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市場調查報告書

Stelara(克隆氏症)- 預測與市場分析

Stelara (Crohn's Disease) - Forecast and Market Analysis to 2022

出版商 GlobalData 商品編碼 297508
出版日期 內容資訊 英文 60 Pages
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Stelara(克隆氏症)- 預測與市場分析 Stelara (Crohn's Disease) - Forecast and Market Analysis to 2022
出版日期: 2014年01月31日 內容資訊: 英文 60 Pages
簡介

克隆氏症(CD)治療藥市場,由於新的生物療法來到而非常活躍。由於TNF上市藥失去專利保護,新興生技仿製藥抬頭。譬如,REMICADE的生技仿製藥,Hospira的Inflectra(infliximab)等。

本報告提供Janssen Biotech正在開發的Stelara(ustekinumab)的治療方法調查分析、疾病概要和治療指南、競爭情形、產品資訊、主要國家的銷售額預測等,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
  • 症狀
  • 預測
  • QOL

第4章 疾病的管理

  • 治療概要

第5章 競爭評估

  • 概要
  • 策略性競爭企業的評估

第6章 機會及未滿足需求

  • 概要
  • 個別治療用生物標記的要求
  • 對抗TNF無反應的患者用治療
  • 未滿足需求的差距分析
  • 標靶治療
  • 早期診斷、治療的預測工具

第7章 開發平台評估

  • 概要
  • 臨床開發中的有前途藥物

第8章 Stelara(ustekinumab)

  • 概要
  • 功效
  • 安全性
  • 給藥、處方
  • 潛在的臨床性地位
  • 潛在的商業性地位
  • 價格與回本
  • SWOT分析
  • 預測

第9章 附錄

圖表

目錄
Product Code: GDHC328DFR

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.

Janssen Biotech (a J&J subsidiary) is developing Stelara for the treatment of patients with moderate to severe CD (see the Disease Overview section for further discussion). Stelara is an IgG1 mAb that simultaneously targets the common p40 subunit of the IL-12/IL-23 cytokines, which are implicated in CD. According to J&J's October 15, 2013 product pipeline, Stelara is currently undergoing Phase III trials in CD patients who have failed anti-TNF therapies (UNITI-1 trial), as well as in those who have failed conventional corticosteroid and immunomodulator therapies (UNITI-2 trial).

Scope

  • Overview of Crohn's disease (CD), including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Stelara including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Stelara for the top eight countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Canada

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 Stelara performance
  • Obtain sales forecast for Stelara from 2012-2022 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Canada)

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

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Strategic Competitor Assessment

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

8. Stelara (ustekinumab)

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

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed CD 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. Primary Research - Prescriber Survey
  • 9.7. About the Authors
    • 9.7.1. Author/Reviewer
    • 9.7.2. Global Head of Healthcare
  • 9.8. About GlobalData
  • 9.9. 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: Overall Unmet Needs in CD - Current Level of Attainment
  • Table 6: Clinical Unmet Needs in CD - Gap Analysis, 2013
  • Table 7: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013
  • Table 8: Comparison of Therapeutic Classes in Development for CD, 2013
  • Table 9: Product Profile - Stelara
  • Table 10: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients
  • Table 11: Stelara SWOT Analysis, 2013
  • Table 12: Global Sales Forecasts ($) for Stelara, 2012-2022
  • Table 13: 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
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