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).


Key features of this report


- - Comprehensive examination of recent trends and developments in the featured countries.
- Market sizes and category sizes in 7 core markets.
- Case studies of the switches of orlistat and statins.
- Examination of regulatory changes that are likely to impact upon OTC markets in the future


Scope of this report


- Provides a clear and concise understanding of the dynamics of the global OTC market.
- Demonstrates how the dynamics of the OTC markets in the various countries differ widely, but also how they relate to each other.
- Identifies and examines examples of successful switches, which can be used as a model for future switches.
- Highlights switches that failed and examines possible causes for failure.
- Allows marketers to plan ahead: Anticipating what switches are likely to take place in future; and take into account other regulatory changes that are likely to take place.


Key Market Issues


- In 2008, the global pharmaceutical market grew by 4.8% to reach $773bn (MSP), while the global OTC market grew by 7.6% to reach $79.3bn (MSP). Although OTC growth in recent years has been driven by emerging markets such as China and Eastern Europe, the developed markets of North America, Western Europe and the Pacific Rim together account for over 50% of global OTC turnover.
- Although most Rx-to-OTC switches are driven by manufacturers; governments around the world increasingly view Rx-to-OTC switching as a means of relieving pressure on overburdened health insurance systems.
- Throughout the world, access to OTCs is increasing. In some countries, the increased access is derived mainly from pioneering switches from Rx-to-OTC; while, in others, the increased access is derived mainly from the opening up of distribution channels and from an easing of advertising restrictions.

Key findings from this report


- In all seven featured countries, OTC market expansion is being fuelled by Rx-to-OTC switching.
- The success of new-generation switches often relies on a collaborative care model, involving co-operation between consumers, doctors and pharmacists.
- In the future, the collaborative care model could potentially be used as a basis for switching products for treating conditions such as asthma, hypertension, hyperglycemia and osteoporosis. There is also scope for switching products for treating conditions for which the timing of treatment is critical: for example, adrenaline injectors containing epinephrine and antivirals such as Roche’s Tamiflu (oseltamivir).

Key questions answered


- What opinion do various stakeholders (i.e. consumers, regulators, manufacturers, healthcare professionals) have on Rx-to-OTC switches?
- What does the future hold for the global OTC market?
- What Rx-to-OTC switches might there be in the future?


Report Highlights

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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

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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

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