FABRAZYME, Drug Insight and Market Forecast - 2032

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

FABRAZYME (also known as agalsidase beta) is a recombinant human α-galactosidase A enzyme created by Genzyme (a Sanofi subsidiary). FABRAZYME is an enzyme replacement therapy that can help patients who are deficient in the human enzyme -galactosidase A. The therapeutic candidate effectively reduces the Globotriaosylceramide (GL-3) deposition in the capillary endothelium of the kidney and other cell types. It is effective in catalyzing the hydrolysis of glycosphingolipids, including GL-3.

Genzyme developed FABRAZYME by using recombinant DNA technology in a Chinese Hamster Ovary mammalian cell expression system. FABRAZYME is administered by intravenous infusion once every two weeks and is recommended as the long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease among adults, children, and adolescents aged 8 years and older. FABRAZYME has been approved in about 75 countries. The FDA granted accelerated approval to FABRAZYME in 2003. Eighteen years later, the FDA converted the authorization of the enzyme replacement therapy to a full, traditional approval.

The recommended dose of FABRAZYME is 1 mg/kg body weight given every two weeks as an IV infusion. Patients should receive antipyretics before the infusion. A single dose of 5 mg or 35 mg of lyophilized cake or powder is available in a vial for reconstitution. The initial intravenous infusion rate is no more than 0.25 mg/min (15 mg/h).

Scope of the Report

The report provides insights into:

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

FABRAZYME Analytical Perspective

In-depth FABRAZYME Market Assessment

This report provides a detailed market assessment of FABRAZYME 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.

FABRAZYME Clinical Assessment

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

Key Questions Answered

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