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世界のオーファンドラッグ市場見通し

Global Orphan Drug Market Outlook 2018

発行 KuicK Research 商品コード 302601
出版日 ページ情報 英文 213 Pages
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世界のオーファンドラッグ市場見通し Global Orphan Drug Market Outlook 2018
出版日: 2014年02月01日 ページ情報: 英文 213 Pages
概要

世界の医薬品業界は近年、特許の失効やジェネリック医薬品との競合激化、疲弊するパイプライン、厳格化する法規制などにより成長が鈍化しています。こうした状況の中、製薬会社各社は従来の主力医薬品の製造から、オーファンドラッグと呼ばれる新たなビジネスモデルへの投資へと変換しつつあります。オーファンドラッグの投資回収率は、ブロックバスター薬の特許失効による損益の影響を解決できるものと期待されています。

当レポートでは、世界のオーファンドラッグ市場の概要と主要市場におけるオーファンドラッグの指定基準、償還政策と法規制、パイプライン動向とともに、参入する企業の競合環境をまとめ、概略下記の構成で取り上げております。

第1章 オーファンドラッグのイントロダクション

  • オーファンドラッグの定義
  • オーファンドラッグの人気上昇

第2章 なぜ非オーファンからオーファンドラッグに移行するのか

  • 疲弊する製品パイプライン
  • オーファンドラッグの収益性
  • 研究開発投資の増加
  • 経済的インセンティブの役割
  • 特許保護と市場独占性

第3章 世界のオーファンドラッグ市場見通し

  • 市場概要
  • 生物学的、非生物学的オーファンドラッグ
  • 治療セグメンテーション
  • 地域的セグメンテーション

第4章 米国のオーファンドラッグ市場見通し

  • オーファンドラッグ指定基準
  • 市場概要
  • 償還政策
  • 法規制の枠組み

第5章 欧州のオーファンドラッグ市場見通し

  • オーファンドラッグ指定基準
  • 市場概要
  • 償還政策
  • 法規制の枠組み

第6章 アジアのオーファンドラッグ市場見通し

  • オーファンドラッグ指定基準
  • 市場概要
  • 償還政策
  • 法規制の枠組み

第7章 世界の相、オーファンドラッグ指定疾患別、国別パイプライン動向

第8章 解決すべき課題

  • 初期投資の高さ
  • 治験のハードル
  • 法規制のハードル
  • 様々な償還政策
  • 流通問題

第8章 競合環境

  • Pfizer
  • Roche
  • Sanofi
  • Rare Disease Therapeutics
  • Glaxosmithkline
  • Merck
  • Novartis Pharmaceuticals
  • Alexion
  • Celgene
  • Biogen Idec
  • Eli Lilly
  • Bristol Myers Squibb

図表

目次

The global pharmaceutical industry has been experiencing a slow growth in recent years owing to many factors such as expiration of patents, competition from generic drugs segment, exhausting pipelines, and an increasingly stringent regulatory framework. It is most likely that many blockbuster drugs would lose their exclusivity in the next 5 year horizon.

Thus, due to significant competition from generics and the current economic situation, the focus area of the pharmaceutical companies is undergoing a paradigm shift from manufacturing traditional essential medicines to investing in the new business model, which is also called orphan drugs. The returns on investment from orphan drugs are expected to help the pharma companies to overcome the impact of revenue loss due to expiry of patents of blockbuster drugs.

The major drivers for companies to increasingly invest in orphan drugs include government incentives for drug development and strong support from the FDA and EU Commission in special protocols. Inspite of pharma companies facing many obstacles in this field, this segment of orphan drugs is likely to have the potential to provide the key to recovery and stability within the market.

The orphan drugs enjoy significant competitive advantages in the market owing to the market exclusivity period after the drug has been authorized. Through this clause, the manufacturer of orphan drugs is given a monopoly status in the market because according to the law, no other company is allowed to market the orphan drugs during the exclusivity period. Additionally, this monopolistic power is further strengthened with the fact that no other alternative health technology exists for many orphan drugs.

"Global Orphan Drug Market Outlook 2018" research report by KuicK Research comprehensive insight on following developments related to global orphan drug market:

  • Global & Regional Orphan Drug Market Overview
  • Orphan Drug Designation Criteria Across Key Markets
  • Market Specific Reimbursement Policy & Regulatory Framework
  • Orphan Drug Pipeline by Phase, Orphan Designated Disease & Country
  • Competitive Landscape

Table of Contents

1. Introduction to Orphan Drugs

  • 1.1. Orphan Drug Defined
  • 1.2. Rising Popularity of Orphan Drugs

2. Why Shift from Non-Orphan to Orphan Drugs?

  • 2.1. Exhausting Product Pipelines
  • 2.2. Profitability of Orphan Drugs
  • 2.3. Increasing R&D Investment
  • 2.4. Role of Economic Incentives
  • 2.5. Patent Protection & Market Exclusivity

3. Global Orphan Drug Market Outlook

  • 3.1. Market Overview
  • 3.2. Biological & Non-Biological Orphan Drugs
  • 3.3. Therapeutic Segmentation
  • 3.4. Regional Segmentation

4. US Orphan Drug Market Outlook

  • 4.1. Orphan Drug Designation Criteria
  • 4.2. Market Overview
  • 4.3. Reimbursement Policy
  • 4.4. Regulatory Framework

5. Europe Orphan Drug Market Outlook

  • 5.1. Orphan Drug Designation Criteria
  • 5.2. Market Overview
  • 5.3. Reimbursement Policy
  • 5.4. Regulatory Framework

6. Asia Orphan Drug Market Outlook

  • 6.1. Orphan Drug Designation Criteria
  • 6.2. Market Overview
  • 6.3. Reimbursement Policy
  • 6.4. Regulatory Framework

7. Global Orphan Drug Pipeline Insight by Phase, Orphan Designated Disease & Country

  • 7.1. Clinical Phase: Research
  • 7.2. Clinical Phase: Preclinical
  • 7.3. Clinical Phase: Phase I
  • 7.4. Clinical Phase: Phase I/II
  • 7.5. Clinical Phase: Phase II
  • 7.6. Clinical Phase: Phase II/III
  • 7.7. Clinical Phase: Phase III
  • 7.8. Clinical Phase: Preregistration
  • 7.9. Clinical Phase: Registered

8. Key Issue to be Resolved

  • 8.1. High Initial Investment
  • 8.2. Clinical Study Hurdles
  • 8.3. Regulatory Hurdles
  • 8.4. Different Reimbursement Policy
  • 8.5. Distribution Challenges

9. Competitive Landscape

  • 9.1. Pfizer
  • 9.2. Roche
  • 9.3. Sanofi
  • 9.4. Rare Disease Therapeutics
  • 9.5. Glaxosmithkline
  • 9.6. Merck
  • 9.7. Novartis Pharmaceuticals
  • 9.8. Alexion
  • 9.9. Celgene
  • 9.10. Biogen Idec
  • 9.11. Eli Lilly
  • 9.12. Bristol Myers Squibb

List of Figures

  • Figure 2-1: Orphan v/s Non-Orphan Drugs -Phase II to Launch Clinical Development Time
  • Figure 2-2: Probability of Regulatory Success of Orphan v/s Non-Orphan Drugs
  • Figure 3-1: Global Orphan Drugs Market Value (US$ Billion), 2012-2018
  • Figure 3-2: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
  • Figure 3-3: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
  • Figure 3-4: Global Orphan Drugs Market by Therapeutic Area, 2012 & 2018
  • Figure 3-5: Regional Markets for Orphan Drugs, 2012 & 2018
  • Figure 4-1: US Market for Orphan Drugs (US$ Billion), 2012-2018
  • Figure 4-2: US - Orphan Drug Development by Clinical Phase (%)
  • Figure 4-3: US - Number of Orphan Drug by Clinical Phase
  • Figure 5-1: European Market for Orphan Drugs (US$ Billion), 2012-2018
  • Figure 5-2: Europe - Orphan Drug Development by Clinical Phase (%)
  • Figure 5-3: Europe - Number of Orphan Drug by Clinical Phase
  • Figure 6-1: Asia- Orphan Drug Development by Clinical Phase (%)
  • Figure 6-2: Asia - Number of Orphan Drug by Clinical Phase
  • Figure 6-3: Japan Orphan Drug/Medical Device Designation System
  • Figure 6-4: Japan Orphan Drug/Device Designation Process
  • Figure 7-1: Global - Orphan Drug Development by Clinical Phase (%)
  • Figure 7-2: Global - Number of Orphan Drug by Clinical Phase
  • Figure 7-3: Global - Number of Orphan Drug by Clinical Phase & Region
  • Figure 8-1: Orphan Drug Regulatory Hurdles

List of Tables

  • Table 2-1: Drugs Patent Expiry in 2014
  • Table 2-2: Drugs Patent Expiry in 2015
  • Table 2-3: Drugs Patent Expiry in 2016
  • Table 2-4: Orphan Drugs in the US and their Costs
  • Table 2-5: Orphan Drugs in the EU and their Costs
  • Table 2-6: Incentives for the Development of Orphan Drugs
  • Table 2-7: Orphan Drug Incentives by Country
  • Table 7-1: Global - Orphan Drugs in Clinical Development Phase: Research
  • Table 7-2: Global -Orphan Drugs in Clinical Development Phase: Preclinical
  • Table 7-3: Global - Orphan Drugs in Clinical Development Phase I
  • Table 7-4: Global - Orphan Drugs in Clinical Development Phase I/II
  • Table 7-5: Global - Orphan Drugs in Clinical Development Phase II
  • Table 7-6: Global - Orphan Drugs in Clinical Development Phase II/III
  • Table 7-7: Global - Orphan Drugs in Clinical Development Phase III
  • Table 7-8: Global - Orphan Drugs in Clinical Development Phase: Preregistration
  • Table 7-9: Global - Orphan Drugs in Clinical Development Phase: Registered
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