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市場調查報告書

孤兒藥 (罕見疾病治療藥) 的全球市場:2015∼2019年

Global Orphan Drugs Market 2015-2019

出版商 TechNavio (Infiniti Research Ltd.) 商品編碼 294950
出版日期 內容資訊 英文 108 Pages
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孤兒藥 (罕見疾病治療藥) 的全球市場:2015∼2019年 Global Orphan Drugs Market 2015-2019
出版日期: 2015年11月11日 內容資訊: 英文 108 Pages
簡介

孤兒藥使用在罕見疾病的治療上。根據WHO,罕見疾病全球以1萬人中0.65∼1人的比例發病,全球6,000個罕見疾病中有80%為遺傳性。預計全球孤兒藥市場2014∼2019年以年複合成長率10.05%擴大。

本報告提供全球孤兒藥市場相關調查、各地區趨勢、今後的市場成長預定、2019年的市場規模預測、市場成長的課題、主要供應商趨勢等彙整資料。

第1章 摘要整理

第2章 本報告的範圍

第3章 市場調查方法

第4章 簡介

第5章 概要

  • 孤兒藥相關法規
  • 美國/EU的孤兒藥集中次序
  • 日本的孤兒藥的產品登記流程
  • 孤兒藥指定與核准
  • 孤兒藥的年度成本
  • 孤兒藥和非孤兒藥的研究開發成本

第6章 開發平台概要

第7章 市場環境

  • 市場概要
  • 市場規模與預測
  • 波特的五力分析

第8章 各產品市場區隔

  • 全球生物學的孤兒藥市場
  • 全球非生物學的孤兒藥市場

第9章 各地區市場區隔

  • 南北美洲
  • 歐洲、中東、非洲
  • 亞太地區

第10章 推動市場的要素

  • 開發期間短
  • 來自法規團體的支援
  • 開發的獎勵
  • 投資報酬率的高度
  • 來自藥價規定的免除

第11章 促進要素的影響

第12章 市場課題

  • 藥物開發成本高
  • 行銷的投資減少
  • 臨床實驗實施的問題
  • 不明的病理學
  • FDA的政策不足

第13章 促進要素與課題的影響

第14章 市場趨勢

  • 對生物藥品的著重
  • 對孤兒藥的認知提升
  • 流通管道行銷策略
  • 產業擴大
  • 未開發市場的進入

第15章 供應商環境

  • 競爭模式
  • 主要供應商:2014年
  • 全球收益
  • 美國的前十大企業
  • 其他值得注意的供應商

第16章 主要供應商分析

  • BMS
  • Celgene
  • Novartis
  • Pfizer

第17章 附錄

第18章 關於Techvavio

圖表

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目錄
Product Code: IRTNTR7493

About orphan drugs

An orphan drug is used to treat rare diseases or disorders. According to WHO, orphan or rare diseases are the pathological conditions that affect 0.65-1 out of 10,000 population worldwide. There are around 6,000 orphan diseases, of which 80% are genetic. Orphan drugs are developed by the pharmaceutical industry to serve the public health need. These are designated as "Orphan Designations" by the regulatory agencies to accelerate the approval process.

Technavio's analysts forecast the global orphan drugs market to grow at a CAGR of 10.05% over the period 2014-2019.

Covered in this report

The report covers the current scenario and the growth prospects of the global orphan drugs market for the period of 2015-2019. To calculate the market size, the report considers revenue generated from the sales orphan drugs.

Technavio's report, Global Orphan Drugs Market 2015-2019, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the Americas, APAC, and Europe; it also covers the landscape of the global orphan drugs market and its growth prospects in the coming years. The report includes a discussion of the key vendors operating in this market.

Key regions

  • Americas
  • APAC
  • Europe

Key vendors

  • Bristol-Mayer Squibb
  • Celgene
  • F. Hoffmann La Roche
  • Novartis
  • Pfizer

Other Prominent Vendors

  • AbbVie
  • Actelion Pharmaceuticals
  • Alexion Pharmaceuticals
  • Alnylam Pharmaceuticals
  • Amgen
  • AstraZeneca
  • Baxter International
  • Biogen Idec
  • Celldex Therapeutics
  • Eisai
  • Eli Lilly
  • GlaxoSmithKline
  • Intercept Pharmaceuticals
  • Johnson & Johnson
  • Merck
  • NewLink Genetics
  • Northwest Biotherapeutics
  • Novo Nordisk
  • Onyx Pharmaceuticals
  • Sanofi
  • Shire
  • Synageva BioPharma
  • Takeda
  • Vertex Pharmaceuticals
  • XOMA

Market driver

  • Shorter development timelines
  • For a full, detailed list, view our report

Market challenge

  • High cost of drug development
  • For a full, detailed list, view our report

Market trend

  • Increased focus on biological drugs
  • For a full, detailed list, view our report

Key questions answered in this report

  • What will the market size be in 2019 and what will the growth rate be?
  • What are the key market trends?
  • What is driving this market?
  • What are the challenges to market growth?
  • Who are the key vendors in this market space?
  • What are the market opportunities and threats faced by the key vendors?
  • What are the strengths and weaknesses of the key vendors?

Table of Contents

PART 01: Executive summary

  • Highlights

PART 02: Scope of the report

  • Top-vendor offerings

PART 03: Market research methodology

  • Research methodology
  • Economic indicators

PART 04: Introduction

  • Key market highlights

PART 05: Overview

  • Orphan medicines legislation
  • Orphan medicines centralized procedure in US/EU
  • Product registration process for orphan drugs in Japan
  • Orphan drug designations and approvals
  • Annual cost of orphan drugs
  • R&D costs for orphan and non-orphan drugs

PART 06: Pipeline snapshot

PART 07: Market landscape

  • Market overview
  • Market size and forecast
  • Five forces analysis

PART 08: Market segmentation by product

  • Global biologic orphan drugs market
  • Global non-biologic orphan drugs market

PART 09: Geographical segmentation

  • Orphan drugs market in Americas
  • Orphan drugs market in EMEA
  • Orphan drugs market in APAC

PART 10: Market drivers

  • Shorter development timelines
  • Assistance from regulatory bodies
  • Incentives for developing orphan drugs
  • High return on investment
  • Exemption from pricing constraints

PART 11: Impact of drivers

PART 12: Market challenges

  • High cost of drug development
  • Decreased investment in marketing
  • Complications in conducting clinical trials
  • Unknown pathophysiology
  • Adverse policies of FDA

PART 13: Impact of drivers and challenges

PART 14: Market trends

  • Increased focus on biological drugs
  • Growing awareness of orphan drugs
  • Channel marketing strategy
  • Expansion of business
  • Entry into untapped market

PART 15: Vendor landscape

  • Competitive scenario
  • Major vendors 2014
  • Worldwide orphan drug sales revenue: Top 17 companies 2013
  • Top 10 orphan drugs in US 2014
  • Other prominent vendors

PART 16: Key vendor analysis

  • BMS
  • Celgene
  • Novartis
  • Pfizer

PART 17: Appendix

  • List of abbreviations

PART 18: Explore Technavio

List of Exhibits

  • Exhibit 01: Product offerings
  • Exhibit 02: History of orphan medicines legislation
  • Exhibit 03: Incentives provided by US regulation
  • Exhibit 04: Incentives provided by Japanese regulation
  • Exhibit 05: Incentives provided by EU regulation
  • Exhibit 06: Incentives provided by Australian regulation
  • Exhibit 07: Incentives provided by South Korean regulation
  • Exhibit 08: Incentives provided by Singapore regulation
  • Exhibit 09: Orphan drug regulatory process in EU/US
  • Exhibit 10: Orphan drug registration process in Japan
  • Exhibit 11: Orphan drug development and regulatory challenges
  • Exhibit 12: Orphan drug designations and approvals in US 2000-2014
  • Exhibit 13: Number of novel orphan molecular entities launched in US 2004-2013
  • Exhibit 14: Novel orphan molecular entities launched in US 2013
  • Exhibit 15: Number of orphan drug designations and approvals in Japan 2000-2012
  • Exhibit 16: Number of orphan medicinal products launched in Europe 2002-2014
  • Exhibit 17: Top orphan drug designation indications in EU 2014
  • Exhibit 18: Approved and designated orphan pharmaceutical products in US, EU, Japan, and Australia
  • Exhibit 19: Cumulative orphan designations in US, EU, and Japan per year 2000-2013
  • Exhibit 20: Source: Technavio, 2015Orphan drug designations by therapy areas 2013
  • Exhibit 21: Average annual cost of orphan drugs per patient in US 2010-2014 ($)
  • Exhibit 22: Annual cost of several orphan drugs
  • Exhibit 23: Cost comparison of branded orphan drugs versus generic versions 2013 ($)
  • Exhibit 24: Orphan drug expenditure by therapeutic class 2007-2013
  • Exhibit 25: R&D cost for Phase III trial for orphan and non-orphan drugs 2013 and 2014 ($ billions)
  • Exhibit 26: The worldwide top late-stage and filed orphan drugs are given below:
  • Exhibit 27: Global orphan drugs market ($ billions)
  • Exhibit 28: Five forces analysis
  • Exhibit 29: Global orphan drugs market by product
  • Exhibit 30: Global orphan drugs market by product 2014
  • Exhibit 31: Global biologic orphan drugs market 2014-2019 ($ billions)
  • Exhibit 32: Global non-biologic orphan drugs market 2014-2019 ($ billions)
  • Exhibit 33: Global orphan drugs market by geographical segmentation 2014
  • Exhibit 34: Orphan drugs market in Americas 2014-2019 ($ billions)
  • Exhibit 35: Orphan drugs market in EMEA 2014-2019 ($ billions)
  • Exhibit 36: Orphan drugs market in APAC 2014-2019 ($ billions)
  • Exhibit 37: )Global orphan drugs market by geographical segmentation 2014-2019 ($ billions)
  • Exhibit 38: Drivers of global orphan drugs market
  • Exhibit 39: FDA filed to approved time: orphan versus non-orphan drugs (median time months)
  • Exhibit 40: Phase III trial length orphan versus non-orphan drugs (median length years)
  • Exhibit 41: Impact of drivers
  • Exhibit 42: Challenges in global orphan drugs market
  • Exhibit 43: Impact of key drivers and challenges
  • Exhibit 44: Trends in global orphan drugs market
  • Exhibit 45: BMS: Key takeaways
  • Exhibit 46: Celgene: Global year-over-year growth and revenue of Vidaza 2012-2014 ($ millions)
  • Exhibit 47: Celgene: Global year-over-year growth and revenue of Revlimid 2012-2014 ($ billions)
  • Exhibit 48: Celgene: Key takeaways
  • Exhibit 49: Novartis: Key takeaways
  • Exhibit 50: Pfizer: Year-on-year growth rate and revenue of Inlyta 2012-2014 ($ millions)
  • Exhibit 51: Pfizer: Key takeaways
  • Exhibit 52: Global year-over-year growth and revenue of Rituxan/MabThera 2010-2014 ($ billions)
  • Exhibit 53: Avastin: Global revenue and year-over-year growth 2010-2014 ($ billions)
  • Exhibit 54: Roche: Key takeaways
  • Exhibit 55: Worldwide orphan drug sales 2007-2013 ($ billions)
  • Exhibit 56: BMS: Business segmentation by revenue 2014
  • Exhibit 57: BMS: Business segmentation by revenue 2013 and 2014 ($ billions)
  • Exhibit 58: BMS: Geographical segmentation by revenue 2014
  • Exhibit 59: Celgene: Product segmentation by revenue 2014
  • Exhibit 60: Celgene: Product segmentation by revenue 2013 and 2014 ($ billions)
  • Exhibit 61: Celgene: Geographical segmentation by revenue 2014
  • Exhibit 62: Roche: Business segmentation by revenue 2014
  • Exhibit 63: Roche: Business segmentation by revenue 2013 and 2014 ($ billions)
  • Exhibit 64: Roche: Geographical segmentation by revenue 2014
  • Exhibit 65: Novartis: Business segmentation by revenue 2014
  • Exhibit 66: Novartis: Business segmentation by revenue 2013 and 2014 ($ billions)
  • Exhibit 67: Novartis: Geographical segmentation by revenue 2014
  • Exhibit 68: Pfizer: Business segmentation by revenue 2014
  • Exhibit 69: Pfizer: Business segmentation by revenue 2014 (%)
  • Exhibit 70: Pfizer: Geographical segmentation by revenue 2014
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