Bipolar disorder is a spectrum disorder that encompasses two symptom domains: mania and depression. The symptoms of bipolar depression can include fatigue, insomnia, suicidal ideation, and feelings of worthlessness. Presently, there are a handful of therapies approved to treat bipolar depression, but none can sufficiently address this symptom domain, in particular the acute treatment of patients’ depressive symptoms. Thus, treatments with a rapid onset of therapeutic action are needed. Understanding the drivers of clinical decision-marking in the treatment of bipolar depression will help drug developers focus on agents that fulfill the indication’s treatment needs and help marketers determine how to leverage their products’ attributes.

QUESTIONS ANSWERED

  • What are surveyed psychiatrists’ opinion of the relative performances of bipolar depression therapies, including aripiprazole (Otsuka Pharmaceutical’s Abilify, generics) and lurasidone (Sunovion’s Latuda), on key efficacy, safety/tolerability, and convenience of administration attributes?
  • Based on the responses of surveyed physicians, what level of unmet need exists on key drug performance attributes?
  • What attributes drive decision-making in the treatment of bipolar depression, which have limited impact, and which are hidden opportunities? How do off-label treatments perform on these attributes?
  • Based on a conjoint analysis and TPP simulation, what trade-offs between efficacy, safety, convenience of administration, and price are psychiatrists willing to make for a hypothetical new drug to treat bipolar depression?

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, France, Germany, United Kingdom

Primary research: Survey of 60 U.S. psychiatrists and 31 psychiatrists in Europe.

Key companies: AstraZeneca, Lundbeck A/S, Otsuka Pharmaceuticals, Sunovion

Key drugs: Aripiprazole (Abilify, generics), lamotrigine (Lamictal, generics), lithium, Latuda, and sertraline (Zoloft, generics)

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 subpopulation(s) covered and related diseases/subpopulations.
  • Analysis of remaining drug development opportunities.

Table of contents

  • Bipolar Disorder - Unmet Need - Detailed, Expanded Analysis (US/EU)
    • 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 Bipolar Depression
    • 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 Bipolar Depression
      • Importance of Efficacy Attributes to Prescribing Decisions in Bipolar Depression: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Bipolar Depression: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Bipolar Depression: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Bipolar Depression: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Bipolar Depression: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Bipolar Depression: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Bipolar Depression: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Bipolar Depression: 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 Bipolar Depression: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Bipolar Depression: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Bipolar Depression: United States
      • Overall Performance of Key Therapies for Bipolar Depression: Europe
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Bipolar Depression Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Bipolar Depression
      • Surveyed Psychiatrists’ Satisfaction with the Performance of Key Therapies for Bipolar Depression on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Psychiatrists’ Satisfaction with the Performance of Key Therapies for Bipolar Depression on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Bipolar Depression: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Bipolar Depression: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Bipolar Depression: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Bipolar Depression: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Bipolar Depression: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Bipolar Depression: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Bipolar Depression: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Bipolar Depression: Europe
      • Key Findings: Unmet Need in Bipolar Depression and Related Indications
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Bipolar Depression and Related Indications: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Bipolar Depression and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Bipolar Depression Market and Emerging Therapy Insights
        • Opportunity: A Favorably Reimbursed Therapy That Effectively Reduces Depressive Symptoms
        • Opportunity: A New Therapy with Improved Efficacy as a Long-Term Mood Stabilizer and Having a Short Titration Schedule
        • Opportunity: A Therapy with a Rapid Onset of Therapeutic Effect for Depressive Symptoms
      • Lack of Opportunity in the Bipolar Depression Market and Emerging Therapy Insights
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
        • Attribute Importance and Part-Worth Utilities
          • Bipolar Depression Target Product Profile: Attribute Importance
          • Impact on the Severity of Depression Symptoms: Mean Change in MADRS at Eight Weeks
          • Rate of Remission of Depression Symptoms: % of Patients with MADRS ≤ 12 at Eight Weeks
          • Average Number of Days from Treatment Initiation for Drug's Effects to Occur
          • Risk of Significant Weight Gain: % of Patients with ≥ 7% Increase in Weight
          • Risk of Somnolence: % of Patients Experiencing Somnolence
          • Titration Schedule: Maximum Length of Titration Period (Days)
          • Price/Treated Day
        • Conjoint Analysis-Based Simulations of Market Scenarios
          • Bipolar Depression Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
          • Bipolar Depression Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
          • Bipolar Depression Market Simulations: Target Product Profiles Included in Scenario 1
          • Bipolar Depression Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
          • Bipolar Depression Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
          • Bipolar Depression Market Simulations: Target Product Profiles Included in Scenario 2
      • Appendix
        • Key Abbreviations
        • Bibliography

    Author(s): Lisa Cloonan, BA

    Lisa joined Decision Resources Group in 2015 as a business insights analyst for the Central Nervous System and Ophthalmology division. In this role, she analyzes the commercial opportunities for pharmacological therapies across the psychiatry space.

    Prior to joining Decision Resources Group, Lisa spent 6 years in clinical stroke research at Massachusetts General Hospital. While in the clinical research field, Lisa developed an expertise in neuroimaging analysis, as well as authored and co-authored articles on the influence of white matter hyperintensity burden on stroke risk and recovery. Lisa holds bachelor of arts from Connecticut College, where her course work focused on behavioral neuroscience.


    Related Reports

    Schizophrenia - Special Topics - Special Topics: Agitation In Bipolar And Schizophrenia (US)

    Agitation is a common behavioral aspect often associated with bipolar disorder (BPD) and schizophrenia. It often manifests in the form of tension, violence, or...

    View Details