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November 2024
The North America diabetic foot ulcer treatment market size is calculated at USD 1.27 billion in 2024, grew to USD 1.34 billion in 2025, and is projected to reach around USD 2.22 billion by 2034. The market is expanding at a CAGR of 5.74% between 2025 and 2034. The rising prevalence of diabetes, technological advancements, and growing research and development activities drive the market.
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Diabetic foot ulcers are open wounds at the bottom of the foot that develop in patients with type 1 and type 2 diabetes mellitus. They are the most common complications of diabetes that cannot be managed through diet, exercise, and insulin treatment. They affect approximately 15% of patients with diabetes. Diabetic foot ulcers are evaluated through physical examination or imaging techniques such as MRI and X-rays and . The treatment of diabetic foot ulcers depends on ulcer size, ulcer thickness, ulcer location, and presence of concomitant infection. The treatment strategies involve off-loading, debridement, and applying medication or dressings to the ulcer. Medications include antibiotics, antiplatelets, or anti-clotting agents.
The rising prevalence of diabetes leads to poor circulation, peripheral neuropathy, and uncontrolled sugar levels, which are the major reasons for developing diabetic foot ulcers. The growing research and development activities in North America due to state-of-the-art facilities boost the market. Technological advancements are also likely to dominate the market. The rising healthcare expenditure and favorable reimbursement policies allow patients to receive effective and advanced treatment. The advancements in diagnostics enable physicians for early detection of diabetic foot ulcers, supporting efficient treatment.
Artificial intelligence (AI) and machine learning (ML) can potentially impact market growth by driving the latest innovations, leading to enhanced patient care. The major application of AI and ML in diabetic foot ulcers is the early detection and identification of foot ulcers. This allows healthcare professionals to provide timely intervention. AI plays a vital role in automated and semi-automated wound screening. AI and ML can assist healthcare professionals in providing personalized treatment to patients. They can assess disease risk and suggest treatment types. They can also predict treatment outcomes in patients. Moreover, AI can be used to develop customized footwear for off-loading. AI-based sensors can help reduce plantar pressure, minimize any potential interference to the patient, and monitor daily activity.
Rising Prevalence of Diabetes
The major growth factor of the North America diabetic foot ulcer treatment market is the rising prevalence of diabetes. The rising prevalence is mainly attributed to the growing geriatric population and increasing incidences of obesity. According to the Census data, approximately 59.2 million, or 9.4% of the population in the U.S., are above 65 years old. It is estimated that 12.1% of people aged 40-59 years and 20.5% of people aged 60 and above have diabetes. At the same time, 24.2% of obese people have diabetes. Additionally, Native Americans, African Americans, and Hispanics are more likely to develop ulcers. The other risk factors include the use of insulin and alcohol and tobacco consumption. All these factors are responsible for causing diabetes, leading to severe diabetic complications, including foot ulcers.
High Treatment Cost
The major challenge of the market is the high treatment cost of diabetic foot ulcer treatment. The average cost of the treatment in the U.S. amounts to thousands of dollars, limiting the affordability of numerous patients from low- and middle-income countries. The cost of diabetic foot ulcers also has an enormous burden on the U.S. healthcare system, ranging from $9 billion to $13 billion annually, restricting market growth.
Latest Innovations
The latest innovations in diabetic foot ulcer treatment create ample opportunities for North America diabetic foot ulcer treatment market players. The latest innovations are driven by growing research and development activities to investigate the role of several materials in healing diabetic wounds. Several researchers have identified the role of platelet-rich plasma or platelet-rich fibrin and nanomaterials. Novel and advanced drug delivery systems or wound dressings are developed to enable controlled drug release and improved oxygen supply. The growing demand for regenerative medicines such as stem cells also leads to more personalized treatment. Stem cells can influence numerous pathophysiological processes involved in wound healing by stimulating the formation of new blood vessels and supporting tissue regeneration. Thus, the development of advanced wound dressings, platelet-rich plasma injections, and regenerative medicines presents future market growth opportunities.
By treatment, the biologics segment held a dominant presence in the North America diabetic foot ulcer treatment market in 2024. The growing demand for biologics due to targeted treatment and increasing research and development boosts the segment’s growth. Biologics can increase sensation, microcirculation, and oxygenation, as well as reduce side effects. The favorable regulatory policies facilitate the development of biological agents for healing diabetic ulcers. Several researchers have investigated the role of platelet-derived growth factor, vascular endothelial growth factor, and stem cells. The growing genomics and proteomics field and advancements in genetic engineering augment the segment’s growth.
By treatment, the therapy devices segment is anticipated to grow with the highest CAGR in the North America diabetic foot ulcer treatment market during the studied years. The burgeoning medical devices sector and technological advancements fuel the segment’s growth. The devices for treating foot ulcers include insoles, shoes, foot stumps, and other orthoses. They are used to distribute pressure on plantar surfaces, reducing the risk of foot ulcers and infections. The advent of AI and ML has led to the development of smart footwear using sensors to provide a customized management approach. Apart from AI and ML, laser therapy and ultrasound are gaining huge importance. The increasing investments and collaborations also contribute to market growth.
By ulcer type, the neuro-ischemic ulcer segment held the largest share of the North America diabetic foot ulcer treatment market in 2024 and is projected to expand rapidly in the market in the coming years. A neuro-ischemic foot ulcer is a type of ulcer that is caused due to both peripheral neuropathy and poor arterial blood flow. The rising incidences of neuro-ischemic ulcers and the increasing prevalence of diabetes potentiate the segment’s growth. It is estimated that neuro-ischemic ulcers are the most prevalent, resulting in more than 50% of all foot ulcers. Hence, scientists are mainly focusing on developing novel and effective treatment strategies for neuro-ischemic ulcers. Off-loading, dressing with sucrose octasulfate, and antibiotics are commonly used to treat neuro-ischemic ulcers.
By end-use, the homecare segment led the North American market in 2024. The rising geriatric population has led to a growing demand for homecare treatment. Several healthcare professionals educate patients about treating foot ulcers at home by suggesting various measures such as maintaining and monitoring blood glucose levels and cleansing the wound daily using a wound dressing or bandage. The growing demand for natural remedies to treat diabetic foot ulcers also contributes to the segment’s growth. Natural oils such as tea tree oil and coconut oil and other supplements such as vitamin E, honey bee milk, and zinc are found to treat foot ulcers.
The United States (U.S.) dominated the North America diabetic foot ulcer treatment market in 2024. The presence of key players and the rising prevalence of diabetes drive the market. It is estimated that around 1.6 million in the U.S. are affected by diabetic foot ulcers. Favorable government policies and regulatory frameworks also contribute to the market. The U.S. Office of Disease Prevention and Health Promotion launched the “Healthy People 2030” initiative to reduce diabetes cases, complications, and deaths. The Food and Drug Administration (FDA) regulates the approval of diabetic foot ulcer treatment in the U.S. Suitable reimbursement policies increase the accessibility of diabetic foot ulcer treatment among many individuals. The U.S. government offers Medicaid and Medicare services to provide funding for their treatment. The increasing number of clinical trials propel the market.
Canada is estimated to significantly contribute to the North America diabetic foot ulcer treatment market’s growth during the forecast period. The increasing incidences of diabetic foot ulcers and the rising adoption of technologies drive the market. Diabetic foot ulcers are the leading cause of all non-traumatic amputations below the knee in Canada. Diabetes accounts for about two-thirds of lower limb amputations in Canada. The increasing investments, collaborations, and mergers & acquisitions promote the market. Favorable reimbursement policies also support market growth. B.C. Pharmacare coverage recently announced that custom orthotics and adaptive shoes will be covered for those with diabetic foot ulcer patients. The Ontario government is also covering the cost of specialized casts to provide more support to patients.
Dr. Breanne Everett, CEO and Founder of Orpyx, commented on raising CAD 26.9 million (USD 20 million) and said that the partnership would allow them to accelerate commercial efforts in delivering life-changing solutions to patients and healthcare providers. He added that the funding will support the startup’s goal of saving limbs and preventing debilitating foot complications for those living with diabetes and neuropathy.
By Treatment
By Ulcer Type
By End-Use
By Region
November 2024
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September 2024
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