REPLAGAL, Drug Insight and Market Forecast - 2032

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

REPLAGAL (also known as agalsidase alfa) is a recombinant formulation of human α-galactosidase A developed by the Shire and is recommended as the long-term enzyme replacement therapy for the treatment of Fabry Disease. The therapeutic candidate has a fully human glycosylation profile which provides appropriate bio-distribution and uptake by cells. REPLAGAL acts by catalyzing the hydrolysis of Globotriaosylceramide (Gb3) by cleaving a terminal galactose residue from the molecule. It is effective in reducing the accumulation of Gb3 in endothelial and parenchymal cells. The Shire used genetic engineering technology for the development of the therapeutic candidate. REPLAGAL was marketed in Europe and Japan (by Sumitomo Dainippon Pharma) for the treatment of Fabry disease. Although it is in use in many countries, including Canada, Russia, Mexico, Israel, and many members of the European Union, REPLAGAL has not been approved by the US FDA.

Recommended Dose: The recommended dose of REPLAGAL is 0.2 mg/kg body weight every other week by intravenous infusion over 40 min.

Scope of the Report

The report provides insights into:

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

REPLAGAL Analytical Perspective

In-depth REPLAGAL Market Assessment

This report provides a detailed market assessment of REPLAGAL 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.

REPLAGAL Clinical Assessment

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

Key Questions Answered

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