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市場調査レポート

バイオシミラーの未来 (2015年)

The Future of Biosimilars 2015

発行 FirstWord 商品コード 301229
出版日 ページ情報 英文 120 Pages
納期: 即日から翌営業日
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バイオシミラーの未来 (2015年) The Future of Biosimilars 2015
出版日: 2015年06月01日 ページ情報: 英文 120 Pages
概要

当レポートでは、バイオシミラー市場の最新動向と将来的動向について分析し、バイオシミラー市場の抱えるリスクと収益性の高さや、これまでの市場動向・業績、市場に残されている諸問題・不確実性、それに対する専門家の見解、市場関係者 (医師・患者・製薬企業・医療サービスプロバイダー) が取り組むべき今後の課題と機会などについて調査・考察しております。

エグゼクティブ・サマリー

調査目的、調査方法、定義

バイオシミラーの沿革

  • 大々的な成長と、それでも残る不確実性・課題
    • 規制上の主な課題:ガイドライン改訂、製品認証、時として生じる矛盾
    • 臨床上の主な課題:新規治験、タイムラインの変更、データの提示方法
    • 米国における法的戦略:「あらゆる技術進歩の先導者」
    • 重要な不確実領域:政府の政策 (相互互換性・令名法・臨床現場でのバイオシミラーの利用法など) に対する関心の低さ
    • 商業化・収益性に関心が集まるとともに、臨床上の議論から規制上の議論へ移行が急速に進む
    • バイオシミラーに対する関心・理解の低い状態が続くが、事態改善のための取り組みも進む

バイオシミラー・パイプライン製品の現状 (2014〜2015年)

  • 概要
  • 主要な生物製剤ブランドの概要
  • バイオシミラー/NCB (比較できない生物製剤) のパイプライン:薬剤クラス別
  • バイオシミラー/NCBのパイプライン:分子別
  • バイオシミラー/NCBのパイプライン:開発電解別
  • バイオシミラー/NCBのパイプライン:治療領域別
  • バイオシミラー/NCBのパイプライン:企業別
  • バイオシミラー/NCBのパイプライン:本社所在地別
  • バイオシミラーのパイプライン製品の将来性とは?

重大な不確定性、主な問題、今後注目すべきマイルストーン

  • 市場の主な不確実性の概要
  • 教育:バイオシミラーの開発・商業化を左右する重要な課題
    • バイオシミラーがもたらす利益・機会を各家庭にもたらすために、医師・患者に焦点を絞った、更なる教育活動が必要となる
  • バイオシミラーの規制認証の獲得が現在でも課題となっているが、米国では事態が前進し、頑強性分析の重要性が増している
    • 「バイオシミラー規制は業界の持続的成長を支えている」と専門家は信じているが、まだ改善の余地がある
    • 治験のための患者募集は、バイオシミラー企業にとっての大きな課題であり、しかも年々難しくなってきている
    • 「市場参入のし易さ」の観点から、専門家が今後12〜18ヶ月間の「注目すべき事項」として取り上げている項目
  • バイオシミラーの商業化の成功と収益確保が、開発企業にとっての最大の課題である
    • 「生物療法のコスト引き下げが、バイオシミラー普及の細大の鍵となる」と専門家は考えている
    • ...しかし、バイオシミラーの安全性に関する懸念が、現在でもその普及の大きな障害となっている
    • 保険金支払者がバイオシミラーの利用促進に重要な役割を果たしているが、全国レベルでのバイオシミラー政策の一貫性の無さが、現在でも障害となっている
    • ネーミング (令名法) とラベリング (ラベル表記) は現在も政策上の最大の課題であり、市場動向を大きく左右する可能性を秘めている
    • ノルウェー・デンマークでは、薬価の変動とともにバイオシミラーのシェアが拡大したが、他にも様々な影響が生じている
    • 「市場参入のし易さ」の観点から、専門家が今後12〜18ヶ月間の「注目すべき事項」として取り上げている項目

結論

付録

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目次
Product Code: 596200358

The Future of Biosimilars 2015 offers expert insight and opinion on the key issues facing the high risk, high reward biosimilars market: how the market is performing, where the market is headed and which key milestones are being monitored.

Gain insights on the recent market events, the current biosimilar and non-comparable biologics (NCB) pipeline and what experts believe are the key remaining uncertainties in the biosimilars market. In addition, receive an Advisory Highlights management summary which covers key findings from the report.

Since the first edition of FirstWord's The Future of Biosimilars, the opportunities and challenges that biosimilars represent to companies, patients, physicians and health services have continued to dominate discussions around the globe.

The Future of Biosimilars 2015 summarises, analyses and gives insight into the opportunities and challenges biosmilars developers face today.

Key Benefits

  • Gain expert insight and opinion on the latest developments in the biosimilars market across a wide range of topics, including regulations, R&D strategy, IP, policy and commercialisation
  • Understand the implications of recent policy developments, including national attitudes toward biosimilar naming, interchangeability and automatic substitution
  • Identify which companies are likely to be first-to-market in specific classes of biologic, and where biosimilar approvals and clinical trials stand
  • Understand what experts believe needs to be done to drive better biosimilar adoption, both in Europe and the US
  • Benefit from expert opinion on the key future milestones being monitored the most and which have the potential to shape the future of the biosimilars market

A Report for the Entire Industry

The biosimilars market is evolving quickly, making Future of Biosimilars 2015 a must-read reference not only for those working in biosimilars competitive intelligence, brand strategy, business development and licensing, but also brand forecasting, market research and financial analytics.

Answers to Critical Questions

  • How important are biologics to patients, and what do they think about biosimilars as a strategy of providing better access to cheaper therapies?
  • Why have large pharma and biotech companies invested in biosimilars, and what are the critical company capabilities that are needed to compete in the biosimilars market?
  • What have been the most important events in the biosimilars market since the first publication of this report in May 2014, and how could these events help predict future market evolution?
  • What is the current level of awareness of biosimilars amongst patients and physicians and what could industry do to improve this?
  • What do stakeholders believe are the most critical challenges and issues that remain in biosimilars market, including those related to getting biosimilars approved and driving biosimilar adoption, and what they believe needs to be done to address these issues?
  • At the patient, physician and industry level, what are the current perceptions on the critical market shaping issues of indication extrapolation, switching, substitution, pricing, naming and labelling?
  • How has the biosimilar development pipeline changed over the last 12 months, including any key changes in pipeline dynamics from a class, molecule and indication perspective?
  • What key events over the next 12-18 months are being monitored by patients, physicians and industry stakeholders, and what are the expectations for near-term market dynamics?

Top Takeaways

  • Insight and opinion from multiple stakeholder groups, including patients, physicians and industry stakeholders, on the importance of biologics and what biosimilars could offer in terms of managing costs and improving access
  • Qualitative analysis of the most significant events in the biosimilars market over the last 12 months, including regulatory, policy, clinical, legal and commercial developments
  • An assessment of where the market is now, from a pipeline perspective and from the perspective of experts
  • Expectations for the future, including key future milestones and their potential impact on the evolution of the biosimilars market

Experts Interviewed

  • Ailsa Bosworth; Chief Executive and Founder, National Rheumatoid Arthritis Society
  • Andrew Bourgoin; Senior Competitive Intelligence and Analytics Manager, Therapeutic Proteins International LLC
  • Carsten Brockmeyer; CEO, Formycon AG
  • Javier Cortés; Oncologist, Vall d'Hebron University Hospital, Spain
  • Paul Cornes; Consultant Physician, Bristol Oncology Centre
  • Jan Geissler; Co-Founder, CML Advocates Network
  • Fernando Gomollón; Associate Professor Medicine and Chief of the Inflammatory Bowel Disease (IBD) unit, University Hospital Lozano Blesa, Zaragoza, Spain
  • Clare Jacklin; Director of External Affairs, National Rheumatoid Arthritis Society
  • Alex Kudrin; VP and Head of Global Development, Celltrion
  • Lawrence (Larry) LaMotte; VP of Public Policy, Immune Deficiency Foundation
  • Mariah Zebrowski Leach; a rheumatoid arthritis patient, blogger and regular contributor to RheumatoidArthritis.net
  • Steinar Madsen; Medical Director, Norwegian Medicines Agency
  • Reshma Mahtani; Assistant Professor of Clinical Medicine, Division of Haematology/Oncology, Miller School of Medicine, University of Miami, Florida
  • Rupert Roe; Senior Scientific Advisor (Biosimilars), Napp Pharmaceuticals Ltd.
  • Martyn G. Smith; Global Biologics Strategy, F. Hoffmann-La Roche Ltd.

Table of Contents

Executive summary

Methodology, objectives and definitions

  • Objectives
  • Methodology
  • Definitions

Biosimilars; brief history in time

  • Robust progress has been made, but uncertainties and questions remain
    • Guidline refinements, product approvals and the occasional controversy dominate the regulatory agenda
    • New trials, timeline changes and data presentations dominate the clinical agenda
    • Legal strategies In the US seen as a “a good bellwether of how things are progressing”
    • Lack of consensus in relation to national policy on Issues such as Interchangeability, naming and how biosimilars should be used In clinical practice remain areas of significant uncertainity
    • The shift from clinical and regulatory discussions continues at a rapid pace, with commercialisation and profitability now the focus
    • Low levels of awareness and understanding of biosimilars continues to be an issue, but new Initiatives are seeking to drive Improvement

Status of the biosimilars pipeline; 2014-2015

  • Overview
  • Key biologic brands summary
  • Biosimilar/NCB pipeline by class
  • Biosimilar/NCB pipeline by molecule
  • Biosimilar/NCB pipeline by phase of development; May 2014 vs. May 2015
  • Biosimilar/NCB pipeline by therapy area; May 2014 vs. May 2015
  • Biosimilar/NCB pipeline by Company; May 2014 vs. May 2015
  • Biosimilar/NCB pipeline by location of company HQ; May 2015
  • The future of the biosimilars pipeline ?

Critical uncertainties, key questions and future milestones to watch

  • Overview of key market uncertainties
  • Education; a key Issue that Influences the development and commercialisation of biosimilars
    • More education has been called for, with physisian and patient focused activities needed to drive home the benefits and opportunities that biosimilars represent
  • Gaining regulatory approved for a biosimilar remains as challenging as ever, but progress has been seen In the US and robust analytics Is growing In Importance
    • Experts believe that the biosimilar regulations are supportive of a sustainable biosimilars Industry, but there Is always room for Improvement
    • Recruiting patients for clinical trials has been Indentified as a key challenge for biosimilar companies, and things are only going to get tougher
    • From an “ease of entry” perspective, experts give their views on “what to watch” over the next 12-18 months
  • The successful and profitable commercialisation of biosimilars in now the number one challenge for biosimilar developers
    • Experts believe that the opportunity to drive the costs of biologic therapy down will be the number one driver of biosimilar adoption.....
    • ...but coninuing concers about the safety of biosimilars is likely to remain as a key barrier to better biosimilar adoption
    • Payers have an Important role In driving biosimilar adoption, but Inconsistent tactics and procedures for biosimilars at the national level remain a concer
    • Naming and labeling remain top of the policy agenda and have the potential to significantly Influence market dynamics
    • While pricing developments in Norway and Denmark have driven biosimilar market share, the wider Implications remain to be seen
    • From an “ease of uptake” perspective, experts give their views on “what to watch” onver the next 12-18 months

Concluding remarks

Appendix

  • Contributors
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