Epidermolysis Bullosa Market Size in the 7MM is ~USD ~1,700 million in 2023, estimated DelveInsight

DelveInsight's "Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast- 2034" report delivers an in-depth understanding, historical and forecasted epidemiology, as well as the Epidermolysis Bullosa market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Epidermolysis Bullosa Market is an evolving segment of the global healthcare landscape, driven by the increasing Epidermolysis Bullosa prevalence of the disorder and the continuous development of innovative treatment options. The Epidermolysis Bullosa Market encompasses various therapeutic categories, including antipsychotics, adjunctive therapies, and emerging treatment modalities.

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Key Takeaways from the Epidermolysis Bullosa Market Report

* In November 2024:- TWi Biotecnology Inc.- An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS) [EBShield Study].
* In November 2024:- Holostem Terapie Avanzate s.r.l.- Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa.
* The United States contributed to the Epidermolysis Bullo's highest prevalent cases, accounting for ~65% of the 7MM in 2023. Whereas EU4 and the UK, and Japan accounted for around 30% and ~5% of the total population share, respectively, in 2023.
* Among the EU4 countries and the UK, the United Kingdom accounted for the largest number of Epidermolysis Bullosa cases, followed by Germany, whereas Spain accounted for the lowest number of cases in 2023.
* According to DelveInsight estimates, in the United States, there were around 18,000, 1,450, and 8,500 cases of Epidermolysis Bullosa simplex, junctional Epidermolysis Bullosa, and dystrophic Epidermolysis Bullosa, respectively, in 2023.
* The leading Epidermolysis Bullosa Companies such as Amryt Pharma, Abeona Therapeutics, Castle Creek Pharmaceuticals, RegeneRx, Krystal Biotech, Fibrocell Technologies, RHEACELL GmbH, Holostem Terapie Avanzate, StemRim, Shionogi, Phoenix Tissue Repair (BridgeBio Pharma, Inc), Menlo Therapeutics, JCR Pharmaceuticals, Amicus Therapeutics and others.
* Promising Epidermolysis Bullosa Therapies such as Oleogel-S10, SD-101 dermal cream (3%), Diacerein 1% Ointment, and others

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Epidermolysis Bullosa Epidemiology

* Total Epidermolysis Bullosa prevalent cases
* Total Epidermolysis Bullosa diagnosed prevalent cases
* Epidermolysis Bullosa Gender-specific cases
* Epidermolysis Bullosa Age-specific cases
* Epidermolysis Bullosa Type-specific cases

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Epidermolysis Bullosa Marketed Drugs

* VYJUVEK (beremagene geperpavec): Krystal Biotech

B-VEC is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. In May 2023, VYJUVEK (beremagene geperpavec-svdt) was approved for treating patients 6 months of age or older with DEB. VYJUVEK is the first-ever redosable gene therapy and the first and only medicine approved by the FDA for treating DEB, both recessive and dominant; a healthcare professional can administer that in either a healthcare professional setting or in the home.

* FILSUVEZ (oleogel-S10): Chiesi Farmaceutici

FILSUVEZ (oleogel-S10/birch triterpenes/formerly known as AP101) is an herbal medicinal product that contains birch triterpenes from birch bark. FILSUVEZ received a marketing authorization valid throughout the EU on 21 June 2022. FILSUVEZ gel is indicated for patients 6 months and older to treat superficial wounds associated with Junctional Epidermolysis Bullosa and Dystrophic Epidermolysis Bullosa. In February 2022, Amryt announced it received a Complete Response Letter (CRL) from the US FDA regarding its New Drug Application (NDA) for Oleogel-S10 for the treatment of the cutaneous manifestations of dystrophic and Junctional Epidermolysis Bullosa. The FDA asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in epidermolysis bullosa. In April 2023, Chiesi Farmaceutici announced the completion of the acquisition of Amryt Pharma.

Emerging Epidermolysis Bullosa Drug

* EB-101: Abeona Therapeutics

EB-101 is an autologous, engineered cell therapy currently being developed to treat Recessive Dystrophic Epidermolysis Bullosa. Treatment with EB-101 involves using gene transfer to deliver the COL7A1 gene into a patient's skin cells (keratinocytes and its progenitors) and transplanting those cells back to the patient. EB-101 is being investigated for its ability to enable normal Type VII collagen expression and to facilitate wound healing. EB-101 has the potential to be the first approved therapy for RDEB and the only durable treatment to address large chronic wounds, which are the most painful and debilitating.

* D-Fi (dabocemagene autoficel): Castle Creek Biosciences

D-Fi, also known as FCX-007 (dabocemagene autoficel), is an autologous gene therapy candidate to treat dystrophic Epidermolysis Bullosa (DEB), a progressive, devastatingly painful, and debilitating, rare genetic skin disorder. D-Fi is currently in Phase III clinical development for the localized treatment of chronic wounds in individuals with Recessive Dystrophic Epidermolysis Bullosa. The clinical study plan includes a multi-center, within-patient randomized, controlled, open-label study of D-Fi and builds on data reported from the Phase I/II clinical trial.

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Epidermolysis Bullosa Market Outlook

There is no cure for any of the subtypes of Epidermolysis Bullosa resulting from different mutations, and current therapy only focuses on managing wounds and pain. Novel effective therapeutic approaches are therefore urgently required. Management of Epidermolysis Bullosa focuses on supportive and wound care, prevention of blistering and infection, symptomatic relief of pain and itch, and prevention, monitoring, and treatment of complications. Wound care remains the cornerstone of treatment and includes the use of semi-occlusive, protective bandages to the affected area to decrease pain and reduce and prevent blistering, scarring, and infection. Dressing changes and wound care can be time-consuming and expensive, making them burdensome to patients and caregivers.

Scope of the Epidermolysis Bullosa Market Report

* Coverage- 7MM
* Epidermolysis Bullosa Companies- Amryt Pharma, Abeona Therapeutics, Castle Creek Pharmaceuticals, RegeneRx, Krystal Biotech, Fibrocell Technologies, RHEACELL GmbH, Holostem Terapie Avanzate, StemRim, Shionogi, Phoenix Tissue Repair (BridgeBio Pharma, Inc), Menlo Therapeutics, JCR Pharmaceuticals, Amicus Therapeutics and others
* Epidermolysis Bullosa Therapies- Oleogel-S10, SD-101 dermal cream (3%), Diacerein 1% Ointment, and others
* Epidermolysis Bullosa Market Dynamics: Epidermolysis Bullosa Market Drivers and Barriers
* Epidermolysis Bullosa Market Access and Reimbursement, Unmet Needs and Future Perspectives

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Table of Content

1. Key Insights

2. Report Introduction

3. Executive Summary of Epidermolysis Bullosa (EB)

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Epidermolysis Bullosa Market Overview at a Glance

7. Epidermolysis Bullosa (EB): Disease Background and Overview

8. Treatment and Management of Epidermolysis Bullosa

9. Guidelines

10. Epidemiology and Patient Population of 7MM

11. Patient Journey

12. Marketed Drugs

13. Emerging Drugs

14. Epidermolysis Bullosa: 7MM Analysis

15. Unmet needs

16. SWOT Analysis

17. KOL Views

18. Market Access and Reimbursement

19. Appendix

20. DelveInsight Capabilities

21. Disclaimer

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