4D-310, Emerging Drug Insight and Market Forecast

“4D-310, Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about 4D-310 for Fabry Disease in the 7MM. A detailed picture of the 4D-310 for Fabry Disease in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019-2032 is provided in this report along with a detailed description of the 4D-310 for Fabry Disease. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the 4D-310 market forecast, analysis for Fabry Disease in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Fabry Disease.

Drug Summary

4D-310 is a gene medicine engineered with a proprietary optimized Adeno-associated virus (AAV) capsid discovered by 4DMT through its proprietary Therapeutic Vector Evolution platform. It holds promise for the treatment of Fabry by using an AAV vector to deliver a functional copy of the GLA gene, resulting in a-GAL A production in target tissues. The drug received Fast Track designation from the FDA in the third quarter of 2020.

4D-310 is currently in an ongoing Phase I/II clinical trial in adult patients with classic (severe) FD.

The dual mechanism-of-action design of 4D-310 opens the potential to treat target tissues through cross-correction from high and sustained blood AGA activity, as well as through direct transduction and AGA expression in target tissues such as the heart, kidney, and blood vessels. The evidence of 4D-310's AGA clinical activity and tolerability, as well as the preliminary encouraging effects on cardiac endpoints, strengthens the belief that 4D-310 represents a promising therapeutic approach for a wide range of Fabry disease patients.

The clinical data suggests that 4D-310 is well-tolerated over time and has the potential to effectively treat a broad range of patients with Fabry disease.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the 4D-310 description, mechanism of action, dosage and administration, research and development activities in Fabry Disease.
• Elaborated details on 4D-310 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the 4D-310 research and development activity in Fabry Disease in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around 4D-310.
• The report contains forecasted sales of 4D-310 for Fabry Disease till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Fabry Disease.
• The report also features the SWOT analysis with analyst views for 4D-310 in Fabry Disease.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a 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.

4D-310 Analytical Perspective

In-depth 4D-310 Market Assessment

This report provides a detailed market assessment of 4D-310 in Fabry Disease in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data for the 4D-310.

4D-310 Clinical Assessment

The report provides the clinical trials information of 4D-310 in Fabry Disease covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Fabry Disease 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 are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence 4D-310 dominance.
• Other emerging products for Fabry Disease are expected to give tough market competition to 4D-310 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of 4D-310 in Fabry Disease.
• Our in-depth analysis of the forecasted sales data of 4D-310 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the 4D-310 in Fabry Disease.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of 4D-310?
• What is the clinical trial status of the study related to 4D-310 in Fabry Disease and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the 4D-310 development?
• What are the key designations that have been granted to 4D-310 for Fabry Disease?
• What is the forecasted market scenario of 4D-310 for Fabry Disease?
• What are the forecasted sales of 4D-310 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 in Fabry Disease and how are they giving competition to 4D-310 for Fabry Disease?
• Which are the late-stage emerging therapies under development for the treatment of Fabry Disease?