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オーファンドラッグ (希少疾患治療薬) の世界市場:2015〜2019年

Global Orphan Drugs Market 2015-2019

発行 TechNavio (Infiniti Research Ltd.) 商品コード 294950
出版日 ページ情報 英文 108 Pages
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オーファンドラッグ (希少疾患治療薬) の世界市場:2015〜2019年 Global Orphan Drugs Market 2015-2019
出版日: 2015年11月11日 ページ情報: 英文 108 Pages
概要

オーファンドラッグは希少疾患の治療に用いられます。WHOによると、希少疾患は世界で1万人に0.65〜1人の割合で発症しており、世界の6,000の希少疾患のうち80%が遺伝的なものです。世界のオーファンドラッグ市場は2014〜2019年にかけCAGR10.05%で拡大すると予測されています。

当レポートでは、世界のオーファンドラッグ市場について調査し、地域別動向、今後の市場成長見込み、2019年の市場規模予測、市場成長の課題、主要ベンダーの動向などをまとめています。

第1章 エグゼクティブサマリー

第2章 当レポートの範囲

第3章 市場調査方法

第4章 イントロダクション

第5章 概要

  • オーファンドラッグに関する法規制
  • 米国/EUにおけるオーファンドラッグ集約手順
  • 日本におけるオーファンドラッグの製品登録プロセス
  • オーファンドラッグ指定と承認
  • オーファンドラッグの年間コスト
  • オーファンドラッグと非オーファンドラッグの研究開発コスト

第6章 パイプライン概要

第7章 市場環境

  • 市場概要
  • 市場規模と予測
  • ファイブフォース分析

第8章 製品別市場セグメンテーション

  • 世界の生物学的オーファンドラッグ市場
  • 世界の非生物学的オーファンドラッグ市場

第9章 地域別セグメンテーション

  • 南北アメリカ
  • 欧州・中東・アフリカ
  • アジア太平洋地域

第10章 市場促進因子

  • 開発期間の短さ
  • 規制団体からの支援
  • 開発のためのインセンティブ
  • 投資回収率の高さ
  • 薬価制約からの免除

第11章 促進因子の影響

第12章 市場の課題

  • 薬剤開発コストの高さ
  • マーケティングへの投資減少
  • 治験実施における問題
  • 不明な病態生理学
  • FDAの政策不備

第13章 促進因子と課題の影響

第14章 市場動向

  • 生物学的薬剤への注力
  • オーファンドラッグへの意識向上
  • チャネルマーケティング戦略
  • 事業拡大
  • 未開拓市場への参入

第15章 ベンダー環境

  • 競合シナリオ
  • 主要ベンダー:2014年
  • 世界の収益
  • 米国の上位10社
  • その他の注目すべきベンダー

第16章 主要ベンダー分析

  • BMS
  • Celgene
  • Novartis
  • Pfizer

第17章 付録

第18章 Techvavioについて

図表

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目次
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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