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Depression Disease Market and Forecast Analysis 2024

  • ID: 3797449
  • Drug Pipelines
  • December 2020
  • Region: Global
  • 94 pages
  • Datamonitor Healthcare
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Latest Key Takeaways
  • The publisher estimates that in 2018, there were 223.1 million prevalent cases of major depressive disorder (MDD) worldwide, and forecasts that number to increase to 248.9 million prevalent cases by 2027.
  • The drug market for depression is projected to expand in the next 10 years, propelled by a growing patient caseload and uptake of new products approved for indications beyond MDD, including post-partum depression (PPD), treatment-resistant depression (TRD), and suicidal ideation.
  • The primary distinguishing factor in the depression market is a drug’s ability to satisfy unmet needs. The latest market entrants, Spravato and Zulresso, have appeared highly attractive in their capacity to fulfill needs through their approvals for difficult-to-treat patient populations coupled with their refreshing first-in-class mechanisms. Novelty in mechanism of action is a key differentiator that has finally reached the depression market after decades of stagnated innovation, since long-standing standard-of-care drug classes have been inadequate in treating depression. Traditional therapies may take four to six weeks to produce clinically meaningful effects, and refractory depression persists.
  • Serotonergic antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), are forecast to be dethroned from their market-leading positions by pioneering drug classes: steroidal antidepressants and N-methyl-D-aspartate (NMDA) receptor modulators. Although growth of the SSRI market will be spearheaded by Trintellix, traditional serotonergic antidepressants have largely been insufficient in treating depression, and the market is characterized by critical unmet need. This poses prominent opportunities for new therapeutic classes to diverge from the sluggish growth trends of established drug classes. Combined sales of the novel products Spravato, Zulresso, SAGE-217, AXS-05, d-methadone, and seltorexant will greatly expand the depression market.
  • Sage Therapeutics’ steroidal antidepressant franchise will expand the market. The Phase III drug SAGE-217 is anticipated to become a market-leading brand, boasting a broad label to treat PPD, MDD, and co-morbid MDD with insomnia. Its launch for MDD as a monotherapy will be its greatest opportunity as it may be prioritized in the largest patient population. It will be the only launch for this indication that offers convenient, short-course oral dosing, a rapid onset of action, and a new approach to treatment that makes it very competitive compared to currently marketed therapies.
  • In the PPD space, SAGE-217 will build on the market share of its sister product and first-to-market drug for PPD, Zulresso. Despite access hurdles resulting in a slow ramp-up in initial sales since launching in the US in June 2019, Zulresso possesses a robust clinical profile with remarkable, potent effects at 60 hours post-dose. Zulresso patients are expected to switch to the more conveniently administered SAGE-217 following initial Zulresso regimens. This synergy will make Sage Therapeutics’ brexanolone franchise a formidable one.
  • First launched in the US in 2019, Spravato is expected to become a blockbuster brand. Johnson & Johnson has characterized its product well through extensive global studies that consolidate physicians’ off-label experience with the related drug ketamine. Crucially, the first-in-class drug is the second product approved by the FDA for TRD and has the potential to confer fast-acting benefits. Furthermore, it is also approved to treat MDD patients with suicidal ideation and behavior.
  • Axsome Therapeutics’ multi-modal drug AXS-05 is an NMDA receptor antagonist, sigma-1 receptor agonist, and an inhibitor of the reuptake of monoamines. While the company plans to file for a single approval to treat MDD in Q4 2020, the drug also has potential to broadly target different lines of therapy, from first-line and antidepressant-unresponsive MDD patients to TRD and patients with suicidal ideation, depending on the outcome of further trial investigations. Thus, Spravato will be a key competitor as it occupies later lines of therapy. While Spravato holds the benefit of earlier market entry, AXS-05 may secure a broader label and would offer the convenience of oral administration compared to Spravato’s intranasal spray administered by a healthcare professional.
  • D-methadone is a clinically promising pipeline drug that would expand the NMDA class and enter as a more convenient oral competitor to Spravato for TRD. Demonstrating strong efficacy data with fast clinically meaningful responses at Phase III would allow d-methadone to be a significant competitor, especially if Relmada successfully expands investigations into MDD and enters into a strategic partnership to pool resources.
  • Seltorexant is yet to produce convincing, robust clinical trial data as the drug's efficacy appears to taper over time. Nevertheless, Johnson & Johnson is moving forward with Phase III investigations into seltorexant as an adjunctive treatment of MDD with insomnia symptoms since greater efficacy was evident in this patient population.
  • Although there are vast opportunities for new drugs to achieve substantial sales, there are also risks. Potential barriers to eventual uptake include costliness hindering market access, safety issues that necessitate strict REMS programs, and niche target populations which will reduce a product’s commercial potential.
  • Most long-established brands will not enjoy blockbuster growth. The only prominent established brand is Trintellix, and its strong clinical profile for MDD will continue to drive robust sales growth until its patent expiry in 2026 in the US. In contrast, sales of most traditional brands will generally continue to contract as ever-intensifying generic competition progresses through the forecast period covered by our analysis. Fetzima and Rexulti, which are yet to be impacted by generic erosion, will struggle to ramp up the same sales momentum in the crowded generic climate, primarily because they are not distinct enough from existing therapies in their mechanisms and indications. Their lack of novelty is in stark contrast to the new approaches presented by pipeline drugs for MDD such as SAGE-217 and AXS-05.
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OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Subtypes
  • DSM-5 diagnostic criteria – MDD
  • DSM-5 diagnostic criteria – PDD
  • DSM-5 specifier – depressive disorder with peripartum onset
  • Treatment-resistant depression
  • Etiology
  • Prognosis
TREATMENT
  • Standard treatments
  • Novel treatments
  • Treatment guidelines
EPIDEMIOLOGY
  • Prevalence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Same Price & Trial Data: Scotland OKs Spravato Funding After England Says No
  • NICE Updates Neurostim Guidance For Depression, Epilepsy
  • US FDA Opens Door For J&J’s Spravato To Another MDD Population
  • Acadia Hit By Two Surprise Disappointments With Nuplazid
  • J&J’s Spravato Gets EU Okay For Drug-Resistant Depression
  • Last-Minute Pushback On Janssen’s EU Spravato Approval
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Dealmaking Quarterly Statistics, Q3 2020
  • Finance Watch: Axsome Therapeutics
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL
  • Marketed drugs
  • Pipeline drugs
MARKET DYNAMICS

FUTURE TRENDS
  • Pioneering drug classes will surpass serotonergic antidepressants as the most lucrative classes
  • Sage Therapeutics’ steroidal antidepressant franchise will expand the market
  • NMDA receptor modulators will garner significant share, with particular benefits towards more severe patients
  • Co-morbid insomnia is an area of opportunity that is yet to be realized
  • Barriers to uptake include cost, REMS programs, side effects, and small target populations
  • Most long-established brands will not enjoy blockbuster growth
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • SAGE-217 for Major Depressive Disorder (October 15, 2020)
  • PRAX-114 for Major Depressive Disorder (September 25, 2020)
  • Nuplazid for Major Depressive Disorder (July 20, 2020)
  • AXS-05 for Major Depressive Disorder (March 30, 2020)
  • MIN-117 for Major Depressive Disorder (December 18, 2019)
  • AXS-05 for Major Depressive Disorder (December 16, 2019)
  • SAGE-217 for Major Depressive Disorder (December 5, 2019)
  • AV-101 for Major Depressive Disorder (November 14, 2019)
  • d-Methadone for Major Depressive Disorder (October 15, 2019)
  • Seltorexant for Major Depressive Disorder (October 1, 2019)
  • Spravato for Major Depressive Disorder (September 10, 2019)
  • Spravato for Major Depressive Disorder (September 9, 2019)
  • Multiple Drugs for Major Depressive Disorder (June 25, 2019)
  • Seltorexant for Major Depressive Disorder (May 13, 2019)
  • AXS-05 for Major Depressive Disorder (May 6, 2019)
  • AV-101 for Major Depressive Disorder (May 2, 2019)
KEY UPCOMING EVENTS

UNMET NEEDS AND KEY OPINION LEADER INSIGHTS
  • More effective therapies for treatment-resistant depression
  • Additional therapy choices for post-partum depression
  • Onset of action
  • Treatments for MDD with suicidal ideation
BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of MDD, 2018–27
Figure 2: Overview of pipeline drugs for MDD in the US
Figure 3: Pipeline drugs for MDD, by company
Figure 4: Pipeline drugs for MDD, by drug type
Figure 5: Pipeline drugs for MDD, by classification
Figure 6: Probability of success in the MDD pipeline
Figure 7: Clinical trials in MDD
Figure 8: Top 10 drugs for clinical trials in MDD
Figure 9: Top 10 companies for clinical trials in MDD
Figure 10: Trial locations in MDD
Figure 11: MDD trials status
Figure 12: MDD trials sponsors, by phase
Figure 13: The publisher's drug assessment summary for depression
Figure 14: Market dynamics in depression
Figure 15: Future trends in depression
Figure 16: Nuplazid for Major Depressive Disorder (July 20, 2020): Phase III - CLARITY-2, Phase III - CLARITY-3
Figure 17: AXS-05 for Major Depressive Disorder (March 30, 2020): Phase III - STRIDE-1 (TRD)
Figure 18: AXS-05 for Major Depressive Disorder (December 16, 2019): Phase III - GEMINI
Figure 19: SAGE-217 for Major Depressive Disorder (December 5, 2019): Phase III - MOUNTAIN (MDD-301)
Figure 20: AV-101 for Major Depressive Disorder (November 14, 2019): Phase II - ELEVATE
Figure 21: d-Methadone for Major Depressive Disorder (October 15, 2019): Phase IIa - TRD (Adjunctive)
Figure 22: Spravato for Major Depressive Disorder (September 10, 2019): Phase III – ASPIRE II
Figure 23: Spravato for Major Depressive Disorder (September 9, 2019): Phase III – ASPIRE I
Figure 24: Seltorexant for Major Depressive Disorder (May 13, 2019): Phase IIb - Adjunctive to Antidepressants
Figure 25: Key upcoming events in MDD

List of Tables
Table 1: Depression subtypes as classified by the US National Institute of Mental Health
Table 2: MDD diagnostic criteria
Table 3: PDD diagnostic criteria
Table 4: Depression treatment guidelines in the US and UK
Table 5: Prevalent cases of MDD, 2018–27
Table 6: Marketed drugs for MDD
Table 7: Pipeline drugs for MDD in the US
Table 8: Historical global sales, by drug ($m), 2015–19
Table 9: Forecasted global sales, by drug ($m), 2020–24
Table 10: SAGE-217 for Major Depressive Disorder (October 15, 2020)
Table 11: PRAX-114 for Major Depressive Disorder (September 25, 2020)
Table 12: Nuplazid for Major Depressive Disorder (July 20, 2020)
Table 13: AXS-05 for Major Depressive Disorder (March 30, 2020)
Table 14: MIN-117 for Major Depressive Disorder (December 18, 2019)
Table 15: AXS-05 for Major Depressive Disorder (December 16, 2019)
Table 16: SAGE-217 for Major Depressive Disorder (December 5, 2019)
Table 17: AV-101 for Major Depressive Disorder (November 14, 2019)
Table 18: d-Methadone for Major Depressive Disorder (October 15, 2019)
Table 19: Seltorexant for Major Depressive Disorder (October 1, 2019)
Table 20: Spravato for Major Depressive Disorder (September 10, 2019)
Table 21: Spravato for Major Depressive Disorder (September 9, 2019)
Table 22: Multiple Drugs for Major Depressive Disorder (June 25, 2019)
Table 23: Seltorexant for Major Depressive Disorder (May 13, 2019)
Table 24: AXS-05 for Major Depressive Disorder (May 6, 2019)
Table 25: AV-101 for Major Depressive Disorder (May 2, 2019)
Note: Product cover images may vary from those shown
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