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在PharmaPoint:神經性病變疼痛--日本的醫藥品預測與市場分析

PharmaPoint: Neuropathic Pain - Japan Drug Forecast and Market Analysis to 2022

出版商 GlobalData 商品編碼 301145
出版日期 內容資訊 英文 138 Pages
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在PharmaPoint:神經性病變疼痛--日本的醫藥品預測與市場分析 PharmaPoint: Neuropathic Pain - Japan Drug Forecast and Market Analysis to 2022
出版日期: 2014年04月30日 內容資訊: 英文 138 Pages
簡介

神經性病變痛(NP)是感覺運動系統的障礙,和傷害性疼痛(外傷、傷害、發炎造成的疼痛)儼然不同。神經性病變疼痛與傷害性疼痛主要差別在於神經性病變疼痛並沒有持續性刺激傷害受體。尤其是糖尿病神經痛(PDN)、帶狀疱疹後神經痛、三叉神經痛等三個主要症狀。目前所使用的藥劑主要層級有抗驚厥劑、抗憂鬱劑、鴉片類藥物及局部治療等。但儘管有各種治療藥,仍僅有50%的患者顯示有療效,同時還會產生各種副作用,造成耐受性降低。日本和全球各國相同,高齡人口的增加都是推動神經性病變痛的要素,但程度等級可說是大不相同。同時,和其他先進國家不同,並非開發平台產品的新上市,而是其他國家已上市產品(Lyrica及Cymbalta)的延遲上市,一般認為銷售額擴大是市場成長的主因。這二個產品比起美國及歐洲都要5年上市,因此專利及壟斷銷售權皆被延長(Lyrica到2022年、Cymbalta到2017年)。

本報告提供日本的神經病變性止痛法相關的最新研究·開發情形及市場未來展望分析,彙整疾病概要和治療方法,市場機會及未滿足需求,市場規模趨勢(今後10年份),已上市/臨床實驗中主要的治療藥簡介(功效·安全性·市場競爭力),日本市場現狀與今後的方向性等資訊,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 神經性病變疼痛臨床症狀:症狀
    • 糖尿病神經痛(PDN)
    • 帶狀皰疹後神經痛(PHN)
    • 三叉神經痛(TN)
  • 病因·病理
    • 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
  • 日本
    • 診斷·介紹
    • 藥物治療

第5章 競爭企業的評估

  • 概要
  • 三環抗憂鬱藥物
    • 概要
    • 功效
    • 安全性
  • 鈣離子通道α-2-δ配體(抗痙攣藥)
    • Lyrica
  • 鈉離子通道阻斷抗痙攣藥(TN)
  • 正腎上腺素再吸收抑制劑(抗憂鬱劑)
    • Cymbalta
  • Opioids(類鴉片物質)
    • Opioids Nucynta ER/Palexia SR
  • 局部療法
    • Lidoderm/Versatis
    • Qutenza

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
  • 低治療率與給藥量少
  • 對藥理學性治療的功效·安全性方面的不滿
  • 高齡患者:藥物的耐受性
  • 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
    • Eslicarbazepine Acetate
    • Topical Clonidine Gel
    • Cebranopadol
    • DS-5565
    • CNV-2197944
    • CNV-1014802
    • Eladur(bupibakain·貼片)

第8章 市場未來展望

  • 市場促進·阻礙因素:全世界的課題
    • 推動因素:老年人口的增加
    • 推動因素:第二型糖尿病患病人數的增加擴大了PDN市場
    • 推動因素:新藥的認證
    • 阻礙因素:學名藥支配市場
    • 阻礙因素:選擇臨床實驗最適當的病理學標的之困難
    • 阻礙因素:三叉神經痛治療體制的落後
    • 阻礙因素:與侵入性治療方法的競爭
  • 日本市場
    • 預測
    • 近幾年的主要趨勢
    • 市場促進·阻礙因素

第9章 附錄

圖表一覽

目錄
Product Code: GDHC241CFR

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.

Similar to the rest of the global markets, this will be fueled predominantly by the growing incidence of NP as a result of the increasing elderly population, which is even more pronounced in Japan. However, unlike the other countries in the 7MM, most of the growth in the NP market in Japan will not be due to the entry of numerous pipeline drugs, but rather will be the result of the delayed launch and continued growth of both Lyrica and Cymbalta. Both these drugs launched in Japan approximately five years after their launch in the US and EU. Furthermore, both drugs are subject to extended exclusivity in Japan, with the patent for Lyrica not set to expire in Japan until 2022, and the post-marketing exclusivity for Cymbalta estimated to extend to 2017.

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 the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Japan from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting the Japan Neuropathic Pain market.

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 drug performance
  • Obtain sales forecast for drugs from 2012-2022 in Japan.

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
  • 4.2. Japan
    • 4.2.1. Diagnosis and Referral
    • 4.2.2. Drug Treatment

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Tricyclic Antidepressants
    • 5.2.1. Overview
    • 5.2.2. Efficacy
    • 5.2.3. Safety
  • 5.3. Calcium Channel Alpha-2-Delta Ligands (Anticonvulsants)
    • 5.3.1. Overview
    • 5.3.2. Efficacy
    • 5.3.3. Safety
    • 5.3.4. Lyrica
  • 5.4. Sodium Channel-Blocking Anticonvulsants (TN)
    • 5.4.1. Overview
    • 5.4.2. Efficacy
    • 5.4.3. Safety
  • 5.5. Serotonin-Norepinephrine Reuptake Inhibitors (Antidepressants)
    • 5.5.1. Overview
    • 5.5.2. Efficacy
    • 5.5.3. Safety
    • 5.5.4. Cymbalta
  • 5.6. Opioids
    • 5.6.1. Overview
    • 5.6.2. Efficacy
    • 5.6.3. Safety
  • 5.7. Topical Therapies
    • 5.7.1. Overview
    • 5.7.2. Efficacy
    • 5.7.3. Safety

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
    • 7.2.1. DS-5565

8. Market Outlook

  • 8.1. Drivers and Barriers - Global Issues
    • 8.1.1. Driver: Aging Population in the 7MM
    • 8.1.2. Driver: Increase in Prevalence and Diagnosis of Type 2 Diabetes Will Grow the PDN Market
    • 8.1.3. Driver: Approval of New NP Drugs
    • 8.1.4. Barrier: NP Market Dominated by Generics
    • 8.1.5. Barrier: Challenges Selecting the Most Relevant Pathophysiological Targets for Drug Development
    • 8.1.6. Barrier: Underserved Trigeminal Neuralgia Indication
    • 8.1.7. Barrier: Competition from Interventional Therapies
  • 8.2. Japan
    • 8.2.1. Forecast
    • 8.2.2. Key Events
    • 8.2.3. Drivers and Barriers

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. Drugs Included In Each Therapeutic Class
    • 9.4.4. Launch and Patent Expiry Dates
    • 9.4.5. General Pricing Assumptions
    • 9.4.6. Individual Drug Assumptions
    • 9.4.7. Generic Erosion
    • 9.4.8. 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: Japan - NP Diagnosis and Referral Metrics
  • Table 9: Japan - NP Treatment Metrics
  • Table 10: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013
  • Table 11: Select Products Used for NP Treatment, 2013
  • Table 12: Product Profile - Lyrica
  • Table 13: Lyrica SWOT Analysis, 2013
  • Table 14: Product Profile - Cymbalta
  • Table 15: Cymbalta SWOT Analysis, 2013
  • Table 16: Unmet Need and Opportunity in NP
  • Table 17: NP - Promising Drugs in Clinical Development
  • Table 18: Comparison of Drugs in Development for NP, 2014
  • Table 19: Product Profile - DS-5565
  • Table 20: DS-5565 SWOT Analysis, 2013
  • Table 21: NP Market - Drivers and Barriers, 2012-2022
  • Table 22: Sales Forecasts ($) for NP in Japan, 2012-2022
  • Table 23: Sales Forecasts ($) for PDN in Japan, 2012-2022
  • Table 24: Sales Forecasts ($) for PHN in Japan, 2012-2022
  • Table 25: Sales Forecasts ($) for TN in Japan, 2012-2022
  • Table 26: Key Events Impacting Sales for NP in Japan, 2012-2022
  • Table 27: NP Market - Drivers and Barriers in Japan, 2012-2022
  • Table 28: Key Launch Dates
  • Table 29: Key Patent/Exclusivity Expiries

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
  • Figure 9: Sales for NP in Japan by Drug Class, 2012-2022
  • Figure 10: Sales for PDN in Japan by Drug Class, 2012-2022
  • Figure 11: Sales for PHN in Japan by Drug Class, 2012-2022
  • Figure 12: Sales for TN in Japan by Drug Class, 2012-2022
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