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市場調查報告書

全球孤兒藥市場預測

Global Orphan Drug Market Outlook 2018

出版商 KuicK Research 商品編碼 302601
出版日期 內容資訊 英文 213 Pages
商品交期: 最快1-2個工作天內
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全球孤兒藥市場預測 Global Orphan Drug Market Outlook 2018
出版日期: 2014年02月01日 內容資訊: 英文 213 Pages
簡介

全球醫藥品產業近幾年,由於專利失效和與學名藥的競爭激化,疲乏的開發平台,嚴格化的法律規章等使成長鈍化。這樣的情形中,各製藥公司正從傳統的主力醫藥品的製造,轉投資到稱為孤兒藥的新經營模式。孤兒藥的投資報酬率,預期可解決暢銷藥物的專利失效的損益影響。

本報告提供全球孤兒藥市場概要和主要市場上孤兒藥的指定標準、給付政策與法律規章、開發平台趨勢,以及參與企業的競爭環境彙整,為您概述為以下內容。

第1章 孤兒藥的簡介

  • 孤兒藥定義
  • 孤兒藥的廣為流行

第2章 為何從非孤兒藥轉移到孤兒藥

  • 疲乏的產品平台
  • 孤兒藥的盈利
  • 研究開發投資的增加
  • 經濟獎勵所扮演的角色
  • 專利保護與市場壟斷性

第3章 全球孤兒藥市場預測

  • 市場概要
  • 生物學性、非生物學性孤兒藥
  • 治療市場區隔
  • 地區的市場區隔

第4章 美國的孤兒藥市場預測

  • 孤兒藥指定標準
  • 市場概要
  • 給付政策
  • 相關法規

第5章 歐洲的孤兒藥市場預測

  • 孤兒藥指定標準
  • 市場概要
  • 給付政策
  • 相關法規

第6章 亞洲的孤兒藥市場預測

  • 孤兒藥指定標準
  • 市場概要
  • 給付政策
  • 相關法規

第7章 全球各相、孤兒藥指定疾病、各國開發平台趨勢

第8章 應解決的課題

  • 初期投資的高度
  • 臨床實驗的門檻
  • 法律規章的門檻
  • 各種給付政策
  • 流通問題

第8章 競爭環境

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

圖表

目錄

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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