SPI Infoamtion

Table of Contents

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

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)