world otc pharmaceutical market 2013-2023

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World OTC Pharmaceutical Market 2013-2023

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Contents 1. Executive Summary

1.1 Overview of Findings

1.2 Structure of the Report

1.3 Research and Analysis Methods

2. 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

1. Executive Summary

2. Introduction to OTC Pharmaceuticals

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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. 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

3. The World OTC Pharma Market 2013-2023

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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. 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

4. The Leading National Markets 2013-2023

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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. 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

5. Leading Companies in the OTC Pharma Market 2013-2023

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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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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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Contents 6. 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)

6. OTC Switching and Prospects for Future OTC Drugs

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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. 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

7. Qualitative Analysis of the OTC Pharma Market, 2013

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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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Contents 8. 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


8.2.2 Will Statins Switch to OTC in the US?




8.2.6 How Will US Healthcare Reform Affect the OTC Pharma Market?


8.3 Interview with Professor Daniel Hussar, Remington Professor of Pharmacy, Philadelphia

College of Pharmacy, University of the Sciences in Philadelphia, USA


8.3.2 A Decline In OTC Switches?


8. Research Interviews

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Contents 8.3.4 How Will US Healthcare Reform Affect the OTC Pharma Market?




8.3.8 Development of the OTC Sector

9. 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?

9. Conclusions

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Contents

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 (%), 2012-

2023

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

List of Tables

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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 (%), 2012-

2023

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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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 (%), 2012-

2023

Table 4.13 The EU5 OTC Pharmaceutical Market: Revenues ($bn) and Market Shares (%) by

National Market, 2012





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 (%), 2012-

2023

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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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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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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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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Contents

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




2017


2023

Figure 3.8 The Cough, Cold and Allergy OTC Pharma Market Forecast: Revenues ($bn), 2012-

2023

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), 2012-

2023

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

List of Figures

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Contents Figure 4.5 The World OTC Pharmaceutical Market Forecast: CAGR (%), 2012-2023



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, 2012-

2023

Figure 4.13 The EU5 OTC Pharmaceutical Market: Market Shares (%) by National Market, 2012



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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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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Contents

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)

Organisations Mentioned in This Report

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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

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

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

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

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

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

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

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 Page 100

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 2023Russia ($bn) 3.6 4.1 4.7 5.4 6.2 7.1 8.1 9.2 10.4 11.6 12.8 13.9Annual Growth Rate (%) 14.0 14.5 14.5 15.0 15.0 14.3 13.6 13.0 11.0 10.0 9.0CAGR (%, 2012-2017 and 2017-2023) 14.6 11.8CAGR (%, 2012-2023) 13.1

Figure 4.21 The Russian OTC Pharma Market Forecast: Revenues ($bn), 2012-2023

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.

3.6 4.1 4.7

5.4 6.2

7.1 8.1

9.2 10.4

11.6 12.8

13.9

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Mar

ket S

ize

($bn

)

Year

Source: visiongain 2013

Source: visiongain 2013



Table 5.7 Boehringer Ingelheim: Overview, 2012 Company Boehringer Ingelheim

Notable subsidiaries Roxane Laboratories (1978), Ben Venue Laboratories (1997)

Business areas Pharmaceuticals, animal healthEstablished 1885Employees 46,228Headquarters Ingelheim, GermanyGlobal presence 100+ countriesFiscal year end 30-DecFY 2012 Revenue $18.89bnFY 2012 OTC Revenue $1.760bn (estimated)

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 Major Markets

Bisolvon bromhexine, dextromethorphan Cough, cold and allergy International (excluding North America)

Buscopan hyoscine butylbromide Gastrointestinal International (excluding North America)

Dulcolax bisacodyl / sodium picosulfate / macrogol depending on product

Gastrointestinal International

Mucoangin ambroxol Cough, cold and allergy European and South American markets

Mucosolvan bromhexine Cough, cold and allergy China, European markets

Thomapyrin acetylsalicylic acid, paracetamol, caffeine

Analgesic Germany

Zantac ranitidine Cough, cold and allergy US

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.

Source: visiongain 2013.

Source: Company reports; visiongain 2013.



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 OTC Status Possible Future Switches

Antifungal agents bifonazole OTC in China, Japan, Australia, Germany, Italy, UK, and other markets

US, Canada, other European markets

butenafine OTC in China, Japan Other leading clotrimazole OTC in most major markets Phillippines, Bulgaria,

Lithuania, Chilefluconazole OTC in Australia, Canada Other leading ketoconazole OTC in most major markets Japan, Francemiconazole OTC in most major markets Smaller European

marketsnystatin OTC in Japan, China, Canada, Australia,

New Zealand, Germany, UKUS, other leading European markets

terbinafine OTC in most major markets Smaller European markets

tolnaftate OTC in most major markets ChinaAntivirals aciclovir OTC in Japan, China, and most

European marketsUS, Canada

famciclovir OTC in New Zealand (2010) Australia; other switches unlikely

penciclovir OTC in Australia, New Zealand, leading EU markets

US, Japan, China, Canada

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.

Source: Association of the European Self-Medication Industry; visiongain 2013.

world otc pharmaceutical market 2013-2023

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