FUSION BIOPSY MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Fusion Biopsy Market Size and Forecast – 2025-2032

The Global Fusion Biopsy Market is estimated to be valued at USD 791.1 Mn in 2025and is expected to reach USD 1,418.2 Mn by 2032 exhibiting a compound annual growth rate (CAGR) of 8.7% from 2025 to 2032.

Key Takeaways of the Fusion Biopsy Market:

• By biopsy route, the transrectal segment is expected to contribute the highest share of the market with 53.1% in 2025.
• By product, the equipment segment is expected to contribute the highest share of the market with 53.2% in 2025.
• By application, the prostate cancer segment is expected to contribute the highest share of the market with 80.2% in 2025.
• North America is expected to top the global market with 38.3% share, followed by Asia Pacific with 27.7% share in 2025.

Market Overview:

Advancements in biopsy devices and growing preference for minimally invasive procedures is expected to fuel the market growth during the forecast period. The market is witnessing positive trends with increasing adoption of fusion biopsy globally. Fusion biopsy helps overcome the issues with traditional biopsy methods by combining Magnetic Resonance Imaging (MRI) and ultrasound images to guide the biopsy needle to the suspected area, improving accuracy and maximizing tissue yields. As fusion biopsy provides real-time images to guide needle placement, it enables efficient sampling of tissues while reducing damage to nearby healthy tissues. This trend is expected to drive the demand for fusion biopsy devices.

Segmental Insights

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Biopsy Route Insights – Transrectal Segment Dominates Due to Accuracy and Ease of Use

In terms of biopsy route, the transrectal segment is expected to contribute the highest share of the market with 53.1% in 2025 owing to its proven record of accuracy and minimal invasiveness. As prostate cancer screening has become more widespread, transrectal biopsy has emerged as the standard of care for initial prostate tumor detection and diagnosis. This is because it offers real-time ultrasound guidance to help physicians reach the entire prostate with precision. It also eliminates the need for an incision which reduces pain and risk of infection compared to transperineal procedures. Moreover, transrectal biopsies are generally well-tolerated by patients and do not require general anesthesia. These advantages have led to its preferential use over transperineal biopsy in most clinical settings for initial diagnosis. However, transrectal may have some limitation for repeat biopsies due to factors like needle damage from prior samples. This gap is expected to drive increased adoption of the transperineal route in future.

Product Insights - Constant Technological Advancements Fuel Equipment Demand

In terms of product, the equipment segment is expected to contribute the highest share of the market with 53.2% in 2025 driven by the need for the latest technology solutions. Physicians are demanding advanced fusion biopsy devices that integrate MRI/TRUS imaging for improved lesion targeting. This is spurring manufacturers to focus on developing novel biopsy guns, software for image registration, and platforms that enhance precision and diagnostic quality. Regular software and hardware upgrades are also required to support these fusion systems. Meanwhile, MRI machines continue to play a vital role in pre-biopsy mapping of prostate cancer. Manufacturers are designing new open and closed MRI systems specifically tailored for prostate interventions with improved ergonomics and workflow. 

Application Insights - Rising Prostate Cancer Incidence Drives Diagnostic Applications

In terms of application, the prostate cancer segment is expected to contribute the highest share of the market with 80.2% in 2025 driven by its growing incidence rates worldwide. Prostate cancer is the second most commonly occurring cancer in men globally. With aging populations and adoption of Western lifestyles in developing nations, its diagnosis has significantly increased over past decades. Early detection through biopsy remains critical for treatment selection and success outcomes. This is resulting in unprecedented procedure volumes for urologists to confirm prostate cancer diagnosis, determine aggressiveness, and rule out malignancy for elevated Prostate-Specific Antigen (PSA) levels.

Regional Insights

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North America Fusion Biopsy Market Trends

North America’s dominance in the fusion biopsy market with a share of 38.3% in 2025 can be attributed to factors such as established healthcare infrastructure, favorable reimbursement policies, and presence of leading market players. The region has witnessed considerable technological advancements and comprehensive research efforts aiding the clinical adoption of fusion biopsy.

Asia Pacific Fusion Biopsy Market Trends

Asia Pacific exhibits the fastest growth in the fusion biopsy market with a share of 27.7% in 2025 owing to increasing investments to develop healthcare facilities, rising medical tourism, and growing awareness among physicians and patients regarding novel diagnostic techniques. The region provides lucrative opportunities for market players to enhance their geographical presence.

Fusion Biopsy Market Outlook for Key Countries

U.S. Fusion Biopsy Market Trends

The U.S. drives the global fusion biopsy market due to its adoption of advanced diagnostic technologies, such as the transperineal biopsy with 3D MRI fusion, which enhances cancer detection accuracy and reduces infection risks. In April 2023, UC San Diego Health was the first in San Diego County to offer transperineal prostate biopsies, a minimally invasive procedure combined with 3D MRI fusion technology for improved cancer detection. Unlike traditional transrectal biopsies, this method avoids the rectum, significantly reducing infection risk and allowing the procedure to be performed in a clinic setting under local anesthesia.

China Fusion Biopsy Market Trends

China fusion biopsy market has expanded rapidly, fueled by the nation's efforts to improve healthcare services and tackle the rising burden of prostate cancer. An aging population has contributed to a higher incidence of prostate cancer, driving the adoption of advanced diagnostic technologies. According to World Cancer Research Fund, China recorded the second-highest global prevalence of prostate cancer, with 1,467,854 cases reported in 2022.

U.K. Fusion Biopsy Market Trends

The U.K. drives the global fusion biopsy market by pioneering advanced diagnostic technologies such as MRI-US fusion-guided transperineal prostate biopsies (M-TTP). Centers like Cambridge Urology Partnership lead in innovation, offering purpose-built solutions with proven higher cancer detection rates and precise tumor mapping. The U.K.’s focus on integrating cutting-edge imaging with clinical expertise enhances diagnostic accuracy, influencing global standards in prostate cancer care and driving adoption of similar technologies worldwide.

Japan Fusion Biopsy Market Trends

Japan is experiencing growth in fusion biopsy market due to its aging population, according to World Economic Forum, In September 2023, more than 10% of Japan's population is now aged 80 or older, solidifying its position as the country with the world's oldest population. The Japanese government has initiated programs to improve cancer screening and diagnostic technologies, including fusion biopsy.

Market Players, Key Devlopment, and Competitive Intelligence

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Key Developments:

• In September 2024, Koelis, a global leader and innovator in prostate care, announced a partnership with DeepHealth to enhance prostate cancer care through the integration of DeepHealth’s AI-powered prostate MRI software with Koelis' Trinity 3D Ultrasound Platform. This collaboration aims to streamline the prostate MRI reading process and enable seamless MRI-US fusion for biopsy and treatment. The Koelis Trinity system combines 3D ultrasound imaging with MRI-US fusion guidance, offering unique prostate motion tracking software.
• In August 2024, Perineologic, a pioneer in transperineal prostate biopsy technology, announced a strategic investment from a group of private equity and hedge fund executives. This investment will support the company’s expansion and commercial sales efforts. CEO Mr. Matthew Allaway highlighted the endorsement of their vision and market leadership. With the new funding, Perineologic plans to accelerate market penetration of its Precision Point Transperineal Access System, known for its high cancer detection and low infection rates.
• In April 2023, FUJIFILM Healthcare, a pioneer in diagnostic imaging and information systems, launched the ARIETTA 65 IntuitiveFusion, an MRI-US fusion prostate biopsy system on April 6, 2023. This system combines FUJIFILM's ARIETTA 65 ultrasound and MedCom's BiopSee software to enhance prostate biopsy efficiency. The integration of the device and software enables miniaturization and high operability, supporting more efficient and accurate MRI-US fusion prostate biopsies with various advanced functions.

Top Strategies Followed by Global Fusion Biopsy Market Players

• Established players in the global fusion biopsy market focus heavily on research and development to drive innovation. Industry leaders such as Becton, Dickinson and Company invest over 5% of annual revenue into creating new fusion biopsy technologies. They leverage advances in robotics, imaging, and artificial intelligence to develop high-performance products.
• Mid-sized companies concentrate on strategic partnerships and global expansion. Companies like Hologic partner with major hospitals and diagnostic centers to test and validate their fusion biopsy systems. Through such clinical collaborations, they improve product features to meet medical needs. Additionally, they grow international sales teams and distribution networks in key regions like Europe and Asia Pacific.
• Smaller players focus on cost-effective solutions and niche specialization. They aim to make quality fusion biopsy affordable and accessible for budget-constrained healthcare facilities. For example, companies like MedCom target public hospitals and clinics in developing nations with economically priced devices. Some also collaborate with technology startups to incorporate features like automated biopsy reports and cloud connectivity in their products.

Emerging Startups - Fusion Biopsy Industry Ecosystem

• Several startups are disrupting the fusion biopsy market through innovative technologies. Companies like Anthropic develop advanced AI algorithms to offer precision targeted biopsies. Their deep learning models can detect anomalies unnoticed on ultrasound and MRI scans, helping diagnose cancers sooner. Other startups offer smart biopsy gun platforms that provide real-time tissue sampling feedback using MEMS sensors and visual analytics. This enhances biopsy accuracy and minimizes repeat procedures.
• More startups focus on sustainable innovations in fusion biopsy. BiopsyZen has developed biopsy devices using bio-based and recycled plastics, reducing medical waste. Their cartridges and needles are compostable to minimize environmental impact. PathAI applies computer vision to digitize biopsy samples, enabling virtual consultations and remote expert analysis. This promotes equitable access while reducing carbon footprint from transportation.
• Many startups address niche clinical demands through partnerships. Companies work with top cancer centers and research universities to customize products for rare diseases. Others form consortiums to tackle global health issues like liver cancer diagnosis in underserved regions. Such collaborations accelerate the development and access of advanced yet affordable fusion biopsy technologies.

Market Report Scope

Market Dynamics

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Market Driver - Increasing prevalence of prostate cancer

The global fusion biopsy market is witnessing significant growth driven by the rising incidence of prostate cancer worldwide. Prostate cancer has become one of the most commonly occurring cancers in men. The rising prevalence can be attributed to many factors such as growing and aging global population, widespread adoption of prostate specific antigen testing, and changing lifestyle patterns in developing countries. Advanced medical technologies, wider health insurance coverage, and higher per capita healthcare spending have also improved access to advanced diagnostic tools in developed regions. In April 2024, as per Prostate Cancer Foundation, prostate cancer cases are projected to double from 1.4 million in 2020 to 2.9 million in 2040, with annual deaths rising by 85% to nearly 700,000, primarily in low- and middle-income countries (LMICs). The Lancet Commission highlights the need for early-detection programs for high-risk individuals, especially in LMICs, where late-stage diagnoses are common.

Market Challenge - High cost of fusion biopsy systems

One of the major challenges faced by the global fusion biopsy market is the high cost of fusion biopsy systems. These advanced biopsy systems that integrate MRI/TRUS imaging with biopsy require expensive MRI or ultrasound devices along with the biopsy hardware and software. This pushes the total installation cost of a fusion biopsy system to over half a million dollars or more. The steep capital investment poses a significant barrier for small hospitals and clinics in developing countries to adopt fusion biopsy. Moreover, the need for regular maintenance and software upgrades further adds to the operational costs. The pricing pressure to recover the high fixed costs also makes fusion biopsy procedures relatively expensive for patients compared to conventional biopsy.

Market Opportunity - Growing demand for minimally invasive diagnostic procedures

A key opportunity for the global fusion biopsy market is the rising demand for minimally invasive diagnostic procedures across the world. There is an increasing preference for procedures that are less painful, cause minimal trauma to tissues and enable faster recovery. Compared to conventional transrectal ultrasound (TRUS) biopsies which require multiple needles insertions, fusion biopsy provides precise tissue sampling with just one insertion guided by multi-parametric MRI images. This significantly reduces discomfort for patients and chances of infections. Given the growing geriatric population globally that is more averse to invasive treatments, the demand for painless and accurate diagnostic procedures like fusion biopsy is expected to grow steadily. Manufacturers have an opportunity to promote the enhanced patient experience, diagnostic accuracy, and quality of life benefits of fusion biopsy over traditional biopsies.

Analyst Opinion (Expert Opinion)

• The global fusion biopsy market presents significant growth opportunities over the forecast period owing to rising preference for minimally invasive cancer diagnosis. Driven by technological advancements, fusion biopsy systems that combine MRI/ultrasound imaging with robotic core needle biopsies are expected to dominate the market. North America will continue leading demand given early adoption of advanced diagnostic technologies among medical practitioners and patients in the region.
• High installation and maintenance costs of fusion biopsy devices pose a major challenge to market expansion. Moreover, lack of adequate healthcare infrastructure and funding in developing nations limits market growth. Nonetheless, growing cancer incidence worldwide is increasing the need for precision diagnosis, presenting opportunities for market players to offer cost-effective solutions.
• The Asia Pacific region is projected to witness the fastest growth and emerge as a lucrative market. This can be attributed to rising healthcare expenditures, growing medical tourism and improving diagnostic capabilities in densely populated countries like China and India. Competitive pricing of products will be a winning strategy to gain market share in Asia Pacific.
• Adoption of fusion biopsy techniques is expected to steadily increase owing to benefits such as real-time monitoring, lower complications, and higher accuracy rates compared to conventional prostate biopsies. Market leaders should focus on developing automated, portable systems for newly diagnosed as well as recurring cancer cases globally to sustain growth momentum.

Market Segmentation

•  Biopsy Route Insights (Revenue, USD Mn, 2020 - 2032)
• • Transrectal
  • Transperineal
•  Product Insights (Revenue, USD Mn, 2020 - 2032)
  • Equipment
    • MRI machines
    • Ultrasound devices
    • Fusion biopsy systems
    • Others
  • Consumables
    • Biopsy needles
    • Imaging contrast agents
    • Others
•  Application Insights (Revenue, USD Mn, 2020 - 2032)
  • Prostate Cancer
  • Others
•  End User Insights (Revenue, USD Mn, 2020 - 2032)
  • Hospitals
  • Diagnostic Centers
  • Ambulatory Care Centers
  • Academic & Research Laboratories
  • Others
• Regional Insights (Revenue, USD Mn, 2020 - 2032)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • GE Healthcare
  • Koninklijke Philips N.V.
  • FUJIFILM Corporation
  • Siemens Healthineers
  • Hitachi, Ltd.
  • Canon Medical Systems Corporation
  • Medtronic
  • Hologic, Inc.
  • Varian Medical Systems
  • Boston Scientific Corporation
  • Becton, Dickinson and Company
  • Agilent Technologies, Inc.
  • 3M Company
  • Carestream Health
  • Neusoft Medical Systems Co., Ltd.