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市場調查報告書

生物相似藥的商業戰略與戰術

Biosimilar Commercial Strategies and Tactics

出版商 Datamonitor Healthcare 商品編碼 911301
出版日期 內容資訊 英文 67 Pages
商品交期: 最快1-2個工作天內
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生物相似藥的商業戰略與戰術 Biosimilar Commercial Strategies and Tactics
出版日期: 2019年05月14日內容資訊: 英文 67 Pages
簡介

本報告提供全球生物相似藥市場上商業戰略與戰術相關調查,生物相似藥市場上機會的掌握與實現,商業性策略,策略檢討,案例研究,及今後的市場方向性等相關分析。

概要

把握生物相似藥的機會

  • 生物學療法的成本及「患者就醫」的課題
  • 生物相似藥為這個課題提供某種程度的解決方案
  • 已製定法規來幫助利用生物仿製藥的機會、其他

實現生物相似藥的機會

  • 保持生物相似藥法規核准與市場引進的平衡
  • 了解生物仿製藥成功商業化的障礙
  • 參考資料

定義生物相似藥的商業性策略

  • 生物仿製藥商業策略制定的時機因公司而異
  • 早期戰略制定需要重視對內部和外部利益相關者的教育
  • 生物仿製藥戰略願景的定義是多個團隊的跨職能工作,需要全球和區域參與
  • 參考資料

生物相似藥策略的檢討

  • 在整體生物仿製藥戰略中平衡發展和商業策略
  • 開發策略
  • 商業化策略
  • 參考資料

案例研究

  • 主要的案例研究的考察
  • 歐洲的Adalimumab生物相似藥
  • 歐洲的Infliximab生物相似藥
  • 美國的Pegfilgrastim生物相似藥
  • 英國的Rituximab生物相似藥
  • 參考資料

課題·機會·未來的方向性

  • 生物相似藥市場長期性的永續性仍然是最大的問題,需要引入商業模式
  • 企業為了促進生物相似藥市場上長期性的商業性成功,應關注重要的成功要素數值
  • 參考資料

附錄

目錄

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)
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