Bipolar Depression: A Detailed Industry Overview 2017-2030 - ResearchAndMarkets.com

The "Bipolar Depression - Market Insights, Epidemiology, and Market Forecast-2030" report has been added to ResearchAndMarkets.com's offering.

The report delivers an in-depth understanding of the Bipolar Depression, historical and forecasted epidemiology as well as the Bipolar Depression market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Bipolar Depression market size from 2017 to 2030. The report also covers current Bipolar Depression treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Bipolar Depression, Type-specific Diagnosed Prevalent Cases of Bipolar Depression and Severity-specific Diagnosed Prevalent Cases of Bipolar Depression scenario of Bipolar Depression in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030.

Key Findings

• As per the analysts, the total diagnosed prevalent population of Bipolar Depression in the 7MM was 1,857,545 in 2017.
• The estimates show the highest diagnosed prevalence of Bipolar Depression in the United States with 740,715 cases.
• Bipolar I and Bipolar II are the major subtypes of BD. In 2017, out of the total diagnosed prevalent population of 740,715 cases in the US for Bipolar Depression, 291,134 and 449,581 cases were contributed by Bipolar I disorder and Bipolar II disorder, respectively.
• Based on the severity of the Bipolar Depression, total diagnosed prevalent cases are categorized into mild, moderate, and severe. In 2017, out of the total diagnosed prevalent population in the US for Bipolar Depression, 28,666 cases were mild, 158,735 cases were moderate, and 553,092 cases were severe.

Drug Chapters

The drug chapter segment of the Bipolar Depression report encloses the detailed analysis of Bipolar Depression marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Bipolar Depression clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

Marketed Drugs

Vraylar (Cariprazine): Allergan (AbbVie)/Gedeon Richter

Vraylar is an oral capsule containing cariprazine as an active ingredient. It is approved in the US for schizophrenia, bipolar disorder, and bipolar depression. In the EU it is approved as Reagila for the treatment of schizophrenia. Cariprazine also received regulatory approval in Singapore and Thailand for the treatment of schizophrenia. The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.

Latuda (Lurasidone Hydrochloride): Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma)

Latuda is an oral tablet containing lurasidone hydrochloride as an active ingredient. It is approved in the US for bipolar depression in pediatric patients (10-17 years of age) and schizophrenic patients (adolescent and adult); given as monotherapy and adjunctive therapy in adult patients with bipolar depression. In the EU, it is approved for the treatment of schizophrenia, whereas in Japan, it is approved for both, schizophrenia and bipolar disorder.

The company is also conducting a phase IIII randomized, 6-week, multicenter, double-blind, placebo-controlled, flexible-dose, parallel-group study of lurasidone for the treatment of bipolar I depression in China. The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.

Emerging Drugs

Abilify: Otsuka Pharmaceutical

Abilify (aripiprazole) is indicated to treat the symptoms of schizophrenia, bipolar I disorder (manic depression), and major depressive disorder. It is available as a tablet and suspension for injection. Oral solution and intramuscular injection of Abilify is discontinued in the US. The mechanism of action of aripiprazole in schizophrenia or bipolar mania is unclear. However, the efficacy of aripiprazole could be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Otsuka Holding is currently evaluating Abilify (tablet) in phase III clinical trial as an adjunctive treatment in the treatment of major depressive episodes associated with bipolar I or II disorder.

Falkieri: Celon Pharma

Falkieri (Esketamine DPI/Esketamine dry powder Inhaler) is an esketamine formulation and acts as an NMDA antagonist. The antidepressant activity of ketamine is established recently, even though it is majorly used in anesthesia. Esketamine as in form S-enantiomer is pharmacologically 3-4 times more potent to R-enantiomer. The goal of the project is to develop an innovative and convenient formulation for the patients to use Esketamine. The molecule has received approval by US FDA in March 2019, under the brand name Spravato, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them.

The US FDA granted this approval of Spravato to Janssen Pharmaceuticals. Janssen had received fast track and Breakthrough Therapy Designation for intranasal ESK in 2013 for treatment-resistant depression (TRD) and in 2016 for the treatment of the major depressive disorder (MDD) with an imminent risk of suicide. Celon Pharma is currently conducting the phase II trial in subjects with treatment-resistant Bipolar Depression (TRBD). It is the first such formulation, which targets both the unipolar and bipolar treatment-resistant depression. It is co-financed from the National Funds Research and Development Center. As plans, Celon Pharma is expecting the Breakthrough designation for bipolar depression and fast track designation for both the indications (TRD and bipolar depression), by 2020.

Zuranolone: Sage Therapeutics

Zuranolone (SAGE-217) is a once-daily, two-week therapy in development for the treatment of the major depressive disorder (MDD) and postpartum depression (PPD). It is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes significantly to regulating brain function.

The Landscape Program is evaluating the potential of zuranolone as a rapid-acting, short-course oral treatment for PPD and MDD. It includes three completed pivotal efficacy studies evaluating zuranolone 30 mg in PPD (ROBIN Study) and MDD (MDD-201, MOUNTAIN Study), the results of which have been previously reported. In March 2020, after a Breakthrough Therapy guidance meeting with the US FDA, Sage Therapeutics announced plans to launch three additional studies of its investigational drug zuranolone. Results are expected in 2021.

Market Outlook

The ultimate goal of treatment is to achieve as high as possible a level of psychosocial function and health-related quality of life. BD is a highly recurrent disorder and sometimes medication needs to continue even if the patient feels well. The treatment has two phases: the acute phase and the maintenance phase. Acute-phase treatment is focused on the management of acute mood episodes (manic, hypomanic, or depressive). Maintenance-phase treatment is focused on preventing recurrences of acute episodes. Each phase is associated with specific treatment needs, and available pharmacotherapies have shown differential efficacy according to the illness phase. Most commonly mood stabilizers, antipsychotics, antidepressants, antianxiety medications, and psychotherapy is used.

In the United States, only four medications are approved for acute treatment of depressive episodes in the context of bipolar disorder: Symbyax (olanzapine-fluoxetine combination), Seroquel and Seroquel XR (quetiapine), Latuda (lurasidone), and Vraylar (cariprazine). Although older medications such as lithium also have modest effects in acute bipolar depression.

In October 2008, the US FDA approved once-daily Seroquel XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. Seroquel XR and Seroquel are also approved in the EU for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Symbyax was the first drug approved by the US FDA for the acute treatment of bipolar depression in adults in 2003. Zyprexa, in combination with fluoxetine, is now approved for the same indication. Oral Zyprexa and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies. Zyprexa monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

The US FDA approved lurasidone (Latuda, Sunovion Pharmaceuticals Inc) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10-17 years. In March 2020, Latuda was approved in Japan for the improvement of depressive symptoms in patients with bipolar disorder.

Recently, in May 2019, a new approval by FDA was made for bipolar depression. The US FDA approved a supplemental New Drug Application for Vraylar for the expanded treatment of depressive episodes associated with bipolar I disorder in adults. Vraylar (cariprazine), developed by Hungary-based Gedeon Richter Ltd. and licensed to Allergan, has also been approved in the US for treatment of manic or mixed episodes associated with bipolar I disorder in adults.

In short, efficacious pharmacologic options for managing the most prevalent and most disabling phases of bipolar disorder are extremely limited. Treatments that work in both phases of bipolar disorder are especially rare. New treatments are desperately needed.

Key Findings

• The market size of Bipolar Depression in the 7MM was USD 762.83 million in 2017.
• According to the estimates, the highest market size of Bipolar Depression was found in the United States, followed by France.
• The market size of the United States in 2017 was found to be USD 431.04 million, and the market size of Japan was USD 60.75 million.
• In the EU5, the highest market share of Bipolar Depression was in France, followed by Germany and the United Kingdom, and the least of Spain, in 2017.
• The upcoming therapy, Abilify (Aripiprazole), is anticipated to enter the market by 2021 in the US, and 2022 in EU-5 and Japan. Other therapies that are expected to enter the market before 2024 are Lumateperone, NRX-100/NRX-101, and Zuranolone.

Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Bipolar Depression market or expected to get launched in the market during the study period 2017-2030. The analysis covers the Bipolar Depression market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Pipeline and Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics. The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Bipolar Depression emerging therapies.

Reimbursement Scenario

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitive and market Intelligence analysis of the Bipolar Depression market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Bipolar Depression, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Bipolar Depression epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Bipolar Depression is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Bipolar Depression market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Bipolar Depression market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing prevalence, effectiveness of drugs as both mono and combination therapy will positively drive the Bipolar Depression market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Bipolar Depression R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Bipolar Depression. Launch of emerging therapies will significantly impact the Bipolar Depression market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Companies Mentioned

• Allergan (AbbVie)/Gedeon Richter
• Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma)
• Otsuka Pharmaceutical
• Intra-cellular Therapies
• NeuroRx
• COMPASS Pathways
• Sage Therapeutics
• Iltoo Pharma
• Celon Pharma

For more information about this report visit https://www.researchandmarkets.com/r/1uzhsw

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