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市場調查報告書

PharmaPoint: 克隆氏症-日本醫藥品的預測與市場分析

PharmaPoint: Crohn's Disease - Japan Drug Forecast and Market Analysis to 2022

出版商 GlobalData 商品編碼 298498
出版日期 內容資訊 英文 113 Pages
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PharmaPoint: 克隆氏症-日本醫藥品的預測與市場分析 PharmaPoint: Crohn's Disease - Japan Drug Forecast and Market Analysis to 2022
出版日期: 2014年01月31日 內容資訊: 英文 113 Pages
簡介

克隆氏症(CD)市場由於新的生物醫藥品出現而活躍。由於該市場中主流TNF抑制劑的專利保護到期,Hospira的Inflectra等新興生技仿製藥興起。預期加拿大與中國、印度等新興市場對該市場的成長而言將扮演重要的角色。預計日本於專利到期的2021年起,生技仿製藥的市場滲透將開始。

本報告提供日本的克隆氏症(CD)市場相關調查分析、疾病的概要與指南、競爭情形、主要藥物的詳細資訊(產品說明、安全性、有效性)、SWOT分析、銷售額預測、影響分析(趨勢、推動因素、阻礙因素)等,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

  • 病因、病理生理學
    • 病因
    • 病理生理學
  • 症狀
  • 預測
  • QOL

第4章 疾病的管理

  • 治療概要
  • 日本
    • 診斷
    • 臨床診療

第5章 競爭評估

  • 概要
  • 策略性競爭企業的評估
  • 產品簡介 - 領導品牌
  • 生技仿製藥

第6章 機會及未滿足需求

  • 概要
  • 個體化治療用生物標記的要求
  • 抗TNF劑無作用的患者用醫藥品
  • 未滿足需求的差距分析
  • 標靶治療藥
  • 早期診斷、治療的預測工具

第7章 開發平台評估

  • 概要
  • 臨床開發中的潛力藥物
  • 其他開發後期階段開發中產品

第8章 市場預測

  • 全球市場

第9章 日本

  • 預測
  • 主要的事項
  • 推動因素及阻礙因素

第10章 附錄

圖表

目錄
Product Code: GDHC210CFR

The Crohn's disease (CD) market is currently very dynamic, with novel biologic therapies on the horizon. These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If their promising safety and efficacy profiles translate to clinical practice once they enter the market, their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and Humira (adalimumab).The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of biosimilars, such as Hospira's Inflectra (infliximab) a Remicade biosimilar. Focusing on country dynamics, Canada and the emerging markets of China and India will also play a key role in driving growth in the long term, with each market forecast to post positive Compound Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of Remicade over the forecast period.

In contrast to the 7MM, but akin to Canada, Remicade will remain on patent in the Japanese CD market for a significant portion of the 10-year forecast period, with biosimilar erosion predicted from 2021 on. This, in turn, will lead to the brand experiencing year-on-year growth through to its peak-year sales in 2022.

Scope

  • Overview of Crohn's disease 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 Crohn's disease 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 Crohn's disease.
  • 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
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Prognosis
  • 3.4. Quality of Life

4. Disease Management

  • 4.1. Treatment Overview
  • 4.2. Japan
    • 4.2.1. Diagnosis
    • 4.2.2. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Strategic Competitor Assessment
  • 5.3. Product Profiles - Major Brands
    • 5.3.1. Remicade (infliximab)
    • 5.3.2. Humira (adalimumab)
    • 5.3.3. Other Marketed Products
  • 5.4. Biosimilars
    • 5.4.1. Introduction
    • 5.4.2. Hospira's Inflectra Versus J&J's Remicade in Key Autoimmune Diseases
    • 5.4.3. Biosimilars in the Immunology Community
    • 5.4.4. By the Numbers: Biosimilars in Development
    • 5.4.5. The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry

6. Opportunity and Unmet Need

  • 6.1. Overview
  • 6.2. Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach
  • 6.3. More Therapies for Anti-TNF-Refractory Patients
  • 6.4. Unmet Needs Gap Analysis
  • 6.5. Targeted Therapies
  • 6.6. Predictive Tools for Early Diagnosis and Treatment

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development
    • 7.2.1. Entyvio (vedolizumab)
    • 7.2.2. Stelara (ustekinumab)
  • 7.3. Other Late-Stage Pipeline Products
    • 7.3.1. Cx601
    • 7.3.2. RHB-104 (clarithromycin + clofazimine + rifabutin)

8. Market Outlook

  • 8.1. Global Markets
    • 8.1.1. Drivers and Barriers - Global Issues

9. Japan

  • 9.1. Forecast
  • 9.2. Key Events
  • 9.3. Drivers and Barriers
    • 9.3.1. Driver: Pathways for biosimilar approval are already in place
    • 9.3.2. Driver: Increasing number of prevalent cases of CD
    • 9.3.3. Driver: Continued uptake of TNF inhibitors, particularly Remicade
    • 9.3.4. Driver: Launch of the first non-anti-TNF during the mid-forecast
    • 9.3.5. Driver: The well-developed universal healthcare system ensures insurance coverage for patients with chronic diseases
    • 9.3.6. Barrier: Biennial pricing system may limit long-term revenues for companies operating in this market
    • 9.3.7. Barrier: Time lag between drug approval and launch, due to the process required for listing a drug on the NHI
    • 9.3.8. Barrier: Regulatory approval is often contingent upon companies presenting domestic and/or Japanese-specific clinical trial data

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed CD Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch and Patent Expiry Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Drug Assumptions
    • 10.4.7. Generic Erosion
    • 10.4.8. Pricing of Pipeline agents
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Author/Reviewer
    • 10.7.2. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Symptoms of CD
  • Table 2: Treatment Guidelines for CD
  • Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013
  • Table 4: Leading Branded Drugs Used to Treat CD
  • Table 5: Product Profile - Remicade
  • Table 6: Remicade SWOT Analysis, 2013
  • Table 7: Product Profile - Humira
  • Table 8: Humira SWOT Analysis, 2013
  • Table 9: Summary of the Minor Therapeutic Classes in CD, 2013
  • Table 10: Biosimilars Pipeline, 2013
  • Table 11: Overall Unmet Needs in CD - Current Level of Attainment
  • Table 12: Clinical Unmet Needs in CD - Gap Analysis, 2013
  • Table 13: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013
  • Table 14: Comparison of Therapeutic Classes in Development for CD, 2013
  • Table 15: Product Profile - Entyvio
  • Table 16: Efficacy of Entyvio in GEMINI II Studies of CD
  • Table 17: Entyvio SWOT Analysis, 2013
  • Table 18: Product Profile - Stelara
  • Table 19: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients
  • Table 20: Stelara SWOT Analysis, 2013
  • Table 21: Product Profile - Cx601
  • Table 22: Cx601 SWOT Analysis, 2013
  • Table 23: Product Profile - RHB-104
  • Table 24: RHB-104 SWOT Analysis, 2013
  • Table 25: Global CD Market - Drivers and Barriers, 2012-2022
  • Table 26: Sales Forecasts ($) for CD in Japan, 2012-2022
  • Table 27: Key Events Impacting Sales for CD in Japan, 2012-2022
  • Table 28: CD Market in Japan - Drivers and Barriers, 2012-2022
  • Table 29: Key Launch Dates
  • Table 30: Key Patent Expiries
  • Table 31: Physicians Surveyed, By Country

List of Figures

  • Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right)
  • Figure 2: Potential Biologic Drug Targets for CD
  • Figure 3: Patient Care Path for CD
  • Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022
  • Figure 5: Sales for CD in Japan by Drug Class, 2012-2022
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