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Follow on Google News | New Market Report Now Available: Orphan Drugs: Strategic Approaches for the IndustryRecently published research from Espicom Business Intelligence, "Orphan Drugs: Strategic Approaches for the Industry", is now available at Fast Market Research
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. ------------------------------------------------------------ Full Report Details at - http://www.fastmr.com/ ------------------------------------------------------------ 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: 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/ 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/ 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. # # # 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. End
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