The focused ultrasound system market will demonstrate steady growth throughout the 2025 to 2035 period because healthcare providers increasingly need non-invasive therapeutic treatments and imaging technologies improve for robotic surgery and new healthcare applications emerge in oncology and neurology and women's health.
Focused ultrasound technology delivers precise high-frequency sound waves which allow body tissue treatment without surgery leading to improved treatment accuracy and reduced recovery time accompanied by reduced treatment complications. Market experts predict high growth of USD 15,579.7 million by 2035 from an initial value of USD 8,378 million in 2025 at a compounded annual growth rate (CAGR) of 6.4%.
The clinical approval of focused ultrasound for treating uterine fibroids alongside prostate cancer and essential tremor and bone metastases drives its market expansion. The combination of MRI scanners with expert ultrasound guidance systems leads to better procedure accuracy as well as improved patient results.
This technology experiences expanded therapeutic potential because researchers study new applications including blood-brain barrier opening while developing drug delivery approaches. The growth of day-care treatment facilities linked to patient demand for minimally invasive procedures accelerates the adoption of focused ultrasound systems by hospitals and specialized centers.
Key Market Metrics
| Metric | Value |
|---|---|
| Industry Size (2025E) | USD 8,378 million |
| Industry Value (2035F) | USD 15,579.7 million |
| CAGR (2025 to 2035) | 6.4% |
Explore FMI!
Book a free demo
North America currently is the paramount region for the focused ultrasound systems market with large-scale adoption for cancer and neurological treatments in place. The USA and Canada are bringing on focused ultrasound systems for clinical practice primarily through some specialized training at academic institutions or private outpatient surgical centers, ongoing FDA approvals, and a strong healthcare setting in general.
There is going to be steady growth in Europe due to the various public funding schemes available for gaining access to advanced therapies aimed at non-invasive cancer intervention. This is because there is adequate awareness among doctors, as well as, linked clinical research networks from different countries like Germany, France, and the UK, for promotion of focused ultrasound application for neurology, urology, and gynecology.
Healthcare is flourishing in this region as investments are buoyed up, chronic disease prevalence increases, and there arise growing awareness about alternatives that include non-invasive therapies. In this case, China, Japan, South Korea, and India are riding the waves of public and private healthcare sector adoption of focused ultrasound systems with strong emphasis on the treatment of uterine fibroids and liver cancer.
Limited Indications and Reimbursement Barriers
Market on focused ultrasound systems has been restricted by scant indications as stated by clinical FDA approvals, as well as inconsistent reimbursement policies. Non-invasive and much targeted, the focus of the procedure is yet seen as experimental in many of the healthcare systems, limiting its adoption to research and selected hospitals.
Equipment costs, long procedure times, and MR guidance in some applications also add to operational complexities. Not to mention how unacquainted most physicians are with this technology and the absence of training programs using this technology among medical practitioners. These are the delays in commercialization and access, especially in low-resource sites where the capital investment and the throughput of procedures are the major criteria.
Rising Demand for Non-Invasive, Precision Therapy
The market for focused ultrasound systems has been stimulated by increasing demand for non-invasive incision-free procedures in oncology, neurology, and women's health. FUS provides thermal ablation, neuromodulation, and drug delivery enhancement without damaging surrounding tissues. Advancements are made to technologies, such as those related to real-time imaging, robotic arms, and AI-based targeting, all aimed at improving safety and efficacy during its procedures.
Patient preference shifts to outpatient and low-recovery therapies such as the uterus fibroids, prostate cancer, essential tremor, and bone metastases, focused ultrasound is now gaining ground. Future research and developments in global regulations, thus further carving out new therapeutic indications and prospective market growth.
Between the years 2020 to 2024, the focus of the marketplace restricted itself to treating uterine fibroids, essential tremor, and bone metastases, with rising clinical evidence and an extremely limited number of FDA approvals. MRI-guided FUS consequences were high-precision applications.
The period from 2025 through 2035 will instead be focused on increased oncology and brain disorder usage as well as drug delivery through blood-brain barrier modulation. Increased accessibility will also be fueled by AI-guided planning, portable FUS platforms, and widened regulatory clearances. FUS will be expected to become mainstream according to surgical alternatives and chronic disease management as the reimbursement schemes mature and the efficiency of the procedures improves.
Market Shifts: Comparative Analysis (2020 to 2024 vs. 2025 to 2035)
| Market Factor | 2020 to 2024 |
|---|---|
| Regulatory Landscape | Limited to specific, high-evidence indications. |
| Technological Advancements | MRI-guided thermal ablation and early neuromodulation techniques. |
| Sustainability Trends | Focused on reducing surgical waste through non-invasive therapy. |
| Market Competition | Led by specialized medical imaging and surgical device firms. |
| Industry Adoption | Common in academic centers and specialized neurology/gynecology clinics. |
| Consumer Preferences | Focused on pain-free, incisionless treatment and minimal downtime. |
| Market Growth Drivers | Boosted by fibroid and tremor treatment demand. |
| Market Factor | 2025 to 2035 |
|---|---|
| Regulatory Landscape | Expansion to broader applications in oncology, neurology, and chronic pain with global approvals. |
| Technological Advancements | Rise of AI-driven targeting, real-time tissue response mapping, and portable FUS systems. |
| Sustainability Trends | Growth in energy-efficient systems, mobile FUS units, and reusable component integration. |
| Market Competition | Entry of robotics-integrated platforms and AI-focused therapeutic ultrasound developers. |
| Industry Adoption | Expands to ambulatory surgery centers, oncology hubs, and multidisciplinary outpatient facilities. |
| Consumer Preferences | Shift to personalized, image-guided therapy with faster recovery and non-pharma disease management. |
| Market Growth Drivers | Accelerated by chronic disease burden, AI-enhanced therapy, and shift toward non-invasive medicine. |
Focused ultrasound system markets would expand in the United States due to a growing demand for theranostic approaches for noninvasive therapy in oncology, neurology, and orthopedics. There are numerous MR-enabled and HIFU facilities being adopted by hospitals and academic centers in the USA toward treatment of essential tremor, prostate cancer, and bone metastases.
Approval by the FDA, large-scale progress in clinical trials, and increasing reimbursement initiatives are exciting quick technology adoption.
| Country | CAGR (2025 to 2035) |
|---|---|
| USA | 6.3% |
The United Kingdom market growth is being fed by NHS interest in minimally invasive treatment options and spread of focused ultrasound centers among academic hospitals. Uterine fibroid and prostate disease treatment expectancies, along with burgeoning clinical application of drug delivery and brain disorders, are keeping demand alive.
With its support of clinical research and engagement in patient advocacy groups within the UK, this will contribute to the wider acceptance and funding of focused ultrasound technologies.
| Country | CAGR (2025 to 2035) |
|---|---|
| UK | 6.1% |
Within the EU, France, Germany, and Italy constitute a strong and innovation-led market for focused ultrasound systems. European institutions lead in the conduct of clinical trials on FUS for pancreatic cancer treatment, Alzheimer disease, and non-invasive neuromodulation.
CE-marked devices find widespread use in public hospitals and private centers alike, where they benefit from a favorable regulatory framework and increasing popularity of outpatient treatment alternatives.
| Region | CAGR (2025 to 2035) |
|---|---|
| European Union | 6.4% |
Japan's focused ultrasound market has moderately expanded with early adoption in neurology and oncology. Japanese hospitals are implementing ultrasound systems to treat tremors, uterine conditions, and soft tissue tumors.
The expressed need within the country for high-precision low-complication interventions, along with good imaging infrastructure, promotes extensive use of MRgFUS systems in everyday clinical practice.
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 6.2% |
Strong growth in market is occurring within South Korea, supported by advanced medical imaging and broad availability of non-invasive treatment technologies. Korean hospitals treat liver tumors, thyroid nodules, and cosmetic dermatology using focused ultrasound, thus widening its appeal for several applications.
Government investment in smart hospital systems and local device innovation further accelerates domestic adoption and export potential.
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 6.8% |
The focused ultrasound system market is seeing significant growth as healthcare practitioners adopt alternative non-invasive methods for complex surgical and therapeutic procedures. For focused ultrasound systems that utilize acoustic energy in the ablation/disruption/stimulation of tissue deep within the body without making incisions, these works offer the advantages of rapid patient recovery and low complication risks.
Among all technologies, the MR-guided focused ultrasound system holds market leadership by providing high-resolution imaging for real-time treatment monitoring. Clinically, oncology remains the key application segment in which focused ultrasound shows great potential for tumor ablation, palliative treatment, and enhancing drug delivery.
As advances continue in the field of precision medicine, and with a shift in preference toward less invasive therapeutic modalities, these two segments continue to guide the course of innovation, acceptance, and sustained demand for focused ultrasound technologies in worldwide healthcare systems.
| Technology Type | Market Share (2025) |
|---|---|
| MR-Guided | 53.2% |
Technical section related to focused ultrasound systems under focused ultrasound could be said to be ridden by MR-guided focused ultrasound. This stands out due to its excellent imaging capabilities and unprecedented precision in being able to target tissues.
MRI systems even allow real-time anatomical guidance and temperature monitoring, directing the physician's focus toward treating areas and delivering high-precision energy; thus, these systems enhance the possibility of off-target effects in treatment and are particularly suited for treating sensitive or deep-seated conditions like brain disorders, bone metastases, or uterine fibroids.
MR-guided focused ultrasound conveys the basis for patient preference in hospitals and specialty clinics because of its non-invasive and measurable feedback throughout treatment. The most efficient systems continue to update, enhancing performance and access to MR-guided platforms through transducer design, motion compensation, and treatment planning software.
Manufacturers also value seamless compatibility between MRI systems and therapeutic ultrasound units. Hence, they work with imaging vendors toward that end goal. As the demand by clinicians strives for higher precision with predictable outcomes, MR-guided focused ultrasound systems are likely to exist at the gold standard marker for accuracy with non-invasive options.
| Application Area | Market Share (2025) |
|---|---|
| Oncology | 47.5% |
The application section of the market for focused ultrasound system reflects a major one - oncology. Rising cancer cases across the globe, along with the demand for less invasive forms of treatment, is what brings the market to take this direction.
For this reason, focused ultrasound becomes the best option for noninvasive tumor ablation. It is very beneficial for those patients who do not get selected for surgery or are not that willing to undergo the same and prefer less aggressive approaches.
Focused ultrasound is used for the treatment of many cancers such as liver, breast, prostate, kidney tumors, and also palliation using metastatic bone lesions for pain relief. It destroys the cancer tissue by thermal or mechanical energy without supposedly injuring surrounding healthy parts.
Focus ultrasound is very much welcomed in oncology because of its ability to perform repeatability safety and capability to combine with adjunct therapies such as chemotherapy, immunotherapy, and radiation. Studies would be further carried out to investigate its role in "penetration of drugs into tumors and modulation of tumor microenvironments" to enhance immunotherapeutic responses.
It won't be long before oncology becomes the main driver for focused ultrasound systems, as regulations extend indications and clinical trials keep proving efficacy on new tumors. This sector benefits from the existing international cancer initiatives and health reforms that aim to make non-invasive technologies part of the standard oncology care pathways.
Focused ultrasound system technologies continue to fast-evolve as part of non-invasive therapeutic tools to deliver ablation treatment of targeted tissues using high-intensity focused ultrasound (HIFU) along with MR-guided focused ultrasound (MRgFUS).
The medical applications involving these systems include treatment of tumors together with uterine fibroids as well as essential tremor, Parkinson’s disease, prostate diseases and chronic pain using non-surgical methods.
The combination of accurate energy delivery coupled with real-time imaging systems based on ultrasound or MRI provides specific treatment effects only at target areas without affecting adjacent tissues. The market experiences expansion because of rising demand for non-invasive medical procedures coupled with growing uses of treatment in oncology and more approvals from the FDA and CE directed for neurological and women's health.
The market competition between key players exists through their abilities to deliver precise targeting along with integrated imaging solutions and their expertise in clinical indications, therapeutic depth and regulatory approval in targeted therapeutic sectors.
Market Share Analysis by Company
| Company Name | Estimated Market Share (%) |
|---|---|
| Insightec Ltd. | 24-28% |
| Chongqing Haifu Medical Technology Co. | 18-22% |
| Profound Medical Corp. | 12-16% |
| EDAP TMS S.A. | 9-13% |
| Sonablate Corp. | 6-10% |
| Other Companies (combined) | 15-20% |
| Company Name | Key Offerings/Activities |
|---|---|
| Insightec Ltd. | Markets the Exablate Neuro® and Exablate Body® MR-guided focused ultrasound systems approved for essential tremor, uterine fibroids, and bone metastases in 2025. |
| Chongqing Haifu Medical | Offers USgFUS systems for tumor ablation, including Model JC and JC200, with CE-marked use in liver, breast, and pancreatic cancers in Asia and Europe in 2024. |
| Profound Medical Corp. | Provides TULSA-PRO® for MRI-guided transurethral ultrasound ablation of prostate tissue, offering precise, incision-free treatment for prostate cancer and BPH in 2025. |
| EDAP TMS S.A. | Developed Focal One® and Ablatherm® HIFU systems for prostate cancer therapy with real-time imaging and robotic precision, widely adopted in Europe and Asia in 2024. |
| Sonablate Corp. | Markets Sonablate® HIFU for prostate ablation under transrectal ultrasound guidance, FDA-cleared for localized prostate tissue treatment in 2024. |
Key Company Insights
Insightec Ltd.
Insightec leads the global market with its FDA-approved Exablate Neuro® platform for non-invasive neurosurgery in essential tremor and Parkinson’s. It also offers Exablate Body® for treating uterine fibroids, pain from bone metastases, and investigational oncology targets.
Chongqing Haifu Medical Technology Co.
Haifu dominates in Asia with a range of USgFUS devices used in oncology and gynecology. Its systems are CE-certified and used in liver, pancreatic, and soft tissue tumor ablation, with growing adoption in public hospitals and academic centers.
Profound Medical Corp.
Profound specializes in MRI-guided, transurethral ultrasound ablation (TULSA) for prostate therapy. TULSA-PRO® offers incision-free, precise, and customizable tissue destruction, positioning the company strongly in the urology and prostate cancer markets.
EDAP TMS S.A.
EDAP is a leading HIFU device provider for prostate cancer, particularly in Europe. It’s Ablatherm® and Focal One® systems are known for high precision, integration with multiparametric MRI, and suitability for focal therapy and salvage treatment.
Sonablate Corp.
Sonablate delivers focused ultrasound systems for prostate cancer and benign prostatic hyperplasia (BPH) under ultrasound guidance. The system is FDA-cleared and widely used in outpatient settings for tissue-sparing prostate procedures.
Other Key Players (15 to 20% Combined)
Several emerging technology developers, OEM suppliers, and regional medical device companies contribute to the focused ultrasound market through niche clinical innovations, research collaborations, and targeted indications:
The overall market size for the focused ultrasound system market was USD 8,378 million in 2025.
The focused ultrasound system market is expected to reach USD 15,579.7 million in 2035.
The increasing prevalence of cancer and neurological disorders, rising adoption of non-invasive therapeutic solutions, and growing use of MR-guided technology.
The top 5 countries driving the development of the focused ultrasound system market are the USA, UK, European Union, Japan, and South Korea.
MR-guided technology and oncology applications lead market growth to command a significant share over the assessment period.
Focused Ultrasound System Market
Thank you!
You will receive an email from our Business Development Manager. Please be sure to check your SPAM/JUNK folder too.
