New Market Report Now Available: Orphan Drugs: Strategic Approaches for the Industry

Recently published research from Espicom Business Intelligence, "Orphan Drugs: Strategic Approaches for the Industry", is now available at Fast Market Research
 
June 13, 2011 - PRLog -- With many companies facing the "patent cliff", orphan drugs offer potentially high returns, lower development costs and less intense competition. So what are the issues affecting this sector at a time of challenge for the branded industry?

Orphan Drugs Snapshot
In recent years, there has been a surge of interest in this area as, despite the increasing number of products, the unmet medical needs of patients with rare diseases remain high. Scientific advances, regulatory and government support, active patient advocacy organisations and commercial factors all contribute to this increase in interest in rare diseases.

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Full Report Details at
- http://www.fastmr.com/prod/170059_orphan_drugs_strategic_approaches_for_the_industry.aspx
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Estimates of the number of rare diseases range from approximately 5,700 to almost 7,000. These diseases affect an estimated 622 million people across the globe. Most rare diseases have genetic origins; others are caused by infection, including infectious diseases that are more common outside developed nations, toxic agents, or have other causes.

A complete and perceptive oversight of orphan drugs and their strategic potential is provided in this new report:

Market perspectives and trends - provides an analysis of the orphan drug market, detailing the drivers for recent growth, regulatory trends, and profiles of key companies and their pipelines

Regulatory landscape - provides an in-depth analysis of current regulations in major markets (US, EU, Australia and Japan)

Leading companies - summarises leading and emerging companies and their pipelines including a summary of innovative areas of research (antisense therapy, gene therapy, cellular therapy, therapeutic vaccines) in which orphan drugs play a key role in bringing new drugs to the market

Challenges - provides an analysis of the preclinical and clinical development challenges, as well as pricing and reimbursement issues, for orphan drugs

Outlook - summarises the future outlook for the orphan drug sector

This new strategy report from Espicom will tell you...
What the definitions of orphan drugs are in different geographic regions
Why orphan drugs represent potentially attractive targets for drug development
Who the leading companies in orphan drug development are and why
What the regulatory landscape for orphan drug developments look like and how this affects future growth
How orphan drug development, pricing and reimbursement differ from more traditional drug development
Why the orphan drug sector has grown in recent years.
More Information...
Use this insightful report to...

Identify why the orphan drug sector is currently undergoing high levels of growth
Discuss the regulatory and legislative support for orphan drug development and its impact on growth within the sector
Learn which companies are well established within the orphan drug space, which are emerging and what their pipelines look like
Discover which companies are forming alliances with large pharma to help develop their orphan drug pipelines
Analyse the orphan drug market now and in the future"

Partial Table of Contents:

The Business Implications
CHAP TER 1 - The landscape for orphan drug development
Executive Summary
Introduction
Rare diseases
Definitions
Prevalence
Causes of rare diseases
Neglected diseases
Drugs for rare diseases
Orphan drug designations and approvals in the US
Orphan drug designations and approvals in the EU
Interest in developing drugs for rare diseases
Scientific advances
Government support
Patient advocates
Markets
Challenges in the development of drugs for rare diseases
CHAP TER 2 - the market environment: regulation, legislation and incentives for orphan
drug development
Executive Summary
Legislation in the US
EXPERT COMMENTARY: Dr Tim Cote, Director, FDA Office of Orphan Products Development
Clinical data
Accelerating approval
Post-marketing approval commitments
Applying for orphan drug designation
Criticism of orphan drug legislation in the US
Regulation in other markets
EU Orphan Drug Regulations
EXPERT COMMENTARY: JOrn Aldag, CEO, AMT BioPharma
Company background
Regulatory environment for orphan products
Market access
Market leaders
Australian Orphan Drug Regulations
Japanese Orphan Drug Regulations
Harmonisation of US and EU regulation and advice
Incentives for orphan drug development
Conclusions
CHAP TER 3 - Key pharma players and their str ategies
Executive Summary
Leading biotech and specialty pharma companies in the orphan space
Genzyme, MA, US
Products and product pipeline
Manufacturing issues
The future for Genzyme
BioMarin, CA, US
Shire plc, UK
Swedish Orphan Biovitrum, Sweden
Actelion Pharmaceuticals Ltd, Switzerland
Sigma-Tau Group, Italy
Other big biotech players with interests in orphan drugs
Celgene Corporation, NJ, US
Gilead Sciences, CA, US
Emerging biotech companies
Alexion Pharmaceuticals, CT, US
ViroPharma Inc, PA, US
InterMune Inc, CA, US
Protalix Biotherapeutics, Israel
Incyte Corporation, DE, US
Acorda Therapeutics, NY, US
Amicus Therapeutics, NJ, US
Santhera Pharmaceuticals, Switzerland
Innovative technology platforms
Antisense therapy
EXPERT COMMENTARY: Luc Dochez, Chief Business Officer, Prosensa
Company background
Research funding
Exon skipping in DMD
Pipeline

Full Table of Contents is available at:
-- http://www.fastmr.com/catalog/product.aspx?productid=1700...

About Espicom Business Intelligence

Espicom Business Intelligence is a highly-regarded and established provider of business intelligence services. Founded in 1982 as MDIS Publications Ltd, the company changed its name to Espicom in 1992. Initially a publisher in a wide range of industries such as power generation and telecommunications, they now focus on the global pharmaceutical and medical device sectors.  View more research from Espicom Business Intelligence at http://www.fastmr.com/catalog/publishers.aspx?pubid=1025

About Fast Market Research

Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available.

For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.

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Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available.
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