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スイッチOTC戦略:体重管理と禁煙における新たなスイッチ機会、しかし自己医療の導入促進が課題として残る

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

発行 GBI Research 商品コード 238360
出版日 ページ情報 英文 106 Pages
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スイッチOTC戦略:体重管理と禁煙における新たなスイッチ機会、しかし自己医療の導入促進が課題として残る Rx-to-OTC Switching Strategies - New Switching Opportunities in Weight Management and Smoking Cessation, but Encouraging the Uptake of Self-Medication Remains a Challenge
出版日: 2012年04月20日 ページ情報: 英文 106 Pages
概要

当レポートでは、上位7か国におけるスイッチOTC市場のデータと分析、国別収益、市場規模、市場シェアなどの地域別状況、市場に多大な影響をもたらす主要発展/阻害要因、製品承認プロセスや規制機関の概要などの規制的状況、主要企業プロファイルを含む競合状況、などの詳細な調査・分析を盛り込み、概略下記の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 市場特性化と将来予測

  • 世界の収益別OTC市場
  • 世界の地域別OTC市場
  • 主要プレーヤ
  • 世界の治療別OTC市場
  • 欧州のOTC市場
  • 日本のOTC市場
  • 北米のOTC市場

第4章 市場発展/阻害要因

第5章 人口増加と高齢化人口

  • 新たな消費者
  • 消費者の権利拡大と教育
  • 満たされていない医療的需要
  • 製品ライフサイクル管理
  • 特許失効
  • 医療改革と政府の支援
  • 広告
  • トレンドと結論

第6章 規制状況

  • 米国の規制
  • OTC新薬申請 (NDA)
  • 欧州の規制
  • 日本の規制
  • トレンドと結論

第7章 治療分野

  • 咳、風邪、アレルギー
  • 鎮痛剤と疼痛管理
  • 胃腸薬と消化不良
  • 皮膚用薬剤
  • トレンドと結論

第8章 企業分析

第9章 OTC市場における課題と機会

  • 事業的戦略
  • スイッチOTCのモデル
  • ブランド・アイデンティティと自社ブランド
  • Behind-the-Counterの機会
  • 新興市場における機会
  • 展望

第10章 付録

図表

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: GBIHC231MR

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.

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
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