Biological Skin Substitute Market Size, Share, and Industry Analysis, By Source (Human, Bovine, and Porcine), By Type (Acellular Skin Substitutes and Cellular Allogenic Skin Substitutes), By Application (Chronic Wounds [Diabetic Foot Ulcers, Pressure Ulcers, Leg Ulcers, and Others], and Acute Wounds [Surgical Wounds, and Others]), By End-user (Hospitals and ASCs, Specialty Clinics, and Others), and Regional Forecast, 2026-2034

The global biological skin substitute market size was valued at USD 383.71 million in 2025. The market is projected to grow from USD 418.43 million in 2026 to USD 836.68 million by 2034, exhibiting a CAGR of 9.05% during the forecast period.

The global biological skin substitute market is anticipated to witness substantial expansion over the forecast period owing to the high burden of chronic wounds across the. The skin substitutes are designed to facilitate wound healing by mimicking the properties of natural skin. These products are beneficial for the treatment of chronic wounds and acute wounds. For example, as per data provided by the International Wound Journal in December 2021, the global prevalence of chronic wounds is projected at 1.51 to 2.21 per 1000 population in 2019.

Furthermore, the growing initiatives by organizations to increase awareness about diabetic foot ulcers, as well as their diagnosis and treatment by organizing campaigns, are additional factors boosting the market growth throughout the forecast period.

• For example, in July 2022, the ‘Save the Feet and Keep Walking’ campaign was organized by the Research Society for the Study of Diabetes in India (RSSDI) from July to August 2022. The main aim of this campaign was to create awareness about this disease among diabetic patients in India.

Biological Skin Substitute Market Driver

Rising Prevalence of Chronic and Acute Wounds to Drive Demand for Treatment, Boosting Market Growth

Chronic wounds are imposing a significant burden on individuals and the rising prevalence of chronic and acute wounds such as diabetic ulcers, pressure ulcers, arterial ulcers, surgical wounds, burn wounds, and others are affecting the general population. This scenario is expected to propel the number of patients undergoing treatment, boosting the adoption of wound care products during 2024-2032.

• For instance, as per data published by the National Center for Biotechnology Information (NCBI) in January 2024, the reported prevalence of pressure ulcers in the U.S. was 2.5 million in 2023.

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The incidence of venous leg ulcers per 1,000 individuals was estimated for the key countries for 2023 on the basis of several sources including the Global Burden of Disease (GBD). Germany was one of the key countries with a substantial burden of venous leg ulcers.

Biological Skin Substitute Market Restraint

High Cost of Biological Substitutes to Impede Market Growth

Biological skin substitutes are widely used in the treatment of acute and chronic wounds, such as surgical wounds, burns, diabetic foot ulcers, pressure ulcers, and others. Therefore, the high cost of these products significantly restricts market growth, especially for middle-class people belonging to low-income countries.

• For instance, the price of Apligraf in U.S. pharmacies starts at USD 1,914.4 per product. Similarly, the cost of Integra bilayer matrix wound dressing is around USD 3,250.0 per package.

Therefore, such products can be prohibitively expensive for patients without adequate insurance coverage, which restricts access to necessary treatment options. This limits its adoption and impedes market growth during the forecast period.

Biological Skin Substitute Market Opportunity

Rising Research and Development Activities by Biopharmaceutical Companies for the Development of Personalized Medications

Several biopharmaceutical companies are largely investing in R&D activities to expand their product portfolio, boosting market growth. These personalized medicines allow for the development of tailored skin substitutes based on individual patient needs. Due to these facts, market players initiated clinical trials to provide novel treatments for acute and chronic wounds.

• For instance, in July 2024, CUTISS AG, a Swiss clinical-stage life sciences company, announced a positive interim analysis on efficacy from the phase 2 clinical trial of its lead product, DenovoSkin is a personalized human skin graft in patients undergoing reconstructive skin surgery due to various conditions.

Hence, the clinically proven efficacy of biological skin substitutes in the treatment of hard-to-heal chronic wounds, coupled with increasing demand for urgent treatment among the patient population, represents a lucrative growth opportunity for market players, driving market growth.

Segmentation

Key Insights

The report covers the following key insights:

• Prevalence of Key Chronic Diseases, By Key Countries/Regions, 2023
• Pricing Analysis, By Key Players
• New Product Launches, By Key Players
• Key Industry Developments (Mergers, Acquisitions, Partnerships)
• Impact of COVID-19 on the Market

Analysis by Source

Based on source, the biological skin substitute market is divided into human, bovine, and porcine.

The human segment is anticipated to grow significanty over 2024-2032 owing to increasing product launches in the global market.

• For instance, in October 2024, BioLab Holdings, Inc., announced the launch of its newest amniotic membrane tissue product, the Tri-Membrane Wrap, in the global market. This product provides more membrane than other skin substitute options and is ideal for more extensive wounds over which a wound vacuum-assisted closure (VAC) system could be placed.

Analysis by Type

In terms of type, the global biological skin substitute market is segmented into acellular skin substitutes and cellular allogenic skin substitutes.

The cellular allogenic skin substitutes segment held a substantial market share in 2023 due to the increasing product launches for the treatment of chronic wounds, such as diabetic foot ulcers, pressure ulcers, and venous leg ulcers. Further, the rising prevalence of acute wounds and increasing hospitalizations for these conditions across the globe is another factor driving segmental growth throughout the forecast period.

• For example, as per data provided by the National Center for Biotechnology Information (NCBI) in September 2024, an estimated 30,135 burn admissions occurred in the U.S. in 2022.

Analysis by Application

On the basis of application, the global biological skin substitute market is divided into chronic wounds and acute wounds. The chronic wound segment is further categorized into diabetic foot ulcers, pressure ulcers, leg ulcers, and others.

The chronic wounds segment is anticipated to grow at a significant CAGR throughout the forecast period. The high burden of diabetic foot ulcers across the world is one of the significant factors propelling segmental growth over 2024-2032.

• For example, as per data provided by the National Health Service (NHS) England in May 2024, a total of 122,030 ulcer episodes in 106,880 people with diabetes have been registered with the National Diabetes Foot Care Audit (NDFA) during the 2018-19 to 2022-23 audit period.

Analysis by End-user

Based on end-user, the market is categorized into hospitals and ASCs, specialty clinics, and others.

The hospitals and ASCs segment is expected to hold a major market share from 2024 to 2032. The growth of the segment is owing to the increasing number of hospital admissions for burn cases in the region, which is expected to increase the adoption of wound care products.

• For instance, as per data provided by the State of New South Wales NSW Ministry of Health in January 2024, there were 1,471 burns-related hospital admissions among NSW residents in the financial year 2022-23.

Regional Analysis

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Based on region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for a major share of the global biological skin substitute market in 2023 and is expected to grow at the highest CAGR from 2024-2032. The presence of key market players in this region is one of the important factors contributing to market growth. Further, the growing focus of market players on receiving regulatory approvals for biological skin substitutes is an additional factor driving market growth in North America during the forecast period.

• For example, in June 2021, Mallinckrodt plc, a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved StrataGraft for the treatment of adults with thermal burns.

Europe accounted for a moderate market share in 2023 and is expected to grow at a considerable CAGR during the forecast period. The increasing number of cases of chronic wounds, such as diabetic foot ulcers, leg ulcers, and others, is one of the major factors enhancing the regional market growth.

Key Players Covered

The global biological skin substitute market consists of companies such as Stryker, Organogenesis Inc., Smith+Nephew, and AbbVie, among other players.

The report includes the profiles of the following key players:

• Organogenesis Inc. (U.S.)
• INTEGRA LIFESCIENCES (U.S.)
• Smith+Nephew (U.K.)
• MIMEDX Group, Inc. (U.S.)
• Stryker (U.S.)
• AbbVie (U.S.)
• EUCARE PHARMACEUTICALS (P) LTD. (India)
• BioTissue (U.S.)

Key Industry Developments

• In May 2024, Kerecis presented research data regarding fish-skin grafts at the symposium on Advanced Wound Care Spring, which was held from 14^th to 18^th May 2024 in Orlando, Florida.
• In October 2021, Kerecis received authorization from the U.S. Food and Drug Administration (FDA) to market Kerecis Omega3 SurgiBind. This skin graft product is now available in the U.S. market and used in plastic surgeries.
• In January 2021, Medskin Suwelack announced that it had received the U.S. Food and Drug Administration (FDA) approval for dermal matrix MatriDerm, which is for use in the management of full-thickness and partial-thickness wounds.