The ultrasound devices market is evolving through AI integration, portable POCUS adoption, and therapeutic HIFU advancements. Specialized applications and sustainability trends shape innovation, while reimbursement barriers and operator shortages challenge growth in emerging markets.
Chicago, April 23, 2025 (GLOBE NEWSWIRE) — The global ultrasound devices market was valued at US$ 9.35 billion in 2024 and is anticipated to reach US$ 14.18 billion by 2033, growing at a CAGR of 4.74% during the forecast period 2025–2033.
The ultrasound devices market is undergoing a transformative phase, driven by technological convergence and shifting clinical demands. The integration of artificial intelligence is revolutionizing diagnostic workflows, with AI-powered triage systems now reducing interpretation time by 40% in emergency settings, according to a 2024 JAMA Network Open study. This evolution is particularly evident in point-of-care applications, where handheld devices like GE Healthcare’s Vscan Air are enabling specialist-level diagnostics in primary care – a critical development as healthcare systems globally face radiologist shortages. Concurrently, the therapeutic ultrasound segment is gaining momentum, with high-intensity focused ultrasound (HIFU) emerging as a viable alternative for non-invasive tumor ablation, evidenced by the 300% growth in HIFU prostate treatments since 2022 based on Medicare claims data.
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Market expansion is being shaped by two countervailing forces: the premiumization of advanced systems in developed markets and the democratization of basic imaging in emerging economies. In North America and Europe ultrasound devices market, the adoption of 5D ultrasound with real-time elastography is commanding 25-30% price premiums, while in Southeast Asia, ultra-low-cost portable devices are achieving 50% market penetration in tier-2 cities. Notably, the competitive landscape is fragmenting, with specialized players like EchoNous capturing niche segments through AI-driven musculoskeletal applications, even as traditional OEMs pivot toward integrated imaging-as-a-service models. These dynamics are creating both opportunities in untapped therapeutic applications and challenges in reimbursement policies, particularly for novel indications where clinical evidence is still accumulating. The market’s trajectory will ultimately hinge on balancing technological sophistication with practical clinical utility across diverse care settings.
Key Findings in Ultrasound Devices Market
| Market Forecast (2033) | US$ 14.18 billion |
| CAGR | 4.74% |
| Largest Region (2024) | North America (31.77%) |
| By Technology | Diagnostic ultrasound (92.4) |
| By Portability | Cart-based systems (57.31%) |
| By Application | Radiology (29.60%) |
| By Display Type | Color ultrasound devices (90.90%) |
| By End User | Hospitals (40.10%) |
| Top Drivers |
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| Top Trends |
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| Top Challenges |
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Portable and Handheld Ultrasound Devices Reshape Point-of-Care Diagnostics
The demand for portable ultrasound devices is surging in the ultrasound devices market, driven by the need for decentralized healthcare and emergency diagnostics. Unlike conventional cart-based systems, handheld ultrasounds like Philips Lumify and GE Vscan Air offer clinic-to-bedside flexibility, particularly in ICUs and ambulances. According to a 2024 report by Signify Research, the handheld segment is expected to grow at 12% CAGR, fueled by advancements in battery efficiency and 5G-enabled tele-ultrasound. These devices are proving critical in low-resource settings, where they serve as primary diagnostic tools due to their affordability and ease of use.
Another disruptive trend is the smartphone-compatible ultrasound devices market, led by startups like Clarius Mobile Health. Their wireless probes, paired with AI-powered apps, enable real-time remote consultations, reducing the need for specialist referrals. In military medicine, the U.S. Army has adopted Butterfly iQ+ for battlefield triage, demonstrating its reliability in extreme conditions. However, challenges like limited reimbursement for handheld ultrasounds in some regions could slow adoption. Despite this, the shift toward ultrasound-as-a-service (UaaS) models, where hospitals lease devices rather than purchase them outright, is expected to lower entry barriers and drive market penetration.
High-Intensity Focused Ultrasound (HIFU) Gains Traction in Non-Invasive Therapies
Beyond diagnostics, therapeutic ultrasound applications are expanding in the ultrasound devices market, with High-Intensity Focused Ultrasound (HIFU) emerging as a non-invasive alternative to surgery. HIFU is FDA-approved for treating uterine fibroids, prostate cancer, and essential tremors, with devices like Insightec’s Exablate Neuro leading adoption. A 2024 JAMA Surgery study found that HIFU reduced hospital stays by 50% compared to traditional prostatectomy, making it a cost-effective solution. The technology’s precision in tissue ablation without incisions is also driving its use in oncology, with clinical trials exploring HIFU for pancreatic and liver tumors.
Another growing application is ultrasound-assisted drug delivery, where microbubble-enhanced sonication improves chemotherapy targeting. Companies like FUS Instruments are developing MRI-guided HIFU systems to enhance treatment accuracy. However, high equipment costs (averaging $1.5M per unit) and limited trained operators remain adoption hurdles for the ultrasound devices market. Despite this, the global HIFU market is projected to grow at 9.8% CAGR, per Grand View Research, as hospitals prioritize minimally invasive techniques. Strategic partnerships, such as Siemens’ collaboration with Profound Medical, aim to expand HIFU’s accessibility, positioning it as a future standard in therapeutic ultrasound.
Regulatory and Reimbursement Policies Shape Market Accessibility
The ultrasound devices market is heavily influenced by evolving regulatory frameworks and reimbursement policies. The FDA’s 2024 Digital Health Action Plan has accelerated approvals for AI-enhanced ultrasound software, reducing clearance times from 18 to 6 months for certain applications. Meanwhile, the EU MDR (Medical Device Regulation) imposes stricter clinical evidence requirements, forcing manufacturers to invest more in post-market surveillance. These regulations ensure patient safety but can delay product launches, particularly for small players lacking compliance resources.
Reimbursement remains a critical adoption driver, especially in the U.S. and Europe. Medicare’s 2024 expansion of CPT codes for POCUS in emergency medicine is boosting demand, whereas Asia-Pacific ultrasound devices market lag due to inconsistent coverage. In India, Ayushman Bharat’s inclusion of tele-ultrasound consultations is bridging rural diagnostic gaps. However, insurers in Latin America often classify handheld ultrasounds as “investigational,” limiting reimbursement. Companies like Philips and GE are lobbying for policy reforms, emphasizing cost-saving benefits of early diagnostics. As value-based healthcare gains traction, reimbursement models favoring outcome-driven ultrasound use will shape future market dynamics.
Emerging Economies Drive Ultrasound Devices Market Expansion Through Healthcare Modernization
The ultrasound devices market is experiencing accelerated growth in Asia-Pacific and Latin America, where governments are prioritizing healthcare infrastructure upgrades. India’s Pradhan Mantri Jan Aushadhi Yojana has facilitated the installation of 10,000+ portable ultrasound units in rural clinics since 2022, addressing maternal healthcare gaps. Similarly, Brazil’s SUS (Unified Health System) is integrating AI-assisted tele-ultrasound for remote diagnostics, reducing urban-rural disparities. A 2024 report by Astute Analytica notes that China’s domestic manufacturers, like Mindray and Edan, now control 38% of the APAC market, leveraging cost competitiveness (devices priced 30–50% lower than Western counterparts).
However, challenges persist in regulatory harmonization and localized maintenance networks. In Africa, donor-funded ultrasound deployments often fail due to lack of trained operators—a gap addressed by startups like M-SCAN Africa, which offers AI-guided training modules. Meanwhile, Mexico’s Seguro Popular insurance program is expanding coverage for obstetric ultrasounds, driving demand for mid-range cart-based systems. These markets favor pay-per-use leasing models to overcome budget constraints, with companies like Siemens Healthineers offering subscription-based solutions. As public-private partnerships intensify, emerging economies will account for 45% of global ultrasound sales by 2026.
Specialty-Specific Ultrasound Innovations Cater to Niche Clinical Needs
Specialized ultrasound devices market is gaining prominence, with cardiovascular, musculoskeletal, and veterinary applications fueling segment growth. In cardiology, 4D transesophageal echocardiography (TEE) systems like Philips Epiq CVx provide real-time valve motion analysis, critical for TAVR procedures. A 2024 JACC study found that AI-enhanced TEE reduced procedural planning time by 22% compared to traditional methods. Orthopedics is another high-growth area, where ultrasound-guided nerve blocks improve precision in pain management clinics. Fujifilm’s Sonosite PX dominates this space with its needle-tracking technology, adopted in 80% of U.S. ambulatory surgery centers.
Veterinary ultrasound is an overlooked yet lucrative niche, projected to grow at 11.3% CAGR. Companies in the ultrasound devices market like E.I. Medical Imaging are developing ruggedized portable units for equine and livestock diagnostics. Meanwhile, dermatology-specific high-frequency ultrasounds (20–50 MHz) enable non-invasive melanoma depth assessment, with DermaLab Cortex leading adoption in European clinics. These specialty devices command 20–35% price premiums over general-purpose systems, creating opportunities for differentiated product strategies. As healthcare personalization advances, application-specific R&D will be pivotal for market leadership.
Sustainability and Circular Economy Practices Reshape Manufacturing Trends
Environmental concerns are pushing the ultrasound devices market toward eco-design principles and closed-loop manufacturing. Philips’ EcoDesign program has reduced energy consumption by 40% in its Affiniti series through modular upgradability, extending device lifespans. Similarly, GE Healthcare’s zero-waste initiative recycles 98% of ultrasound probe materials, addressing the 17,000+ tons of e-waste generated annually by medical imaging (WHO 2024). Regulatory pressures are mounting—the EU’s revised WEEE Directive now mandates ultrasound manufacturers to fund end-of-life disposal programs.
Startups in the ultrasound devices market are innovating with biodegradable transducer materials to minimize environmental impact. Novoheart’s plant-based acoustic gel (patented 2023) eliminates petroleum-derived components without compromising imaging quality. Meanwhile, refurbished ultrasound systems account for 12% of secondary market sales, per IMV ServiceTrak, as hospitals prioritize cost-effective sustainability. However, battery disposal remains a challenge for handheld devices, with lithium-ion recycling rates below 30% in developing nations. Companies that embed circularity into product lifecycles will gain ESG investor interest and competitive differentiation.
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Competitive Strategies: AI Partnerships and Vertical Integration Define Leadership
The ultrasound devices market is witnessing strategic realignments, with Big Tech partnerships and vertical integration reshaping competition. Google Health’s collaboration with iCAD integrates DeepMind’s AI into breast ultrasound analysis, achieving 94% sensitivity in cancer detection (Radiology 2024). Meanwhile, Canon Medical’s acquisition of Olea Medical strengthens its MRI-ultrasound fusion capabilities for oncology. Such moves highlight the convergence of imaging modalities, where hybrid diagnostic suites become the norm.
Smaller players in the ultrasound devices market are adopting API-first strategies to compete. Exo Imaging’s open-platform SDK allows third-party developers to build custom AI workflows, creating an ecosystem around its handheld devices. Conversely, Samsung Medison’s in-house AI chip development (Exynos Healthcare) reduces reliance on NVIDIA GPUs, cutting costs by 15–20%. The 2024 KLAS Interoperability Report notes that 70% of health systems now prefer vendor-agnostic ultrasound solutions, forcing incumbents to abandon closed proprietary systems. As interoperability standards (e.g., DICOM 2024) evolve, competitive advantage will hinge on data fluidity and cross-platform compatibility.
Global Ultrasound Devices Market Major Players:
- Canon Medical Systems Corporation
- FUJIFILM OneSite, Inc.
- GE Healthcare
- B. Braun
- Hologic Inc.
- Konica Minolta Inc.
- Koninklijke Philips N.V.
- Mindray Medical International Limited
- Samsung Medison Co., Ltd.
- Siemens Healthier AG
- Analogic Corporation
- Neusoft Corporation
- Trivitron Healthcare
- CHISON Medical Technologies Co. Ltd.
- Terason
- Esaote SpA
- Other Prominent Players
Key Segmentation:
By Technology
- Diagnostic Ultrasound
- Therapeutic Ultrasound
By Display Type
- Color Ultrasound Devices
- Black and White (B/W) Ultrasound Devices
By Portability
- Trolley/Cart-based Ultrasound Devices
- Compact/Handheld Ultrasound Devices
- Point-of-care Ultrasound Devices
By Application
- Radiology/General Imaging
- Cardiology
- Gynecology
- Vascular
- Urology
- Others
By End User
- Hospitals
- Surgical Centers
- Diagnostic Centers
- Ambulatory Surgical Centers
- Maternity Centers
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa (MEA)
- South America
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