FCX-007：新興医薬品の考察・市場予測 (2030年)

FCX-007は Fibrocell の臨床段階にあり、タンパク質COL7の欠乏によって引き起こされる先天性および進行性の孤児の皮膚疾患であるRDEBの治療のための遺伝子治療製品候補です。

当レポートでは、米国、欧州5ヶ国（ドイツ、フランス、イタリア、スペイン、英国）、および日本の7つの主要市場における FCX-007 について詳細に説明し (作用機序、投与量、合成経路、規制のマイルストーンを含む研究開発活動、およびその他の開発活動)、SWOT分析、市場の競合企業、およびその他の新たな治療法を含む将来の市場評価を提供しています。

目次

第1章 医薬品の概要

• 製品の詳細
• 作用機序
• 投薬と管理
• 研究開発活動
  • 臨床開発
  • 安全性と有効性
• その他の開発活動

第2章 市場評価

• 主要7ヶ国市場分析
• 米国市場
• ドイツ市場
• フランス市場
• イタリア市場
• スペイン市場
• 英国市場
• 日本市場

第3章 SWOT分析

第4章 アナリストの見解

第5章 市場の競合企業

第6章 その他の新しい治療法

第7章 付録

第8章 レポート購入オプション

List of Tables

• Table 1 FCX-007, Description
• Table 2 FCX-007, Clinical Trial Description
• Table 3 FCX-007, 7MM Market Size from 2020 to 2030 (in Million USD)
• Table 4 Market Competitors
• Table 5 Other Emerging Therapies

List of Figures

• Figure 1 The Development Timeline of FCX-007
• Figure 2 Patent Details, FCX-007
• Figure 3 FCX-007, 7MM Market Size from 2020 to 2030 (in Million USD)
• Figure 4 FCX-007, US Market Size from 2020 to 2030 (in Millions USD)
• Figure 5 FCX-007, EU5 Market Size from 2020 to 2030 (in Millions USD)
• Figure 6 FCX-007, Japan Market Size from 2020 to 2030 (in Millions USD)

"FCX-007- Emerging Drug Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Epidermolysis bullosa in 7 Major Markets. A detailed picture of the FCX-007 in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2020-2030 is provided in this report along with a detailed description of the product. The product details cover mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.

Drug Summary:

FCX-007 is Fibrocell's clinical stage, gene therapy product candidate for the treatment of RDEB, a congenital and progressive orphan skin disease caused by the deficiency of the protein COL7. FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution. Fibrocell is developing FCX-007 in collaboration with Intrexon. In addition, Fibrocell is working in collaboration with Castle Creek Pharmaceuticals to develop and commercialize FCX-007 for the treatment of RDEB. Castle Creek is recognized for its innovation in drug development for rare skin diseases and its commitment to bringing novel therapies to those living with epidermolysis bullosa.

Scope of the report:

The report provides insights into:

• A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity.

• Elaborated details on regulatory milestones and other development activities have been provided in this report.

• The report also highlights the drug research and development activity details across the United States, Europe and Japan.

• The report also covers the patents information with expiry timeline around FCX-007.

• The report contains forecasted sales for FCX-007 till 2030.

• Comprehensive coverage of the late-stage emerging therapies (Phase III) for Epidermolysis bullosa.

• The report also features the SWOT analysis with analyst insights and key findings of FCX-007.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

FCX-007 Analytical Perspective by DelveInsight

• In-depth FCX-007 Market Assessment

This report provides a detailed market assessment of FCX-007 in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2020 to 2030.

• FCX-007 Clinical Assessment

The report provides the clinical trials information of FCX-007 covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights:

• In the coming years, the market scenario for Epidermolysis bullosa is set to change due to the extensive research and incremental healthcare spending across the world; 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 FCX-007 dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.

• Other emerging products for Epidermolysis bullosa are giving market competition to FCX-007 and launch of late-stage emerging therapies in the near future will significantly impact the market.

• A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of FCX-007.

• Our in-depth analysis of the forecasted sales data of FCX-007 from 2020 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FCX-007.

Key Questions:

• Which company is developing FCX-007 along with the phase of the clinical study?

• What is the technology utilized in the development of FCX-007?

• What is the product type, route of administration and mechanism of action of FCX-007?

• What is the clinical trial status of the study and study completion date?

• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FCX-007 development?

• What are the key designations that have been granted to FCX-007?

• What is the forecasted market scenario of FCX-007?

• What is the history of FCX-007 and what is its future?

• What is the forecasted sales of FCX-007 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?

• What are the other emerging products available and how these are giving competition to FCX-007?

• Which are the late-stage emerging therapies under development for the treatment of the PPD?

Table of Contents

1. Drug Overview

• 1.1. Product Detail
• 1.2. Mechanism of Action
• 1.3. Dosage and Administration
• 1.4. Research and development activity
  • 1.4.1. Clinical Development
  • 1.4.2. Safety and Efficacy
• 1.5. Other Development Activities

2. Market Assesment

• 2.1. 7MM Market Analysis
• 2.2. The United States Market
• 2.3. Germany Market
• 2.4. France Market
• 2.5. Italy Market
• 2.6. Spain Market
• 2.7. United Kingdom Market
• 2.8. Japan Market

3. SWOT Analysis

4. Analyst Views

5. Market Competitors

6. Other Emerging Therapies

7. Appendix

8. Report Purchase Options