2014

Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge

NEW YORK, Feb. 7, 2013 /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
http://www.reportlinker.com/p0845628/Rx-to-OTC-Switching-Strategies---New-Switching-Opportunities-in-Weight-Management-and-Smoking-Cessation-but-Encouraging-the-Uptake-of-Self-Medication-Remains-a-Challenge.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Over-The-Counter_Drug

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 aging 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.

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

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

Contact Clare: clare@reportlinker.com
US:(339) 368 6001
Intl:+1 339 368 6001

SOURCE Reportlinker



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