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World otc pharmaceutical market 2013 2023

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For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website: …

For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website: http://www.visiongain.com/Report/1125/World-OTC-Pharmaceutical-Market-2013-2023

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  • 1. World OTC Pharmaceutical Market 2013-2023 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  • 2. Contents 1.1. Executive Summary Executive Summary 1.1 Overview of Findings 1.2 Structure of the Report 1.3 Research and Analysis Methods 2.2. Introduction to OTC Pharmaceuticals Introduction to OTC Pharmaceuticals 2.1 What are OTC Pharmaceuticals? 2.2 Classification of OTC Pharmaceuticals 2.3 The Main Features of OTC Pharmaceuticals 2.4 OTC Switching 2.4.1 How is a Drug Switched from Prescription to OTC? 2.5 Manufacturing and Distribution of OTC Pharmaceuticals 2.6 Regulation of OTC Pharmaceuticals 2.6.1 Regulation of OTC Pharmaceuticals in the US 2.6.2 Regulation of OTC Pharmaceuticals in Japan 2.6.3 Regulation of OTC Pharmaceuticals in Europe 2.6.4 Regulation of OTC Pharmaceuticals in Other Countries 2.7 OTC Pharmaceuticals: Market Segmentation 2.7.1 Analgesics 2.7.1.1 Internal Analgesics 2.7.1.2 External Analgesics 2.7.2 Cough, Cold and Allergy Products 2.7.2.1 Cough and Cold Remedies 2.7.2.2 Anti-Allergy Products www.visiongain.com
  • 3. Contents 2.7.3 Dermatological Products 2.7.3.1 Minor Cuts and Wounds 2.7.3.2 Acne 2.7.3.3 Rashes, Itchy Skin, and Dermatitis/Eczema 2.7.3.4 Cold Sores 2.7.3.5 Warts 2.7.3.6 Fungal Skin Infections 2.7.3.7 Haemorrhoids 2.7.3.8 Other Dermatological Products 2.7.4 Gastrointestinal Products 2.7.4.1 Indigestion and Heartburn 2.7.4.2 Anti-Diarrhoea OTC Pharmaceuticals 2.7.4.3 Laxatives 2.7.4.4 Anti-Emetic OTC Pharmaceuticals 2.7.4.5 Anti-Obesity OTC Pharmaceuticals 2.7.5 Smoking Cessation Aids 2.7.6 Other OTC Pharmaceuticals 2.7.7 Vitamins, Minerals and Supplements 3.3. The World OTC Pharma Market 2013-2023 The World OTC Pharma Market 2013-2023 3.1 The World OTC Pharma Market in 2012 3.1.1 OTC Pharma Market Segmentation, 2012 3.1.2 Leading OTC Pharma Brands, 2012 3.1.3 Leading Companies in the OTC Market, 2012 www.visiongain.com
  • 4. Contents 3.2 The World OTC Pharma Market: Sales Forecast, 2013-2023 3.3 OTC Pharma Market Segments: Sales Forecasts, 2013-2023 3.3.1 CAGRs by OTC Segment, 2013-2023 3.3.2 Changing Market Shares by OTC Segment, 2013-2023 3.3.3 Cough, Cold and Allergy Drugs Lead the OTC Market 3.3.4 Analgesic OTC Drugs: Moderate Growth 3.3.5 Gastrointestinal OTC Drugs: Steady Growth 3.3.6 Dermatological OTC Drugs: Strong Growth 3.3.7 Smoking Cessation Aids Will Grow in Emerging Markets 3.3.8 OTC Switching Will Create New OTC Markets 4.4. The Leading National Markets 2013-2023 The Leading National Markets 2013-2023 4.1 Regional Breakdown of the World OTC Pharma Market, 2012 4.2 The World OTC Pharmaceutical Market: Regional Forecast, 2013-2023 4.3 Changing Market Shares of Leading National Markets, 2013-2023 4.4 The OTC Pharmaceutical Market in the US, 2013-2023 4.4.1 The US OTC Pharma Market: Leading Companies 4.5 The OTC Pharmaceutical Market in Japan to 2023 4.5.1 The Japanese OTC Pharma Market: Leading Companies 4.6 The OTC Pharmaceutical Market in China to 2023 4.6.1 The Chinese OTC Pharma Market: Leading Companies 4.6.2 The Chinese OTC Pharma Market: An Overview 4.6.3 The Chinese OTC Pharma Market: Regulation and Reimbursement 4.7 The OTC Pharmaceutical Market in the Five Leading European National Markets to 2023 www.visiongain.com
  • 5. Contents 4.7.1 The EU5 OTC Pharma Market: Leading Companies 4.7.2 The OTC Pharmaceutical Market in Germany to 2023 4.7.3 The OTC Pharmaceutical Market in the UK to 2023 4.7.4 The OTC Pharmaceutical Market in France to 2023 4.7.5 The OTC Pharmaceutical Market in Italy to 2023 4.7.6 The OTC Pharmaceutical Market in Spain to 2023 4.8 The OTC Pharmaceutical Market in Russia to 2023 4.8.1 The Russian OTC Pharma Market: Leading Companies 4.8.2 The Russian OTC Pharma Market: Overview 4.9 The OTC Pharmaceutical Market in India to 2023 4.9.1 The Indian OTC Pharma Market: Leading Companies 4.9.2 The Indian OTC Pharma Market: An Overview 4.10 The OTC Pharmaceutical Market in Brazil to 2023 4.10.1 The Brazilian OTC Pharma Market: Leading Companies 4.10.2 The Brazilian OTC Pharma Market: An Overview 5.5. Leading Companies in the OTC Pharma Market 2013-2023 Leading Companies in the OTC Pharma Market 2013-2023 5.1 Leading OTC Pharmaceutical Manufacturers, 2012 5.2 Leading OTC Pharma Companies: Sales Forecasts, 2013-2023 5.3 Bayer 5.3.1 Bayer: OTC Sales Forecast, 2013-2023 5.3.2 Bayer Aspirin 5.3.2.1 Bayer Aspirin: Sales Forecast, 2013-2023 5.4 Boehringer Ingelheim www.visiongain.com
  • 6. Contents 5.4.1 Boehringer Ingelheim: OTC Sales Forecast, 2013-2023 5.4.2 The Dulcolax Franchise 5.4.3 Mucosolvan/Lasolvan and Other OTC Products 5.5 GSK 5.5.1 GSK: OTC Sales Forecast, 2013-2023 5.5.2 Panadol 5.5.2.1 Panadol: Sales Forecast, 2013-2023 5.5.3 Alli 5.5.4 GSK Smoking Cessation Products 5.6 Johnson & Johnson 5.6.1 FDA Governance of McNeil Manufacturing Activity 5.6.2 Expansion in Developing Markets through Acquisitions 5.6.3 Johnson & Johnson: OTC Sales Forecast, 2013-2023 5.6.4 Tylenol 5.6.4.1 Tylenol: Sales Forecast, 2013-2023 5.6.5 Nicorette 5.7 Merck 5.7.1 Merck: OTC Sales Forecast, 2013-2023 5.7.2 Merck Withdraws from Joint Venture with Johnson & Johnson 5.7.3 FDA Approval of First-in-Class Switch: Oxytrol for Women 5.7.4 Claritin OTC (loratadine) 5.7.4.1 Claritin OTC: Sales Forecast, 2013-2023 5.8 Novartis 5.8.1 Novartis: OTC Sales Forecast, 2013-2023 www.visiongain.com
  • 7. Contents 5.8.2 Resolving Manufacturing Problems at Lincoln, Nebraska 5.9 Perrigo 5.9.1 Perrigo: OTC Sales Forecast, 2013-2023 5.9.2 Perrigo is Focused on Organic and Inorganic Growth 5.9.3 Perrigo’s Product Launches in FY 2013 5.9.4 Perrigo Benefits from Challenges Faced in the Industry 5.10 Pfizer 5.10.1 Pfizer: OTC Sales Forecast, 2013-2023 5.10.2 Pfizer Acquires Rights to AstraZeneca’s OTC Nexium 5.10.3 Pfizer Continues to Expand via Consumer Health Acquisitions 5.10.4 Advil 5.10.4.1 Advil: Sales Forecast, 2013-2023 5.11 Procter & Gamble 5.11.1 PGT Healthcare – Procter & Gamble’s Joint Venture with Teva 5.11.2 Prilosec OTC 5.12 Reckitt Benckiser 5.12.1 Reckitt Benckiser: OTC Sales Forecast, 2013-2023 5.12.2 Purchase of Paras Pharmaceuticals and Expansion into Developing Markets 5.13 Sanofi 5.13.1 Sanofi: OTC Sales Forecast, 2013-2023 5.13.2 Sanofi: Consumer Health Acquisitions 5.14 Taisho Pharmaceutical www.visiongain.com
  • 8. Contents 6.6. OTC Switching and Prospects for Future OTC Drugs OTC Switching and Prospects for Future OTC Drugs 6.1 OTC Switching: An Overview 6.1.1 What is OTC Switching? 6.1.2 Which Products Will Switch? 6.1.3 How Does OTC Switching Occur? 6.1.4 How Does OTC Switching Affect The OTC Pharma Market? 6.1.5 Opposition to OTC Switching 6.2 Recent OTC Switching Activity 6.2.1 A Decline in OTC Switching? 6.2.2 The FDA NSURE Paradigm May Increase OTC Switch Rates 6.3 Prospects for OTC Switching, 2013-2023 6.4 Cough, Cold and Allergy: OTC Switches 6.4.1 First-Generation Antihistamines 6.4.2 Allegra (fexofenadine) 6.4.3 Clarinex (desloratadine) 6.4.4 Flixotide/Flonase (fluticasone) 6.4.5 Nasacort (triamcinolone) 6.5 Analgesics: OTC Switches 6.5.1 Triptans 6.5.2 NSAIDs for Arthritis 6.5.3 Other Analgesics 6.6 Gastrointestinals: OTC Switches 6.6.1 H2-Receptor Blockers 6.6.2 Proton pump inhibitors (PPIs) www.visiongain.com
  • 9. Contents 6.6.2.1 Omeprazole 6.6.2.2 Lansoprazole 6.6.2.3 Pantoprazole 6.6.2.4 Esomeprazole 6.6.2.5 Rabeprazole 6.6.3 Anti-obesity drugs 6.7 Dermatologicals: OTC Switches 6.7.1 Antivirals for Oral Herpes Simplex 6.8 Anticholinergics for Incontinence: OTC Switches 6.9 Oral Contraceptives: OTC Switches 6.10 Cholesterol-Lowering Drugs: OTC Switches 6.10.1 Lipitor (atorvastatin) 6.10.2 Zocor Heart Pro (simvastatin) in the UK 6.10.3 Prospects for OTC Statins in the US 6.10.4 Worldwide Prospects for OTC Statins 6.11 Other Potential OTC Switch Categories 6.11.1 Erectile Dysfunction: Viagra (sildenafil) 6.11.2 Insomnia: Silenor (doxepin) 6.11.3 High blood pressure: thiazide diuretics 7.7. Qualitative Analysis of the OTC Pharma Market, 2013 Qualitative Analysis of the OTC Pharma Market, 2013 7.1 SWOT Analysis of the OTC Pharmaceutical Market 7.2 Strengths 7.2.1 Many Pharma Companies Have a Strong Potential OTC Portfolio www.visiongain.com
  • 10. Contents 7.2.2 Regulators Are Encouraging OTC Approvals 7.2.3 Effective Distribution Networks Due to Expansion of Retail Pharmacy and Alternative Distributors 7.2.4 Cultural Changes Will Support Self-Medication With OTC Medicines 7.3 Weaknesses 7.3.1 Pharma Companies Remain Focused on Prescription Drugs 7.3.2 Manufacturing Problems Affect Sales of Some OTC Products 7.3.3 OTC Products are Vulnerable to Price Controls 7.4 Opportunities 7.4.1 Demographic and Economic Changes Will Create Growth Opportunities 7.4.2 OTC Switching Will Create New Markets and Expand Existing Markets 7.4.3 Strong Growth in Emerging Markets 7.4.4 New Healthcare Technologies May Enable OTC Approvals 7.4.5 Opportunities in Social Media and Online Marketing 7.5 Threats 7.5.1 Competition From Private-Label Brands Will Reduce Profits 7.5.2 Regulatory Concerns May Lead to Withdrawal of Products 7.5.3 Resistance to OTC Switching From Some Groups 7.6 Porter’s Five Forces Analysis of the OTC Pharmaceutical Market 7.7 Rivalry Among Competitors [High] 7.8 Threat of New Entrants [Medium] 7.9 Power of Suppliers [Low] 7.10 Power of Buyers [Medium] 7.11 Threat of Substitutes [High] www.visiongain.com
  • 11. Contents 8.8. Research Interviews Research Interviews 8.1 Interview with Mr David Spangler, Senior Vice President, US Consumer Health Products Association, Washington DC, USA 8.1.1 A Decline In OTC Switches? 8.1.2 How will NSURE affect the OTC pharma market? 8.1.3 Prospects for a Behind-the-Counter Class of OTC Drugs in the US 8.1.4 Is OTC Big Pharma’s New Business Model? 8.1.5 Future OTC Switches 8.1.6 How Will US Healthcare Reform Affect the OTC Pharma Market? 8.1.7 New Distribution Channels 8.1.8 Development of the OTC Sector 8.2 Interview with Professor Joshua P. Cohen, PhD, Tufts Center for the Study of Drug Development, Boston, Massachusetts, USA 8.2.1 How will NSURE affect the OTC pharma market? 8.2.2 Will Statins Switch to OTC in the US? 8.2.3 Prospects for a Behind-the-Counter Class of OTC Drugs in the US 8.2.4 Is OTC Big Pharma’s New Business Model? 8.2.5 Future OTC Switches 8.2.6 How Will US Healthcare Reform Affect the OTC Pharma Market? 8.2.7 New Distribution Channels 8.3 Interview with Professor Daniel Hussar, Remington Professor of Pharmacy, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, USA 8.3.1 How will NSURE affect the OTC pharma market? 8.3.2 A Decline In OTC Switches? 8.3.3 Prospects for a Behind-the-Counter Class of OTC Drugs in the US www.visiongain.com
  • 12. Contents 8.3.4 How Will US Healthcare Reform Affect the OTC Pharma Market? 8.3.5 Is OTC Big Pharma’s New Business Model? 8.3.6 Future OTC Switches 8.3.7 New Distribution Channels 8.3.8 Development of the OTC Sector 9.9. Conclusions Conclusions 9.1 The World OTC Pharma Market in 2012 9.1.1 Leading OTC Product Categories 9.1.2 Leading OTC Pharma Brands, 2012 9.1.3 Leading OTC Pharmaceutical Manufacturers 9.1.4 Leading National Markets 9.1.5 OTC Market Growth 9.1.6 OTC Switching 9.1.7 Emerging OTC Markets 9.2 The Future of the OTC Pharma Market? www.visiongain.com
  • 13. Contents List of Tables Table 2.1 OTC Internal Analgesic Active Ingredients, 2013 Table 2.2 OTC External Analgesic Active Ingredients, 2013 Table 2.3 OTC Cough, Cold and Allergy Active Ingredients, 2013 Table 2.4 OTC Antifungal Active Ingredients, 2013 Table 2.5 OTC Indigestion and Heartburn Active Ingredients, 2013 Table 2.6 OTC Anti-Diarrhoea Active Ingredients, 2013 Table 2.7 OTC Laxative Active Ingredients, 2013 Table 2.8 OTC Smoking Cessation Aid Active Ingredients, 2013 Table 3.1 The World OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by Product Category, 2012 Table 3.2 Top 10 OTC Pharmaceutical Products: Revenues ($m), 2012 Table 3.3 Top 10 OTC Pharmaceutical Manufacturers: Revenues ($bn) and Market Shares (%), 2012 Table 3.4 The World OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122023 Table 3.5 The World OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Product Category, 2012-2023 Table 3.6 The World OTC Pharmaceutical Market: CAGR (%) by Product Category, 2012-2017, 2017-2023 and 2012-2023 Table 3.7 Market Shares (%) of the OTC Pharmaceutical Market, By Category, 2012, 2017 and 2023 Table 3.8 The Cough, Cold and Allergy OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 www.visiongain.com
  • 14. Contents Table 3.9 The Analgesics OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 3.10 The Gastrointestinals OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 3.11 The Dermatologicals OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 3.12 The Smoking Cessation Aids OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 3.13 The Other Products OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.1 The World OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by Region, 2012 Table 4.2 The World OTC Pharmaceutical Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Region, 2012-2017 Table 4.3 The World OTC Pharmaceutical Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Region, 2017-2023 Table 4.4 Regional OTC Pharmaceutical Market Forecast: CAGR (%), 2012-2017, 2017-2023 and 2012-2023 Table 4.5 Market Shares (%) of the Leading Regional OTC Pharmaceutical Markets, 2012, 2017 and 2023 Table 4.6 The US OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122023 Table 4.7 Top 10 US OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 4.8 The Japanese OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.9 Top 10 Japanese OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 www.visiongain.com
  • 15. Contents Table 4.10 The Chinese OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.11 Top 10 Chinese OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 4.12 The EU5 OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122023 Table 4.13 The EU5 OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by National Market, 2012 Table 4.14 The EU5 OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by National Market, 2018 Table 4.15 The EU5 OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by National Market, 2023 Table 4.16 Selected EU5 OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 4.17 The German OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.18 The UK OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122023 Table 4.19 The French OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.20 The Italian OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.21 The Spanish OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.22 The Russian OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 www.visiongain.com
  • 16. Contents Table 4.23 Top 8 Russian OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 4.24 The Indian OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.25 Top 10 Indian OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 4.26 The Brazilian OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 Table 4.27 Top 5 Brazilian OTC Pharma Companies: OTC Revenues ($m), Net Revenues ($m), 2012 Table 5.1 Top 10 OTC Pharmaceutical Manufacturers: Revenues ($bn) and Market Shares (%), 2012 Table 5.2 The World OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Leading Company, 2012-2023 Table 5.3 Bayer: Overview, 2012 Table 5.4 Bayer OTC Brands, 2013 Table 5.5 Bayer: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.6 Bayer Aspirin: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.7 Boehringer Ingelheim: Overview, 2012 Table 5.8 Boehringer Ingelheim OTC Brands, 2013 Table 5.9 Boehringer Ingelheim: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.10 GSK: Overview, 2012 Table 5.11 GSK OTC Brands, 2013 Table 5.12 GSK: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.13 Panadol OTC Products, 2013 Table 5.14 Panadol: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 www.visiongain.com
  • 17. Contents Table 5.15 Nicorette OTC Products, 2013 Table 5.16 Johnson & Johnson: Overview, 2012 Table 5.17 Johnson & Johnson OTC Brands, 2013 Table 5.18 Johnson & Johnson: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.19 Tylenol OTC Products, 2013 Table 5.20 Johnson & Johnson: Tylenol Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.21 Nicorette OTC Products, 2013 Table 5.22 Merck: Overview, 2012 Table 5.23 Merck OTC Brands, 2013 Table 5.24 Merck: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.25 Claritin OTC: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.26 Novartis: Overview, 2012 Table 5.27 Novartis OTC Brands, 2013 Table 5.28 Novartis: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.29 Perrigo: Overview, 2012 Table 5.30 Perrigo: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.31 Pfizer: Overview, 2012 Table 5.32 Pfizer OTC Brands, 2013 Table 5.33 Pfizer: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.34 Advil OTC Products, 2013 Table 5.35 Advil: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.36 Procter & Gamble: Overview, 2012 Table 5.37 Reckitt Benckiser: Overview, 2012 Table 5.38 Reckitt Benckiser: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 www.visiongain.com
  • 18. Contents Table 5.39 Sanofi: Overview, 2012 Table 5.40 Sanofi OTC Brands, 2013 Table 5.41 Sanofi: OTC Sales Forecast ($m), AGR (%), CAGR (%), 2012-2023 Table 5.42 Taisho Pharmaceutical: Overview, 2012 Table 6.1 US OTC Switches By Manufacturer, 2002-2012 Table 6.2 Potential Cough, Cold and Allergy OTC Switches By Active Ingredient, 2013-2023 Table 6.3 Potential Analgesics OTC Switches By Active Ingredient, 2013-2023 Table 6.4 Potential Gastrointestinals OTC Switches By Active Ingredient, 2013-2023 Table 6.5 Potential Dermatologicals OTC Switches By Active Ingredient, 2013-2023 Table 7.1 SWOT Analysis of the OTC Pharmaceutical Market, 2013 Table 7.2 World Population Forecast: Size (bn), AGR (%), CAGR (%), 2013-2023 www.visiongain.com
  • 19. Contents List of Figures Figure 2.1 The OTC Pharmaceutical Supply Chain, 2013 Figure 3.1 The World OTC Pharmaceutical Market: Market Shares (%) by Product Category, 2012 Figure 3.2 The World OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 3.3 The World OTC Pharmaceutical Market: CAGR (%) by Product Category, 2012-2017 Figure 3.4 The World OTC Pharmaceutical Market: CAGR (%) by Product Category, 2017-2023 Figure 3.5 The World OTC Pharmaceutical Market: CAGR (%) by Product Category, 2012-2023 Figure 3.6 The World OTC Pharmaceutical Market: Market Shares (%) by Product Category, 2017 Figure 3.7 The World OTC Pharmaceutical Market: Market Shares (%) by Product Category, 2023 Figure 3.8 The Cough, Cold and Allergy OTC Pharma Market Forecast: Revenues ($bn), 20122023 Figure 3.9 The Analgesics OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 3.10 The Gastrointestinals OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 3.11 The Dermatologicals OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 3.12 The Smoking Cessation Aids OTC Pharma Market Forecast: Revenues ($bn), 20122023 Figure 3.13 The Other Products OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.1 The World OTC Pharmaceutical Market: Revenues ($bn) by Region, 2012 Figure 4.2 The World OTC Pharmaceutical Market: Market Shares (%) by Region, 2012 Figure 4.3 The World OTC Pharmaceutical Market Forecast: CAGR (%), 2012-2017 Figure 4.4 The World OTC Pharmaceutical Market Forecast: CAGR (%), 2017-2023 www.visiongain.com
  • 20. Contents Figure 4.5 The World OTC Pharmaceutical Market Forecast: CAGR (%), 2012-2023 Figure 4.6 The World OTC Pharmaceutical Market: Market Shares (%) by Region, 2017 Figure 4.7 The World OTC Pharmaceutical Market: Market Shares (%) by Region, 2023 Figure 4.8 The US OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.9 The Japanese OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.10 The Chinese OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.11 The EU5 OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.12 The EU5 OTC Pharma Market Forecast: Revenues ($bn), By National Market, 20122023 Figure 4.13 The EU5 OTC Pharmaceutical Market: Market Shares (%) by National Market, 2012 Figure 4.14 The EU5 OTC Pharmaceutical Market: Market Shares (%) by National Market, 2018 Figure 4.15 The EU5 OTC Pharmaceutical Market: Market Shares (%) by National Market, 2023 Figure 4.16 The German OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.17 The UK OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.18 The French OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.19 The Italian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.20 The Spanish OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.21 The Russian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.22 The Indian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 4.23 The Brazilian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 5.1 Leading OTC Pharmaceutical Manufacturers by Market Share (%), 2012 Figure 5.2 Bayer: OTC Sales Forecast ($m), 2012-2023 Figure 5.3 Bayer Aspirin: OTC Sales Forecast ($m), 2012-2023 Figure 5.4 Boehringer Ingelheim: OTC Sales Forecast ($m), 2012-2023 Figure 5.5 GSK: OTC Sales Forecast ($m), 2012-2023 www.visiongain.com
  • 21. Contents Figure 5.6 Panadol: OTC Sales Forecast ($m), 2012-2023 Figure 5.7 Johnson & Johnson: OTC Sales Forecast ($m), 2012-2023 Figure 5.8 Johnson & Johnson: Tylenol Sales Forecast ($m), 2012-2023 Figure 5.9 Merck: OTC Sales Forecast ($m), 2012-2023 Figure 5.10 Claritin OTC: OTC Sales Forecast ($m), 2012-2023 Figure 5.11 Novartis: OTC Sales Forecast ($m), 2012-2023 Figure 5.12 Perrigo: OTC Sales Forecast ($m), 2012-2023 Figure 5.13 Pfizer: OTC Sales Forecast ($m), 2012-2023 Figure 5.14 Advil: OTC Sales Forecast ($m), 2012-2023 Figure 5.15 Reckitt Benckiser: OTC Sales Forecast ($m), 2012-2023 Figure 5.16 Sanofi: OTC Sales Forecast ($m), 2012-2023 Figure 6.1 Number Of FDA-Approved OTC Switches, By Year, 1976-2013 Figure 6.2 Number Of FDA-Approved OTC Switches, By 5-Year Periods, 1976-2013 Figure 7.1 World Population Forecast: Size (bn), 2013-2023 Figure 7.2 World 65+ Population Forecast: Size (m), 2013-2023 Figure 7.3 Porter’s Five Forces Analysis of the OTC Pharmaceutical Market, 2013 Figure 9.1 The World OTC Pharmaceutical Market: Revenues ($bn) by Product Category, 2012 Figure 9.2 The World OTC Pharmaceutical Market: Revenues ($bn) by Region, 2012 Figure 9.3 The World OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 Figure 9.4 World Population Forecast: Size (bn), 2013-2023 Figure 9.5 World 65+ Population Forecast: Size (m), 2013-2023 www.visiongain.com
  • 22. Contents Organisations Mentioned in This Report Aché Laboratórios Farmacêuticos Actavis Adams Respiratory Therapeutics AFIPA (France) Agis Industries (subsidiary of Perrigo) Akrikhin Alacer (acquired by Pfizer) Alcon (subsidiary of Novartis) Allergan Alliance Boots American Medical Association American Pharmacists Association American Society of Association Executives American Society of Health-System Pharmacists Amerisource Bergen Arena Pharmaceuticals Ascherm B.F. & Company Aspen Pharmacare Association of the European Self-Medication Industry (AESGP) Astellas Pharma AstraZeneca Aurobindo Aventis (now part of Sanofi) www.visiongain.com
  • 23. Contents Bayer Ben Venue Laboratories (subsidiary of Boehringer Ingelheim) Biofermin Pharmaceutical (subsidiary of Taisho) BMP Sunstone (acquired by Sanofi) Boehringer Ingelheim Brazilian Health Surveillance Agency (ANVISA) Bristol-Myers Squibb Candem Pharma (acquired by Sanofi) Cardinal Health Celesio Chattem (subsidiary of Sanofi) Chiese Farmaceutici China Resources Sanjiu Pharmaceutical Chiron Corporation (subsidiary of Novartis) CIBA VISION (subsidiary of Novartis) Cilag GmbH (subsidiary of Johnson & Johnson) Cipla CISCA (Compania Internacional de Comercio, S.A.P.I. de C.V.) (acquired by Taisho) Consumer Health Products Association (CHPA) Costco CSPC (China Shijiazhuang Pharmaceutical Group) CVS Daiichi Sankyo Dalkhimpharm www.visiongain.com
  • 24. Contents Department of Health and Human Services (US) Dexcel Pharma District of Columbia Bar Dollar General Dr. Reddy's Laboratories Drug Information Association Duramed Pharmaceuticals (acquired by Teva) Eisai Elan (acquired by Perrigo) Eli Lilly and Company EMS Eurofarma European Medicines Agency (EMA) Facebook Federal Trade Commission Ferrosan (consumer healthcare division acquired by Pfizer) Fosun Pharma Fougera Pharmaceuticals (subsidiary of Novartis) French Ministry of Health Galderma Galpharm Healthcare (subsidiary of Perrigo) German Ministry of Health Gillette (subsidiary of Procter & Gamble) Golong Medicine (acquired by Reckitt Benckiser) www.visiongain.com
  • 25. Contents GSK Guangzhou Pharmaceutical Harbin Pharmaceutical Group Hisamitsu Hoepharma Holdings (subsidiary of Taisho) Human Genome Sciences (subsidiary of GSK) Hypermarcas INSIGHT Pharmaceuticals (formerly Heritage Brands) Ipca Laboratories Janssen Pharmaceutica (subsidiary of Johnson & Johnson) JB Chemicals and Pharmaceuticals Jenapharm (subsidiary of Bayer) Johnson & Johnson Kangmei Pharmaceutical Kernpharm (acquired by Sanofi) Kowa Group Laboratoire Oenobiol (acquired by Sanofi) Laboratorios Diba Leonard Davis Institute for Health Economics Lion Corporation L'Oréal Lupin Limited Mankind Pharma Marico www.visiongain.com
  • 26. Contents Materia Medica McKesson Corporation McNeil Consumer Healthcare (subsidiary of Johnson & Johnson) Medicines and Healthcare Products Regulatory Agency (MHRA) (UK) Menarini Group Merck & Co. (Merck) Merck Consumer Pharmaceuticals Co. (subsidiary of Johnson & Johnson) Ministry of Health (China) Ministry of Health, Labour and Welfare (MHLW) (Japan) Ministry of Human Resources and Social Security (MOHRSS) (China) Minsheng Pharmaceuticals (acquired by Sanofi) Mitsubishi Tanabe Pharma Mylan National Development and Reform Commission (China) National Health Service (NHS) (UK) National Pharmaceutical Pricing Authority (NPPA) (India) Nepentes (acquired by Sanofi) Nepstar Nichi-Iko Pharmaceutical Co. North China Pharmaceutical Novartis Nycomed (acquired by Takeda) Obolensk Omega Pharma www.visiongain.com
  • 27. Contents Orion Laboratories (subsidiary of Perrigo) Otsuka Pharmaceutical Paras Pharmaceuticals (acquired by Reckitt Benckiser) Pernix Perrigo Pfizer Pharmstandard Philadelphia College of Pharmacy Phoenix Pierre Fabre Prestige Brands Procter & Gamble Purdue Pharma Ranbaxy Laboratories (subsidiary of Daiichi Sankyo) Ratiopharm (acquired by Teva) Reckitt Benckiser Recordati Roche Roche Consumer Health (acquired by Bayer) Rohto Pharmaceutical Roxane Laboratories (subsidiary of Boehringer Ingelheim) Sam's Club Sandoz (subsidiary of Novartis) Sanofi www.visiongain.com
  • 28. Contents Sanofi Pasteur (subsidiary of Sanofi) Sato Pharmaceutical Schering AG (acquired by Bayer) Schering-Plough (subsidiary of Merck) Schiff Nutrition (acquired by Reckitt Benckiser) Sepracor Sergeant's (acquired by Perrigo) Shanghai Pharmaceuticals Shionogi Sinopharm Somaxon Pharmaceuticals (subsidiary of Pernix) Sotex SSL International (subsidiary of Reckitt Benckiser) SSP Co. (acquired by Boehringer Ingelheim) STADA Arzneimittel State Administration of Industry and Commerce (SAIC) (China) State Administration of Quality Supervision Inspection and Quarantine (AQSIQ) (China) State Food and Drug Administration (SFDA) (China) Steigerwald (acquired by Bayer) Stiefel Laboratories (subsidiary of GSK) Sun Pharma Synthélabo (now part of Sanofi) Synthes Inc (acquired by Johnson & Johnson) Taisho Pharmaceutical www.visiongain.com
  • 29. Contents Taisho Toyama Pharmaceutical (Taisho/Toyama Chemical Co. joint venture) Takeda Pharmaceutical Target Teuto Teva Torrent Pharmaceuticals Tufts Center for the Study of Drug Development Twitter U.S. Food and Drug Administration (FDA) (US) Unico Holdings United Nations Department for Economic and Social Affairs Universal Medicare (acquired by Sanofi) University of Amsterdam University of Pennsylvania University of the Sciences in Philadelphia Valenta Velcera (acquired by Perrigo) Veropharm Veteran Affairs Medical Center, Philadelphia ViiV Healthcare (GSK/Pfizer joint venture) Vivus Inc. Walgreens Walmart Warner Chilcott www.visiongain.com
  • 30. Contents Wockhardt World Bank World Self-Medication Industry (WSMI) World Trade Organization (WTO) Wyeth (subsidiary of Pfizer) Yangtze River Pharmaceutical Zydus Cadila www.visiongain.com
  • 31. World OTC Pharmaceutical Market 2013-2023 Table 4.22 The Russian OTC Pharma Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2023 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 3.6 4.1 4.7 5.4 6.2 7.1 8.1 9.2 10.4 11.6 12.8 13.9 Russia ($bn) Annual Growth Rate (%) 14.0 14.5 14.5 15.0 15.0 14.3 13.6 13.0 11.0 10.0 9.0 CAGR (%, 2012-2017 14.6 11.8 and 2017-2023) 13.1 CAGR (%, 2012-2023) Source: visiongain 2013 Figure 4.21 The Russian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023 16.0 13.9 14.0 12.8 11.6 Market Size ($bn) 12.0 10.4 9.2 10.0 8.1 7.1 8.0 6.2 6.0 4.0 3.6 4.1 4.7 5.4 2.0 0.0 2012 2013 2014 2015 2016 2017 2018 Year 2019 2020 2021 2022 2023 Source: visiongain 2013 Visiongain believes the following factors will drive growth in the Russian market: • Demographic changes: Russia’s population is more recently projected to grow slowly instead of shrinking, due to a combination of improving economic conditions and net immigration; unusually low male life expectancy in Russia is also expected to improve, increasing demand for OTC medicines • Increasing government expenditure on healthcare • Russia joined the World Trade Organization in 2012, which will drive pharma exports • The effects of Pharma2020 (see below) and changes to healthcare provision. www.visiongain.com Page 100
  • 32. World OTC Pharmaceutical Market 2013-2023 Table 5.7 Boehringer Ingelheim: Overview, 2012 Company Boehringer Ingelheim Roxane Laboratories (1978), Ben Venue Notable subsidiaries Laboratories (1997) Business areas Pharmaceuticals, animal health Established 1885 Employees 46,228 Headquarters Ingelheim, Germany Global presence 100+ countries Fiscal year end 30-Dec FY 2012 Revenue $18.89bn FY 2012 OTC Revenue $1.760bn (estimated) Source: Company reports; visiongain 2013. Boehringer Ingelheim’s Consumer Health Care business markets a range of OTC pharmaceuticals in addition to vitamins and other dietary products and supplements. The division contributes around 10% to the company’s total sales. In 2012, sales for the Consumer Health Division were $1,935m of which $1,760m is due to OTC pharmaceuticals and $175m is due to sales of Pharmaton, a range of vitamin and mineral supplements. Another brand, Antistax (extract of red vine leaf for leg health) is marketed as a food supplement in some markets and a medicine in others. Table 5.8 shows Boehringer Ingelheim’s core OTC brands in 2013. Table 5.8 Boehringer Ingelheim OTC Brands, 2013 OTC Brand Active Ingredients Category Bisolvon bromhexine, dextromethorphan Cough, cold and allergy Buscopan hyoscine butylbromide Gastrointestinal Dulcolax bisacodyl / sodium picosulfate / macrogol depending on product Gastrointestinal Mucoangin ambroxol Cough, cold and allergy Mucosolvan bromhexine acetylsalicylic acid, paracetamol, caffeine ranitidine Cough, cold and allergy European and South American markets China, European markets Analgesic Germany Cough, cold and allergy US Thomapyrin Zantac Major Markets International (excluding North America) International (excluding North America) International Source: visiongain 2013. 5.4.1 Boehringer Ingelheim: OTC Sales Forecast, 2013-2023 Boehringer Ingelheim’s Consumer Health Care division has a good track record of growth, with a CAGR of around 6.2% from 2009-2012 (sales of Pharmaton excluded). Visiongain expects OTC revenues to continue growing at around 6-7%, keeping pace with the world OTC pharma market, to reach sales of $3,519m in 2023. www.visiongain.com Page 116
  • 33. World OTC Pharmaceutical Market 2013-2023 Table 6.5 shows selected dermatological drugs’ active ingredients and their OTC status and prospects for switching in leading OTC pharma markets. Table 6.5 Potential Dermatologicals OTC Switches By Active Ingredient, 2013-2023 Drug type Drug Antifungal agents bifonazole butenafine clotrimazole fluconazole ketoconazole miconazole nystatin terbinafine Antivirals tolnaftate aciclovir famciclovir penciclovir Possible Future Switches OTC in China, Japan, Australia, US, Canada, other Germany, Italy, UK, and other markets European markets OTC in China, Japan Other leading OTC in most major markets Phillippines, Bulgaria, Lithuania, Chile OTC in Australia, Canada Other leading OTC in most major markets Japan, France OTC in most major markets Smaller European markets OTC in Japan, China, Canada, Australia, US, other leading New Zealand, Germany, UK European markets OTC in most major markets Smaller European markets OTC in most major markets China OTC in Japan, China, and most US, Canada European markets OTC in New Zealand (2010) Australia; other switches unlikely OTC in Australia, New Zealand, leading US, Japan, China, EU markets Canada OTC Status Source: Association of the European Self-Medication Industry; visiongain 2013. 6.7.1 Antivirals for Oral Herpes Simplex Aciclovir, famciclovir and penciclovir are examples of antiviral agents used topically to treat oral infection with herpes simplex virus. These agents can shorten the duration of an outbreak and accelerate healing of skin lesions. They are available OTC in some markets, but notably remain prescription-only in the US. An attempt at an OTC switch of Zovirax (aciclovir) in 1995 failed when an FDA advisory committee was not convinced that a patient could self-diagnose the condition. However, famciclovir was successfully reclassified as OTC in New Zealand in 2010, and it is possible that other countries may follow suit with further switches, especially if pharmacy-only methods of dispensing these products can be used to support a switch. 6.8 Anticholinergics for Incontinence: OTC Switches In January 2013, the FDA approved Merck’s switch, Oxytrol for Women (oxybutynin), which creates a new switch category in medicines to treat overactive bladder (a cause of urinary incontinence). Oxybutynin is an anticholinergic agent which blocks receptors in the muscle of the bladder wall, reducing the effects of involuntary muscle spasms of the bladder. Actavis markets the prescription form of Oxytrol. Oxytrol for Women delivers 3.9 mg of oxybutynin as a skin patch applied every four days. The product became available in pharmacies in September 2013. www.visiongain.com Page 167

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