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バイオベター:主要参入企業と市場見通し(第2版)

Biobetters: Major Players and Market Prospects (2nd edition)

発行 FirstWord 商品コード 216737
出版日 ページ情報 英文 48 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=114.58円で換算しております。
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バイオベター:主要参入企業と市場見通し(第2版) Biobetters: Major Players and Market Prospects (2nd edition)
出版日: 2011年09月30日 ページ情報: 英文 48 Pages
概要

当レポートでは、バイオベター市場の概要と市場における役割、同市場に参入する企業の概要、今後の成長見通しなどについてまとめ、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

ブランド、バイオシミラー、バイオベター

  • 生物医薬品市場
  • コスト削減ツールとしてのバイオシミラーの登場

MabThera/Rituxanの国際的価格比較

  • バイオベターの合理性

バイオベター:旧薬のための新しい名前

  • 小分子
  • すでに上市されている"バイオベター"
  • バイオベターはどれほどベターなのか
  • バイオベターを"より良いもの"に
    • 変更の程度と種類
    • 半減期拡張とペグ
    • グリコエンジニアリングと細胞生成システム
    • 新興の手法
  • バイオベターの標的
    • インターフェロン、成長ホルモン、血液因子
    • モノクローナル抗体が改善見込み
    • 癌はバイオベターの成長分野
  • 免疫原性:バイオベターのアキレス腱
    • 創始者は免疫原性を防御策として活用
    • 予測はリスクゲーム
    • 現在の免疫原性試験の黄金率としての治験
  • バイオベター:市場へのルート
    • 完全なる承認経路
    • データパッケージ要件
    • バイオベター特有の治験要件
    • 特許の複雑さ
    • バイオベターの価格設定と償還
    • バイオベターの混雑した市場
  • バイオベターの競争:主要企業
    • バイオベターに関心を寄せる多国籍企業
    • 大手ジェネリック薬メーカーのバイオベターへの熱望
    • 小規模バイオテクノロジー企業
    • 提携による成功
    • アジア市場
      • 法規制の圧力がアジア企業の侵入を阻害
      • 製造コストがバイオベターの成功に及ぼす影響は最小限
      • ステークホルダーの短期的不信感がアジアバイオベターの成功に制限

結論

謝辞

目次
Product Code: 400200055

Marketing gimmick or natural evolution?

For some, biobetters - drugs similar but superior to the branded reference product - are little more than the natural outcome of a drug' s life-cycle management strategy.

Even so, interest in biobetters is increasing, since they can and will command higher prices while providing a significant improvement to the reference drug. At the forefront of those turning to biobetters are branded pharma, biotech and large generic companies who have already established themselves in the biosimilars industry. But will the emerging biobetter industry prove to be more lucrative than has been the case for biosimilars?

Overview

In Biobetters: Major Players and Market Prospects (2nd edition), FirstWord describes the biobetters market and how interest has mounted in what is still a very young market. The report reviews the role biosimilars have played, presents the rationale behind biobetters and how interest is is stirring in their development. In addition, the report concisely outlines how companies are evolving biobetters, the areas of greatest potential and reviews the ‘Achilles Heel' of immunogenicity. Based on frontline expert interviews, the report addresses the question of approval pathways, who the major players are and, perhaps most importantly, offers a compelling picture of biobetters' future prospects.

Key features

  • A comprehensive overview of the nascent biobetters market and where it is going
  • An outline of what biobetters are, how they are being developed and what their likely targets are
  • A discussion of the regulatory landscape
  • An insight into the biobetters manufacturers of tomorrow
  • An overview of optimal strategies for success

Key Benefits

  • Access to top expert opinion and insights
  • Compelling overview of the biobetters industry
  • Frontline reporting on how it' s evolving and who will be the industry leaders

Key Questions Asked

  • How do second generation biologics vary from biobetters proper?
  • Will biobetters go through an abbreviated or full new drug approval pathway?
  • Who will be the pioneers of the biobetter industry and what is spurring their success?
  • How is interest by third-party manufacturers affecting the development of superior biosimilars?
  • How is the risk of immunogenicity affecting the case for branded biotech?
  • What areas of improvement exist for creating improved biobetters?

Who Should Read This Report

  • Licensing and Business Development Managers
  • Sales and Marketing Executives
  • Strategic Management
  • Medical Affairs
  • Regulatory Affairs
  • New Product Development Managers
  • Marketing Research
  • Preclinical and Clinical Development Executives
  • Intellectual Property Executives
  • Pricing and Reimbursement Heads
  • Market Access Executives

Expert Views

  • Dr. Sandy Eisnen, formerly Chief Medical Officer at Teva
  • Dr. Jesús Zurdo, Head of Innovation at Lonza Biologics
  • Dr. David Szymkowski, Senior Director of Biotherapeutics at Xencor Inc.
  • Ronald A. Rader, President of Biotechnology Information Institute
  • In addition to an Indian Biotech executive, an executive at a major US generic company, a Development Director of a specialist Biotech company, and a Senior Manager at a biotech manufacturer.

Table of Contents

Executive summary

Brands, Biosimilars, and Biobetters

  • The market for biological medicines
  • The emergence of biosimilars as a cost-saving tool

Comparison of international list prices for MabThera/Rituxan

  • The rationale for biobetters

Biobetters - new name for an old drug?

  • Small molecule parallels
  • ‘Biobetters' already on the market
  • How much better are Biobetters?
  • Putting the ‘Better' into Biobetter
  • Extent and type of changes
    • Half-life extension and pegylation
    • Glyco-engineering and cell production systems
    • Emerging methods
    • Prolonging half-life via deuteration
    • Modifying formulation
  • Biobetter targets - possibilities abound
    • Interferons, growth hormones, and blood factors: good biobetter candidates
    • Monoclonal antibodies could be improved upon
    • Oncology could be a growth area for biobetters
  • Immunogenicity - the Achilles Heel of Biobetters?
    • Originators could use immunogenicity as a defensive shield
    • Prediction is a risky game
    • Clinical trials as the current gold-standard for immunogenicity testing
  • Biobetters - the route to market
    • The full approval pathway beckons for biobetters
    • Data package requirements could vary
    • Clinical trial requirements likely to be biobetter specific
      • The bar for regulatory approval could be higher
      • ...but the risks are lower
    • Patent complications
    • Biobetter pricing and reimbursement
      • Biobetter benefit must justify price
      • Cost of treatment versus unit pricing
    • A crowded market for biobetters?
      • Opening up new markets
      • Market access strategies
  • The Biobetters Race - Major Players
    • Multinational interest in biobetters - the usual suspects?
    • The biobetter aspirations of larger generics companies
    • Small biotech - a key biobetter player
    • Success through collaboration
    • The Asian factor
      • Regulatory pressures could resist incursion of Asian players
      • Manufacturing costs will have minimal impact on biobetter success
      • Stakeholder distrust in the short-term could restrict Asian biobetter success

Conclusion

Acknowledgements

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