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

Date: January 22, 2010
Pages: 125
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), Hard Copy Mail Delivery, CD-ROM Mail Delivery
ID: O6E5E6104B2EN

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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?

  • 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


    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


    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


    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


    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


    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


    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


    References 120
    Abbreviations 121
    Index of companies 124


    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


    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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