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Orphan Drugs Market 2015-2019

  • November 2015
  • -
  • Infiniti Research Limited
  • -
  • 108 pages

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

Orphan Drugs Market 2015-2019
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
RandD 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: RandD 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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