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市场调查报告书

生物相似药的商业战略与战术

Biosimilar Commercial Strategies and Tactics

出版商 Datamonitor Healthcare 商品编码 911301
出版日期 内容资讯 英文 67 Pages
商品交期: 最快1-2个工作天内
价格
生物相似药的商业战略与战术 Biosimilar Commercial Strategies and Tactics
出版日期: 2019年05月14日内容资讯: 英文 67 Pages
简介

本报告提供全球生物相似药市场上商业战略与战术相关调查,生物相似药市场上机会的掌握与实现,商业性策略,策略检讨,案例研究,及今后的市场方向性等相关分析。

概要

把握生物相似药的机会

  • 生物学疗法的成本及「患者就医」的课题
  • 生物相似药为这个课题提供某种程度的解决方案
  • 已制定法规来帮助利用生物仿制药的机会、其他

实现生物相似药的机会

  • 保持生物相似药法规核准与市场引进的平衡
  • 了解生物仿制药成功商业化的障碍
  • 参考资料

定义生物相似药的商业性策略

  • 生物仿制药商业策略制定的时机因公司而异
  • 早期战略制定需要重视对内部和外部利益相关者的教育
  • 生物仿制药战略愿景的定义是多个团队的跨职能工作,需要全球和区域参与
  • 参考资料

生物相似药策略的检讨

  • 在整体生物仿制药战略中平衡发展和商业策略
  • 开发策略
  • 商业化策略
  • 参考资料

案例研究

  • 主要的案例研究的考察
  • 欧洲的Adalimumab生物相似药
  • 欧洲的Infliximab生物相似药
  • 美国的Pegfilgrastim生物相似药
  • 英国的Rituximab生物相似药
  • 参考资料

课题·机会·未来的方向性

  • 生物相似药市场长期性的永续性仍然是最大的问题,需要引入商业模式
  • 企业为了促进生物相似药市场上长期性的商业性成功,应关注重要的成功要素数值
  • 参考资料

附录

目录

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.

TABLE OF CONTENTS

OVERVIEW

  • In order to realize the biosimilar opportunity, companies must understand the barriers to commercial success and leverage expertise from multiple stakeholder groups
  • When firms begin to define a biosimilar commercial strategy varies from company to company, but across all companies it requires cross-functional collaboration
  • Companies must balance commercial and developmental tactics within a biosimilar's overarching commercial strategy
  • Case studies focused on the commercialization of biosimilars in Europe and the US point to a wide range of successful tactics, while national payers have led the way with forward-looking procurement tactics
  • Sustainability has now become the industry's buzzword, with governments, payers, regulators, and biosimilars companies all working in unison to secure a long-term future for the industry

UNDERSTANDING THE BIOSIMILAR OPPORTUNITY

  • The cost of biological therapies and the "patient access" challenge
  • Biosimilars offer part of the solution to this challenge
  • Regulations have been put in place to help exploit the biosimilar opportunity
  • Current status of European and US biosimilar approvals
  • Commercial performance of biosimilars in Europe and the US has been hugely variable
  • Bibliography

REALIZING THE BIOSIMILAR OPPORTUNITY

  • Balancing regulatory approval and in-market adoption for biosimilars
  • Understanding barriers to the successful commercialization of a biosimilar
  • Bibliography

DEFINING A BIOSIMILAR COMMERCIAL STRATEGY

  • The timing of biosimilar commercial strategy formulation varies from company to company
  • Early strategy development needs to focus on internal and external stakeholder education
  • Defining the strategic vision for a biosimilar is a multi-team, cross-functional effort that requires global and local involvement
  • Bibliography

BIOSIMILAR TACTICS REVIEW

  • Balancing developmental and commercial tactics within a biosimilar's overall strategy
  • Developmental tactics
  • Commercial tactics
  • Bibliography

CASE STUDIES

  • Key case study insights
  • Adalimumab biosimilars in Europe - a new, sustainable model for the procurement of biosimilars
  • Infliximab biosimilars in Europe - Celltrion's extensive partner network gives way to its own commercial infrastructure
  • Pegfilgrastim biosimilars in the US - Coherus seeks commercial differentiation for Udenyca with a "brand-like" strategy
  • Rituximab biosimilars in the UK - commercial strategies focus on education and supporting introduction into clinical practice
  • Bibliography

CHALLENGES, OPPORTUNITIES, AND FUTURE DIRECTIONS

  • The long-term sustainability of the biosimilars market remains the biggest concern, so commercial models will need to adapt
  • Companies must focus on a number of critical success factors in order to drive long-term commercial success in the biosimilars market
  • Bibliography

APPENDIX

  • About the author
  • Scope
  • Methodology

LIST OF TABLES

  • Table 1: Biosimilars approved in Europe during 2018 and early 2019
  • Table 2: Biosimilars approved in the US during 2018 and early 2019
  • Table 3: Key biosimilar market access barriers
  • Table 4: Key commercial and developmental tactics used in the biosimilars market
  • Table 5: Key insights from biosimilar commercialization case studies
  • Table 6: Approved adalimumab biosimilars in Europe (as of 30 April 2019)
  • Table 7: Approved infliximab biosimilars in Europe (as of 30 April 2019)
  • Table 8: Approved pegfilgrastim biosimilars in the US (as of 30 April 2019)
  • Table 9: Approved rituximab biosimilars in Europe (as of 30 April 2019)