Transrectal Ultrasound Market Poised for Strong Growth Driven by Rising Prostate Cancer Screenings 2025 | Top Companies - Exact Imaging, GE Healthcare, Bayer Ag.

Market Overview:

The Transrectal Ultrasound Market is expected to grow at a CAGR of 4.4% during the forecasting period 2024-2031. The Market Growth is driven by the rising prevalence of prostate cancer and increasing adoption of minimally invasive diagnostic procedures. According to DataM Intelligence

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The Transrectal Ultrasound Market involves diagnostic imaging systems that use high-frequency sound waves to produce detailed images of the prostate gland and surrounding tissues. It is widely used for detecting prostate abnormalities, guiding biopsies, and monitoring treatment. Growing prevalence of prostate disorders and technological advancements are driving demand for these ultrasound-based diagnostic solutions.

Industry Recent Developments: United States

✅ October 2025: Ongoing technological and clinical integration in TRUS systems, supported by reimbursement and regulatory policies, drives market growth in the U.S., with a significant focus on prostate cancer screening awareness and treatment advancements.

✅ September 2025: Market growth is propelled by expanding healthcare infrastructure, increased prostate cancer cases, and the integration of frontier technologies such as AI and IoT into ultrasound diagnostics.

✅ August 2025: The introduction of advanced real-time elastography and MRI-US fusion biopsy techniques in TRUS systems enhances diagnostic accuracy and adoption in clinical settings.

Industry Recent Developments: Japan

✅ October 2025: Japan's ultrasound device market, including TRUS, is expanding due to rising demand for diagnostic imaging, increased minimally invasive surgeries, and growing healthcare infrastructure.

✅ September 2025: Growth driven by innovation in ultrasound modalities, including trolley-based and handheld devices, with increasing adoption across hospitals, surgical centers, and diagnostic facilities.

✅ August 2025: The market benefits from ongoing technological advancements and increasing awareness for early disease detection, with a forecasted continuous CAGR growth over the 2025-2033 period.

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FDA / Regulatory Approvals (2025):

✅ Philips - 510(k) clearance (K250886): Philips' EPIQ/Affiniti diagnostic ultrasound systems received a 510(k) determination in 2025; the cleared indications explicitly include "Transrectal" use. (FDA 510(k) letter dated May 21, 2025).

✅ Academic/robotic TRUS systems - clinical trial approvals in 2025: Development teams (e.g., "ProBot" robotic ultrasound probe) secured FDA clinical-trial (IDE-like) clearance / FDA acceptance for clinical evaluation plus IRB approvals for initial TR biopsy cases in 2025, showing progress toward clinical testing of robotic TRUS-guided biopsy systems. (Conference/clinical reports & NIH award summary).

✅ Dedicated TRUS device CE or FDA full PMA approvals in 2025 that I could find beyond platform-level or incremental clearances (many TRUS capabilities are added via system 510(k)s or software/module clearances). Historical CE/FDA-cleared TRUS/micro-ultrasound products (e.g., Exact Imaging's ExactVu) remain on the market but their major regulatory clearances were earlier, not new in 2025.

Mergers & Acquisitions in 2025:

✅ Boston Scientific - agreement to acquire SoniVie (announced March 3, 2025): Boston Scientific agreed to acquire ultrasound-based SoniVie (TIVUS intravascular ultrasound system). While SoniVie's TIVUS is not a TRUS prostate device, the deal is a notable 2025 ultrasound-tech M&A that affects vendor capabilities and R&D investment in ultrasound modalities.

✅ RadNet - acquisition of See-Mode Technologies (completed June 4, 2025): RadNet acquired See-Mode (AI for ultrasound). See-Mode has FDA-cleared thyroid ultrasound AI and is expanding AI across ultrasound modalities - this kind of AI / imaging consolidation influences workflow and adoption in high-volume ultrasound exams (including prostate imaging workflows/integration over time).

✅ Broader 2025 trend: The ultrasound sector saw continued M&A and consolidation in 2025 (platform vendors, AI players, and imaging service providers), but few transactions exclusively labeled "TRUS company acquired" - most deals were platform/AI or adjacent-ultrasound technology acquisitions.

Major Key Players:

Exact Imaging
BK Medical Holding Company,Inc
KOELIS
GE Healthcare
The Prometheus Group
TELEMED
Shenzhen Mindray Bio-Medical Electronics Co,Ltd
Bayer Ag
Boehringer Ingelheim Gmbh
Ceva Sante Animale
Dechra Pharmaceuticals Plc
Eli Lilly And Company
Merck Animal Health
Sanofi
Virbac
Vetoquinol S.a.
Zodis, Inc.

Segments Covered in the Transrectal Ultrasound Market:

By Type: Cart/Trolley based, Portable.

By Application: Diagnostic, Image-guided treatment.

By End-User: Hospitals, Diagnostic Laboratories, Others.

Regional Analysis for Transrectal Ultrasound Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Transrectal Ultrasound market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Transrectal Ultrasound Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Transrectal Ultrasound market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Transrectal Ultrasound Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Transrectal Ultrasound market?

➠ Who are the global key manufacturers of the Transrectal Ultrasound Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Transrectal Ultrasound market opportunities and threats faced by the vendors in the global Transrectal Ultrasound Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Transrectal Ultrasound market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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