Although the schizophrenia drug market is crowded, few, if any, effective therapies are available in the United States and Europe to treat the disease’s negative symptoms (e.g., blunted affect, alogia). Of note, Allergan’s Vraylar has shown some efficacy in the treatment of predominant negative symptoms, and amisulpride is specifically approved in some European countries for the treatment of negative symptoms. Nevertheless, more therapies are needed. Given that a sizable proportion of schizophrenia patients exhibit negative symptoms, it is essential to understand how psychiatrists perceive the performance of current therapies and determine the greatest areas of unmet need and thus the opportunities in this space.

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 of negative symptoms, improvement of patient functioning, improvement of positive symptoms)?
  • How do U.S. psychiatrists rate Vraylar as performing 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 the 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: Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.

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

Primary research: Survey of 60 psychiatrists in the United States and 33 psychiatrists in Europe.

Key companies: Allergan, Gedeon Richter, Recordati, Sanofi, Bristol-Myers Squibb, Janssen, Eli Lilly, Lundbeck, Otsuka Pharmaceuticals, Minerva Neurosciences.

Key drugs: Vraylar (U.S.)/Reagila (Europe), amisulpride (Europe), aripiprazole, risperidone, olanzapine, fluoxetine, citalopram, roluperidone (MIN-101).

Key metrics included:

  • Stated versus derived analysis of U.S. and European physician prescribing behavior.
  • Conjoint analysis with U.S. and European physicians, includes market simulator.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet need in disease/subpopulation covered and related diseases/subpopulations.
  • Analysis of remaining drug development opportunities.

Table of contents

  • Schizophrenia - Unmet Need - Detailed, Expanded Analysis (Negative Symptoms)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for Negative Symptoms of Schizophrenia
    • 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
      • 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 Psychiatrists’ 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 Psychiatrists’ 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 of Negative Symptoms in Schizophrenia Patients
        • Opportunity: A Therapy Offering Improvement of Functioning in Patients with the Negative Symptoms of Schizophrenia
        • Opportunity: An Efficacious 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
        • Risk of EPS: % of Patients Who Experience EPS at Week 26
        • Long-Term Tolerability: % of Patients Ceasing Therapy due to Adverse Events ≤ One Year
        • Delivery Profile
        • Price per Treated Day Relative to Branded Aripiprazole
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Negative Symptoms of Schizophrenia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Negative Symptoms of Schizophrenia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Negative Symptoms of Schizophrenia Market Simulations: Target Product Profiles Included in Scenario 1
        • Negative Symptoms of Schizophrenia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Negative Symptoms of Schizophrenia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Negative Symptoms of Schizophrenia Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Experts Interviewed
      • Bibliography

Author(s): Himanshu Jain, M.S. Pharm

Himanshu joined the CNS / ophthalmology team at Decision Resources Group in 2016. He has authored content for psychiatry and ophthalmology (retinal / nonretinal) indications, including schizophrenia, age-related macular degeneration, diabetic retinopathy / diabetic macular edema, dry eye disease, glaucoma, and uveitis.

Himanshu has more than ten years of experience working in market research and consulting firms, and has managed multiple market assessment projects, including bottom-up forecasts, across multiple therapy areas. He holds a M.S. degree in Pharmacology and Toxicology from the National Institute of Pharmaceutical Education and Research in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.


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