.
Key Questions Answered in the Report
How big is the Fusion Biopsy Market?
The Fusion Biopsy Market size is expected to reach USD 0.82 billion in 2025 and grow at a CAGR of 8.06% to reach USD 1.21 billion by 2030.
What is the current Fusion Biopsy Market size?
In 2025, the Fusion Biopsy Market size is expected to reach USD 0.82 billion.
Who are the key players in Fusion Biopsy Market?
Canon Inc., FUJIFILM Holdings Corporation, GE Healthcare, Koninklijke Philips N.V. and Koelis are the major companies operating in the Fusion Biopsy Market.
Which is the fastest growing region in Fusion Biopsy Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Fusion Biopsy Market?
In 2025, the North America accounts for the largest market share in Fusion Biopsy Market.
What years does this Fusion Biopsy Market cover, and what was the market size in 2024?
In 2024, the Fusion Biopsy Market size was estimated at USD 0.75 billion. The report covers the Fusion Biopsy Market historical market size for years: 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Fusion Biopsy Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Fusion Biopsy Market Report
Statistics for the 2025 Fusion Biopsy market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Fusion Biopsy analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
