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Established Drug Classes in Ophthalmology 10
Emerging Drug Classes 10
VEGF-Trap Eye 10
Combination Therapies 11
Competition between VEGF Inhibitors in Wet AMD 11
TABLE 2 NOTABLE EVENTS IN LUCENTIS VERSUS AVASTIN: PREVIOUS AND EXPECTED 12
Expected Outcome of CATT trial: Avastin v. Lucentis 12
Genetic Specifications of Ophthalmic Disease 13
TABLE 3 SUMMARY OF KNOWN GENES INFLUENCING DISEASE 14
Summary Pipeline of Drugs in Development 14
TABLE 4 RECENTLY APPROVED DRUGS, 2009 15
TABLE 5 SUMMARY PIPELINE FORECAST, 2012-2014 15
INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 15
INDUSTRY STRUCTURE 15
Market Concentration and Price Sensitivity 16
TABLE 6 COMPANY BY DISEASE CLASS, 2009 REVENUE ($ MILLIONS) 17
Competitive Factors 17
TABLE 7 LARGE REVENUE, BRANDED DRUG SALES COMING OFF PATENT, 2009 18
Chapter-3: GLOBAL MARKETS FOR ORPHAN DRUGS (PHM038C)
INTRODUCTION 19
STUDY GOAL AND OBJECTIVES 19
REASONS FOR DOING THE STUDY 20
INTENDED AUDIENCE 20
SCOPE OF REPORT 21
INFORMATION SOURCES AND METHODOLOGY 21
AUTHOR'S CREDENTIALS 22
RELATED REPORTS FROM BCC RESEARCH 22
SUMMARY 23
TABLE 8
GLOBAL ORPHAN DRUGS DEMAND BY VALUE, THROUGH 2014 ($ MILLIONS) 24
FIGURE 2 GLOBAL ORPHAN DRUGS DEMAND BY VALUE, 2008-2014 ($ MILLIONS) 25
OVERVIEW 25
DEFINITION OF AN ORPHAN DRUG 25
HISTORY OF ORPHAN DRUG LEGISLATION 26
First Legislation on Orphan Drugs 26
Amendments to the ODA 26
Bills Passed in 2002 Increased Funding and Established the Office of Rare Diseases 26
Orphan Drug Legislation — Global Status 26
INCENTIVES FOR ORPHAN DRUG DEVELOPMENT 27
THE NEED FOR INCENTIVES 27
TABLE 9 NUMBER OF ORPHAN DRUG DESIGNATIONS AND APPROVALS PER YEAR BY U.S. FD
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