OXLUMO Drug Insight and Market Forecast - 2032

“This “OXLUMO Drug Insight and Market Forecast - 2032” report provides comprehensive insights about OXLUMO for Primary Hyperoxaluria (PH) in the six major markets. A detailed picture of the OXLUMO for primary hyperoxaluria in the 6MM, i.e., United States, EU4 (Germany, France, Italy, Spain), the United Kingdom for the study period 2019 -2032 is provided in this report along with a detailed description of the OXLUMO for primary hyperoxaluria. 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 OXLUMO market forecast analysis for primary hyperoxaluria in the 6MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in primary hyperoxaluria.

Drug Summary

Lumasiran (formerly ALN-GO1) being developed by Alnylum Pharma, is a subcutaneously administered, investigational RNAi therapeutic targeting glycolate oxidase (GO). Lumasiran is designed to reduce hepatic levels of GO enzyme (encoded by HAO1), thereby depleting the substrate necessary for oxalate production, which directly contributes to the pathophysiology of PH1.

Lumasiran utilizes the companies' Enhanced Stabilization Chemistry (ESC)-GalNAc delivery platform, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. Lumasiran has received Orphan Drug Designations from both the US and EU and a Breakthrough Therapy Designation from the US FDA. Currently, the company is evaluating lumasiran for severe PH1. Recently, Alnylam submitted regulatory applications to the US Food and Drug Administration and European Medicines Agency to support label expansion for OXLUMO for the treatment of advanced primary hyperoxaluria Type 1.

Mechanism of Action

Lumasiran reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 (HAO1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. As the GO enzyme is upstream of the deficient alanine: glyoxylate aminotransferase (AGT) enzyme that causes PH1, the mechanism of action of lumasiran is independent of the underlying AGXT gene mutation. OXLUMO is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3) because its mechanism does not affect the metabolic pathways causing hyperoxaluria in PH2 and PH3.

Scope of the Report

The report provides insights into:

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

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher'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.

OXLUMO Analytical Perspective

In-depth OXLUMO Market Assessment

This report provides a detailed market assessment of OXLUMO for primary hyperoxaluria in the six major markets, i.e., United States, EU4 (Germany, France, Italy, Spain), and the United Kingdom. This segment of the report provides forecasted sales data from 2023 to 2032.

OXLUMO Clinical Assessment

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

Report Highlights

• In the coming years, the market scenario for primary hyperoxaluria 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 OXLUMO dominance.
• Other emerging products for primary hyperoxaluria are expected to give tough market competition to OXLUMO 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 OXLUMO in primary hyperoxaluria.
• The in-depth analysis of the forecasted sales data of OXLUMO from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the OXLUMO in primary hyperoxaluria.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of OXLUMO?
• What is the clinical trial status of the study related to OXLUMO in primary hyperoxaluria and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the OXLUMO development?
• What are the key designations that have been granted to OXLUMO for primary hyperoxaluria?
• What is the forecasted market scenario of OXLUMO for primary hyperoxaluria?
• What are the forecasted sales of OXLUMO in the six major countries, including the United States and Europe (Germany, France, Italy, Spain, and the United Kingdom)?
• What are the other emerging products available and how are these giving competition to OXLUMO for primary hyperoxaluria?
• Which are the late-stage emerging therapies under development for the treatment of primary hyperoxaluria?

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