Dystrophic Epidermolysis Bullosa - Market Insight, Epidemiology And Market Forecast - 2032

This ‘Dystrophic Epidermolysis Bullosa (DEB) - Market Insights, Epidemiology, and Market Forecast - 2032' report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Dystrophic Epidermolysis Bullosa (DEB) in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Dystrophic Epidermolysis Bullosa (DEB) market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted Dystrophic Epidermolysis Bullosa (DEB) market size from 2019 to 2032 segmented by seven major markets. The report also covers the current Dystrophic Epidermolysis Bullosa (DEB) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Dystrophic Epidermolysis Bullosa (DEB): Disease Understanding and Treatment Algorithm

Dystrophic Epidermolysis Bullosa (DEB) Overview

Dystrophic epidermolysis bullosa (DEB) is the major subtype of epidermolysis bullosa (EB). EB is a group of skin diseases that cause various degrees of skin and mucous membrane fragility. The skin becomes fragile when proteins essential for skin integrity are absent, reduced, or abnormal. EB is classified into four main types and several clinical subtypes. The main classification relates to the layer of skin in which the formation of blisters occurs: EB simplex (EBS; intraepidermal 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).

According to the National Institute of Cancer, DEB is a rare inherited disorder in which blisters form on the skin and the moist inner lining of some organs and body cavities. The blisters usually appear at birth and may occur on certain body parts or all over the body, leading to scarring in the affected areas and thinning of the skin. DEB comprises four major and several rare sub-types, with the three most common being intermediate dominant DEB, severe recessive DEB, and intermediate recessive DEB.

The signs and symptoms can vary widely among affected people. In mild cases, blistering may primarily affect the hands, feet, knees, and elbows. Severe cases often involve widespread blistering, leading to vision loss, disfigurement, and other serious medical problems.

As per the National Organization for Rare Diseases, some EB occurs in an estimated 1 out of every 50,000 live births. The disorder occurs in every racial and ethnic group worldwide and affects both sexes equally.

The disease is caused by changes in the COL7A1 gene and may be inherited in an autosomal dominant or autosomal recessive manner, depending on the subtype.

Currently, no curative therapy is available. The present treatment focuses on managing symptoms and complications associated with DEB. Use of non-adhesive bandages and dressings to protect the wound, moisturizers for reducing friction and itching, and medication to relieve pain are used to manage symptoms. In addition, some patients need nutritional support, supplements, occupational therapy, and/or surgery, depending on the associated features of the disease. Hence there is an urgent unmet medical need to diagnose better, treat, and possibly one day cure and eradicate this devastating disease.

Dystrophic Epidermolysis Bullosa (DEB) Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnoses available in the Dystrophic Epidermolysis Bullosa (DEB) market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

Dystrophic Epidermolysis Bullosa (DEB) Epidemiology

The Dystrophic Epidermolysis Bullosa (DEB) epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The report also provides the diagnosed prevalent patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted Dystrophic Epidermolysis Bullosa (DEB) epidemiology segmented as the Diagnosed Prevalent cases of Dystrophic Epidermolysis Bullosa, Age-specific cases of Dystrophic Epidermolysis Bullosa, Severity-specific cases, and Type-specific cases of Dystrophic Epidermolysis Bullosa. The report includes the diagnosed prevalent scenario of Dystrophic Epidermolysis Bullosa (DEB) symptoms in the 7MM covering the United States, and EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country-wise Dystrophic Epidermolysis Bullosa (DEB) Epidemiology

The epidemiology segment also provides the Dystrophic Epidermolysis Bullosa (DEB) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The total diagnosed prevalence of the Dystrophic Epidermolysis Bullosa (DEB) population in the 7MM countries was estimated to be close to 3,500 cases in 2021.

Dystrophic Epidermolysis Bullosa (DEB) Drug Chapters

The drug chapter segment of the Dystrophic Epidermolysis Bullosa (DEB) report encloses the detailed analysis of Dystrophic Epidermolysis Bullosa (DEB) marketed drugs and late-stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the Dystrophic Epidermolysis Bullosa (DEB) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Currently, no curative therapy is available. The present treatment focuses on managing symptoms and complications associated with DEB. Use of nonadhesive bandages and dressings to protect the wound, moisturizers for reducing friction and itching, and medication to relieve pain are used to manage symptoms. In addition, some patients need nutritional support, supplements, occupational therapy, and/or surgery, depending on the associated features of the disease.

A systemic cure is still out of reach, despite advances in understanding the spectrum of pathologies associated with the different subtypes of EB. Hence there is an urgent unmet medical need to diagnose better, treat, and possibly one day cure and eradicate this devastating disease.

Dystrophic Epidermolysis Bullosa (DEB) Emerging Drugs

To meet the current demands of the patient pool and to counter the unmet needs of the therapeutic market, few drug developers are gradually shifting their attention toward dystrophic epidermolysis bullosa as a possible indication for new targeted therapies.

Many companies are developing possible treatments for DEB with continuous efforts in research and development. Castle Creek Biosciences (FCX-007), Amryt Pharma (Oleogel-S10), Krystal Biotech (Beremagene Geperpavec), Abeona Therapeutics (EB-101), and Phoenix Tissue Repair (PTR-01) are key players working on potential therapies like gene therapy, symptomatic relief therapy, and disease-modifying therapies. Currently, these therapies are in the mid and late phases of development and are expected to enter the market during the forecast period.

FCX-007 (Dabocemagene autoficel) is an investigational gene therapy to address the deficiency of functional type VII collagen protein (COL7) in patients with Dystrophic epidermolysis bullosa (DEB). It is a genetically-modified autologous fibroblast that encodes the gene for COL7 and treats wounds locally via injection. Furthermore, the company is conducting a Phase III clinical trial to determine whether the administration of FCX-007, in addition to the standard of care, improves wound healing in children, adolescents, and adults with RDEB.

Oleogel-S10 is an herbal medicinal product that contains birch triterpenes from birch bark. The drug is a keratinocyte modulator; transient receptor potential channel stimulants are being used to speed up the healing of wounds in adults and children with DEB. The company received a complete response letter from the USA FDA regarding NDA. The US FDA has granted Rare Pediatric Disease Designation, Fast Track, and Priority Review to Oleogel-S10 for the treatment of DEB. Further, it has been granted Orphan Drug Designation by the US FDA and EMA. The EMA has approved Oleogel-S10 (Filsuvez) for the treatment of the cutaneous manifestations of DEB.

Beremagene geperpavec (KB103) is an investigational non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. It provides a template for the patient's skin cells to make normal COL7 protein, thereby addressing the disease-causing mechanism. The FDA and EMA have granted B-VEC Orphan Drug Designation to treat DEB, and the FDA has granted B-VEC Fast Track designation and Rare Pediatric Designation to treat DEB. In addition, the FDA granted regenerative medicine advanced therapy (RMAT) to B-VEC, and the EMA granted PRIority MEdicines (“PRIME”) for B-VEC to treat DEB.

Dystrophic Epidermolysis Bullosa (DEB) Market Outlook

The Dystrophic Epidermolysis Bullosa (DEB) market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Dystrophic Epidermolysis Bullosa (DEB) market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.

This segment gives a thorough detail of the Dystrophic Epidermolysis Bullosa (DEB) 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 for 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 market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to the publisher, the Dystrophic Epidermolysis Bullosa (DEB) market in the 7MM is expected to change in the study period 2019-2032.

Key Findings

This section includes a glimpse of the Dystrophic Epidermolysis Bullosa (DEB) market in the 7MM. In the seven major markets, the Dystrophic Epidermolysis Bullosa (DEB) market size was more than USD 500 Million in 2021.

The United States: Market Outlook

This section provides the total Dystrophic Epidermolysis Bullosa (DEB) market size and market size by Dystrophic Epidermolysis Bullosa (DEB) therapies in the United States.

Dystrophic Epidermolysis Bullosa (DEB) is a rare inherited disorder in which blisters form on the skin and the moist inner lining of some organs and body cavities. The blisters usually appear at birth and may occur on certain body parts or all over the body. It leads to scarring in the affected areas and thinning of the skin. DEB comprises four major and several rare sub-types, with the three most common being intermediate dominant DEB, severe recessive DEB, and intermediate recessive DEB. The signs and symptoms can vary widely among affected people. In mild cases, blistering may primarily affect the hands, feet, knees, and elbows. Severe cases often involve widespread blistering, leading to vision loss, disfigurement, and other serious medical problems.

The United States accounts for the highest market size of Dystrophic Epidermolysis Bullosa (DEB) compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

EU-5 Countries: Market Outlook

The total Dystrophic Epidermolysis Bullosa (DEB) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total Dystrophic Epidermolysis Bullosa (DEB) market size and market size by therapies of Dystrophic Epidermolysis Bullosa (DEB) in Japan are also mentioned.

Dystrophic Epidermolysis Bullosa (DEB) Drugs Uptake

This section focuses on the uptake rate of potential drugs recently launched or expected to get launched in the market during the study period 2019-2032. The analysis covers Dystrophic Epidermolysis Bullosa (DEB) market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size, which will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Dystrophic Epidermolysis Bullosa (DEB) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stages. It also analyses the Dystrophic Epidermolysis Bullosa's key players involved in developing targeted therapeutics.

Castle Creek Biosciences (FCX-007), Amryt Pharma (Oleogel-S10), Krystal Biotech (Beremagene Geperpavec), and others whose key products are expected to get launched in the US market by 20XX.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging Dystrophic Epidermolysis Bullosa (DEB) therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the Dystrophic Epidermolysis Bullosa (DEB) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Dystrophic Epidermolysis Bullosa (DEB) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs a Competitive and Market Intelligence analysis of the Dystrophic Epidermolysis Bullosa (DEB) market using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Dystrophic Epidermolysis Bullosa (DEB), explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
• Comprehensive insight is provided into the Dystrophic Epidermolysis Bullosa (DEB) epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both current and emerging therapies for Dystrophic Epidermolysis Bullosa (DEB) is provided, along with the assessment of new therapies that will impact the current treatment landscape
• A detailed review of the Dystrophic Epidermolysis Bullosa (DEB) market; historical and forecasted, is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Dystrophic Epidermolysis Bullosa (DEB) market

Report Highlights

• In the coming years, the Dystrophic Epidermolysis Bullosa (DEB) market is set to change due to the rising awareness of the disease and incremental healthcare spending worldwide; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Dystrophic Epidermolysis Bullosa (DEB) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Dystrophic Epidermolysis Bullosa (DEB). The launch of emerging therapies will significantly impact the Dystrophic Epidermolysis Bullosa (DEB) market.
• A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for Dystrophic Epidermolysis Bullosa (DEB).
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Dystrophic Epidermolysis Bullosa (DEB) Report Insights

• Patient Population
• Therapeutic Approaches
• Dystrophic Epidermolysis Bullosa (DEB) Pipeline Analysis
• Dystrophic Epidermolysis Bullosa (DEB) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Dystrophic Epidermolysis Bullosa (DEB) Report Key Strengths

• 11-year Forecast
• 7MM Coverage
• Dystrophic Epidermolysis Bullosa (DEB) Epidemiology Segmentation
• Key Competitors
• Highly Analyzed Market
• Drugs Uptake

Dystrophic Epidermolysis Bullosa (DEB) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions Answered

Market Insights:

• What was the market share (%) distribution, and how would it look in 2032?
• What would be the total market size and market size of Dystrophic Epidermolysis Bullosa (DEB) by therapies across the 7MM forecast period (2019-2032)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest Dystrophic Epidermolysis Bullosa (DEB) market Size during the forecast period (2019-2032)?
• At what CAGR is the Dystrophic Epidermolysis Bullosa (DEB) market expected to grow in the 7MM forecast period (2019-2032)?
• What would be the Dystrophic Epidermolysis Bullosa (DEB) market outlook across the 7MM forecast period (2019-2032)?
• What would be the Dystrophic Epidermolysis Bullosa (DEB) market growth until 2032 and the resultant market size by 2032?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the major factors that will drive the change in the patient population in Dystrophic Epidermolysis Bullosa (DEB) disease during the forecast period (2019-2032))?
• What is the historical patient pool of Dystrophic Epidermolysis Bullosa (DEB) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Dystrophic Epidermolysis Bullosa (DEB) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What are the major factors that will drive the change in the patient population in XYZ disease during the forecast period (2019-2032)?
• Out of all 7MM countries, which country would have the highest diagnosed incidence of Dystrophic Epidermolysis Bullosa (DEB) during the forecast period (2019-2032)?
• At what CAGR is the population expected to grow in the 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Dystrophic Epidermolysis Bullosa (DEB)?
• What are the current treatment guidelines for treating Dystrophic Epidermolysis Bullosa (DEB) in the US, Europe, and Japan?
• What are the Dystrophic Epidermolysis Bullosa (DEB) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies to treat Dystrophic Epidermolysis Bullosa (DEB)?
• How many therapies are developed by each company to treat Dystrophic Epidermolysis Bullosa (DEB)?
• How many emerging therapies are in the mid-stage and late stages of development to treat Dystrophic Epidermolysis Bullosa (DEB)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Dystrophic Epidermolysis Bullosa (DEB) therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies for Dystrophic Epidermolysis Bullosa (DEB) and its status?
• Which key designations have been granted for the emerging therapies for Dystrophic Epidermolysis Bullosa (DEB)?
• What are the global historical and forecasted Dystrophic Epidermolysis Bullosa (DEB) markets?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Dystrophic Epidermolysis Bullosa (DEB) market
• To understand the future market competition in the Dystrophic Epidermolysis Bullosa (DEB) market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Dystrophic Epidermolysis Bullosa (DEB) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identifying upcoming solid players in the market will help devise strategies that will help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Dystrophic Epidermolysis Bullosa (DEB) market.
• To understand the future market competition in the Dystrophic Epidermolysis Bullosa (DEB) market.