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市場調查報告書

Topical Clonidine(神經病變性疼痛治療藥):市場預測與分析

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

出版商 GlobalData 商品編碼 302379
出版日期 內容資訊 英文 88 Pages
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Topical Clonidine(神經病變性疼痛治療藥):市場預測與分析 Topical Clonidine (Neuropathic Pain) - Forecast and Market Analysis to 2022
出版日期: 2014年04月30日 內容資訊: 英文 88 Pages
簡介

BioDelivery Sciences International(BDSI)在2013年和Arcion Therapeutics簽下共同享有Clonidine gel相關的國際授權契約之後,目前正在籌劃治療糖尿病疼痛性神經病變(PDN)用Topical Clonidine Gel(局部塗抹Clonidine用凝膠、0.1%鹽酸、Clonidine)的第三代實驗計劃。Arcion在2009年12月已完成PDN治療藥第二代實驗,並得到其可有效減輕PDN相關疼痛這樣的結論(尤其是仍留有傷害感証據的患者這個傾向更強烈)。2010年9月,Arcion Therapeutics通過了美國FDA(食品藥物管理局)的PDN相關疼痛治療用topical clonidine gel之Fast Track認証。

本報告提供神經病變性止痛藥之一──Topical Clonidine的全球市場相關分析,彙整神經病變性疼痛概要和治療方法,競爭的企業·藥品概要,市場競爭概況,Topical Clonidine用zeru的商品資訊(特色·功效·安全性等),全球主要國家的市場販售額預測(今後10年份)等調查,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 神經病變性疼痛臨床症狀:症狀
    • 糖尿病疼痛性神經病變(PDN)
    • 帶狀皰疹後神經痛(PHN)
    • 三叉神經痛(TN)
  • 病因與病情
    • 病因
    • 病理生理學

第4章 疾病的管理

  • 診斷·治療概要
    • 診斷
    • 治療的概要與指南

第5章 競爭企業的評估

  • 概要

第6章 未滿足需求與市場機會

  • 概要
  • 醫生的知識/認知度
    • 未滿足需求
    • 差距分析
    • 市場機會
  • 診斷上的課題
  • 治療率低與過小量給藥
  • 藥物治療有效性及安全性不足
  • 高齡患者人口 - 藥物耐受性
  • 合理的/個人化醫療

第7章 開發平台評估

  • 概要
  • 臨床實驗中的有潛力的藥劑

第8章 Topical Clonidine 關於Gel(Clonidine局部涂布用zeru)

  • 概要
  • 功效
  • 安全性
  • 給藥·劑型方法
  • 臨床方面·商業方面的潛在性地位
  • 價格設定和醫療費給付
  • SWOT分析
  • 預測

第9章 附錄

圖表一覽

目錄
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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