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Reportlinker Adds 2010 Pharmaceuticals Research Review
Date:12/14/2010

A, 1983-2009 27

APPLICATIONS FOR ORPHAN DRUG DESIGNATIONS HAVE DOUBLED 28

PROFITABILITY OF ORPHAN DRUGS 28

Market Exclusivity 28

No Regulatory Restrictions on Pricing 29

Off-Label Use 29

CHALLENGES FOR EFFECTIVE USE OF THE ODA 30

MARKET EXCLUSIVITY VERSUS PATENT PROTECTION 30

MARKET SIZE AND KEY PLAYERS 31

TABLE 10 TOP 10 COMPANIES IN THE ORPHAN DRUG MARKET AND THEIR MARKET SHARES (%) 32

THE ORPHAN DRUG ACT — A BONUS FOR BIOTECH 32

BIG PHARMA IS ENTERING THE ORPHAN DRUGS SECTOR AGGRESSIVELY 32

CONCERNS ABOUT THE ORPHAN DRUG ACT 33

COST-EFFECTIVENESS 34

PRICING OF ORPHAN DRUGS 34

TABLE 11 SOME EXAMPLES OF HIGHLY EXPENSIVE ORPHAN DRUGS AND THEIR PRICES 35

High-Priced Orphan Drugs Leading to Price Control Measures by Governments 36

TABLE 12 SOME OF THE RECENT CONTROVERSIES RELATED TO ORPHAN DRUGS PRICING 37

ACCESS TO ORPHAN DRUGS AND REIMBURSEMENT — CURRENT PRACTICES 38

Orphan Drug Access and Reimbursement Scenario in the U.S. 38

Access and Reimbursement Scenario in Europe 38

TABLE 13 ORPHAN DRUG ACCESS AND REIMBURSEMENT PRACTICES  IN EUROPEAN COUNTRIES 39

TABLE 13 (CONTINUED) 40

TABLE 13 (CONTINUED) 41

Call for Unification of Orphan Drug Access Across Europe 41

INNOVATIVE APPROACHES OF PRICING AND REIMBURSEMENT 42

TABLE 14 EMERGING TRENDS IN PRICING AND REIMBURSEMENT OF HIGH-PRICED DRUGS 42

TABLE 14 (CONTINUED) 43

Chapter-4: DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET (PHM045B)

INTRODUCTION 44

STUDY GOALS AND OBJECTIVES 44

REASONS FOR DOING THIS STUDY AND ITS IMPORTANCE 44

INTENDED AUDIENCE 45

SCOPE OF REPORT 45

METHODOLOGY AND INFORMATION SOURCES 45

ANALYST CREDENTIALS 46

SUMMARY 46

SCOPE OF THE INDUSTRY 46

DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKE
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