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バイオシミラーの商品化市場:成功のための多機能的チームワーク

Commercialisaton of Biosimilars: Multifunctional teamwork for success

発行 FirstWord 商品コード 581398
出版日 ページ情報 英文
納期: 即日から翌営業日
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バイオシミラーの商品化市場:成功のための多機能的チームワーク Commercialisaton of Biosimilars: Multifunctional teamwork for success
出版日: 2017年11月01日 ページ情報: 英文
概要

当レポートでは、世界のバイオシミラーの商品化市場について調査し、市場の概要と商品化戦略のタイミングと定義、チームの枠割、将来的課題などをまとめています。

第1章 エグゼクティブサマリー

第2章 調査目的と調査方法

第3章 現在の市場概要

  • 投資の戦略的理由
  • 現在の機会
  • 現在の商品化動向
  • パイプラインサマリー
  • 法規制・政策動向
  • 促進因子と阻害因子、影響因子

第4章 商品化戦略のタイミングと定義

  • 主な動向
    • バイオシミラー企業はバイオシミラーブランド・ポートフォリオの商品化戦略策定において"目標を念頭に置かなければならない"
    • バイオシミラーの商品化戦略策定には複数のステークホルダーと多機能アプローチが必要
    • 商品化チームは戦略策定に重要な役割を担うが、他の機能は必要な専門性と考察を提供する
    • 外部の運営委員会や諮問委員会が使用されるが関与のレベルは市場成熟とともに減少する

第5章 商品化戦略策定と実施におけるチームの役割と責任

  • 主な動向
    • 複合チームが戦略策定、支持、実施に関わる
    • 技術と製造チームがプログラムに命を吹き込み将来の戦略策定に重要な役割を担う
    • 臨床・規制チームはバイオシミラーの臨床経験の蓄積に責任を負う
    • 医療部門は商品化、教育、ステークホルダー管理を通じた商品化戦略策定に重要な役割を担う 他

第6章 事前承認活動と事後承認活動の比較と構成

  • 主な動向
    • 研究開発チームは事後承認活動については"バトン"を受けた同僚と共に事前承認活動の管理をする
    • 企業がこの意義あるメッセージを翻訳する能力が重要であるため、データは商品化戦略全体に重要な影響を及ぼす
    • 商品化戦略の成功率測定については非商品化KPと共にパフォーマンス指標に注目する

第7章 戦略策定と実施における世界と地域的管理の調整

  • 主な動向
    • バイオシミラーブランドおよび/またはポートフォリオの商品化戦略は5つの重要要素から構成
    • 製品開発の早期段階ではグローバルチームは製品とポートフォリオの商品化戦略策定を主導する
    • 上市されるバイオシミラーに近くグローバルチームのサポートがあるため地域のチームが商品化戦略実施の主導権を握る
    • 世界のブランド/ポートフォリオ洗堀を適応してすべての市場に関連するバイオシミラーの商品化戦略のために地域市場を適合させていくべき

第8章 バイオシミラーの最適な戦略策定と実施に関連する将来的課題

  • 主な動向
    • 市場が成熟すれば商品化戦略は教育に注目をし、技術革新と価格が議論の中心に
    • より効果的な連携のため、世界と地域の連携チームが商品化、教育、ベストプラクティスの共有に注力すべき
    • 成功する商品化戦略は確固とした市場の理解と選定、融通性のある価格設定、差別化、製品品質、効果的ステークホルダーの管理によって支えられる

第9章 結論

目次

Commercialisation of Biosimilars

From bench to bedside, biosimilars continue to dominate boardroom discussions around the world. But after all the talking, what's the secret to success in this high stakes market? Against a backdrop of ever increasing competition and great expectations, the most effective and lucrative commercial strategies for biosimilars are emerging. Is it a case of 'business as usual' or do experts believe companies need to choose 'a road less travelled'? Commercialisation of Biosimilars: Team Tactics & Strategies Across the Product Lifecycle reveals what you need to know, and what you need to avoid.

Discover on this page…

1.Key themes covered in the report

2.What you will learn from the report

3.Detailed table of contents

4.Research objectives and methodologies employed producing in the report

1. Reasons to buy this report

Operating in a biosimilar world means that companies need to find new and innovative ways to differentiate themselves versus the competition; conversations have moved from clinical differentiation to commercial differentiation. So when it comes to commercial differentiation, is it just about being the cheapest product on the pharmacy shelf? Not so, say experts. While price gives you the 'ticket to the game', it will only take you so far. So what are the options? Experts suggest that the way forward is a hybrid approach, where the best bits of innovative drug and generic drug commercialisation are blended in order to forge a new path.

This report will enable you to:

  • Get up-to-speed on the current biosimilars landscape including opportunities, investment drivers, regulatory and policy developments, and the key factors influencing the market.
  • Define team roles and responsibilities across spectrum biosimilar asset's lifecycle, including technical and manufacturing, clinical and regulatory, medical affairs, commercial and legal.
  • Set out timings and key stages for commercial strategy development and implementation including guidance on when to involve specific functions.
  • Formulate a plan of attack for data, key performance indicators and pre- versus post-approval activities and responsibilities.
  • Build a strategy for global and local implementation success, considering who takes the lead and the five critical elements not to be ignored.
  • Look ahead to potential future strategy development and implementation challenges facing biosimilars as the market matures, and discover longer term ideas to boost success rates.

2. Research Methodology and Objectives

This report draws on the views and experience of experts directly involved in developing biosimilars and bringing them to market. It provides a valuable perspective on this growth area and offers the benefit of lessons learned, pitfalls to avoid, plus ideas on how to proceed.

The insights presented are based on detailed interviews carried out between 8 August 2017 and 3 October 2017 with 9 biosimilar-focused professionals.

  • Caroline Boulliat, Head of Biosimilar, Business Unit Director, Amgen (UK/Ireland)
  • Rakesh Dixit, VP R&D, MedImmune (AstraZeneca)
  • Dr. Rudiger Jankowsky, Managing Director, Cinfa Biotech
  • Steven Lehrer, Managing Director, SBLehrer LLC
  • Grzegorz Orlik, MD, Head of Medical Affairs, Biosimilars and Generics (Europe), Accord Healthcare
  • Erik Skullerud, Owner & Managing Partner, Element Consulting
  • VP Medical, Global Biotech Company (anonymous)
  • Pricing & Reimbursement Strategy Manager, Top 10 Pharma Company (anonymous)
  • Account Manager, European Biosimilars Company (anonymous)

Key questions explored in this report include:

  • When should a biosimilar commercial strategy be formulated and who should be involved?
  • Who should define the strategic vision at each stage in the biosimilar lifecycle?
  • What is the importance of steering committees?
  • What role do specific internal teams play, and when are they most critical?
  • What are the key differences between the pre- and post-approval phases for commercial strategy development and implementation?
  • How should global tactics be adapted to fit local markets; what market-specific tactics are needed?
  • What influences decision-making at each stage of commercial strategy development?
  • How do experts see biosimilars commercial strategies and market tactics evolving?

3. Table of Contents

Executive summary

Research objectives and methodology

  • Objectives
  • Methodology

Biosimilars: a quick snapshot of the current market

  • Strategic reasons for investing in the biosimilars market
  • Sizing the current biosimilars opportunity
  • The current commercial landscape for biosimilars
  • A summary of the current biosimilars pipeline
  • Key regulatory and policy developments in the biosimilars market
  • Key drivers and resistors, and their influence on the commercial landscape for biosimilars

Timing and defining the commercial strategy for biosimilars

  • Key insights
  • Biosimilar companies need to 'begin with the end in mind' when it comes to developing the commercial strategy for biosimilar brands and portfolios
  • Defining the commercial strategy for a biosimilar requires a multi-stakeholder, cross-functional approach
  • Commercial teams have an important role in commercial strategy development, but other functions provide much needed expertise and insight
  • External steering committees and advisory boards are used, but their level of involvement will decline as the market matures

Team roles and responsibilities during commercial strategy development and implementation

  • Key insights
  • Multiple teams are involved in developing, supporting and implementing the commercial strategy for biosimilars
  • Technical and manufacturing teams give life to biosimilar programmes and play a key role in driving future commercial strategy
  • Clinical and regulatory teams are responsible for the accumulation of positive clinical experience for a biosimilar, but visibility within certain organisations could be an issue
  • Medical affairs plays a critical role in shaping biosimilar commercial strategy via communication, education and key stakeholder management
  • Legal teams provide much needed visibility on a biosimilar company's freedom to operate, without which commercial strategy would be unable to evolve
  • Commercial teams form the sharp end of the spear in relation to commercial strategy, owning both development and implementation across multiple countries
  • Biosimilar companies are advised to develop strong relationships with patient advocacy and support groups in order to understand what levels of support will be needed

Comparing and contrasting pre- and post-approval activities

  • Key insights
  • Commercial strategy for a biosimilar brand and/or portfolio must build from five critical elements
  • In the early stages of product development, global teams tend to take the lead on developing product and portfolio commercial strategy
  • Local teams take more ownership over commercial strategy implementation as a biosimilar gets closer to being launched, with global teams supporting where needed
  • Global brand/portfolio tactics must be adapted to fit the local market in order for a biosimilar's commercial strategy to be relevant in all markets

Key future challenges in relation to optimal strategy development and implementation for biosimilars

  • Key insights
  • As the biosimilar market matures, commercial strategies will evolve to focus more on education, embrace innovation and put price front and centre of decision making
  • To support more effective collaboration, global and local affiliate teams need to focus on communication, education and sharing best practice
  • A successful commercial strategy will be supported by robust market understanding and selection, flexible pricing, differentiation, product quality and effective stakeholder management

Concluding remarks

About FirstWord

FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.

FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company's success.

FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.

Table of Contents

1. Executive summary

2. Research objectives and methodology

  • 2.1 Objectives
  • 2.2 Methodology

3. Biosimilars: a quick snapshot of the current market

  • 3.1 Strategic reasons for investing in the biosimilars market
  • 3.2 Sizing the current biosimilars opportunity
  • 3.3 The current commercial landscape for biosimilars
  • 3.4 A summary of the current biosimilars pipeline
  • 3.5 Key regulatory and policy developments in the biosimilars market
  • 3.6 Key drivers and resistors, and their influence on the commercial landscape for biosimilars

4. Timing and defining the commercial strategy for biosimilars

  • 4.1 Key insights
    • 4.1.1 Biosimilar companies need to 'begin with the end in mind' when it comes to developing the commercial strategy for biosimilar brands and portfolios
    • 4.1.2 Defining the commercial strategy for a biosimilar requires a multi-stakeholder,cross-functional approach
    • 4.1.3 Commercial teams have an important role in commercial strategy development, but other functions provide much needed expertise and insight
    • 4.1.4 External steering committees and advisory boards are used, but their level of involvement will decline as the market matures

5. Team roles and responsibilities during commercial strategy development and implementation

  • 5.1 Key insights
    • 5.1.1 Multiple teams are involved in developing, supporting and implementing the commercial strategy for biosimilars
    • 5.1.2 Technical and manufacturing teams give life to biosimilar programmes and play a key role in driving future commercial strategy
    • 5.1.3 Clinical and regulatory teams are responsible for the accumulation of positive clinical experience for a biosimilar, but visibility within certain organisations could be an issue
    • 5.1.4 Medical affairs plays a critical role in shaping biosimilar commercial strategy via communication, education and key stakeholder management
    • 5.1.5 Legal teams provide much needed visibility on a biosimilar company's freedom to operate, without which commercial strategy would be unable to evolve
    • 5.1.6 Commercial teams form the sharp end of the spear in relation to commercial strategy, owning both development and implementation across multiple countries
    • 5.1.7 Biosimilar companies are advised to develop strong relationships with patient advocacy and support groups in order to understand what levels of support will be needed

6. Comparing and contrasting pre- and post-approval activities

  • 6.1 Key insights
    • 6.1.1 R&D teams take control of pre-approval activities, with commercially focused colleagues taking the 'baton' when it comes to post-approval activities
    • 6.1.2 Data remains the most critical influence on overall commercial strategy, with a company's ability to translate this into meaningful messages also important
    • 6.1.3 Typical pressures include lack of information upon which to make decisions, including what level of competition could exist and the 'go to market' approach
    • 6.1.4 Commercially focused key performance indicators (KPIs) trump other non-commercial KPIs when it comes to measuring the success (or failure) of the commercial strategy

7. Balancing global and local control of strategy development and implementation

  • 7.1 Key insights
    • 7.1.1 Commercial strategy for a biosimilar brand and/or portfolio must build from five critical elements
    • 7.1.2 In the early stages of product development, global teams tend to take the lead on developing product and portfolio commercial strategy
    • 7.1.3 Local teams take more ownership over commercial strategy implementation as a biosimilar gets closer to being launched, with global teams supporting where needed
    • 7.1.4 Global brand/portfolio tactics must be adapted to fit the local market in order for a biosimilar's commercial strategy to be relevant in all markets

8. Key future challenges in relation to optimal strategy development and implementation for biosimilars

  • 8.1 Key insights
    • 8.1.1 As the biosimilar market matures, commercial strategies will evolve to focus more on education, embrace innovation and put price front and centre of decision making
    • 8.1.2 To support more effective collaboration, global and local affiliate teams need to focus on communication, education and sharing best practice
    • 8.1.3 A successful commercial strategy will be supported by robust market understanding and selection, flexible pricing, differentiation, product quality and effective stakeholder management

9. Concluding remarks

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