The unipolar depression market is crowded and highly genericized. The prominent use of selective serotonin reuptake inhibitors (SSRIs) and, to a lesser extent, serotonin / norepinephrine reuptake inhibitors (SNRIs) as early-line treatments contributes to the challenges branded therapies face when entering this market. Newer-to-market brands (e.g., Lundbeck / Takeda’s Trintellix / Brintellix, Lundbeck / Otsuka Pharmaceutical’s Rexulti / Rxulti) largely compete for use in treatment-resistant depression (TRD) patients, who make up one-third of the major depressive disorder population. The most recent entrant into the depression market, Janssen’s Spravato, offers the fastest onset of therapeutic effect among the approved therapies—fulfilling a key unmet need—but its use for TRD is constrained by multiple factors. Because of remaining unmet need, physicians will continue to look to emerging therapies—many of which offer novel mechanisms of action—as potential future treatment options in this market.

QUESTIONS ANSWERED:

  • What factors drive and constrain the use of branded antidepressants and atypical antipsychotics? What branded therapy is expected to experience the greatest commercial success during the forecast period?
  • What clinical role will Spravato (Janssen’s esketamine) play in the treatment of TRD?
  • Given the crowded, highly genericized unipolar depression market, what is the commercial potential of key emerging therapies for unipolar depression?
  • What are the greatest areas of unmet need in the treatment of unipolar depression, and how are late-phase emerging therapies expected to address these unmet needs?

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

Primary research: Approximately 15 country-specific interviews with thought-leading psychiatrists and PCPs / GPs; supported by survey data collected for this and other DRG research.

Epidemiology: 12-month prevalence of unipolar depression by country, segmented by MDD, minor depression, and dysthymia; diagnosed and drug-treated cases of unipolar depression; 12-month prevalence of MDD by country, segmented by chronic pain status; 12-month prevalence of MDD by country, segmented by treatment-resistant status.

Emerging therapies: Phase III/preregistration: 5 drugs. Coverage of select Phase II and Phase I products.

Market forecast features: 10-year, annualized, drug-level sales and patient share of key unipolar depression therapies from 2019-2029, segmented by brands / generics

Key companies: AbbVie, AstraZeneca, Axsome Therapeutics, Biogen, Gedeon Richter, GlaxoSmithKline, Janssen, Lundbeck, Luye Pharma Group, Otsuka Pharmaceutical, Pfizer, Relmada Therapeutics, Sage Therapeutics, Shionogi, Sumitomo Dainippon, Sunovion, Takeda

Key drugs: Ansofaxine hydrochloride, aripiprazole, bupropion HCl SR/XR, duloxetine, escitalopram, Latuda (lurasidone), quetiapine IR/XR, Rexulti / Rxulti (brexpiprazole), Spravato (esketamine), Trintellix / Brintellix (vortioxetine), venlafaxine IR / XR, Vraylar / Reagila (cariprazine), AXS-05, REL-1017, seltorexant, zuranolone (SAGE-217)

Table of contents

  • Unipolar Depression - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
        • November 2020
      • Q3 2020
        • September 2020
      • Q2 2020
        • April 2020
      • Q1 2020
        • January 2020
    • Key Findings
      • Unipolar Depression - Key Findings - March 2021
        • January 2020
    • Market Outlook
      • Key Findings
        • Market Share of Unipolar Depression Drug Classes: 2019
        • Market Share of Unipolar Depression Drug Classes: 2029
        • Unipolar Depression SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Unipolar Depression?
          • What Factors Are Constraining the Market for Unipolar Depression?
        • Drug-Class-Specific Trends
          • Major-Market Sales of SSRIs in Unipolar Depression, 2019-2029
          • Patient Share of SSRIs in Unipolar Depression in the United States, 2019-2029
          • Patient Share of SSRIs in Unipolar Depression in Europe, 2019-2029
          • Patient Share of SSRIs in Unipolar Depression in Japan, 2019-2029
          • Major-Market Sales of SNRIs in Unipolar Depression, 2019-2029
          • Patient Share of SNRIs in Unipolar Depression in the United States, 2019-2029
          • Patient Share of SNRIs in Unipolar Depression in Europe, 2019-2029
          • Patient Share of SNRIs in Unipolar Depression in Japan, 2019-2029
          • Major-Market Sales and Patient Share of Dopaminergic / Noradrenergic Agents in Unipolar Depression, 2019-2029
          • Major-Market Sales of Atypical Antipsychotics in Unipolar Depression, 2019-2029
          • Patient Share of Atypical Antipsychotics in Unipolar Depression in the United States, 2019-2029
          • Patient Share of Atypical Antipsychotics in Unipolar Depression in Europe, 2019-2029
          • Patient Share of Atypical Antipsychotics in Unipolar Depression in Japan, 2019-2029
          • Major-Market Sales of Mixed Serotonin Modulators in Unipolar Depression, 2019-2029
          • Patient Share of Mixed Serotonin Modulators in Unipolar Depression in the United States, 2019-2029
          • Patient Share of Mixed Serotonin Modulators in Unipolar Depression in Europe, 2019-2029
          • Patient Share of Mixed Serotonin Modulators in Unipolar Depression in Japan, 2019-2029
          • Major-Market Sales of NMDA Receptor Modulators in Unipolar Depression, 2019-2029
          • Patient Share of NMDA Receptor Modulators in Unipolar Depression in the United States, 2019-2029
          • Patient Share of NMDA Receptor Modulators in Unipolar Depression in Europe, 2019-2029
          • Patient Share of NMDA Receptor Modulators in Unipolar Depression in Japan, 2019-2029
          • Major-Market Sales and Patient Share of Zuranolone (SAGE-217) in Unipolar Depression, 2019-2029
      • Forecast
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Environmental Factors
            • Genetic Factors
              • Select Genes Related to Depression
              • Hypothalamic-Pituitary-Adrenal Axis and Depression
            • Key Pathways and Drug Targets
              • The Monoamine Hypothesis and Antidepressant Drugs
              • SSRI Action at the Serotonergic Synapse
              • Key Pathways and Drug Targets in Unipolar Depression
          • Epidemiology Overview
            • Key Findings
              • Epidemiology Populations
                • Disease Definition
                • Unipolar Depression
                • Major Depressive Disorder
                • Minor Depression
                • Dysthymia
                • Sources for 12-Month Prevalence of Unipolar Depression
                • Number of 12-Month Prevalent Cases of Unipolar Depression in the Major Pharmaceutical Markets by Type, 2019-2029 (thousands)
                • Disease Definition
                • Methods
                • Sources for Comorbid Chronic Pain with Major Depressive Disorder
                • Number of 12-Month Prevalent Cases of Major Depressive Disorder in the Major Pharmaceutical Markets by Chronic Pain Status, 2019-2029 (thousands)
                • Disease Definition
                • Methods
                • Sources for Treatment-Resistant Depression of Major Depressive Disorder
                • Number of 12-Month Prevalent Cases of Major Depressive Disorder in the Major Pharmaceutical Markets by Treatment Stage, 2019-2029 (thousands)
                • Treatment-Resistant Depression: Patient-Flow Diagram
                • Percentage Diagnosed
                • Diagnosed Prevalent Cases of Unipolar Depression: 2019-2029 (thousands)
                • Percentage Drug-Treated
                • Drug-Treated Prevalent Cases of Unipolar Depression: 2019-2029 (thousands)
            • Current Treatment Overview
              • Key Findings
                • Treatment Goals
                  • Key Endpoints Used in Clinical Trials for Unipolar Depression
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drug Classes Used for Unipolar Depression
                  • Current Treatments Used for Unipolar Depression
                  • Market Events Impacting the Use of Key Current Therapies in Unipolar Depression
                  • Advantages and Disadvantages of Citalopram
                  • Expert Insight: Citalopram
                  • Advantages and Disadvantages of Escitalopram
                  • Expert Insight: Escitalopram
                  • Advantages and Disadvantages of Fluoxetine
                  • Expert Insight: Fluoxetine
                  • Advantages and Disadvantages of Paroxetine
                  • Expert Insight: Paroxetine
                  • Advantages and Disadvantages of Sertraline
                  • Expert Insight: Sertraline
                  • Advantages and Disadvantages of Desvenlafaxine
                  • Advantages and Disadvantages of Duloxetine
                  • Expert Insight: Duloxetine
                  • Advantages and Disadvantages of Levomilnacipran
                  • Advantages and Disadvantages of Venlafaxine
                  • Expert Insight: Venlafaxine
                  • Advantages and Disadvantages of Bupropion
                  • Expert Insight: Bupropion
                  • Advantages and Disadvantages of Aripiprazole
                  • Expert Insight: Aripiprazole
                  • Advantages and Disadvantages of Brexpiprazole
                  • Expert Insight: Brexpiprazole
                  • Advantages and Disadvantages of Cariprazine
                  • Ongoing Clinical Development of Cariprazine
                  • Expert Insight: Cariprazine
                  • Advantages and Disadvantages of Lurasidone
                  • Expert Insight: Lurasidone
                  • Advantages and Disadvantages of Quetiapine XR
                  • Expert Insight: Quetiapine XR
                  • Advantages and Disadvantages of Vilazodone
                  • Expert Insight: Vilazodone
                  • Advantages and Disadvantages of Vortioxetine
                  • Ongoing Clinical Development of Vortioxetine
                  • Key Ongoing Clinical Trials of Vortioxetine in the Treatment of Unipolar Depression and Other Psychiatric Disorders
                  • Expert Insight: Vortioxetine
                  • Agomelatine
                  • Advantages and Disadvantages of Agomelatine
                  • Expert Insight: Agomelatine
                  • Advantages and Disadvantages of Mirtazapine
                  • Expert Insight: Mirtazapine
                  • Advantages and Disadvantages of Selegiline
                  • Expert Insight: Selegiline
                  • Advantages and Disadvantages of Esketamine
                  • Expert Insight: Esketamine
                • Medical Practice
                  • Overview
                  • Country-Specific Unipolar Depression Treatment Guidelines
                  • Factors Influencing Drug Selection in Unipolar Depression
                  • Treatment Decision Tree for Unipolar Depression: United States
                  • Treatment Decision Tree for Unipolar Depression: Europe
                  • Treatment Decision Tree for Unipolar Depression: Japan
              • Unmet Need Overview
                • Current and Future Attainment of Unmet Needs in Unipolar Depression
                • Expert Insight: Unmet Needs in Unipolar Depression
              • Emerging Therapies Overview
                • Key Findings
                  • Pipeline Trends for Unipolar Depression
                • Key Emerging Therapies
                  • Key Therapies in Development for Unipolar Depression
                  • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Unipolar Depression
                  • Zuranolone (SAGE-217) Profile
                  • Key Ongoing Clinical Trials of Zuranolone in the Treatment of Unipolar Depression
                  • Analysis of the Clinical Development Program for Zuranolone (SAGE-217)
                  • Expert Insight: Zuranolone (SAGE-217)
                  • Expectations for Launch and Sales Opportunity of Zuranolone (SAGE-217) in Unipolar Depression
                  • AXS-05 Profile
                  • Analysis of the Clinical Development Program for AXS-05
                  • Expert Insight: AXS-05
                  • Expectations for Launch and Sales Opportunity of AXS-05 in Unipolar Depression
                  • Ansofaxine Hydrochloride Profile
                  • Analysis of the Clinical Development Program for Ansofaxine Hydrochloride
                  • Expert Insight: Ansofaxine Hydrochloride
                  • Expectations for Launch and Sales Opportunity of Ansofaxine Hydrochloride in Unipolar Depression
                • Early-Phase Pipeline Analysis
                  • Select Phase I and Phase II Compounds in Development for Unipolar Depression
                • Key Discontinuations and Failures in Unipolar Depression
                • Access and Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                    • Key Market Access Considerations in Unipolar Depression: United States
                    • General Reimbursement Environment: United States
                    • Key Market Access Considerations in Unipolar Depression: EU5
                    • General Reimbursement Environment: EU5
                    • Key Market Access Considerations in Unipolar Depression: Japan
                    • General Reimbursement Environment: Japan
                • Appendix
                  • Key Abbreviations Related to Unipolar Depression
                  • Brands, Marketers, and Generic Availability of Key Therapies Used for Unipolar Depression by Market
                  • Unipolar Depression Bibliography

              Author(s): Joyce Spadafora, A.L.M.; Arava Suresh, M.Pharm.; Audreza Das, P.G. Dip. ; Shilpa Thakur

              Joyce Spadafora, A.L.M., is a senior analyst on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. She authors content on various chronic pain and psychiatric indications. Prior to joining DRG, she spent several years in the biotech industry focusing on new product development and consulting. She holds a master’s degree in extension studies in psychology from Harvard University and a B.S. in mechanical engineering from the Massachusetts Institute of Technology.

              Arava Suresh, M.Pharm., is a research associate on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. He earned a master’s degree in pharmaceutical administration and management from Manipal University in India.

              Audreza Das, P.G. Dip., B.E., is a senior analyst on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. She has authored content on neuropathic pain, age-related macular degeneration, attention-deficit/hyperactivity disorder, unipolar depression, bipolar disorder, treatment-related depression, postherpetic neuralgia, painful diabetic neuropathy, and migraine. Ms. Das obtained her P.G. Dip. in cancer immunology and biotechnology from the University of Nottingham and a B.E. in biotechnology from the Birla Institute of Technology.

              Shilpa Thakur, M.P.H., is an associate epidemiologist at DRG, part of Clarivate. Before joining DRG, she monitored HIV sentinel surveillance in Himachal Pradesh. She has also studied the patterns of antimicrobial resistance in India. She received her M.P.H. from the Postgraduate Institute of Medical Education and Research with a specialization in epidemiology and biostatistics.


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