Tofersen Emerging Drug Insight and Market Forecast - 2032

“Tofersen Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about Tofersen for Amyotrophic Lateral Sclerosis in the 7MM. A detailed picture of the Tofersen for Amyotrophic Lateral Sclerosis 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 Tofersen for Amyotrophic Lateral Sclerosis. 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 Tofersen market forecast, analysis for Amyotrophic Lateral Sclerosis in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about emerging therapies in Amyotrophic Lateral Sclerosis.

Drug Summary

Tofersen (formerly IONIS-SOD1Rx), also known as BIIB067, is an antisense drug designed to reduce the production of SOD1, which is the best understood genetic cause of familial ALS. It works by binding to SOD1 mRNA, allowing for its degradation by RNase-H and reducing SOD1 protein production. This is thought to decrease the toxicity of mutant SOD1 and potentially provide therapeutic benefit through improved survival and function to ALS patients with SOD1 mutations.

Biogen licensed Tofersen from Ionis Pharmaceuticals under a collaborative development and license agreement and led its clinical development for ALS (Ionis Pharmaceuticals, n.d.-b). The EMA has granted this candidate Orphan Drug designation.

The Biogen Company says it is actively engaging with regulators, the medical community, patient advocacy groups, and other key stakeholders worldwide to determine potential next steps. The company plans to expand its ongoing early access program (EAP) to all people with SOD1-ALS in countries where such programs are permitted by local regulations, and future access may be secured.

In July 2022, The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for Amyotrophic Lateral Sclerosis (ALS). The application has been granted priority review and given a Prescription Drug User Fee Act action date of January 25, 2023.

Scope of the Report

The report provides insights into:

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

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.

Tofersen Analytical Perspective

In-depth Tofersen Market Assessment

This report provides a detailed market assessment of Tofersen in Amyotrophic Lateral Sclerosis 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.

Tofersen Clinical Assessment

The report provides the clinical trials information of Tofersen for Amyotrophic Lateral Sclerosis covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Amyotrophic Lateral Sclerosis 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 Tofersen dominance.
• Other emerging products for Amyotrophic Lateral Sclerosis are expected to give tough market competition to Tofersen 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 Tofersen in Amyotrophic Lateral Sclerosis.
• Our in-depth analysis of the forecasted sales data of Tofersen from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Tofersen in Amyotrophic Lateral Sclerosis.

 

Key Questions Answered

• What is the product type, route of administration and mechanism of action of Tofersen?
• What is the clinical trial status of the study related to Tofersen in Amyotrophic Lateral Sclerosis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Tofersen development?
• What are the key designations that have been granted to Tofersen for Amyotrophic Lateral Sclerosis?
• What is the forecasted market scenario of Tofersen for Amyotrophic Lateral Sclerosis?
• What are the forecasted sales of Tofersen in the 7MM, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available in Amyotrophic Lateral Sclerosis and how are they giving competition to Tofersen for Amyotrophic Lateral Sclerosis?
• Which are the late-stage emerging therapies under development for the treatment of Amyotrophic Lateral Sclerosis?