Entyvio(潰瘍性大腸炎) - 預測與市場分析

2012年到2022年潰瘍性大腸炎(UC)治療藥市場，預測將在Johnson & Johnson（Simponi）、武田藥品工業（Entyvio）的加入下大幅成長，主要國家（美國、歐盟五國、日本、加拿大）預計接受生技藥品治療的患者數將會增加。此外由於UC的暢銷藥物(Remicade，Humira)在美國專利到期，生技仿製藥的發售有影響市場的可能性。

本報告提供UC治療藥物Entyvio的調查分析，提供疾病概要和治療指南，競爭情形，產品資訊，及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

第4章 疾病的管理

• 診斷和治療概要

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
• 未滿足需求
• 未滿足需求的差距分析
• 疾病的嚴重程度與以大腸癌生物標靶為基礎的預後工具
• 難治性的預測因素

第7章 開發平台評估

• 概要
• 臨床開發中的潛力藥物

第8章 Entyvio(vedolizumab)

• 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
• 價格與給付
• SWOT分析
• 預測

第9章 附錄

圖表

During the forecast period from 2012-2022, the growth of the UC market will be driven largely by the entry of Johnson & Johnson's (J&J's) Simponi and Takeda's Entyvio, which will lead to an increase in the overall number of patients being treated with biologics in the US, 5EU, Japan, and Canada. Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.

Takeda Pharmaceuticals developed Entyvio for the treatment of moderate to severe CD and UC. Takeda's subsidiary, Millennium Pharmaceuticals, sponsored the Entyvio clinical trials, GEMINI I, GEMINI II, and GEMINI III, as well as the ongoing GEMINI LTS trial. Entyvio has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program ever conducted evaluating both CD and UC patients.

Scope

• Overview of Ulcerative Colitis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on Entyvio including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Entyvio 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 Ulcerative Colitis
• 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 Entyvio performance
• Obtain sales forecast for Entyvio from 2012-2022 in the 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
  • 3.2.1. Quality of Life

4. Disease Management

• 4.1. Diagnosis and Treatment Overview
  • 4.1.1. Diagnosis
  • 4.1.2. Treatment Guidelines and Leading Prescribed Drugs
  • 4.1.3. Clinical Practice

5. Competitive Assessment

• 5.1. Overview
• 5.2. Strategic Competitor Assessment

6. Opportunity and Unmet Need

• 6.1. Overview
• 6.2. Unmet Needs
  • 6.2.1. Curative Therapy for Severe UC Patients
  • 6.2.2. Diagnostic Markers for Disease Severity
  • 6.2.3. Personalized Therapy
  • 6.2.4. A Replacement for Steroids
  • 6.2.5. Novel Oral Drug Formulations
  • 6.2.6. Preventative Medicine for Lowering the Associated Colorectal Cancer Risk
  • 6.2.7. Improved Management of Infectious Adverse Events
• 6.3. Unmet Needs Gap Analysis
• 6.4. Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools
• 6.5. Predictors of Medically-Refractory Disease

7. Pipeline Assessment

• 7.1. Overview
• 7.2. Promising Drugs in Clinical Development

8. Entyvio (vedolizumab)

• 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 UC 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
• 9.8. About GlobalData
• 9.9. Disclaimer

List of Tables

• Table 1: Genetic Factors That Confer a Predisposition to UC
• Table 2: Typical Symptoms of UC
• Table 3: Truelove and Witts UC Severity Index
• Table 4: UCDAI
• Table 5: Treatment Guidelines for UC Used in the 10MM
• Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013
• Table 7: Leading Treatments for UC, 2014
• Table 8: Overall Unmet Needs - Current Level of Attainment
• Table 9: Corticosteroid Long-Term Side Effects
• Table 10: Clinical Unmet Needs in UC - Gap Analysis, 2013
• Table 11: Prognostic Markers in UC
• Table 12: UC - Pre-Registration and Phase III Pipeline, 2014
• Table 13: Comparison of Therapeutic Classes in Development for UC, 2014
• Table 14: Product Profile - Entyvio
• Table 15: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC
• Table 16: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC
• Table 17: Most Common Adverse Events with Vedolizumab in the GEMINI I Study
• Table 18: Entyvio SWOT Analysis, 2014
• Table 19: Global Sales Forecasts ($m) for Entyvio, 2012-2022
• Table 20: Physicians Surveyed, By Country

List of Figures

• Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC
• Figure 2: UC Disease Management Flowchart
• Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022