PRX-102 (Pegunigalsidase alfa), Emerging Drug Insight and Market Forecast - 2032

“PRX-102 (Pegunigalsidase alfa), Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about PRX-102 (Pegunigalsidase alfa) for Fabry Disease in the 7MM. A detailed picture of the PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) market forecast, analysis for Fabry Disease in the 7MM, descriptive analysis such as SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in Fabry Disease.

Drug Summary

PRX-102 (also known as Recombinant Human Alpha Galactosidase-A [a-GAL A]) is an experimental Enzyme Replacement Therapy (ERT) under development by Protalix Biotherapeutics. It is being developed using Protalix's plant-based ProCellEx platform, a plant cell culture expressed, and a chemically modified version of the recombinant a-GAL A protein. As per the company's expectation, PRX-102 will provide better clinical efficacy and an improved safety profile than currently available treatments.

The company has completed three Phase III studies (BALANCE, BRIGHT, and BRIDGE).

In February 2024, Protalix BioTherapeutics and Chiesi Global Rare Diseases announced the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease, and the subsequent validation of the MAA by the EMA.

In April 2022, the companies planned to resubmit a biologics license application to the US Food and Drug Administration (FDA) requesting its approval later this year. A previous application was rejected by the FDA due to issues with facility inspections and the manufacturing process. The companies are also seeking the therapy's approval in Europe.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the PRX-102 (Pegunigalsidase alfa) description, mechanism of action, dosage and administration, research and development activities in Fabry Disease PRX-102 (Pegunigalsidase alfa).
• Elaborated details on PRX-102 (Pegunigalsidase alfa) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa).
• The report contains forecasted sales of PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) 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.

PRX-102 (Pegunigalsidase alfa) Analytical Perspective

In-depth PRX-102 (Pegunigalsidase alfa) Market Assessment

This report provides a detailed market assessment of PRX-102 (Pegunigalsidase alfa) 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 2023 to 2032

PRX-102 (Pegunigalsidase alfa) Clinical Assessment

The report provides the clinical trials information of PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) dominance.
• Other emerging products for Fabry Disease are expected to give tough market competition to PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) in Fabry Disease.
• Our in-depth analysis of the forecasted sales data of PRX-102 (Pegunigalsidase alfa) from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the PRX-102 (Pegunigalsidase alfa) in Fabry Disease.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of PRX-102 (Pegunigalsidase alfa)?
• What is the clinical trial status of the study related to PRX-102 (Pegunigalsidase alfa) in Fabry Disease and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PRX-102 (Pegunigalsidase alfa) development?
• What are the key designations that have been granted to PRX-102 (Pegunigalsidase alfa) for Fabry Disease?
• What is the forecasted market scenario of PRX-102 (Pegunigalsidase alfa) for Fabry Disease?
• What are the forecasted sales of PRX-102 (Pegunigalsidase alfa) 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 PRX-102 (Pegunigalsidase alfa) for Fabry Disease?
• Which are the late-stage emerging therapies under development for the treatment of Fabry Disease?