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LYBALVI Drug Insight and Market Forecast - 2032

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    Drug Pipelines

  • 30 Pages
  • July 2023
  • Region: Global
  • DelveInsight
  • ID: 5849486
“This “LYBALVI Drug Insight and Market Forecast - 2032” report provides comprehensive insights about LYBALVI for schizophrenia in the seven major markets. A detailed picture of the LYBALVI for schizophrenia in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and 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 LYBALVI for schizophrenia. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the LYBALVI market forecast analysis for schizophrenia in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in schizophrenia.

Drug Summary

LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug for the treatment of adults with schizophrenia and bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5, 10, 15, or 20 mg of olanzapine.

Dosage and Administration

Initiate LYBALVI at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once daily.

Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI) depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily.

Mechanism of Action

The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.

Scope of the Report

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

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.

LYBALVI Analytical Perspective

In-depth LYBALVI Market Assessment

This report provides a detailed market assessment of LYBALVI for schizophrenia in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

LYBALVI Clinical Assessment

The report provides the clinical trials information of LYBALVI for schizophrenia covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

  • In the coming years, the market scenario for schizophrenia 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 LYBALVI dominance.
  • Other emerging products for schizophrenia are expected to give tough market competition to LYBALVI 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 LYBALVI in schizophrenia.
  • The in-depth analysis of the forecasted sales data of LYBALVI from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the LYBALVI in schizophrenia.

Key Questions Answered

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


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Table of Contents

1. Report Introduction
2. LYBALVI Overview in Schizophrenia
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.3. Regulatory Milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)4. Competitive Landscape (Late-stage Emerging Therapies)
5. LYBALVI Market Assessment
5.1. Market Outlook of LYBALVI in Schizophrenia
5.2. 7MM Analysis
5.2.1. Market Size of LYBALVI in the 7MM for Schizophrenia
5.3. Country-wise Market Analysis
5.3.1. Market Size of LYBALVI in the United States for Schizophrenia
5.3.2. Market Size of LYBALVI in Germany for Schizophrenia
5.3.3. Market Size of LYBALVI in France for Schizophrenia
5.3.4. Market Size of LYBALVI in Italy for Schizophrenia
5.3.5. Market Size of LYBALVI in Spain for Schizophrenia
5.3.6. Market Size of LYBALVI in the United Kingdom for Schizophrenia
5.3.7. Market Size of LYBALVI in Japan for Schizophrenia
6. SWOT Analysis7. Analysts’ Views
8. Appendix
8.1. Bibliography
8.2. Report Methodology
9. Publisher Capabilities10. Disclaimer11. About the Publisher12. Report Purchase Options
List of Tables
Table 1: LYBALVI, Clinical Trial Description, 2023
Table 2: LYBALVI, General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Emerging Therapies)
Table 5: LYBALVI Market Size in the 7MM, in USD million (2019-2032)
Table 6: LYBALVI Market Size in the US, in USD million (2019-2032)
Table 7: LYBALVI Market Size in Germany, in USD million (2019-2032)
Table 8: LYBALVI Market Size in France, in USD million (2019-2032)
Table 9: LYBALVI Market Size in Italy, in USD million (2019-2032)
Table 10: LYBALVI Market Size in Spain, in USD million (2019-2032)
Table 11: LYBALVI Market Size in the UK, in USD million (2019-2032)
Table 12: LYBALVI Market Size in Japan, in USD million (2019-2032)
List of Figures
Figure 1: LYBALVI Market Size in the 7MM, USD million (2019-2032)
Figure 2: LYBALVI Market Size in the United States, USD million (2019-2032)
Figure 3: LYBALVI Market Size in Germany, USD million (2019-2032)
Figure 4: LYBALVI Market Size in France, USD million (2019-2032)
Figure 5: LYBALVI Market Size in Italy, USD million (2019-2032)
Figure 6: LYBALVI Market Size in Spain, USD million (2019-2032)
Figure 7: LYBALVI Market Size in the United Kingdom, USD million (2019-2032)
Figure 8: LYBALVI Market Size in Japan, USD million (2019-2032)