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시장보고서
상품코드
2083000
화상 : 시장 인사이트, 역학 및 예측(2036년)Burns - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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, 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.
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.
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.
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 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 역학적 분석 및 예측을 통해 얻은 주요 인사이트
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.
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
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.
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.
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.
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 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.
Key Findings from Burn Epidemiological Analysis and Forecast
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
Burn Drug Updates
Drug Class Insights
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.
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.
Market Insights
Continued emerging therapies will be provided in the final report.