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市場調査レポート

後発吸入薬の収益性評価

Profitability Assessment of Branded Generic Inhalers

発行 Datamonitor Healthcare 商品コード 342052
出版日 ページ情報 英文 48 Pages
納期: 即日から翌営業日
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後発吸入薬の収益性評価 Profitability Assessment of Branded Generic Inhalers
出版日: 2015年06月02日 ページ情報: 英文 48 Pages
概要

当レポートでは、後発吸入薬の収益性について評価し、欧州・米国における規制環境、吸入器の開発動向、および主要な後発吸入薬の収益・損失分析などをまとめています。

図表

エグゼクティブサマリー

イントロダクション

規制環境のレビュー

  • 欧州における規制経路
  • 米国における規制経路
  • 規制経路のサマリー
  • 参考文献

予測・経済評価

  • 予測アプローチ
  • 米国:Advair (アドベアー) の予測
  • EU:Symbicort (シムビコート) および Advair の予測
  • 収益・損失分析
  • 経済的評価
  • 参考文献

結論

付録1

付録2

参考文献

図表リスト

目次
Product Code: DMKC0140315

This analysis examines the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products. The analysis shows that, in some cases, sufficiently attractive financial gains cannot be expected beyond the first few market entrants, as indicated by the appearance of negative net present values for later entrants. This emphasizes the importance of developers paying close attention to, and making frank assessments of, their ability to reach the market ahead of their competitors.

This report addresses the following questions:

  • What are the regulatory requirements for approval of generic inhaled products in Europe and the US?
  • What market share can manufacturers of generic inhaled products expect to achieve depending on their order of market entry?
  • Which branded inhaled products should generic manufacturers target in order to achieve commercial success
  • What factors should generic inhaled product manufacturers assess when deciding on the economic viability of a new product?

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

  • What access controls are payers imposing on interleukins in psoriatic arthritis?
  • What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?
  • How do US and European payers view the launch of oral small molecules in psoriatic arthritis?
  • What impact will biosimilar entry have on pricing and reimbursement of branded biologics?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

INTRODUCTION

  • 1. Bibliography

REGULATORY LANDSCAPE REVIEW

  • 2. Regulatory pathway in Europe
  • 3. Regulatory pathway in the US
  • 4. Regulatory pathway summary
  • 5. Bibliography

FORECASTING AND ECONOMIC ASSESSMENT

  • 6. Forecasting approach
  • 7. US: Advair forecast
  • 8. EU: Symbicort and Advair forecast
  • 9. Profit and loss analysis
  • 10. Economic appraisal
  • 11. Bibliography

CONCLUSION

APPENDIX 1

APPENDIX 2

BIOGRAPHIES

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