Bipolar Disorder – Global Drug Forecast and Market Analysis to 2030

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GlobalData estimated that drug sales for bipolar disorder in 2020 was valued at $4.1 billion across the eight major markets (8MM) – the US, the five major European markets (5EU) (France, Germany, Italy, Spain, and the UK), Japan, and Canada. It is anticipated that the bipolar disorder market will grow at a compound annual growth rate (CAGR) of more than 1.5% during the forecast period of 2021-2030.

The US market makes up the majority of total global sales, contributing to more than 80% due to the large bipolar disorder prevalent population, combined with the high price of medication in the country. Sumitomo Dainippon Pharma, along with its subsidiary Sunovion Pharmaceuticals, is one of the leading players in the bipolar disorder market and is expected to remain so during the forecast period.

Overview of the bipolar disorder drug market

Overview of the bipolar disorder drug market

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What are the market dynamics in the bipolar disorder drug market?

The major drivers of growth in the bipolar disorder market during the forecast period will include the following, seven new pipeline products will launch throughout the 8MM, and they will have significantly higher costs of therapy when compared with the cost of the most commonly used bipolar disorder treatments that have high generic availability. In the 8MM, the number of 12-month total prevalent cases of bipolar disorder is expected to increase during the forecast period.

The major barriers to growth in the bipolar disorder market during the forecast period will include the following, continued generic erosion is expected to further increase with the patent expiries of several key products, including Sumitomo Dainippon Pharma/ Sunovion Pharmaceuticals’ Latuda (lurasidone), Otsuka Pharmaceutical/Lundbeck’s Abilify Maintena (aripiprazole ER), and Johnson and Johnson’s Risperdal Consta (risperidone PR), during the forecast period. High use of inexpensive generic products, such as lithium, is expected to continue throughout the forecast period.

The misdiagnosis of bipolar disorder is common, and often results in patients receiving inappropriate pharmacological treatment and psychosocial support. Diagnosis rates for bipolar disorder are expected to remain low throughout the forecast period.

What are the diagnosed incident cases of bipolar disorder in the 8MM?

The 8MM include the US, Canada, France, Germany, Italy, Spain, UK, and Japan. In 2020, In 2020, the US accounted for more than 50% of the 12-month total prevalent cases of bipolar I disorder in the 8MM. There were more than 1,264,000 cases in the 5EU in 2020, of the 12-month total prevalent cases, while Japan had more than 1% cases and Canada had more than 6% cases of the total cases in 8MM. In the 8MM, the number of 12-month total prevalent cases of bipolar I disorder will grow by more than 4% over the forecast period at an Annual Growth Rate (AGR) of more than 0.40%. Of the 8MM, the US is expected to have 12-month total prevalent cases of bipolar I disorder increasing by 2030. Japan had the lowest number of 12-month total prevalent cases of bipolar I disorder in 2030. Any change in the 12-month total prevalent cases of bipolar I disorder is attributable to changing population demographics in the 8MM.

Diagnosed incident cases of bipolar disorder in the 8MMDiagnosed incident cases of bipolar disorder in the 8MM

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Which are the key players in the bipolar disorder drug market?

Sumitomo Dainippon Pharma, along with its subsidiary Sunovion Pharmaceuticals, is one of the leading players in the bipolar disorder market and is expected to remain so during the forecast period. Other major players include AbbVie, Actavis, Alexza Pharmaceuticals, Alkermes, Allergan, AstraZeneca, BioXcel Therapeutics, Bristol-Myers Squibb, Celon Pharma, Eli Lilly, Intra-Cellular Therapies, Jina Pharmaceuticals, Johnson and Johnson, Lundbeck, Meiji Seika, Merck, NRX Pharmaceuticals, Otsuka Pharmaceutical, Pfizer, Richter Gedeon, Sumitomo Dainippon Pharma, Sunovion Pharmaceuticals, and Vanda Pharmaceuticals.

Bipolar disorder drug market, by key players

Bipolar disorder drug market, by key players

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Market report scope

Market Size (Year – 2020) $4.1 billion
Growth rate (CAGR) >1.5%
Base Year 2020
Forecast period 2021-2030
Key Countries The US, Canada, France, Germany, Italy, Spain, UK, and Japan
Key Players Sumitomo Dainippon Pharma, AbbVie, Actavis, Alexza Pharmaceuticals, Alkermes, Allergan, AstraZeneca, BioXcel Therapeutics, Bristol-Myers Squibb, Celon Pharma, Eli Lilly, Intra-Cellular Therapies, Jina Pharmaceuticals, Johnson and Johnson, Lundbeck, Meiji Seika, Merck, NRX Pharmaceuticals, Otsuka Pharmaceutical, Pfizer, Richter Gedeon, Sumitomo Dainippon Pharma, Sunovion Pharmaceuticals, and Vanda Pharmaceuticals

Scope

This report provides an in-depth analysis of the following:

  • Overview of bipolar disorder, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized bipolar disorder therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (bipolar I, bipolar II and cyclothymic disorder) forecast from 2020 to 2030.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the bipolar disorder therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for bipolar disorder therapy. The most promising candidates in Phase III and IIb development are profiled.
  • Analysis of the current and future market competition in the global bipolar disorder therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global bipolar disorder therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global bipolar disorder therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

AbbVie
Actavis
Alexza Pharmaceuticals
Alkermes
Allergan
AstraZeneca
BioXcel Therapeutics
Bristol-Myers Squibb
Celon Pharma
Eli Lilly
Intra-Cellular Therapies
Jina Pharmaceuticals
Johnson and Johnson
Lundbeck
Meiji Seika
Merck
NRX Pharmaceuticals
Otsuka Pharmaceutical
Pfizer
Richter Gedeon
Sumitomo Dainippon Pharma
Sunovion Pharmaceuticals
Vanda Pharmaceuticals

Table of Contents

| Contents

| List of Tables

| List of Figures

| About GlobalData

1 Bipolar Disorder: Executive Summary

1.1 Modest Growth Expected in the Bipolar Disorder Market from 2020–2030

1.2 In a Market Dominated by Atypical Antipsychotics, Novel Mechanisms of Action Are a Key R&D Strategy for Bipolar Disorder

1.3 Opportunities Remain for Products that Will Fulfill Unmet Needs in the Bipolar Disorder Market

1.4 Novel Late-Stage Pipeline Drugs Will Be a Key Driver of Growth

1.5 What Do Physicians Think?

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Classification

3.3 Prognosis

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global and Historical Trends

4.4 Forecast Methodology

4.4.1 Sources

4.4.2 Forecast Assumptions and Methods

4.4.3 Forecast Assumptions and Methods: 12-Month and Lifetime Prevalent Cases of Bipolar Disorder

4.5 Epidemiological Forecast for Bipolar Disorder (2020–2030)

4.5.1 12-Month Total Prevalent Cases of Bipolar I Disorder

4.5.2 Age-Specific 12-Month Total Prevalent Cases of Bipolar I Disorder

4.5.3 Sex-Specific 12-Month Total Prevalent Cases of Bipolar I Disorder

4.5.4 Lifetime Total Prevalent Cases of Bipolar I Disorder

4.5.5 Age-Specific Lifetime Total Prevalent Cases of Bipolar I Disorder

4.5.6 Sex-Specific Lifetime Total Prevalent Cases of Bipolar I Disorder

4.5.7 12-Month Total Prevalent Cases of Bipolar II Disorder

4.5.8 Age-Specific 12-Month Total Prevalent Cases of Bipolar II Disorder

4.5.9 Sex-Specific 12-Month Total Prevalent Cases of Bipolar II Disorder

4.5.10 Lifetime Total Prevalent Cases of Bipolar II Disorder

4.5.11 Age-Specific Lifetime Total Prevalent Cases of Bipolar II Disorder

4.5.12 Sex-Specific Lifetime Total Prevalent Cases of Bipolar II Disorder

4.5.13 12-Month Total Prevalent Cases of Cyclothymic Disorder

4.5.14 Age-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder

4.5.15 Sex-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder

4.5.16 Lifetime Total Prevalent Cases of Cyclothymic Disorder

4.5.17 Age-Specific Lifetime Total Prevalent Cases of Cyclothymic Disorder

4.5.18 Sex-Specific Lifetime Total Prevalent Cases of Cyclothymic Disorder

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 COVID-19 Impact

4.6.3 Limitations of the Analysis

4.6.4 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.2 Additional KOL Insights on Disease Management

6 Competitive Assessment

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Effective Treatment Options for Bipolar Depression

7.3 Antipsychotics With a Low Risk of EPS and Metabolic Changes

7.4 Mood Stabilizers With Improved Safety Profiles

7.5 Education for Physicians in Order to Improve Diagnosis Rates

7.6 Novel Drugs Developed Specifically for Bipolar Disorder

8 R&D Strategies

8.1 Overview

8.1.1 Label Expansion

8.1.2 Novel Mechanisms of Action

8.1.3 Reformulations

8.2 Clinical Trials Design

8.2.1 Endpoints

8.2.2 Inclusion/Exclusion Criteria

8.2.3 Trial Duration

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

10.1 Overview

10.2 Competitive Assessment

10.2.1 Bipolar Depression

10.2.2 Bipolar Mania

10.2.3 Agitation Associated With Bipolar Disorder

11 Current and Future Players

11.1 Overview

11.2 Deal-Making Trends

12 Market Outlook

12.1 Global Markets

12.1.1 Forecast

12.1.2 Drivers and Barriers – Global Issues

12.2 US

12.2.1 Forecast

12.2.2 Key Events

12.2.3 Drivers and Barriers

12.3 5EU

12.3.1 Forecast

12.3.2 Key Events

12.3.3 Drivers and Barriers

12.4 Japan

12.4.1 Forecast

12.4.2 Key Events

12.4.3 Drivers and Barriers

12.5 Canada

12.5.1 Forecast

12.5.2 Key Events

12.5.3 Drivers and Barriers

13 Appendix

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting Methodology

13.4 Primary Research – KOLs Interviewed for This Report

13.4.1 KOLs

13.5 Primary Research – Prescriber Survey

13.6 About the Authors

13.6.1 Analyst

13.6.2 Therapy Area Director

13.6.3 Epidemiologist

13.6.4 Managing Epidemiologist

13.6.5 Vice President of Disease Analysis and Intelligence

13.6.6 Global Head and EVP of Healthcare Operations and Strategy

| Contact Us

Table

Table 1: Bipolar Disorder: Key Metrics in the 8MM

Table 2: Symptom Criteria for Manic, Hypomanic and Major Depressive Episodes

Table 3: DSM-V Classification of Bipolar Disorder

Table 4: Risk Factors and Comorbid Conditions Associated with Bipolar Disorder

Table 5: Treatment Guidelines for Bipolar Disorder

Table 6: Bipolar Disorder Market – Global Drivers and Barriers, 2020–2030

Table 7: Key Events Impacting Sales for Bipolar Disorder in the US, 2020–2030

Table 8: Bipolar Disorder Market – Drivers and Barriers in the US, 2020–2030

Table 9: Key Events Impacting Sales for Bipolar Disorder in the 5EU, 2020–2030

Table 10: Bipolar Disorder Market – Drivers and Barriers in the 5EU, 2020–2030

Table 11: Key Events Impacting Sales for Bipolar Disorder in Japan, 2020–2030

Table 12: Bipolar Disorder Market – Drivers and Barriers in Japan, 2020–2030

Table 13: Key Events Impacting Sales for Bipolar Disorder in Canada, 2020–2030

Table 14: Bipolar Disorder Market – Drivers and Barriers in Canada, 2020–2030

Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales Forecast by Country for Bipolar Disorder in 2020 and 2030

Figure 2: Analysis of the Company Portfolio Gap in Bipolar Disorder During the Forecast Period

Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs for Bipolar Depression Benchmarked Against the Standard of Care, Generic Lithium

Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs for Bipolar Mania Benchmarked Against the Standard of Care, Generic Lithium

Figure 5: Competitive Assessment of the Marketed and Pipeline Drugs for Agitation Associated with Bipolar Disorder Benchmarked Against the Standard of Care, Generic Haloperidol

Figure 6: The Etiology and Pathophysiology of Bipolar Disorder

Figure 7: 8MM, 12-Month and Lifetime Total Prevalence of Bipolar Spectrum Disorder, Men and Women (%), Ages ≥13 Years, 2020

Figure 8: 8MM, Sources Used and Not Used to Forecast the 12-Month Total Prevalent Cases of Bipolar I Disorder

Figure 9: 8MM, Sources Used and Not Used to Forecast the Lifetime Total Prevalent Cases of Bipolar I Disorder

Figure 10: 8MM, Sources Used to Forecast the 12-Month Total Prevalence of Bipolar II Disorder

Figure 11: 8MM, Sources Used to Forecast the Lifetime Total Prevalent Cases of Bipolar II Disorder

Figure 12: 8MM, Sources Used to Forecast the 12-Month Total Prevalence of Cyclothymic Disorder

Figure 13: 8MM, Sources Used to Forecast the Lifetime Total Prevalence of Cyclothymic Disorder

Figure 14: 8MM, 12-Month Total Prevalent Cases of Bipolar I Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 15: 8MM, 12-Month Total Prevalent Cases of Bipolar I Disorder by Age, N, Both Sexes, 2020

Figure 16: 8MM, 12-Month Total Prevalent Cases of Bipolar I Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 17: 8MM, Lifetime Total Prevalent Cases of Bipolar I Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 18: 8MM, Lifetime Total Prevalent Cases of Bipolar I Disorder by Age, N, Both Sexes, 2020

Figure 19: 8MM, Lifetime Total Prevalent Cases of Bipolar I Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 20: 8MM, 12-Month Total Prevalent Cases of Bipolar II Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 21: 8MM, 12-Month Total Prevalent Cases of Bipolar II Disorder by Age, N, Both Sexes, 2020

Figure 22: 8MM, 12-Month Total Prevalent Cases of Bipolar II Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 23: 8MM, Lifetime Total Prevalent Cases of Bipolar II Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 24: 8MM, Lifetime Total Prevalent Cases of Bipolar II Disorder by Age, N, Both Sexes, 2020

Figure 25: 8MM, Lifetime Total Prevalent Cases of Bipolar II Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 26: 8MM, 12-Month Total Prevalent Cases of Cyclothymic Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 27: 8MM, 12-Month Total Prevalent Cases of Cyclothymic Disorder by Age, N, Both Sexes, 2020

Figure 28: 8MM, 12-Month Total Prevalent Cases of Cyclothymic Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 29: 8MM, Lifetime Total Prevalent Cases of Cyclothymic Disorder, N, Both Sexes, Ages ≥18 Years, 2020

Figure 30: 8MM, Lifetime Total Prevalent Cases of Cyclothymic Disorder by Age, N, Both Sexes, 2020

Figure 31: 8MM, Lifetime Total Prevalent Cases of Cyclothymic Disorder by Sex, N, Ages ≥18 Years, 2020

Figure 32: Unmet Needs and Opportunities in Bipolar Disorder

Figure 33: Overview of the Development Pipeline in Bipolar Disorder

Figure 34: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for Bipolar Disorder in the 8MM During the Forecast Period

Figure 35: Competitive Assessment of the Marketed and Pipeline Drugs for Bipolar Depression Benchmarked Against the SOC, Generic Lithium

Figure 36: Competitive Assessment of the Marketed and Pipeline Drugs for Bipolar Mania Benchmarked Against the SOC, Generic Lithium

Figure 37: Competitive Assessment of the Marketed and Pipeline Drugs for Agitation Associated with Bipolar Disorder Benchmarked Against the SOC, Generic Haloperidol

Figure 38: Analysis of the Company Portfolio Gap in Bipolar Disorder During the Forecast Period

Figure 39: Global (8MM) Sales Forecast by Country for Bipolar Disorder in 2020 and 2030

Figure 40: Global (8MM) Sales Forecast by Class for Bipolar Disorder in 2020 and 2030

Figure 41: Sales Forecast by Class for Bipolar Disorder in the US in 2020 and 2030

Figure 42: Sales Forecast by Class for Bipolar Disorder in the 5EU in 2020 and 2030

Figure 43: Sales Forecast by Class for Bipolar Disorder in Japan in 2020 and 2030

Figure 44: Sales Forecast by Class for Bipolar Disorder in Canada in 2020 and 2030

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