NurOwn (MSC-NTF Cells), Emerging Drug Insight and Market Forecast - 2032

“NurOwn (MSC-NTF Cells), Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about NurOwn (MSC-NTF Cells) for Amyotrophic Lateral Sclerosis in the 7MM. A detailed picture of the NurOwn (MSC-NTF Cells) 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 NurOwn (MSC-NTF Cells) 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 NurOwn (MSC-NTF Cells) 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 other emerging therapies in Amyotrophic Lateral Sclerosis.

Drug Summary

MSC-NTF cells (NurOwn) are autologous bone marrow-derived mesenchymal stem cells (MSC) induced in culture to secrete high levels of neurotrophic factors (NTFs) that support neuronal growth and survival. Thus, MSC-NTF cells combine MSC's immunomodulatory therapeutic benefits with enhanced neurotrophic factor secretion.

Autologous MSC-NTF cells are produced from the patient's bone marrow-derived MSCs that have been differentiated in culture. A patient's MSCs are harvested and differentiated to secrete high levels of NTFs using proprietary technology. The differentiated MSCs, known as MSC-NTF cells, are then harvested and prepared for injection into the patient. The MSC-NTF cells are not genetically modified. Each treatment consists of a ready-for-injection syringe containing 100-125 × 106 freshly-harvested autologous MSC-NTF cells in a volume of 4 mL. The MSC-NTF cells are autologous and, therefore, unlikely to induce an adverse immune response. In August 2020, the company announced the publication of new preclinical data supporting the proposed NurOwn mechanism in Amyotrophic Lateral Sclerosis, progressive multiple sclerosis, and Alzheimer's disease.

Autologous MSC-NTF cells have been administered to a total of about 70 Amyotrophic Lateral Sclerosis patients in three completed clinical trials, including two open-label trials in Israel and a multicenter, double-blind, placebo-controlled trial in the United States. Overall, the results show that the administration of autologous MSC-NTF cells is safe and well tolerated.

In December 2021, the FDA authorized further NurOwn dosing under the Expanded Access Program (EAP). The FDA recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase III NurOwn trial and met specific eligibility criteria had the opportunity to receive three doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the initial EAP treatments aided in making an informed decision to move forward with additional doses for participants who completed it.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the NurOwn (MSC-NTF Cells) description, mechanism of action, dosage and administration, research and development activities in Amyotrophic Lateral Sclerosis.
• Elaborated details on NurOwn (MSC-NTF Cells) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the NurOwn (MSC-NTF Cells) 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 NurOwn (MSC-NTF Cells).
• The report contains forecasted sales of NurOwn (MSC-NTF Cells) 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 NurOwn (MSC-NTF Cells) 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.

NurOwn (MSC-NTF Cells) Analytical Perspective

In-depth NurOwn (MSC-NTF Cells) Market Assessment

This report provides a detailed market assessment of NurOwn (MSC-NTF Cells) 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.

NurOwn (MSC-NTF Cells) Clinical Assessment

The report provides the clinical trials information of NurOwn (MSC-NTF Cells) in 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 NurOwn (MSC-NTF Cells) dominance.
• Other emerging products for Amyotrophic Lateral Sclerosis are expected to give tough market competition to NurOwn (MSC-NTF Cells) 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 NurOwn (MSC-NTF Cells) in Amyotrophic Lateral Sclerosis.
• Our in-depth analysis of the forecasted sales data of NurOwn (MSC-NTF Cells) from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the NurOwn (MSC-NTF Cells) in Amyotrophic Lateral Sclerosis.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of NurOwn (MSC-NTF Cells)?
• What is the clinical trial status of the study related to NurOwn (MSC-NTF Cells) in Amyotrophic lateral sclerosis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the NurOwn (MSC-NTF Cells) development?
• What are the key designations that have been granted to NurOwn (MSC-NTF Cells) for Amyotrophic Lateral Sclerosis?
• What is the forecasted market scenario of NurOwn (MSC-NTF Cells) for Amyotrophic Lateral Sclerosis?
• What are the forecasted sales of NurOwn (MSC-NTF Cells) 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 Amyotrophic Lateral Sclerosis and how are they giving competition to NurOwn (MSC-NTF Cells) for Amyotrophic Lateral Sclerosis?
• Which are the late-stage emerging therapies under development for the treatment of Amyotrophic Lateral Sclerosis?