시장보고서
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화상 : 시장 인사이트, 역학 및 예측(2036년)

Burns - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 227 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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화상에 대한 인사이트 및 동향

  • 화상 치료의 현황은 여전히 큰 임상적 부담을 수반하는 상황입니다. 이는 쇼크, 감염증, 장기 부전, 장기적인 기능 장애로 진행될 수 있는 심각한 염증 반응, 면역 반응, 대사 반응에 더해, 신체적 및 심리적 영향도 막대하기 때문입니다.
  • 현재의 치료는 소생술, 상처 관리, 감염 관리, 통증 관리, 데브리드먼트 및 외과적 중재의 조합을 중심으로 이루어지며, 치료법의 선택은 화상의 깊이와 전신 표면적(TBSA)을 기준으로 결정됩니다. 이러한 요소들은 여전히 치료 성과와 의료 자원 활용에 있어 중요한 결정 요인으로 작용하고 있습니다.
  • 지지 요법의 발전에도 불구하고, 특히 심부 부분층 화상 및 전층 화상의 경우, 신속한 상처 봉합, 최적의 흉터 형성, 그리고 완전한 조직 재생을 실현하는 데 여전히 한계가 있어, 이러한 사례에서는 외과적 개입이 여전히 치료의 주축을 이루고 있습니다.
  • 승인된 첨단 치료법에는 NexoBrid(효소 기반 데브리드먼트), StrataGraft(재생형 피부 대체재), 그리고 RECELL 및 Epicel과 같은 기타 세포 치료법이 포함되어 있으며, 이는 생물학적 접근법 및 조직 보존 전략으로의 점진적인 전환을 반영하고 있습니다.
  • 개발 중인 파이프라인은 denovoSkin(CUTISS AG) 및 AGLE-102(Aegle Therapeutics) 등, 재생의학 및 조직공학을 기반으로 한 솔루션에 점점 더 초점을 맞추고 있으며, 피부 재생 개선, 기증 부위에 대한 의존도 감소, 장기적인 기능적 및 미용적 성과 향상을 목표로 하고 있지만, 그 도입 여부는 임상적 검증과 규제 당국의 승인 여부에 달려 있습니다.
  • 전반적으로, 외과적 이식이 여전히 골드 스탠다드로 남아 있는 한편, 치유 속도, 흉터 완화, 기능 회복과 관련된 미충족 의료 수요가 촉진요인이 되어 화상 치료의 양상은 효소를 이용한 데브리드먼트나 재생의학을 기반으로 한 접근 방식으로 점차 진화하고 있습니다.

본 '화상 시장 보고서'에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, 화상 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제시하고 있습니다. 본 보고서는 화상 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 상황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

화상 치료 시장을 주도하는 주요 요인

  • 전 세계 화상 관련 부담 증가

화상, 산업재해, 감전으로 인한 화상, 화재 관련 외상이 여전히 빈번하게 발생하고 있어, 효과적인 화상 치료법에 대한 수요를 부추기고 있습니다. 중증 화상의 경우, 장기간에 걸친 상처 관리, 감염 관리, 재건 수술이 필요한 경우가 많아, 고도의 치료법에 대한 수요가 지속적으로 발생하고 있습니다.

  • 치유 촉진 및 흉터 형성 개선에 대한 높은 미충족 의료 수요

상처 치유 지연, 비후성 흉터, 기능적 합병증은 화상 회복 과정에서 여전히 주요 과제로 남아 있습니다. 이에 따라 상피화 촉진, 조직 재생 개선 및 장기적인 흉터 완화를 목적으로 한 치료법 개발이 가속화되고 있습니다.

  • 증가하는 화상 상처의 감염 및 항생제 내성

화상 후 피부 장벽 기능이 상실되면 세균의 정착 및 감염에 대한 감수성이 높아집니다. 항생제 내성 병원체에 대한 우려가 커지면서, 새로운 항균 전략 및 감염 관리 기법의 개선에 대한 수요가 증가하고 있습니다.

  • 재생의학 및 생물학적 치료의 확대

줄기세포 치료, 세포외 소포, 성장 인자 및 생체공학 기법의 발전으로 인해, 혈관 신생을 촉진하고 염증을 조절하며 화상 상처의 재생을 개선할 수 있는 새로운 기회가 열리고 있습니다.

화상의 이해와 치료 알고리즘

화상의 개요와 진단

화상은 열, 화학 물질, 전기, 방사선 또는 기타 요인에 의해 유발되며, 피부 및 그 하부 조직의 손상을 수반하는 외상입니다. 화상의 중증도는 깊이(표재성, 부분층, 전층) 및 전신 표면적(TBSA)을 포함한 손상 범위에 따라 분류됩니다. 중증 화상은 조직 괴사, 염증, 면역 기능 장애, 감염 위험, 상처 치유 지연 및 흉터 형성을 동반합니다. 상처 관리, 데브리드먼트, 감염 관리 및 재건 수술의 발전에도 불구하고, 비후성 흉터, 구축, 삶의 질 저하와 같은 합병증으로 인해 여전히 충족되지 않은 중요한 요구 사항이 남아 있으며, 이는 치유와 조직 재생 개선에 초점을 맞춘 첨단 화상 치료법 개발을 촉진하고 있습니다.

화상 진단은 주로 손상 깊이, 전신 표면적(TBSA)의 병변 비율 및 중증도 평가를 바탕으로 이루어지며, 이러한 요소들이 치료 방침을 결정하는 지침이 됩니다. 평가에는 부상 기전, 열원, 발생 시각 및 관련 외상에 대한 상세한 병력 청취가 포함되며, 이어 임상 검사를 통해 상처의 특징, 화상의 깊이, 해부학적 부위, 그리고 흡입 손상이나 감염증 등의 합병증을 평가합니다. 중증 환자의 경우, 전신으로의 확산 여부를 평가하기 위해 추가 검사가 실시될 수 있습니다. 정확한 화상 평가는 소생술, 데브리드먼트, 상처 관리, 감염 예방 및 재건 전략의 지침이 될 뿐만 아니라, 치유 지연, 흉터 형성, 기능 장애 등의 합병증을 줄이기 위해서도 필수적입니다.

화상 치료

화상 치료는 흉터나 구축 등의 합병증을 최소화하면서, 상태 안정화, 상처 치유, 감염 예방, 통증 관리 및 기능 회복에 중점을 둡니다. 치료 방침은 화상의 깊이, 전신 표면적(TBSA)의 침범률, 부상 부위 및 전반적인 임상 상태에 따라 결정됩니다. 초기 처치에는 수액 요법을 통한 소생, 체온 관리, 진통, 그리고 흡입 손상 등 동반된 손상의 평가가 포함됩니다. 화상 상처 관리에는 세척, 데브리드먼트, 적응증이 있는 경우의 국소 항균 요법, 적절한 붕대 감기, 그리고 치유를 촉진하고 감염을 예방하기 위한 상처 피복 전략이 포함됩니다. 심부 또는 광범위한 화상의 경우, 효소를 이용한 데브리드먼트, 재생의학, 그리고 피부 이식을 동반한 외과적 절제술과 같은 고도의 치료법이 사용되기도 합니다.

화상의 역학

화상의 역학적 분석 및 예측을 통해 얻은 주요 인사이트

  • DelveInsight의 분석에 따르면, 2025년 주요 7개국에서 발생한 신규 화상 사례 수는 약 549만 7,000건이었습니다.
  • EU4 및 영국에서 2025년에 의료 처치가 필요한 화상 신규 환자 수가 가장 많았던 곳은 영국(약 28만 5,900건)이었으며, 그 다음은 프랑스(약 20만 5,000건)였습니다. 한편, 이탈리아는 2025년에 약 12만 건으로, 확진자 수가 가장 적었던 국가가 되었습니다.
  • 중증도에 따라 화상은 '1도', '2도', '3도', '미상'으로 분류되었습니다. EU4 및 영국에서는 2도 화상이 가장 많은 사례를 차지했으며, 그 수는 약 76만 8,000건이었습니다.
  • 미국에서 원인별로는 전체 화상 사례의 41%가 화염에 의한 것이었고, 31%는 뜨거운 물에 의한 것이었으며, 9%는 접촉에 의한 것이었고, 4%는 전기에 의한 것이었으며, 4%는 화학 물질에 의한 것이었고, 나머지 12%는 기타 화상이었습니다.
  • 일본에서는 2025년에 의료적 처치가 필요한 화상 사례가 약 33만 건으로 추산되었습니다.

화상 치료 시장 전망

현재 화상 치료의 현황은 상처의 안정화, 감염 예방, 조직 보존 및 피부 기능 회복에 중점을 두고 있으며, 그 관리 방법은 화상의 중증도, 깊이 및 체표면적(TBSA)의 침범 범위에 따라 결정됩니다. 표준 치료에는 수액 요법, 통증 관리, 상처 관리, 국소 항균제 투여, 데브리드먼트 및 외과적 중재가 포함됩니다. 그러나 기존의 치료법은 주로 상처 관리를 돕는 데 그치며, 진정한 조직 재생을 실현하는 능력에는 한계가 있습니다.

중증 화상의 경우, 조기 절제술에 이어 자가 박층 피부 이식술(STSG)을 시행하는 것이 여전히 표준 치료법이지만, 피부 기증 부위의 부족, 수술 부담, 흉터 형성, 구축 발생 등의 제한으로 인해 여전히 충족되지 않은 의료적 수요가 존재합니다.

선진적인 치료 옵션으로는 화상 딱지를 선택적으로 제거하는 데 사용되는 브로멜라인을 주성분으로 하는 효소 데브리드먼트용 생물학적 의약품 'NexoBrid'나, 심부 부분층 화상에 사용되는 생체공학적으로 제조된 동종 세포·조직 유래 피부 대체재 'StrataGraft' 등이 있습니다. 또한, 자가 유래 스프레이형 피부 세포를 생성하는 세포 채취·처리 의료기기 ‘RECELL’, 세포 치료법인 ‘Epicel(배양 표피 자가 이식편)’ 등의 기술도 상처 치유를 촉진하고, 기존 이식술에 대한 의존도를 낮추는 것을 목표로 하고 있습니다.

화상 치료 시장은 재생의학, 조직공학을 활용한 피부 대체재, 그리고 세포 치료로 점차 전환되고 있습니다. 자가 유래 생명공학을 통해 개발된 진피·표피 복합 피부 대체재인 'denovoSkin'(CUTISS AG)과 같은 신제품들은 피부 재생을 돕고, 현재의 이식 요법의 한계를 극복하기 위해 개발이 진행되고 있습니다. denovoSkin은 스위스 및 유럽연합(EU)에서 성인 및 청소년을 대상으로 한 중증 화상 치료에 대한 3상 임상 개발이 진행 중이며, 스위스 의약품청(Swissmedic), 유럽의약품청(EMA), 그리고 미국 식품의약국(FDA)으로부터 희귀질환 치료제(Orphan Drug) 지정을 받았습니다. AGLE-102(Aegle Therapeutics사)는 동종 간엽 줄기세포 유래 세포외 소포를 이용한 재생의학 치료제로, 조직 복구와 염증 조절을 목표로 하는 새로운 접근법 중 하나입니다.

  • 효소를 이용한 창면 데브리드먼트제 : anacaulase-bcdb(NexoBrid) 등의 치료법은 단백질 분해 활성을 통해 화상 딱지를 효소적으로 분해함으로써 작용하며, 생존 가능한 창면 구조를 보존하면서 생존 불가능한 조직을 선택적으로 제거할 수 있게 합니다.
  • 재생형 피부 대체재 : StrataGraft 및 denovoSkin과 같은 치료법은 피부 재생, 조직 복구 및 상처 치유를 돕는 세포 유래 또는 생체공학적으로 제조된 피부 성분을 제공함으로써, 손상된 피부의 구조를 회복하도록 설계되었습니다.

자주 묻는 질문

  • 화상 치료의 현재 상황은 어떤가요?
  • 화상 치료 시장에서 주요 요인은 무엇인가요?
  • 2025년 화상 치료 시장의 신규 환자 수는 어떻게 되나요?
  • 화상 치료에 사용되는 첨단 치료법은 무엇이 있나요?
  • 화상 치료의 진화 방향은 어떻게 되나요?
  • 화상 치료에서의 진단 과정은 어떻게 이루어지나요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 화상 : 역학 및 시장 조사 방법

제6장 화상 : 시장 개요

제7장 화상 : 질환 배경 및 개요

제8장 관리와 치료

제9장 화상 : 역학 및 환자 인구

제10장 화상 : 환자 경과

제11장 시판 치료제

제12장 신흥 치료법

제13장 화상 : 주요 7개국 분석

제14장 화상 : 미충족 수요

제15장 화상 : SWOT 분석

제16장 화상 : KOL(Key Opinion Leader)의 견해

제17장 화상 : 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

KTH

Burn Insights and Trends

  • The burn care landscape remains associated with a high clinical burden, driven by severe inflammatory, immune, and metabolic responses that can progress to shock, infection, organ failure, and long-term functional impairment, along with significant physical and psychological impact.
  • Current management is centered on a combination of resuscitation, wound care, infection control, pain management, debridement, and surgical intervention, with treatment selection guided by burn depth and total body surface area (TBSA), which remain key determinants of outcomes and resource utilization.
  • Despite advances in supportive care, limitations persist in achieving rapid wound closure, optimal scar outcomes, and full tissue regeneration, particularly in deep partial-thickness and full-thickness burns, where surgical intervention remains the mainstay of treatment.
  • The approved advanced therapy landscape includes NexoBrid (enzymatic debridement), StrataGraft (regenerative skin substitute), and other cellular approaches such as RECELL and Epicel, reflecting a gradual shift toward biologically driven and tissue-preserving strategies.
  • The emerging pipeline is increasingly focused on regenerative and tissue engineered solutions, including denovoSkin (CUTISS AG) and AGLE-102 (Aegle Therapeutics), aiming to improve skin regeneration, reduce donor-site dependence, and enhance long-term functional and cosmetic outcomes, though adoption will depend on clinical validation and regulatory success.
  • Overall, while surgical grafting remains the gold standard, the burn treatment landscape is progressively evolving toward enzymatic debridement and regenerative medicine-based approaches, driven by unmet needs in healing speed, scarring reduction, and functional restoration.

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

The Burn market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, Burn 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 Burn 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 Burn Market

  • Increasing Global Burden of Burn Injuries

The continued prevalence of thermal injuries, industrial accidents, electrical burns, and fire-related trauma is driving demand for effective burn management therapies. Severe burns often require prolonged wound care, infection control, and reconstructive interventions, creating a sustained need for advanced treatment options.

  • High Unmet Need for Faster Healing and Improved Scar Outcomes

Delayed wound closure, hypertrophic scarring, and functional complications remain major challenges in burn recovery. This is accelerating development of therapies aimed at enhancing re-epithelialization, improving tissue regeneration, and reducing long-term scarring.

  • Rising Burn Wound Infections and Antimicrobial Resistance

Loss of skin barrier integrity after burns increases susceptibility to bacterial colonization and infection. Growing concerns around antimicrobial-resistant pathogens are driving demand for novel antimicrobial strategies and improved infection management approaches.

  • Expansion of Regenerative and Biologic Therapies

Advances in stem cell therapies, extracellular vesicles, growth factors, and bioengineered approaches are creating new opportunities to enhance angiogenesis, modulate inflammation, and improve burn wound regeneration.

Burn Understanding and Treatment Algorithm

Burn Overview and Diagnosis

Burns are traumatic injuries involving damage to the skin and underlying tissues caused by thermal, chemical, electrical, radiation, or other sources. Burn severity is classified based on depth (superficial, partial-thickness, and full-thickness) and extent of injury, including total body surface area (TBSA) involvement. Severe burns are associated with tissue necrosis, inflammation, immune dysfunction, infection risk, delayed wound healing, and scarring. Despite advances in wound care, debridement, infection management, and reconstructive procedures, significant unmet needs remain due to complications such as hypertrophic scarring, contractures, and impaired quality of life, driving development of advanced burn therapies focused on improving healing and tissue regeneration.

Diagnosis of burns is primarily based on assessment of injury depth, total body surface area (TBSA) involvement, and severity to guide treatment decisions. Evaluation includes a detailed history of the mechanism of injury, burn source, timing, and associated trauma, followed by clinical examination to assess wound characteristics, burn depth, anatomical location, and complications such as inhalation injury or infection. Additional investigations may be performed in severe cases to evaluate systemic involvement. Accurate burn assessment is essential for guiding resuscitation, debridement, wound management, infection control, and reconstructive strategies, while reducing complications such as delayed healing, scarring, and functional impairment.

Burn Treatment

Treatment of burns focuses on stabilization, wound healing, infection prevention, pain control, and functional recovery while reducing complications such as scarring and contractures. Management is based on burn depth, total body surface area (TBSA) involvement, injury location, and overall clinical status. Initial care includes fluid resuscitation, temperature control, analgesia, and assessment of associated injuries such as inhalation injury. Burn wound management involves cleaning, debridement, topical antimicrobial therapy when indicated, appropriate dressings, and wound coverage strategies to support healing and prevent infection. Advanced approaches, including enzymatic debridement, regenerative therapies, and surgical excision with skin grafting, may be used for deeper or extensive burns.

Burn Unmet Needs

The section "unmet needs of Burn" 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. Delayed onset of current pharmacological therapies

2. High burden of hypertrophic scarring and contracture formation

3. Increasing challenges in burn wound infection management and antimicrobial resistance

4. Need for safer and more effective alternatives to surgical debridement and grafting, and others.....

Burn Epidemiology

Key Findings from Burn Epidemiological Analysis and Forecast

  • According to DelveInsight's analysis, The total Incident cases of burn injury in the 7MM were ~ 5,497,000 cases in 2025.
  • Among EU4 and the UK, the highest Incident cases of Burn injury that require medical treatment were recorded in the UK (~285,900) followed by France (~205,000), in 2025. On the other hand, Italy accounted for the least cases, approximately 120,000 in 2025.
  • On the basis of severity, burns was bifurcated into First-degree, Second-degree, Third-degree, and Unspecified. In EU4 and the UK, Second-degree burns accounted for the maximum number of cases, which was approximately 768,000.
  • In the United States, among etiology-specific cases 41% cases were due to flame, 31% cases were of scald, 9% cases of contact, 4% cases of electrical, 4% cases of chemical and 12% cases were of other burn.
  • Japan recorded an estimated ~330,000 burn injury cases requiring medical treatment in 2025.

Burn Drug Analysis & Competitive Landscape

The Burn drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I/II-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 Burn treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Burn therapeutics market.

Approved Therapies for Burn

Anacaulase-bcdb (NEXOBRID): MediWound

NexoBrid is MediWound's FDA-approved enzymatic debridement therapy developed for the removal of eschar in deep partial-thickness and full-thickness thermal burns. The therapy addresses a key unmet need in burn care by providing a non-surgical, selective eschar removal approach, aiming to reduce reliance on surgical debridement and support effective wound-bed preparation.

Following commercialization, NexoBrid has demonstrated increasing adoption in the U.S. burn care setting, with Vericel reporting expanding utilization across more than 70 burn centers and continued growth in product uptake. MediWound has also expanded manufacturing capacity to support anticipated global demand, reflecting increasing commercial focus on enzymatic burn management.

Burn Pipeline Analysis

DenovoSkin: CUTISS

DenovoSkin being developed by CUTISS, is bio-engineered within large quantities (>1:100) with a thick, double layer, robust structure. DenovoSkin is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medical Product (ATMP). In parallel, CUTISS is advancing denovoSkin in an ongoing Phase III clinical trial for adolescents and adults with severe burns across the EU and Switzerland.

MW-III: Skingenix

MW-III is a topical product being evaluated for second-degree burns in adult patients. The drug is a botanical drug product developed for treating burns and other cutaneous wounds, which will be made from natural ingredients. In February 2023, the first patient was treated with Skingenix's investigational drug MW-III in a Phase II trial at MedStar Washington Hospital Center, led by Dr. Jeffrey Shupp. Currently, the drug is in Phase II study (NCT01297400) of the clinical trial.

Burn Key Players, Market Leaders and Emerging Companies

  • Vericel Corporation
  • Skingenix
  • Aegle Therapeutics
  • CUTISS, and others

Burn Drug Updates

  • In March 2026, CUTISS announced publication of 1-year Phase II results for denovoSkin in reconstructive surgery, reporting favorable safety and clinical outcomes with the bioengineered dermo-epidermal skin substitute.
  • In May 2025, CUTISS completed an interim analysis of its Phase II clinical trial evaluating the safety and efficacy of DenovoSkin in pediatric patients with severe burns. The analysis confirmed a favorable safety profile and demonstrated promising signals of efficacy, supporting the continued clinical development of denovoSkin for pediatric burn treatment.
  • In January 2024, Aegle Therapeutics announced positive 12-week data for the first patient enrolled in a Phase I/IIa clinical trial of AGLE-102 for the treatment of severe second-degree burns. The patient achieved 99% epithelialization of the burn wound and had a significant reduction in edema within seven days of treatment. Subsequent doses of AGLE-102 were not required.

Drug Class Insights

Burn Market Outlook

The current burn treatment landscape focuses on wound stabilization, infection prevention, tissue preservation, and restoration of skin function, with management determined by burn severity, depth, and TBSA involvement. Standard care includes fluid resuscitation, pain management, wound care, topical antimicrobials, debridement, and surgical intervention. However, conventional therapies largely support wound management and have limited ability to achieve true tissue regeneration.

For severe burns, early excision followed by autologous split-thickness skin grafting (STSG) remains the standard of care, but limitations such as donor-site scarcity, surgical burden, scarring, and contracture formation continue to drive unmet need.

Advanced treatment options include NexoBrid, a bromelain-based enzymatic debridement biologic medicinal product used for selective burn eschar removal, and StrataGraft, a bioengineered allogeneic cellular/tissue-based skin substitute for deep partial-thickness burns. Additional technologies such as RECELL, a cell-harvesting and processing medical device that generates autologous spray-on skin cells, Epicel (cultured epidermal autograft), a cell-based therapy aim to improve wound closure outcomes and reduce reliance on conventional grafting procedures.

The burn market is shifting toward regenerative medicine, tissue-engineered skin substitutes, and cell-based therapies. Emerging assets such as denovoSkin (CUTISS AG), an autologous bioengineered dermo-epidermal skin substitute, are being developed to support skin regeneration and address limitations of current grafting approaches. denovoSkin is advancing in Phase III clinical development for severe burns in adults and adolescents in Switzerland and the European Union and has received Orphan Drug Designation from Swissmedic, EMA, and the FDA. AGLE-102 (Aegle Therapeutics), an extracellular vesicle-based regenerative therapy derived from allogeneic mesenchymal stem cells, represents another emerging approach targeting tissue repair and inflammatory modulation.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Burn (2022-2036 Forecast)

The Burn treatment landscape comprises antidepressants, anxiolytics, adjunctive agents, and emerging novel therapies, each targeting different aspects of neurotransmitter imbalance and symptom control.

  • Enzymatic Debridement Agents: Therapies such as anacaulase-bcdb (NexoBrid) act by enzymatically degrading burn eschar through proteolytic activity, enabling selective removal of non-viable tissue while preserving viable wound structures.
  • Regenerative Skin Substitutes: Therapies such as StrataGraft and denovoSkin are designed to restore damaged skin architecture by providing cellular or bioengineered skin components that support skin regeneration, tissue repair, and wound closure.

Burn 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 Burn drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The uptake of therapies in the burn market is expected to vary across standard surgical approaches, approved advanced therapies, and emerging regenerative technologies. Autologous split thickness skin grafting (STSG) is expected to remain the standard of care due to established clinical experience, while advanced therapies such as NexoBrid and StrataGraft may see increasing adoption due to their ability to address limitations of conventional burn management through enzymatic debridement and regenerative skin replacement approaches.

Emerging therapies such as denovoSkin (CUTISS AG) and AGLE-102 (Aegle Therapeutics) are expected to gain gradual adoption as clinical data mature, driven by their potential to improve skin regeneration, reduce surgical burden, and address unmet needs such as donor-site limitations and scarring.

Detailed insights of emerging therapies' drug uptake is included in the report.

Market Access and Reimbursement of Burn

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.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

NOTE: Further Details are provided in the final report....

Burn Therapies Price Scenario & Trends

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

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

Industry Experts and Physician Views for Burn

To keep up with Burn 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 Burn 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 Burn, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at country level. Centers such as the USDA Forest Service, Pacific Southwest Research Station, Department of Plastic and Reconstructive Surgery, Germany, and Department of Trauma and Critical Care Medicine, Tokyo, Japan, etc. were contacted.Their opinion helps understand and validate current and emerging Burn therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Burn.

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 Burn, 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 majorly 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 Burn, 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 Burn market, historical and forecasted market size, 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 Burn market.

Report Insights

  • Burn Patient Population Forecast
  • Burn Therapeutics Market Size
  • Burn Pipeline Analysis
  • Burn Market Size and Trends
  • Burn 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
  • Burn Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Burn Treatment Addressable Market (TAM)
  • Burn Competitive Landscape
  • Burn Major Companies Insights
  • Burn Price Trends and Analogue Assessment
  • Burn Therapies Drug Adoption/Uptake
  • Burn Therapies Peak Patient Share Analysis

Report Assessment

  • Burn Current Treatment Practices
  • Burn Unmet Needs
  • Burn Clinical Development Analysis
  • Burn Emerging Drugs Product Profiles
  • Burn Market attractiveness
  • Burn Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the Burn market size, the market size by therapies, 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 Burn?
  • What are the disease risks, burdens, and unmet needs of Burn? What will be the growth opportunities across the 7MM concerning the patient population with Burn?
  • 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 Burn? What are the current guidelines for treating Burn 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 Burn 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 on 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 with in 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

4. Key Events

  • 4.1. Key Conferences And Meetings
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Methodology of Burn

6. Burn Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Burn By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Burn By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Burn

  • 7.1. Introduction
  • 7.2. Etiology
  • 7.3. Classification of Burn
  • 7.4. Evaluation of Burn Severity
  • 7.5. Pathophysiology
  • 7.6. Phases of Wound Healing
  • 7.7. Systemic Response
  • 7.8. Diagnosis, screening, and prevention
    • 7.8.1. Diagnosis Guidelines
      • 7.8.1.1. The wound/burn guidelines -Guidelines for the management of burns

8. Management and Treatment

  • 8.1. Treatment Algorithm
  • 8.2. Treatment Guidelines
    • 8.2.1. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient
    • 8.2.2. European Practice Guidelines for Burn Care
    • 8.2.3. The wound/burn guidelines -Guidelines for the management of burn

9. Epidemiology and Patient Population of Burn

  • 9.1. Key Findings
  • 9.2. Assumption and Rationale
  • 9.3. Incident Cases of Burn Patients Requiring Treatment in the 7MM
  • 9.4. Incident Cases of Hospitalized Burn Patients in the 7MM
  • 9.5. The United States
    • 9.5.1. Incident Cases of Burn Patients Requiring Treatment in the US
    • 9.5.2. Treated Burn Injuries Gender-specific Incident Cases in the US
    • 9.5.3. Treated Burn Injuries Etiology-specific Incident Cases in the US
    • 9.5.4. Treated Burn Injuries Severity-specific Incident Cases in the US
    • 9.5.5. Hospitalized Burn Patients Incident Cases in the US
  • 9.6. EU4 and the UK
    • 9.6.1. Incident Cases of Burn Patients Requiring Treatment in EU4 and the UK
    • 9.6.2. Treated Burn Injuries Gender-specific Incident Cases in EU4 and the UK
    • 9.6.3. Treated Burn Injuries Etiology-specific Incident Cases in EU4 and the UK
    • 9.6.4. Treated Burn Injuries Severity-specific Incident Cases in EU4 and the UK
    • 9.6.5. Hospitalized Burn Patients Incident Cases in EU4 and the UK
  • 9.7. Japan
    • 9.7.1. Incident Cases of Burn Patients Requiring Treatment in Japan
    • 9.7.2. Treated Burn Injuries Gender-specific Incident Cases in Japan
    • 9.7.3. Treated Burn Injuries Etiology-specific Incident Cases in Japan
    • 9.7.4. Treated Burn Injuries Severity-specific Incident Cases in Japan
    • 9.7.5. Hospitalized Burn Patients Incident Cases in Japan

10. Patient Journey of Burn

11. Marketed Therapies

  • 11.1. Competitive Landscape of Marketed Therapies
  • 11.2. Anacaulase-bcdb (NEXOBRID): MediWound
    • 11.2.1. Product Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Clinical Trials
    • 11.2.5. Analyst Views

12. Emerging Therapies

  • 12.1. Competitive Landscape of Emerging Therapies
  • 12.2. MW-III: Skingenix
    • 12.2.1. Product Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trial Information
    • 12.2.4. Safety and Efficacy
    • 12.2.5. Analyst's View
  • 12.3. AGLE-102: Aegle Therapeutics
    • 12.3.1. Product Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trial Information
    • 12.3.4. Safety and Efficacy
    • 12.3.5. Analyst's View

Continued emerging therapies will be provided in the final report.

13. Burn: Seven Major Market Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook
  • 13.3. Conjoint Analysis
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions and Rebates
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of Burn in the 7MM
  • 13.6. United States Market Size
    • 13.6.1. Total Market Size of Burn in the United States
    • 13.6.2. Market Size of Burn by Therapies in United States
  • 13.7. EU4 and the UK Market Size
    • 13.7.1. Total Market Size of Burn in EU4 and the UK
    • 13.7.2. Market Size of Burn by Therapies in EU4 and the UK
  • 13.8. Japan Market Size
    • 13.8.1. Total Market Size of Burn in Japan
    • 13.8.2. Market Size of Burn by Therapies in Japan

14. Unmet Needs of Burn

15. SWOT Analysis of Burn

16. KOL Views of Burn

  • 16.1. Expert/KOL Interview Highlights

17. Market Access and Reimbursement of Burn

  • 17.1. United States
    • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
  • 17.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of Burn Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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