OVER-THE-COUNTER (OTC) DRUGS AND DIETARY SUPPLEMENTS: GLOBAL MARKETS

Transcription

1 OVER-THE-COUNTER (OTC) DRUGS AND DIETARY SUPPLEMENTS: GLOBAL MARKETS PHM050B February 2014 Anand Gijare Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 SCOPE OF REPORT 2 INTENDED AUDIENCE 3 INFORMATION SOURCES 3 ANALYST CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH ONLINE SERVICES 4 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 SUMMARY TABLE GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS THROUGH 2018 SUMMARY FIGURE GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS HIGHLIGHTS OF THE YEAR TRENDS IN OTC MEDICINES AND DIETARY SUPPLEMENTS THROUGH FORECAST TRENDS IN OTC MEDICINES BY THERAPEUTIC CLASS THROUGH CHAPTER 3 OVERVIEW 12 RECLASSIFYING PRESCRIPTION MEDICINES TO NONPRESCRIPTION (RX TO OTC) 13 COMMON ADMINISTRATION METHODS FOR OTC MEDICINES 14 AL ADMINISTRATION 14 Lotion 15 Cream 15 Ointment 15 Gel 16 Transdermal Patch 16 ORAL ADMINISTRATION 16 Tablets 16 Capsules 16 Medicinal Syrups 17 Medicated Chewing Gums 17 LEADING THERAPUTIC CLASSIFICATIONS OF OTC MEDICINES 17 ANALGESICS AND ANTIPYRATICS 17 Acetaminophen 17 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) 18 TABLE 1 KEY OTC ANALGESICS AND ANTIPYRETICS BRANDS 18 ANTIHISTAMINES 19 TABLE 2 KEY OTC ANTIHISTAMINE BRANDS 19 COUGH AND COLD REMEDIES 19 Nasal Decongestants 20 Cough Remedies 20 TABLE 3 KEY OTC COUGH & COLD TREATMENT BRANDS 20 GASTROINTESTINAL DISORDER TREATMENTS 20

3 Antacids 21 TABLE 4 KEY OTC ANTACID BRANDS 21 H2 Blockers 21 TABLE 5 KEY OTC H2 BLOCKER BRANDS 22 Proton Pump Inhibitors (PPIs) 22 TABLE 6 KEY OTC PPIS BRANDS 22 SKINCARE AND DERMATOLOGICAL MEDICINES 23 Acne Treatments 23 TABLE 7 KEY OTC ACNE TREATMENT BRANDS 24 Psoriasis 24 TABLE 8 KEY OTC PSORIASIS TREATMENT BRANDS 24 EYE CARE PRODUCTS 25 Treatments for Dry Eye 25 TABLE 9 KEY OTC DRY EYE CARE BRANDS 25 Ocular Allergy Symptoms 25 TABLE 10 KEY OTC RED EYE TREATMENT BRANDS 25 Ocular/Eye Vitamins 26 TABLE 11 KEY OTC RED EYE TREATMENT BRANDS 26 Eyelid Hygiene 26 TABLE 12 KEY OTC RED EYE TREATMENT BRANDS 27 Contact Lenses Solution 27 TABLE 13 KEY OTC RED EYE TREATMENT BRANDS 27 ORAL MEDICAL CARE 27 Oral Debriding Agents and Wound Cleansers 27 Treatments for Dental Carries 28 Treatments on Gum Diseases 28 Treatments for Cold Sores 28 TABLE 14 KEY OTC ORAL MEDICAL CARE PRODUCTS 28 SMOKING CESSATION 29 Nicotine Gum 29 TABLE 15 NICOTINE GUM DOSAGE AND SCHEDULE 30 Additonal Notes Regarding Nicotine Gum: 30 TABLE 16 KEY BRANDS AND MARKETERS OF NICOTINE GUMS 31 Nicotine Lozenges 31 TABLE 17 NICOTINE LOZENGE DOSAGE AND SCHEDULE 31 Additonal Notes Regarding Nicotine Lozenges: 32 TABLE 18 KEY BRANDS AND MARKETERS OF NICOTINE LOZENGES 32 Nicotine Patch 32 TABLE 19 NICOTINE PATCH DOSAGES AND SCHEDULE 33 Additonal Notes Regarding Nicotine Patches: 33 TABLE 20 KEY BRANDS AND MARKETERS OF NICOTINE PATCHES 34 DIETARY SUPPLEMENTS (VMS) 34 Eating Disorders 35 Treatments for Vitamins and Mineral Deficiency 35 Vitamins and Mineral Supplements (VMS) 35 Regulations for Dietary Supplements 35 TABLE 21 KEY DIETARY SUPPLEMENT BRANDS 37

4 CHAPTER 4 GLOBAL MARKETS FOR OTC MEDICINES AND DIETARY SUPPLEMENTS 39 GLOBAL OTC MEDICINE AND DIETARY SUPPLEMENT MARKET TABLE 22 GLOBAL OTC MEDICINES AND DIETARY SUPPLEMENT MARKET BY SEGMENT, THROUGH 2018 TABLE 23 ESTABLISHING MARKETS' PERFORMANCE, 2012 ($ MILLIONS/%) 40 TABLE 24 LOW PERFORMERS OF YEAR TABLE 25 EMERGING MARKETS OF YEAR GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS, 2013 TO 2018 TABLE 26 GLOBAL OTC MEDICINE AND DIETARY SUPPLEMENT MARKET THROUGH 2018 GLOBAL MARKET REVIEW 42 U.S. Market 42 European Market 42 Asia-Pacific Market 42 BRIC Market 43 TABLE 27 CHANGE IN MARKET SHARE OF OTC MEDICINES & DIETARY SUPPLEMENTS BY MARKET 2012 AND MARKETS FOR OTC MEDICINES AND DIETARY SUPPLEMENTS BY REGION TO 2018 THE U.S. OTC MEDICINES MARKET 2013 TO REGULATIONS AND APPROVAL PROCESS: THE U.S. 45 Medicines Developed Under the OTC Drug Monograph Process 45 OTC Drug Review 45 OTC Monograph 46 OTC Medicines Developed Through the NDA Process 46 Updated List of Prescription to Over-the-Counter (OTC) Switches 47 TABLE 28 UPDATED LIST OF RX-TO-OTC SWITCH IN THE U.S. FROM 2001 TO THE U.S. NONPRESCRIPTION SAFE-USE REGULATORY EXPANSION (NSURE) INITIATIVE THE U.S. OTC MEDICINE MARKET 2013 THROUGH TABLE 29 GLOBAL MARKET FORECAST FOR THE U.S. BY CATEGORY THROUGH 2018 TABLE 30 CHANGE IN SHARE OF THE U.S. MARKET BY MARKET SECTOR, 2012 AND EUROPE'S OTC MEDICINES MARKET 51 REGULATIONS AND APPROVAL PROCESS IN EUROPE 52 National Procedure 52 Decentralized Procedure 52 Mutual Recognition Procedure 53 Centralized Procedure 53 SMART REGULATION 2015-EUROPE AS A SINGLE MARKET 53 EUROPE'S OTC MEDICINE MARKET 2013 THROUGH TABLE 31 GLOBAL MARKET FORECAST FOR EUROPE THROUGH TABLE 32 GLOBAL MARKET FORECAST FOR EUROPE BY CATEGORY THROUGH 2018 TABLE 33 CHANGE IN MARKET SHARE OF EUROPEAN MARKET BY CATEGORY 2012 AND

5 THE U.K. OTC MEDICINES MARKET 2013 THROUGH REGULATIONS AND APPROVAL PROCESS IN THE U.K. 57 Better Regulation of Over-the-Counter Medicines Initiative (BROMI) U.K. POM TO P AND P TO GSL RECLASSIFICATIONS TO JUNE TABLE 34 UPDATED LIST OF PERSCRIPTION ONLY MEDICINES TO PHARMACY AND PHARMACY TO GENERAL SALE LIST RECLASSIFICATIONS - U.K. ([YEAR] TO JUNE 2013) RECLASSIFICATIONS IN THE U.K. APPROVED SINCE JUNE TABLE 35 RECENT RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS U.K. U.K. OTC MARKET 2013 THROUGH TABLE 36 GLOBAL MARKET FORECAST FOR THE U.K. BY CATEGORY THROUGH 2018 TABLE 37 CHANGE IN MARKET SHARE OF THE U.K. MARKET BY CATEGORY 2012 AND GERMANY'S OTC MEDICINES MARKET 2013 THROUGH REGULATIONS AND APPROVAL PROCESS IN GERMANY 64 GERMAN OTC MARKET 2013 THROUGH TABLE 38 GLOBAL MARKET FORECAST FOR GERMANY BY CATEGORY, THROUGH 2018 TABLE 39 CHANGE IN MARKET SHARE FOR GERMANY BY CATEGORY THROUGH FRANCE'S OTC MEDICINES MARKET 2013 THROUGH TABLE 40 GLOBAL MARKET FORECAST FOR FRANCE BY CATEGORY THROUGH 2018 TABLE 41 CHANGE IN MARKET SHARE OF FRANCE BY CATEGORY THROUGH 2018 (%) POLAND'S OTC MEDICINES MARKET 2013 THROUGH TABLE 42 GLOBAL MARKET FORECAST FOR POLAND BY CATEGORY THROUGH 2018 TABLE 43 CHANGE IN MARKET SHARE OF POLAND BY CATEGORY 2012 AND 2018 (%) ASIA-PACIFIC OTC MEDICINES MARKET 2013 THROUGH TABLE 44 GLOBAL MARKET FORECAST FOR ASIA-PACIFIC BY CATEGORY THROUGH 2018 TABLE 45 CHANGE IN MARKET SHARE OF ASIA-PACIFIC BY CATEGORY, 2012 AND JAPAN'S OTC MEDICINES MARKET 72 Regulations and Approval Process - Japan 72 Developments in First Kind Pharmaceutical Newly Approved Japan s OTC Pharmaceutical Sales System TABLE 46 UPDATED LIST OF OTC TO FIRST KIND PHARMACEUTICAL DRUGS IN JAPAN NOV TO MAY 2013 Japan's OTC MEDICINES MARKET 2013 through TABLE 47 GLOBAL MARKET FORECAST FOR JAPAN BY CATEGORY THROUGH 2018 TABLE 48 CHANGE IN MARKET SHARE OF ASIA-PACIFIC BY CATEGORY 2011 AND

6 AUSTRALIA AND NEW ZEALAND'S OTC MEDICINES MARKET 2013 THROUGH 2018 Regulations and Approval Process - Australia 78 NEW ZEALAND 79 JOINT AUSTRALIAN AND NEW ZEALAND PHASED IMPLEMENTATION PLAN 2013 N2 Applications (Using OTC Monographs) Version1, September Level N3, N4 and N5 Applications 81 AUSTRALIA AND NEW ZEALAND - OTC MEDICINES MARKET 2013 THROUGH 2018 TABLE 49 GLOBAL MARKET FORECAST FOR AUSTRALIA AND NEW ZEALAND BY CATEGORY, THROUGH 2018 TABLE 50 CHANGE IN MARKET SHARE OF AUSTRALIA/NEW ZEALAND 2012 AND BRAZIL, RUSSIA, INDIA AND CHINA (BRIC) - OTC MEDICINES MARKET 2013 THROUGH 2018 TABLE 51 GLOBAL MARKET FORECAST FOR BRIC BY CATEGORY THROUGH 2018 ($ SPURRING LATENT NEED 83 BRIC OTC MEDICINES MARKET 2013 THROUGH TABLE 52 CHANGE IN MARKET SHARE OF BRIC COUNTRIES BY CATEGORY 2012 AND BRAZIL - OTC MEDICINES MARKET 85 BRAZIL - OTC MEDICINES MARKET 2013 THROUGH TABLE 53 GLOBAL MARKET FORECAST FOR BRAZIL BY CATEGORY THROUGH 2018 TABLE 54 CHANGE IN MARKET SHARE OF BRAZIL BY CATEGORY, 2012 AND 2018 (%) RUSSIA - OTC MEDICINES MARKET 86 RUSSIA - OTC MEDICINES MARKET 2013 THROUGH TABLE 55 GLOBAL MARKET FORECAST FOR RUSSIA BY CATEGORY THROUGH 2018 TABLE 56 CHANGE IN MARKET SHARE OF RUSSIA BY CATEGORY, 2012 AND 2018 (%) CHINA - OTC MEDICINES MARKET 88 REGULATIONS AND APPROVAL PROCESS - CHINA 88 CHINA - OTC MEDICINES MARKET 2013 THROUGH TABLE 57 GLOBAL MARKET FORECAST FOR CHINA BY CATEGORY THROUGH 2018 TABLE 58 CHANGE IN MARKET SHARE OF CHINA BY CATEGORY, 2012 AND 90 INDIA - OTC MEDICINES MARKET 91 INDIA - REGULATIONS AND APPROVAL PROCESSES 91 INDIA - OTC MEDICINES MARKET 2013 THROUGH TABLE 59 GLOBAL MARKET FORECAST FOR INDIA BY CATEGORY THROUGH 2018 ($ TABLE 60 CHANGE IN MARKET SHARE OF INDIA BY CATEGORY, 2012 AND CHAPTER 5 GLOBAL SALES OF OTC MEDICINES AND DIETARY SUPPLEMENTS BY SALES CHANNELS 95

7 GLOBAL MARKET FORECAST FOR OTC MEDICINES AND DIETARY SUPPLEMENTS BY SALES CHANNELS, THROUGH 2018 TABLE 61 GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS BY SALES CHANNELS, THROUGH 2018 TABLE 62 CHANGE IN MARKET SHARE BY SALES CHANNELS, 2012 AND CHAPTER 6 GLOBAL MARKET FORECAST FOR OTC MEDICINES BY THERUPEUTIC CLASSIFICATION GLOBAL SALES FORECAST BY THERUPEUTIC CLASSIFICATION FOR OTC MEDICINES TABLE 63 GLOBAL SALES FOR OTC MEDICINES BY REGION, THROUGH 2018 ($ TABLE 64 CHANGE IN MARKET SHARE OF OTC MEDICINES BY COUNTRY, 2012 AND TABLE 65 GLOBAL MARKET FOR OTC MEDICINES BY THERUPEUTIC CLASSIFICATION, THROUGH 2018 TABLE 66 CHANGE IN MARKET SHARE OF OTC MEDICINES BY THERUPEUTIC CLASSIFICATION, 2012 AND GLOBAL MARKET FORECAST FOR OTC ANALGESICS/ANTIPYRETICS 2013 THROUGH 2018 Analgesics and Antipyretics OTC Market 2013 through TABLE 67 GLOBAL MARKET FORECAST FOR OTC ANALGESICS AND ANTIPYRETICS, THROUGH 2018 TABLE 68 CHANGE IN MARKET SHARE OF OTC ANALGESICS AND ANTIPYRETIC, 2012 AND GLOBAL MARKET FORECAST FOR OTC ANTIHISTAMINE AND COUGH AND COLD MEDICINES 2013 THROUGH 2018 TABLE 69 GLOBAL MARKET FORECAST FOR OTC ANTIHISTAMINE AND COUGH AND COLD THROUGH 2018 TABLE 70 CHANGE IN MARKET SHARE OF OTC ANTIHISTAMINE AND COUGH AND COLD, 2012 AND GLOBAL MARKET FORECAST FOR OTC GASTROINTESTINAL PRODUCTS 2013 THROUGH 2018 TABLE 71 GLOBAL MARKET FORECAST FOR OTC GASTROINTESTINAL PRODUCTS, THROUGH 2018 TABLE 72 CHANGE IN MARKET SHARE OF OTC GASTROINTESTINAL PRODUCTS, 2012 AND GLOBAL MARKET FORECAST FOR OTC DERMATOLOGICAL MEDICINES 2013 THROUGH 2018 TABLE 73 GLOBAL MARKET FORECAST FOR OTC DERMATOLOGICAL MEDICINES, THROUGH 2018 TABLE 74 CHANGE IN MARKET SHARE OF OTC DERMATOLOGICAL MEDICINES, THROUGH GLOBAL MARKET FORECAST FOR OTC ORAL MEDICAL CARE PRODUCTS 2013 THROUGH 2018 TABLE 75 GLOBAL MARKET FORECAST FOR OTC ORAL MEDICAL CARE PRODUCTS THROUGH 2018 TABLE 76 CHANGE IN MARKET SHARE OF OTC ORAL MEDICAL CARE PRODUCTS, 2012 AND GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS 2013 THROUGH

8 TABLE 77 GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS, THROUGH 2018 TABLE 78 CHANGE IN MARKET SHARE OF OTC EYE CARE PRODUCTS, 2012 AND GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS 2013 THROUGH 2018 High Rate of Smokers Quitting in Developed Countries 109 Decrease in Smoking Rates at Saturation Point in Developed Markets 109 Smoking Rates are Increasing in Developing Markets 110 Strategic Initiatives to Increase Smoking Cessation in Developing Countries Developing and Poor Countries Sign WHO FCTC Treaty 110 WHO FCTC Progress Report TABLE 79 ARTICLES REPORTED TO HAVE HIGHEST IMPLEMENTATION RATES IN 2012 WHO FCTC PROGRESS REPORT (%) TABLE 80 ARTICLES REPORTED MODERATE IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) TABLE 81 ARTICLES REPORTED LOWEST IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) FIGURE 1 GLOBAL IMPLEMENTATION OF ARTICLES OF 2012 WHO FCTC PROGRESS REPORT (%) TABLE 82 GLOBAL IMPLEMETATION OF FCTC ARTICLES: 2012 REPORT 113 Implementation of Article 14 in TABLE 83 GLOBAL IMPLEMENTATION OF ARTICLE 14 OF FCTC 116 Political and Legal Interventions Influence Markets 117 TABLE 84 INITIATIVES IMPLEMENTED BY PARTIES TO FCTC TREATY IN 2012 (%) 118 Socioeconomic Factors of Smoking 119 TABLE 85 PROJECTED GLOBAL CAUSE OF DEATH BY DISEASE (%) 120 TABLE 86 PUBLIC HEALTH BURDEN DUE TO SMOKING-RELATED DISEASES ($ BILLIONS) Technological Developments Concerning Smoking 121 FIGURE 2 ONGOING STUDIES, BY REGION (NO. OF STUDIES) 121 TABLE 87 GLOBAL SIZE OF SMOKING CESSATION MEDICINE MARKET BY REGION, THROUGH 2018 TABLE 88 GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS BY REGION THROUGH 2018 TABLE 89 CHANGE IN MARKET SHARE OF OTC SMOKING CESSATION PRODUCTS THROUGH GLOBAL MARKET FORECAST FOR OTC DIETARY SUPPLEMENTS (VMS) 2013 THROUGH 2018 TABLE 90 GLOBAL MARKET FORECAST FOR OTC DIETARY SUPPLEMENT PRODUCTS BY REGION, THROUGH 2018 TABLE 91 CHANGE IN MARKET SHARE OF DIETARY SUPPLEMENTS BY REGION, 2012 AND CHAPTER 7 OTC MEDICINES AND DIETARY SUPPLEMENT INDUSTRY AND MARKET ANALYSIS OVERVIEW 128 ESTABLISHED MARKETS 128 ESTABLISHING MARKETS

9 NON-ESTABLISHED MARKETS 130 THE PRACTICE OF BUYING OTC MEDICINES 130 ROLE OF PHARMACY IN OTC MEDICINES 130 REGULATORY INFLUENCE ON OTC MEDICINE MARKET 131 KEY STRATEGIC INITIATIVES FOR MARKET PENETRATION AND EXPANSION 131 ACQUISITION OF MARKETING AUTHORIZATION KEY MARKET PENETRATION AND EXPANSION STRATEGY EXPANSIONS, PARTNERSHIPS AND JOINT VENTURES 132 THIRD-PARTY CONTRACTING 133 DRIVERS AND BARRIERS OF OTC MEDICINE INDUSTRY 133 THE RECENT DRIVERS FOR THE OTC MEDICINES AND DIETARY SUPPLEMENT MARKET STRENGTHS, WEAKNESSES, OPPORTUNITIES AND THREATS (SWOT) ANALYSIS OF THE OTC MEDICINE AND DIETARY SUPPLEMENT INDUSTRY TABLE 92 SWOT ANALYSIS OF OTC MEDICINE AND DIETARY SUPPLEMENT INDUSTRY CHAPTER 8 COMPANY PROFILES 137 ALACER CORP. 137 ALCON INC. 137 ALFRESA PHARMA CORPORATION 137 ALKALON A/S 137 ALLIANCE BOOTS 138 ALLIANCE HEALTHCARE 138 ALLIANCE HEALTHCARE DEUTSCHLAND 138 ALLIANCE HEALTHCARE FRANCE 138 ALLERGAN, INC. 139 ALTICOR 139 NUTRILITE 139 ARKOPHARMA PHARMACEUTICAL LABORATORIES (LABORATOIRES PHARMACEUTIQUES) ASPEN HOLDINGS 140 ASPEN PHARMACARE AUSTRALIA PTY. LTD. 140 BAUSCH & LOMB 140 BAYER HEALTHCARE AG 140 BOEHRINGER INGELHEIM GMBH 141 CARMA LABORATORIES, INC. 141 CHATTEM INC. 141 CILAG AG 142 COLGATE-PALMOLIVE COMPANY 142 CORDIA HEALTHCARE (CAVENDISH PHARMACEUTICALS) 142 DAIICHI SANKYO CO., LTD. 143 DERMA SCIENCES 143 EYESCIENCE LABS 143 FERTIN PHARMA A/S 144 GABA INTERNATIONAL AG 144 GALDERMA S.A. 144 GEMINI PHARMACEUTICALS, INC

10 GENOMMA LAB INTERNATIONAL 145 GLAXOSMITHKLINE PLC 145 HISAMITSU PHARMACEUTICAL CO., INC. 146 INSIGHT PHARMACEUTICALS LLC 146 JOHNSON & JOHNSON 146 KOWA COMPANY, LTD. 147 LAKE CONSUMER PRODUCTS, INC. 147 MANX HEALTHCARE LIMITED 147 MCM KLOSTERFRAU VERTRIEBS GMBH (KLOSTERFRAU HEALTHCARE GROUP) 148 MCNEIL CONSUMER HEALTHCARE 148 MEDA AB 148 MELALEUCA, INC. 148 MERCK CORPORATE HEADQUARTERS 149 MERZ PHARMA 149 MOCHIDA PHARMACEUTICAL CO., LTD. 149 NEPENTES SA / NEPENTES PHARMA SP. Z O.O. 150 NEUTROGENA CORP. 150 NORTHEAST PHARMACEUTICAL GROUP CO. LTD 150 NOVARTIS INTERNATIONAL AG 150 NOW FOODS 151 PERRIGO CO. 151 PFIZER INC. 151 PGT HEALTHCARE (DIVISION OF PROCTER & GAMBLE) 151 PHARMAVITE LLC 152 PIERRE FABRE PHARMACEUTICALS INC. 152 PIRAMAL HEALTHCARE LTD 152 PRESTIGE BRANDS HOLDINGS, INC. 153 RECKITT BENCKISER PLC. 153 RECKITT BENCKISER (NORTH AMERICA) INC. 153 RECORDATI PHARMA GMBH 153 REVOLYMER (U.K.) LTD 154 SAGE PRODUCTS LLC 154 SANOFI 154 SATO PHARMACEUTICAL CO., LTD. 155 SHAKLEE CORPORATION 155 SHAKLEE CHINA-CORPORATE OFFICE 155 STADA ARZNEIMITTEL AG 155 SWISSE WELLNESS PTY LTD. 156 TAISHO PHARMACEUTICAL HOLDINGS 156 TAKEDA PHARMACEUTICALS LTD. 156 TISSO NATURPRODUKTE GMBH 157 WELLSPRING PHARMACEUTICAL CORPORATION 157 ZEAVISION, LLC 157

11 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS THROUGH 2018 TABLE 1 KEY OTC ANALGESICS AND ANTIPYRETICS BRANDS 18 TABLE 2 KEY OTC ANTIHISTAMINE BRANDS 19 TABLE 3 KEY OTC COUGH & COLD TREATMENT BRANDS 20 TABLE 4 KEY OTC ANTACID BRANDS 21 TABLE 5 KEY OTC H2 BLOCKER BRANDS 22 TABLE 6 KEY OTC PPIS BRANDS 22 TABLE 7 KEY OTC ACNE TREATMENT BRANDS 24 TABLE 8 KEY OTC PSORIASIS TREATMENT BRANDS 24 TABLE 9 KEY OTC DRY EYE CARE BRANDS 25 TABLE 10 KEY OTC RED EYE TREATMENT BRANDS 25 TABLE 11 KEY OTC RED EYE TREATMENT BRANDS 26 TABLE 12 KEY OTC RED EYE TREATMENT BRANDS 27 TABLE 13 KEY OTC RED EYE TREATMENT BRANDS 27 TABLE 14 KEY OTC ORAL MEDICAL CARE PRODUCTS 28 TABLE 15 NICOTINE GUM DOSAGE AND SCHEDULE 30 TABLE 16 KEY BRANDS AND MARKETERS OF NICOTINE GUMS 31 TABLE 17 NICOTINE LOZENGE DOSAGE AND SCHEDULE 31 TABLE 18 KEY BRANDS AND MARKETERS OF NICOTINE LOZENGES 32 TABLE 19 NICOTINE PATCH DOSAGES AND SCHEDULE 33 TABLE 20 KEY BRANDS AND MARKETERS OF NICOTINE PATCHES 34 TABLE 21 KEY DIETARY SUPPLEMENT BRANDS 37 TABLE 22 GLOBAL OTC MEDICINES AND DIETARY SUPPLEMENT MARKET BY SEGMENT, THROUGH 2018 TABLE 23 ESTABLISHING MARKETS' PERFORMANCE, 2012 ($ MILLIONS/%) 40 TABLE 24 LOW PERFORMERS OF YEAR TABLE 25 EMERGING MARKETS OF YEAR TABLE 26 GLOBAL OTC MEDICINE AND DIETARY SUPPLEMENT MARKET THROUGH 2018 TABLE 27 CHANGE IN MARKET SHARE OF OTC MEDICINES & DIETARY SUPPLEMENTS BY MARKET 2012 AND TABLE 28 UPDATED LIST OF RX-TO-OTC SWITCH IN THE U.S. FROM 2001 TO TABLE 29 GLOBAL MARKET FORECAST FOR THE U.S. BY CATEGORY THROUGH 2018 TABLE 30 CHANGE IN SHARE OF THE U.S. MARKET BY MARKET SECTOR, 2012 AND TABLE 31 GLOBAL MARKET FORECAST FOR EUROPE THROUGH TABLE 32 GLOBAL MARKET FORECAST FOR EUROPE BY CATEGORY THROUGH 2018 TABLE 33 CHANGE IN MARKET SHARE OF EUROPEAN MARKET BY CATEGORY 2012 AND TABLE 34 UPDATED LIST OF PERSCRIPTION ONLY MEDICINES TO PHARMACY AND PHARMACY TO GENERAL SALE LIST RECLASSIFICATIONS - U.K. ([YEAR] TO JUNE 2013) TABLE 35 RECENT RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS U.K. TABLE 36 GLOBAL MARKET FORECAST FOR THE U.K. BY CATEGORY THROUGH

12 TABLE HEADING TABLE 37 CHANGE IN MARKET SHARE OF THE U.K. MARKET BY CATEGORY 2012 AND TABLE 38 GLOBAL MARKET FORECAST FOR GERMANY BY CATEGORY, THROUGH 2018 TABLE 39 CHANGE IN MARKET SHARE FOR GERMANY BY CATEGORY THROUGH 2018 (%) TABLE 40 GLOBAL MARKET FORECAST FOR FRANCE BY CATEGORY THROUGH 2018 TABLE 41 CHANGE IN MARKET SHARE OF FRANCE BY CATEGORY THROUGH 68 TABLE 42 GLOBAL MARKET FORECAST FOR POLAND BY CATEGORY THROUGH 2018 TABLE 43 CHANGE IN MARKET SHARE OF POLAND BY CATEGORY 2012 AND 70 TABLE 44 GLOBAL MARKET FORECAST FOR ASIA-PACIFIC BY CATEGORY THROUGH 2018 TABLE 45 CHANGE IN MARKET SHARE OF ASIA-PACIFIC BY CATEGORY, 2012 AND TABLE 46 UPDATED LIST OF OTC TO FIRST KIND PHARMACEUTICAL DRUGS IN JAPAN NOV TO MAY 2013 TABLE 47 GLOBAL MARKET FORECAST FOR JAPAN BY CATEGORY THROUGH 2018 ($ TABLE 48 CHANGE IN MARKET SHARE OF ASIA-PACIFIC BY CATEGORY 2011 AND TABLE 49 GLOBAL MARKET FORECAST FOR AUSTRALIA AND NEW ZEALAND BY CATEGORY, THROUGH 2018 TABLE 50 CHANGE IN MARKET SHARE OF AUSTRALIA/NEW ZEALAND 2012 AND TABLE 51 GLOBAL MARKET FORECAST FOR BRIC BY CATEGORY THROUGH 2018 ($ TABLE 52 CHANGE IN MARKET SHARE OF BRIC COUNTRIES BY CATEGORY 2012 AND TABLE 53 GLOBAL MARKET FORECAST FOR BRAZIL BY CATEGORY THROUGH 2018 TABLE 54 CHANGE IN MARKET SHARE OF BRAZIL BY CATEGORY, 2012 AND 86 TABLE 55 GLOBAL MARKET FORECAST FOR RUSSIA BY CATEGORY THROUGH 2018 TABLE 56 CHANGE IN MARKET SHARE OF RUSSIA BY CATEGORY, 2012 AND 88 TABLE 57 GLOBAL MARKET FORECAST FOR CHINA BY CATEGORY THROUGH 2018 ($ TABLE 58 CHANGE IN MARKET SHARE OF CHINA BY CATEGORY, 2012 AND 90 TABLE 59 GLOBAL MARKET FORECAST FOR INDIA BY CATEGORY THROUGH 2018 ($ TABLE 60 CHANGE IN MARKET SHARE OF INDIA BY CATEGORY, 2012 AND 93 TABLE 61 GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS BY SALES CHANNELS, THROUGH 2018 TABLE 62 CHANGE IN MARKET SHARE BY SALES CHANNELS, 2012 AND 96 TABLE 63 GLOBAL SALES FOR OTC MEDICINES BY REGION, THROUGH 2018 ($ TABLE 64 CHANGE IN MARKET SHARE OF OTC MEDICINES BY COUNTRY, 2012 AND TABLE 65 GLOBAL MARKET FOR OTC MEDICINES BY THERUPEUTIC CLASSIFICATION, THROUGH

13 TABLE HEADING TABLE 66 CHANGE IN MARKET SHARE OF OTC MEDICINES BY THERUPEUTIC CLASSIFICATION, 2012 AND TABLE 67 GLOBAL MARKET FORECAST FOR OTC ANALGESICS AND ANTIPYRETICS, THROUGH 2018 TABLE 68 CHANGE IN MARKET SHARE OF OTC ANALGESICS AND ANTIPYRETIC, 2012 AND TABLE 69 GLOBAL MARKET FORECAST FOR OTC ANTIHISTAMINE AND COUGH AND COLD THROUGH 2018 TABLE 70 CHANGE IN MARKET SHARE OF OTC ANTIHISTAMINE AND COUGH AND COLD, 2012 AND TABLE 71 GLOBAL MARKET FORECAST FOR OTC GASTROINTESTINAL PRODUCTS, THROUGH 2018 TABLE 72 CHANGE IN MARKET SHARE OF OTC GASTROINTESTINAL PRODUCTS, 2012 AND TABLE 73 GLOBAL MARKET FORECAST FOR OTC DERMATOLOGICAL MEDICINES, THROUGH 2018 TABLE 74 CHANGE IN MARKET SHARE OF OTC DERMATOLOGICAL MEDICINES, THROUGH TABLE 75 GLOBAL MARKET FORECAST FOR OTC ORAL MEDICAL CARE PRODUCTS THROUGH 2018 TABLE 76 CHANGE IN MARKET SHARE OF OTC ORAL MEDICAL CARE PRODUCTS, 2012 AND TABLE 77 GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS, THROUGH 2018 TABLE 78 CHANGE IN MARKET SHARE OF OTC EYE CARE PRODUCTS, 2012 AND TABLE 79 ARTICLES REPORTED TO HAVE HIGHEST IMPLEMENTATION RATES IN 2012 WHO FCTC PROGRESS REPORT (%) TABLE 80 ARTICLES REPORTED MODERATE IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) TABLE 81 ARTICLES REPORTED LOWEST IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) TABLE 82 GLOBAL IMPLEMETATION OF FCTC ARTICLES: 2012 REPORT 113 TABLE 83 GLOBAL IMPLEMENTATION OF ARTICLE 14 OF FCTC 116 TABLE 84 INITIATIVES IMPLEMENTED BY PARTIES TO FCTC TREATY IN 2012 (%) 118 TABLE 85 PROJECTED GLOBAL CAUSE OF DEATH BY DISEASE (%) 120 TABLE 86 PUBLIC HEALTH BURDEN DUE TO SMOKING-RELATED DISEASES ($ BILLIONS) TABLE 87 GLOBAL SIZE OF SMOKING CESSATION MEDICINE MARKET BY REGION, THROUGH 2018 TABLE 88 GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS BY REGION THROUGH 2018 TABLE 89 CHANGE IN MARKET SHARE OF OTC SMOKING CESSATION PRODUCTS THROUGH TABLE 90 GLOBAL MARKET FORECAST FOR OTC DIETARY SUPPLEMENT PRODUCTS BY REGION, THROUGH 2018 TABLE 91 CHANGE IN MARKET SHARE OF DIETARY SUPPLEMENTS BY REGION, 2012 AND TABLE 92 SWOT ANALYSIS OF OTC MEDICINE AND DIETARY SUPPLEMENT INDUSTRY

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR OTC MEDICINES AND DIETARY SUPPLEMENTS FIGURE 1 GLOBAL IMPLEMENTATION OF ARTICLES OF 2012 WHO FCTC PROGRESS REPORT (%) FIGURE 2 ONGOING STUDIES, BY REGION (NO. OF STUDIES)