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Epidermolysis Bullosa Market Insight, Epidemiology and Market Forecast -2030

Epidermolysis Bullosa Market Insight, Epidemiology and Market Forecast -2030

  • August 2020
  • 214 pages
  • ID: 6025269
  • Format: PDF
  • Delve Insight


Table of Contents

‘Epidermolysis Bullosa (EB)-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the EB, historical and forecasted epidemiology as well as the EB market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The EB market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM EB market size from 2017 to 2030. The Report also covers current EB treatment practice/algorithm, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities, and assesses the underlying potential of the market.
Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Epidermolysis Bullosa (EB) Disease Understanding and Treatment Algorithm

Epidermolysis Bullosa (EB) Overview
Epidermolysis Bullosa (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. It is characterized by blister formation in response to mechanical trauma. EB is generally caused by mutations involving at least 18 genes encoding structural proteins within keratin intermediate filaments, focal adhesions, desmosome cell junctions, and hemidesmosome attachment complexes, which form the intraepidermal adhesion and dermo-epidermal anchoring complex within the basement membrane zone (BMZ) of the skin and mucosae.
There are four major types of EB, depending on the location of the target proteins and level of the blisters: EB simplex (EBS), junctional EB (JEB), dystrophic EB (DEB), and Kindler syndrome.

Epidermolysis Bullosa (EB) Diagnosis
EB is usually diagnosed in babies and children, but milder types can develop later in adulthood. Dermatologists can suspect EB just from the appearance of the skin, however, there are laboratory tests to confirm the diagnosis. These include skin biopsy, genetic, and prenatal testing.
Continued in the report…..

Epidermolysis Bullosa (EB) Treatment
Since all the types of EB are characterized by fragile skin and a range of cutaneous involvement from blistering, primarily on the hands and feet, through to more generalized wounding, skin and wound management are primarily required. The presence of multiple wounds of varying duration and ability to heal makes the management of EB difficult and complex.
In addition to wound management, attention must also be paid to optimizing nutrition and dental health, minimizing deformity, ophthalmic complications, and genitourinary problems. For mild pain, paracetamol and ibuprofen may be sufficient while opioids and anxiolytics are necessary for severe pain associated with dressing changes. Long-acting opioids benefits in severely affected patients. Psychological evaluation and treatment, and chlorhexidine baths are also beneficial. Antihistamines, gabapentin, pregabalin, TCA, serotonin-norepinephrine uptake inhibitors (SNRIs), and other nontraditional antipruritic agents are considered for itch treatment.

Epidermolysis Bullosa (EB) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of EB, Diagnosed Prevalent Patient Population of EB, and Type-specific Diagnosed Prevalent Population of EB scenario of EB in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.

Key Findings
• According to the report’s, the total prevalent population of EB in seven major markets ranges was 41,509 in 2017.
• The total diagnosed prevalent cases of EB in the 7MM was 39,433 in 2017.
• In 2017, there were 26,104 prevalent cases of EB in the United States. In the same years, there were a total of 24,799 diagnosed prevalent cases of EB in the United States.
• Epidermolysis Bullosa is of several types, and three major types of Epidermolysis bullosa includes Epidermolysis bullosa simplex (EBS), junctional EB (JEB), and dystrophic EB (DEB). Assessments as per analysts show that the majority of cases of EB are EBS in the United States. In 2017, there were 14,879 cases of EBS, 1,240 cases of JEB, and 8,680 cases of DEB in the United States. DEB is further divided as recessive and dominant.
• Out of 8,680 cases of DEB in the United States in 2017, 4,554 cases were dominant DEB and 4,126 cases were recessive DEB.
• Among the European countries, the United Kingdom had the highest prevalent population of EB with 5,037 cases, followed by Germany which had a prevalent population of 4,919 in 2017. On the other hand, Spain had the lowest prevalent population of 928 in 2017.

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

Epidermolysis Bullosa (EB) Drug Chapters
The drug chapter segment of the EB report encloses the detailed analysis of EB current therapies, mid-phase, and late-stage pipeline drugs. It also helps to understand the EB clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug, and the latest news and press releases.

Epidermolysis Bullosa (EB) Emerging Drugs
Oleogel-S10 (AP-101): Amryt Pharma
Oleogel-S10 (AP-101) is a topical product that is being developed for the treatment of EB. It incorporates a betulin-based active ingredient formulated with sunflower oil. AP-101 acts by promoting the differentiation and migration of keratinocytes (skin cells with wound repair capabilities) as well as transiently increasing the level of proinflammatory mediators (which also promote healing).
AP101 has already received marketing approval for the treatment of partial-thickness wounds (PTWs) in adults from the European Commission in January 2016 under the brand name Episalvan. The company is also developing AP103, a potential treatment for patients with RDEB. Oleogel-S10 is currently in phase III clinical trial and recently reported positive unblinded interim efficacy and safety analyses.
Products detail in the report…
EB-101: Abeona Therapeutics
EB-101 (LZRSE-Col7A1) is an autologous, ex-vivo gene therapy in which the COL7A1 gene is inserted into a patient’s skin cells (keratinocytes) for the treatment of the underlying disease in recessive dystrophic epidermolysis bullosa (RDEB). The patient’s cell is genetically engineered in the lab to express a missing protein called type VII collagen and then these corrected cells will be transplanted back to the patient. These cells should then make type VII collagen. The process of adding inserting the correct type VII collagen gene into cells is called gene transfer. Post this process i.e. gene transfer the engineered cells are grown in culture into a sheet of cells that look like a plastic film. This sheet is then grafted to wounds.
The company has evaluated the safety of EB-101 in phase I/II trial in which product has shown significant results, wound treated with EB-101 were significantly healed >50% for more than two years post-administration.
Products detail in the report…
CCP-020 (Diacerein 1% Ointment): Castle Creek Pharmaceuticals
CCP-020 (Diacerein 1% Ointment) is a topical ointment that is being developed by Castle Creek Pharmaceuticals for the treatment of EBS. The drug is engineered to potentially block the activity of interleukin-1? (IL-1?), a pro-inflammatory cytokine that is involved in the inflammatory signaling pathway associated with EBS. Blocking of IL-1? reduces the auto-inflammatory effects in the skin of patients with EBS and strengthen epidermal tissue and support healing.
Diacerein is a commercially available medicine used to treat osteoarthritis. Its therapeutic potential in treating blistering in patients with epidermolysis bullosa simplex was initially discovered by a team of researchers at the EB House Austria, University Clinic for Dermatology at the Paracelsus Medical University (PMU). Diacerein is commonly marketed as tablets but for EBS researchers have developed an ointment with 1% of diacerein. Presently Castle Creek is developing CCP-020 is in the phase II stage of development. Earlier a phase II trial of CCP-020 for EBS got terminated because an independent data monitoring committee suggested that the study will not meet statistical objectives.
Products detail in the report…
List to be continued in the report…

Epidermolysis Bullosa (EB) Market Outlook
There is currently no cure for EB and treatments focus on preventing blisters or managing the wounds caused by the condition. Different types of EB are associated with blisters forming in different locations on the body and that vary in severity. Different treatments are used depending on the type of EB.
The primary goals of EB care are the protection of the skin against trauma, prevention of infection, maintaining the highest possible level of nutrition and avoiding dietary complications, minimizing deformities and contractures, and lastly, sustaining a strong support system and a positive attitude. Many of the complications of EB can be lessened or even avoided with proper early intervention and care.
Local treatment of the skin (and mucosa) is part of daily care. It is especially important to avoid trauma and heat; regular skincare (frequent application of a high-fat lotion or cream), early opening of blisters, and local disinfection are essential. Topical antibiotics should be used only for a short period in case of secondary infection, as well as external steroids for the treatment of eczema. Vaseline or silicon-coated non-stick lattice-structured gauze dressings, for example, a Sofratulle dressing, as well as self-adherent bandages and tube bandages are good options for dressing skin defects.
Management of EBS is by lancing blisters, reducing friction, and use of measures to keep cool such as using socks containing silver thread, cooling insoles and shoes offering ventilation. Appropriate dressings include sheet hydrogels, bi-stretch silicone dressings, and bordered soft silicone dressings. However, many affected individuals prefer not to use any dressings at all.
There are no EB-specific medications. Depending on the severity of the condition, doctors may recommend over-the-counter pain medication or may prescribe stronger painkillers, such as morphine, if needed. If the patient is experiencing chronic pain, then medicines such as amitriptyline, gabapentin, or pregabalin may be prescribed. If a wound becomes infected, it may be treated with antibiotics. These can be applied as a topical lotion, a soaking solution, or taken as an oral tablet. Anti-inflammatory drugs such as corticosteroids may be prescribed to reduce pain from swallowing, making it easier to eat.
Until a cure is found, it is considered a lifelong condition. The outlook for children with EB varies depending on the type they have inherited. Research is underway to better understand the causes of epidermolysis bullosa and seek new treatments and potential cures. CHOP is currently involved in EB clinical trials looking at new topical therapies to help promote wound healing. From the various ongoing clinical studies, it can be concluded that gene therapies and stem cell therapies can provide an effective therapeutic approach for the management of epidermolysis bullosa.
According to the report, EB 7MM is expected to change in the study period 2017–2030.

Key Findings
• The market size of EB in seven major markets (7MM) was USD 2,283.40 million in 2017.
• The United States accounts for the highest market size of EB, in comparison to the other major markets i.e., EU5 countries and Japan.
• Among the EU5 countries, the UK had the highest market size with USD 195.25 million in 2017, while Spain had the lowest market size of Epidermolysis Bullosa with USD 35.99 million in 2017.
• With the expected launch of upcoming therapies, CCP-020 in 2023, AP101 in 2021, RGN-137 in 2024, and S-005151 (Redasemtide) in 2023, FCX-007 and Beremagene geperpavec (KB103) in 2022, EB-101 in 2023 in the 7MM.
• CCP-020 is the only drug that is being investigated for the treatment of EBS, so it is expected to cover a major market share as it has no competition. The drug is expected to be launched in the year 2023.
• According to the analysis, among all these gene therapies that are under development, Beremagene geperpavec (KB103) will cover decent market share. KB103 is under development for DEB.
• The market size for EB in Japan was calculated to be USD 77.46 Million in 2017.

The United States Market Outlook
This section provides the total EB market size and; market size by therapies in the United States.

EU-5 Market Outlook
The total EB market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook
The total EB market size and market size by therapies in Japan are provided.

Epidermolysis Bullosa (EB) Drugs Uptake
This section focusses on the rate of uptake of the drugs expected to get launched in the market during the study period 2017–2030. The analysis covers EB market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Epidermolysis Bullosa (EB) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for EB emerging therapies.
Reimbursement Scenario in Epidermolysis Bullosa (EB)
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the EB market by using various competitive intelligence tools that include–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 EB, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the EB epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for EB is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the EB market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM EB market.

Report Highlights
• The increasing prevalence of the disease along with promising emerging pipeline therapies will positively drive the EB market.
• The companies and academics are working to assess challenges and seek opportunities that could influence EB R&D.
• Major players are involved in developing therapies for EB. The launch of emerging therapies will significantly impact the EB market.
• 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-competition, 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.

Epidermolysis Bullosa (EB) Report Insights
• Patient Population
• Therapeutic Approaches
• EB Pipeline Analysis
• EB Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Epidermolysis Bullosa (EB) Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• EB Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

• Drugs Uptake

Epidermolysis Bullosa (EB) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT Analysis
• Market Access and Reimbursement

Key Questions

Market Insights:
• What was the EB market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the EB total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest EB market size during the forecast period (2020–2030)?
• At what CAGR, the EB market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the EB market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the EB market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:
• What are the disease risk, burden, and unmet needs of EB?
• What is the historical EB patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of EB at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to EB?
• Out of the above-mentioned countries, which country would have the highest prevalent population of EB during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of EB along with the approved therapy?
• What are the EB emerging drugs and their MOA, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of EB?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of EB?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the EB 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 going on for EB and their status?
• What are the key designations that have been granted for the emerging therapies for EB?
• What are the 7MM historical and forecasted market of EB?

Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the EB.
• To understand the future market competition in the EB market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for EB in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the EB market.
• To understand the future market competition in the EB market.

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