Global Fusion Biopsy Market Outlook
Revenue, 2024
$733M
Forecast, 2034
$1.70B
CAGR, 2025 - 2034
8.8%
The Fusion Biopsy industry revenue is expected to be around $797.3 million in 2025 and expected to showcase growth with 8.8% CAGR between 2025 and 2034. The market for fusion biopsy has evolved into a fundamental element of modern prostate cancer diagnosis because of increasing MRI ultrasound fusion biopsy programs and widespread acceptance by Hospitals and Diagnostic Centers which represent 83.8% of market demand. The increasing clinical value of this technology stems from prostate cancers rising worldwide prevalence and healthcare systems adoption of precise medical approaches and non invasive imaging based biopsy methods and positive insurance coverage in developed nations.
The advanced image guided biopsy technique known as fusion biopsy combines pre acquired multiparametric MRI with real time transrectal ultrasound to locate suspicious lesions for targeted sampling which improves upon conventional systematic biopsy methods. The system provides three dimensional lesion identification and automated MRI ultrasound alignment and enhanced detection of important tumors and simplified diagnostic procedures for urology teams and interventional radiology staff. The medical device serves mainly for prostate cancer diagnosis and active surveillance and treatment planning in high volume centers that now use it for prostate cancer screening. The combination of AI decision support tools with miniaturized equipment for outpatient use and standardized clinical protocols has driven up demand for fusion biopsy systems in both established and developing healthcare markets.
Market Key Insights
The Fusion Biopsy market is projected to grow from $732.8 million in 2024 to $1.70 billion in 2034. This represents a CAGR of 8.8%, reflecting rising demand across Hospital Settings, Diagnostic Centers, and Ambulatory Care Centers.
Eigen, Koninklijke Philips N.V., and KOELIS are among the leading players in this market, shaping its competitive landscape.
The Fusion Biopsy market shows the United States and Germany as its leading markets which will experience CAGR growth rates of 6.4% to 9.2% from 2024 to 2030.
The market research predicts that India, Brazil and South Korea will experience the fastest growth among emerging markets at a combined annual rate of 8.4% to 11.0%.
Transition like Imaging And Workflow Integration is expected to add $118 million to the Fusion Biopsy market growth by 2030
.The Fusion Biopsy market will experience $970 million growth during 2024-2034 while Diagnostic Centers & Ambulatory Care Centers Application will dominate market expansion.
With
rising prostate cancer incidence and preference for targeted diagnostics accelerating adoption of fusion biopsy solutions, and
Advancements in multiparametric MRI imaging quality directly enhancing accuracy and clinical confidence in fusion biopsy, Fusion Biopsy market to expand 132% between 2024 and 2034.
Opportunities in the Fusion Biopsy
Outpatient urology clinics across the United States now use fusion biopsy technology to detect prostate cancer at earlier stages with better accuracy. The use of MRI ultrasound fusion biopsy and other image guided biopsy methods helps healthcare providers avoid performing unnecessary biopsies which results in reduced overtreatment and supports payer goals to decrease healthcare expenses. Patients now choose diagnostic procedures that minimize invasion and provide quick recovery times and immediate discharge after treatment. The highest expansion rate will also occur in MRI ultrasound fusion prostate biopsy procedures at large community practices which can increase procedure numbers through optimized workflows and AI based targeting and established protocols.
Growth Opportunities in North America and Europe
The adoption of fusion biopsy in North America occurs because of elevated prostate cancer detection rates and favorable insurance coverage for MRI ultrasound fusion procedures and fast integration of multiparametric MRI into urology treatment protocols. The main influence on end user selection comes from hospitals because they operate advanced imaging facilities and conduct academic research and handle complex biopsy procedures. The strategic value of diagnostic centers increases because they develop their outpatient image guided biopsy services which creates prime opportunities for fusion biopsy systems and automated reporting systems and training solutions that enhance radiology urology team collaboration. The ambulatory care sector continues to expand as a new market segment which focuses on performing minimally invasive procedures with shorter patient stays to create opportunities for product differentiation through user friendly design and compact size and fast patient processing in high volume prostate cancer screening facilities. The competitive landscape exists between established medical device companies which maintain strong ties with hospitals but new market entrants can succeed through their delivery of AI based lesion identification and cloud based data solutions and service based models that minimize ownership expenses for hospitals with 100 500 beds and diagnostic networks.
The European market for fusion biopsy experiences rapid expansion because healthcare organizations now use pre biopsy multiparametric MRI and targeted biopsy for prostate cancer diagnosis as per new guidelines which makes university and tertiary hospitals the main customers because they handle complex cases and train staff and test new biopsy technology. The hub and spoke healthcare system in certain markets requires independent diagnostic centers and hospital based facilities to expand MRI ultrasound fusion access which creates the most promising opportunities for standardized protocols and interoperable reporting solutions and scalable platforms that enable cross site benchmarking of treatment results. The adoption of ambulatory care centers happens at a slow pace but vendors who focus on day surgery models can succeed by offering fusion biopsy systems which combine minimal invasiveness with efficient workflows and electronic health record integration for outpatient prostate care. The European market shows diverse competition between multinational imaging companies and specialized regional businesses which requires vendors to prove their health economic value and European regulatory compliance and data protection standards and establish enduring partnerships with public health organizations and large hospital networks that focus on evidence based adoption and equal access to healthcare.
Market Dynamics and Supply Chain
01
Driver: Rising prostate cancer incidence and preference for targeted diagnostics accelerating adoption of fusion biopsy solutions
The increasing worldwide prostate cancer cases require better detection methods which will also enable fusion biopsy systems to become more widespread in urologic oncology centers. Medical professionals now use image guided biopsy techniques instead of random systematic sampling because they need better methods to locate significant prostate lesions during screening programs. The medical field now uses targeted prostate biopsy methods which reduce unnecessary procedures and overtreatment because they follow precision oncology and minimally invasive diagnostics trends. The combination of multiparametric MRI with AI assisted imaging enables fusion biopsy to target specific areas of suspicion while producing lower false negative results than traditional transrectal biopsy methods. Medical facilities purchase advanced fusion biopsy systems to create standardized biopsy workflows and biopsy automation systems which improve diagnostic accuracy and patient results.
The clinical value of fusion biopsy for prostate cancer treatment continues to grow because of improved multiparametric MRI technology and standardized lesion detection methods. The precise identification and segmentation of suspicious lesions through higher quality MRI datasets leads to better targeting results during image guided fusion biopsy procedures. The implementation of advanced imaging protocols and post processing software by radiology departments enables urologists to perform more accurate matches between MRI located lesions and ultrasound images during real time targeted prostate biopsy. The advanced technology enables better tumor detection of significant cancers while supporting individualized treatment plans which makes fusion biopsy an essential tool for contemporary urologic oncology practice.
02
Restraint: High capital costs and workflow complexity constrain hospital adoption of fusion biopsy imaging platforms globally
Urology centers postpone their purchases of MRI ultrasound fusion equipment and software updates and multiparametric MRI systems which results in reduced unit sales and ongoing service revenue despite increasing prostate cancer diagnosis numbers; smaller hospitals maintain standard systematic ultrasound biopsy instead of targeted prostate biopsy which restricts growth in diagnostic imaging and minimally invasive procedures and interventional radiology services that need fusion biopsy technology.
03
Opportunity: AI enhanced fusion biopsy software for precision oncology in European and Asia Pacific tertiary hospitals and Growing adoption of fusion biopsy equipment in prostate cancer centers across India and Brazil
European and Asian Pacific tertiary hospitals have made AI enhanced fusion biopsy software their top priority to support their precision oncology initiatives. The combination of real time image registration with analytics and robot assisted biopsy technology enhances both lesion detection accuracy and treatment consistency. The software operates seamlessly with current MRI and ultrasound systems which allows organizations to implement updates through their existing equipment base. The market for fusion biopsy disposables will experience the fastest growth because it will expand from 257.95 million units in 2024 to 410.32 million units by 2030 at an annual growth rate of 8.04% due to rising procedure numbers and increased sampling requirements.
The fusion biopsy equipment market in India and Brazil remains unexplored because these countries have not only established enough specialized prostate cancer centers. The increasing number of middle class consumers and better healthcare insurance coverage and expanding private medical facilities create conditions for capital investments in MRI ultrasound fusion biopsy systems. Manufacturers who provide customized training programs and service networks and flexible financing options will quickly replace traditional transrectal ultrasound biopsy with 3D imaging based targeted prostate biopsy. The equipment segment leads global revenue growth because it drives market expansion from 474.85 million in 2024 to 805.19 million by 2030 at a 9.2% annual rate.
04
Challenge: Variable reimbursement policies and clinical guideline ambiguity dampen physician confidence and slow fusion biopsy utilization
The lack of standardized fusion biopsy coverage between different insurance providers and geographic areas along with varying professional guidelines for prostate cancer screening and precision oncology pathways forces clinicians to limit this technology to the most severe cases which results in reduced procedure numbers and restricted revenue from consumables and software and inconsistent market growth.
Supply Chain Landscape
1
MRI-Ultrasound Imaging
Koninklijke Philips N.V.BK Medical Holding Company Inc
2
Platforms
EigenKOELIS
3
Image-Guided Software
MedComEigen
4
Clinical End Users
hospitalsurology clinicsprostate cancer centers
1
MRI-Ultrasound Imaging
Koninklijke Philips N.V.BK Medical Holding Company Inc
2
Platforms
EigenKOELIS
3
Image-Guided Software
MedComEigen
4
Clinical End Users
hospitalsurology clinicsprostate cancer centers
Applications of Fusion Biopsy in Hospital Settings, Diagnostic Centers & Ambulatory Care Centers
Hospital Settings : The majority of hospital based fusion biopsy procedures use MRI ultrasound fusion biopsy systems which operate within urology imaging and interventional radiology suites to perform complex prostate cancer detection and multiple biopsy procedures. The hospital sector produces the highest revenue from end users who will reach 456.53 million in 2024 and continue to expand at 8.3% annually until 2030 because of oncology multidisciplinary care and growing use of transrectal and transperineal fusion biopsy techniques. The hospital market leaders Koninklijke Philips N.V. and BK Medical Holding Company Inc. and Eigen and KOELIS and MedCom maintain their position through complete image guided fusion biopsy systems which unite MRI and ultrasound and navigation software to achieve precise targeting and automated workflows and extensive service availability. The hospital based patient base establishes organized pathways for complex and first stage cancer diagnosis which directs additional procedures to Diagnostic Centers for executing high volume targeted prostate biopsy protocols.
Diagnostic Centers : The main focus of diagnostic centers involves performing outpatient fusion biopsy procedures through software based prostate fusion biopsy systems which merge pre acquired multiparametric MRI images with real time ultrasound for efficient standardized high volume targeted prostate biopsy. The diagnostic center segment generates 157.55 million in annual revenue during 2024 while experts predict it will expand at a 9.3% annual rate until 2030 because of its affordable day care procedures and fast imaging result delivery. The diagnostic center market benefits from Eigen and KOELIS and MedCom because these companies provide flexible workstation based MRI ultrasound fusion biopsy solutions which integrate well with current scanners and PACS systems and reporting tools to reduce capital costs while delivering precise and reproducible image registration. The vendors provide diagnostic centers with compact hardware solutions and software updates and distant technical assistance to handle rising hospital referrals while maintaining fusion biopsy image quality for patient transitions to Ambulatory Care facilities.
Ambulatory Care Centers : The fastest growing end user group for fusion biopsy consists of ambulatory care centers which generated 88.67 million in revenue during 2024 and show a 10.8% CAGR projection because healthcare systems now perform office based minimally invasive targeted prostate biopsy under local anesthesia. The facilities use portable cart based MRI ultrasound fusion biopsy systems for transperineal fusion biopsy procedures which provide real time ultrasound guidance to minimize infection risks and enhance patient comfort and reduce recovery duration compared to traditional hospital based methods. BK Medical Holding Company Inc. and KOELIS lead the market in ambulatory settings through their ergonomic probes and user friendly interfaces and compact systems which operate in small procedure rooms. Eigen supports this approach through its adaptable software solutions which enable outpatient networks to implement the technology across multiple sites. The combination of lower procedure costs and decreased hospital visits and enhanced diagnostic accuracy enables the transition of appropriate prostate fusion biopsy procedures from hospitals and diagnostic centers to ambulatory care facilities which maintain clinical excellence with operational efficiency.
Impact of Industry Transitions on the Fusion Biopsy Market
As a core segment of the Medical Device industry,
the Fusion Biopsy market develops in line with broader industry shifts.
Over recent years, transitions such as Imaging And Workflow Integration and Shift Toward Ambulatory Settings have redefined priorities
across the Medical Device sector,
influencing how the Fusion Biopsy market evolves in terms of demand, applications and competitive dynamics.
These transitions highlight the structural changes shaping long-term growth opportunities.
01
Imaging And Workflow Integration
The market expansion of fusion biopsy will reach $114 million by 2030 because imaging systems and workflow integration now connect diagnostic systems into complete diagnostic networks. Hospitals now use unified real time dashboards to combine radiology data with urology information and pathology results and multiparametric MRI and PSA tracking and targeted biopsy results for immediate decision making. The integrated system streamlines medical planning processes while enhancing precision in disease assessment and minimizing the requirement for additional systematic biopsies which leads to better clinical performance and higher procedure success rates. The market evolution requires oncology centers to allocate their resources toward scalable interoperable systems instead of individual solutions which will make vendors who provide complete system integration solutions dominant in the additional $114 million market segment. This industry transition is expected to add $118 million in the industry revenue between 2024 and 2030.
02
Shift Toward Ambulatory Settings
The combination of reimbursement challenges and patient preference for non invasive medical procedures has led to the transition of fusion biopsy procedures from hospital operating rooms to office based facilities and ambulatory surgical centers. Urologists now use compact MRI fusion biopsy systems which work with standard ultrasound technology to perform procedures under local anesthesia while enabling quick patient turnover and immediate prostate cancer risk evaluation. The transition to outpatient image guided biopsy procedures has forced medical device suppliers to change their procurement strategies which now focus on service contracts and disposable products while payers need to modify their payment systems.