Bipolar disorder is a multifactorial condition characterized by fluctuating mood states BD is a multifactorial psychiatric mood disorder influenced by social, environmental, and genetic risk factors underlying its etiology. The disorder is characterized by fluctuating mood states, such as mania and depression, interspersed with periods of wellbeing over days and weeks. BD describes a range of disease subtypes, including BD type I, BD type II, and cyclothymia.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
11 Patient segmentation
12 TREATMENT
12 Drug therapy is used in the vast majority of bipolar disorder patients
12 Therapy can be integrated with non-pharmacological interventions to improve patient outcomes
13 The goal of treatment is to bring patients to a state of recovery and minimize relapses
13 Bipolar disorder treatment guideline recommendations by drug class
14 Acute mania
15 Acute depression
16 Maintenance therapy
18 EPIDEMIOLOGY
18 Prevalence methodology
21 MARKETED DRUGS
29 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 Alkermes Expects Gradual Ramp-Up For Lybalvi Launch
35 Recent NDA Submissions Include BioXcel’s Dexmedetomidine Oral Film
35 Caplyta Aims For Broad Range In Bipolar Depression Claim
35 Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Sumitomo, Otsuka Both Stand To Gain From CNS Partnership
39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase
43 DRUG ASSESSMENT MODEL
43 Marketed drugs
44 Pipeline drugs
46 MARKET DYNAMICS
47 FUTURE TRENDS
47 The LAI atypical antipsychotic market will see increasing growth and little competition
47 The oral atypical antipsychotic market will see further widespread genericization
48 New market entrants will be directed towards underserved patient segments and improved tolerability
49 CONSENSUS FORECASTS
53 RECENT EVENTS AND ANALYST OPINION
53 Falkieri for Bipolar Disorder (January 8, 2021)
54 Lybalvi for Bipolar Disorder (October 9, 2020)
57 Lybalvi for Bipolar Disorder (October 7, 2020)
61 Caplyta for Bipolar Disorder (September 9, 2020)
63 BXCL501 for Bipolar Disorder (July 20, 2020)
65 SEP-4199 for Bipolar Disorder (July 6, 2020)
67 KEY UPCOMING EVENTS
68 KEY OPINION LEADER INSIGHTS
69 UNMET NEEDS
69 BD depression
69 Delay of correct diagnosis
69 Cognitive impairment
70 BIBLIOGRAPHY
71 APPENDIX
LIST OF FIGURES
10 Figure 1: DSM-5 diagnostic criteria for mood episodes based on symptoms
11 Figure 2: DSM-5 diagnostic criteria for bipolar disorder subtypes
12 Figure 3: Psychological interventions for bipolar disorder
13 Figure 4: Guidelines for bipolar disorder treatment
14 Figure 5: Drug classes recommended in bipolar disorder treatment guidelines, by disease phase and line of therapy
15 Figure 6: Guideline recommendations for acute mania, by line of treatment
16 Figure 7: Guideline recommendations for acute depression, by line of treatment
17 Figure 8: Guideline recommendations for maintenance therapy, by line of treatment
20 Figure 9: Trends in prevalent cases of bipolar disorder, 2018–27
29 Figure 10: Overview of pipeline drugs for bipolar disorder in the US
29 Figure 11: Pipeline drugs for bipolar disorder, by company
30 Figure 12: Pipeline drugs for bipolar disorder, by drug type
30 Figure 13: Pipeline drugs for bipolar disorder, by classification
37 Figure 14: Probability of success in the bipolar disorder pipeline
39 Figure 15: Clinical trials in bipolar disorder
39 Figure 16: Top 10 drugs for clinical trials in bipolar disorder
40 Figure 17: Top 10 companies for clinical trials in bipolar disorder
40 Figure 18: Trial locations in bipolar disorder
41 Figure 19: Bipolar disorder trials status
42 Figure 20: Bipolar disorder trials sponsors, by phase
43 Figure 21: Datamonitor Healthcare’s drug assessment summary for bipolar disorder
46 Figure 22: Market dynamics in bipolar disorder
47 Figure 23: Future trends in bipolar disorder
54 Figure 24: Falkieri for Bipolar Disorder (January 8, 2021): Phase II – Treatment-Resistant Bipolar Depression
63 Figure 25: Caplyta for Bipolar Disorder (September 9, 2020): Phase III – Study 402 (Adjunctive)
65 Figure 26: BXCL501 for Bipolar Disorder (July 20, 2020): Phase III – SERENITY II
66 Figure 27: SEP-4199 for Bipolar Disorder (July 6, 2020): Phase II – SEP380-201
67 Figure 28: Key upcoming events in bipolar disorder
LIST OF TABLES
19 Table 1: Prevalent cases of bipolar disorder, 2018–27
22 Table 2: Marketed drugs for bipolar disorder
31 Table 3: Pipeline drugs for bipolar disorder in the US
50 Table 4: Historical global sales, by drug ($m), 2016–20
51 Table 5: Forecasted global sales, by drug ($m), 2021–25
53 Table 6: Falkieri for Bipolar Disorder (January 8, 2021)
54 Table 7: Lybalvi for Bipolar Disorder (October 9, 2020)
58 Table 8: Lybalvi for Bipolar Disorder (October 7, 2020)
62 Table 9: Caplyta for Bipolar Disorder (September 9, 2020)
64 Table 10: BXCL501 for Bipolar Disorder (July 20, 2020)
66 Table 11: SEP-4199 for Bipolar Disorder (July 6, 2020)
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