Bipolar disorder (BPD) is a spectrum disorder that encompasses two symptom domains: mania and depression. BPD treatment is usually initiated with atypical antipsychotics and antiepileptic drugs (AEDs); their long-standing stronghold as patient-share leaders contributes to the challenges that branded therapies face entering this crowded generic market. However, treatments with the potential to sufficiently address mania and depression will drive growth of the market. Newer-to-market therapies (e.g., Allergan/Gedeon Richter’s Vraylar/Reagila, Lundbeck/Otsuka Pharmaceutical’s Rexulti/RXulti) continue to be incorporated in the treatment paradigm, and emerging therapies (e.g., NeuroRx’s NRX-100/NRX-101) are hoping to demonstrate their ability to fulfill additional unmet needs in BPDtreatment.

Questions Answered:

  • What factors drive and constrain the use of branded atypical antipsychotics in the treatment of BPD? What branded therapy is expected to experience the greatest commercial success during the forecast period?
  • Given the crowded and highly genericized BPDtherapymarket, what is the commercial potential of key late-phase emerging therapies for BPD?
  • What are the greatest areas of unmet need in the treatment of BPD, and how are emerging therapies expected to address these unmet needs?
  • Effective treatment of BPD-associated cognitive impairment is a great unmet need in this market. To what extent will emerging therapies capitalize on this unmet need? How will physicians likely incorporate these treatments into their clinical practice?

Product description: Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: Eighteen country-specific interviews with thought-leading psychiatrists, supported by survey data collected for this and other DRG research.

Epidemiology: Lifetime prevalence of BPD by country; diagnosed- and drug-treated prevalence of BPD by country.

Emerging therapies: Phase II: 13 drugs; Phase III: 11 drugs; preregistration: 3 drugs; launched: 1 drugs. Coverage of 8 preclinical and Phase I products.

Market forecast features: Ten-year, annualized, patient-based market forecast extending through 2027, segmented by brands/generics.

Key companies: Allergan, Alkermes, AstraZeneca, Eli Lilly, Gedeon Richter, GlaxoSmithKline, Indivior, Janssen, Lundbeck, Minerva Neurosciences, NeuroRx, Noven Pharmaceuticals, Otsuka Pharmaceutical, Pfizer, Sumitomo Dainippon/Sunovion Pharmaceuticals, Takeda Pharmaceutical.

Key drugs: ALKS-3831, ALKS-5461, aripiprazole, esketamine, lamotrigine IR/XR, Latuda (lurasidone), lithium, lumateperone (ITI-007), NRX-100/NRX-101, , Perseris (risperidone one-month depot, RBP-7000), rapastinel, Rexult/RXulti (brexpiprazole), Risperdal Consta (risperidone microspheres depot), roluperidone (MIN-101), Seroquel IR/XR (quetiapine IR/XR), Trintellix/Brintellix (vortioxetine), Vraylar/Reagila (cariprazine), Wellbutrin IR/SR/XL.

Table of contents

  • Bipolar Disorder - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • November 2018
      • August 2018
      • June 2018
      • March 2018
    • Market Outlook
      • Key Findings
        • Market Overview
        • Market Share of Bipolar Disorder Drug Classes: 2017
        • Market Share of Bipolar Disorder Drug Classes: 2027
        • Bipolar Disorder SWOT Analysis
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Bipolar Disorder?
        • What Factors Are Constraining the Market for Bipolar Disorder?
        • Key Market Events for Bipolar Disorder: 2017-2027
      • Drug-Class-Specific Trends
        • Major-Market Sales of Oral Atypical Antipsychotics in Bipolar Disorder, 2017-2027
        • Patient Share of Key Oral Atypical Antipsychotics for Bipolar Disorder in the United States: 2017-2027
        • Patient Share of Key Oral Atypical Antipsychotics for Bipolar Disorder in the EU5: 2017-2027
        • Patient Share of Key Oral Atypical Antipsychotics for Bipolar Disorder in Japan: 2017-2027
        • Major-Market Sales of Depot Atypical Antipsychotics in Bipolar Disorder, 2017-2027
        • Patient Share of Depot Atypical Antipsychotics for Bipolar Disorder in the United States: 2017-2027
        • Patient Share of Depot Atypical Antipsychotics for Bipolar Disorder in the EU5: 2017-2027
        • Patient Share of Depot Atypical Antipsychotics for Bipolar Disorder in Japan: 2017-2027
        • Major-Market Sales of Antidepressants in Bipolar Disorder: 2017-2027
        • Patient Share of Antidepressants for Bipolar Disorder in the United States: 2017-2027
        • Patient Share of Antidepressants for Bipolar Disorder in the EU5: 2017-2027
        • Patient Share of Antidepressants for Bipolar Disorder in Japan: 2017-2027
        • Major-Market Sales of Antiepileptic Drugs in Bipolar Disorder: 2017-2027
        • Patient Share of Antiepileptic Drugs for Bipolar Disorder in the United States: 2017-2027
        • Patient Share of Antiepileptic Drugs for Bipolar Disorder in the EU5: 2017-2027
        • Patient Share of Antiepileptic Drugs for Bipolar Disorder in Japan: 2017-2027
        • U.S. Sales of Mixed Neurotransmitter Modulators in Bipolar Disorder: 2017-2027
        • U.S. Patient Share of Mixed Neurotransmitter Modulators for Bipolar Disorder: 2017-2027
        • U.S. and EU5 Sales of 5-HT2A and Sigma2 Receptor Antagonists in Bipolar Disorder: 2017-2027
        • U.S. and EU5 Patient Share of 5-HT2A and Sigma2 Receptor Antagonists for Bipolar Disorder: 2017-2027
        • Major-Market Sales of NMDA Receptor Modulators in Bipolar Disorder: 2017-2027
        • Patient Share of NMDA Receptor Modulators for Bipolar Disorder in the United States: 2017-2027
        • Patient Share of NMDA Receptor Modulators for Bipolar Disorder in the EU5: 2017-2027
        • Patient Share of NMDA Receptor Modulators for Bipolar Disorder in Japan: 2017-2027
        • U.S. Sales of Opioid Receptor Modulators in Bipolar Disorder: 2017-2027
        • U.S. Patient Share of Opioid Receptor Modulators for Bipolar Disorder: 2017-2027
    • Forecast
      • Market-Forecast-Assumptions
      • Market-Forecast-Dashboard
      • Sales of Drugs to Treat Bipolar Disorder in the Major Pharmaceutical Markets: 2017-2027
    • Etiology and Pathophysiology
      • Genetic Factors
        • Genes Linked to Bipolar Disorder
      • Environmental Factors
        • Key Pathways and Drug Targets
          • Etiology and Pathophysiology of Bipolar Disorder: Levels of Understanding
          • Key Pathways in Bipolar Disorder
      • Epidemiology
        • Key Findings
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Total Lifetime Prevalence Estimates of Bipolar Disorder
            • Total Lifetime Prevalent Cases of Bipolar Disorder: 2017-2027
            • Diagnosed Prevalent Cases of Bipolar Disorder: 2017-2027 (thousands)
            • Drug-Treated Prevalent Cases of Bipolar Disorder: 2017-2027 (thousands)
        • Current Treatment Overview
          • Key Findings
            • Treatment Goals
              • Key End Points Used in Clinical Trials for Bipolar Disorder
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Bipolar Disorder
              • Current Treatments Used for Bipolar Disorder
              • Advantages and Disadvantages of Lithium
              • Expert Insight: Lithium
              • Advantages and Disadvantages of Valproic Acid/Divalproex/Valproate Semisodium
              • Expert Insight: Valproic Acid/Divalproex/Valproate Semisodium
              • Advantages and Disadvantages of Lamotrigine
              • Expert Insight: Lamotrigine
              • Advantages and Disadvantages of Aripiprazole
              • Expert Insight: Aripiprazole
              • Advantages and Disadvantages of Asenapine
              • Expert Insight: Asenapine
              • Advantages and Disadvantages of Brexpiprazole
              • Expert Insight on Brexpiprazole
              • Advantages and Disadvantages of Cariprazine
              • Expert Insight on Cariprazine
              • Advantages and Disadvantages of Lurasidone
              • Expert Insight: Lurasidone
              • Advantages and Disadvantages of Quetiapine
              • Expert Insight: Quetiapine
              • Advantages and Disadvantages of Depot Formulations
              • Expert Insight: Depot Formulations
              • Advantages and Disadvantages of Aripiprazole Lauroxil
              • Expert Insights on Aripiprazole Lauroxil
              • Advantages and Disadvantages of Antidepressants
              • Expert Insight: Antidepressants
              • Advantages and Disadvantages of Bupropion
              • Expert Insight: Bupropion
            • Medical Practice
              • Overview
              • Treatment Guidelines
              • Regional Bipolar Disorder Treatment Guidelines
              • Factors Influencing Drug Selection in Bipolar Disorder
              • Treatment Decision Tree for Bipolar Disorder: United States
              • Treatment Decision Tree for Bipolar Disorder: Europe
              • Treatment Decision Tree for Bipolar Disorder: Japan
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Bipolar Disorder
            • Top Unmet Needs in Bipolar Disorder: Current and Future Attainment
            • Expert Insight: Unmet Needs in Bipolar Disorder
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends in Bipolar Disorder
            • Key Emerging Therapies
              • Notable Developments Among Key Emerging Therapies for Bipolar Disorder
              • Key Therapies in Development for Bipolar Disorder
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Bipolar Disorder
              • Lu-AF35700 Profile
              • Analysis of Clinical Development for Lu-AF35700
              • Expert Insight: Lu-AF35700
              • Expectations for Launch and Sales Opportunity of Lu-AF35700 in Bipolar Disorder
              • ALKS-3831 Profile
              • Analysis of Clinical Development for ALKS-3831
              • Expert Insight: ALKS-3831
              • Expectations for Launch and Sales Opportunity of ALKS-3831 in Bipolar Disorder
              • NRX-100/NRX-101 Profile
              • Analysis of Clinical Development Program for NRX-100/NRX-101
              • Expert Insight: NRX-100/NRX-101
              • Expectations for Launch and Sales Opportunity of NRX-100/NRX-101 in Bipolar Disorder
              • Perseris Profile
              • Doria Profile
              • TV-46000 Profile
              • Analysis of Clinical Development Program for Extended-Release Forms of Risperidone
              • Expert Insight: Extended-Release Risperidone
              • Expectations for Launch and Sales Opportunity of Extended-Release Risperidone in Bipolar Disorder
              • HP-3070 Profile
              • Analysis of Clinical Development Program for HP-3070
              • Expert Insight: HP-3070
              • Expectations for Launch and Sales Opportunity of HP-3070 in Bipolar Disorder
              • SAGE-217 Profile
              • Analysis of the Clinical Development Program for SAGE-217
              • Expert Insight: SAGE-217
              • Expectations for Launch and Sales Opportunity of SAGE-217 in Bipolar Disorder
              • Lumateperone Profile
              • Analysis of Clinical Development Program for Lumateperone
              • Expert Insight: Lumateperone
              • Expectations for Launch and Sales Opportunity of Lumateperone in Bipolar Disorder
              • Evenamide Profile
              • Analysis of Clinical Development Program for Evenamide
              • Expert Insight: Evenamide
              • Expectations for Launch and Sales Opportunity of Evenamide in Bipolar Disorder
              • Esketamine Profile
              • Analysis of Clinical Development Program for Esketamine
              • Expert Insight: Esketamine
              • Expectations for Launch and Sales Opportunity of Esketamine in Bipolar Disorder
              • Rapastinel Profile
              • Analysis of Clinical Development Program for Rapastinel
              • Expert Insight on Rapastinel
              • Expectations for Launch and Sales Opportunity of Rapastinel in Bipolar Disorder
              • ALKS-5461 Profile
              • Analysis of Clinical Development of ALKS-5461
              • Expert Insight: ALKS-5461
              • Expectations for Launch and Sales Opportunity of ALKS-5461 in Bipolar Disorder
              • Roluperidone Profile
              • Analysis of the Clinical Development Program for Roluperidone
              • Expert Insight: Roluperidone
              • Expectations for Launch and Sales Opportunity of Roluperidone in Bipolar Disorder
            • Early-Phase Pipeline Analysis
              • Notable Developments in the Early-Phase Pipeline for Bipolar Disorder
              • Select Compounds in Phase II Development for Bipolar Disorder
              • Select Phase I and Preclinical Development Programs for Bipolar Disorder
          • Access and Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • Key Market Access Considerations in Bipolar Disorder: United States
              • General Reimbursement Environment: United States
              • Key Market Access Considerations in Bipolar Disorder: EU5
              • General Reimbursement Environment: EU5
              • Key Market Access Considerations in Bipolar Disorder: Japan
              • General Reimbursement Environment: Japan
            • Looking for More?
          • Methodology
            • Bottom-Up Forecasting Overview
              • Patient Populations
              • Drug-Specific Assumptions
            • Bottom-Up Forecast Assumptions
              • General Sources of Data
              • Agents Included in Our Market Analysis
              • General Statements About Pricing
              • Sources for Drug Prices
              • 2017 Exchange Rates
              • Dosing, Days of Therapy, and Compliance
              • Generic Erosion
              • Out-Year Forecasting
              • Emerging Therapy Prices
            • Primary Market Research
              • Experts Interviewed
          • Appendix
            • Key Abbreviations Related to Bipolar Disorder
            • Brands, Marketers, and Generic Availability of Key Therapies for Bipolar Disorder by Market
            • Bipolar Disorder Bibliography

        Author(s): Audreza Das, P.G. Dip. ; Abey John, MPH

        Audreza Das is a Senior Analyst in the CNS/Ophthalmology team at Decision Resources Group

        She has authored content across indications, including neuropathic pain, age-related macular degeneration, treatment-related depression, painful diabetic neuropathy, and migraine. Ms. Das has previously worked at Novo Nordisk, as a Market Analyst for European markets. Previous experience at a SME, included developing disease competitive landscapes, covering global conferences etc. Ms. Das received her B.E. degree in Biotechnology from Birla Institute of Technology, a deemed university and her P.G. Diploma in Cancer Immunology & Biotechnology from University of Nottingham.

        Abey John is a medical graduate with a Master’s in Public Health and has been associated with DRG since September 2015. He works with a global team of epidemiologists in performing systematic reviews of assigned diseases and prepare forecast models for clients. He also is involved in producing analyses for pharmaceutical drug developers on the descriptive epidemiology of major drug indications in mature and developing markets and have an overall experience of three years working in different healthcare sectors across the country.

        Prior to joining DRG, Abey had been working with Jhpiego (an affiliate of Johns Hopkins Medical University) in implementing Family Planning Health Programs in India with collaborating with the Government of India. He also has worked with a grassroots level NGO as a health team manager which worked for the benefit of the rural population living in the foothills of the Himalayas.


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