NEW YORK, April 26, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge
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Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge
SummaryGBI 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 buyThe 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.
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 What Defines an OTC Product? 8
2.2 Why do Companies Switch Rx Products OTC? 8
2.3 Which OTC Products are Currently Available? 8
2.4 What Geographical Markets Attract OTC Switching? 10
2.5 What Are the Potential New Areas For OTC Drug Development and Why? 12
2.6 GBI Research Report Guidance 13
3 Market Characterization and Forecasts 14
3.1 Global OTC Market by Revenues 14
3.2 Global OTC Market by Region 15
3.3 Global OTC Market - Key Players 16
3.4 Global OTC Market by Therapy 17
3.5 The European OTC Market 18
3.5.1 France 20
3.5.2 Germany 20
3.5.3 Italy 21
3.5.4 The UK 21
3.5.5 Other European Countries 22
3.5.6 European OTC Market Forecasts 23
3.6 Japanese OTC Market 24
3.6.1 Japanese OTC Market Forecasts 25
3.7 North American OTC Market 26
3.7.1 The US 27
3.7.2 Canada 28
3.7.3 Latin American Countries 28
3.7.4 North America OTC Market Forecasts 29
3.8 Trends and Conclusions 30
4 Market Drivers and Restraints 31
5 Growing and Aging Populations 32
5.1 Emerging Consumer 34
5.2 Consumer Empowerment and Education 35
5.3 Unmet Medical Need 36
5.4 Product Life-Cycle Management 39
5.5 Patent Expiration 41
5.6 Healthcare Reform and Government Support 42
5.7 Advertising 43
5.8 Trends and Conclusions 44
6 Regulatory Landscape 45
6.1 Regulation in the US 45
6.2 OTC New Drug Application (NDA) 46
6.2.1 OTC Drug Monograph 46
6.2.2 Labeling 46
6.2.3 Rx-to-OTC Switches 47
6.3 Regulations in Europe 48
6.3.1 Centralized Route for Drug Approval 48
6.3.2 Decentralized Procedure for drug approval 49
6.3.3 National Procedure for Drug Approval 50
6.3.4 Drug Classification in Europe 52
6.3.5 EU Harmonization 53
6.4 Regulations in Japan 54
6.5 Trends & Conclusions 57
7 Therapy Areas 58
7.1 Coughs, Colds and Allergies 59
7.1.1 Case Study: Claritin (Merck) 60
7.1.2 Case Study: Sudafed (J&J) 62
7.1.3 Case Study: Allegra (Sanofi) 62
7.1.4 OTC Respiratory Conclusions 62
7.2 Analgesics and Pain Management 63
7.2.1 Case Study: Nurofen (Reckitt Benckiser) 64
7.2.2 Case Study: Advil (Pfizer/Wyeth) 65
7.2.3 Case Study: Tylenol (McNeil/J&J) 66
7.2.4 OTC Pain Conclusions 66
7.3 Gastrointestinal Remedies and Indigestion 67
7.3.1 Case Study: Zantac (GlaxoSmithKline/Warner-Lambert) 68
7.3.2 Prilosec OTC (Proctor & Gamble/AstraZeneca) 69
7.3.3 Pantazol/Pantazol Control (Nycomed) 69
7.3.4 Gastrointestinal OTC Conclusions 70
7.4 Medicated Dermatological Products 70
7.4.1 Case Study: Lamisil (Novartis) 71
7.5 Trends and Conclusions 71
8 Company Analysis 72
8.1 Johnson & Johnson 73
8.1.1 OTC M&A activity 74
8.1.2 OTC Production Issues 74
8.2 GlaxoSmithKline 75
8.2.1 OTC Divestment 78
8.3 Reckitt Benckiser 79
8.3.1 OTC M&A Activity 80
8.4 Bayer Healthcare AG 81
8.4.1 Restructuring 82
8.4.2 Product Line Extensions 82
8.4.3 Expansion in Fast-Growing Regions 83
8.5 Procter & Gamble 83
8.5.1 Joint Venture 85
8.6 Novartis 85
8.7 Sanofi 88
8.7.1 New Product Launches 89
8.8 Boehringer Ingelheim GmbH 90
8.9 Merck & Co. 92
8.10 Pfizer 94
8.11 Trends & conclusions 95
9 Challenges and Opportunities in the OTC Market 96
9.1 Business Strategies 96
9.2 Model for Rx-to-OTC switching 96
9.3 Brand identity and private labeling 98
9.4 Behind-the-Counter Opportunities 99
9.5 Opportunities in the emerging markets 100
9.6 Outlook 100
10 Appendix 102
10.1 Key Definitions 102
10.2 Abbreviations (in alphabetical order) 102
10.3 Sources 103
10.4 Methodology 105
10.4.1 Primary Research 106
10.4.2 Secondary Research 106
10.4.3 Contacts Us 106
10.4.4 Disclaimer 107
1.1 List of TablesTable 1: Rx-to OTC Switch, Examples of OTC Drug Classes 9
Table 2: RX to OTC Switch, Global, Pharma and OTC sales ($bn), 2006-2010 10
Table 3: Rx-to OTC Switch, Leading OTC Drug Classes, 2010 11
Table 4: Rx-to OTC Switch, Global, OTC and Rx-to-OTC Sales ($bn), 2006-2010 14
Table 5: Rx-to OTC Switch, Global, OTC Sales by Region ($bn), 2006-2010 15
Table 6: Rx-to OTC Switch, Global, OTC Revenues of Top 10 Companies ($bn and %), 2010 16
Table 7: Rx-to OTC Switch, Global, OTC Sales by Therapy ($bn and %), 2010 17
Table 8: Rx to OTC Switch, Europe, OTC Sales by Region ($bn), 2006-2010 18
Table 9: Rx-to OTC Switch, Europe, OTC Sales by Region and Key Countries ($bn), 2011-2015 23
Table 10: Rx-to OTC Switch, Japan, OTC Sales ($ and JPY, bn), 2006- 2010 24
Table 11: Rx-to OTC Switch, Japan, OTC Sales (JPY bn and $bn), 2011-2015 26
Table 12: Rx-to OTC Switch, North America and Latin America OTC Market ($bn), 2006-2010 26
Table 13: Rx-to OTC Switch, North America and Latin America, OTC Sales ($bn), 2011-2015 29
Table 14: Rx-to OTC Switch, Treatment Decisions for Common Ailments 36
Table 15 Rx-to OTC Switch, Potential New Indications for Self-Medication 37
Table 16: Rx-to-OTC Switches Approved by FDA (number), 2000-2010 40
Table 17: Rx-to OTC Switch, Global, Patent Expiry of Leading Pharmaceutical Brands 41
Table 18: Rx-to OTC Switch, Comparison of NDA and OTC Monograph Processes 45
Table 19: Rx-to OTC Switch, National Regulation of Drug Classes and Their Distribution in France, Germany, Italy and the UK 52
Table 20: Rx-to OTC Switch, Japan, Amendments to PAL, 2005 55
Table 21: Rx-to-OTC Switch, Respiratory OTC Drugs by Indication (Number and %), 2005-2011 60
Table 22: Rx-to OTC Switch, Leading Retailer OTC Brands to Treat Coughs, Colds and Allergies 61
Table 23 Rx-to-OTC Switch, Analgesic and Pain Management OTC Drugs by Indication (Number and %), 2005-2011 63
Table 24 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat Pain 64
Table 25 Rx-to-OTC Switch, Gastrointestinal and Indigestion OTC Drugs by Indication (Number and %), 2005-2011 67
Table 26 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat GI Conditions 68
Table 27 Rx-to OTC Switch, Indications for Medicated Dermatological OTC Products, 2010 70
Table 28 Rx-to OTC Switch, Leading Retailer OTC Brands To Treat Dermatological Conditions 71
Table 29 Rx-to OTC Switch, Global Leading OTC Companies, 2010 72
Table 30 Rx-to OTC Switch, Johnson & Johnson Leading OTC Products, 2010 74
Table 31 Rx-to OTC Switch, GlaxoSmithKline's Revenue by Business Segment ($m), 2010 75
Table 32: Rx-to OTC Switch, GlaxoSmithkline Leading OTC Products, 2010 77
Table 33: Rx-to OTC Switch, OTC Products Identified For Divestment By GSK, 2011 78
Table 34: Rx-to OTC Switch, Reckitt Benckiser Regional Revenues ($m), 2010 80
Table 35: Rx-to OTC Switch, Reckitt Benckiser Leading OTC Products, 2010 80
Table 36: Rx-to OTC Switch, Bayer HealthCare Revenues ($m), 2010 81
Table 37: Rx-to OTC Switch, Bayer Healthcare Leading OTC Products, 2010 82
Table 38: Rx-to OTC Switch, Proctor & Gamble Leading OTC Products, 2011 84
Table 39: Rx-to OTC Switch, Novartis HealthCare Revenues ($m), 2010 86
Table 40: Rx-to OTC Switch, Novartis Leading OTC Products, 2010 87
Table 41: Rx-to OTC Switch, Boehringer Ingelheim Leading OTC Products, 2010 91
Table 42: Rx-to OTC Switch, Merck & Co.s Leading OTC Products, 2010 92
Table 43: Rx-to OTC Switch, Pfizer's leading OTC Products, 2010 94
Table 44: Rx-to OTC Switch, Profit Margins on Private Labels vs. National Brands 98
Table 45: Rx-to OTC Switch, Examples of BTC products, 2010 99
1.2 List of FiguresFigure 1: Rx-to OTC Switch, Global, OTC Market Revenues by Region (%), 2010 10
Figure 2: Rx-to OTC Switch, Sales Growth Of The OTC Market by Region (%), 2010 11
Figure 3: Rx-to OTC Switch, Leading Pharmaceutical Company Product Switches (Number), 2001-2011 12
Figure 4: Rx-to OTC Switch, Global Rx-to-OTC Sales by Region, (%), 2010 15
Figure 5: Rx to OTC Switch, Global, OTC Sales by Company (%), 2010 16
Figure 6: Rx-to OTC Switch, Global, OTC Sales by Therapy (%), 2010 17
Figure 7: Rx-to OTC Switch, Europe, OTC Sales by Region (%), 2010 18
Figure 8: Rx-to OTC Switch, Western Europe, OTC Expenditure Per Capita ($), 2010 19
Figure 9: Rx to OTC Switch, Sales Of Non-Prescription Drugs Used for Self-Medication (%), 2010 19
Figure 10: Rx-to OTC Switch, Central and Eastern Europe, OTC Expenditure Per Capita ($), 2010 22
Figure 11: Rx-to OTC Switch, Japan, OTC Drug Market by Category (%), March 31, 2011* 25
Figure 12: Rx-to OTC Switch, North America and Latin America, Sales by Region (%), 2010 26
Figure 13: Rx-to OTC Switch, North America, OTC Sales by Category (%), 2010 27
Figure 14: Rx-to OTC Switch, Market Drivers & Restraints for OTC Growth, 2011 31
Figure 15: Rx-to OTC Switch, Population Change by Region (millions), 2010 to 2100 32
Figure 16: Rx to OTC Switch, Global, Proportion of the Population Over 60 (%), 2010, 2025, 2050 33
Figure 17: Rx-to OTC Switch, Proportion of the Population Over 60 (million), 2010–2100 34
Figure 18: Rx-to OTC Switch, Emerging Economies, New Opportunities by Consumer Income Group, 2008–2018 35
Figure 19: Rx-to OTC Switch as an Integral Part of Product Line Extension 39
Figure 20: Rx-to-OTC Switches Approved by FDA (%), 2000-2010 40
Figure 21: Rx-to OTC Switch, Schematic of the Centralized Procedure 48
Figure 22: Rx-to OTC Switch, Schematic of the Decentralized Procedure 49
Figure 23: Rx-to OTC Switch, Schematic of the National Procedure 50
Figure 24: Rx-to OTC Switch, Data Exclusivity For Rx-to-OTC Switch Cycle 51
Figure 25: Rx-to OTC Switch, Criteria to Switch a Drug from a POM to P Status in the UK 53
Figure 26: Rx-to OTC Switch, MHLW Vision OTC Medicines and Generics Will Stimulate Future Pharmaceutical Growth 56
Figure 27: Rx-to OTC Switch, Top 20 Aliments for Self-Medication 58
Figure 28: Rx-to OTC Switch, Global, OTC Sales by Category (%), 2010 59
Figure 29: Rx-to OTC Switch, Johnson & Johnson Global Revenues (%), 2010 73
Figure 30: Rx-to OTC Switch, Johnson & Johnson Consumer Healthcare Revenues (%), 2010 73
Figure 31: Rx-to OTC Switch, GlaxoSmithKline's Revenue by Business Segment (%), 2010 75
Figure 32: Rx-to OTC Switch, GlaxoSmithKline Consumer Healthcare Revenues (%), 2010 76
Figure 33: Rx-to OTC Switch, Reckitt Benckiser Revenues (%), 2010 79
Figure 34: Rx-to OTC Switch, Reckitt Benckiser Regional Revenues, 2010 (%)* 79
Figure 35: Rx-to OTC Switch, Bayer HealthCare Revenues (%), 2010 81
Figure 36: Rx-to OTC Switch, Proctor & Gamble Global Revenues (%), 2011 83
Figure 37: Rx-to OTC Switch, Proctor & Gamble Regional Revenues (%), 2011 84
Figure 38: Rx-to OTC Switch, Novartis Revenues (%), 2010 85
Figure 39: Rx-to OTC Switch, Novartis HealthCare Revenues (%), 2010 86
Figure 40: Rx-to OTC Switch, Sanofi Revenues (%), 2010 88
Figure 41: Rx-to OTC Switch, Sanofi Regional Revenues (%), 2010 88
Figure 42: Rx-to OTC Switch, Boehringer Ingelheim Revenues (%), 2010 90
Figure 43: Rx-to OTC Switch, Boehringer Ingelheim Consumer Healthcare Regional Revenues (%), 2010 91
Figure 44: Rx-to OTC Switch, Merck & Co. Revenues (%), 2010 92
Figure 45: Rx-to OTC Switch, Merck Consumer Healthcare Revenues (%), 2010 93
Figure 46: Rx-to OTC Switch, Pfizer Global Revenues (%), 2010 94
Figure 47: Rx-to OTC Switch, Number of Products Approved by Company, 2010 97
Companies mentionedJohnson & Johnson
GlaxoSmithKline
Reckitt Benckiser
Bayer Healthcare AG
Procter & Gamble
Novartis
Sanofi
Boehringer Ingelheim GmbH
Merck & Co.
Pfizer
Trends & conclusions
To order this report:Over-The-Counter Drug Industry: Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge
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