Major Depressive Disorder (DSM-V) – Landscape & Forecast – Disease Landscape & Forecast
The unipolar depression therapy market is crowded and highly genericized. The prominent use of drugs such as selective serotonin reuptake inhibitors (SSRIs) as early-line treatments contributes to the challenges that 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 inadequate responders / treatment-resistant depression (TRD) patients; TRD patients make up one-third of the major depressive disorder (MDD) population. The most recent entrant to the depression market, Janssen’s Spravato, has 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 the substantial remaining unmet need in MDD treatment, physicians will continue to look to emerging therapies—many of which offer novel mechanisms of action—as potential treatments in this market.
QUESTIONS ANSWERED
- What is the current size of the MDD therapy market in the G7 countries? What key events will influence the market over the next decade?
- What factors drive and constrain the use of branded antidepressants and atypical antipsychotics in MDD? What branded therapy is expected to experience the most commercial success during the forecast period?
- What are the areas of most unmet need in the treatment of unipolar depression? Which late-phase therapies have the potential to fulfill these needs?
- What improvements would key late-phase therapies need to demonstrate in order to compete effectively in this crowded market? Where will these agents be placed in the treatment algorithm?
CONTENT HIGHLIGHTS
Geographies: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 26 country-specific interviews with thought-leading psychiatrists; supported by survey data collected for this and other Clarivate research.
Epidemiology: Prevalence of MDD by country; diagnosed / drug-treated prevalence of MDD by country.
Forecast: 10-year, annualized, drug-level sales and patient share of key MDD therapies in 2021-2031, segmented by brands / generics.
Emerging therapies: Phase III/PR: 7 drugs. Coverage of select early-phase products.
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.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Major Depressive Disorder (DSM-V) - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Unipolar depression - Key findings - November 2022
- Key updates
- September 2023
- June 2023
- January 2023
- Q4 2022
- November 2022
- Market outlook
- Key findings
- Market share of MDD drug classes: 2021
- Market share of MDD drug classes: 2031
- MDD SWOT analysis
- Market drivers and constraints
- What factors are driving the market for MDD?
- What factors are constraining the market for MDD?
- Drug-class-specific trends
- Major-market sales of SSRIs in MDD: 2021-2031
- Patient share of SSRIs in MDD in the United States: 2021-2031
- Patient share of SSRIs in MDD in the EU5: 2021-2031
- Patient share of SSRIs in MDD in Japan: 2021-2031
- Major-market sales of SNRIs in MDD: 2021-2031
- Patient share of SNRIs in MDD in the United States: 2021-2031
- Patient share of SNRIs in MDD in the EU5: 2021-2031
- Patient share of SNRIs in MDD in Japan: 2021-2031
- Major-market sales and patient share of dopaminergic / noradrenergic agents in MDD: 2021-2031
- Major-market sales of atypical antipsychotics in MDD: 2021-2031
- Patient share of atypical antipsychotics in MDD in the United States: 2021-2031
- Patient share of atypical antipsychotics in MDD in the EU5: 2021-2031
- Patient share of atypical antipsychotics in MDD in Japan: 2021-2031
- Major-market sales of mixed serotonin modulators in MDD: 2021-2031
- Patient share of mixed serotonin modulators in MDD in the United States: 2021-2031
- Patient share of mixed serotonin modulators in MDD in the EU5: 2021-2031
- Patient share of mixed serotonin modulators in MDD in Japan: 2021-2031
- Major-market sales of NMDA receptor modulators in MDD: 2021-2031
- Patient share of NMDA receptor modulators in MDD in the United States: 2021-2031
- Patient share of NMDA receptor modulators in MDD in the EU5: 2021-2031
- Sales and patient share of zuranolone (SAGE-217) in MDD in the United States: 2021-2031
- Sales and patient share of zuranolone (SAGE-217) in MDD in Japan: 2021-2031
- Sales and patient share of seltorexant in MDD in the United States: 2021-2031
- Sales and patient share of seltorexant in MDD in the EU5: 2021-2031
- Key findings
- 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
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition
- 12-month prevalent cases of major depressive disorder (DSM-5): 2021-2031 (thousands)
- Percentage diagnosed
- Diagnosed prevalent cases of major depressive disorder: 2021-2031
- Percentage drug-treated
- Drug-treated prevalent cases of major depressive disorder: 2021-2031
- Key findings
- Current treatment
- 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
- Ongoing clinical development of brexpiprazole in MDD
- Advantages and disadvantages 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
- Advantages and disadvantages of vortioxetine
- 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
- Ongoing clinical development of esketamine
- Expert insight: esketamine
- Potential advantages and disadvantages of dextromethorphan HBr / bupropion HCl
- Expert insight: dextromethorphan HBr / bupropion HCl
- Medical practice
- Overview
- 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
- Key findings
- Unmet need overview
- Current and future attainment of unmet needs in major depressive disorder
- Top unmet needs in major depressive disorder: current and future attainment
- Expert insight: unmet needs in major depressive disorder
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- Key emerging therapies
- Key therapies in development for MDD
- Estimated launch dates of key emerging therapies for the treatment of MDD
- Zuranolone (SAGE-217) profile
- Key clinical trials of zuranolone (SAGE-217) in the treatment of MDD
- 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 MDD
- REL-1017 profile
- Key late-phase clinical trials of REL-1017 in the treatment of MDD
- Analysis of the clinical development program for REL-1017
- Expert insight: REL-1017
- Expectations for launch and sales opportunity of REL-1017 in MDD
- Ansofaxine hydrochloride profile
- Analysis of the clinical development program for ansofaxine hydrochloride
- Seltorexant profile
- Key ongoing clinical trials of seltorexant in the treatment of MDD
- Analysis of the clinical development program for seltorexant
- Expectations for launch and sales opportunity of seltorexant in MDD
- Lumateperone profile
- Analysis of the clinical development program for lumateperone
- Expert insight: lumateperone
- Expectations for launch and sales opportunity of lumateperone in MDD
- COMP360 profile
- Analysis of the clinical development program for COMP360
- Expert insight: COMP360
- Expectations for launch and sales opportunity of COMP360 in MDD
- Aticaprant profile
- Key ongoing clinical trials of aticaprant in the treatment of MDD
- Analysis of the clinical development program for aticaprant
- Expert insight: aticaprant
- Early-phase pipeline analysis
- Select compounds in early-phase development for MDD
- Key discontinuations and failures in MDD
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Unipolar depression bibliography
- Abbreviations
- Key findings
Soumya Soni, M.Tech., Healthcare Research & Data Analyst, CNS and Ophthalmology. Ms. Soni has substantial experience in market research, competitive intelligence, promotional intelligence, and consulting. She has produced multiple competitive intelligence-based landscape reports in oncology and contributed to ad-hoc market research projects. She also has experience in post-conference report preparation for key medical conferences such as AACR, ESMO, SITC, and ASH. Ms. Soni holds a master’s degree in biotechnology from Jaypee Institute of Information Technology in Noida, India.
Himanshu Jain, M.S.(Pharm.), Senior Manager, CNS and Ophthalmology. He has authored content for psychiatry and ophthalmology indications, including forecasting markets for schizophrenia, depression, and dry eye disease. He has about 15 years of experience working in market research and consulting firms. He earned his master’s degree in Pharmacology & Toxicology from the National Institute of Pharmaceutical Education and Research and holds an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.