Bipolar Disorder – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Bipolar Disorder Market Outlook and Forecast

Bipolar Disorder – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-03-31

Updated On : 2024-02-15

Pages : 153

Bipolar Disorder Market Outlook

Thelansis’s “Bipolar Disorder Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Bipolar Disorder treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Bipolar Disorder Overview

Bipolar disorder is a persistent and intricate mood disorder characterized by a blend of manic (bipolar mania), hypomanic, and depressive (bipolar depression) episodes, often accompanied by significant subsyndromal symptoms that typically emerge between major mood episodes. These disorders have a multifaceted origin involving genetic predisposition influenced by environmental stressors. Children with parents affected by bipolar disorders face a 4% to 15% risk of developing the condition, while those with parents lacking bipolar disorder have less than a 2% risk. The onset and recurrence of bipolar disorder are often linked to acute stressors, including adverse childhood events, trauma, familial suicide, and sleep disruption. Multiple factors such as biological susceptibility, inflammation in the central and peripheral nervous systems, irregular endocrine and neuronal pathways, and mitochondrial dysfunction inheritance patterns have been implicated in these disorders. There are four distinct types of bipolar disorder, each marked by noticeable shifts in mood, energy levels, and activity:

  1. Bipolar I disorder features manic episodes lasting at least 7 days, often accompanied by depressive episodes lasting at least 2 weeks. Rapid cycling involves experiencing four or more episodes of mania or depression within a year.
  2. Bipolar II disorder is characterized by recurrent depressive and hypomanic episodes, with hypomania being less severe than the manic episodes seen in bipolar I.
  3. Bipolar Disorder Not Otherwise Specified (BP-NOS) is diagnosed when symptoms align with bipolar disorder but do not meet the criteria for either bipolar I or II. These symptoms noticeably deviate from the person's typical behavior.
  4. Cyclothymic disorder, or cyclothymia, involves recurring hypomanic and depressive symptoms that do not reach the intensity or duration of hypomanic or depressive episodes.

Patients typically seek treatment for depression or anxiety, sometimes with mixed features, where they experience concurrent mania and depression. Diagnosis may be delayed as several depressive episodes precede the manifestation of mixed features, mania, or hypomania. Patients often do not seek care for hypomania, viewing it positively despite potential negative consequences. Physicians must inquire about manic or hypomanic symptoms when patients present with depression. Hypomania and mania can be triggered by shift work, travel across time zones, and seasonal light changes, affecting up to 25% of patients with a seasonal pattern. Increased mortality in patients with bipolar disorder is attributed to both unnatural (suicide and accidents) and natural (cardiovascular disorders, diabetes mellitus, chronic obstructive pulmonary disease, influenza, or pneumonia) causes. Approximately 15%–19% of patients with bipolar disorder die by suicide, with a suicide rate 20–30 times higher than that of the general population. The risk of suicide in bipolar disorder is 1.2 times higher than in major depressive disorder. Suicidal behavior primarily occurs during major depressive episodes, less frequently during mixed-line mania, and rarely during euphoric mania, hypomania, or euthymia. Currently, only three approved agents are available for treatment: OFC, quetiapine (immediate or extended-release), and lurasidone (monotherapy or as an adjunct to lithium or valproate).

  • An estimated 4.4% of U.S. adults experience bipolar disorder at some point. 

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Bipolar Disorder Competitive Landscape

S. no Asset Company Stage
1 Aripiprazole Otsuka Pharmaceutical Development & Commercialization, Inc Phase 1/2
2 BXCL501 BioXcel Therapeutics Inc Phase 3
3 Asenapine and Olanzapine Organon and Co Phase 3
4 FK949E Astellas Pharma Inc Phase 2/3
5 Lumateperone Intra-Cellular Therapies, Inc. Phase 3
6 Cariprazine AbbVie Phase 3
7 JNJ-55308942 Janssen Pharmaceutica N.V., Belgium Phase 2
8 SAPHRIS and Asenapine Sun Pharmaceutical Industries Limited Phase 1
9 ILT101 Iltoo Pharma Phase 2
10 SAGE-217 Biogen Phase 2

Continued...

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Bipolar Disorder Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Bipolar Disorder Market Forecast

1.       Bipolar Disorder – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Bipolar Disorder market scenario 2023
                     1.2.2. Bipolar Disorder market scenario 2028
                     1.2.3. Bipolar Disorder market scenario 2033

2.       Bipolar Disorder Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Bipolar Disorder
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Bipolar Disorder Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Bipolar Disorder management
         2.16.  Market Opportunity for Bipolar Disorder
         2.17. KOL Comments on current and upcoming/expected treatment practices in Bipolar Disorder

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1.  Bipolar Disorder Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Bipolar Disorder
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2.  Bipolar Disorder Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Bipolar Disorder
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3.  Bipolar Disorder Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Bipolar Disorder
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4.  Bipolar Disorder Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Bipolar Disorder
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Bipolar Disorder Market Forecast 2023-2033
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Bipolar Disorder Market Forecast 2023-2033
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Bipolar Disorder Market Forecast 2023-2033
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Bipolar Disorder Market Forecast 2023-2033
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Bipolar Disorder Market Forecast 2023-2033
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Bipolar Disorder Market Forecast 2023-2033
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Bipolar Disorder Market Forecast 2023-2033
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Bipolar Disorder Market Forecast 2023-2033
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Bipolar Disorder
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Bipolar Disorder Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Bipolar Disorder
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Bipolar Disorder Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer