Schizophrenia – Unmet Need – Detailed, Expanded Analysis (Negative Symptoms) – 2021

Although the schizophrenia drug market is crowded, few, if any, effective therapies are available in the United States and Europe to treat the negative symptoms of schizophrenia (e.g., apathy, social withdrawal, affective flattening). Of note, AbbVie’s Vraylar / Gedeon Richter / Recordati’s Reagila has shown some efficacy for the treatment of predominant negative symptoms in Phase III trials, and amisulpride is specifically approved in some European countries for the treatment of negative symptoms. Given the sizable percentage of schizophrenia patients who exhibit negative symptoms and the paucity of therapeutic options in this segment, there is high unmet need and commercial opportunity for an efficacious and safe therapy to treat the negative symptoms of schizophrenia in this underserved segment.

QUESTIONS ANSWERED

  • What is the relative importance of a therapy’s various attributes in psychiatrists’ prescribing decisions for the negative symptoms of schizophrenia (e.g., improvement in negative symptoms, improvement in patient functioning, improvement in positive symptoms)?
  • How do U.S. and European psychiatrists rate the performance of Vraylar / Reagila on key treatment drivers and goals for the negative symptoms of schizophrenia?
  • What are the prevailing areas of unmet need and opportunity in the treatment of negative symptoms of schizophrenia?
  • What trade-offs across key drug attributes and price are acceptable to psychiatrists for a hypothetical new drug for the negative symptoms of schizophrenia?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

CONTENT HIGHLIGHTS

Markets covered: United States, United Kingdom, France, Germany.

Primary research: Survey of 61 U.S. and 30 European psychiatrists fielded in January 2021.

Key companies: Janssen, Otsuka Pharmaceutical, AbbVie, Sanofi, Eli Lilly, Lundbeck, Gedeon Richter, Recordati.

Key drugs: Aripiprazole, cariprazine, risperidone,amisulpride, olanzapine, fluoxetine, citalopram.

Table of contents

  • Schizophrenia - Unmet Need - Detailed, Expanded Analysis (Negative Symptoms) - 2021
    • Executive Summary
      • Unmet Need - Negative Symptoms of Schizophrenia - Executive Summary - March 2021
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for the Negative Symptoms of Schizophrenia and Rationale for Drug Selection
      • Treatment Drivers and Goals
        • Key Findings: Attribute Importance
        • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Psychiatrists' Prescribing Decisions in Negative Symptoms of Schizophrenia
        • Importance of Efficacy Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Negative Symptoms of Schizophrenia: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Negative Symptoms of Schizophrenia: Europe
        • Key Findings: Stated vs. Derived Importance
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Negative Symptoms of Schizophrenia: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Negative Symptoms of Schizophrenia: United States
        • Overall Performance of Key Therapies for Negative Symptoms of Schizophrenia: Europe
        • Mean Overall Performance of Key Therapies for Negative Symptoms of Schizophrenia: United States and Europe
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Negative Symptoms of Schizophrenia Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Negative Symptoms of Schizophrenia
        • Surveyed Psychiatristsu2019 Satisfaction with the Performance of Key Therapies for Negative Symptoms of Schizophrenia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Psychiatristsu2019 Satisfaction with the Performance of Key Therapies for Negative Symptoms of Schizophrenia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Negative Symptoms of Schizophrenia: United States
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Negative Symptoms of Schizophrenia: Europe
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Negative Symptoms of Schizophrenia: United States
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Negative Symptoms of Schizophrenia: Europe
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Negative Symptoms of Schizophrenia: United States
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Negative Symptoms of Schizophrenia: Europe
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Negative Symptoms of Schizophrenia: United States
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Negative Symptoms of Schizophrenia: Europe
        • Key Findings: Unmet Need in Negative Symptoms of Schizophrenia and Related Indications
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Negative Symptoms of Schizophrenia and Related Indications: United States
        • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Negative Symptoms of Schizophrenia and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Negative Symptoms of Schizophrenia Market and Emerging Therapy Insights
          • Opportunity: A Therapy Offering Improvement in Negative Symptoms in Schizophrenia Patients
          • Opportunity: A Therapy Offering Improvement in Functioning in Patients with the Negative Symptoms of Schizophrenia
          • Opportunity: An Efficacious Negative Symptoms Therapy Offering Improved Safety and Tolerability Profile in Patients with the Negative Symptoms of Schizophrenia
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
        • Attribute Importance and Part-Worth Utilities
          • Negative Symptoms of Schizophrenia Target Product Profile: Attribute Importance
          • Negative symptoms: Mean change from baseline in PANSS-FSNS at week 26
          • Patient functioning: Mean change from baseline in PSP scale total score at week 26
          • Positive symptoms: Mean change from baseline in PANSS positive subscale at week 26
          • % of patients who experience serious adverse events at week 26
          • Long-term tolerability: % of patients ceasing therapy due to adverse events u2264 1 year
          • Delivery profile
          • Price per treated day
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Negative Symptoms of Schizophrenia Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Negative Symptoms of Schizophrenia Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Negative Symptoms of Schizophrenia Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography

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