StrataGraft Global Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

The stratagraft market research report is one of a series of new reports that provides stratagraft market statistics, including stratagraft industry global market size, regional shares, competitors with a stratagraft market share, detailed stratagraft market segments, market trends, and opportunities, and any further data you may need to thrive in the stratagraft industry. This stratagraft market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The growth in the forecast period can be attributed to the rising incidence of diabetes and obesity, a growing aging population, increasing industrial accidents, higher adoption of bioengineered solutions, supportive government policies, growing healthcare infrastructure in emerging markets, and escalating prevalence of chronic wounds. Major trends in the forecast period include gradual adoption of skin substitutes, focus on reducing donor site morbidity, increasing clinical trials for bioengineered products, advancements in skin substitute technology, and advancements in burn care protocols.

The increasing prevalence of chronic wounds and burn injuries is expected to drive growth in the stratagraft market in the coming years. Chronic wounds occur when skin or underlying tissue is damaged and heals slowly due to conditions such as diabetes or poor circulation, while burn injuries can result from thermal, chemical, or electrical exposures and often require advanced medical interventions. Factors contributing to the rise in chronic wounds and burn injuries include the growing incidence of diabetes, obesity, an aging population, workplace accidents, and inadequate access to preventive care in many areas. Stratagraft offers a bioengineered solution for these injuries, providing an alternative to traditional skin grafts that promotes healing while minimizing the need for donor site procedures. According to the World Health Organization (WHO), approximately 180,000 deaths are caused by burns globally each year, with most occurring in low- and middle-income countries. In the United States alone, an estimated 410,000 burn injuries occurred in 2023, with about 40,000 requiring hospitalization, highlighting the ongoing public health challenge posed by burn injuries. This increasing incidence is fueling the growth of the stratagraft market.

The rise in clinical trials is also contributing to the expansion of the stratagraft market. Clinical trials are critical for assessing the effectiveness, safety, and potential side effects of medical treatments, and their increasing frequency reflects advancements in medical research and the growing complexity of healthcare needs. These trials play a crucial role in supporting stratagraft, providing valuable data on its safety and efficacy in treating severe burn injuries. This evidence is essential for validating its ability to enhance skin regeneration, reduce complications, and facilitate its approval for broader use in clinical settings. For example, in November 2023, the Association of the British Pharmaceutical Industry reported a 4.3% increase in the number of industry-sponsored clinical trials in the UK, from 394 trials in 2021 to 411 in 2022. This trend underscores the growing role of clinical trials in advancing medical treatments and, in turn, driving the growth of the stratagraft market.

Innovation in the development of stratagraft is another key factor enhancing its market potential. The focus is on creating allogeneic cultured keratinocytes and dermal fibroblasts embedded in murine collagen, which significantly improves wound healing and offers a promising alternative to autografts for treating severe burns and skin injuries. These biological constructs are specifically designed to accelerate skin regeneration and aid in wound healing. For instance, Mallinckrodt Pharmaceuticals developed StrataGraft, an innovative treatment for adults with deep partial-thickness thermal burns, which has been approved by the U.S. Food and Drug Administration. This product contains allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen and aims to reduce the need for autografting, which typically involves using a patient's own skin to close wounds.

The key company operating in the stratagraft market is Mallinckrodt Pharmaceuticals plc

North America was the largest region in the stratagraft market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in stratagraft report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the stratagraft market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

StrataGraft is a bioengineered skin substitute created to treat deep partial-thickness burns and other intricate skin injuries. It is made up of both epidermal and dermal layers, which are derived from human keratinocytes and dermal fibroblasts that are cultured on a collagen matrix.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

StrataGraft is primarily indicated for the treatment of thermal burns and full-thickness burns. Thermal burns occur when skin is exposed to heat sources such as flames, steam, or hot surfaces, leading to tissue and skin damage. The product’s formulations include cultured allogeneic keratinocytes and dermal fibroblasts, and it is used by hospitals, specialized wound care centers, and outpatient care facilities.

The stratagraft market consists of sales of bioengineered skin substitutes, dermal replacement Grafts. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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