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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

NEW YORK, Jan. 13, 2020 /PRNewswire/ --

INTRODUCTION
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.

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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. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail, in the document.

Figure 1.1 Depressive Disorders: Scope and Competitive Insights

Source: Roots Analysis

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.

RESEARCH METHODOLOGY
The data presented in our reports is gathered via secondary and primary research. For most of our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts' views

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on 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 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 were 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 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.

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