Dystrophic Epidermolysis Bullosa Market Forecast 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies, and Companies by DelveInsight

The Dystrophic Epidermolysis Bullosa market, valued at ~$550 million in 2023, is projected to grow due to rising awareness and upcoming gene therapies. The US holds the largest market share. DEB is a rare inherited skin disorder caused by mutations in skin structural proteins, with ~6,500 diagnosed cases in the 7MM in 2023-about 3,500 in the US alone. Approved treatments include VYJUVEK and FILSUVEZ, while pipeline candidates like D-Fi (FCX-007) and ALLO-ASC-SHEET offer promise.
(Albany, USA) DelveInsight's "Dystrophic Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Dystrophic Epidermolysis Bullosa, historical and forecasted epidemiology as well as the Dystrophic Epidermolysis Bullosa market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Dystrophic Epidermolysis Bullosa market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Dystrophic Epidermolysis Bullosa market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Dystrophic Epidermolysis Bullosa treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Dystrophic Epidermolysis Bullosa market.

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Key Takeaways from the Dystrophic Epidermolysis Bullosa Market Report

* According to DelveInsight's analysis, the growth of the DEB market is expected to be mainly driven by increasing prevalence, patient awareness, label expansion of approved therapies, high cost of therapies, and robust clinical pipeline during the forecast period [2025-2034].
* DelveInsight estimates that the dystrophic epidermolysis bullosa market size in the 7MM is expected to grow from USD 550 million in 2023 at a significant CAGR by 2034.
* In July 2025, Krystal Biotech announced it is targeting first European launch of VYJUVEK in Germany in 3Q 2025 and France in 4Q 2025. The company also announced that the results of the open label extension (OLE) study of VYJUVEK in Japanese DEB patients was published in the Journal of Dermatology.
* In July 2025, StemRIM announced that patient enrollment for the additional Phase II clinical trial on Redasemtide, which was previously out-licensed to Shionogi for DEB has been completed
* In June 2025, Abeona Therapeutics announced publication of results from the pivotal Phase III VIITAL study (NCT04227106) evaluating the efficacy and safety of ZEVASKYN gene-modified cellular sheets, also known as pzcel, for the treatment of wounds in adult and pediatric patients with RDEB.
* In May 2025, RHEACELL announced that it has entered into an exclusive partnership agreement with the AOP Health Group, who will commercialize RHEACELL's two stem cell products, EBESANAR and AMESANAR, in Europe, Turkey, Israel and the MENA region (Middle East and Northern Africa). RHEACELL retains full commercialization rights to EBESANAR and AMESANAR in other major markets, including North America, Asia-Pacific and Latin America, and will seek strategic distribution partners in those markets.
* In February 2025, Castle Creek Biosciences secured USD 75 million in financing to support a Phase III trial testing its gene therapy to promote wound healing in people with DEB. The royalty financing agreement for Castle Creek's treatment, D-Fi, was led by Ligand Pharmaceuticals, making a USD 50 million investment.
* In September 2024, FILSUVEZ, was approved for use in the UK by the National Institute for Health Care and Excellence (NICE) for the treatment of dystrophic EB (DEB) and junctional EB (JEB).
* As of 2023, according to DEBRA (a patient support organization for individuals with epidermolysis bullosa), approximately 25,000 people are living with epidermolysis bullosa in the US. This condition occurs in every racial and ethnic group and affects both genders equally.
* Epidermolysis bullosa is slightly more prevalent in males than females.
* The total prevalent population of DEB in the 7MM comprised ~14,400 cases in 2024. These cases are projected to Increase for the study period of 2020-2034.
* As per analysis, among the EU4 and the UK, the United Kingdom had the highest number of prevalent cases of DEB, i.e., ~1,700 in 2024, followed by Germany. On the other hand, France had the lowest prevalent population in 2024.

* As of now, only four therapies, namely FILSUVEZ (Chiesi Farmaceutici), VYJUVEK (Krystal Biotech), JACE (Japan Tissue Engineering), and recently approved ZEVASKYN (Abeona Therapeutics), have been approved for treating DEB, leaving a significant unmet need for effective and targeted dystrophic epidermolysis bullosa treatments.

* Globally, leading dystrophic epidermolysis bullosa companies such as Phoenix Tissue Repair, Castle Creek Biosciences, Phoenicis Therapeutics, Aegle Therapeutics, RHEACELL GmbH & Co. KG, Anterogen Co., Ltd., Abeona Therapeutics, Inc., InMed Pharmaceuticals, BridgeBio Inc., Eloxx Pharmaceuticals, Relief Therapeutics, Quoin Pharmaceuticals, among others are developing novel dystrophic epidermolysis bullosa drugs that can be available in the dystrophic epidermolysis bullosa market in the coming years.
* The promising dystrophic epidermolysis bullosa therapies in the pipeline include D-Fi (FCX-007), FCX-007, Oleogel-S10, VYJUVEK (beremagene geperpavec), FILSUVEZ (birch triterpenes), EB-101, PTR-01, RGN-137, INM-755, and others
* The current dystrophic epidermolysis bullosa diagnosis has improved in recent decades, leading to growing awareness, improved management, and better outcomes.
* There remains a significant unmet need for effective treatment of RDEB wounds, particularly those that are chronic and susceptible to infection. With a single surgical application, ZEVASKYN offers individuals with RDEB a promising solution, promoting wound healing and reducing pain, even in the most severe cases.

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Dystrophic Epidermolysis Bullosa Overview

Dystrophic epidermolysis bullosa (DEB) is one of the most frequent kinds of epidermolysis bullosa. Epidermolysis bullosa generates highly sensitive skin that blisters easily. Dystrophic epidermolysis bullosa is caused by alterations (mutations) in the COL7A1 gene and is inherited in an autosomal dominant or autosomal recessive way, depending on the subtype. Dystrophic epidermolysis bullosa causes are usually hereditary. The disease's gene may have been passed down from one of the disease's parents (autosomal dominant inheritance).

Based on this, Dystrophic epidermolysis bullosa is divided into Dominant DEB (DDEB-mild form) and Recessive DEB (RDEB- severe and incurable). Blisters, itchy, painful skin, dysphagia, dental issues, and others are the common dystrophic epidermolysis bullosa symptoms.

Dystrophic Epidermolysis Bullosa Epidemiology

Across the 7MM (excluding the US), recessive DEB (RDEB) was more common than dominant DEB (DDEB). The prevalent population of DEB in Japan was approximately 850 cases in 2024. These cases are anticipated to increase by 2034.

As per analysis, among the EU4 and the UK, the United Kingdom had the highest number of prevalent cases of DEB, i.e., ~1,700 in 2024, followed by Germany. On the other hand, France had the lowest prevalent population in 2024.

The dystrophic epidermolysis bullosa market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Diagnosed Prevalent Cases of Dystrophic Epidermolysis Bullosa (DEB)
* Age-specific Cases of Dystrophic Epidermolysis Bullosa (DEB)
* Type-specific Cases of Dystrophic Epidermolysis Bullosa (DEB)
* Severity-specific Cases of Dystrophic Epidermolysis Bullosa (DEB)

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Dystrophic Epidermolysis Bullosa Treatment Market

The current dystrophic epidermolysis bullosa treatment comprises contemporary wound care as well as the removal of external factors that induce blistering and impede wound healing. Proper skin care necessitates strict personal hygiene and thorough moisturizing dystrophic epidermolysis bullosa therapy. Blisters that do not cause further damage or infection heal well with regular skincare and hygiene. Today's aqueous disinfectants are very effective and easy to apply. Adhesives and compressive dressings should be avoided since they stimulate the production of new blisters. Silicon-based, slightly adherent wound care dystrophic epidermolysis bullosa therapies have proven to be highly useful, particularly for tough skin areas such as the elbows, shoulders, and trunk.

Moreover, currently, there are no approved therapies for dystrophic epidermolysis bullosa treatment. The current dystrophic epidermolysis bullosa treatment just alleviates symptoms; it does not provide a long-term cure. As a result, there is an urgent need for more effective and personalized therapies with improved long-term side effect profiles.

Stem cell-based therapies are becoming increasingly important, especially for previously incurable diseases. Due to the special immunomodulatory and anti-inflammatory properties, ABCB5+ mesenchymal stromal cells (ABCB5+ MSCs) represent a new, promising therapeutic approach for various chronic inflammatory diseases, including epidermolysis bullosa.

Gene therapies for epidermolysis bullosa are becoming a reality with the approval of VYJUVEK, the first FDA approved topical gene therapy.

The high costs associated with developing treatments for rare diseases like epidermolysis bullosa may limit access to treatment for many patients, which can hamper the uptake of innovative therapies. Obtaining adequate reimbursement from healthcare payers can be challenging for novel therapies, impacting their adoption and patient access.

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Dystrophic Epidermolysis Bullosa Pipeline Therapies and Key Companies

* FCX-007: Castle Creek Biosciences
* Oleogel-S10: Amryth Pharma
* Beremagene Geperpavec: Krystal Biotech
* EB-101: Abeona Therapeutics
* PTR-01: BridgeBio/Phoenix Tissue Repair
* RGN-137: Lenus Therapeutics
* INM-755: InMed Pharmaceuticals

Dystrophic Epidermolysis Bullosa Market Dynamics

The dystrophic epidermolysis bullosa market is expected to show positive growth in the coming years. As there is no approved dystrophic epidermolysis bullosa treatment, so developing therapies is a viable option. The extensive clinical dystrophic epidermolysis bullosa pipeline, which includes innovative RoA and MoA medicines, shows promise for the future dystrophic epidermolysis bullosa market.

Furthermore, patients' willingness to pay for expensive treatments such as gene therapy, cell-based therapy, and molecular therapy to treat the disease is increasing, which is driving the dystrophic epidermolysis bullosa market. Additionally, the widespread dystrophic epidermolysis bullosa prevalence is also a prominent factor bolstering the dystrophic epidermolysis bullosa market.

However, certain factors impede the expansion of the dystrophic epidermolysis bullosa market. Improving QOL and wound care can be costly, and healthcare insurance may not cover the costs. Furthermore, several countries lack a patient registration system for epidermolysis bullosa. Moreover, despite increasing improvements in gene and cell therapies for dystrophic epidermolysis bullosa, a lack of awareness of the condition may hinder the growth of the DEB care and dystrophic epidermolysis bullosa market. Furthermore, gene therapy is costly; also, most countries' healthcare systems, including the United States', are not geared to manage large one-time expenses.

Therefore, the above-mentioned aspects are likely to hamper the growth of the dystrophic epidermolysis bullosa market in the future.

Scope of the Dystrophic Epidermolysis Bullosa Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
* Dystrophic Epidermolysis Bullosa Market Size in 2023: ~USD 550 Million
* Key Dystrophic Epidermolysis Bullosa Companies: Phoenix Tissue Repair, Castle Creek Biosciences, Phoenicis Therapeutics, Aegle Therapeutics, RHEACELL GmbH & Co. KG, Anterogen Co., Ltd., Abeona Therapeutics, Inc., InMed Pharmaceuticals, BridgeBio Inc., Eloxx Pharmaceuticals, Relief Therapeutics, Quoin Pharmaceuticals, among others.
* Key Dystrophic Epidermolysis Bullosa Therapies: D-Fi (FCX-007), FCX-007, Oleogel-S10, VYJUVEK (beremagene geperpavec), FILSUVEZ (birch triterpenes), EB-101, PTR-01, RGN-137, INM-755, and others
* Therapeutic Assessment: Dystrophic Epidermolysis Bullosa current marketed and emerging therapies
* Dystrophic Epidermolysis Bullosa Market Dynamics: Dystrophic Epidermolysis Bullosa market drivers and barriers
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
* Unmet Needs, KOL's views, Analyst's views, Dystrophic Epidermolysis Bullosa Market Access and Reimbursement

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Table of Contents

1. Dystrophic Epidermolysis Bullosa Market Key Insights

2. Dystrophic Epidermolysis Bullosa Market Report Introduction

3. Dystrophic Epidermolysis Bullosa Market Overview at a Glance

4. Dystrophic Epidermolysis Bullosa Market Executive Summary

5. Disease Background and Overview

6. Dystrophic Epidermolysis Bullosa Treatment and Management

7. Dystrophic Epidermolysis Bullosa Epidemiology and Patient Population

8. Patient Journey

9. Dystrophic Epidermolysis Bullosa Emerging Drugs

10. Seven Major Dystrophic Epidermolysis Bullosa Market Analysis

11. Dystrophic Epidermolysis Bullosa Market Outlook

12. Potential of Current and Emerging Therapies

13. KOL Views

14. Dystrophic Epidermolysis Bullosa Market Drivers

15. Dystrophic Epidermolysis Bullosa Market Barriers

16. Unmet Needs

17. SWOT Analysis

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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