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市場調查報告書

ALKS-5461 (重度憂鬱症)-預測與市場分析

ALKS-5461 (Major Depressive Disorder) - Forecast and Market Analysis to 2023

出版商 GlobalData 商品編碼 305486
出版日期 內容資訊 英文 59 Pages
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ALKS-5461 (重度憂鬱症)-預測與市場分析 ALKS-5461 (Major Depressive Disorder) - Forecast and Market Analysis to 2023
出版日期: 2014年05月30日 內容資訊: 英文 59 Pages
簡介

重度憂鬱症(MDD)是世界最常見的精神疾病之一。其市場競爭激烈,有超過30個產品上市中。在Eli Lilly的Cymbalta、大塚製薬/BMS的Abilify等主力產品專利即將到期,及Lundbeck/武田薬品工業的Brintellix等位於最終階段平台產品即將上市的當下,市場正在大大變化中。ALKS-5461是Alkermes所開發,為了傳統治療法反應不佳的患者所用的輔助治療藥。由於第二期實驗結果良好,FDA指定ALKS-546為 Fast Track status(快速追蹤),以促進其快速審查通過。

本報告提供重度憂鬱症的治療藥物ALKS-5461之調查分析,為您提供疾病概要和治療指南,競爭情形,產品資訊,銷售額預測等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因·病理生理學
    • 病因
    • 病理生理學
  • 分類
  • 症狀及亞型
  • 預後
  • QOL

第4章 疾病的管理

  • 症狀和治療概要

第5章 競爭評估

  • 概要

第6章 機會及未滿足需求

  • 概要
  • 更有效的藥物療法
  • 更佳副作用簡介
  • 效果快速的抗憂鬱效果
  • 個人化醫療的方法

第7章 開發平台分析

  • 概要
  • 臨床開發中的潛力藥物

第8章 ALKS-5461

  • 概要
  • 功效
  • 安全性
  • 給藥與處方
  • 臨床及市場上的潛在地位
  • SWOT分析
  • 預測

第9章 附錄

圖表

目錄
Product Code: GDHC427DFR

Major depressive disorder (MDD) is one of the most common psychiatric diseases worldwide. The MDD market is a crowded and competitive market, with more than 30 marketed products available for the treatment of patients with MDD. The depression market is about to enter a dynamic phase with imminent patent expiries for top selling products, such as Eli Lilly's Cymbalta, and Otsuka/BMS's Abilify, along with the recent launch of the multimodal antidepressant, Lundbeck/Takeda's Brintellix, in January 2014, and the potential introduction of seven promising late-stage pipeline products into the market during the forecast period, from 2013 to 2023.

ALKS-5461 is being developed by Alkermes as an adjunctive treatment for MDD in patients who have had an inadequate response to standard therapies. According to Alkermes, ALKS-5461 is expected to enter Phase III development during the first half of 2014. Following its very successful Phase II trial, the FDA granted Fast Track status for ALKS-5461 in order to facilitate its development and expedite its review by the regulatory authority (Alkermes, press release, October 10, 2013).

Scope

  • Overview of Major depressive disorder, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on ALKS-5461 including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for ALKS-5461 for the top eight countries from 2013 to 2023.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Australia.

Reasons to buy

  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Major depressive disorder
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of ALKS-5461 performance
  • Obtain sales forecast for ALKS-5461 from 2013-2023 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Classification
  • 3.3. Symptoms and Subtypes of Major Depressive Disorder
  • 3.4. Prognosis
  • 3.5. Quality of Life

4. Disease Management

  • 4.1. Diagnosis and Treatment Overview
    • 4.1.1. Diagnosis
    • 4.1.2. Treatment Guidelines and Leading Prescribed Drugs
    • 4.1.3. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview

6. Unmet Needs and Opportunities

  • 6.1. Overview
  • 6.2. More Effective Pharmacotherapies
    • 6.2.1. Unmet Needs
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunities
  • 6.3. More Favorable Side Effect Profiles
    • 6.3.1. Unmet Needs
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunities
  • 6.4. Rapid Onset of Antidepressant Effects
    • 6.4.1. Unmet Needs
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunities
  • 6.5. Personalized Treatment Approach
    • 6.5.1. Unmet Needs
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunities

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development

8. ALKS-5461

  • 8.1. Overview
  • 8.2. Efficacy
  • 8.3. Safety
  • 8.4. Dosing and Formulation
  • 8.5. Potential Clinical and Commercial Positioning
  • 8.6. SWOT Analysis
  • 8.7. Forecast

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed MDD Patients
    • 9.4.2. Percent of Drug-Treated Patients
    • 9.4.3. General Pricing Assumptions
    • 9.4.4. Generic Erosion
    • 9.4.5. Pricing of Pipeline Agents
  • 9.5. Physicians and Specialists Included in this Study
  • 9.6. About the Authors
    • 9.6.1. Analyst
    • 9.6.2. Therapy Area Directors
    • 9.6.3. Global Head of Healthcare
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10)
  • Table 2: Subtypes of Major Depressive Disorder
  • Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria
  • Table 4: Treatment Guidelines for Major Depressive Disorder
  • Table 5: Most Prescribed Drugs for MDD by Class in the 7MM and Australia, 2013
  • Table 6: Leading Treatments for MDD, 2013
  • Table 7: Unmet Needs and Opportunities in MDD
  • Table 8: Comparison of Therapeutic Classes in Development for MDD, 2013
  • Table 9: Product Profile - ALKS-5461
  • Table 10: ALKS-5461 SWOT Analysis, 2014
  • Table 11: Global MDD Sales Forecasts ($m) for ALKS-5461, 2013-2023
  • Table 12: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons
  • Figure 2: Disease Management Model for Major Depressive Disorder
  • Figure 3: Major Depressive Disorder Treatment Algorithm
  • Figure 4: MDD - Phase IIb-III Pipeline, 2014
  • Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013-2023
  • Figure 6: Clinical and Commercial Positioning of ALKS-5461
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