Reportlinker Adds OTC Opportunities in Europe, the US and Japan: Key trends, leading players and future Rx-OTC switching

Wednesday, February 17, 2010 Press Release
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NEW YORK, Feb. 16 announces that a new market research report is available in its catalogue:

OTC Opportunities in Europe, the US and Japan: Key trends, leading players and future Rx-OTC switching

The developed OTC markets such as the US and UK are heavily reliant on Rx-to-OTC switching of "new generation" products as a means of generating growth. Switching also plays an important role for less-developed markets (e.g. France, Spain, Italy, Japan), though in this case they are playing "catch-up" with the more developed markets. The "Power of Switch" was brought into sharp focus in 2009 with the first ever use of the Centralized Procedure for switching products throughout the European Union. This comprehensive report provides background on market dynamics (including overall market size and therapeutic category size) for each of the core countries under analysis. This report also examines products and categories that are likely to be switched in the future, regulatory changes that are likely to impact the OTC market, and provides growth forecasts to 2013. Included in the report are case studies for two of the most significant switches of recent years - i.e. Alli (orlistat) and Zocor (simvastatin).

Table of Contents

OTC opportunities in Europe, the US and Japan

Executive summary 10

Introduction 10

OTC opportunities in Europe 11

OTC opportunities in the US 12

OTC opportunities in Japan 13

Case studies of major Rx-to-OTC switches 14

Conclusions and forecasts 15

Chapter 1 Introduction 18

Summary 18

OTC market in context 19

General growth drivers 19

The power of switch 20

Attitudes to switch 21

Switch drivers 21

Definitions 22

Chapter 2 OTC trends and opportunities in

Europe 24

Summary 24

Introduction 25

Regulatory background 26

Rx-to-OTC switch mechanism 27

OTC market dynamics 28

France 30

Germany 32

Italy 34

Spain 36

UK 37

Key recent developments 39

Centralized Procedure for Rx-to-OTC switching makes debut in 2009 39

OTC pantoprazole 39

OTC Viagra ruled to be too risky 40

France 40

Low switch 40

De-reimbursement 41

Line extensions 41

Self selection of OTCs introduced in 2008 41

Germany 42

Pioneering switch 42

Italy 43

Spain 44

UK 45

Pioneering switch 45

Tamsulosin to become world's first BPH treatment available OTC 46

P-to-GSL switching 47

Leading new products 48

New opportunities 50

Momentum gathers to increase OTC accessibility in France and Italy 52

Self-selection in France 52

Government proposes "starter OTCs" for mass market in Italy 52

Rx-to-OTC switch opportunities 53

Collaborative care 53

UK has several switches in the pipeline 56

"Unofficial" OTCs 57

Comparison with other regions 57

Stakeholder attitudes to switches 58

Chapter 3 OTC trends and opportunities in the US 62

Summary 62

Introduction 63

Regulatory background 63

OTC market dynamics 65

Key recent developments 68

Recent switches make major impact 69

Cetirizine 69

Orlistat 69

Omeprazole + sodium bicarbonate 72

Switch of lovastatin stalls 73

New opportunities 75

Foreign switches provide possible switch candidates for the US 76

FDA proposes new BTC drug category 76

Consumers are ready to embrace BTC drugs 78

Price implications of BTC products 78

Chapter 4 OTC trends and opportunities in

Japan 82

Summary 82

Introduction 83

Regulatory background 83

Rx-to-OTC switch procedure 84

OTC market dynamics 84

Leading players 86

Key recent developments 86

Rx-to-OTC switching 87

Opening up of mass market 91

Sales implications of new OTC classifications 91

New opportunities 92

Corporate initiatives 94

Chapter 5 Case studies of switches of orlistat and statins 96

Summary 96

Introduction 97

Orlistat 97

Australia establishes switch model for orlistat 98

US switch model 99

European switch model 99

Availability of orlistat OTC continues to face resistance 101

Sales performance 101

Future prospects 102

Statins 103

Simvastatin 103

Sales of Zocor Heart-Pro fail to meet expectations 104

Other statins 105

Long track record of failed attempts to switch statins in the US 106

Future prospects for OTC statins 106

Chapter 6 Conclusions and forecasts 110

Summary 110

Introduction 111

Main switch opportunities 111

Collaborative care model facilitates new switches 112

Regulatory challenges 113

Forecasts 113

France 114

Germany 114

Italy 114

Spain 114

UK 115

US 115

Japan 116

Chapter 7 Appendix 117

References 120

Abbreviations 121

Index of companies 124

List of Figures

Figure 2.1: Europe: OTC sales as proportion of total non Rx-bound* sales ($bn) in the Big Fivemarkets, 2008 30

Figure 2.2: France: OTC sales (RSP $m) by major therapeutic market, 2008 31

Figure 2.3: Germany: OTC sales (RSP $m) by major therapeutic market, 2008 33

Figure 2.4: Italy: OTC sales (RSP $m) by major therapeutic market, 2008 35

Figure 2.5: Spain: OTC sales (RSP $m) by major therapeutic market, 2008 37

Figure 2.6: UK: OTC sales (RSP $m) by major therapeutic market, 2008 38

Figure 2.7: UK packaging for Flomax relief 47

Figure 2.8: Key goals of AESGP's Smart Regulation 2015 51

Figure 2.9: Europe: Possible new areas for self-medication in collaborative care setting 54

Figure 3.10: US OTC sales (RSP $m) by major therapeutic market, 2008 66

Figure 3.11: US packaging for Zegerid OTC 72

Figure 4.12: Japan: OTC sales (RSP $m) by major therapeutic market, 2008 85

Figure 4.13: Packaging Lipovitan D in Japan 86

Figure 4.14: JSMI goals to 2014 93

Figure 5.15: UK packaging for Alli 100

Figure 6.16: Forecast OTC growth in key countries ($m), 2008-13 115

List of Tables

Table 2.1: Europe: OTC classifications in the Big Five markets 26

Table 2.2: Total pharmaceutical sales (RSP $m) in the Big Five EU markets, 2007-08 28

Table 2.3: OTC sales (RSP $m) in the Big Five EU markets, 2007-08 29

Table 2.4: UK: Recent Rx-to-OTC switches 49

Table 2.5: UK: Products under review for switch from Rx-to-OTC* 56

Table 3.6: US OTC sales ($m, RSP) 2006-08 65

Table 3.7: US: OTC sales (RSP $m) by therapeutic category 2007-08 67

Table 3.8: US: Rx-to-OTC switches, 2002-09 74

Table 4.9: Japan: MHLW switch candidates, August 2008 87

Table 4.10: Japan: JSMI switch candidates, 2007-08 89

Table 7.11: Legal status of selected ingredients in key markets 117

Table 7.12: Legal status of selected ingredients in key markets (ctd 1) 118

Table 7.13: Legal status of selected ingredients in key markets (ctd 2) 119

To order this report:

Over-The-Counter Drug Industry: OTC Opportunities in Europe, the US and Japan: Key trends, leading players and future Rx-OTC switching

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Contact: Nicolas Bombourg Reportlinker Email: US: (805)652-2626 Intl: +1 805-652-2626

SOURCE Reportlinker

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