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バイオシミラーの世界市場:医療費抑制の動きや、主力生物製剤の特許満了に支えられた、収益性豊かな市場

Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics

発行 GlobalData 商品コード 772749
出版日 ページ情報 英文 108 Pages
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バイオシミラーの世界市場:医療費抑制の動きや、主力生物製剤の特許満了に支えられた、収益性豊かな市場 Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics
出版日: 2019年01月01日 ページ情報: 英文 108 Pages
概要

世界のバイオシミラー市場は今後、45.22%ものCAGR (複合年間成長率) で成長していくと見込まれています。世界各国での医療費削減の動きや、主な医薬品の特許満了などが、主な市場促進要因となっています。他方、開発コストや複雑さ、既存企業の対抗策、互換性の問題などが、市場成長の妨げとなっています。

当レポートでは、世界のバイオシミラー市場における最新の開発・上市動向について分析し、製薬業界が現在直面している問題点や (バイオシミラー開発による) 解決方法、主要なパイプライン製品の治験動向、現在/将来の市場規模、薬剤開発の主な促進・抑制要因、政策当局の動向や規制改訂の動き、といった情報を取りまとめてお届けいたします。

第1章 目次

第2章 イントロダクション

  • 薬剤開発コストの上昇
  • 多くの医薬品が研究開発 (R&D) 費用の回収に失敗
  • 上市済み製品の契約ライフサイクル
  • 画期的医薬品 (first-in-class) の開発事例
  • 難病治療薬の開発事例
  • 結論

第3章 製薬業界のパイプライン製品の評価

  • パイプライン製品と治験環境:治療領域別
  • パイプライン製品:治験段階別
  • パイプライン製品:分子の種類別
  • 主な治療領域:症状別
    • 腫瘍
    • 感染症
    • 中枢神経系 (CNS)
    • 免疫疾患
  • 結論

第4章 製薬産業のパイプライン製品:開発動向の評価

  • 画期的医薬品の開発状況:治験段階別
  • 主な治療領域:症状別
    • 腫瘍
    • 感染症
    • 中枢神経系 (CNS)
    • 免疫疾患
  • 結論

第5章 付録

目次
Product Code: GBI096CBR

The Global Biosimilar market by product is projected to grow at a compound annual growth rate (CAGR) of 45.22%. The market is driven mainly by a constrained payer environment and patent expiration of several best-selling biologics. However, developmental cost and complexities, strategies from originators and interchangeability concerns pose a challenge to market growth.

A biosimilar is a biotherapeutic that is clinically highly similar to an approved original biologic (reference product) in terms of active ingredients and has no meaningful differences in efficacy and safety. Biosimilars are also known as follow-on biologics or subsequent entry biologics.

A total of 492 products are in development. The Preclinical stage contains the largest number of pipeline products: 232. The late-stage pipeline (Phase III and Pre-registration) account for 24% of the overall pipeline, with 120 products. The global biosimilar pipeline is dominated by companies from emerging markets. The most active companies in the early-stage pipeline are from India and China. South Korean companies such as Celltrion and Samsung Bioepis and Indian companies such as Biocon and Dr. Reddy's Laboratories have a strong late-stage pipeline. Pfizer and Amgen have a strong late-stage pipeline as well.

There exist enormous commercial opportunities for biosimilar manufacturers over the coming years, given the number of high-revenue-generating biologics that will go off patent in the next five years, and promising revenue forecasts for biosimilars in late-stage development. There exist a diverse number of biosimilars in the pipeline for a wide range of therapy areas, with several of these in the later stages of development. Government support for biosimilars is increasing in key mature and emerging markets, given the cost-saving opportunities that these products represent for national healthcare budgets.

The latest report, "Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics" provides an in-depth assessment of the current developments and trends in the global biosimilars market. This report also assesses the state of the biosimilar R&D and commercial landscape through multilevel analytics that include data split by therapy area, stage of development, molecule, and company. Global revenue forecasts to 2024 for biosimilars with strong market potential, both in development and in the market, are provided.

The report also details out current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan, China, South Korea, India and Brazil, and recent developments in the landscape within these markets

Scope:

  • How does the global biosimilar pipeline look like in 2018?
  • What is the distribution of pipeline biosimilars by stage of development?
  • Which are the therapy areas set to benefit the most from biosimilar drugs in development?
  • Which biosimilars are commonly targeted in the pipeline?
  • How many companies are currently involved in biosimilar drug development? Which are the most active in the pipeline?
  • What is the size of the global biosimilar market?
  • How much revenue will promising biosimilar drugs in the market, and in development, record to 2024?
  • What are the key factors driving growth in the global biosimilars market?
  • What are the factors restraining the growth of global biosimilar market?
  • How does legislation regarding biosimilar interchangeability differ among key geographical markets?
  • How will legal or political changes in the landscape affect the biosimilar market?
  • What are the key differences in biosimilar regulatory pathways between US, Europe, Japan, South Korea, China, Brazil, and India?
  • What are the regulatory evidence requirements in each country?

Reasons to buy:

  • Develop an overview of the current biosimilar landscape in key markets
  • Learn how regulatory or legal changes will affect the market
  • Identify market prospects

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Increasing Cost of Drug Development
  • 2.2. Most Drugs Fail to Recuperate R&D Costs
  • 2.3. Contracting Life Cycles for Approved Products
  • 2.4. The Case for First-in-Class Pharmaceutical Innovation
  • 2.5. Status of Innovation in Rare Diseases
  • 2.6. Conclusion

3. Assessment of Pharmaceutical Industry Pipeline

  • 3.1. Pipeline and Clinical Trials Landscape by Therapy Area
  • 3.2. Pipeline by Stage of Development
  • 3.3. Pipeline by Molecule Type
  • 3.4. Key Therapy Areas by Indication
    • 3.4.1. Oncology
    • 3.4.2. Infectious Diseases
    • 3.4.3. Central Nervous System
    • 3.4.4. Immunology
  • 3.5. Conclusion

4. Assessment of Innovation in the Pharmaceutical Industry Pipeline

  • 4.1. First-in-Class Innovation by Stage of Development
  • 4.2. Key Therapy Areas by Indication
    • 4.2.1. Oncology
    • 4.2.2. Infectious Diseases
    • 4.2.3. Central Nervous System
    • 4.2.4. Immunology
  • 4.3. Conclusion

5. Appendix

  • 5.1. References
  • 5.2. Abbreviations
  • 5.3. Contact Us
  • 5.4. Disclaimer
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