KUVAN (Sapropterin Hydrochloride), Drug Insight and Market Forecast - 2032

"KUVAN (Sapropterin Hydrochloride), Drug Insight and Market Forecast - 2032” report provides comprehensive insights about KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU) in the 7MM. A detailed picture of the KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU) 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 KUVAN (Sapropterin Hydrochloride) for Phenylketonuria (PKU). 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 KUVAN (Sapropterin Hydrochloride) market forecast, analysis for Phenylketonuria (PKU) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Phenylketonuria (PKU).

Drug Summary

KUVAN is indicated to reduce blood phenylalanine (Phe) levels in patients with Hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. In order to determine if there is a response to KUVAN, the recommended starting dose of KUVAN is 10 mg/kg/day taken once daily for up to a month. If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5-20 mg/kg/day in patients who respond to KUVAN. KUVAN was developed in partnership with Merck Serono, a division of Merck.

Dosage and administration
All patients with PKU who are being treated with KUVAN should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction.

Starting Dosage

• Pediatric patients aged 1 month to 6 years: The recommended starting dose of KUVAN is 10 mg/kg is taken once daily.
• Patients 7 years and older: The recommended starting dose of KUVAN is 10-20 mg/kg is taken once daily.

Dosage Adjustment

• Doses of KUVAN may be adjusted in the range of 5-20 mg/kg, taken once daily.
• Blood Phe is monitor regularly, especially in pediatric patients.

Mechanism of action
KUVAN is a synthetic form of BH4, the cofactor for the enzyme Phenylalanine Hydroxylase (PAH). PAH hydroxylates Phe through an oxidative reaction to form tyrosine. In patients with PKU, PAH activity is absent or deficient. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of Phe, and decrease Phe levels in some patients.

Scope of the Report

The report provides insights into:

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

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.

KUVAN (Sapropterin Hydrochloride) Analytical Perspective

In-depth KUVAN (Sapropterin Hydrochloride) Market Assessment

This report provides a detailed market assessment of KUVAN (Sapropterin Hydrochloride) in Phenylketonuria (PKU) 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.

KUVAN (Sapropterin Hydrochloride) Clinical Assessment

The report provides the clinical trials information of KUVAN (Sapropterin Hydrochloride) in Phenylketonuria (PKU) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

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

Key Questions Answered

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