Transrectal Ultrasound Market Size, Share & Industry Analysis, By Product (Systems and Transducers) By Type (Cart/Trolley Based and Portable), By Application (Diagnostic (Prostate Cancer, Benign Prostatic Hyperplasia, and Others) and Image-guided Treatment), By End-user (Hospitals & ASCs, Diagnostic Laboratories, and Others), and Regional Forecast, 2025-2032

The global transrectal ultrasound market size was valued at USD 255.6 million in 2024. The market is projected to grow from USD 271.1 million in 2025 to USD 425.1 million by 2032, exhibiting a CAGR of 6.6% during the forecast period. North America dominated the transrectal ultrasound market with a market share of 29.15% in 2024. Transrectal ultrasound is a medical device utilized for diagnosing prostatic diseases in men, including conditions such as prostate cancer, prostatitis, and benign prostatic hyperplasia. It is a minimally invasive technique that employs sound waves to generate images of the prostate. During a transrectal ultrasound procedure, a small probe is inserted into the rectum, emitting sound waves that bounce off surrounding tissues. A computer analyzes the wave patterns (known as echoes) as they bounce off the organs, converting them into an image that a doctor views on a video screen. Transrectal ultrasound is also referred to as Endorectal Ultrasound (ERUS), prostate sonogram, or prostate ultrasound.

The increase in the prevalence of prostate cancer is a major factor influencing the global transrectal ultrasound market growth. Additionally, the rise in government funding to develop new treatments and advancements in TRUS devices are projected to drive market's growth over the forecast period. For example, in March 2023, the Defense Appropriations Act funded the Prostate Cancer Research Program (PCRP) to develop new treatments and conduct high-impact prostate cancer research. Moreover, systems with improved and efficient imaging capabilities, techniques integrated with MRI-US fusion biopsies, high-resolution ultrasound scanning, and real-time elastography for the diagnosis of prostate cancer are being introduced on a large scale. These systems are driving the shift of diagnostic approaches from conventional to advanced techniques in diagnosing prostate cancer. In addition, the large and aging population base in emerging countries such as China and India, along with the expanding healthcare infrastructure in these countries, is propelling the adoption of transrectal ultrasound systems. However, product recalls due to safety issues and stringent healthcare policies by regulatory authorities are projected to hamper market's growth to a certain extent.

The global market was significantly impacted by the COVID-19 pandemic in 2020. A decline in the number of urological surgical procedures was observed during this period, posing a challenge for market growth. For instance, during the pandemic, the British Association of Urological Surgeons Limited published a triage schema for the step-down cancellation of urological surgical procedures to prioritize the treatment of COVID-19 patients. The postponement of capital equipment installations and elective procedures further exacerbated the market’s decline.

However, there was a resumption in elective surgeries between Q4-2020 and Q1-2021 as governments relaxed imposed regulations worldwide. This scenario led to an increase in the number of patient visits to diagnostic centers and hospitals, partially stabilizing the adoption of transrectal ultrasound devices globally. Furthermore, in 2022 and 2023, the market experienced gradual growth and the trend is expected to continue throughout the forecast period.

Transrectal Ultrasound Market Trends

Launch of Innovative and Advanced Systems to Boost Market Potential

Major players in the market are focusing on launching advanced technologies to treat prostate cancer. For example, ExactVu is a micro-ultrasound platform that helps urologists or radiologists perform targeted biopsies within a standard urological workflow. The unique 29MHz frequency of this tool allows urologists to visualize unseen prostate images before surgery. The ExactVu micro-ultrasound system is available for sale in the U.S., Canada, and Europe.

Furthermore, the growing approvals from government agencies to sell ultrasound devices in different countries are projected to boost the growth of the market in the coming years. For example, in April 2023, EDAP TMS, a manufacturer of robotic energy-based therapies, received approval from the Pharmaceutical and Medical Devices Agency (PMDA) to commercialize its ExactVu micro-ultrasound biopsy platform in Japan.

In addition, researchers from different institutions are focusing on the development of AI-based tools for the effective diagnosis of prostate cancer. For instance, as per an article published by Postgraduate Medical Journal in December 2023, a retrospective study was conducted by using an Artificial Intelligence (AI) model based on the transrectal ultrasound images of biopsy needle tract tissues to differentiate prostate cancer. The study results indicated that this model can improve diagnostic performance and can be a helpful tool in guiding prostate biopsy.

Moreover, the rising efforts toward manufacturing and launching urological devices are projected to create significant growth opportunities for the market during the forecast period.

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Transrectal Ultrasound Market Growth Factors

Increasing Prevalence of Prostate Cancer to Drive Market Growth

Prostate cancer is a type of cancer that occurs in the prostate, a part of the male reproductive system which includes the penis, seminal vesicles, prostate, and testicles. According to data published by the World Cancer Research Fund International, prostate cancer is the second most occurring cancer and the fourth most common cancer overall. Additionally, there were more than 1.4 million new cases of prostate cancer globally in 2020. Furthermore, according to data reported by the American Cancer Society (ACS), the prevalence of prostate cancer is increasing, marking a trend over the last 20 years. The rise in the prevalence of this ailment will drive the demand for more effective therapeutic measures, thereby boosting market growth during the forecast period.

Strong Reimbursement Policies and Coverage Will Boost Market Growth

Favorable reimbursement policies and increasing government efforts to spread awareness among people about prostate cancer and the benefits of its early diagnosis are projected to drive market growth over the forecast period. For instance, in March 2020, the Focused Ultrasound Foundation and the Advanced Medical Technology Association (AdvaMed) hosted a conference on reimbursement strategies for focused ultrasound. The conference aimed to create a framework for focused ultrasound reimbursement and coverage policies. The foundation supported manufacturers' reimbursement efforts in collaboration with partners such as AdvaMed and MITA. Such strong initiatives to support the reimbursement efforts of manufacturers are projected to create numerous growth opportunities for the market.

RESTRAINING FACTORS

Shortage of Trained Technicians and Product Recalls May Limit Market Development

Advancements in artificial imaging are creating numerous growth opportunities for the market. However, recent recalls of ultrasound devices are hampering market growth to a certain extent. For instance, in April 2019, Koninklijke Philips N.V. recalled its Philips EPIQ and Affiniti Ultrasound Systems intended for use in transrectal biopsy procedures. Furthermore, a shortage of trained technicians will limit growth opportunities for the market. For instance, according to data from the Association of American Medical Colleges, the U.S. is projected to experience a shortage of physicians, including urologists, between 61,700 and 94,700 by 2025.

Transrectal Ultrasound Market Segmentation Analysis

By Product Analysis

Transrectal Ultrasound Systems to Dominate Market Due to New Product Launches

Based on product, the global market is segmented into systems and transducers. The system segment dominated the global transrectal ultrasound market share in 2023. Rising number of regulatory approvals and product launches will drive the segment’s growth to meet the growing demand from patients diagnosed with prostate cancer.

• For instance, in December 2021, Insightec revealed that its Exablate Prostate system had been granted the FDA’s clearance for the treatment of prostate tissue using high-intensity focused ultrasound. This system employs sound waves to ablate or eradicate the targeted tissue within the prostate gland.


• Similarly, in May 2021, RSIP Vision launched a new prostate MRI-to-ultrasound registration tool that provides MRI-to-ultrasound registration using standard MRI scans and transrectal ultrasound images.

Such launches by market players will increase the adoption of these products to meet robust demand, leading to the segment’s growth in the upcoming years.

The transducers segment is projected to record the highest CAGR over the forecast period owing to their widespread use in prostate cancer screening and diagnosis.

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By Type Analysis

Cart/Trolley-based Devices to Gain Traction Due to Their High Adoption by Hospitals

Based on type, the market is divided into cart/trolley-based and portable. The cart/trolley-based segment held the largest market share in 2024 owing to higher adoption of these devices in hospitals and ASCs. This is further augmented by the increasing adoption of these systems in emergency care for critical patients. Moreover, clinical advantages of these devices such as rapid diagnosis and accurate results further contributes to the rising adoption of these systems.

The portable segment is projected to register the highest CAGR during the forecast period of 2025-2032. The segment’s dominance is mainly attributed to the launch of technologically advanced handheld equipment by market players. In addition, rising preference of healthcare providers towards minimally invasive treatments and extensive adoption of imaging systems in emergency cases are other factors projected to influence segmental growth over the forecast period.

By Application Analysis

Growing Incidence of Prostate Cancer to Boost Product Use in Diagnostic Applications

Based on the application, the market is segmented into diagnostic and image-guided treatment. The diagnostic segment accounted for the highest market share in 2024 and is projected to record a substantial CAGR over the forecast period. The segment’s growth is mainly attributed to the rising prevalence of prostate cancer and the growing demand for transrectal procedures globally. For instance, according to data published by the European Cancer Information System (ECIS) in 2020, prostate cancer accounted for 23.2% of all new cancer cases (excluding non-melanoma skin cancers) diagnosed in men in EU-27 countries. The diagnostic segment is further segmented into prostate cancer, benign prostatic hyperplasia, and others.

The image-guided treatment segment will account for a considerable market share during the forecast timeframe owing to the increasing number of initiatives for cancer radiotherapy.

By End-user Analysis

Higher Preference for Treatment Through Hospitals & ASCs to Boost Product Use in These Centers

By end-user, the global market is classified into hospitals & ASCs, diagnostic laboratories, and others. The hospitals & ASCs segment accounted for the highest market share in 2023 and is projected to maintain its dominant position over the forecast period. The segment’s dominance is mainly attributed to the fact that most patients prefer to be treated in hospitals & ASCs.

The diagnostic laboratories segment held the second-largest market share in 2024 and is projected to record a significant CAGR over the forecast period. Increasing adoption of minimally invasive procedures and the adequate reimbursement policies offered by diagnostic laboratories are projected to drive the segment's growth in the coming years.

REGIONAL INSIGHTS

In terms of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

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North America transrectal ultrasound market size was valued at USD 74.4million in 2024 and is likely to dominate the global market throughout the forecast period. The regional market’s growth is attributed to the increasing prevalence of prostate cancer, the establishment of well-developed infrastructure, and a strong presence of key players. For instance, according to data published by the American Society of Clinical Oncology (ASCO), it is estimated that around 288,300 men in the U.S. will be diagnosed with prostate cancer by the end of 2024. This scenario will likely surge the demand for transrectal ultrasound devices, thereby contributing to the regional market growth during the forecast period. Furthermore, increased government initiatives and reimbursement policies to raise patient awareness regarding early diagnosis are projected to drive market growth in the U.S.

Europe market is projected to record a significant CAGR in the upcoming years due to growing government initiatives in the region to reduce mortality and morbidity caused by prostate cancer. For instance, in April 2023, PRAISE-U (Prostate Cancer Awareness and Initiative for Screening in the European Union) announced that it was working to encourage the early detection and diagnosis of prostate cancer in the European Union. Such initiatives are projected to boost the market growth in the region. Also, several market players are focusing on receiving regulatory approvals for the launch of their prostate cancer detection systems. For instance, in November 2019, Focal Healthcare received the CE Mark for its Fusion Bx 2.0 prostate fusion biopsy solution. With the help of this device, urologists across Europe can perform targeted transrectal and transperineal prostate biopsies by combining information from multiparametric MRI with a semi-robotic arm and user-friendly interface.

Asia Pacific uses outdated ultrasound systems to a great extent, which is one of the major factors boosting the adoption of replacement unit shipments to fuel the regional market’s growth in 2024. This growth is further boosted by the presence of a strong hospital infrastructure that is rapidly developing, and high per capita spending on healthcare in India, China, and many other South East Asian nations. This factor is expected to increase the need for new unit shipments of transrectal ultrasound systems.

Latin America and the Middle East and Africa regions are estimated to register a comparatively lower CAGR during the forecast period owing to a lack of awareness amongst people regarding the treatment options for prostate cancer. Also, the low out-of-pocket expenditure for diagnosing and treating this disease in these regions is another factor that can slow down the market’s growth.

List of Key Companies in Transrectal Ultrasound Market

BK Medical Holding Company, Inc.  Held Significant Market Share Due to Strong Brand Presence

The market's competitive landscape is characterized by a semi-consolidated environment, where the top 2-3 players dominated the global market in 2024, while other players also accounted for a significant market share. A well-established brand presence, a diversified portfolio of ultrasound systems for urology, and widespread geographic presence are some of the factors responsible for the strong market position held by BK Medical Holding Company, Inc. in 2024. Other key players include KOELIS, Exact Imaging, Telemed Medical Systems, and FUJIFILM Corporation.

LIST OF KEY COMPANIES PROFILED:

• KOELIS (Germany)


• GE Healthcare (BK Medical Holding Company, Inc., U.S.)


• Exact Imaging (Canada)


• Telemed Medical Systems


• FUJIFILM Corporation (Japan)


• Strata Imaging (U.S.)


• HALO Medical Technologies (U.S)


• GEOTEK (U.K.)


• Koninklijke Philips N.V. (Netherlands)

KEY INDUSTRY DEVELOPMENTS:

• July 2023: Teleflex Incorporated, a manufacturer of medical technologies announced the acquisition of Palette Life Sciences AB. The acquisition will help to expand the Teleflex Incorporated product portfolio for the interventional urology segment.


• April 2022: Mount Sinai Health System launched a mobile prostate cancer screening unit in New York City. The mobile van is equipped to perform screenings and tests, including the prostate-specific antigen test, ExactVu micro-ultrasound system, digital rectal exam, EchoNous bladder scanner, and genomics testing.


• December 2021: GE Healthcare announced the acquisition of BK Medical Holding Company, Inc., a leader in advanced surgical visualization with a strong product portfolio in this market. 


• April 2021: KOELIS, an international leader in prostate fusion imaging, announced enrollment of the first patients in the VIOLETTE clinical trial (NCT04582656) on 3D fusion imaging-guided focal ablation of prostate cancer.


• May 2020: EDAP TMS, a manufacturer of robotic energy-based therapies, announced a global distribution agreement with Exact Imaging, a developer of high-resolution micro-ultrasound imaging technologies.


• May 2019: Exact Imaging announced that it had received the CE mark approval for its Abdominal Imaging Release including its new EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities. These capabilities were expected to allow urologists to perform complete urological ultrasound assessments including kidney examinations & biopsies and male pelvic & bladder examinations.

REPORT COVERAGE

An Infographic Representation of Transrectal Ultrasound (TRUS) Market

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The market research report provides qualitative and quantitative insights into the global market and offers a detailed analysis of the market’s size and growth rate for all possible segments. The report also provides an elaborate analysis of the market dynamics and competitive landscape. Various key insights presented in this report include the prevalence of prostate cancer in key countries in 2022/2023, key industry developments, new product launches, the regulatory scenario, top industry trends, and an overview of the healthcare industry in key countries

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