Dystrophic Epidermolysis Bullosa Market expected to rise, DelveInsight | Phoenix Tissue Repair, Castle Creek Biosciences, Phoenicis Therapeutics, Aegle Therapeutics, RHEACELL, Anterogen

The Dystrophic Epidermolysis Bullosa market report covers a segment of key events, an executive summary, descriptive overview of Dystrophic Epidermolysis Bullosa (DEB), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
The Dystrophic Epidermolysis Bullosa market growth is driven by factors like increase in the prevalence of Dystrophic Epidermolysis Bullosa, investments in research and development, entry of emerging therapies during the study period 2020-2034.

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Some of the key highlights from the Dystrophic Epidermolysis Bullosa Market Insights Report:

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Epidermolysis Bullosa (EB) refers to a group of rare, inherited disorders caused by mutations in various skin structural proteins. These mutations impact around 15 different genes that are essential for skin integrity. EB is classified into multiple subtypes based on the location of the affected proteins and the level of blistering that occurs.

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Dystrophic Epidermolysis Bullosa (DEB) is primarily divided into six types: dominant DEB (DDEB), recessive DEB (RDEB), RDEB-generalized severe (GS), RDEB-generalized intermediate (GI), RDEB-unknown subtypes, and RDEB-other.

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In 2023, the total diagnosed prevalent cases of DEB in the 7MM were approximately 6,500, with the highest number of cases observed in the United States (around 3,500 cases, or nearly 50% of the total).

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On November 12, 2024, Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), an investigational autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has set a target action date of April 29, 2025, under the Prescription Drug User Fee Act (PDUFA).

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The DEB market is expected to experience significant growth, driven by the anticipated approval of one-time gene therapies and increased awareness of the condition. The total market size for DEB in the 7MM was valued at approximately USD 550 million in 2023 and is expected to continue rising during the forecast period.

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The United States holds the largest market share for Dystrophic Epidermolysis Bullosa (DEB) when compared to the EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Currently, VYJUVEK and FILSUVEZ are the only approved treatments for DEB. Existing management strategies primarily focus on providing symptomatic relief, such as pain and itch management, treating chronic wounds and infections, and preventing complications when possible.

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The DEB pipeline includes promising therapies like D-Fi (FCX-007), ALLO-ASC-SHEET, and others.

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Prevalence data by disease severity indicates that moderate forms of DEB are significantly more common than severe cases.

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Dystrophic Epidermolysis Bullosa Overview

Dystrophic Epidermolysis Bullosa (DEB) is one of the major subtypes of Epidermolysis Bullosa (EB), a group of skin disorders characterized by varying degrees of fragility in the skin and mucous membranes. This fragility occurs due to the absence, reduction, or abnormality of proteins crucial for maintaining skin integrity. EB is classified into four main types based on the layer of the skin where blisters form: EB simplex (EBS; blister formation within the epidermal layer), junctional EB (JEB; within the lamina lucida of the basement membrane), dystrophic EB (DEB; below the basement membrane), and Kindler's EB (KEB; mixed skin cleavage pattern).

The diagnosis of DEB is confirmed in individuals with characteristic clinical features and the identification of pathogenic variants in the **COL7A1** gene-biallelic variants for recessive DEB (RDEB) or a heterozygous variant for dominant DEB (DDEB)-through molecular genetic testing. If molecular testing fails to provide a diagnosis, a skin biopsy with direct immunofluorescence (IF) for specific markers and/or electron microscopy (EM) may be required, as routine histology is generally not helpful.

Current therapeutic strategies for DEB focus on advanced wound care and minimizing the factors that trigger blistering and hinder healing. Key approaches include maintaining high hygiene standards, intensive moisturizing, and careful skin care. Blisters typically heal well with proper daily care, such as disinfection using effective aqueous disinfectants. Avoiding adhesives and compressive dressings is essential to prevent further blister formation. Silicon-based wound care products are particularly useful for delicate or difficult-to-treat skin areas. While systemic therapy is generally not needed, short-term use of antibiotics or corticosteroids may be necessary in certain cases. For severely affected individuals with extra-cutaneous involvement, multidisciplinary management-engaging pediatricians, dermatologists, and other specialists-is crucial for optimal care.

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Dystrophic Epidermolysis Bullosa Epidemiology Insights:

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In 2023, the United States had the highest number of prevalent cases of Dystrophic Epidermolysis Bullosa (DEB) among the 7MM, with a total of approximately 3,500 cases.

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The age group most affected by DEB in 2023 was children between 1 and 9 years old, accounting for about 1,300 cases.

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Among the EU4 countries (Germany, France, Italy, Spain) and the UK, the United Kingdom reported the highest proportion of DEB cases, representing around 33% of the total cases in the region.

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Approximately 48% of DEB cases in 2023 were categorized as moderate in severity.

Dystrophic Epidermolysis Bullosa Epidemiology Segmentation

DelveInsight's Dystrophic Epidermolysis Bullosa market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Dystrophic Epidermolysis Bullosa historical patient pools and forecasted Dystrophic Epidermolysis Bullosa patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Dystrophic Epidermolysis Bullosa Market report proffers epidemiological analysis for the study period 2020-32 in the 7MM segmented into:

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Dystrophic Epidermolysis Bullosa Prevalence

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Age-Specific Dystrophic Epidermolysis Bullosa Prevalence

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Gender-Specific Dystrophic Epidermolysis Bullosa Prevalence

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Diagnosed and Treatable Cases of Dystrophic Epidermolysis Bullosa

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Recent Breakthroughs in the Dystrophic Epidermolysis Bullosa Market

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FDA Approves First Gene Therapy for Dystrophic Epidermolysis Bullosa (DEB)

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Vyjuvek is the first FDA-approved gene therapy for dystrophic epidermolysis bullosa (DEB) and the first topical gene therapy approved in the U.S. It's indicated for use in patients 6 months of age or older.

Dystrophic Epidermolysis Bullosa Treatment Market

The Dystrophic Epidermolysis Bullosa market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Dystrophic Epidermolysis Bullosa market trends by analyzing the impact of current Dystrophic Epidermolysis Bullosa therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Dystrophic Epidermolysis Bullosa market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Dystrophic Epidermolysis Bullosa market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Dystrophic Epidermolysis Bullosa market in 7MM is expected to witness a major change in the study period 2020-2034.

Dystrophic Epidermolysis Bullosa Market Insights

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In 2023, the United States held the largest market share for DEB, with a market size of approximately USD 400 million among the 7MM.

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Among the EU4 and the UK, the UK represented the highest market size at around USD 50 million for DEB.

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Spain had the smallest market size in the 7MM, estimated at approximately USD 20 million. DelveInsight's analysis forecasts market growth driven by the launch of emerging therapies.

Dystrophic Epidermolysis Bullosa Emerging Drugs

PTR-01: Phoenix Tissue Repair

Phoenix Tissue Repair is advancing an investigational therapy known as PTR-01, a systemic recombinant collagen type VII (rC7) for the treatment of Recessive Dystrophic Epidermolysis Bullosa. rC7 is a potentially disease-modifying drug that is delivered intravenously to patients, replacing defective collagen type VII with healthy collagen at the sites where it is needed both internally and externally. Phoenix Tissue Repair acquired worldwide rights to PTR-01 from Shire Plc in 2017 and has initiated its first clinical trial. Preclinical studies of PTR-01 have shown that it selectively anchors in the skin and other tissues affected by an absence of collagen type VII. In four animal models of the disease, intravenous injections of PTR-01 promoted healing of DEB wounds. These experiments have shown improvements in tissue structure, disease presentation and survival, indicating a restoration of natural skin architecture.

FCX-007: Castle Creek Biosciences

D-Fi, also known as FCX-007, (dabocemagene autoficel), is being developed as an ex vivo, autologous cell-based gene therapy to address the deficiency of functional COL7 in patients with dystrophic epidermolysis bullosa (DEB). D-Fi has been clinically studied in a Phase 1/2 clinical study (NCT02810951), which assessed 6 patients with RDEB. In this study, 80% (8/10) of treated chronic wounds demonstrated complete wound healing 12 weeks after the first injection of D-Fi, while none of the untreated wounds were healed. D-Fi was well tolerated post-administration with few reports of temporary redness or discoloration at the injection site. D-Fi is currently in Phase 3 clinical development for the localized treatment of chronic wounds in individuals with RDEB.

Dystrophic Epidermolysis Bullosa Key Companies

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Phoenix Tissue Repair

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Castle Creek Biosciences

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Phoenicis Therapeutics

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Aegle Therapeutics

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RHEACELL GmbH & Co. KG

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Anterogen Co., Ltd.

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Abeona Therapeutics, Inc

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InMed Pharmaceuticals

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BridgeBio Inc.

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Eloxx Pharmaceuticals

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Relief Therapeutics

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Quoin Pharmaceuticals

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Scope of the Dystrophic Epidermolysis Bullosa Market Report:

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11 Years Forecast

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7MM Coverage

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Descriptive overview of Dystrophic Epidermolysis Bullosa, causes, signs and symptoms, diagnosis, treatment

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Comprehensive insight into Dystrophic Epidermolysis Bullosa epidemiology in the 7MM

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Dystrophic Epidermolysis Bullosa marketed and emerging therapies

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Dystrophic Epidermolysis Bullosa companies

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Dystrophic Epidermolysis Bullosa market drivers and barriers

Key Questions Answered in the Dystrophic Epidermolysis Bullosa Market Report 2034:

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What was the Dystrophic Epidermolysis Bullosa market share distribution in 2020, and how would it appear in 2034?

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What is the total Dystrophic Epidermolysis Bullosa market size and the market size by therapy across the 7MM for the study period (2020-32)?

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What are the important findings from 7MM, and which country will have the greatest Dystrophic Epidermolysis Bullosa market size from 2020-32?

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During the study period (2020-2034), at what CAGR is the Dystrophic Epidermolysis Bullosa market projected to expand at 7MM?

Table of Contents:

1 Dystrophic Epidermolysis Bullosa Market Key Comprehensive Insights

2 Dystrophic Epidermolysis Bullosa Market Report Introduction

3 Competitive Intelligence Analysis for Dystrophic Epidermolysis Bullosa

4 Dystrophic Epidermolysis Bullosa Market Analysis Overview at a Glance

5 Executive Summary of Dystrophic Epidermolysis Bullosa

6 Dystrophic Epidermolysis Bullosa Epidemiology and Market Methodology

7 Dystrophic Epidermolysis Bullosa Epidemiology and Patient Population

8 Dystrophic Epidermolysis Bullosa Patient Journey

9 Dystrophic Epidermolysis Bullosa Treatment Algorithm, Dystrophic Epidermolysis Bullosa Current Treatment, and Medical Practices

10 Key Endpoints in Dystrophic Epidermolysis Bullosa Clinical Trials

11 Dystrophic Epidermolysis Bullosa Marketed Therapies

12 Dystrophic Epidermolysis Bullosa Emerging Therapies

13 Dystrophic Epidermolysis Bullosa: 7 Major Market Analysis

14 Attribute analysis

15 Access and Reimbursement Overview of Dystrophic Epidermolysis Bullosa

16 Dystrophic Epidermolysis Bullosa Market Key Opinion Leaders Reviews

18 Dystrophic Epidermolysis Bullosa Market Drivers

19 Dystrophic Epidermolysis Bullosa Market Barriers

20 SWOT Analysis

21 Disclaimer

22 DelveInsight Capabilities

23 About DelveInsight

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