Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge
Summary
GBI Research, a leading business intelligence provider, has released its latest research “Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge” examines the key issues influencing the global OTC market and assesses why companies switch Rx drugs to OTC, their business strategies and the potential challenges and opportunities this creates. It provides an analysis of the global OTC market and forecasts broken down by geography and therapy areas. It discusses the national and international factors which impact the OTC market and companies operating in the OTC market. The report reviews the regulatory landscape in the US, Europe and Japan and highlights recent changes in regulatory procedures and guidelines. Therapy profiles provide a detailed analysis of the leading OTC drug classes and Company profiles provide a detailed analysis of the leading OTC companies. Finally the report discusses the challenges and future opportunities in the OTC market, business strategies and future outlook.
Over-the-counter (OTC) drugs are available on the market without prescription and are widely used by consumers to treat minor ailments. Today there are over 300,000 OTC medicines and ingredients available for purchase to treat a broad range of conditions including high cholesterol, weight management, skin disorders and respiratory infections. OTC medicines are strictly regulated and a number of regulatory processes have now been established to enable new and approved products to be reviewed and approved in a clear and transparent manner.
Many large pharmaceutical companies have already made strategic investment in OTC medicines including J&J, GlaxoSmithKline, Reckitt Benckiser, Bayer Healthcare, Novartis, Sanofi, Pfizer, Merck & Co. and Proctor & Gamble, and whilst their business strategies vary, their success has been based on a combination of careful product selection and positioning, optimal distribution and aggressive marketing. The market will continue to be driven by a number of external factors, including the growing and ageing population, emerging consumers, consumer empowerment and education, unmet medical need, healthcare reform and governmental support, as well as companies actively managing their patent exposure, optimizing PLM and maximizing their advertising and marketing opportunities.
Scope
- Data and analysis on the Rx-to-OTC switch market in the top seven countries which includes the US, the UK, France, Germany, Spain, Italy and Japan,
- Market Data on geographical landscape including country wise revenues, market size and market share.
- Key drivers and restraints that have created significant impact on the market.
- Regulatory landscape including the product approval process and overview of regulatory authorities in the top seven countries.
- Competitive landscape of the Rx-to OTC Switch market, including top companies profiles. The key companies studied in this report are Johnson & Johnson, GlaxoSmithKline, Bayer Healthcare, Reckitt Benckiser, Procter & Gamble, Sanofi, Merck and Pfizer.
Reasons to buy
The report will aid business development and marketing executives strategizing their product launches -
- Build effective strategies to launch their products by identifying potential geographies.
- Exploit in-licensing and out-licensing opportunities by identifying products that might probably fill their portfolio gaps.
- Develop key strategic initiatives by studying the key strategies of top competitors.
- Develop market-entry and market expansion strategies by identifying the geographic markets poised for strong growth.
Over-the-counter Drug Industry
Table of Contents
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 What Defines an OTC Product? 7
2.2 Why do Companies Switch Rx Products OTC? 7
2.3 Which OTC Products are Currently Available? 7
2.4 What Geographical Markets Attract OTC Switching? 9
2.5 What Are the Potential New Areas For OTC Drug Development and Why? 11
2.6 GBI Research Report Guidance 12
3 Market Characterization and Forecasts 13
3.1 Global OTC Market by Revenues 13
3.2 Global OTC Market by Region 14
3.3 Global OTC Market - Key Players 15
3.4 Global OTC Market by Therapy 16
3.5 The European OTC Market 17
3.5.1 France 19
3.5.2 Germany 19
3.5.3 Italy 20
3.5.4 The UK 20
3.5.5 Other European Countries 21
3.5.6 European OTC Market Forecasts 22
3.6 Japanese OTC Market 23
3.6.1 Japanese OTC Market Forecasts 24
3.7 North American OTC Market 25
3.7.1 The US 26
3.7.2 Canada 27
3.7.3 Latin American Countries 27
3.7.4 North America OTC Market Forecasts 28
3.8 Trends and Conclusions 29
4 Market Drivers and Restraints 30
5 Growing and Aging Populations 31
5.1 Emerging Consumer 33
5.2 Consumer Empowerment and Education 34
5.3 Unmet Medical Need 35
5.4 Product Life-Cycle Management 38
5.5 Patent Expiration 40
5.6 Healthcare Reform and Government Support 41
5.7 Advertising 42
5.8 Trends and Conclusions 43
6 Regulatory Landscape 44
6.1 Regulation in the US 44
6.2 OTC New Drug Application (NDA) 45
6.2.1 OTC Drug Monograph 45
6.2.2 Labeling 45
6.2.3 Rx-to-OTC Switches 46
6.3 Regulations in Europe 47
6.3.1 Centralized Route for Drug Approval 47
6.3.2 Decentralized Procedure for drug approval 48
6.3.3 National Procedure for Drug Approval 49
6.3.4 Drug Classification in Europe 51
6.3.5 EU Harmonization 52
6.4 Regulations in Japan 53
6.5 Trends & Conclusions 56
7 Therapy Areas 57
7.1 Coughs, Colds and Allergies 58
7.1.1 Case Study: Claritin (Merck) 59
7.1.2 Case Study: Sudafed (J&J) 61
7.1.3 Case Study: Allegra (Sanofi) 61
7.1.4 OTC Respiratory Conclusions 61
7.2 Analgesics and Pain Management 62
7.2.1 Case Study: Nurofen (Reckitt Benckiser) 63
7.2.2 Case Study: Advil (Pfizer/Wyeth) 64
7.2.3 Case Study: Tylenol (McNeil/J&J) 65
7.2.4 OTC Pain Conclusions 65
7.3 Gastrointestinal Remedies and Indigestion 66
7.3.1 Case Study: Zantac (GlaxoSmithKline/Warner-Lambert) 67
7.3.2 Prilosec OTC (Proctor & Gamble/AstraZeneca) 68
7.3.3 Pantazol/Pantazol Control (Nycomed) 68
7.3.4 Gastrointestinal OTC Conclusions 69
7.4 Medicated Dermatological Products 69
7.4.1 Case Study: Lamisil (Novartis) 70
7.5 Trends and Conclusions 70
8 Company Analysis 71
8.1 Johnson & Johnson 72
8.1.1 OTC M&A activity 73
8.1.2 OTC Production Issues 73
8.2 GlaxoSmithKline 74
8.2.1 OTC Divestment 77
8.3 Reckitt Benckiser 78
8.3.1 OTC M&A Activity 79
8.4 Bayer Healthcare AG 80
8.4.1 Restructuring 81
8.4.2 Product Line Extensions 81
8.4.3 Expansion in Fast-Growing Regions 82
8.5 Procter & Gamble 82
8.5.1 Joint Venture 84
8.6 Novartis 84
8.7 Sanofi 87
8.7.1 New Product Launches 88
8.8 Boehringer Ingelheim GmbH 89
8.9 Merck & Co. 91
8.10 Pfizer 93
8.11 Trends & conclusions 94
9 Challenges and Opportunities in the OTC Market 95
9.1 Business Strategies 95
9.2 Model for Rx-to-OTC switching 95
9.3 Brand identity and private labeling 97
9.4 Behind-the-Counter Opportunities 98
9.5 Opportunities in the emerging markets 99
9.6 Outlook 99
10 APPENDIX 101
10.1 Key Definitions 101
10.2 Abbreviations (in alphabetical order) 101
10.3 Sources 102
10.4 Methodology 104
10.4.1 Primary Research 105
10.4.2 Secondary Research 105
10.4.3 Contacts Us 105
10.4.4 Disclaimer 106
List of Tables
Table 1: Rx-to OTC Switch, Examples of OTC Drug Classes 8
Table 2: RX to OTC Switch, Global, Pharma and OTC sales ($bn), 2006-2010 9
Table 3: Rx-to OTC Switch, Leading OTC Drug Classes, 2010 10
Table 4: Rx-to OTC Switch, Global, OTC and Rx-to-OTC Sales ($bn), 2006-2010 13
Table 5: Rx-to OTC Switch, Global, OTC Sales by Region ($bn), 2006-2010 14
Table 6: Rx-to OTC Switch, Global, OTC Revenues of Top 10 Companies ($bn and %), 2010 15
Table 7: Rx-to OTC Switch, Global, OTC Sales by Therapy ($bn and %), 2010 16
Table 8: Rx to OTC Switch, Europe, OTC Sales by Region ($bn), 2006-2010 17
Table 9: Rx-to OTC Switch, Europe, OTC Sales by Region and Key Countries ($bn), 2011-2015 22
Table 10: Rx-to OTC Switch, Japan, OTC Sales ($ and JPY, bn), 2006- 2010 23
Table 11: Rx-to OTC Switch, Japan, OTC Sales (JPY bn and $bn), 2011-2015 25
Table 12: Rx-to OTC Switch, North America and Latin America OTC Market ($bn), 2006-2010 25
Table 13: Rx-to OTC Switch, North America and Latin America, OTC Sales ($bn), 2011-2015 28
Table 14: Rx-to OTC Switch, Treatment Decisions for Common Ailments 35
Table 15 Rx-to OTC Switch, Potential New Indications for Self-Medication 36
Table 16: Rx-to-OTC Switches Approved by FDA (number), 2000-2010 39
Table 17: Rx-to OTC Switch, Global, Patent Expiry of Leading Pharmaceutical Brands 40
Table 18: Rx-to OTC Switch, Comparison of NDA and OTC Monograph Processes 44
Table 19: Rx-to OTC Switch, National Regulation of Drug Classes and Their Distribution in France, Germany, Italy and the UK 51
Table 20: Rx-to OTC Switch, Japan, Amendments to PAL, 2005 54
Table 21: Rx-to-OTC Switch, Respiratory OTC Drugs by Indication (Number and %), 2005-2011 59
Table 22: Rx-to OTC Switch, Leading Retailer OTC Brands to Treat Coughs, Colds and Allergies 60
Table 23 Rx-to-OTC Switch, Analgesic and Pain Management OTC Drugs by Indication (Number and %), 2005-2011 62
Table 24 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat Pain 63
Table 25 Rx-to-OTC Switch, Gastrointestinal and Indigestion OTC Drugs by Indication (Number and %), 2005-2011 66
Table 26 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat GI Conditions 67
Table 27 Rx-to OTC Switch, Indications for Medicated Dermatological OTC Products, 2010 69
Table 28 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat Dermatological Conditions 70
Table 29 Rx-to OTC Switch, Global Leading OTC Companies, 2010 71
Table 30 Rx-to OTC Switch, Johnson & Johnson Leading OTC Products, 2010 73
Table 31 Rx-to OTC Switch, GlaxoSmithKline’s Revenue by Business Segment ($m), 2010 74
Table 32: Rx-to OTC Switch, GlaxoSmithkline Leading OTC Products, 2010 76
Table 33: Rx-to OTC Switch, OTC Products Identified For Divestment By GSK, 2011 77
Table 34: Rx-to OTC Switch, Reckitt Benckiser Regional Revenues ($m), 2010 79
Table 35: Rx-to OTC Switch, Reckitt Benckiser Leading OTC Products, 2010 79
Table 36: Rx-to OTC Switch, Bayer HealthCare Revenues ($m), 2010 80
Table 37: Rx-to OTC Switch, Bayer Healthcare Leading OTC Products, 2010 81
Table 38: Rx-to OTC Switch, Proctor & Gamble Leading OTC Products, 2011 83
Table 39: Rx-to OTC Switch, Novartis HealthCare Revenues ($m), 2010 85
Table 40: Rx-to OTC Switch, Novartis Leading OTC Products, 2010 86
Table 41: Rx-to OTC Switch, Boehringer Ingelheim Leading OTC Products, 2010 90
Table 42: Rx-to OTC Switch, Merck & Co.s Leading OTC Products, 2010 91
Table 43: Rx-to OTC Switch, Pfizer’s leading OTC Products, 2010 93
Table 44: Rx-to OTC Switch, Profit Margins on Private Labels vs. National Brands 97
Table 45: Rx-to OTC Switch, Examples of BTC products, 2010 98
List of Figures
Figure 1: Rx-to OTC Switch, Global, OTC Market Revenues by Region (%), 2010 9
Figure 2: Rx-to OTC Switch, Sales Growth Of The OTC Market by Region (%), 2010 10
Figure 3: Rx-to OTC Switch, Leading Pharmaceutical Company Product Switches (Number), 2001-2011 11
Figure 4: Rx-to OTC Switch, Global Rx-to-OTC Sales by Region, (%), 2010 14
Figure 5: Rx to OTC Switch, Global, OTC Sales by Company (%), 2010 15
Figure 6: Rx-to OTC Switch, Global, OTC Sales by Therapy (%), 2010 16
Figure 7: Rx-to OTC Switch, Europe, OTC Sales by Region (%), 2010 17
Figure 8: Rx-to OTC Switch, Western Europe, OTC Expenditure Per Capita ($), 2010 18
Figure 9: Rx to OTC Switch, Sales Of Non-Prescription Drugs Used for Self-Medication (%), 2010 18
Figure 10: Rx-to OTC Switch, Central and Eastern Europe, OTC Expenditure Per Capita ($), 2010 21
Figure 11: Rx-to OTC Switch, Japan, OTC Drug Market by Category (%), March 31, 2011* 24
Figure 12: Rx-to OTC Switch, North America and Latin America, Sales by Region (%), 2010 25
Figure 13: Rx-to OTC Switch, North America, OTC Sales by Category (%), 2010 26
Figure 14: Rx-to OTC Switch, Market Drivers & Restraints for OTC Growth, 2011 30
Figure 15: Rx-to OTC Switch, Population Change by Region (millions), 2010 to 2100 31
Figure 16: Rx to OTC Switch, Global, Proportion of the Population Over 60 (%), 2010, 2025, 2050 32
Figure 17: Rx-to OTC Switch, Proportion of the Population Over 60 (million), 2010–2100 33
Figure 18: Rx-to OTC Switch, Emerging Economies, New Opportunities by Consumer Income Group, 2008–2018 34
Figure 19: Rx-to OTC Switch as an Integral Part of Product Line Extension 38
Figure 20: Rx-to-OTC Switches Approved by FDA (%), 2000-2010 39
Figure 21: Rx-to OTC Switch, Schematic of the Centralized Procedure 47
Figure 22: Rx-to OTC Switch, Schematic of the Decentralized Procedure 48
Figure 23: Rx-to OTC Switch, Schematic of the National Procedure 49
Figure 24: Rx-to OTC Switch, Data Exclusivity For Rx-to-OTC Switch Cycle 50
Figure 25: Rx-to OTC Switch, Criteria to Switch a Drug from a POM to P Status in the UK 52
Figure 26: Rx-to OTC Switch, MHLW Vision OTC Medicines and Generics Will Stimulate Future Pharmaceutical Growth 55
Figure 27: Rx-to OTC Switch, Top 20 Aliments for Self-Medication 57
Figure 28: Rx-to OTC Switch, Global, OTC Sales by Category (%), 2010 58
Figure 29: Rx-to OTC Switch, Johnson & Johnson Global Revenues (%), 2010 72
Figure 30: Rx-to OTC Switch, Johnson & Johnson Consumer Healthcare Revenues (%), 2010 72
Figure 31: Rx-to OTC Switch, GlaxoSmithKline’s Revenue by Business Segment (%), 2010 74
Figure 32: Rx-to OTC Switch, GlaxoSmithKline Consumer Healthcare Revenues (%), 2010 75
Figure 33: Rx-to OTC Switch, Reckitt Benckiser Revenues (%), 2010 78
Figure 34: Rx-to OTC Switch, Reckitt Benckiser Regional Revenues, 2010 (%)* 78
Figure 35: Rx-to OTC Switch, Bayer HealthCare Revenues (%), 2010 80
Figure 36: Rx-to OTC Switch, Proctor & Gamble Global Revenues (%), 2011 82
Figure 37: Rx-to OTC Switch, Proctor & Gamble Regional Revenues (%), 2011 83
Figure 38: Rx-to OTC Switch, Novartis Revenues (%), 2010 84
Figure 39: Rx-to OTC Switch, Novartis HealthCare Revenues (%), 2010 85
Figure 40: Rx-to OTC Switch, Sanofi Revenues (%), 2010 87
Figure 41: Rx-to OTC Switch, Sanofi Regional Revenues (%), 2010 87
Figure 42: Rx-to OTC Switch, Boehringer Ingelheim Revenues (%), 2010 89
Figure 43: Rx-to OTC Switch, Boehringer Ingelheim Consumer Healthcare Regional Revenues (%), 2010 90
Figure 44: Rx-to OTC Switch, Merck & Co. Revenues (%), 2010 91
Figure 45: Rx-to OTC Switch, Merck Consumer Healthcare Revenues (%), 2010 92
Figure 46: Rx-to OTC Switch, Pfizer Global Revenues (%), 2010 93
Figure 47: Rx-to OTC Switch, Number of Products Approved by Company, 2010 96
Companies Mentioned
Johnson & Johnson
GlaxoSmithKline
Reckitt Benckiser
Bayer Healthcare AG
Procter & Gamble
Novartis
Sanofi
Boehringer Ingelheim GmbH
Merck & Co.
Pfizer
