The epidermolysis bullosa market size is anticipated to increase during the forecast period (2023–2032) owing to the increase in the clinical and genetic testings, recent approvals of potential gene-based cell therapies, and expected launch of emerging therapies into the epidermolysis bullosa market.
LAS VEGAS, Aug. 10, 2023 /PRNewswire/ -- DelveInsight's Epidermolysis Bullosa Market Insights report includes a comprehensive understanding of current treatment practices, epidermolysis bullosa emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the Epidermolysis Bullosa Market Report
- As per DelveInsight analysis, the epidermolysis bullosa market size in the 7MM was approximately USD 1.5 billion in 2022.
- According to the assessment done by DelveInsight, the estimated total prevalent epidermolysis bullosa cases in the 7MM were approximately 46K in 2022.
- Epidermolysis is more prevalent in children and young adults as ~78% cases were in the age group of <19 years in the 7MM in 2019.
- VYJUVEK is the only FDA-approved therapy in the US, and FILSUVEZ is the only approved therapy in the EU, which is available in Germany only. Japan also has one approved cell therapy for epidermolysis bullosa with the name of JACE.
- Among all the therapies VYJUVEK is expected to capture the largest market share followed by EB-101 and FILSUVEZ by 2032 in the 7MM.
- Leading epidermolysis bullosa companies such as Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen, and others are developing novel epidermolysis bullosa drugs that can be available in the epidermolysis bullosa market in the coming years.
- The promising epidermolysis bullosa therapies in the pipeline include EB-101, D-Fi (dabocemagene autoficel), ABCB5+ mesenchymal stem cells (ABCB5+ MSCs), ISN001, RV-LAMB3-transduced epidermal stem cells, PTR-01, INM-755, Redasemtide, ALLO-ASC-SHEET, and others.
Discover which therapies are expected to grab the major epidermolysis bullosa market share @ Epidermolysis Bullosa Market Report
Epidermolysis Bullosa Overview
Epidermolysis bullosa is a rare, inherited genetic disorder that affects the skin and mucous membranes. It belongs to a group of disorders known as "blistering skin diseases." Epidermolysis bullosa is characterized by extreme skin fragility, causing the skin to be exceptionally sensitive to friction or trauma, leading to the formation of painful blisters and sores. The primary cause of epidermolysis bullosa is genetic mutations that affect the production of proteins responsible for holding the layers of the skin together.
The hallmark symptom of epidermolysis bullosa is the development of blisters on the skin and mucous membranes, often triggered by minor friction or pressure. These blisters can occur on any part of the body, both external and internal, and can be painful and prone to infection. In severe cases, the blisters may lead to chronic wounds, scarring, and deformities. Diagnosing epidermolysis bullosa involves a combination of clinical examination, family history assessment, and skin biopsy. The doctor will carefully examine the patient's skin and note the characteristic blistering patterns.
Epidermolysis Bullosa Epidemiology Segmentation
DelveInsight estimates that there were approximately 46K prevalent cases of epidermolysis bullosa in the 7MM in 2022.
The United States contributed to the largest prevalent cases of epidermolysis bullosa, accounting for ~65% of the 7MM in 2022. Whereas EU4 and the UK, and Japan accounted for around 30% and ~5% of the total population share, respectively, in 2022.
The epidermolysis bullosa market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- Total Epidermolysis Bullosa Prevalent Cases
- Total Epidermolysis Bullosa Diagnosed Prevalent Cases
- Epidermolysis Bullosa Cases by Gender
- Epidermolysis Bullosa Cases by Age
- Epidermolysis Bullosa Type-specific Cases
Epidermolysis Bullosa Treatment Market
Currently, there is no cure for epidermolysis bullosa, and treatments primarily focus on managing symptoms and improving patients' quality of life. The main goal of epidermolysis bullosa treatment is to prevent or reduce blistering, promote wound healing, and manage associated complications, such as infection and pain. Wound care is a fundamental aspect of epidermolysis bullosa management, involving gentle handling of the skin, dressing changes, and meticulous wound cleaning to minimize the risk of infection. Advanced wound dressings and bandages are used to protect the affected areas and provide a supportive environment for healing. Pain management is crucial, and pain relief medications, including topical anesthetics and systemic analgesics, are often prescribed to alleviate discomfort.
In recent years, there has been significant progress in research and the development of innovative therapies for epidermolysis bullosa. Gene therapy and other experimental approaches hold promise for potential future treatments. Clinical trials investigating gene-editing techniques, such as CRISPR-Cas9, have shown encouraging results in preclinical models. Moreover, cell-based therapies, such as stem cell transplants, are being explored as potential treatments for epidermolysis bullosa.
To manage complications and enhance the overall well-being of epidermolysis bullosa patients, a multidisciplinary approach is crucial. This involves a team of healthcare professionals, including dermatologists, wound care specialists, pain management experts, nutritionists, and psychologists, working collaboratively to address the various aspects of the condition. While significant strides have been made in understanding and treating epidermolysis bullosa, continued research and funding are essential to improve existing therapies and eventually find a cure for this challenging and life-altering disease.
To know more about epidermolysis bullosa treatment guidelines, visit @ Epidermolysis Bullosa Management
Epidermolysis Bullosa Pipeline Therapies and Key Companies
- EB-101: Abeona Therapeutics
- D-Fi (dabocemagene autoficel): Castle Creek Biosciences
- ABCB5+ mesenchymal stem cells (ABCB5+ MSCs): RHEACELL
- ISN001: Ishin Pharma
- RV-LAMB3-transduced epidermal stem cells: Holostem Terapie Avanzate
- PTR-01: BridgeBio (Phoenix Tissue Repair)
- INM-755: InMed Pharmaceuticals
- Redasemtide: Shionogi
- ALLO-ASC-SHEET: Anterogen
Learn more about the FDA-approved drugs for epidermolysis bullosa @ Drugs for Epidermolysis Bullosa Treatment
Epidermolysis Bullosa Market Dynamics
The epidermolysis bullosa market dynamics have witnessed significant changes in recent years. As awareness about this condition has increased, there has been a surge in early diagnosis and better disease management, leading to a growing patient population seeking treatment options. This has subsequently attracted increased research and development activities by pharmaceutical companies and biotechnology firms, resulting in the emergence of potential novel therapies.
The epidermolysis bullosa treatment market has become more competitive, with several companies vying to develop innovative products, including gene therapies, cell-based therapies, and advanced wound care products. Regulatory agencies have also become more proactive in facilitating the development and approval of epidermolysis bullosa treatments, which has further accelerated the pace of progress.
However, challenges persist, primarily related to the high cost of research and development for rare diseases like epidermolysis bullosa and the limited patient pool. Pricing and reimbursement complexities for novel therapies have also been obstacles, impacting their accessibility to patients worldwide. Additionally, there is a need for improved diagnostic tools and better patient support systems to ensure timely and effective treatment.
Despite these challenges, the epidermolysis bullosa market continues to show promise and growth potential, driven by scientific advancements, increased funding, and collaborative efforts among stakeholders. The ultimate goal is to alleviate the burden on epidermolysis bullosa patients and improve their quality of life through innovative and transformative therapeutic approaches. As the landscape evolves, ongoing efforts from the medical community, policymakers, and advocacy groups are critical in fostering advancements and addressing the unmet needs of individuals living with this devastating condition.
Report Metrics | Details |
Study Period | 2019–2032 |
Coverage | 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Epidermolysis Bullosa Market CAGR | ~8% |
Epidermolysis Bullosa Market Size in 2022 | USD 1.5 Billion |
Key Epidermolysis Bullosa Companies | Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen, and others |
Key Pipeline Epidermolysis Bullosa Therapies | EB-101, D-Fi (dabocemagene autoficel), ABCB5+ mesenchymal stem cells (ABCB5+ MSCs), ISN001, RV-LAMB3-transduced epidermal stem cells, PTR-01, INM-755, Redasemtide, ALLO-ASC-SHEET, and others |
Scope of the Epidermolysis Bullosa Market Report
- Therapeutic Assessment: Epidermolysis Bullosa current marketed and emerging therapies
- Epidermolysis Bullosa Market Dynamics: Conjoint Analysis of Emerging Epidermolysis Bullosa Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Epidermolysis Bullosa Market Access and Reimbursement
Discover more about epidermolysis bullosa drugs in development @ Epidermolysis Bullosa Clinical Trials
Table of Contents
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 |
6.1. | Market Share (%) Distribution By Therapies In 2023 |
6.2. | Market Share (%) Distribution By Therapies In 2032 |
7. | Epidermolysis Bullosa (EB): Disease Background And Overview |
7.1. | Introduction |
7.2. | Causes Of Epidermolysis Bullosa |
7.3. | Signs And Symptoms Of Epidermolysis Bullosa |
7.4. | Pathogenesis Of Epidermolysis Bullosa |
7.5. | Pathophysiology Of Itch In Epidermolysis Bullosa Skin |
7.6. | Classification Of Epidermolysis Bullosa |
7.7. | Genetic Bases Of Epidermolysis Bullosa |
7.8. | Diagnosis Of Epidermolysis Bullosa |
7.8.1. | Types Of Laboratory Referral |
7.8.1.1. | Neonate With Skin Fragility |
7.8.1.2. | Pediatric And Adult Patients With Skin Fragility |
7.8.1.3. | Carrier Testing |
7.8.1.4. | Prenatal Diagnosis |
7.8.2. | Further Testing |
7.8.2.1. | Skin Biopsy |
7.8.2.2. | Molecular Testing |
7.8.2.3. | Genetic Testing For Epidermolysis Bullosa |
7.8.2.3.1. | Next–generation Sequencing (NGS) Targeted Gene Panel And Whole–exome Sequencing In Epidermolysis Bullosa |
7.8.2.3.2. | Sanger Sequencing (SS) |
8. | Treatment And Management Of Epidermolysis Bullosa |
8.1. | Management Of Blisters |
8.2. | Skin And Wound Management |
8.2.1. | Management Of Epidermolysis Bullosa Simplex (EBS) |
8.2.1.1. | Management Of Junctional Epidermolysis Bullosa (JEB) |
8.2.1.2. | Management Of Dystrophic Epidermolysis Bullosa (DEB) |
8.2.1.3. | Management Of Kindler Syndrome |
9. | Guidelines |
9.1. | Diagnostic Guidelines |
9.1.1. | Clinical Practice Guidelines For Epidermolysis Bullosa Laboratory Diagnosis |
9.1.2. | Japanese Guidelines For Diagnosis And Treatment Of Junctional And Dystrophic Epidermolysis Bullosa |
10. | Epidemiology And Patient Population Of 7MM |
10.1. | Key Findings |
10.2. | Assumption And Rationale |
10.3. | Total Prevalent Cases Of Epidermolysis Bullosa In The 7MM |
10.4. | Diagnosed Prevalent Cases Of Epidermolysis Bullosa In The 7MM |
10.5. | The United States |
10.5.1. | Total Prevalent Cases Of Epidermolysis Bullosa In The United States |
10.5.2. | Diagnosed Prevalent Cases Of Epidermolysis Bullosa In The United States |
10.5.3. | Gender-Specific Cases Of Epidermolysis Bullosa In The United States |
10.5.4. | Age-Specific Cases Of Epidermolysis Bullosa In The United States |
10.5.5. | Type-Specific Cases Of Epidermolysis Bullosa In The United States |
10.6. | EU4 And The UK |
10.6.1. | Total Prevalent Cases Of Epidermolysis Bullosa In EU4 And The UK |
10.6.2. | Diagnosed Prevalent Cases Of Epidermolysis Bullosa In EU4 And The UK |
10.6.3. | Gender-Specific Cases Of Epidermolysis Bullosa In EU4 And The UK |
10.6.4. | Age-Specific Cases Of Epidermolysis Bullosa In EU4 And The UK |
10.6.5. | Type-Specific Cases Of Epidermolysis Bullosa In EU4 And The UK |
10.7. | Japan |
10.7.1. | Total Prevalent Cases Of Epidermolysis Bullosa In Japan |
10.7.2. | Diagnosed Prevalent Cases Of Epidermolysis Bullosa In Japan |
10.7.3. | Gender-Specific Cases Of Epidermolysis Bullosa In Japan |
10.7.4. | Age-Specific Cases Of Epidermolysis Bullosa In Japan |
10.7.5. | Type-Specific Cases Of Epidermolysis Bullosa In Japan |
11. | Patient Journey |
12. | Marketed Drugs |
12.1. | Key Competitors |
12.2. | Vyjuvek (Beremagene Geperpavec): Krystal Biotech |
12.2.1. | Product Description |
12.2.2. | Regulatory Milestones |
12.2.3. | Other Developmental Activities |
12.2.4. | Clinical Developmental Activities |
12.2.4.1. | Clinical Trial Information |
12.2.5. | Safety And Efficacy |
12.2.6. | Product Profile |
12.3. | Filsuvez (Oleogel-S10): Chiesi Farmaceutici |
12.3.1. | Product Description |
12.3.2. | Regulatory Milestone |
12.3.3. | Other Development Activities |
12.3.4. | Safety And Efficacy |
12.3.5. | Product Profile |
12.4. | JACE (Human Epidermal Cell Sheet): Japan Tissue Engineering |
12.4.1. | Product Description |
12.4.2. | Regulatory Milestones |
12.4.3. | Safety And Efficacy |
12.4.4. | Product Profile |
13. | Emerging Drugs |
13.1. | Key Competitors |
13.2. | EB-101: Abeona Therapeutics |
13.2.1. | Product Description |
13.2.2. | Other Developmental Activities |
13.2.3. | Clinical Developmental Activities |
13.2.3.1. | Clinical Trial Information |
13.2.4. | Safety And Efficacy |
13.3. | D-Fi (Dabocemagene Autoficel): Castle Creek Biosciences |
13.3.1. | Product Description |
13.3.2. | Other Developmental Activities |
13.3.3. | Clinical Developmental Activities |
13.3.3.1. | Clinical Trial Information |
13.3.4. | Safety And Efficacy |
13.4. | ABCB5+ Mesenchymal Stem Cells (ABCB5+ MSCS): Rheacell |
13.4.1. | Product Description |
13.4.2. | Other Developmental Activities |
13.4.3. | Clinical Developmental Activities |
13.4.3.1. | Clinical Trial Information |
13.4.4. | Safety And Efficacy |
13.5. | ISN001: Ishin Pharma |
13.5.1. | Product Description |
13.5.2. | Other Developmental Activities |
13.5.3. | Clinical Developmental Activities |
13.5.3.1. | Clinical Trial Information |
13.6. | RV-LAMB3-Transduced Epidermal Stem Cells: Holostem Terapie Avanzate |
13.6.1. | Product Description |
13.6.2. | Other Developmental Activities |
13.6.3. | Clinical Developmental Activities |
13.6.3.1. | Clinical Trial Information |
13.7. | PTR-01: Bridgebio (Phoenix Tissue Repair) |
13.7.1. | Product Description |
13.7.2. | Other Development Activities |
13.7.3. | Clinical Development |
13.7.3.1. | Clinical Trials Information |
13.7.4. | Safety And Efficacy |
13.8. | INM-755: Inmed Pharmaceuticals |
13.8.1. | Product Description |
13.8.2. | Clinical Development |
13.8.2.1. | Clinical Trials Information |
13.8.3. | Safety And Efficacy |
13.9. | Redasemtide: Shionogi |
13.9.1. | Product Description |
13.9.2. | Other Development Activities |
13.9.3. | Clinical Development |
13.9.3.1. | Clinical Trials Information |
13.9.4. | Safety And Efficacy |
13.10. | ALLO-ASC-Sheet: Anterogen |
13.10.1. | Product Description |
13.10.2. | Other Developmental Activities |
13.10.3. | Clinical Developmental Activities |
13.10.3.1. | Clinical Trial Information |
14. | Epidermolysis Bullosa: 7MM Analysis |
14.1. | Key Findings |
14.2. | Market Outlook |
14.3. | Key Market Forecast Assumptions |
14.4. | Conjoint Analysis |
14.5. | Total Market Size Of Epidermolysis Bullosa In The 7MM |
14.6. | United States Market Size |
14.6.1. | Total Market Size Of Epidermolysis Bullosa In The United States |
14.6.2. | Market Size Of Epidermolysis Bullosa By Current And Emerging Therapies In The United States |
14.7 | EU4 And The UK Market Size |
14.7.1. | Total Market Size Of Epidermolysis Bullosa In EU4 And The UK |
14.7.2. | Market Size Of Epidermolysis Bullosa By Current And Emerging Therapies In EU4 And The UU |
14.8. | Japan Market Size |
14.8.1. | Total Market Size Of Epidermolysis Bullosa In Japan |
14.8.2. | Market Size Of Epidermolysis Bullosa By Current And Emerging Therapies In Japan |
15. | Unmet Needs |
16. | Swot Analysis |
17. | Kol Views |
18. | Market Access And Reimbursement |
18.1. | United States |
18.1.1. | Centre For Medicare & Medicaid Services (CMS) |
18.2. | EU4 And The UK |
18.2.1. | Germany |
18.2.2. | France |
18.2.3. | Italy |
18.2.4. | Spain |
18.2.5. | United Kingdom |
18.3. | Japan |
18.3.1. | MHLW |
18.4. | Epidermolysis Bullosa Market Access And Reimbursement |
19. | Appendix |
19.1. | Bibliography |
19.2. | Report Methodology |
20. | Delveinsight Capabilities |
21. | Disclaimer |
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