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市場調査レポート

免疫学におけるバイオシミラー

Biosimilars in Immunology

発行 GlobalData 商品コード 929733
出版日 ページ情報 英文 137 Pages
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免疫学におけるバイオシミラー Biosimilars in Immunology
出版日: 2020年02月28日 ページ情報: 英文 137 Pages
概要

当レポートでは、世界の主要9ヶ国 (米国、欧州 (フランス、ドイツ、イタリア、スペイン、英国)、日本、インド、韓国) における、免疫薬のバイオシミラーの市場について分析し、技術・製品の概略、主な活用分野、の概略、主要企業のプロファイル、主な市場競争戦略などを調査すると共に、各国ごとに市場構造や規制・認証体制、潜在的な市場規模の見通し、今後の技術開発・市場発展の方向性といった情報を取りまとめてお届けいたします。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 イントロダクション

  • バイオシミラーとは何か
  • 免疫学バイオシミラー:開発のタイムライン
  • 世界の主要国で上市されている、パイプライン上の免疫バイオシミラー

第4章 世界各地のバイオシミラー規制経路

  • バイオシミラーの規制経路
  • 米国のバイオシミラー規制経路
  • 欧州のバイオシミラー規制経路
  • 日本のバイオシミラー規制経路
  • 韓国のバイオシミラー規制経路
  • インドのバイオシミラー規制経路

第5章 バイオシミラー市場:国別の動向 (主要国)

  • バイオシミラー市場の動向見通し:国別 (主要国)
  • 米国のバイオシミラー市場の可能性
  • 欧州のバイオシミラー市場の可能性
  • 日本のバイオシミラー市場の可能性
  • 韓国のバイオシミラー市場の可能性
  • インドのバイオシミラー市場の可能性

第6章 免疫学における重要な活用分野

  • 免疫学における生物製剤の活用分野
  • 関節リウマチ
  • 乾癬性関節炎
  • 軸性脊椎関節炎
  • 潰瘍性大腸炎
  • クローン病
  • プラーク乾癬

第7章 主要企業

  • メーカーの評判の重要性
  • Sandoz
  • Celltrion
  • Amgen
  • Mylan and Biocon
  • Pfizer
  • Biogen

第8章 バイオシミラー:臨床面・商業面での主要な概念

  • コスト削減と市場アクセス
  • 患者の種類
  • 処方薬の割り当て
  • バイオシミラー性と互換性
  • ブランドの選好
  • データの外挿

第9章 バイオシミラー・メーカーの機会

  • バイオシミラーの接種力を拡大するための戦略
  • 価格による市場差別化
  • イノベーションによる市場差別化

第10章 付録

目次
Product Code: GDHCHT048

"GlobalData's Biosimilars in Immunology Thematic Analysis report combines key opinion leader insight and interviews with payers in the US, France, Germany, Italy, Spain, the UK, Japan, India and South Korea to provide an in-depth review of the biosimilars market for major autoimmune diseases."

The report includes an assessment of ongoing clinical trials, the geographical location of trial sponsors, discussion of the key players in the medical marijuana space as well as insights from industry experts discussing market challenges and considerations of stakeholders in the arena."

Europe leads the way for immunology biosimilars in the 7MM, and India is at the forefront in the emerging markets. In terms of immunology biosimilar penetration, the 5EU and India demonstrate the highest favorability towards uptake of biosimilars.

Japan and South Korea have an intermediate biosimilar penetration index, while the US market is the least favorable towards biosimilars. Pricing is a key issue for expensive-to-develop biosimilars entering an increasingly crowded autoimmune disease market.Biosimilars are intended to relieve healthcare-associated cost burden; however, the economic effects of incorporating them into clinical practice are unclear, due to increased time and staff costs required for switching patients onto biosimilars.

Pricing can be a differentiating strategy among different biosimilars and larger discounts over originator brands can boost greater uptake of specific biosimilars. Quotas dictate prescribing patterns in the 5EU; however, physicians show concern about switching to a biosimilar from the originator brand. The majority of KOLs interviewed by GlobalData indicated that they used biosimilars mostly for new patients. KOLs also cited reluctance to switch existing patients to biosimilars, highlighting that they did not want to change a biologic treatment that was working for the patient.

Other reasons against switching included lack of incentives for physicians, lack of switching data, and nocebo effects.Biogen, Sandoz, Pfizer, and Amgen are dominating the immunology biosimilars field. The immunology biosimilars space is dominated in developed markets by established brand names, including Biogen, Sandoz, Pfizer, and Amgen.

In India and South Korea, major biosimilar players include Celltrion, Cipla, and Zydus Cadila.

Scope

Components of the report include -

  • Introduction to*Biosimilars in Immunology*-*Defining biosimilars in immunology and discussing the history of drugs approved across the 9MM.
  • Assessment of Marketed and Pipeline Products*- An overview of biosimilar products on the market and drugs currently in clinical development.
  • Regulatory Strategies*-*Overview of biosimilar regulatory strategies by country.
  • Market Dynamics - Overview of biosimilar market dynamics by country.
  • Focus Indications*and Market Potential - In-depth assessment of biosimilars in major autoimmune indications, market potential as well as drivers and barriers to uptake.

Reasons to Buy

  • Key Players - In-depth assessment of key players in the space across the 9MM
  • Key Clinical and Commercial Concepts*- An examination of key clinical and commercial concepts in the biosimilars in immunology space, based on KOL and payer insights.
  • Pricing and reimbursement infrastructure and challenges are examined.
  • Future Opportunities*- Overview of future strategies recommended by KOLs and payers for boosting biosimilar uptake is discussed.

TABLE OF CONTENTS

1. Preface

  • 1.1 Related Reports
  • 1.2 Upcoming Reports
  • 1.3 Abbreviations

2. Executive Summary

  • 2.1 Key Findings
  • 2.2 KOL and Payer Insights

3. Introduction

  • 3.1 What Is a Biosimilar?
  • 3.2 Timeline of Immunology Biosimilar Development
  • 3.3 Marketed and Pipeline Immunology Biosimilars in the 9MM

4. Biosimilar Regulatory Pathways Across Geographies

  • 4.1 Biosimilar Regulatory Pathways
  • 4.2 US Biosimilar Regulatory Pathway
  • 4.3 EU Biosimilar Regulatory Pathway
  • 4.4 Japan Biosimilar Regulatory Pathway
  • 4.5 South Korea Biosimilar Regulatory Pathway
  • 4.6 India Biosimilar Regulatory Pathway

5. Biosimilar Country-Specific Dynamics, 9MM

  • 5.1 Biosimilar Country-Specific Dynamics, 9MM
  • 5.2 US Biosimilar Market Potential
  • 5.3 5EU Biosimilar Market Potential
  • 5.4 Japan Biosimilar Market Potential
  • 5.5 South Korea Biosimilar Market Potential
  • 5.6 India Biosimilar Market Potential

6. Important Indications in Immunology

  • 6.1 Biologic Use in Immunology
  • 6.2 Rheumatoid Arthritis
  • 6.3 Psoriatic Arthritis
  • 6.4 Axial Spondyloarthritis
  • 6.5 Ulcerative Colitis
  • 6.6 Crohn's Disease
  • 6.7 Plaque Psoriasis

7. Major Players

  • 7.1 Importance of Manufacturer Reputation
  • 7.2 Sandoz
  • 7.3 Celltrion
  • 7.4 Amgen
  • 7.5 Mylan and Biocon
  • 7.6 Pfizer
  • 7.7 Biogen

8. Biosimilars - Key Clinical and Commercial Concepts

  • 8.1 Cost Savings and Market Access
  • 8.2 Patient Type
  • 8.3 Prescription Quotas
  • 8.4 Biosimilarity and Interchangeability
  • 8.5 Brand Preference
  • 8.6 Extrapolation of Data

9. Opportunities for Biosimilar Manufacturers

  • 9.1 Strategies for Increasing Uptake of Biosimilars
  • 9.2 Differentiation by Pricing
  • 9.3 Differentiation by Innovation

10. Appendix

  • 10.1 Primary Research
  • 10.2 Sources
  • 10.3 About the Authors
  • 10.4 About GlobalData
  • 10.5 Contact Us
  • 10.6 Disclaimer