Fusion Biopsy Market Size, Share and Trends 2025 to 2034

Fusion Biopsy Market Size and Forecast 2025 to 2034

The global fusion biopsy market size was calculated at USD 738.94 million in 2024 and is anticipated to reach around USD 1,690.87 million by 2034, expanding at a CAGR of 8.63% from 2025 to 2034. The increasing incidence of prostate cancer worldwide is the key factor driving the fusion biopsy market growth. Advancements in molecular profiling, coupled with the development of technology, can fuel market growth further.

Fusion Biopsy Market Key Takeaways

• In terms of revenue, the fusion biopsy market is valued at $802.72 million in 2025.
• It is projected to reach $1,690.87 million by 2034.
• The fusion biopsy market is expected to grow at a CAGR of 8.63% from 2025 to 2034.
• North America dominated the global market with the largest market share of 41% in 2024.
• Asia Pacific is expected to show the fastest CAGR during the forecast period.
• By biopsy route, the transrectal segment contributed the highest market share of 86% in 2024.
• By biopsy route, the transperineal fusion biopsy segment is expected to grow at a fast rate in the market over the forecast period.
• By end use, the hospital segment captured the biggest market share of 61% in 2024.
• By end use, the ambulatory care centers segment will grow rapidly during the forecast period.

Role of Artificial Intelligence (AI) in the Fusion Biopsy Market

In the last few years innovations in artificial intelligence have opened new doors for the diagnosis and treatment of prostate cancer. The most substantial advancement in this area is the combination of fusion magnetic resonance technology with AI technology. Also, AI algorithms can use large sets of clinical data, MRI images, and histopathologic outcomes to recognize the pattern related to disease progression in the fusion biopsy market. Furthermore, the integration of fusion MRI-TB and AI seems promising for enhancing overall patient outcomes and transforming urologic oncology.

• In December 2024, UCLA Spinoff developed an AI tool that enhances the accuracy of prostate cancer diagnosis. The software, called Unfold AI, was developed by Avenda Health, a University of California Los Angeles (UCLA) spinoff company. Software processes imaging scans and clinical laboratory data to help oncologists and anatomic pathologists visualize a tumor's extent.
• In September 2024, Koelis, a global leader and innovator in prostate care, announced the collaboration and successful initial experience using the DeepHealth Prostate software to streamline the prostate MRI reading process and seamless fusion of MRI with Koelis Trinity 3D Ultrasound Platform for prostate fusion biopsy and treatment.

U.S. Fusion Biopsy Market Size and Growth 2025 to 2034

The U.S. fusion biopsy market size was exhibited at USD 212.08 million in 2024 and is expected to be worth around USD 494.71 million by 2034, growing at a CAGR of 8.84% from 2025 to 2034.

North America dominated the fusion biopsy market in 2024. The dominance of the region can be attributed to the increasing number of cancer cases along with the growing adoption of innovative diagnostic technologies. In North America, the U.S. led the market owing to the improved effectiveness and adoption of advanced cancer detection technologies. Furthermore, strong government support and developed healthcare infrastructure can support this market growth further.

North America remains the front-runner in the global fusion biopsy space. With a substantial market share secured, the region’s leadership is anchored by a combination of robust healthcare systems, high rates of prostate cancer screening, and extensive insurance coverage for diagnostic procedures. In the United States, continued support from federal health agencies, including initiatives promoting early detection and improving diagnostic accuracy, has encouraged widespread adoption of fusion biopsy techniques. Additionally, the presence of top-tier medical device companies contributes to the region’s innovation pipeline and market resilience. 

• In February 2023, Exact Sciences received FDA approval for its Oncotype DX Breast Recurrence Score test, which predicts the risk of breast cancer recurrence and helps guide treatment decisions.

Asia Pacific region is expected to show the fastest growth over the studied period. The growth of the region can be credited to the rising awareness regarding protests against cancer in the region and advanced healthcare infrastructure in emerging countries such as China, India, and Japan. Furthermore, the surge in the aging population in countries like Japan and South Korea impacts market growth positively.

In Middle East and Africa, growth in the fusion biopsy market is being stimulated by broad healthcare reforms and rising public health awareness. Countries such as the UAE and Saudi Arabia are investing heavily in advanced diagnostic infrastructure as part of their national health strategies. Alongside the development of specialist cancer treatment centres, this has enabled wider deployment of fusion biopsy equipment, especially in urban regions. The increasing availability of MRI imaging and urology specialists is also helping accelerate the transition from conventional diagnostics to image-guided biopsy procedures. 

Market Overview

The fusion biopsy market encompasses the diagnosis, treatment, and surgical procedures for detecting and curing cancer. This innovative diagnostic method offers physicians a complete picture of the targeted area by blending the insights from Country traditional magnetic resonance imaging and ultrasound imaging. This technology further reduces the chances of negative results by offering enhanced precision and imaging, which triggers more accurate tissue harvesting.

Men prostate cancer rates across the globe (2022)

Fusion Biopsy Market Growth Factors

• Increasing demand for minimally invasive surgeries is expected to fuel fusion biopsy market growth shortly.
• Ongoing innovations in imaging technologies like ultrasound, MRI, and CT can propel market growth soon.
• The growing trend towards point-of-care diagnostics procedures will likely contribute to the market expansion further.

Market key trend  

The fusion biopsy industry is undergoing a period of transformative growth, largely propelled by the need for more accurate, minimally invasive diagnostic techniques for prostate cancer. Medical professionals are increasingly turning to fusion biopsy over traditional random sampling, due to its ability to combine real-time ultrasound imaging with MRI data for precise tumour targeting. Another innovation driving market expansion is the integration of AI and machine learning algorithms into fusion biopsy platforms.  

One of the prevailing trends reshaping this market is the increasing shift towards transperineally biopsy procedures. This technique is gaining traction over the conventional transrectal method, primarily because it poses a significantly lower risk of post-procedure infections and offers greater accuracy in accessing various parts of the prostate. The move towards safer, more effective approaches is enhancing patient outcomes and boosting market adoption. These technologies are proving invaluable in automating lesion detection, refining biopsy guidance, and reducing operator-dependent variability, resulting in faster, more reliable diagnoses. 

Market Scope

Market Dynamics

Driver

Rising use of Multi-Modality Imaging

There is a growing trend towards the utilization of multi-modality imaging (ultrasound, MRI, and CT) in the fusion biopsy market for more precise tumor detection. In addition, the use of point-of-care (POC) diagnostics is also escalating owing to the increasing use of fusion biopsy technologies in healthcare settings and outpatient clinics for rapid diagnosis and treatment.

• In October 2024, Boston Scientific Corporation announced the launch of AVVIGO™+ Multi-Modality Guidance System, a new intravascular ultrasound (IVUS) and fractional flow reserve (FFR) system with innovative software and hardware features designed to offer high-quality IVUS vessel imaging and physiology experience medical procedures.

Restraint

Limited reimbursement policies

Sufficient reimbursement policies in some areas may constrain the extensive adoption of fusion biopsy market procedures, as the cost is being borne by healthcare institutions or patients. Moreover, requirements for skilled personnel and technical complexities can impact market growth negatively as they can pose hurdles in the widespread adoption with limited access to skilled persons.

Opportunity

Increasing adoption of liquid biopsies

Liquid biopsies, assess cell-free nucleic acids in a blood vessel and provide a non-invasive solution to conventional tissue biopsies. Fusion biopsies can be carried out by using liquid biopsies, which enable the early detection of genomic alterations in tumor cells or cDNAs. Furthermore, the increasing adoption of liquid biopsies for the detection and control of cancer is anticipated to create future opportunities for the fusion biopsy market.

• In September 2024, Strand Life Sciences announced the launch of its Somatic Advantage 74 Liquid Biopsy (SA74 LB) Test. According to the company's statement, this test detects circulating tumor DNA in blood samples of cancer patients to offer a comprehensive analysis of 74 clinically relevant genes, offering invaluable insights for cancer treatment.

Biopsy Route Insights

The transrectal segment led the fusion biopsy market in 2024. The dominance of the segment can be attributed to the increasing commercial availability of fusion biopsy systems for the transrectal approach. Despite this, the segment's growth has been constrained because of the complexities like sepsis, fever, rectal bleeding, and hematuria, following transrectal procedures. Transrectal ultrasound can identify abnormalities in the nearby area of the rectum, including the prostate. Also known as endorectal ultrasound.

• In May 2024, GE HealthCare launched an AI-powered prostate volume assist for ultrasound. With the introduction of Prostate Volume Assist, clinicians can ascertain prostate measurements and calculations with one click, according to GE HealthCare, the manufacturer of the software.

The transperineal fusion biopsy segment is expected to grow at a fast rate in the fusion biopsy market over the forecast period. The growth of the segment can be credited to the effectiveness provided by this segment in terms of accuracy and the entire sampling procedure. However, transperineal biopsy reduces the risk of infection associated with the diagnostic procedure. This biopsy also allows a greater chance of detecting the cancer, especially in the anterior of the prostate.

End-use Insights

The hospital segment dominated the global fusion biopsy market in 2024. The dominance of the segment can be linked to the high purchasing power of the hospitals and associated organizations. The widespread availability of resources and skilled personnel in hospitals including anesthesiologists, MRI scanners, urologists, and radiologists enable them to perform on-demand fusion biopsies. Furthermore, in the hospital segment, there is increasing adoption of transperineal fusion biopsy systems to gain wide hospital acceptance, fuelling segment growth.

• In July 2024, Hologic Inc. finalized its acquisition of a rival breast care company for USD 310 million, the Marlborough, Massachusetts, mammography system maker announced Endomagnetics Ltd.Which is a developer of breast surgery localization and lymphatic tracking technologies.

The ambulatory care centers segment is anticipated to show the fastest growth in the fusion biopsy market during the projected period. The growth of the segment is driven by the growing incidence of prostate cancer especially, in rural areas where having short access to medical services. Additionally, the launch of low-cost and highly portable MRI can improve the adoption rate of targeted ultrasound biopsies in these centers.

Fusion Biopsy Market Companies

• Eigen
• Koninklijke Philips N.V.
• Hitachi Ltd.
• MedCom
• ESAOTE SPA
• KOELIS
• Focal Healthcare
• BK Medical Holding Company, Inc.
• Exact Imaging
• Biobot Surgical Pte Ltd.
• UC-Care Medical Systems Ltd

Latest Announcement by Market Leaders

• In September 2024, Htachi Energy announced plans to invest an additional USD 155 million to expand its manufacturing capacity in North America. This involves a new distribution transformer factory in Reynosa, Mexico, and expansions to its transformer factory in South Boston, Virginia, and its high-voltage switchgear and breakers factory in Mount Pleasant, Pennsylvania.
• In September 2024, Koelis, SAS, a global leader and innovator in prostate care, announced the release of a new, compact 3D transducer for transperineal fusion biopsy and treatment. Koelis is now compatible with both the market-leading high-level disinfection systems.

Recent updates on fusion biopsy-2025 

Rising prostate cancer incidence accelerates fusion biopsy adoption 

• In March 2025, the market for fusion biopsy is expanding rapidly because of the increased prevalence of prostate cancer worldwide. When compared to conventional techniques, fusion biopsy, which combines MRI and ultrasound imaging, provides greater tumor localization accuracy. Urologists are increasingly favoring this minimally invasive method for accurate and early detection. Adoption is being accelerated, particularly in North America and Europe, by increased awareness, better reimbursement practices, and the need for targeted diagnostics. 

Technological advancements improve diagnostic precision 

• By April 2025, Advanced fusion biopsy platforms with robotic assistance, 3D navigation, and AI-guided imaging have become available. These developments are lowering false negatives and greatly increasing sampling accuracy. For usage in ambulatory surgical centers and outpatient clinics, businesses are concentrating on portable cloud-connected systems. Additionally, AI algorithms are being trained to identify high-grade tumors, which will enable more individualized treatment plans and better biopsy planning. 

Recent Developments

• On 10 March 2025, a prominent market research firm emphasized the expanding adoption of fusion biopsy technologies in cancer diagnosis. The focus on combining MRI and ultrasound imaging to enhance the accuracy of prostate cancer detection has gained significant traction among healthcare providers globally. This advancement is expected to improve early diagnosis and treatment outcomes.
• On 15 January 2025, industry experts highlighted the increasing demand for advanced image-guided biopsy systems that offer superior precision over traditional biopsy methods. Training programs for clinicians are being expanded to ensure effective use of these sophisticated diagnostic tools, facilitating improved patient care.
• On 20 February 2025, companies announced the ongoing integration of artificial intelligence and machine learning into fusion biopsy devices. These developments aim to support clinicians by providing enhanced imaging interpretation, thereby improving diagnostic accuracy and reducing procedural risks. 
• In October 2023, Medtronic unveiled the Hugo™ robotic-assisted biopsy platform which is the latest version of its Biopsy System. This state-of-the-art technology brings together advanced imaging and artificial intelligence (AI) in an attempt to increase precision and reduce procedure time. 
• In June 2024, Hologic Inc. introduced the Affirm™ Prone Biopsy System, designed to offer superior imaging and patient comfort. This system is a breakthrough in ergonomic patterns together with better imaging abilities that help to facilitate breast biopsy accuracy.
• In March 2023, Biocept announced a partnership with Illumina to develop and commercialize next-generation sequencing-based liquid biopsy tests for cancer detection and monitoring. 
• In January 2023, Guardant Health, Inc. announced a partnership with AstraZeneca to develop liquid biopsy tests for cancer diagnosis and treatment monitoring. 

Segments Covered in the Report

By Biopsy Route

• Transrectal
• Transperineal

By End Use

• Hospitals
• Diagnostic Centers
• Ambulatory Care Centers

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa