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Optina(糖尿病の細小血管合併症)- 予測と市場分析

Optina (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023

発行 GlobalData 商品コード 294518
出版日 ページ情報 英文 109 Pages
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Optina(糖尿病の細小血管合併症)- 予測と市場分析 Optina (Macular Edema and Macular Degeneration) - Forecast and Market Analysis to 2023
出版日: 2014年10月31日 ページ情報: 英文 109 Pages
概要

糖尿病の細小血管合併症(糖尿病性腎症・網膜症・神経障害)の市場全体は、主要7ヶ国(米国、欧州5ヶ国、日本)において極めて高いレベルのアンメットニーズに直面しています。莫大な可能性にもかかわらず、過疎のパイプラインで世界的な障壁に直面しています。糖尿病性網膜症の市場では、新しい抗VEGF(血管内皮増殖因子)療法の急速な取り込みが進み、力強い成長を示しています。その一方で、糖尿病性腎症・神経障害の市場では、ジェネリックの競合企業の数が増加しています。

当レポートでは、Ampio Pharmaceuticalsが開発し、糖尿病性網膜症・黄斑浮腫の治療薬として第III相試験中のOptinaについて調査分析し、疾病の概要と治療ガイドライン、競合情勢、製品情報、主要国の売上予測などを提供して、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 疾病の概要

  • 病因・病態生理
    • 糖尿病性腎症
    • 糖尿病性網膜症
    • 糖尿病性神経障害
  • 予後
  • QOL
  • 症状

第4章 疾病の管理

  • 治療の概要
    • 診断と照会
    • スクリーニング
    • 治療ガイドライン

第5章 競合評価

  • 概要
  • 戦略的競合企業の評価

第6章 機会とアンメットニーズ

  • 概要
  • アンメットニーズ
  • アンメットニーズのギャップ分析
  • 機会

第7章 パイプライン評価

  • 概要
  • 臨床開発中の有望な薬剤

第8章 Optina(danazol)

  • 概要
  • 効能
  • 安全性
  • 投与・処方
  • 潜在的な臨床的位置付け
  • 潜在的な商業的位置付け
  • 価格と償還
  • SWOT分析
  • 予測

第9章 付録

図表

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目次
Product Code: GDHC490DFR

Macular Edema is a condition where fluid accumulates on the macula, leading to vision impairment or in severe cases even vision loss. The three main types of ME are diabetic macular edema (DME), and macular edema following either a central or branch retinal vein occlusion (ME-CRVO and ME-BRVO). Age-related macular degeneration (AMD) is a painless eye condition which leads to gradual, irreversible, loss of central vision, and is one of the leading causes of blindness among people aged 50 and over in the developed world. Currently the ME and AMD markets are dominated by the use of anti-VEGF monotherapy, however, in recent years, corticosteroid implants have been reaching the ME market which could challenge the stronghold these drugs have in this sector. The AMD market will see the arrival of the first therapies to treat dry AMD, fulfilling a huge unmet need in the management of this retinal disease, and these first-in-class therapies will strongly drive the market growth over the next ten years. The launch of wet AMD adjunctive therapies will also see a significant change in the treatment of AMD patients and have a positive impact on the market growth.

Optina is an orally-administered, ultra-low-dose capsule reformulation of the steroid danazol that is in Phase III of clinical development by Ampio Pharmaceuticals for the treatment of DME. An effective non-surgical drug treatment for DME is a high unmet need, and Optina is the only drug in late-phase development addressing this need.

Scope

  • Overview of Macular Edema and Macular Degeneration, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Optina including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Optina for the top country from 2013 to 2023.
  • Sales information covered for the US.

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 Macular Edema and Macular Degeneration.
  • 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 Optina performance.
  • Obtain sales forecast for Optina from 2013-2023 in top country(the US).

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Related Reports

3. Disease Overview

  • 3.1. Macular Degeneration Overview
    • 3.1.1. Etiology and Pathophysiology
    • 3.1.2. Classification
    • 3.1.3. Symptoms and Diagnosis
  • 3.2. Macular Edema Overview
    • 3.2.1. Etiology and Pathophysiology
    • 3.2.2. Classification
    • 3.2.3. Symptoms and Diagnosis

4. Disease Management

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

5. Competitive Assessment

  • 5.1. Overview

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Treatment for Dry AMD
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Longer-Acting Anti-VEGF Drug Therapy
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Increased Efficacy of Anti-VEGF Therapy for wAMD
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Less Invasive Drug Formulations
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Awareness and Earlier Patient Diagnosis
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity
  • 6.7. Home Monitoring of AMD Progression
    • 6.7.1. Unmet Need
    • 6.7.2. Gap Analysis
    • 6.7.3. Opportunity

7. Pipeline Assessment

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

8. Optina

  • 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 ME and AMD Patients
    • 9.4.2. Percentage of Drug-Treated Patients
    • 9.4.3. General Pricing Assumptions
    • 9.4.4. Pricing of Pipeline Agents
  • 9.5. Primary Research - KOLs Interviewed for this Report
  • 9.6. Primary Research - High-Prescribers Survey
  • 9.7. About the Authors
    • 9.7.1. Analyst
    • 9.7.2. Therapy Area Director
    • 9.7.3. Global Head of Healthcare
  • 9.8. About GlobalData
  • 9.9. Disclaimer

List of Tables

  • Table 1: ARM System Classification of AMD
  • Table 2: Symptoms of AMD
  • Table 3: National and International Treatment Guidelines for ME and AMD
  • Table 4: Most Prescribed Drugs for ME and AMD in the Global Markets, 2013
  • Table 5: Leading Treatments for ME and AMD, 2014
  • Table 6: Unmet Needs and Opportunities in ME and AMD
  • Table 7: Promising Drugs in Clinical Development for ME and AMD
  • Table 8: Comparison of Drugs in Development for ME and AMD, 2014
  • Table 9: Product Profile - Optina
  • Table 10: SWOT Analysis - Optina, 2014
  • Table 11: Global Sales Forecast ($m) for Optina, 2013-2023
  • Table 12: Surveyed High-Prescribing Physicians (Non-KOLs), by Country

List of Figures

  • Figure 1: Anatomy of the Eye and Macula
  • Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD
  • Figure 3: Color Fundus Photographs of Dry and Wet AMD
  • Figure 4: FAF Imaging of GA
  • Figure 5: Imaging of wAMD
  • Figure 6: CMT in DME
  • Figure 7: RVOs (BRVO and CRVO) on an FA
  • Figure 8: Increased CRT in ME-RVO
  • Figure 9: ME Clinical Treatment Flowchart
  • Figure 10: AMD Clinical Treatment Flowchart
  • Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013-2023
  • Figure 12: Optina's Clinical Development in DME
  • Figure 13: Clinical and Commercial Positioning of Optina
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