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만성 상처 : 시장 인사이트, 역학 및 시장 예측(2036년)

Chronic Wounds - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 236 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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영문목차

만성 상처에 대한 인사이트와 동향

  • 당뇨병, 말초혈관 질환, 운동 기능 저하와 같은 노화에 따른 질환 및 만성 질환의 유병률 증가로 인해 만성 상처의 위험이 현저히 높아지고 있습니다. 신체 활동 부족, 영양 불균형, 흡연 등의 생활 습관 요인은 치유 과정을 더욱 저해하여 발병률 상승, 회복 지연, 재발률 증가로 이어지고 있습니다.
  • 진단 기술의 발전과 의료진의 인식 제고를 통해 만성 상처의 조기 발견과 정확한 진단이 촉진될 것으로 기대됩니다. 이러한 추세에 따라, 예측 기간(2026-2036년) 동안 보고율이 향상되고 치료를 받는 환자 수가 증가할 것으로 전망됩니다.
  • 만성 상처의 주요 유형으로는 당뇨병성 족부궤양, 정맥성 하퇴부 궤양, 동맥성 궤양, 욕창 등이 있으며, 각각의 원인은 다르지만 혈류 장애나 조직 손상과 관련된 병리학적 기전에는 공통점이 있습니다.
  • 현재의 치료 패러다임에는 베카프레르민과 같은 생물학적 제제, DERMAGRAFT나 APLIGRAF와 같은 세포 치료법, 그리고 TRAFERMIN과 같은 성장 인자가 포함됩니다. 또한, 첨단 상처 피복재, 상처 데브리드먼트 제품, 음압상처치료, 고압 산소 요법, 생체공학을 활용한 피부 대체재 등 폭넓은 보조적 접근법이 활용되고 있습니다. 이러한 다양성에도 불구하고, 대부분의 치료법은 대증요법에 그치고 있으며, 지속적이고 완전한 치유라는 성과를 일관되게 이끌어내지는 못하고 있습니다. 스마트 상처 드레싱이나 원격의료를 기반으로 한 상처 모니터링과 같은 새로운 혁신이 주목을 받고 있습니다.
  • 상처의 진행 상황을 평가하고 치유 경과를 예측할 수 있는 신뢰할 수 있는 바이오마커가 존재하지 않는다는 점은 여전히 중대한 과제로 남아 있습니다. 이러한 제약으로 인해 적시 개입, 위험도 계층화 및 맞춤형 치료 접근이 저해되어, 결국 임상적 결과에 영향을 미치고 있습니다.
  • 만성 상처에 관한 최신의 종합적인 역학 데이터가 부족하기 때문에 질병 부담을 정확하게 추정하기 어렵습니다. 이러한 제약은 의료 계획, 자원 배분 및 표적화된 공중보건 개입책의 수립에 영향을 미치며, 결과적으로 치료 전반의 효율을 저하시키고 있습니다.
  • TTAX01이나 ELU42와 같은 재생의학 제품 및 조직 유래 제품을 포함한 새로운 치료 접근법이 개발 중이며, 치유의 근본적인 과제를 해결할 가능성을 내포하고 있습니다. 지속적인 연구 개발 노력을 통해 시장은 보다 목표가 명확하고, 질병의 경과를 변화시킬 가능성이 있는 솔루션으로 전환될 것으로 예상됩니다.

본 만성 상처 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, 만성 상처 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하는 한편, 세계 각 지역의 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서는 만성 상처 분야에서 주요 미충족 의료 수요를 부각시키고, 경쟁 환경 및 임상 상황을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

만성 상처 시장을 주도하는 주요 요인

기저 질환으로서의 만성 질환 유병률 증가

당뇨병, 심혈관질환, 비만 등의 질환으로 인한 전 세계적 질병 부담의 증가는 만성 궤양, 특히 당뇨병성 족부궤양 및 정맥성 하퇴부 궤양의 발생에 크게 기여하고 있습니다. 고령화의 진행은 이러한 경향을 더욱 악화시키고 있으며, 장기적인 상처 관리 치료가 필요한 환자층이 지속적으로 확대되고 있습니다.

인식 제고와 진단 기술의 발전

의료진과 환자의 인식 제고뿐만 아니라, 진단 기술의 발전과 상처 평가 프로토콜의 표준화를 통해 조기 발견과 개입이 가능해졌습니다. 이러한 적시 진단으로의 전환은 임상적 예후를 개선하고, 치료 과정에 진입하는 환자 수를 늘리고 있습니다.

상처 관리 기술과 생물학적 제제의 발전

생체공학을 활용한 피부 대체재, 성장인자 요법, 줄기세포를 이용한 치료법, 음압상처치료법 등 첨단 상처 관리 분야의 혁신이 치료 패러다임을 변화시키고 있습니다. 이러한 기술들은 혈관신생 장애나 만성 염증과 같은 근본적인 병태생리학적 장벽을 해결함으로써 시장 성장을 주도하고 있습니다.

만성 상처의 이해와 치료 알고리즘

만성 상처의 개요

만성 상처란, 예상되는 기간 내에 치유되지 않는 상처로 정의됩니다. 이러한 증상은 흔히 나타나며, 잘못된 치료가 이루어지는 경우도 빈번합니다. 상처는 선별 검사 후 4-6주가 지나도 완전히 치유되지 않은 경우, 만성 또는 비치유성으로 간주됩니다. 정맥성 궤양(정맥성 궤양, 동맥성 궤양), 당뇨병성 족부궤양(DFU), 욕창은 일반적인 만성 상처의 예입니다. 만성 상처의 원인이 다르면 증상도 다소 다르지만, 만성 상처를 식별하는 가장 일반적인 방법은 돌출되어 있고 과증식된, 움직이지 않는 상처 가장자리를 관찰하는 것입니다. 상처 주변에는 염증이 발생해 있으며, 이것이 치유 과정을 방해할 가능성이 있습니다. 그 밖의 일반적인 징후 및 증상 체크리스트로는 출혈, 부기, 통증 및 물집, 상처 주변 피부의 검게 변한 부분, 환부의 가동성 저하, 상처의 확대 및 심화, 발열, 가려움증, 유백색 고름, 만졌을 때 느껴지는 따뜻함이나 열감 등이 있습니다.

만성 상처의 진단

상처를 임상적으로 평가하는 첫 번째 단계는 급성 상처와 만성 상처를 구분하는 것입니다. 그 후, 상처의 크기, 깊이, 위치 및 감염 징후의 유무를 평가하기 위한 철저한 신체 검사가 이루어집니다. 또한, 주변 피부나 조직에 염증, 괴사, 부종 등의 징후가 없는지 확인하는 것도 매우 중요합니다. 당뇨병, 말초혈관 질환, 면역 억제, 그리고 과거 상처 치유 시 발생한 합병증 등의 병세는 치유에 중대한 영향을 미칠 수 있으므로, 환자의 병력을 파악하는 것도 매우 중요합니다. 따라서 기록에는 일반적으로 상처의 위치, 크기, 깊이, 삼출액의 유무, 조직의 종류 등의 세부 사항이 포함됩니다. 상처의 부위와 외관을 고려함으로써, 대부분의 만성 상처는 근본적인 원인에 따라 분류할 수 있으며, 이를 통해 적절한 평가와 치료법을 제안할 수 있습니다.

만성 상처의 치료

환자와 상처에 대한 철저한 평가를 통해 해결해야 할 근본적인 문제점을 파악하고, 이를 바탕으로 향후 치료 방침을 결정하는 지침이 됩니다. 당뇨병 환자의 경우, 상처 치유에 악영향을 미칠 수 있는 고혈당, 신장 기능 장애, 영양 상태 및 기타 관련 동반 질환의 관리를 개선해야 할 필요가 자주 있습니다. 하지 정맥성 궤양 환자의 경우, 혈역학적 이상이 나타나는 경우가 많아 의학적 관리의 개선이 필요할 수 있습니다. 욕창 환자는 동반 질환으로 인해 주로 침상에 누워 지내는 경우가 많으며, 조직 회복을 최적화하기 위해서는 시급히 해결해야 할 심각한 영양 결핍 상태에 처해 있습니다.

치료는 주로 원인을 치료하는 데 중점을 둡니다. 우선, 모든 만성 상처는 'TIME' 원칙에 따라 관리되어야 합니다. 즉, 조직 데브리드먼트(동맥성 궤양을 제외한 모든 사례), 감염 관리, 체액 균형, 그리고 상처 가장자리 관리입니다. 만성 상처에서 효과적인 감염 관리를 위해서는 데브리드먼을 통한 괴사 조직, 세포 잔여물, 생물막의 제거와 항균제(국소 소독제 및 전신 항생제 포함)의 적절한 사용이 포함됩니다.

만성 상처의 역학

만성 상처의 역학적 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight의 분석에 따르면, 2025년에는 주요 7개국에서 만성 상처로 진단받은 유병 사례 수가 총 약 1,200만 건에 달할 것으로 추정됩니다.
  • 2025년, 미국에서는 약 710만 건을 차지했습니다. 이 중 욕창이 약 38%, 당뇨병성 족부궤양이 35%, 정맥성 궤양이 18%, 그 밖의 만성 상처가 나머지 9%를 차지했습니다.
  • EU4 국가 및 영국 중에서 독일이 가장 많은 사례를 차지하고 있으며, 즉 만성 상처로 진단받은 유병 사례 수는 100만 건에 육박했고, 그 뒤를 프랑스, 영국이 이었습니다. 이러한 사례 수는 주로 이 질환에 대한 조사 및 임상시험에 대한 관심이 높아지고 있는 데 따라 2036년까지 증가할 것으로 예상됩니다.
  • 일본의 만성 상처 중 진단된 유병 사례의 내역(유형별)을 보면, 2025년에는 욕창이 54% 가까이 차지하여 가장 많았고, 그 다음으로 정맥성 궤양이 약 23%, 당뇨병성 족부궤양이 10%, 기타가 10%를 차지했습니다.

만성 상처 시장의 전망

표재성 상처가 치유되기 위해서는 수많은 요소가 서로 조화를 이루어야 합니다. 또한, 감염에서 저산소 상태에 이르기까지 상처 치유의 잠재적 장애 요인을 해결하기 위해 상처 피복재와 치료법은 크게 발전해 왔습니다. 이상적인 조건하에서도 손상된 조직의 강도는 완전히 회복되지 않으며, 몇 가지 비정상적인 치유 상태가 치유되지 않는 지속성 상처로 이어질 가능성이 있습니다. 기술 혁신이 눈부시게 발전하고 다양한 상처 치료법이 등장했음에도 불구하고, 치유되지 않는 상처는 여전히 의사들에게 과제로 남아 있습니다. 이러한 상처 관리를 지원하기 위해 다양한 비수술적 접근법이 개발되었으며, 많은 약제가 도입되고 있습니다.

데브리드먼트란 괴사된 상처 부위의 조직을 제거하는 시술을 말하며, 외과적, 자가 용해적, 효소적, 생물학적 또는 기계적인 방법을 통해 수행할 수 있습니다. 만성 상처 관리에는 여러 가지 보습성 드레싱을 사용할 수 있지만, 최적의 드레싱이란 상처 부위를 촉촉하게 유지하면서도 지나치게 젖거나 건조해지지 않는 것입니다. 보습성 드레싱에는 여러 종류가 있지만, 기본적으로 5가지 범주로는 필름, 폼, 하이드로콜로이드, 알지네이트, 하이드로겔이 있습니다. 드레싱 외에도 NPWT(진공 보조 폐쇄 요법이라고도 함)는 주로 당뇨병성 족부궤양이나 욕창과 같은 만성 상처 관리에 사용되어 왔습니다. 만성 상처가 진행됨에 따라, 이러한 상황을 개선하기 위한 보다 고도화된 기술이 요구되고 있습니다. 그렇긴 하지만, TTAX01을 비롯한 유망한 치료법의 등장이 예측 기간(2026-2036년) 동안 시장 규모에 긍정적인 영향을 미칠 것으로 전망됩니다.

  • G7 국가들의 만성 상처 시장 규모는 2025년에 90억 달러에 달하며, 예측 기간(2026-2036년) 동안 확대될 것으로 전망됩니다.
  • EU4 및 영국 중에서 독일이 약 26%로 가장 큰 시장 규모를 차지하고 있으며, 그 다음으로 프랑스가 약 21%, 영국이 약 20%를 차지하고 있습니다. 이러한 수치는 만성 상처 치료를 위한 보다 효과적인 약물 및 치료법 개발로 이어질 가능성이 있는 지속적인 연구 개발 노력을 바탕으로, 예측 기간(2026-2036년) 동안 변화할 것으로 예상됩니다.
  • 2025년 기준 일본의 만성 상처 시장 규모는 주요 7개국의 총 시장 규모 중 약 6%를 차지했으나, 이러한 수치는 2036년까지 변화할 것으로 예상됩니다.

성장 인자를 이용한 치료법 : 베카프레르민 등의 표적형 생물학적 제제는 세포 증식, 혈관 신생, 육아 조직 형성을 촉진하여 상처 치유를 돕습니다. 이러한 치료법은 생물학적 활성 치료를 향한 중요한 한 걸음이지만, 그 임상적 효과는 특정 상처 유형으로 제한되는 경우가 많으며, 표준 보조 치료를 병행해야 합니다.

세포 치료 및 재생 의학 : 줄기세포를 이용한 치료, 혈소판이 풍부한 혈장(PRP), 생체공학적으로 제작된 피부 대체재 등의 접근법은 조직의 완전성을 회복하고 치유 능력을 높이는 것을 목적으로 합니다. 이러한 치료법은 세포 신호 전달 장애나 세포외 기질의 기능 부전 등 만성 상처에서 발생하는 주요 문제를 해결하기 위한 것입니다. 그러나 치료 규모의 확대, 비용, 임상 결과의 편차, 그리고 장기적인 내구성과 관련된 과제는 여전히 남아 있습니다.

자주 묻는 질문

  • 만성 상처의 주요 원인은 무엇인가요?
  • 만성 상처의 주요 유형은 어떤 것들이 있나요?
  • 2025년 만성 상처 시장 규모는 어떻게 예상되나요?
  • 만성 상처 치료에 사용되는 주요 기술은 무엇인가요?
  • 만성 상처의 진단 과정은 어떻게 이루어지나요?
  • 만성 상처 치료의 원칙은 무엇인가요?
  • 만성 상처의 치료에 있어 생물학적 제제의 역할은 무엇인가요?

목차

제1장 주요 인사이트

제2장 소개

제3장 만성 상처 : 주요 요약

제4장 주요 사건

제5장 역학 및 시장 예측 조사 방법

제6장 만성 상처 : 시장 개요

제7장 만성 상처 : 질환 배경과 개요

제8장 만성 상처 : 치료와 관리

제9장 가이드라인

제10장 만성 상처 : 역학 및 환자 인구

제11장 환자 경과

제12장 일반의약품

제13장 신흥 치료제

제14장 만성 상처 : 주요 7개국 분석

제15장 만성 상처 : 미충족 수요

제16장 만성 상처 : SWOT 분석

제17장 만성 상처 : KOL의 견해

제18장 만성 상처 : 시장 진입 및 상환

제19장 부록

제20장 DelveInsight의 서비스 내용

제21장 면책사항

제22장 DelveInsight 소개

KSM 26.07.20

Chronic Wounds Insights and Trends

  • The increasing prevalence of age-related and chronic conditions such as Diabetes Mellitus, peripheral vascular disease, and immobility is significantly elevating the risk of chronic wounds. Lifestyle factors, including physical inactivity, poor nutrition, and smoking, further impair healing processes, contributing to higher incidence, delayed recovery, and increased recurrence rates.
  • Advancements in diagnostic techniques and growing awareness among healthcare professionals are expected to enhance early detection and accurate diagnosis of chronic wounds. This trend is likely to improve reporting rates and expand the treated patient population during the forecast period (2026-2036).
  • The major types of chronic wounds include diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers, each with distinct etiologies but overlapping pathological mechanisms related to poor perfusion and tissue damage.
  • The current treatment paradigm includes biologics such as Becaplermin, cell-based therapies like DERMAGRAFT and APLIGRAF, and growth factors such as TRAFERMIN. In addition, a wide range of adjunctive approaches, including advanced dressings, wound debridement products, negative pressure wound therapy, hyperbaric oxygen therapy, and bioengineered skin substitutes, are utilized. Despite this diversity, most therapies are supportive and fail to consistently deliver durable, complete healing outcomes. Emerging innovations such as smart wound dressings and telemedicine-based wound monitoring are gaining traction.
  • The absence of reliable biomarkers for assessing wound progression and predicting healing trajectories remains a critical gap. This limitation hinders timely intervention, risk stratification, and personalized treatment approaches, ultimately impacting clinical outcomes.
  • The scarcity of recent and comprehensive epidemiological data on chronic wounds restricts accurate disease burden estimation. This limitation affects healthcare planning, resource allocation, and the design of targeted public health interventions, thereby reducing overall treatment efficiency.
  • Novel therapeutic approaches, including regenerative and tissue-based products such as TTAX01 and ELU42, are under development and hold potential to address underlying healing deficits. Continued R&D efforts are expected to shift the market toward more targeted and potentially disease-modifying solutions.

DelveInsight's 'Chronic Wounds - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the chronic wounds, historical and forecasted epidemiology, as well as the chronic wounds market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The chronic wounds market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates chronic wounds patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in chronic wounds and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Chronic Wounds Market

Rising prevalence of underlying chronic conditions

The increasing global burden of diseases such as diabetes mellitus, cardiovascular disorders, and obesity is significantly contributing to the incidence of chronic wounds, particularly diabetic foot ulcers and venous leg ulcers. Aging populations further exacerbate this trend, leading to a sustained and expanding patient pool requiring long-term wound care management.

Growing awareness and improved diagnosis

Enhanced awareness among healthcare professionals and patients, coupled with improved diagnostic techniques and standardized wound assessment protocols, is enabling earlier identification and intervention. This shift toward timely diagnosis is improving clinical outcomes and increasing the number of patients entering the treatment pathway.

Advancements in wound care technologies and biologics

Innovations in advanced wound care, including bioengineered skin substitutes, growth factor therapies, stem cell-based approaches, and negative pressure wound therapy, are transforming treatment paradigms. These technologies address underlying pathophysiological barriers such as impaired angiogenesis and chronic inflammation, thereby driving market growth.

Chronic Wounds Understanding and Treatment Algorithm

Chronic Wounds Overview

Chronic wounds are defined as wounds with an inability to heal within an anticipated time frame. They are widespread and frequently mistreated. A wound is considered chronic or non-healing when it has not fully healed even after four to six weeks of screening. Venous ulcers (Vein ulcers, arterial ulcers), diabetic foot ulcers (DFU), and pressure ulcers are examples of common chronic wound types. While different etiologies of chronic wounds are associated with slightly different symptoms, the most common way to recognize a chronic wound is by its elevated, hyperproliferative, yet immobile wound edge. There will be inflammation in the vicinity of the wound, which could harm the healing process. Other common signs and symptom checklists include bleeding, swelling, pain or blistering, darkened skin around the wound, difficulty moving the injured area, enlarged or deepened injury, fever, itching, milky pus, and warmth or heat when touched.

Chronic Wounds Diagnosis

The initial step in evaluating a wound clinically involves distinguishing between acute and chronic wounds. This is followed by a thorough physical examination, which includes assessing the wound's size, depth, location, and any indications of infection. Additionally, inspecting the surrounding skin and tissues for signs like inflammation, necrosis, or edema is crucial. Understanding the patient's medical history is also paramount, as conditions such as diabetes, peripheral vascular disease, immunosuppression, and prior wound healing complications can significantly impact healing. Consequently, documentation typically includes details such as the wound's location, size, depth, presence of drainage, and tissue type. By considering the wound's location and appearance, most chronic wounds can be categorized by their underlying cause, facilitating appropriate assessment and treatment recommendations.

Chronic Wounds Treatment

A thorough assessment of the patient and the wound will guide subsequent treatment by elucidating underlying areas of concern that need to be addressed. Diabetic patients frequently need improved control of their hyperglycemia, renal insufficiency, nutrition, and other associated medical comorbidities that may adversely affect the healing of their wound(s). Patients with venous leg ulcers might often have hemodynamic perturbations requiring improved medical management. Pressure ulcer patients, often bedridden from intercurrent illness, will have significant nutritional deficits that need to be corrected to optimize tissue repair.

Treatment primarily focuses on treating the cause. First, all chronic wounds should be managed according to the principle of TIME: tissue debridement (in all cases except arterial ulcers), infection control, fluid balance, and wound margins. Effective management of infection in chronic wounds includes removal of necrotic tissue, cellular debris, and biofilm by debridement, and appropriate use of antimicrobial agents (including topical antiseptics and systemic antibiotics).

Chronic Wounds Unmet Needs

The section "unmet needs of chronic wounds" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Lack of effective, durable healing therapies

2. Delayed diagnosis and poor risk stratification

3. High recurrence rates

4. Limited access to advanced therapies

5. Inadequate pain and quality-of-life management, and others.....

Comprehensive unmet needs insights in chronic wounds and their strategic implications are provided in the full report.

Chronic Wounds Epidemiology

Key Findings from Chronic Wounds Epidemiological Analysis and Forecast

  • As per DelveInsight analysis, in 2025, the total diagnosed prevalent cases of chronic wounds in the 7MM are estimated to be approximately 12 million cases.
  • In 2025, the US accounted for approximately 7.1 million cases. Among these, pressure ulcers accounted for approximately 38%, diabetic foot ulcers for 35%, venous ulcers for 18%, and other types of chronic wounds for the remaining 9%.
  • Among the EU4 and the UK, Germany accounted for the highest cases, i.e., nearly 1 million diagnosed prevalent cases of chronic wounds, followed by France and the UK. These cases are expected to rise by 2036 primarily due to the heightened focus on research and clinical trials for the disease.
  • Among type-specific diagnosed prevalent cases of chronic wounds in Japan, pressure ulcers had the highest contribution of cases in 2025, with nearly 54% cases, followed by around 23%, 10%, and 10% cases for venous ulcers, diabetic foot ulcers, and others, respectively.

Chronic Wounds Drug Chapters & Competitive Analysis

The chronic wounds drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the chronic wounds treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the chronic wounds therapeutics market.

Approved Therapies for Chronic Wounds

Becaplermin (REGRANEX): Lynch Regenerative Medicine

Becaplermin is indicated for treating lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices, including initial sharp debridement, pressure relief, and infection control. REGRANEX Gel contains becaplermin, a recombinant human platelet-derived growth factor (rhPDGF-BB) for topical administration. Becaplermin is produced by recombinant DNA technology by inserting the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast Saccharomyces cerevisiae.

In March 2025, Lynch Regenerative Medicine announced that it had acquired exclusive rights to REGRANEX gel and recombinant purified platelet-derived growth factor (PDGF) from Smith & Nephew, for use in skin rejuvenation and regeneration, as well as other soft tissue wound healing and tissue regeneration applications. PDGF is the first and only pure recombinant growth factor to have received approval from the US FDA for the treatment of wounds in the lower extremities of diabetic patients.

ON-101 (BONVADIS): Oneness Biotech

ON-101 is a new botanical drug ointment that possesses the function of diabetic wound healing and high safety. The active pharmaceutical ingredient (API) of ON101 is composed of extracts from two commonly used traditional Chinese herbal medicines, Plectranthus amboinicus and Centella asiatica. It is a first-in-class drug targeting the subsets of macrophages to promote the healing of chronic wounds. It has been demonstrated with superior efficacy to the standard care dressing in a Phase III MRCT completed in the US, Taiwan, and China.

  • In March 2026, Oneness received an EU Notified Body (ECM) issued EU Quality Management System Certificate (EU market approval) that grants marketing authorization across all 27 EU member states for BONVADIS, used for acute and chronic wounds and scar management.
  • In June 2025, Oneness Biotech announced a major milestone in its global commercialization, with the US FDA granting market approval for BONVADIS cream for full-thickness chronic wound indications. The approved indications include full-thickness and partial-thickness wounds, post-surgical wounds, first- and superficial second-degree burns, as well as chronic wounds such as diabetic foot ulcers, venous ulcers, and pressure sores, effectively covering both acute and chronic wound indications in the US market.

Chronic Wounds Pipeline Analysis

TTAX01: Biotissue

TTAX01 is being developed by Biotissue to manage diabetic foot ulcer (DFU) and non-healing wounds. It is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarean section, full-term births after determining donor eligibility and placenta suitability. The company's proprietary technology, the CRYOTEK process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue, is being used. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP).

The drug candidate is being investigated in two planned multicenter randomized controlled Phase III clinical trials conducted at 20 investigational sites across the US, with 220 patients in each trial. These trials, titled AMBULATE DFU and AMBULATE DFU II, are expected to evaluate the benefits and risks of using TTAX01 to achieve complete wound closure of complex non-healing DFUs with high-risk factors of ulcer depth indicating exposed bone, tendon, muscle, and/or joint capsule, and clinical suspicion of osteomyelitis.

Chronic Wounds Key Players, Market Leaders, and Emerging Companies

  • Biotissue
  • Smith & Nephew
  • Lynch Regenerative Medicine
  • Kaken Pharmaceutical
  • Oneness Biotech, and others

Chronic Wounds Drug Updates

  • In March 2026, Oneness received an EU Notified Body (ECM) issued EU Quality Management System Certificate (EU market approval) that grants marketing authorization across all 27 EU member states for BONVADIS, used for acute and chronic wounds and scar management.
  • In June 2025, Oneness Biotech announced a major milestone in its global commercialization, with the US FDA granting market approval for BONVADIS cream for full-thickness chronic wound indications. The approved indications include full-thickness and partial-thickness wounds, post-surgical wounds, first- and superficial second-degree burns, as well as chronic wounds such as diabetic foot ulcers, venous ulcers, and pressure sores, effectively covering both acute and chronic wound indications in the US market.
  • In March 2025, Lynch Regenerative Medicine announced that it had acquired exclusive rights to REGRANEX gel and recombinant purified PDGF from Smith & Nephew, for use in skin rejuvenation and regeneration, as well as other soft tissue wound healing and tissue regeneration applications. PDGF is the first and only pure recombinant growth factor to have received approval from the US FDA for the treatment of wounds in the lower extremities of diabetic patients.

Chronic Wounds Market Outlook

Numerous elements must cooperate for a superficial wound to heal; moreover, wound dressings and treatments have advanced significantly to address potential obstacles to wound healing, from infection to hypoxia. Even under ideal conditions, the strength of the injured tissue never restores, and several aberrant healing states can lead to persistent non-healing wounds. Despite significant advances in technological innovation and the advent of various wound treatments, non-healing wounds continue to challenge physicians. Various nonsurgical approaches have been developed, and many drugs have been introduced to assist in managing such wounds.

Debridement is the removal of nonviable wound tissue, and it can be performed using surgical, autolytic, enzymatic, biological, or mechanical methods. Although several moisture-retentive dressings are available to manage chronic wounds, the best dressing is the one that keeps the wound moist but not too wet or dry. While there are multiple types of moisture-retentive dressings, the five basic categories include films, foams, hydrocolloids, alginates, and hydrogels. In addition to dressings, NPWT (also known as vacuum-assisted closure) has been used primarily in chronic wound management for diabetic foot ulcers and pressure ulcers. With the advancement of chronic wounds, there is a need for a more advanced technique to cure this situation. Nonetheless, the anticipated release of promising treatments like TTAX01 and others is anticipated to positively influence the market size throughout the forecast period (2026-2036).

  • The market size of chronic wounds in the 7MM is USD 9,000 million in 2025, which is expected to rise in the forecast period (2026-2036).
  • Among the EU4 and the UK, Germany holds the highest market size of around 26%, followed by France and the UK with approximately 21% and 20% respectively. These numbers are expected to change during the forecast period (2026-2036), driven by the ongoing research and development efforts that may lead to the discovery of more effective medications and therapies for treating chronic wounds.
  • The chronic wound market size in Japan accounted for nearly 6% of the total 7MM market size in 2025; these numbers are expected to change by 2036.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Chronic Wounds (2026-2036 Forecast)

The chronic wounds therapeutic landscape remains largely supportive and symptom-driven; however, recent advances in regenerative medicine and biologics are initiating a shift toward mechanism-based approaches that target the underlying drivers of impaired healing, such as chronic inflammation, poor angiogenesis, and tissue hypoxia.

Growth factor-based therapies: Targeted biologics such as Becaplermin promote cellular proliferation, angiogenesis, and granulation tissue formation, supporting wound closure. While these therapies represent an important step toward biologically active treatment, their clinical impact is often limited to specific wound types and requires adjunctive standard care.

Cell and regenerative therapies: Approaches including stem cell-based treatments, platelet-rich plasma (PRP), and bioengineered skin substitutes aim to restore tissue integrity and enhance healing capacity. These therapies address key deficits in chronic wounds, such as impaired cellular signaling and extracellular matrix dysfunction. However, challenges related to scalability, cost, variability in clinical outcomes, and long-term durability persist.

Chronic Wounds Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the chronic wounds market's uptake by drugs, patient uptake by therapy, and sales of each drug.

Drug uptake in chronic wounds is currently highest for Oneness Biotech's ON101, a new botanical drug ointment that possesses the function of diabetic wound healing and high safety to reduce wound inflammation, increase epithelialization of the epidermal tissues, promote collagen production, and decrease granulation tissue development in the wound.

Market Access and Reimbursement of Chronic Wounds

  • US

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

Further details are provided in the final report....

Chronic Wounds Therapies Price Scenario & Trends

Pricing and analogue assessment of chronic wound therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of Chronic Wound-Approved Drugs

In the current treatment paradigm, advanced therapies for chronic wounds, including skin substitutes and growth factors, cost approximately USD 4,200, with many patients requiring multiple applications to achieve healing.

Further details are provided in the final report....

Industry Experts and Physician Views for Chronic Wounds

To keep up with chronic wounds market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the chronic wounds emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in chronic wounds, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, the Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging chronic wounds therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in chronic wounds.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Chronic Wounds, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of chronic wounds, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the chronic wounds market, historical and forecasted market size, and market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM chronic wounds market.

Report Insights

  • Chronic Wounds Patient Population Forecast
  • Chronic Wounds Therapeutics Market Size
  • Chronic Wounds Pipeline Analysis
  • Chronic Wounds Market Size and Trends
  • Chronic Wounds Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • Chronic Wounds Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Chronic Wounds Treatment Addressable Market (TAM)
  • Chronic Wounds Competitive Landscape
  • Chronic Wounds Major Companies Insights
  • Chronic Wounds Price Trends and Analogue Assessment
  • Chronic Wounds Therapies Drug Adoption/Uptake
  • Chronic Wounds Therapies Peak Patient Share Analysis

Report Assessment

  • Chronic Wounds Current Treatment Practices
  • Chronic Wounds Unmet Needs
  • Chronic Wounds Clinical Development Analysis
  • Chronic Wounds Emerging Drugs Product Profiles
  • Chronic Wounds Market Attractiveness
  • Chronic Wounds Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the chronic wounds market size, the market size by therapies, the market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of chronic wounds?
  • What are the disease risks, burdens, and unmet needs of chronic wounds? What will be the growth opportunities across the 7MM concerning the patient population with chronic wounds?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of chronic wounds? What are the current guidelines for treating Chronic Wounds in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the chronic wounds market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Chronic Wounds

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Conferences and Meetings
  • 4.3. Key Transactions and Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Forecast Methodology

6. Chronic Wounds Market Overview at a Glance

  • 6.1. Market Share (%) Distribution by Therapies in 2025
  • 6.2. Market Share (%) Distribution by Therapies in 2036

7. Disease Background and Overview of Chronic Wounds

  • 7.1. Introduction
  • 7.2. Causes of Chronic Wounds
  • 7.3. Signs and Symptoms of Chronic Wounds
  • 7.4. Pathogenesis of Chronic Wounds
  • 7.5. Pathophysiology of Itch in Chronic Wound Skin
  • 7.6. Diagnosis of Chronic Wounds

8. Treatment and Management of Chronic Wounds

  • 8.1. Management of Wounds
  • 8.2. Skin and Wound Management

9. Guidelines

  • 9.1. Diagnostic Guidelines
    • 9.1.1. Clinical Practice Guidelines for Chronic Wounds: Laboratory Diagnosis

10. Epidemiology and Patient Population of Chronic Wounds

  • 10.1. Key Findings
  • 10.2. Assumption and Rationale
  • 10.3. Total Diagnosed Prevalent Cases of Chronic Wounds in the 7MM
  • 10.4. The United States
    • 10.4.1. Total Diagnosed Prevalent Cases of Chronic Wounds in the United States
    • 10.4.2. Type-specific Diagnosed Prevalent Cases of Chronic Wounds in the United States
    • 10.4.3. Total Treated Cases of Chronic Wounds in the United States
  • 10.5. EU4 and the UK
    • 10.5.1. Total Diagnosed Prevalent Cases of Chronic Wounds in EU4 and the UK
    • 10.5.2. Type-specific Diagnosed Prevalent Cases of Chronic Wounds in EU4 and the UK
    • 10.5.3. Total Treated Cases of Chronic Wounds in EU4 and the UK
  • 10.6. Japan
    • 10.6.1. Total Diagnosed Prevalent Cases of Chronic Wounds in Japan
    • 10.6.2. Type-specific Diagnosed Prevalent Cases of Chronic Wounds in Japan
    • 10.6.3. Total Treated Cases of Chronic Wounds in Japan

11. Patient Journey

12. Marketed Drugs

  • 12.1. Marketed Competitive Landscape of Chronic Wounds
  • 12.2. Becaplermin (REGRANEX): Lynch Regenerative Medicine
    • 12.2.1. Product Description
    • 12.2.2. Regulatory Milestones
    • 12.2.3. Other Developmental Activities
    • 12.2.4. Summary of Pivotal Trials
      • 12.2.4.1. Safety and Efficacy
    • 12.2.5. Analyst's View
  • 12.3. ON-101 (BONVADIS): Oneness Biotech
    • 12.3.1. Product Description
    • 12.3.2. Regulatory Milestones
    • 12.3.3. Other Developmental Activities
    • 12.3.4. Summary of Pivotal Trials
    • 12.3.5. Safety and Efficacy
    • 12.3.6. Analyst's View

13. Emerging Drugs

  • 13.1. Emerging Competitive Landscape of Chronic Wounds
  • 13.2. TTAX01: Biotissue
    • 13.2.1. Product Description
    • 13.2.2. Other Developmental Activities
    • 13.2.3. Clinical Developmental Activities
      • 13.2.3.1. Clinical Trial Information
    • 13.2.4. Safety and Efficacy
    • 13.2.5. Analyst's View

14. Chronic Wounds: 7MM Analysis

  • 14.1. Key Findings
  • 14.2. Market Outlook
  • 14.3. Key Market Forecast Assumptions
    • 14.3.1. Cost Assumptions and Rebates
    • 14.3.2. Pricing Trends
    • 14.3.3. Analogue Assessment
    • 14.3.4. Launch Year and Therapy Uptakes
  • 14.4. Conjoint Analysis
  • 14.5. Total Market Size of Chronic Wounds in the 7MM
  • 14.6. United States Market Size
    • 14.6.1. Total Market Size of Chronic Wounds in the United States
    • 14.6.2. Market Size of Chronic Wounds by Current and Emerging Therapies in the United States
  • 14.7. EU4 and the UK Market Size
    • 14.7.1. Total Market Size of Chronic Wounds in EU4 and the UK
    • 14.7.2. Market Size of Chronic Wounds by Current and Emerging Therapies in EU4 and the UK
  • 14.8. Japan Market Size
    • 14.8.1. Total Market Size of Chronic Wounds in Japan
    • 14.8.2. Market Size of Chronic Wounds by Current and Emerging Therapies in Japan

15. Unmet Needs of Chronic Wounds

16. SWOT Analysis of Chronic Wounds

17. KOL Views of Chronic Wounds

18. Market Access and Reimbursement of Chronic Wounds

  • 18.1. United States
    • 18.1.1. Centre for Medicare & Medicaid Services (CMS)
  • 18.2. EU4 and the UK
    • 18.2.1. Germany
    • 18.2.2. France
    • 18.2.3. Italy
    • 18.2.4. Spain
    • 18.2.5. United Kingdom
  • 18.3. Japan
    • 18.3.1. MHLW
  • 18.4. Chronic Wounds: Market Access and Reimbursement

19. Appendix

  • 19.1. Bibliography
  • 19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

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