While it is not uncommon to experience feelings of sadness occasionally, in most people these emotions are usually fleeting and pass after a few days. When this manifests in a depressive disorder, a patient’s symptoms interfere with daily life and normal functioning. Depression is the leading cause of disability globally and can cause a multitude of symptoms, many of which are associated with impairment and, ultimately, decreased productivity. Not only is there the presence of depressed mood, but the condition can subsequently lead to changes in endocrine and immune function, which can increase susceptibility to physical diseases. In the worst cases, depression can lead to suicide.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Subtypes
10 DSM-5 diagnostic criteria – MDD
11 DSM-5 diagnostic criteria – PDD
13 DSM-5 specifier – depressive disorder with peripartum onset
14 Treatment-resistant depression
14 Etiology
15 Prognosis
16 TREATMENT
16 Standard treatments
16 Novel treatments
16 Treatment guidelines
21 EPIDEMIOLOGY
21 Prevalence methodology
24 MARKETED DRUGS
32 PIPELINE DRUGS
42 KEY REGULATORY EVENTS
42 Axsome’s Wait Pays Off With Broad Auvelity Label For Major Depression
42 Janssen May Challenge English Funding Rejection For Depression Nasal Spray
42 Biogen/Sage Zuranolone On Track For H2 NDA Completion
43 Sage/Biogen Delay Zuranolone Filing, Commercial Path Remains Unclear
43 ANDA Sponsors Fail To Knock Out Trintellix Active Ingredient Patent
44 PROBABILITY OF SUCCESS
45 LICENSING AND ASSET ACQUISITION DEALS
45 Neuraxpharm Boosts Branded Business With Established Sanofi Portfolios
45 Cryptic Terran Licences Advanced CNS Assets From Sanofi
45 AbbVie Continues Development Of Novel Synaptic Function Modulators
46 Pear Therapeutics Adds Two PDTs To Treat Depression
46 BI Teams With King’s College On Neuropsychiatric Research
46 Sumitomo Dainippon, BehaVR Ink Deal For Prescription VR-Based Digital Therapeutics
47 Aurobindo And MSN Labs Join Others In Settling On Allergan’s Fetzima
48 CLINICAL TRIAL LANDSCAPE
49 Sponsors by status
50 Sponsors by phase
51 Recent events
55 DRUG ASSESSMENT MODEL
55 Marketed drugs
59 Pipeline drugs
64 MARKET DYNAMICS
65 FUTURE TRENDS
65 Pioneering drug classes will surpass serotonergic antidepressants as the most lucrative classes
65 Sage Therapeutics’ steroidal antidepressant franchise will expand the market
66 NMDA receptor modulators will garner significant share, with particular benefits for more severe patients
66 Co-morbid insomnia is an area of opportunity that is yet to be realized
67 Barriers to uptake include cost, REMS programs, side effects, and small target populations
67 Most long-established brands will not enjoy blockbuster growth
69 CONSENSUS FORECASTS
74 RECENT EVENTS AND ANALYST OPINION
74 REL-1017 for Major Depressive Disorder (October 13, 2022)
75 SAGE-217 for Major Depressive Disorder (June 1, 2022)
77 SAGE-217 for Major Depressive Disorder (February 16, 2022)
79 R107 for Major Depressive Disorder (December 16, 2021)
81 COMP360 for Major Depressive Disorder (November 9, 2021)
83 Vraylar for Major Depressive Disorder (October 29, 2021)
85 COMP360 for Major Depressive Disorder (October 20, 2021)
87 AXS-05 for Major Depressive Disorder (August 9, 2021)
89 SAGE-217 for Major Depressive Disorder (June 15, 2021)
91 SLS-002 for Major Depressive Disorder (May 17, 2021)
93 KEY UPCOMING EVENTS
94 KEY OPINION LEADER INSIGHTS
94 LY03005
95 UNMET NEEDS
95 More effective therapies for treatment-resistant depression
95 Additional therapy choices for post-partum depression
96 Faster onset of action
96 Well-tolerated drugs with minimal side effects
97 Treatments for MDD with suicidal ideation
99 BIBLIOGRAPHY
101 APPENDIX
LIST OF FIGURES
23 Figure 1: Trends in prevalent cases of MDD, 2018–27
32 Figure 2: Overview of pipeline drugs for MDD in the US
32 Figure 3: Pipeline drugs for MDD, by company
33 Figure 4: Pipeline drugs for MDD, by drug type
33 Figure 5: Pipeline drugs for MDD, by classification
44 Figure 6: Probability of success in the MDD pipeline
48 Figure 7: Clinical trials in MDD
48 Figure 8: Top 10 drugs for clinical trials in MDD
49 Figure 9: Top 10 companies for clinical trials in MDD
49 Figure 10: Trial locations in MDD
50 Figure 11: MDD trials status
51 Figure 12: MDD trials sponsors, by phase
55 Figure 13: Datamonitor Healthcare’s drug assessment summary for depression
64 Figure 14: Market dynamics in depression
65 Figure 15: Future trends in depression
75 Figure 16: REL-1017 for Major Depressive Disorder (October 13, 2022): Phase III – RELIANCE III
77 Figure 17: SAGE-217 for Major Depressive Disorder (June 1, 2022): Phase III – SKYLARK
79 Figure 18: SAGE-217 for Major Depressive Disorder (February 16, 2022): Phase III – CORAL
81 Figure 19: R107 for Major Depressive Disorder (December 16, 2021): Phase IIa – BEDROC (New Zealand)
83 Figure 20: COMP360 for Major Depressive Disorder (November 9, 2021): Phase IIb – Dose-ranging (North America and EU)
85 Figure 21: Vraylar for Major Depressive Disorder (October 29, 2021): Phase III – 3111-301-001, Phase III – 3111-302-001
89 Figure 22: AXS-05 for Major Depressive Disorder (August 9, 2021): Phase II – MERIT (TRD)
91 Figure 23: SAGE-217 for Major Depressive Disorder (June 15, 2021): Phase III – WATERFALL
93 Figure 24: Key upcoming events in MDD
LIST OF TABLES
10 Table 1: Depression subtypes as classified by the US National Institute of Mental Health
11 Table 2: MDD diagnostic criteria
13 Table 3: PDD diagnostic criteria
17 Table 4: Depression treatment guidelines in the US and UK
22 Table 5: Prevalent cases of MDD, 2018–27
25 Table 6: Marketed drugs for MDD
34 Table 7: Pipeline drugs for MDD in the US
70 Table 8: Historical global sales, by drug ($m), 2017–21
72 Table 9: Forecasted global sales, by drug ($m), 2022–26
74 Table 10: REL-1017 for Major Depressive Disorder (October 13, 2022)
76 Table 11: SAGE-217 for Major Depressive Disorder (June 1, 2022)
78 Table 12: SAGE-217 for Major Depressive Disorder (February 16, 2022)
79 Table 13: R107 for Major Depressive Disorder (December 16, 2021)
81 Table 14: COMP360 for Major Depressive Disorder (November 9, 2021)
84 Table 15: Vraylar for Major Depressive Disorder (October 29, 2021)
86 Table 16: COMP360 for Major Depressive Disorder (October 20, 2021)
88 Table 17: AXS-05 for Major Depressive Disorder (August 9, 2021)
90 Table 18: SAGE-217 for Major Depressive Disorder (June 15, 2021)
91 Table 19: SLS-002 for Major Depressive Disorder (May 17, 2021)
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