PUBLISHER: DelveInsight | PRODUCT CODE: 1118528
PUBLISHER: DelveInsight | PRODUCT CODE: 1118528
DelveInsight's, '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
Study Period: 2019-2032
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.
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.
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.
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.
Products detail in the report…
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.
Products detail in the report…
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 DelveInsight, 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.
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.
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.
The total Dystrophic Epidermolysis Bullosa (DEB) market size and market size by therapies of Dystrophic Epidermolysis Bullosa (DEB) in Japan are also mentioned.
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
We perform 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.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies: