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
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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