fabhalta drug insight and market forecast

“FABHALTA Market Size, Forecast, and Drug Insight – 2032” report provides comprehensive insights about FABHALTA for paroxysmal nocturnal hemoglobinuria (PNH) in the seven major markets. A detailed picture of the FABHALTA for PNH in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and 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 FABHALTA for PNH. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the FABHALTA market forecast analysis for PNH in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in PNH.

Drug Summary

Iptacopan, or FABHALTA, is a first-in-class, orally administered, potent, and highly selective factor B inhibitor of the alternative complement pathway. FABHALTA is currently in clinical development for PNH and several renal conditions with complement system involvement, including IgA nephropathy, complement 3 glomerulopathies (C3G), atypical hemolytic uremic syndrome, and membranous nephropathy. In PNH, FABHALTA acts upstream of the C5 terminal pathway, preventing intravascular hemolysis and extravascular hemolysis. In doing so, FABHALTA may have a therapeutic advantage over the current standard of care by targeting the underlying pathophysiology. 

Currently, Novartis is conducting multiple clinical studies to evaluate the drug for treating PNH. In the Phase III clinical trial, the efficacy and safety of FABHALTA are being evaluated in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody. In another Phase II study, FABHALTA is evaluated as monotherapy for anti-C5 naïve PNH patients.

Scope of the Report 

The report provides insights into:

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

Methodology

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

FABHALTA Analytical Perspective by DelveInsight

• In-depth FABHALTA Market Assessment

This report provides a detailed market assessment of FABHALTA for paroxysmal nocturnal hemoglobinuria (PNH) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

• FABHALTA Clinical Assessment

The report provides the clinical trials information of FABHALTA for PNH covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights  

• In the coming years, the market scenario for paroxysmal nocturnal hemoglobinuria (PNH) 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 FABHALTA dominance.
• Other emerging products for PNH are expected to give tough market competition to FABHALTA 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 FABHALTA in PNH.
• Our in-depth analysis of the forecasted sales data of FABHALTA from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FABHALTA in PNH. 

Key Questions

• What is the product type, route of administration and mechanism of action of FABHALTA?
• What is the clinical trial status of the study related to FABHALTA in paroxysmal nocturnal hemoglobinuria (PNH) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FABHALTA development?
• What are the key designations that have been granted to FABHALTA for PNH?
• What is the forecasted market scenario of FABHALTA for PNH?
• What are the forecasted sales of FABHALTA 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 and how are these giving competition to FABHALTA for PNH?
• Which are the late-stage emerging therapies under development for the treatment of PNH?