DataM Intelligence’s report segments the market by product type, pressure-ulcer stage, end user and region. It evaluates market size and share alongside competitive positioning, country-level conditions and product developments.
-- The global Pressure Ulcer Devices Market is forecast to grow from US$4.11 billion in 2025 to US$7.93 billion by 2035, at a compound annual growth rate of 6.8% between 2026 and 2035, according to DataM Intelligence. The market includes pressure-relief mattresses and specialty beds, cushions, positioning accessories, advanced wound dressings, negative-pressure wound therapy systems used in pressure-ulcer care, and sensor-enabled monitoring products. Connected monitoring is drawing attention, but it also faces a proof threshold: purchasers need to know whether the information changes care decisions and improves outcomes enough to justify added cost and training.
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Key Takeaways
- 2025 Market Size: US$4.11 billion
- 2035 Projected Market Size: US$7.93 billion
- Forecast CAGR, 2026–2035: 6.8%
- Largest Product Segment: Pressure relief mattresses, 30.81% share in 2025
- Largest Region: North America, 42.17% share in 2025
- Fastest-Growing Region: Asia-Pacific, reported CAGR of 8.7%
- Fastest-Growing Product Segment: Alternating pressure wheelchair cushions, reported 15.76% share in 2025
United States
More than 2.5 million people in the United States develop pressure ulcers each year, according to the Agency for Healthcare Research and Quality. Hospitals also face an economic incentive to reduce hospital-acquired conditions: the Centers for Medicare & Medicaid Services reduces overall Medicare payments by 1% for applicable hospitals in the worst-performing quartile under its Hospital-Acquired Condition Reduction Program. The program covers a set of conditions and quality measures, so this penalty should not be interpreted as a pressure-ulcer-specific payment reduction.
That environment supports demand for products that can be used consistently within prevention protocols. The practical test is how support surfaces, dressings and repositioning practices work together across intensive care, surgery, transport, post-acute care and home settings. For connected products, procurement teams are likely to ask for evidence of clinical value, compatibility with existing workflows and clarity on how patient data will be handled.
Japan
Japan’s 2025 population estimates counted 36.19 million people aged 65 or older, or 29.4% of the population-the highest proportion recorded at that time by the Statistics Bureau of Japan. Demand therefore spans hospitals, nursing homes and homecare, with product selection shaped by patient mobility, caregiver workload and how easily a device fits the care environment.
Japan is also seeing activity across both established equipment makers and emerging medical-AI developers. Domestic product launches and research programs point to interest in better pressure management and wound assessment. However, a product’s clinical usefulness, regulatory status, service support and ease of operation remain important adoption considerations. DataM Intelligence’s report does not publish Japan’s market revenue or share separately, so this release does not assign a country-level market value.
Recent Developments:
- May 27, 2026 - FDA clearance for RENASYS EDGE: The U.S. Food and Drug Administration found Smith+Nephew’s negative-pressure wound therapy pump substantially equivalent to a legally marketed device. The clearance adds a new system to the wound-management category; its use must follow the product’s cleared indications.
- June 1, 2026 - Smith+Nephew launches next-generation LEAF in the U.S.: The patient-monitoring system uses a wearable sensor to track mobility and provide turn-status updates, linking pressure-injury prevention with care-team workflow.
- August 2026 - VA/DoD issues updated pressure-injury guidance: The clinical practice guideline supports repositioning as part of prevention but identifies insufficient evidence for continuous bedside pressure mapping as a general recommendation. It highlights cost, staff training and implementation as factors that need consideration. The guidance raises the evidence bar for sensor-based products seeking broad adoption.
- August 20, 2026 - Focus Systems advances pressure-ulcer AI development in Japan: The company obtained a Class II medical-device manufacturing and marketing license. It said its pressure-ulcer AI work is progressing toward clinical performance testing following a development consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This is a development program, not a product approval.
- August 31, 2026 - CAPE lists its new Rasim product in Japan: The pressure-care specialist’s product catalog identifies Rasim as a new product. The launch adds to a domestic portfolio that includes air mattresses, foam mattresses, positioning products and wheelchair cushions.
- September 24, 2026 - FDA posts a Baxter mattress recall: The Class II recall covered specified PRO+ mattress surfaces because of an error in the product description on the UDI label. The notice concerns labeling; it should not be read as a finding of a pressure-redistribution performance defect.
- October 1, 2026 - Molten confirms the end of Rayos sales: The Japanese company ended sales of its robotic mattress at the close of September and said it would generally hold repair parts through September 2031, subject to availability and product condition. The notice makes service continuity a consideration for facilities using the system.
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Market Segmentation
Pressure-relief mattresses held the largest product share at 30.81% in 2025. The category covers a range of products, from foam and gel surfaces to powered alternating-pressure and low-air-loss systems. Its broad use across hospitals, nursing homes and homecare supports its leading position. However, product specifications differ by patient acuity, mobility, cleaning protocols and the care setting.
Alternating-pressure wheelchair cushions accounted for 15.76% of the market in 2025. The segment addresses prolonged seated pressure and extends the market beyond bed-based care. Portability, battery operation, setup and maintenance can influence use in homes and outpatient settings. These products serve a distinct need and are not a substitute for clinical assessment or other prevention measures.
Injury stage shapes the mix of products used. Stage I and II care places greater emphasis on early intervention, pressure redistribution, moisture control, and protective dressings. More advanced wounds may require specialty surfaces, dressings and, where clinically appropriate, negative-pressure wound therapy. The report does not provide stage-level revenue shares, so no percentages are assigned.
Company Profiles
Stryker Corporation
Stryker offers support surfaces for beds and stretchers, including IsoAir, Isolibrium, IsoTour and ComfortGel. This portfolio lets the company address pressure-management needs across different hospital environments, including critical care and patient transport. Its positioning is tied to the broader acute-care equipment system: bed compatibility, patient handling and clinical workflows can influence a facility’s selection alongside surface performance.
Baxter International (Hillrom)
Baxter’s Hillrom portfolio includes pressure-management mattresses and hospital beds. The company describes AccuMax Quantum as a non-powered surface that redistributes pressure as a patient moves or is repositioned; its VersaCare bed is designed to support pressure-injury protocols and patient turning. The breadth of the portfolio supports deployment across medical-surgical and intensive-care settings. Recent FDA labeling action also underlines the importance of accurate product identification and traceability in equipment management.
Smith+Nephew
Smith+Nephew participates in prevention and wound management through foam dressings, negative-pressure wound therapy and patient monitoring. Its ALLEVYN dressings are positioned for wound management and to support pressure-injury prevention protocols, while the next-generation LEAF system monitors patient mobility. RENASYS EDGE received FDA 510(k) clearance in May 2026. Together, these offerings give the company exposure to different steps in the care pathway, although each product’s use remains governed by its indications and clinical protocols.
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