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1. World OTC Pharmaceutical Market
2013-2023
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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
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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
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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
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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
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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
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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
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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)
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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
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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]
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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
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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?
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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
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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
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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 ($bn), AGR (%), CAGR (%),
2012-2023
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16. Contents
Table 4.23 Top 8 Russian OTC Pharma Companies: OTC Revenues ($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
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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 ($m), AGR (%), CAGR (%), 2012-2023
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18. Contents
Table 5.39 Sanofi: Overview, 2012
Table 5.40 Sanofi OTC Brands, 2013
Table 5.41 Sanofi: OTC Sales Forecast ($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
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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
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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 ($m), 2012-2023
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21. Contents
Figure 5.6 Panadol: OTC Sales Forecast ($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
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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)
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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
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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)
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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
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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
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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
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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
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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
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30. Contents
Wockhardt
World Bank
World Self-Medication Industry (WSMI)
World Trade Organization (WTO)
Wyeth (subsidiary of Pfizer)
Yangtze River Pharmaceutical
Zydus Cadila
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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.
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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.
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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.
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