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PharmaPoint: クローン病-米国における医薬品の予測と市場分析

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

発行 GlobalData 商品コード 298497
出版日 ページ情報 英文 138 Pages
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PharmaPoint: クローン病-米国における医薬品の予測と市場分析 PharmaPoint: Crohn's Disease - US Drug Forecast and Market Analysis to 2022
出版日: 2014年01月31日 ページ情報: 英文 138 Pages
概要

クローン病(CD)市場は新たなバイオ医薬品の出現により、活発化しています。市場において主流のTNF阻害剤の特許権保護が消失することで、HospiraのInflectraなど新たなバイオシミラーが台頭し、カナダや中国、インドなどの新興市場が同市場の成長にとって主要な役割を果たすと考えられます。米国には約60万人のクローン病(CD)患者がおり、世界最大のCD市場の地位を今後10年は維持すると予測されています。

当レポートでは、米国におけるクローン病(CD)市場について調査分析し、疾病の概要とガイドライン、競合情勢、主要薬剤の詳細情報(製品説明、安全性、有効性)、SWOT分析、売上高予測、影響分析(動向、促進要因・抑制要因)などを提供して、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 疾病の概要

  • 病因・病態生理
    • 病因
    • 病態生理
  • 症状
  • 予後
  • QOL

第4章 疾病の管理

  • 治療の概要
  • 米国
    • 診断
    • 臨床診療

第5章 競合評価

  • 概要
  • 戦略的競合企業の評価
  • 製品プロファイル - 主要ブランド
  • バイオシミラー

第6章 機会とアンメットニーズ

  • 概要
  • 個別化治療用バイオマーカーの要望
  • 抗TNF剤に反応しない患者のための医薬品
  • アンメットニーズのギャップ分析
  • 標的治療薬
  • 早期診断・治療の予測ツール

第7章 パイプライン評価

  • 概要
  • 臨床開発中の有望な薬剤
  • その他開発の後期段階にあるパイプライン製品

第8章 市場の見通し

  • 世界市場

第9章 米国

  • 予測
  • 主な出来事
  • 促進要因および阻害要因

第10章 付録

図表

目次
Product Code: GDHC208CFR

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.

Owing to a large pool of approximately 600,000 patients and the comparatively high cost of drug therapies for CD, the US was the largest CD market by value and volume in 2012, and will retain this position throughout GlobalData's 10-year forecast to 2022. New market players will emerge during the early years of the forecast period - namely, Takeda's Entyvio in 2014 and J&J's Stelara in 2015. Their launches will fuel further growth in the US CD market, albeit to the detriment of Remicade's and Humira's patient shares.

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

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. US
    • 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. Cimzia (certolizumab pegol)
    • 5.3.4. Tysabri (natalizumab)
    • 5.3.5. 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)
    • 7.2.3. Vercirnon (formerly GSK1605786)
    • 7.2.4. Prochymal (Remestemcel-L)
  • 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. US

  • 9.1. Forecast
  • 9.2. Key Events
  • 9.3. Drivers and Barriers
    • 9.3.1. Driver: Launches of the new non-anti-TNF biologics during 2014-2015 will challenge the current anti-TNF market leaders
    • 9.3.2. Driver: Establishing a regulatory framework for biosimilar approval
    • 9.3.3. Driver: Drugs that currently require high co-payment and/or prior authorization may benefit from US healthcare reform
    • 9.3.4. Barrier: Guidance for the use of biosimilars needs to be in place ahead of their arrival
    • 9.3.5. Barrier: Brand erosion following the patent expiries of the market leaders from 2015
    • 9.3.6. Barrier: The established biologics market creates a challenging environment for new market entrants
    • 9.3.7. Barrier: The increasing emphasis on lowering healthcare expenditures may prove to be a hurdle for developers hoping to command premium prices
    • 9.3.8. Barrier: Pricing pressures and reimbursement issues

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: Product Profile - Cimzia
  • Table 10: Cimzia SWOT Analysis, 2013
  • Table 11: Product Profile - Tysabri
  • Table 12: Tysabri SWOT Analysis, 2013
  • Table 13: Summary of the Minor Therapeutic Classes in CD, 2013
  • Table 14: Biosimilars Pipeline, 2013
  • Table 15: Overall Unmet Needs in CD - Current Level of Attainment
  • Table 16: Clinical Unmet Needs in CD - Gap Analysis, 2013
  • Table 17: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013
  • Table 18: Comparison of Therapeutic Classes in Development for CD, 2013
  • Table 19: Product Profile - Entyvio
  • Table 20: Efficacy of Entyvio in GEMINI II Studies of CD
  • Table 21: Entyvio SWOT Analysis, 2013
  • Table 22: Product Profile - Stelara
  • Table 23: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients
  • Table 24: Stelara SWOT Analysis, 2013
  • Table 25: Product Profile - Vercirnon
  • Table 26: Vercirnon SWOT Analysis, 2013
  • Table 27: Product Profile - Prochymal
  • Table 28: Prochymal SWOT Analysis, 2013
  • Table 29: Product Profile - Cx601
  • Table 30: Cx601 SWOT Analysis, 2013
  • Table 31: Product Profile - RHB-104
  • Table 32: RHB-104 SWOT Analysis, 2013
  • Table 33: Global CD Market - Drivers and Barriers, 2012-2022
  • Table 34: Sales Forecasts ($) for CD in the United States, 2012-2022
  • Table 35: Key Events Impacting Sales for CD in the US, 2012-2022
  • Table 36: CD Market in the US - Drivers and Barriers, 2012-2022
  • Table 37: Key Launch Dates
  • Table 38: Key Patent Expiries
  • Table 39: 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 the US by Drug Class, 2012-2022
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