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Depressive Disorders (Major Depression, Bipolar Disorder, Postpartum Depression, Treatment-Resistant Depression, and Others): Pipeline Review, Developer Landscape and Competitive Insights, 2019

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    Report

  • 208 Pages
  • April 2019
  • Region: Global
  • Roots Analysis
  • ID: 4775434
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50% of Treated Patients do not Respond to the First Prescribed Antidepressant

Depression is a chronic medical condition characterized by a persistent feeling of sadness and lack of interest in external stimuli. It is a commonly diagnosed mental health disorder and is considered among the leading causes of disability across the globe. It has been estimated that over 300 million people (considering all age groups) suffer from depression worldwide. Further, depression and other depressive disorders are projected to be responsible for an economic burden of up to USD 210 billion per year in the US. Despite the high prevalence and significant impact of this disease, less than 50% of affected individuals receive treatment in high-income countries; this figure stands at less than 10% for low-income countries. According to the World Health Organization, barriers to effective care for depression and other depressive disorders, include lack of resources, lack of trained healthcare professionals, inaccurate diagnoses of the condition and the social stigma associated with to mental health disorders.

A number of blockbuster drugs are available to treat depression; these include Prozac and Celexa (approved in 1980s), Paxil and Zoloft (approved in 1990s), and Lexapro and Cymbalta (approved in 2000s). These drugs work by modulating monoamine levels in the brain, a mechanism that has been re-evaluated and improved across the last six decades. Since the 1950s, around 30 branded drugs and more than 150 generic products have been approved by the FDA to treat various forms of depression. Currently, selective serotonin reuptake inhibitors (SSRIs) form the mainstay of treatment options for depression. Despite the availability of generics and other branded drugs, patients have voiced the need for better antidepressants as currently available SSRIs take a long time (few weeks) to demonstrate therapeutic benefit. In addition, around 50% of treated patients do not respond to the first prescribed antidepressant and need to go through months of trial and error-based therapy regimens before an appropriate drug is identified to treat their underlying condition. Further, there are many patients who never respond to any of the available therapeutic strategies, highlighting an urgent need for effective treatment solutions for depression. Several stakeholders in the pharmaceutical industry are currently engaged in efforts to develop various types of interventions and drug/therapy candidates with novel mechanisms of action to treat depression.
Scope of the Report

The “Depressive Disorders Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed (approved post-2010), clinical and preclinical molecules available / being developed, for the treatment of depressive disorders.

Amongst other elements, the report includes:


  • A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of therapy (monotherapy, adjunctive therapy or combination therapy), type of depression (major depressive disorder, bipolar disorder, postpartum depression, treatment-resistant depression and depression (type unknown)), type of drug class (anti-depressant and anti-psychotic), mechanism of action, dosing frequency (twice daily, once daily, twice weekly, once weekly, once in 28 days, twice yearly and once only) and route of administration (oral, nasal and parenteral) of the drugs / therapies being developed for the treatment of depressive disorders.
  • A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinued drug development programs, year of discontinuation, geographical location (of discontinued trial), phase at which the development program was discontinued, mechanism of action of discontinued drug, disease indication (for which the drug was being investigated), reason(s) for discontinuation and information on affiliated developer companies.
  • An analysis of the partnerships that have been established between 2012 and 2019 (till March), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, clinical trial agreements, and other relevant deals.
  • An analysis of the investments (between 2010 and 2019 (till March)) made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings.
  • A comprehensive clinical trial analysis of completed, ongoing and planned studies for different types of depressive disorders. For the purpose of this analysis, we considered the clinical studies registered till February 2019, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, type of depressive disorder, mechanism of action, leading industry and non-industry players with highest number of completed / ongoing trials, regional distribution of clinical trials, and enrolled patient population across different geographies.
  • An insightful analysis on clinical end-points being evaluated in late-stage ongoing and planned studies, for various types of depressive disorders. For the purpose of this analysis, we considered the phase III clinical studies registered till February 2019, and identified the most important, primary endpoints being evaluated.
  • An insightful market assessment summary, highlighting the clinical and commercial attractiveness of pipeline molecules (phase II and phase III), taking into consideration size of enrolled patient population (for the trial in the highest phase of development), route of administration, therapy type and dosing frequency (for quantifying clinical attractiveness), and target patient population, expected launch date and size of developer company (for quantifying commercial attractiveness).
  • An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, post-marketing, and near patent expiry, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.
  • A case study on the upcoming digital health solutions for the management/treatment of depression, featuring information on the various product development pathways adopted by companies involved in this segment of the market; it includes brief descriptions of popular digital solutions as well.
  • The insights presented in this report are backed by a deep understanding of data gathered from secondary sources. The opinions generated over the source of the study, were influenced by inputs from key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. An Overview of Depression and Depressive Disorders
3.2. Signs and Symptoms of Depression
3.3. Types of Depression
3.4. Epidemiology of Depression
3.5. Causes of Depression
3.6. Diagnosis of Depression
3.7. Current Treatment Paradigms
3.7.1. Pharmacological Treatment
3.7.2. Psychological Treatment
3.7.3. Other Treatments
3.8. Innovative Therapeutic Strategies
4. PIPELINE REVIEW: MARKETED AND CLINICAL STAGE DRUGS
4.1. Chapter Overview
4.2. Depressive Disorders: Marketed and Development Pipeline
4.3. Depressive Disorders: Pipeline Analysis
4.3.1. Analysis by Phase of Development
4.3.2. Analysis by Type of Molecule
4.3.3. Analysis by Type of Depressive Disorder
4.3.4. Analysis by Drug Class
4.3.5. Analysis by Mechanism of Action
4.3.6. Analysis by Route of Administration
4.3.7. Analysis by Dosing Frequency
4.3.8. Analysis by Type of Therapy
4.3.9. Grid Analysis: Distribution by Type of Depressive Disorder, Phase of Development and Mechanism of Action
4.4. Depressive Disorders: List of Drug Developers
4.4.1. Analysis by Year of Establishment of Developer
4.4.2. Analysis by Geographical Location
4.4.3. Analysis by Company Size and Geographical Location
4.4.4. Leading Developers
4.4.5. Grid Analysis: Distribution by Location, Company Size and Mechanism of Action of Pipeline Drugs
5. CASE STUDY: DISCONTINUED DRUG DEVELOPMENT PROGRAMS
5.1. Chapter Overview
5.2. Depressive Disorders: Discontinued Drugs
5.2.1. Analysis by Year of Discontinuation
5.2.2. Analysis by Phase of Discontinuation
5.2.3. Analysis by Mechanism of Action
5.2.4. Analysis by Type of Depressive Disorder
5.2.5. Key Players
5.2.6. Analysis by Reason for Discontinuation
5.3. Depressive Disorders: Discontinued Clinical Trials
5.3.1. Year-wise Trend of Discontinued Trials
5.3.2. Analysis of Discontinued Clinical Trials by Phase of Development
5.3.3. Analysis of Discontinued Clinical Trials by Sponsor / Collaborator
5.3.4. Analysis of Discontinued Clinical Trials by Geography
5.4. Concluding Remarks
6. PARTNERSHIPS AND COLLABORATIONS
6.1. Chapter Overview
6.2. Partnership Models
6.3. Depressive Disorders: List of Partnerships and Collaborations
6.3.1. Analysis by Year of Partnerships
6.3.2. Analysis by Type of Partnership
6.3.3. Analysis by Area of Focus
6.3.4. Analysis by Type of Depressive Disorder
6.3.5. Analysis by Geographical Activity
6.3.6. Most Active Players
7. FUNDING AND INVESTMENT ANALYSIS
7.1. Chapter Overview
7.2. Types of Funding
7.3. Depressive Disorders: Funding and Investment Analysis
7.3.1. Analysis by Number of Instances
7.3.2. Analysis by Amount Invested
7.3.3. Analysis by Type of Funding
7.3.4. Most Active Players
7.3.5. Most Active Investors
7.4. Concluding Remarks
8. CLINICAL TRIAL ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Depressive Disorders: Clinical Trial Analysis
8.3.1. Analysis by Trial Registration Year
8.3.2. Analysis by Trial Phase
8.3.3. Analysis by Recruitment Status
8.3.4. Analysis by Type of Sponsor / Collaborator
8.3.5. Analysis by Type of Depressive Disorder
8.3.6. Analysis by Mechanism of Action
8.3.7. Most Active Players
8.3.8. Analysis by Number of Clinical Trials and Geography
8.3.9. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
8.3.10. Analysis by Number of Clinical Trials, Mechanism of Action and Geography
8.3.11. Analysis by Number of Clinical Trials, Mechanism of Action, Trial Phase and Geography
8.3.12. Analysis by Number of Clinical Trials, Type of Depressive Disorder and Geography
8.3.13. Analysis by Number of Clinical Trials, Type of Depressive Disorder, Trial Phase and Geography
8.3.14. Analysis by Enrolled Patient Population and Geography
8.3.15. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
8.3.16. Analysis by Enrolled Patient Population, Type of Depressive Disorder and Geography
8.3.17. Analysis by Enrolled Patient Population, Type of Depressive Disorder, Trial Phase and Geography
8.3.18. Analysis by Enrolled Patient Population, Mechanism of Action and Geography
8.3.19. Analysis by Enrolled Patient Population, Mechanism of Action, Trial Phase and Geography
9. CLINICAL TRIAL ENDPOINTS ANALYSIS
9.1. Chapter Overview
9.2. Methodology
9.3. Overview of Most Common Primary Endpoints
9.4. Primary Endpoints Evaluated for Major Depressive Disorder: Comparative Analysis of Late-Stage Drugs
9.5. Primary Endpoints Evaluated for Bipolar Disorder: Comparative Analysis of Late-Stage Drugs
9.6. Primary Endpoints Evaluated for Other Types of Depressive Disorder: Comparative Analysis of Late-Stage Drugs
9.7. Concluding Remarks
10. CLINICAL AND COMMERCIAL ATTRACTIVENESS ANALYSIS
10.1. Chapter Overview
10.2. Methodology
10.2.1. Assumptions and Key Parameters
10.3. Key Insights
10.3.1. Clinical and Commercial Attractiveness Analysis: Major Depressive Disorder
10.3.2. Clinical and Commercial Attractiveness Analysis: Bipolar Disorder
10.3.3. Clinical and Commercial Attractiveness Analysis: Other Types of Depressive Disorder
11. KEY COMMERCIALIZATION STRATEGIES
11.1. Chapter Overview
11.2. Successful Drug Launch Strategy: Framework
11.3. Successful Drug Launch Strategy: Product Differentiation
11.4. Commercialization Strategies Adopted Based on Development Stage of Product
11.5. Approved Molecules for Treating Depressive Disorders
11.5.1. Abilify Mycite®
11.5.2. Abilify Maintena®
11.5.3. Rexulti®
11.5.4. Vraylar ®
11.5.5. Trintellix®
11.5.6. Fetzima®
11.5.7. Latuda®
11.5.8. Viibryd®
11.6. Key Commercialization Strategies Adopted by the Companies Focused on Depressive Disorders
11.6.1. Strategies Adopted Before the Approval of Drug
11.6.1.1. Participation in Global Events
11.6.2. Strategies Adopted During / Post Approval of Drug
11.6.2.1. Collaboration with Internal Stakeholders and Pharmaceutical Firms
11.6.2.2. Awareness through Product Websites
11.6.2.3. Advertising Directly to Consumers
11.6.3. Strategies Adopted Near Patent Expiry of Drug
11.6.3.1. Approval of Drug in Multiple Geographies
11.6.3.2. Approval of Drug for Multiple Indications
11.7. Concluding Remarks
12. DIGITAL THERAPEUTICS FOR DEPRESSIVE DISORDERS
12.1. Chapter Overview
12.2. An Overview on Digital Therapeutics
12.3. Development and Commercialization Pathway for Digital Therapeutics
12.3.1. Discovery and Preclinical Research
12.3.2. Clinical Trials and Validation
12.3.3. Engaging Insurance Providers / Payers
12.3.4. Distribution and Marketing
12.4. Digital Therapeutics for Depressive Disorders
12.4.1. Standalone Software Applications
12.4.2. Personal Coaching
12.4.3. AI Support
12.4.4. Gaming Solutions
13. CONCLUDING REMARKS
13.1. Chapter Overview
13.2. Key Takeaways
14. APPENDIX 1: TABULATED DATA15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
List of Figures
Figure 1.1. Depressive Disorders: Scope and Competitive Insights
Figure 3.1. Depression: Key Facts
Figure 3.2. Depression: Common Signs and Symptoms
Figure 3.3. Prevalence of Depression in Major Geographical Regions
Figure 3.4. Global Prevalence of Depression: Distribution by Gender and Age Groups
Figure 3.5. Prevalence of Various Types of Depression in the US
Figure 3.6. Causes of Depression
Figure 4.1. Depressive Disorders: Distribution by Phase of Development
Figure 4.2. Depressive Disorders: Distribution by Type of Molecule
Figure 4.3. Depressive Disorders: Distribution by Type of Depressive Disorder
Figure 4.4. Depressive Disorders: Distribution by Drug Class
Figure 4.5. Depressive Disorders: Distribution by Mechanism of Action
Figure 4.6. Depressive Disorders: Distribution by Route of Administration
Figure 4.7. Depressive Disorders: Distribution by Dosing Frequency
Figure 4.8. Depressive Disorders: Distribution by Type of Therapy
Figure 4.9. Grid Analysis: Distribution of Pipeline Therapies by Phase of Development, Type of Depressive Disorder and Mechanism of Action
Figure 4.10. Depressive Disorders: Distribution by Year of Establishment of Developer
Figure 4.11. Depressive Disorders: Distribution by Size and Location of Developer
Figure 4.12. Depressive Disorders: Leading Players
Figure 4.13. Grid Analysis: Distribution by Location, Size of Industry Players and Mechanism of Action of Pipeline Drugs
Figure 4.14. Depressive Disorders: Geographical Landscape of Developers
Figure 5.1. Failure Analysis: Cumulative Distribution of Drugs by Year of Discontinuation
Figure 5.2. Failure Analysis: Distribution by Phase of Discontinuation
Figure 5.3. Failure Analysis: Distribution by Mechanism of Action
Figure 5.4. Failure Analysis:  Distribution by Type of Depressive Disorder
Figure 5.5. Failure Analysis: Key Players
Figure 5.6. Failure Analysis: Distribution by Reason of Discontinuation
Figure 5.7. Bubble Analysis: Relative Distribution by Reasons of Discontinuation and Phase of Development
Figure 5.8. Failure Analysis: Year-wise Distribution of Discontinued Trials
Figure 5.9. Failure Analysis: Distribution of Discontinued Trials by Trial Phase and Average Time Duration of Discontinued Trials
Figure 5.10. Failure Analysis: Distribution of Discontinued Trials by Type of Sponsor / Collaborator
Figure 5.11. Failure Analysis: Distribution of Discontinued Trials by Geography
Figure 5.12. Failure Analysis: Distribution of Discontinued Trials by Year of Discontinuation and Geography
Figure 5.13. Bubble Analysis: Distribution of Discontinued Trials by Year of Discontinuation, Reason of Discontinuation and Phase of Development
Figure 6.1. Partnerships and Collaborations: Cumulative Trend of Activity, by Year, 2012-2019
Figure 6.2. Partnerships and Collaborations: Distribution by Type of Partnership
Figure 6.3. Partnerships and Collaborations: Distribution by Area of Focus
Figure 6.4. Partnerships and Collaborations: Distribution by Type of Depressive Disorder
Figure 6.5. Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Figure 6.6. Partnerships and Collaborations: Most Active Players
Figure 7.1. Funding and Investment Analysis: Distribution by Type of Funding and Year of Establishment of Developer, 2010-2019
Figure 7.2. Funding and Investment Analysis: Cumulative Number of Instances by Year, 2010-2019
Figure 7.3. Funding and Investment Analysis: Cumulative Amount Invested by Year, 2010-2019 (USD Million)
Figure 7.4. Funding and Investment Analysis: Distribution of Instances by Type of Funding, 2010-2019
Figure 7.5. Funding and Investment Analysis: Distribution of the Total Amount Invested by Type of Funding, 2010-2019 (USD Million)
Figure 7.6. Funding and Investment Analysis: Most Active Players in Terms of Number of Instances, 2010-2019
Figure 7.7. Funding and Investment Analysis: Most Active Players in Terms of Amount Invested (USD Million), 2010-2019
Figure 7.8. Funding and Investment Analysis: Most Active Investors
Figure 7.9. Funding and Investment Summary, 2010-2019 (USD Million)
Figure 8.1. Clinical Trial Analysis: Cumulative Distribution of Clinical Trials by Start Year, 2001-2019 (till February)
Figure 8.2. Clinical Trial Analysis: Distribution of Clinical Trials by Study Start Year and Geography, 2001-2019 (till February)
Figure 8.3. Clinical Trial Analysis: Distribution of Patients Enrolled by Study Start Year, 2001-2019 (till February)
Figure 8.4. Clinical Trial Analysis: Distribution by Trial Phase
Figure 8.5. Clinical Trial Analysis: Distribution by Trial Status
Figure 8.6. Clinical Trial Analysis: Distribution by Type of Sponsor / Collaborator
Figure 8.7. Clinical Trial Analysis: Distribution by Type of Mechanism of Action
Figure 8.8. Clinical Trial Analysis: Distribution by Type of Depressive Disorder
Figure 8.9. Clinical Trials Analysis: Most Active Industry and Non-Industry Players in Terms of Number of Trials Conducted
Figure 8.10. Clinical Trial Analysis: Distribution of Clinical Trials by Geography
Figure 8.11. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Recruitment Status and Geography
Figure 8.12. Clinical Trial Analysis: Distribution of Clinical Trials by Type of Depressive Disorder and Geography
Figure 8.13. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Type of Depressive Disorder and Geography
Figure 8.14. Clinical Trial Analysis: Distribution of Clinical Trials by Mechanism of Action and Geography
Figure 8.15. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Mechanism of Action and Geography
Figure 8.16. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
Figure 8.17. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Recruitment Status and Geography
Figure 8.18. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Type of Depressive Disorder and Geography
Figure 8.19. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Type of Depressive Disorder and Geography
Figure 8.20.  Clinical Trial Analysis: Distribution of Enrolled Patient Population by Mechanism of Action and Geography
Figure 8.21. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Mechanism of Action and Geography
Figure 9.1. Clinical Trial Endpoints Analysis: Key Endpoints Evaluated for Major Depressive Disorder
Figure 9.2. Clinical Trial Endpoints Analysis: Key Endpoints Evaluated for Bipolar Disorder
Figure 9.3. Clinical Trial Endpoints Analysis: Key Endpoints Evaluated for Other Types of Depressive Disorders
Figure 10.1. Clinical and Commercial Attractiveness Analysis: Phase III and Phase II Molecules for Major Depressive Disorder
Figure 10.2. Clinical and Commercial Attractiveness Analysis: Phase III and Phase II Molecules for Bipolar Disorder
Figure 10.3. Clinical and Commercial Attractiveness Analysis: Phase III and Phase II Molecules for Other Types of Depressive Disorder
Figure 11.1. Successful Drug Launch Strategy: ROOTS Framework
Figure 11.2. Successful Drug Launch Strategy: Differentiation Strategy
Figure 11.3. Key Commercialization Strategies
Figure 11.4. Commercialization Strategies Adopted by Companies Focused on Depressive Disorders
Figure 11.5. Participation in Global Events: Historical Timeline
Figure 11.6. Approved Drugs for Depressive Disorders: Promotional Activities through Product Websites
Figure 11.7. Approval of Drugs in Multiple Geographies: Historical Timeline
Figure 11.8. Approval of Drugs for Multiple Indications: Historical Timeline
Figure 11.9. Key Commercialization Strategies:  Harvey Ball Analysis by Ease of Implementation, Value Addition and Current Adoption
Figure 12.1. Prescription Digital Therapeutics: Process Map
Figure 12.2. Digital Therapeutics: Google Trends (2008-2018)
List of Tables
Table 3.1. List of FDA Approved Antidepressants
Table 4.1. Depressive Disorders: Marketed and Development Pipeline
Table 4.2. Depressive Disorders: List of Developers
Table 5.1. Depressive Disorders: Pipeline of Discontinued Drugs
Table 5.2. Depressive Disorders: List of Discontinued Clinical Trials
Table 5.3. Depressive Disorders: List of Discontinued Drugs (Unvalidated)
Table 6.1. Depressive Disorders: Partnerships and Collaborations, 2012-2019
Table 7.1. Depressive Disorders: Funding and Investments, 2010-2019
Table 7.2. Funding and Investment Analysis: Summary of Investments
Table 9.1. Clinical Trial Endpoints Analysis: List of Molecules Evaluated for Major Depressive Disorder, Phase III Studies
Table 9.2. Clinical Endpoint Analysis: List of Molecules Evaluated for Bipolar Disorder, Phase III Studies
Table 9.3. Clinical Endpoint Analysis: List of Molecules Evaluated for Other Types of Depressive Disorders, Phase III Studies
Table 11.1. Drug Snapshot: Abilify Mycite®
Table 11.2. Drug Snapshot: Abilify Maintena®
Table 11.3. Drug Snapshot: Rexulti®
Table 11.4. Drug Snapshot: Vraylar®
Table 11.5. Drug Snapshot: Trintellix®
Table 11.6. Drug Snapshot: Fetzima®
Table 11.7. Drug Snapshot: Latuda®
Table 11.8. Drug Snapshot: Viibryd®
Table 11.9. Patient Support Services on Product Websites of Drugs for Depressive Disorders: Comparative Analysis
Table 12.1. Digital Therapeutics for Depressive Disorders: List of Solutions
Table 13.1. Depressive Disorders: Summary of Competitive Insights
Table 14.1. Depressive Disorders: Distribution by Phase of Development
Table 14.2. Depressive Disorders: Distribution by Type of Molecule
Table 14.3. Depressive Disorders: Distribution by Type of Depressive Disorder
Table 14.4. Depressive Disorders: Distribution by Drug Class
Table 14.5. Depressive Disorders: Distribution by Mechanism of Action
Table 14.6. Depressive Disorders: Distribution by Route of Administration
Table 14.7. Depressive Disorders: Distribution by Dosing Frequency
Table 14.8. Depressive Disorders: Distribution by Type of Therapy
Table 14.9. Grid Analysis: Distribution of Pipeline Therapies by Phase of Development, Type of Depressive Disorder and Mechanism of Action
Table 14.10. Depressive Disorders: Distribution by Year of Establishment of Developer
Table 14.11. Depressive Disorders: Distribution by Size and Location of Developer
Table 14.12. Depressive Disorders: Leading Players
Table 14.13. Grid Analysis: Distribution by Location, Size of Industry Players and Mechanism of Action of Pipeline Drugs
Table 14.14. Depressive Disorders: Geographical Landscape of Developers
Table 14.15. Failure Analysis: Cumulative Distribution of Drugs by Year of Discontinuation
Table 14.16. Failure Analysis: Distribution by Phase of Discontinuation
Table 14.17. Failure Analysis: Distribution by Mechanism of Action
Table 14.18. Failure Analysis:  Distribution by Type of Depressive Disorder
Table 14.19. Failure Analysis: Key Players
Table 14.20. Failure Analysis: Distribution by Reason of Discontinuation
Table 14.21. Bubble Analysis: Relative Distribution by Reasons of Discontinuation and Phase of Development
Table 14.22. Failure Analysis: Year-wise Distribution of Discontinued Trials
Table 14.23. Failure Analysis: Distribution of Discontinued Trials by Trial Phase and Average Time Duration of Discontinued Trials
Table 14.24. Failure Analysis: Distribution of Discontinued Trials by Type of Sponsor / Collaborator
Table 14.25. Failure Analysis: Distribution of Discontinued Trials by Geography
Table 14.26. Failure Analysis: Distribution of Discontinued Trials by Year of Discontinuation and Geography
Table 14.27. Bubble Analysis: Distribution of Discontinued Trials by Year of Discontinuation, Reason of Discontinuation and Phase of Development
Table 14.28. Partnerships and Collaborations: Cumulative Trend of Activity, by Year, 2012-2019
Table 14.29. Partnerships and Collaborations: Distribution by Type of Partnership
Table 14.30. Partnerships and Collaborations: Distribution by Area of Focus
Table 14.31. Partnerships and Collaborations: Distribution by Type of Depressive Disorder
Table 14.32. Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Table 14.33. Partnerships and Collaborations: Most Active Players
Table 14.34. Funding and Investment Analysis: Distribution by Type of Funding and Year of Establishment of Developer, 2010-2019
Table 14.35. Funding and Investment Analysis: Cumulative Number of Instances by Year, 2010-2019
Table 14.36. Funding and Investment Analysis: Cumulative Amount Invested by Year, 2010-2019 (USD Million)
Table 14.37. Funding and Investment Analysis: Distribution of Instances by Type of Funding, 2010-2019
Table 14.38. Funding and Investment Analysis: Distribution of the Total Amount Invested by Type of Funding, 2010-2019 (USD Million)
Table 14.39. Funding and Investment Analysis: Most Active Players in Terms of Number of Instances, 2010-2019
Table 14.40. Funding and Investment Analysis: Most Active Players in Terms of Amount Invested (USD Million), 2010-2019
Table 14.41. Funding and Investment Analysis: Most Active Investors
Table 14.42. Funding and Investment Summary, 2010-2019 (USD Million)
Table 14.43. Clinical Trial Analysis: Cumulative Distribution of Clinical Trials by Start Year, 2001-2019 (till February)
Table 14.44. Clinical Trial Analysis: Distribution of Clinical Trials by Study Start Year and Geography, 2001-2019 (till February)
Table 14.45. Clinical Trial Analysis: Distribution of Patients Enrolled by Study Start Year, 2001-2019 (till February)
Table 14.46. Clinical Trial Analysis: Distribution by Trial Phase
Table 14.47. Clinical Trial Analysis: Distribution by Trial Status
Table 14.48. Clinical Trial Analysis: Distribution by Type of Sponsor / Collaborator
Table 14.49. Clinical Trial Analysis: Distribution by Type of Mechanism of Action
Table 14.50. Clinical Trial Analysis: Distribution by Type of Depressive Disorder
Table 14.51. Clinical Trials Analysis: Most Active Industry and Non-Industry Players in Terms of Number of Trials Conducted
Table 14.52. Clinical Trial Analysis: Distribution of Clinical Trials by Geography
Table 14.53. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Recruitment Status and Geography
Table 14.54. Clinical Trial Analysis: Distribution of Clinical Trials by Type of Depressive Disorder and Geography
Table 14.55. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Type of Depressive Disorder and Geography
Table 14.56. Clinical Trial Analysis: Distribution of Clinical Trials by Mechanism of Action and Geography
Table 14.57. Clinical Trial Analysis: Distribution of Clinical Trials by Trial Phase, Mechanism of Action and Geography
Table 14.58. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
Table 14.59. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Recruitment Status and Geography
Table 14.60. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Type of Depressive Disorder and Geography
Table 14.61. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Type of Depressive Disorder and Geography
Table 14.62.  Clinical Trial Analysis: Distribution of Enrolled Patient Population by Mechanism of Action and Geography
Table 14.63. Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase, Mechanism of Action and Geography

Executive Summary

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view of current and upcoming trends in the depressive disorders market.

Chapter 3 provides a brief introduction to depression and its associated symptoms. It includes an overview on various types of depressive disorders and features a detailed discussion on the causes and diagnosis of the condition, and the different pharmacological and non-pharmacological interventions that are presently indicated for its treatment. The chapter also includes a discussion on the epidemiology of the disease and highlights the novel approaches for the treatment of depression.

Chapter 4 includes information on over 70 molecules that are currently approved / under development for the treatment of depressive disorders. It features a comprehensive analysis of pipeline molecules, highlighting the phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of therapy (monotherapy or combination therapy), type of depression (major depressive disorder, bipolar disorder, postpartum depression, treatment-resistant depression and depression (type unknown)), type of drug class (anti-depressant and anti-psychotic), mechanism of action, dosing frequency (twice daily, once daily, twice weekly, once weekly, once in 28 days, twice yearly and once only) and route of administration (oral, nasal and parenteral) of the drugs being developed for the treatment of the disease. In addition, the chapter provides information on drug developer(s), highlighting year of their establishment, location of headquarters and employee strength. Additionally, the chapter features a regional landscape of developers engaged in this domain, distributed on the basis of the location of their headquarters.

Chapter 5 features a detailed assessment of 60 discontinued drugs and over 230 discontinued trials, featuring information on the number of discontinued drug development programs, year of discontinuation, geographical location (of discontinued trial), phase at which the development program was discontinued, mechanism of action of discontinued drug, disease indication (for which the drug was being investigated), reason(s) for discontinuation and information on affiliated developer companies.  In addition, the chapter provides a list of over 120 dormant drugs/molecules for which we could not confirm any information regarding the discontinuity on third party sources.

Chapter 6 features an analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed different partnership models, including R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, clinical trial agreements, and other relevant deals, which have been established in this domain, between 2012 and 2019 (till March).

Chapter 7 presents details on various investments received by the start-ups / smaller companies that are engaged in this domain. It also includes an analysis of the funding instances that have taken place in the market, between 2010 and 2019 (till March), highlighting the growing interest of the venture capital community and other strategic investors, within this market.

Chapter 8 is a comprehensive clinical trial analysis of completed, ongoing and planned studies for different types of depressive disorders. For the purpose of this analysis, we considered the clinical studies registered till February 2019, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, type of depressive disorder, mechanism of action, leading industry and non-industry players with the highest number of ongoing / completed trials, regional distribution of clinical trials, and enrolled patient population across different geographies.

Chapter 9 features an analysis on the clinical end-points being evaluated in late-stage, ongoing and planned studies, for various types of depressive disorders. For the purpose of this analysis, we considered the phase III clinical studies registered till February 2019 and identified and analyzed the primary endpoints being evaluated.

Chapter 10 features an analysis of the clinical and commercial attractiveness of the drugs designed for the treatment of various types of depressive disorders. In the chapter, each of the drugs/drug candidates was plotted on a 2X2 matrix, with clinical attractiveness (abscissa) and commercial attractiveness (ordinate) as the two axes. The clinical attractiveness of a drug was determined based on the sample size of the associated trial, route of administration, therapy type and dosing frequency. The commercial attractiveness of a drug was determined based on the size of the target patient population, expected launch date and company size of the developer company.

Chapter 11 An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, post-marketing, and near patent expiry. It also highlights an in-depth analysis and timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products (for depressive disorders) that were approved post-2010. In addition, it provides a general overview of the drugs considered for studying the strategies in detail.

Chapter 12 is a case study providing an overview on the advancing digital health solutions for the self-management and treatment of depressive disorders. Further, the chapter features information on the various product development pathways adopted by the companies involved in this segment of the market. Moreover, it includes brief descriptions of popular digital solutions.

Chapter 13 summarizes the entire report. The chapter presents a list of key takeaways and our independent opinion on the current market scenario based upon the research and analysis described in the previous chapters.

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix, which contains the list of companies and organizations mentioned in the report.

Companies Mentioned

  • 23andMe
  • ACADIA Pharmaceuticals
  • ARCH Venture Partners
  • ATAI Life Sciences
  • AbbVie
  • Abbott Laboratories
  • AbleTo
  • Ad Scientiam
  • Addex Therapeutics
  • Advocate Health Care
  • Aescap Venture
  • Affectis Pharmaceuticals
  • Akili Interactive
  • Alexandria Real Estate Equities
  • Alkermes
  • Allergan
  • Altitude Life Science Ventures
  • American BriVision
  • Amorsa Therapeutics
  • Anavex Life Sciences
  • Angelini
  • Apeiron Investment Group
  • Apple Tree Partners
  • Aptinyx
  • Armistice Capital
  • Aspire Capital Fund
  • AstraZeneca
  • Atlas Venture
  • Axsome Therapeutics
  • Bail Capital
  • Bain Capital Life Sciences
  • Bayer Schering Pharma
  • Bayern Kapital
  • Baylor College of Medicine
  • BioLite
  • Biomatics Capital
  • BlackThorn Therapeutics
  • Boehringer Ingelheim
  • Brace Pharma Capital
  • BrainCells
  • Bristol-Myers-Squibb
  • COMPASS Pathways
  • Canaan Partners
  • CeNeRx BioPharma
  • Cellix Bio
  • Celon Pharma
  • CepTor
  • Cerecor
  • Cingulate Therapeutics
  • Click Therapeutics
  • Cognition Kit
  • Corcept Therapeutics
  • Cormorant Asset Management
  • DAFNA Capital Management
  • Dart NeuroScience
  • Domain Associates
  • EMBL Ventures
  • EPIX Pharmaceuticals
  • Eli Lilly
  • Euthymics Bioscience
  • Evotec
  • FUJIFILM Cellular Dynamics
  • Fabre-Kramer Pharmaceuticals
  • Federated Investors
  • Foundation Medical Partners
  • GAIA
  • GNT Pharma
  • Gedeon Richter
  • GlaxoSmithKline
  • Google Ventures
  • GrowthWorks
  • Hercules Capital
  • Highland Capital Partners
  • Holmusk
  • IBM Watson Health
  • INVENT Pharmaceuticals
  • ITF Pharma
  • Ieso Digital Health
  • Index Ventures
  • Intra-Cellular Therapies
  • Inventages
  • Janssen Pharmaceutica
  • Jiangxi Synergy Pharmaceutical
  • Johnson & Johnson Innovation
  • Joyable
  • Karolinska Institutet
  • KfW
  • King’s College London
  • Lantern Health
  • Leerink Partners
  • Lincoln Park Capital
  • Livongo Health
  • Luc Therapeutics
  • Lundbeck
  • Luye Pharma Group
  • M's Science
  • MPM Capital
  • MSI Methylation Sciences
  • MaRS Innovation
  • Magellan Health
  • Marinus Pharmaceuticals
  • Merck
  • Mercury Fund
  • Meru Health
  • Milken Institute
  • Mindstrong Health
  • Minerva Neurosciences
  • Mission Pharmacal
  • Morrison & Foerster
  • Mylan
  • National Institute of Mental Health
  • National Institute of Neurological Disorders and Stroke
  • Naurex
  • Navitor Pharmaceuticals
  • NeRRe Therapeutics
  • Neuralstem
  • NeuroNascent
  • NeuroRx Pharma
  • NeuroSearch
  • New Enterprise Associates
  • Novartis
  • Omada Health
  • Ono Pharmaceutical
  • Ontario Brain Institute
  • Organon (acquired by Scheing-Plough)
  • Orion
  • Otsuka Pharmaceutical
  • Pear Therapeutics
  • Perceptive Advisors
  • Pfizer
  • Pherin Pharmaceuticals
  • Philips
  • Pierre Fabre
  • Platinum Long Term Growth VII
  • Polaris Partners
  • Principia SGR
  • Proteus Digital Health
  • Pura Vida Investments
  • Quark Venture
  • Reckitt Benckiser
  • Relmada Therapeutics
  • RespireRx Pharmaceuticals (formerly Cortex Pharmaceuticals)
  • Revaax Pharmaceuticals
  • Reviva Pharmaceuticals
  • Rexahn Pharmaceuticals
  • Roche
  • RusnanoMedInvest
  • SAGE Therapeutics
  • SK Biopharmaceuticals
  • SK C & C
  • SR One
  • Salk Institute
  • Sanford Burnham Prebys Medical Discovery Institute
  • Sanofi
  • Schering-Plough
  • Schrödinger
  • Servier
  • Shanghai Medicilon
  • Shenox Pharmaceuticals
  • Shionogi
  • Shire (acquired by Takeda Pharmaceutical)
  • Silicon Valley Bank
  • Sio Capital Management
  • Sofinnova Ventures
  • Solvay
  • Sound Pharmaceuticals
  • Subversive Capital
  • Sumitomo Dainippon Pharma
  • Sun Pharma Advanced Research Company
  • Sunovion Pharmaceuticals
  • Suven Life Sciences
  • Takeda Pharmaceutical
  • Targacept
  • The Johns Hopkins University School of Medicine
  • The Longevity Fund
  • Third Rock Ventures
  • Tianjin Pharmaceutical Holdings
  • Toyota Tsusho
  • University of Michigan
  • University of Oxford
  • University of Toronto
  • VANDA Pharmaceuticals
  • Venrock
  • VistaGen Therapeutics
  • Wellcome Trust
  • WestRiver Group
  • Worldwide Clinical Trials
  • Yungjin Pharmaceuticals
  • e-therapeutics
  • myStrength

Methodology

 

 

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