市場調査レポート

欧州におけるバイオシミラー薬:技術革新の脅威か機会か

Biosimilar Drugs in Europe: threat or opportunity to innovation?

発行 FirstWord 商品コード 222810
出版日 ページ情報 英文 57 Pages
納期: 即日から翌営業日
価格
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欧州におけるバイオシミラー薬:技術革新の脅威か機会か Biosimilar Drugs in Europe: threat or opportunity to innovation?
出版日: 2011年11月08日 ページ情報: 英文 57 Pages
概要

2019年にかけ、多くのブロックバスター薬が特許失効を迎え、欧州ではバイオシミラー市場への門戸が開かれるようになります。2006年からすでに確立されたバイオシミラー市場ですが、2015年までに22億5,000万〜48億米ドル規模にまで成長するとみられています。

当レポートでは、欧州におけるバイオシミラー市場の現状と、開発、製造、承認動向、新薬開発企業の地位と保護主義、連携の役割などをまとめ、概略以下の構成でお届けいたします。

エグゼクティブサマリー

欧州におけるバイオシミラー薬

バイオシミラー薬とは

  • ジェネリック薬とバイオシミラー薬:類似点と相違点
  • 欧州で今までに入手可能なバイオシミラー

欧州におけるバイオシミラー薬市場の機会

  • 生物製剤の特許失効が市場に影響
  • バイオシミラー薬市場の種類は欧州各国で異なる
    • バイオシミラー薬の地域別市場は様々
    • イタリアでは処方はブランド薬で満たされている
    • フランス、スペインでは薬剤の割引が行われている
    • 英国ではバイオシミラー薬の摂取がNICEにて促進されている
    • ドイツではバイオシミラー薬は種類によって異なる
  • バイオシミラー薬の導入は欧州において分子、適応によって異なる
  • バイオシミラー薬の使用は慢性疾患治療と一過性疾患治療とで異なる
  • 確立された治療においては患者がバイオシミラー薬にスイッチすることに抵抗をもつ
  • 病院医師はプライマリケア医師よりもバイオシミラー薬の使用に柔軟
  • バイオシミラー薬は費用に敏感な市場において影響を及ぼす
  • 小児科人口がバイオシミラー薬の摂取に消極的

欧州におけるバイオシミラー薬の課題

  • 欧州における承認取得
    • 欧州のバイオシミラー薬承認プロセス
    • バイオシミラー薬に関する法規制は急な学習カーブをたどっている
    • 法規制はすべての点において公平なものか
  • バイオシミラー薬の課題:開発と製造に関する問題克服
  • バイオシミラー薬の課題:特許問題の克服
  • バイオシミラー薬の課題:ステークホルダーの信頼獲得

防衛的立場:新薬開発企業がバイオシミラー薬の摂取に制限を加える

  • ライフサイクルマネジメントが市場シェアを維持
  • 自動的代用のないことが新薬開発会社を保護
  • 独占的提供と特許が新薬開発会社を保護
  • 新薬開発会社が市場シェア維持のために信頼性を保持
    • 品質、安全性、有効性によって信頼を維持
    • マーケティング、営業、医療専門家トレーニングによって市場シェアを維持
  • 類似性の程度を通じた市場の保護:バイオシミラーは本当に類似しているのか
  • 競合力の価格設定とリベートの合意によってコストに敏感な顧客を確保

攻撃的立場:新規市場への参入

  • 価格設定がバイオシミラー薬の主な差別化因子
  • 市場を知ることが市場シェアを得ることに
  • 情報と教育
    • 営業、マーケティング、アカウントマネジメント
    • 医療従事者向け教育
  • 付加価値による市場シェア獲得:装置、処方
    • バイオシミラー薬の使いやすさ改善
    • バイオシミラー薬の問題解決
  • 特許を通じたバイオシミラー薬の保護

企業環境:バイオシミラー薬における企業の機会

  • ジェネリック薬メーカーが主な参入企業

バイオシミラー薬市場における連携とライセンシング

  • ジェネリック薬メーカー間の提携
  • ジェネリック薬メーカーと新薬開発企業との間の提携
  • より広範な市場にアクセスするための地域的連携
  • バイオシミラー薬取引データ
    • 件数別
    • 金額別
    • 形態別
    • 適応別
  • バイオシミラー薬契約

欧州におけるバイオシミラー薬にとっての次なるもの

  • モノクローナル抗体がバイオシミラー薬市場に劇的に参入
  • バイオベターがバイオシミラー薬の後続に
    • バイオベターは異なる承認ルートを辿る
  • 米国:バイオシミラー薬環境を変革

結論

謝辞

参考情報

目次
Product Code: 400200011

Abstract

Between now and 2019, a vast range of blockbuster drugs will go off patent, opening the floodgates in the EU to the biosimilars market. Already established there since 2006, biosimilars are set to be worth between $2.25 billion and $4.8 billion by 2015.

The potential is undeniable. Yet even in its advanced state compared to other regulated and unregulated markets, European biosimilars continue to be challenged by issues and hurdles, ranging from development and manufacturing to approval and opposition from originator companies. What lessons are there to be learned?

Report Overview

In Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?, FirstWord Dossier examines the emerging biosimilars market. The report, based on expert interviews and analysis, examines market differences across Europe and different therapeutic areas. The impact of biosimilars on originator companies - and their response - is discussed, as well as strategies biosimilar companies will engage in to expand their market share. And most importantly, the report offers insight into biosimilar deals and what the future holds in the EU.

Key features

  • Discussion of biosimilar markets in five geographic areas
  • Examination of key factors driving biosimilar uptake, including molecule and indications
  • Detailed overview of development, manufacturing and approval issues in Europe
  • Insight into the position and protectionism of originator companies
  • Reporting on the role of collaboration

Key Benefits

  • Access to firsthand opinions from experts in the biosimilars and biotechnology industry
  • Review of deal-making data in biosimilars from a deal-making market leader
  • Forward-looking analysis of the future of biosimilars

Key Questions Asked

  • What are the challenges facing biosimilars in Europe?
  • How can biosimilars companies take market share in Europe?
  • How can originator biologics companies keep market share in Europe?
  • Which companies are collaborating over biosimilars development?
  • What deals are being made?
  • What's next for biosimilars?

Who Should Read This Report

  • Market access directors and managers
  • Medical and scientific affairs professionals
  • Pricing and reimbursement teams
  • Intellectual property professionals
  • Patent analysts
  • Legal affairs teams
  • Regulatory and government affairs professionals

Expert Views

  • Carsten Thiel, Regional Vice President, Europe and Australia, Amgen
  • Paul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at Hospira
  • Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare Consulting
  • Asa Cox, Founder of biosimilarlicensing.com
  • Lee Coney, Chief Scientific Officer, Biologics, Huntingdon Life Sciences
  • Jim Furniss, Director, Global Market Access Strategy, Bridgehead International
  • Andrew Teuten, Senior Partner, Sagittarius IP

Key Quotes

  • "The size of the global biologics market creates a massive opportunity for biosimilar developers to come in and take some of that market. The size of the prize in Europe will be significant, so there's a big incentive for biosimilar companies to come in, develop these biosimilar products, and compete against the originator brands for market share."
    - Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare Consulting
  • I can't see the biosimilars market following the classic small molecule generic model where on day one, five molecules enter the market and the price drops to 20 percent of the brand. The economics just will not match those of the small molecule drugs."
    - Asa Cox, founder of biosimilarlicensing.com
  • "You can see that over time the biosimilar products have started to be accepted and used quite broadly in certain markets. There is a difference in uptake between countries - the uptake of biosimilars is not uniform across all the EU - and there is a difference between individual molecules as well."
    -Paul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at Hospira

Table of Contents

Content Highlights

Executive summary

Biosimilar drugs in Europe

What are biosimilars?

  • Generics and biosimilars - similarities and differences
  • Biosimilars available so far in Europe

The market opportunities for biosimilars in Europe

  • The biologics patent cliff will have an impact on the market
  • Market types for biosimilars will differ across Europe
    • Geographic markets for biosimilars will vary across Europe
      • In Italy, prescriptions are fulfilled by brand
      • In France and Spain, drugs are discounted to targets
      • In the UK, biosimilar uptake is driven by NICE
      • In Germany, biosimilars uptake is good but varies by drug type
    • Biosimilar uptake will vary by molecule and indication across Europe
      • Epoetin uptake may have been slowed by immunogenicity issues
      • Filgrastim uptake has been faster in Europe
    • Biosimilar use is likely to vary between chronic and episodic treatment
    • There may be a resistance to switching patients on established treatments
    • Hospital physicians may be more likely to use biosimilars than primary care physicians
    • Biosimilars will have an impact in cost-sensitive markets
    • The paediatric population may be reluctant to take up biosimilars

The challenges for biosimilars in Europe

  • The biosimilars challenge: Gaining approval in Europe
    • The EU regulatory process for biosimilars
    • Biosimilar regulations will be a steep learning curve
    • Will regulations be fair and balanced on all points?
  • The biosimilars challenge: Overcoming development and manufacturing hurdles
    • Biologics are highly variable by nature
    • Variations can cause issues with immunogenicity
  • The biosimilars challenge: Overcoming patent hurdles
  • The biosimilars challenge: Gaining stakeholder trust
    • Payers can be a major driver for biosimilars uptake
    • Physicians will be key gatekeepers for biologics and biosimilars
    • Patients may be cautious about biosimilars

The defensive position: Originator companies will try to limit biosimilar uptake

  • Lifecycle management can maintain market share
  • Lack of automatic substitution will protect originator drugs
  • Exclusivity provisions and patents will protect originator drugs
  • Originator companies can exploit loyalty to maintain market share
    • Focusing on quality, safety and efficacy claims can maintain loyalty
    • Using marketing, sales and healthcare professional training to attract and keep market share
  • Protecting the market through degree of similarity - is a biosimilar really similar?
  • Competitive pricing and rebate agreements will keep cost-sensitive customers

The offensive position: breaking into a new market

  • Pricing is the key differentiator for biosimilars
  • Knowing the market will help gain market share
  • Information and education: defending biosimilars against the naysayers
    • Sales, marketing and account management: Market share through talking to the payers
    • Education for healthcare professionals: Market share through talking to the physicians
  • Gaining market share by adding value: Devices and formulations
    • Making the biosimilar easier to use: Devices
    • Making the biosimilar easier to handle: formulations
    • Protecting biosimilars through patents

The company landscape: Opportunities for companies in biosimilars

  • Generics companies will be key players

Collaboration and licensing in the biosimilars market

  • Collaborations between generics companies - bringing together development and marketing
  • Collaborations between generic and originator companies combines know-how and manufacturing capabilities
  • Geographic collaborations allows access to wider markets
  • Looking into biosimilars deal data
    • Biosimilar deals by volume
    • Biosimilar deals by value
    • Biosimilar deals by type
    • Biosimilar deals by indication
  • Biosimilar deals: Deal case studies
    • Biopharma company signs agreement to access biosimilars
    • Generics company signs agreement to fill pipeline

What's next for biosimilars in Europe?

  • Monoclonal antibodies will be a dramatic entry to the biosimilars market
  • Biobetters could 'follow-on' from biosimilars
    • Biobetters will follow a different route of approval
  • The US: Changing the biosimilars environment

Conclusion

Acknowledgements

Bibliography

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