The global fusion biopsy market size was valued at USD 829.1 million in 2024 and is expected to exhibit growth at a CAGR of 9.9% from 2025 to 2034. High market growth can be attributed to the increasing prevalence of prostate cancer, growing awareness and screening programs, and supportive government policies and reimbursement, among other contributing factors.
Fusion biopsy is an advanced diagnostic technique that combines MRI and ultrasound imaging to accurately identify and target suspicious tissue areas for biopsy, particularly in organs like the prostate. Prostate cancer ranks among the most prevalent cancers in men, particularly affecting older adults. According to the National Cancer Institute, approximately 248,530 new cases of prostate cancer were diagnosed in the U.S. in 2023. The rising incidence can be attributed to an aging population as well as heightened awareness and screening efforts. Conventional biopsy methods often fall short in precision, leading to missed diagnoses or underestimation of the disease's stage.
In contrast, fusion biopsy enhances accuracy by integrating magnetic resonance imaging (MRI) with real-time ultrasound imaging, effectively pinpointing suspicious areas within the prostate. Additionally, as more patients opt for active surveillance for low-risk prostate cancer, there is a growing need for highly accurate diagnostic tools like fusion biopsy. Fusion biopsy enables regular, precise monitoring of prostate changes, helping healthcare providers manage patients on active surveillance more effectively. This capability has made fusion biopsy an essential tool in many urology practices, further driving its demand within the market.
Advancements in imaging technology are pivotal growth drivers for the market, significantly enhancing the accuracy, reliability, and accessibility of prostate cancer diagnostics.
Based on product type, the market is classified into devices and accessories. The devices segment generated the highest revenue of USD 703.1 million in 2024.
Based on procedure type, the fusion biopsy market is classified into transrectal and transperineal. The transrectal segment accounted for USD 677.6 million in market revenue in 2024 and is anticipated to grow at a CAGR of 9.6% between the 2025 and 2034.
Based on application, the fusion biopsy market is classified into prostate cancer diagnosis, kidney cancer diagnosis, and other applications. The prostate cancer diagnosis segment generated the highest revenue of USD 549.8 million in 2024.
Based on end use, the fusion biopsy market is segmented into hospitals, diagnostic imaging centers, ambulatory surgical centers, and other end users. The hospitals segment dominated the market in 2024 and is anticipated to reach USD 1.2 billion by 2034
North America fusion biopsy market accounted for USD 367.1 million in market revenue in 2024 and is anticipated to grow at a CAGR of 9.2% between the 2025 and 2034.
France fusion biopsy market is projected to grow remarkably in the coming years.
Japan holds a dominant position in the Asia Pacific fusion biopsy market.
The market is competitive, with a mix of large multinationals like Koninklijke Philips N.V., Focal Healthcare, and Koelis leading in innovation and extensive product portfolios. Regional companies and new entrants, particularly from APAC, are also making significant strides. The market is characterized by frequent technological advancements, such as improved precision, enhanced real-time guidance, and increased workflow efficiency, which drive ongoing product development. Strategic partnerships, mergers, and acquisitions are common as companies seek to expand market reach and enhance their technological capabilities.
Prominent players operating in the fusion biopsy industry include: