Luxturna (Voretigene neparvovec-rzyl) - Drug Insight and Market Forecast - 2030

Overview

Luxturna (voretigene neparvovec-rzyl) - Drug Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Luxturna (voretigene neparvovec-rzyl) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2017-2030 is provided in this report along with a detailed description of the product. The product details cover mechanism of action, dosage and administration, route of synthesis, and pharmacological studies, including product marketed details, regulatory milestones, and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.

Luxturna (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing. In December 2017, the U.S. Food and Drug Administration approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. Luxturna works by delivering a normal copy of the RPE65 gene directly to retinal cells. These retinal cells then produce the normal protein that converts light to an electrical signal in the retina to restore patient's vision loss. Luxturna uses a naturally occurring adeno-associated virus, which has been modified using recombinant DNA techniques, as a vehicle to deliver the normal human RPE65 gene to the retinal cells to restore vision. Luxturna should be given only to patients who have viable retinal cells as determined by the treating physician(s). The safety and efficacy of Luxturna were established in a clinical development program with a total of 41 patients between the ages of 4 and 44 years. All participants had confirmed biallelic RPE65 mutations. The primary evidence of efficacy of Luxturna was based on a Phase 3 study with 31 participants by measuring the change from baseline to one year in a subject's ability to navigate an obstacle course at various light levels. The group of patients that received Luxturna demonstrated significant improvements in their ability to complete the obstacle course at low light levels as compared to the control group. The FDA granted this application Priority Review and Breakthrough Therapy designations. Luxturna also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Scope of the report

The report provides insights into:

• A comprehensive product overview including the product description, mechanism of action, dosage and administration, route of synthesis, pharmacological studies (pharmacodynamics and pharmacokinetics) and adverse reactions.
• Elaborated details on regulatory milestones and other development activities have been provided in this report.
• The report also highlights the drug marketed details across the United States, Europe and Japan.
• The report also covers the patent's information with expiry timeline around Luxturna (voretigene neparvovec-rzyl).
• The report contains historical and forecasted sales for Luxturna (voretigene neparvovec-rzyl) till 2030.
• Comprehensive coverage of the late-stage emerging therapies (Phase III) in the space with a brief snapshot of the details.
• The report also features the SWOT analysis with analyst insights and key findings of Luxturna (voretigene neparvovec-rzyl).

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.

Luxturna (voretigene neparvovec-rzyl) Analytical Perspective

In-depth Luxturna (voretigene neparvovec-rzyl) Market Assessment

This report provides a detailed market assessment of Luxturna (voretigene neparvovec-rzyl) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides historical and forecasted sales data from 2017 to 2030.

Luxturna (voretigene neparvovec-rzyl) Clinical Assessment

The report provides the clinical trials information of Luxturna (voretigene neparvovec-rzyl) covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights

• In the coming years, the market scenario for Luxturna (voretigene neparvovec-rzyl) is set to change due to the extensive research in the treatment of the indicated condition 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 and academics are working to assess challenges and seek opportunities that could influence Luxturna (voretigene neparvovec-rzyl) dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Other approved products for the disease are giving market competition to Luxturna (voretigene neparvovec-rzyl) and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, development activities, and some key findings provide the current market scenario of Luxturna (voretigene neparvovec-rzyl).
• Our in-depth analysis of the sales data of Luxturna (voretigene neparvovec-rzyl) from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Luxturna (voretigene neparvovec-rzyl) in the market.

Key Questions Answered

• What is the prescribed dosage and strengths of Luxturna (voretigene neparvovec-rzyl) are available in the market?
• What are the common adverse reactions or side effects of Luxturna (voretigene neparvovec-rzyl)?
• What is the product type, route of administration and mechanism of action of Luxturna (voretigene neparvovec-rzyl)?
• What are the chemical specifications of Luxturna (voretigene neparvovec-rzyl)?
• How are the clinical trials diversified on the basis of the trial status?
• What is the history of Luxturna (voretigene neparvovec-rzyl), and what is its future?
• What are the marketed details of Luxturna (voretigene neparvovec-rzyl) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• How many patents have been granted to Luxturna (voretigene neparvovec-rzyl) and when these patents will get expire?
• What are the pros (benefits) and cons (disadvantages) of Luxturna (voretigene neparvovec-rzyl)?
• In which countries Luxturna (voretigene neparvovec-rzyl) got approval and when it gets launched?
• What are the clinical trials are currently ongoing for Luxturna (voretigene neparvovec-rzyl)?
• How the safety and efficacy results determined the approval of Luxturna (voretigene neparvovec-rzyl)?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Luxturna (voretigene neparvovec-rzyl) development?
• What are the key designations that have been granted to Luxturna (voretigene neparvovec-rzyl)?
• What is the historical and forecasted market scenario of Luxturna (voretigene neparvovec-rzyl)?
• How is the market trend of Luxturna (voretigene neparvovec-rzyl) is different in the Seven Major Markets (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan)?
• What are the other approved products available and how these are giving competition to Luxturna (voretigene neparvovec-rzyl)?
• Which are the late-stage emerging therapies under development for the treatment of the indicated condition?