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

Published by	Business Insights
Published	January, 2010	Product code	114249
Content info	125 pages
Price	US $ 3835 PDF by E-mail (Single User License) US $ 14382 PDF by E-mail (Global Site License)

Introduction
Related Reports

OTC Opportunities in Europe, the US and Japan: Key trends, leading players and future Rx-OTC switching published by Business Insights in January, 2010. This report consists of 125 pages and the price starts from US $ 3835.

Introduction

Abstract

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).

Executive summary

Introduction
OTC opportunities in Europe
OTC opportunities in the US
OTC opportunities in Japan
Case studies of major Rx-to-OTC switches
Conclusions and forecasts

Chapter 1 Introduction

Summary
OTC market in context
General growth drivers
The power of switch
- Attitudes to switch
- Switch drivers
Definitions

Chapter 2 OTC trends and opportunities in Europe

Summary
Introduction
Regulatory background
Rx-to-OTC switch mechanism
OTC market dynamics
- France
- Germany
- Italy
- Spain
- UK
Key recent developments
- Centralized Procedure for Rx-to-OTC switching makes debut in 2009
  - OTC pantoprazole
  - OTC Viagra ruled to be too risky
- France
  - Low switch
  - De-reimbursement
  - Line extensions
  - Self selection of OTCs introduced in 2008
- Germany
  - Pioneering switch
- Italy
- Spain
- UK
  - Pioneering switch
  - Tamsulosin to become world' s first BPH treatment available OTC
  - P-to-GSL switching
  - Leading new products
New opportunities
- Momentum gathers to increase OTC accessibility in France and Italy
  - Self-selection in France
  - Government proposes "starter OTCs" for mass market in Italy
- Rx-to-OTC switch opportunities
  - Collaborative care
  - UK has several switches in the pipeline
  - "Unofficial" OTCs
  - Comparison with other regions
  - Stakeholder attitudes to switches

Chapter 3 OTC trends and opportunities in the US

Summary
Introduction
Regulatory background
OTC market dynamics
Key recent developments
- Recent switches make major impact
  - Cetirizine
  - Orlistat
  - Omeprazole + sodium bicarbonate
- Switch of lovastatin stalls
New opportunities
- Foreign switches provide possible switch candidates for the US
- FDA proposes new BTC drug category
- Consumers are ready to embrace BTC drugs
- Price implications of BTC products

Chapter 4 OTC trends and opportunities in Japan

Summary
Introduction
Regulatory background
- Rx-to-OTC switch procedure
OTC market dynamics
- Leading players
Key recent developments
- Rx-to-OTC switching
- Opening up of mass market
- Sales implications of new OTC classifications
New opportunities
- Corporate initiatives

Chapter 5 Case studies of switches of orlistat and statins

Summary
Introduction
Orlistat
- Australia establishes switch model for orlistat
- US switch model
- European switch model
- Availability of orlistat OTC continues to face resistance
- Sales performance
- Future prospects
Statins
- Simvastatin
  - Sales of Zocor Heart-Pro fail to meet expectations
- Other statins
  - Long track record of failed attempts to switch statins in the US
  - Future prospects for OTC statins

Chapter 6 Conclusions and forecasts

Summary
Introduction
Main switch opportunities
- Collaborative care model facilitates new switches
- Regulatory challenges
Forecasts
- France
- Germany
- Italy
- Spain
- UK
- US
- Japan

Chapter 7 Appendix Error! Bookmark not defined.

References
Abbreviations
Index of companies

List of Figures

Figure 2.1: Europe: OTC sales as proportion of total non Rx-bound* sales ($bn) in the Big Five markets, 2008
Figure 2.2: France: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 2.3: Germany: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 2.4: Italy: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 2.5: Spain: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 2.6: UK: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 2.7: UK packaging for Flomax relief
Figure 2.8: Key goals of AESGP' s Smart Regulation 2015
Figure 2.9: Europe: Possible new areas for self-medication in collaborative care setting
Figure 3.10: US OTC sales (RSP $m) by major therapeutic market, 2008
Figure 3.11: US packaging for Zegerid OTC
Figure 4.12: Japan: OTC sales (RSP $m) by major therapeutic market, 2008
Figure 4.13: Packaging Lipovitan D in Japan
Figure 4.14: JSMI goals to 2014
Figure 5.15: UK packaging for Alli
Figure 6.16: Forecast OTC growth in key countries ($m), 2008-13

List of Tables

Table 2.1: Europe: OTC classifications in the Big Five markets
Table 2.2: Total pharmaceutical sales (RSP $m) in the Big Five EU markets, 2007-08
Table 2.3: OTC sales (RSP $m) in the Big Five EU markets, 2007-08
Table 2.4: UK: Recent Rx-to-OTC switches
Table 2.5: UK: Products under review for switch from Rx-to-OTC*
Table 3.6: US OTC sales ($m, RSP) 2006-08
Table 3.7: US: OTC sales (RSP $m) by therapeutic category 2007-08
Table 3.8: US: Rx-to-OTC switches, 2002-09
Table 4.9: Japan: MHLW switch candidates, August 2008
Table 4.10: Japan: JSMI switch candidates, 2007-08
Table 7.11: Legal status of selected ingredients in key markets
Table 7.12: Legal status of selected ingredients in key markets (ctd 1)
Table 7.13: Legal status of selected ingredients in key markets (ctd 2)