GALAFOLD, Drug Insight and Market Forecast - 2032

“GALAFOLD, Drug Insight and Market Forecast - 2032” report provides comprehensive insights about GALAFOLD for Fabry Disease in the 7MM. A detailed picture of the GALAFOLD 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 GALAFOLD 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 GALAFOLD 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

Migalastat is the active ingredient of GALAFOLD, developed by Amicus Therapeutics, which is commercially available for the treatment of Fabry Disease. The orally administered therapeutic candidate acts as a pharmacological chaperone designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of the lysosomal enzyme α - galactosidase A (α - Gal A). These genotypes are referred to as amenable mutations. This results in the stabilization of the mutant forms of α - Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes where dissociation of Migalastat restores α - Gal A activity, leading to the breakdown of Globotriaosylceramide (GL3) and related substrates, thereby preventing the accumulation of same in the tissues. The drug was approved for the treatment of Fabry disease in the US (18 and above), Europe (16 and above), and Japan. Along with this, the company also initiated a Phase III trial for the pediatric population in the age group of 12-17 years. GALAFOLD was approved in Europe and the US; marketing applications were approved in six markets, including Australia, Canada, Israel, South Korea, Switzerland, and Japan.

Recommended Dosage: GALAFOLD is recommended for the long-term treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease and patients with the amenable mutation. The recommended dosage regimen is 123 mg Migalastat (one capsule) once every other day at the same time of the day for patients with Fabry Disease.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the GALAFOLD description, mechanism of action, dosage and administration, research and development activities in Fabry Disease.
• Elaborated details on GALAFOLD regulatory milestones and other development activities have been provided in this report.
• The report also highlights the GALAFOLD 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 GALAFOLD.
• The report contains forecasted sales of GALAFOLD 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 GALAFOLD 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.

GALAFOLD Analytical Perspective

In-depth GALAFOLD Market Assessment

This report provides a detailed market assessment of GALAFOLD 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 from 2022 to 2032.

GALAFOLD Clinical Assessment

The report provides the clinical trials information of GALAFOLD 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 GALAFOLD dominance.
• Other emerging products for Fabry Disease are expected to give tough market competition to GALAFOLD 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 GALAFOLD in Fabry Disease.
• Our in-depth analysis of the forecasted sales data of GALAFOLD from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the GALAFOLD in Fabry Disease.

Key Questions Answered

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