palynziq pegvaliase pqpz drug insight and market forecast

“PALYNZIQ (Pegvaliase-pqpz), Market Size, Forecast, and Drug Insight – 2032” report provides comprehensive insights about PALYNZIQ (Pegvaliase-pqpz) for Phenylketonuria (PKU) in the 7MM. A detailed picture of the PALYNZIQ (Pegvaliase-pqpz) 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 PALYNZIQ (Pegvaliase-pqpz) 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 PALYNZIQ (Pegvaliase-pqpz) 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

PALYNZIQ (Pegvaliase-pqpz) Injection is the first FDA-approved enzyme substitution therapy for adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 µmol/L (10 mg/dL) on their current treatment. PALYNZIQ is a once-daily self-administered therapy that acts independently of the Phenylalanine Hydroxylase (PAH) enzyme, so it is an option for all eligible adult patients living with PKU.

Dosage and administration

• Baseline blood Phe concentration is obtained before initiating treatment.
• The recommended initial dosage is 2.5 mg subcutaneously once weekly for 4 weeks.
• Dosage is titrated in a step-wise manner over at least 5 weeks based on tolerability to achieve a dosage of 20 mg once daily.
• Patient tolerability, blood Phe concentration, and dietary protein and Phe intake are assessed throughout treatment.
• Increasing the dosage to 40 mg once daily in patients who have been on 20 mg once daily is obtained continuously for at least 24 weeks and who have not achieved blood Phe control (blood Phe concentration less than or equal to 600 µmol/L).
• The dosage is administered to a maximum of 60 mg once daily in patients who have been on 40 mg once daily continuously for at least 16 weeks and who have not achieved blood Phe control.
• PALYNZIQ is discontinued in patients who have not achieved an adequate response after 16 weeks of continuous treatment with the maximum dosage of 60 mg once daily.
• Suppose patients experience blood Phe levels of = 30 µmol/L (0.5 mg/dL). In that case, the dosage is reduced and/or dietary Phe intake is modified to keep levels within a clinically acceptable range and above 30 µmol/L (0.5 mg/dL).

Mechanism of action

Pegvaliase-pqpz is a PEGylated phenylalanine ammonia-lyase (PAL) enzyme that converts phenylalanine to ammonia and trans-cinnamic acid. It substitutes for the deficient Phenylalanine Hydroxylase (PAH) enzyme activity in patients with PKU and reduces blood Phe concentrations.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the PALYNZIQ (Pegvaliase-pqpz) description, mechanism of action, dosage and administration, research and development activities in Phenylketonuria (PKU).
• Elaborated details on PALYNZIQ (Pegvaliase-pqpz) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the PALYNZIQ (Pegvaliase-pqpz) 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 PALYNZIQ (Pegvaliase-pqpz).
• The report contains forecasted sales of PALYNZIQ (Pegvaliase-pqpz) 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 PALYNZIQ (Pegvaliase-pqpz) 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 DelveInsight’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.

PALYNZIQ (Pegvaliase-pqpz) Analytical Perspective by DelveInsight

• In-depth PALYNZIQ (Pegvaliase-pqpz) Market Assessment

This report provides a detailed market assessment of PALYNZIQ (Pegvaliase-pqpz) 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.

• PALYNZIQ (Pegvaliase-pqpz) Clinical Assessment

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

Key Questions

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