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Topical Clonidine(神経障害性疼痛治療薬):市場の予測と分析

Topical Clonidine (Neuropathic Pain) - Forecast and Market Analysis to 2022

発行 GlobalData 商品コード 302379
出版日 ページ情報 英文 88 Pages
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Topical Clonidine(神経障害性疼痛治療薬):市場の予測と分析 Topical Clonidine (Neuropathic Pain) - Forecast and Market Analysis to 2022
出版日: 2014年04月30日 ページ情報: 英文 88 Pages
概要

BioDelivery Sciences International(BDSI)では、2013年にクロニジン関連の国際共同ライセンス契約をArcion Therapeuticsと締結した後、現在は有痛性糖尿病性神経障害(PDN)治療のためのTopical Clonidine Gel(クロニジン局所塗布用ゼル、0.1%塩酸クロニジン)の第III相治験の計画を立案しています。Arcionでは2009年12月には既に、PDN治療薬の第II相治験を完了し、PDN関連の疼痛の軽減に有効であるとの結論を得ています(特に、侵害受容体がまだ残存しているというエビデンスのある患者についてはその傾向が強いです)。2010年9月には、Arcion Therapeuticsは米国FDA(食品医薬品局)より、PDN関連の疼痛治療のためのtopical clonidine gelに関するファストトラック(Fast Track)認証を獲得しました。

当レポートでは、神経障害性疼痛の治療薬の一つ、Topical Clonidineの世界市場について分析し、神経障害性疼痛の概要や治療法、競合する企業・薬品の概要、市場競争の概況、Topical Clonidine用ゼルの商品情報(特色・効能・安全性など)、世界の主要国における市場販売額の見通し(今後10年間分)などを調査して、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 神経障害性疼痛の臨床症状:徴候と症状
    • 有痛性糖尿病性神経障害(PDN)
    • 帯状疱疹後神経痛(PHN)
    • 三叉神経痛(TN)
  • 病因と病態
    • 病因
    • 病態生理

第4章 疾患の管理

  • 診断・治療の概要
    • 診断
    • 治療の概要とガイドライン

第5章 競合企業の評価

  • 概要

第6章 アンメットニーズと市場機会

  • 概要
  • 医師の知識/認知度
    • アンメットニーズ
    • ギャップ分析
    • 市場機会
  • 診断上の課題
  • 治療率の低さと薬剤投与量の少なさ
  • 薬理学的処置の効能・安全性に関する不満
  • 高齢患者:薬剤への耐性
  • 合理的/個人化医療

第7章 パイプライン評価

  • 概要
  • 治験中の有望な薬剤

第8章 Topical Clonidine Gel(クロニジン局所塗布用ゼル)について

  • 概要
  • 効能
  • 安全性
  • 投与・剤形方法
  • 臨床面・商業面での潜在的な位置づけ
  • 価格設定と医療費償還
  • SWOT分析
  • 予測

第9章 付録

図表一覧

目次
Product Code: GDHC411DFR

Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability. New treatments will target some key unmet needs in terms of efficacy and tolerability, but opportunities will remain for drugs that can more reliably eradicated NP in targeted patient populations, as well as offering an improved safety profile.

BioDelivery Sciences International (BDSI) is currently planning Phase III clinical trials of a Topical Clonidine gel (0.1% clonidine hydrochloride) for the treatment of PDN, after the company entered into a worldwide licensing agreement with Arcion Therapeutics for clonidine in March 2013. Arcion had previously completed Phase II trials of the drug in PDN in December 2009, the results of which showed that it was effective in reducing pain associated with PDN, particularly in subjects with evidence of preserved nociceptors. In September 2010, Arcion Therapeutics received a Fast-Track designation from the FDA for the topical clonidine gel for the treatment of pain associated with PDN.

Scope

  • Overview of Neuropathic pain, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Topical Clonidine including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Topical Clonidine for the top six countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain and the UK.

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 Neuropathic pain
  • 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 Topical Clonidine performance
  • Obtain sales forecast for Topical Clonidine from 2012-2022 in the top six countries (the US, France, Germany, Italy, Spain and the UK).

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

3. Disease Overview

  • 3.1. Clinical Manifestations of Neuropathic Pain - Signs and Symptoms
    • 3.1.1. Painful Diabetic Neuropathy
    • 3.1.2. Postherpetic Neuralgia
    • 3.1.3. Trigeminal Neuralgia
  • 3.2. Etiology and Pathophysiology
    • 3.2.1. Etiology
    • 3.2.2. Pathophysiology

4. Disease Management

  • 4.1. Diagnosis and Treatment Overview
    • 4.1.1. Diagnosis
    • 4.1.2. Treatment Overview and Guidelines

5. Competitive Assessment

  • 5.1. Overview

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Physician Knowledge or Awareness
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Diagnostic Challenges
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Low Treatment Rate and Underdosing of Medications
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Elderly Patient Population - Drug Tolerability
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity
  • 6.7. Rational or Personalized Therapies
    • 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. Topical Clonidine Gel

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

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed PDN, PHN, and TN Patients
    • 9.4.2. Percent 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. Author
    • 9.6.2. Global Head of Healthcare
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage
  • Table 2: Signs and Symptoms of NP
  • Table 3: Screening Tools for NP
  • Table 4: NP-Related Signs and Symptoms
  • Table 5: Treatment Guidelines for NP
  • Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy
  • Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012
  • Table 8: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013
  • Table 9: Select Products Used for NP Treatment, 2013
  • Table 10: Unmet Need and Opportunity in NP
  • Table 11: NP - Promising Drugs in Clinical Development
  • Table 12: Comparison of Drugs in Development for NP, 2014
  • Table 13: Product Profile - Topical Clonidine Gel
  • Table 14: Topical Clonidine Gel SWOT Analysis, 2013
  • Table 15: Global Sales Forecasts ($) for Topical Clonidine Gel, 2012-2022

List of Figures

  • Figure 1: Nociceptive Versus Neuropathic Pain
  • Figure 2: Etiology and Pathophysiology of NP
  • Figure 3: Pain Pathway - Somatosensory System
  • Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System
  • Figure 5: Pathophysiological Targets of NP Drugs
  • Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP
  • Figure 7: General Treatment Algorithm for NP
  • Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022
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