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Use this report to:
- Receive information concerning the dynamics and forecasts in the OTC drugs and dietary supplements market
- Receive information pertaining to the major regional trends in the global OTC drugs and dietary supplements market
- Identify the key initiatives and strategies to control regulatory and supply chain issues for market growth
- Understand the competitive thrust of the market

Highlights
- The global market for over the counter (OTC) drugs and dietary supplements reached $164.7 billion in 2016 and should reach $220.8 billion in 2021, with a compound annual growth rate (CAGR) of 6.0%.
- Dietary supplements as a segment reached $55.8 billion in 2016 and should reach $74.8 billion in 2021, with a CAGR of 6.1%.
- Oral medical care as a segment reached nearly $22.9 billion in 2016 and should reach $32.1 billion 2021, with a CAGR of 7.0%.

STUDY GOALS AND OBJECTIVES
The study goal of this report is to understand the OTC drugs and dietary supplement market and provide five-year forecasts for the same.

The objective of the study is to inform stakeholders of the OTC drugs and dietary supplement industry about market dynamics of the industry that will help them in planning strategic initiatives.

REASONS FOR DOING THE STUDY
Over the counter (OTC) drugs and dietary supplements encourage people to engage in responsible self-care and to access safe and effective OTC drugs and dietary supplements at the nearest retail counters.

The market for OTC drugs and dietary supplements is still instable due to lack of clear policies on various issues such as contents on the package, sales authorization in stores other than pharmacies, policies on advertising and promoting OTC drugs at point of sales, policies for pharmacy only or behind the counter drugs, and many more. Issues regarding sales promotion and sales in outlets other than pharmacies raise higher concerns.
Regulatory issues are big hurdles in the growth of the OTC drugs market. The latest issue is that of refunds and reimbursing OTC drugs bills. People from various countries produce claims for OTC bills where irregularities were identified that were trying to move prescription drugs to OTC and did not help reduce the public health burden. Many nations are now making it compulsory to produce a prescription for compensating OTC drugs under medical billing. This has again brought sales of OTC drugs down since 2010.

There are no common policies and regulations worldwide and some countries follow US FDA guidelines and other follow the UK MHRA. Another key issue the industry faces is lack of a seamless reclassification of drugs from prescription to OTC. Drugs classified as OTC in one country are restricted in other country and need a prescription. This is another big issue in supply chain management and distribution of drugs especially for online pharmacies and multinational pharmacy chains.

BCC Research identified a need for the study of present markets for OTC drugs and dietary supplements on the basis of regulatory and supply chain issues and decided to find out what are the key initiatives and strategies worldwide to control these issues for market growth.

SCOPE OF REPORT
The report considers only western or modern drugs for this report and excludes any other type of drugs such as alternative therapies.

This study aims at understanding the dynamics and forecasts for OTC drugs and dietary supplements markets worldwide and provides key market propositions within the next five-year period.

The report covers developed and emerging markets in order to help readers understand:
- The current state of the OTC drugs and dietary supplements market and the key markets for its future development.
- New regulations that will influence the development of the OTC drugs and dietary supplements market.
- Market drivers of and threats to the OTC drugs and dietary supplements industry.
- Major regional trends in the global OTC drugs and dietary supplements market.
- The competitive thrust of the market.

INTENDED AUDIENCE
- Executives of pharmaceutical companies that are currently marketing OTC drugs and dietary supplements.
- Executives of companies that provide third-party manufacturing and development facilities for OTC drugs and dietary supplements.
- Manufacturers of bulk active ingredients and inactive ingredients such as base, resins, pigments and other raw materials for the manufacturing of OTC drugs and dietary supplements.
- FMCG companies that intend to enter the OTC drugs and dietary supplements market.
- Entrepreneurs, management consultants, and merger and acquisition (M&A) consultants.
- Financial institutions, venture capitalists and angel investors.
- Manufacturers and exporters of alternate OTC drugs and food supplements.
- Government agencies, public health departments and organizations working in regulations and process development of OTC drugs and dietary supplements.

INFORMATION SOURCES
The information and analysis presented in this BCC Research report are based on firsthand information from primary executives, product managers and clinical specialists; background information obtained from various government, business, medical journal and trade magazines; and statistical data from various governmental organizations and trade associations.

Key information from published literature was used to conduct interviews with industry participants in order to validate and obtain expert opinion on current and future trends. Interviews were also used to confirm and/or adjust market size and market share estimates as well as to formulate market projections Data are expressed in 2015 U.S. dollars. The base year is 2015. Historical data are provided for 2014 and forecast data are provided for 2016 and 2021. Historical, base year and forecast data are provided for each market segment and sub-segment.

Table Of Contents

Over-the-Counter (OTC) Drugs and Dietary Supplements: Global Markets

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'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 5

CHAPTER 2 SUMMARY 7 GLOBAL OTC DRUG MARKETS BY LEADING THERAPEUTIC SEGMENTS, 2016 THROUGH 2021 8
SUMMARY TABLE A GLOBAL THERAPEUTIC MARKETS FOR OTC DRUGS, BY SEGMENT, THROUGH 2021 ($ MILLIONS) 8
SUMMARY FIGURE A GLOBAL THERAPEUTIC MARKETS FOR OTC DRUGS, BY SEGMENT, 2015-2021 ($ MILLIONS) 9
GLOBAL DIETARY SUPPLEMENT MARKETS, 2016 THROUGH 2021 10
SUMMARY TABLE B REGIONAL MARKETS FOR DIETARY SUPPLEMENTS, THROUGH 2021 ($ MILLIONS) 10
SUMMARY FIGURE B REGIONAL MARKETS FOR DIETARY SUPPLEMENTS, 2015-2021 ($ MILLIONS) 10

CHAPTER 3 OVERVIEW 13
EVOLUTION OF OTC DRUGS 13
KEY GROWTH FACTORS FOR OTC DRUGS AND DIETARY SUPPLEMENT MARKETS 15
FIGURE 1 KEY GROWTH FACTORS FOR OTC DRUGS 15
INDUSTRY DRIVERS FOR OTC DRUGS 16
PREVALENCE OF SELF-CARE 16
BURDEN ON PUBLIC HEALTH SYSTEM 17
RETAIN MARKET LEADERSHIP 18
RULES AND REGULATIONS FOR OTC DRUGS AND DIETARY SUPPLEMENTS 19
REGULATIONS FOR OTC DRUGS 20
REGULATIONS FOR DIETARY SUPPLEMENTS 21
MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS 22
WELL-DEVELOPED MARKETS 22
DEVELOPING MARKETS 23
UNDER-DEVELOPED MARKETS 25

CHAPTER 4 GLOBAL OTC DRUGS AND DIETARY SUPPLEMENT MARKETS 27
GLOBAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS 2016 THROUGH 2021 27
TABLE 1 GLOBAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS, THROUGH 2021 ($ MILLIONS) 27
REGIONAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENT MARKETS 2016 THROUGH 2021 28
TABLE 2 REGIONAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS THROUGH 2021 ($ MILLIONS) 28
GLOBAL SALES FORECAST FOR OTC DRUGS BY THERUPEUTIC CLASSIFICATION 29
TABLE 3 GLOBAL MARKET FOR OTC DRUGS, BY THERUPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 29
GLOBAL OTC DRUGS AND DIETARY SUPPLEMENT MARKETS BY LOCATION OF SALES 2016 THROUGH 2021 30
TABLE 4 OTC DRUGS REVENUE BY LOCATION OF SALES, THROUGH 2021 ($ MILLIONS) 30
TABLE 5 DIETARY SUPPLEMENTS REVENUE BY LOCATION OF SALES, THROUGH 2021 ($ MILLIONS) 31
GLOBAL MARKET FORECAST FOR OTC DRUGS AND DIETARY SUPPLEMENTS BY SALES OUTLETS, THROUGH 2021 32

CHAPTER 5 OTC DRUGS AND DIETARY SUPPLEMENT MARKETS IN THE AMERICAS 34
OTC DRUGS AND DIETARY SUPPLEMENT MARKETS IN NORTH AMERICA 2016 THROUGH 2021 34
NORTH AMERICA OTC DRUGS MARKETS 2016 THROUGH 2021 34
TABLE 6 NORTH AMERICA OTC DRUG MARKETS, THROUGH 2021 ($ MILLIONS) 34
NORTH AMERICA DIETARY SUPPLEMENT MARKETS 2016 THROUGH 2021 34
TABLE 7 NORTH AMERICA DIETARY SUPPLEMENT MARKETS, THROUGH 2021 ($ MILLIONS) 34
NORTH AMERICA OTC DRUGS MARKETS BY THERAPEUTIC CLASSIFICATION 2016 THROUGH 2021 35
TABLE 8 NORTH AMERICA MARKETS BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 35
OTC DRUGS AND DIETARY SUPPLEMENTS IN THE U.S. 35
NORTH AMERICA OTC DRUGS MARKETS BY THERAPEUTIC CLASSIFICATION 2016-2021 36
TABLE 8 NORTH AMERICA MARKETS BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 36
VENDOR ECOSYSTEM FOR OTC DRUGS IN THE U.S. 36
MULTINATIONAL OTC DRUG MANUFACTURERS 36
STORE BRANDS 37
FMCG COMPANIES 37
REGULATIONS AND APPROVAL PROCESS: THE U.S. 38
Drugs Developed Under the OTC Drug Monograph Process 38
OTC Drug Review 38
OTC Monograph 39
OTC Drugs Developed Through the NDA Process 39
Updated List of Prescription to Over-the-Counter (OTC) Switches 39
TABLE 9 UPDATED LIST OF RX-TO-OTC SWITCHES IN THE U.S. FROM 2001 TO 2016 39
THE U.S. NONPRESCRIPTION SAFE-USE REGULATORY EXPANSION (NSURE) INITIATIVE 42
THE U.S. OTC DRUGS AND DIETARY SUPPLEMENT MARKET 2016-2021 43
TABLE 10 THE U.S. OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 43
BRAZIL OTC DRUGS MARKET 44
BRAZIL OTC DRUGS MARKET 2016 THROUGH 2021 45
TABLE 11 BRAZIL OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 46

CHAPTER 6 THE OTC DRUG AND DIETARY SUPPLEMENT MARKETS IN EUROPE 48
BREXIT EFFECT ON THE OTC DRUG MARKET IN EUROPE 48
REGULATIONS AND APPROVAL PROCESS IN EUROPE 49
National Procedure 49
Decentralized Procedure 49
Mutual Recognition Procedure 49
Centralized Procedure 50
SMART REGULATION 2015: EUROPE AS A SINGLE MARKET 50
OTC DRUGS AND DIETARY SUPPLEMENT MARKETS IN EUROPE 2016 - 2021 51
EUROPEAN OTC DRUGS AND DIETARY SUPPLEMENT MARKETS 2016 - 2021 52
TABLE 12 EUROPEAN OTC DRUG MARKETS, THROUGH 2021 ($ MILLIONS) 52
OTC DRUGS AND DIETARY SUPPLEMENT MARKETS: WESTERN EUROPE THROUGH 2021 53
TABLE 13 EUROPEAN OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 53
THE U.K. OTC DRUG MARKET 54
THE REGULATIONS AND APPROVAL PROCESS IN THE U.K. 54
Better Regulation of Over-the-Counter Drugs Initiative (BROMI) U.K. 56
POM TO P RECLASSIFICATIONS UP TO OCTOBER 2016 56
TABLE 14 U.K. POM TO P RECLASSIFICATIONS UP TO OCTOBER 2016 56
TABLE 15 P TO GSL RECLASSIFICATIONS UP TO OCTOBER 2016 58
POM TO P RECLASSIFICATIONS IN THE U.K. APPROVED FROM 2010 TO 2015 59
TABLE 16 RECENT POM TO P RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS: U.K., 2010-2015 59
TABLE 17 RECENT P TO GSL RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS - U.K., 2011-2015 59
U.K. OTC DRUGS AND DIETARY SUPPLEMENT MARKET 2016 THROUGH 2021 60
TABLE 18 THE U.K. OTC DRUG MARKET, BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 61
GERMAN OTC DRUG AND DIETARY SUPPLEMENTS MARKET 61
THE REGULATIONS AND APPROVAL PROCESS IN GERMANY 62
OTC DRUG SWITCHES IN GERMANY FROM 2005 TO 2016 62
TABLE 19 OTC DRUG SWITCHES IN GERMANY FROM 2005 TO 2016 62
GERMAN OTC MARKET 2016 THROUGH 2021 63
TABLE 20 GERMANY OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 64
FRANCE'S OTC DRUGS MARKET 2016 THROUGH 2021 64
TABLE 21 FRANCE OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 65
OTC DRUGS AND DIETARY SUPPLEMENT MARKETS IN CENTRAL AND EASTERN EUROPE 66
TABLE 22 CCE OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 66
THE RUSSIAN OTC DRUG MARKET 2016 THROUGH 2021 67
TABLE 23 RUSSIAN OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 67
THE POLISH OTC DRUG MARKET 2016 THROUGH 2021 68
TABLE 24 POLISH OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 69

CHAPTER 7 OTC DRUGS AND DIETARY SUPPLEMENT MARKETS IN ASIA-PACIFIC 71
APAC OTC DRUGS MARKETS 2016 THROUGH 2021 71
TABLE 25 APAC OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 72
JAPAN'S OTC DRUGS MARKET 72
The Regulation and Approval Process in Japan 73
Reviews Conducted for OTC Drugs In Japan, by Fiscal Year 74
TABLE 26 REVIEWS CONDUCTED FOR OTC DRUGS IN JAPAN, BY FISCAL YEAR, 2011-2015 74
First Kind Pharmaceutical Newly Approved - Japan's OTC Pharmaceutical Sales System 74
TABLE 27 UPDATED LIST OF OTC TO FIRST KIND PHARMACEUTICAL DRUGS IN JAPAN, NOV. 2007-MARCH 2016 74
JAPAN'S OTC DRUGS MARKET 2016 THROUGH 2021 76
TABLE 28 JAPAN OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 77
CHINA OTC DRUG MARKETS 2016 THROUGH 2021 77
THE REGULATION AND APPROVAL PROCESS: CHINA 77
New Amendments in Regulating Drug Advertising in 2015 79
CHINA - OTC DRUGS MARKET 2016 THROUGH 2021 79
TABLE 29 CHINA OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 79
INDIA OTC DRUG MARKETS 80
INDIA: REGULATION AND APPROVAL PROCESSES 81
INDIA - OTC DRUGS MARKET 2016 THROUGH 2021 81
TABLE 30 INDIA OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 82
AUSTRALIA AND NEW ZEALAND'S OTC DRUGS MARKET 82
Regulation and Approval Process: Australia 83
NEW ZEALAND 84
JOINT AUSTRALIAN AND NEW ZEALAND PHASED IMPLEMENTATION PLAN 2013 85
N2 Applications (Using OTC Monographs) Version1, September 2013 85
Level N3, N4 and N5 Applications 86
AUSTRALIA AND NEW ZEALAND: OTC DRUGS MARKET 2016 THROUGH 2021 86
TABLE 31 AUSTRALIA AND NEW ZEALAND OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 86

CHAPTER 8 GLOBAL MARKET FORECAST FOR OTC DRUGS BY THERUPEUTIC CLASSIFICATION 88
OTC ANALGESICS/ANTIPYRETICS MARKETS 2021 88
ACETAMINOPHEN 88
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) 88
MARKET FORECASTS 2016 THROUGH 2021 90
TABLE 32 GLOBAL MARKET FORECAST FOR OTC ANALGESICS AND ANTIPYRETICS, THROUGH 2021 ($ MILLIONS) 90
OTC ANTIHISTAMINE AND COUGH AND COLD DRUGS MARKETS 2021 91
ANTIHISTAMINES 91
COUGH AND COLD REMEDIES 92
Nasal Decongestants 92
Cough Remedies 92
GLOBAL MARKET FORECASTS THROUGH 2021 93
TABLE 33 GLOBAL MARKET FORECAST FOR OTC ANTIHISTAMINE AND COUGH AND COLD, THROUGH 2021 ($ MILLIONS) 93
OTC GASTROINTESTINAL PRODUCTS MARKETS 2021 93
GASTROINTESTINAL DISORDER TREATMENTS 93
Antacids 94
H2 Blockers 94
Proton Pump Inhibitors (PPIs) 94
GLOBAL MARKET FORECAST FOR THROUGH 2021 95
TABLE 34 GLOBAL MARKET FORECAST FOR OTC GASTROINTESTINAL PRODUCTS, THROUGH 2021 ($ MILLIONS) 95
OTC DERMATOLOGICAL DRUGS MARKETS 2021 95
SKINCARE AND DERMATOLOGICAL DRUGS 96
Acne Treatments 96
Psoriasis 97
GLOBAL MARKET FORECAST THROUGH 2021 97
TABLE 35 GLOBAL MARKET FORECAST FOR OTC DERMATOLOGICAL DRUGS, THROUGH 2021 ($ MILLIONS) 97
OTC ORAL MEDICAL CARE PRODUCTS MARKETS 2021 98
ORAL MEDICAL CARE 98
Oral Debriding Agents and Wound Cleansers 98
Treatments for Dental Carries 98
Treatments on Gum Diseases 98
Treatments for Cold Sores 99
GLOBAL MARKET FORECAST FOR THROUGH 2021 99
TABLE 36 GLOBAL MARKET FORECAST FOR OTC ORAL MEDICAL CARE PRODUCTS THROUGH 2021 ($ MILLIONS) 99
GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS 99
EYE CARE PRODUCTS 99
Treatments for Dry Eye 100
Ocular Allergy Symptoms 100
Ocular/Eye Vitamins 100
Eyelid Hygiene 100
Contact Lenses Solution 100
Dry Eye 101
GLOBAL MARKET FORECAST THROUGH 2021 101
TABLE 37 GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS, THROUGH 2021 ($ MILLIONS) 101
OTC SMOKING CESSATION PRODUCTS MARKETS 2021 101
SMOKING CESSATION 102
Nicotine Gum 103
Nicotine Lozenges 103
Nicotine Patch 104
GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS BY REGION THROUGH 2021 105
TABLE 38 GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS, BY REGION, THROUGH 2021 ($ MILLIONS) 105
OTC DIETARY SUPPLEMENTS (VMS) MARKETS 2021 106
EATING DISORDERS 106
TREATMENTS FOR VITAMINS AND MINERAL DEFICIENCY 106
VITAMINS AND MINERAL SUPPLEMENTS (VMS) 107
GLOBAL MARKET FORECAST THROUGH 2021 107
TABLE 39 GLOBAL MARKET FORECAST FOR OTC DIETARY SUPPLEMENT PRODUCTS, BY REGION, THROUGH 2021 ($ MILLIONS) 107

CHAPTER 9 OTC DRUG INDUSTRY ROADMAP 109
THE PRACTICE OF BUYING OTC DRUGS 109
ROLE OF PHARMACY IN OTC DRUGS 109
REGULATORY INFLUENCE ON OTC DRUG MARKET 109
KEY STRATEGIC INITIATIVES FOR MARKET PENETRATION AND EXPANSION 110
ACQUISITION OF MARKETING AUTHORIZATION: KEY MARKET PENETRATION AND EXPANSION STRATEGY 110
EXPANSIONS, PARTNERSHIPS AND JOINT VENTURES 111
THIRD-PARTY CONTRACTING 112
DRIVERS OF AND BARRIERS TO THE OTC DRUG INDUSTRY 112
RECENT DRIVERS FOR THE OTC DRUGS AND DIETARY SUPPLEMENT MARKET 112
STRENGTHS, WEAKNESSES, OPPORTUNITIES AND THREATS (SWOT) ANALYSIS OF THE OTC DRUG AND DIETARY SUPPLEMENT INDUSTRY 113
TABLE 40 SWOT ANALYSIS OF THE OTC DRUG AND DIETARY SUPPLEMENT INDUSTRY 113

CHAPTER 10 COMPANY PROFILES 116
ALACER CORP. 116
ALCON INC. 116
ALFRESA PHARMA CORPORATION 116
ALKALON A/S 116
ALLIANCE HEALTHCARE 117
ALLIANCE HEALTHCARE DEUTSCHLAND 117
ALLIANCE HEALTHCARE FRANCE 117
ALLERGAN, PLC. 117
ALTICOR 118
NUTRILITE 118
ARKOPHARMA PHARMACEUTICAL LABORATORIES (LABORATOIRES PHARMACEUTIQUES) 118
ASPEN HOLDINGS 118
ASPEN PHARMACARE AUSTRALIA PTY. LTD. 119
BAUSCH and LOMB 119
BAYER HEALTHCARE AG 119
BOEHRINGER INGELHEIM GMBH 120
CARMA LABORATORIES, INC. 120
CHATTEM INC. 120
CILAG AG 121
COLGATE-PALMOLIVE COMPANY 121
DAIICHI SANKYO CO., LTD. 121
DERMA SCIENCES 122
EYESCIENCE LABS 122
FERTIN PHARMA A/S 122
GABA GMBH, PC 122
GABA SCHWEIZ 123
GALDERMA S.A. 123
GEMINI PHARMACEUTICALS, INC. 123
GENOMMA LAB INTERNATIONAL 123
GENOMMA LAB USA 124
GLAXOSMITHKLINE PLC 124
HISAMITSU PHARMACEUTICAL CO., INC. 124
JOHNSON and JOHNSON 125
KOWA COMPANY, LTD. 125
LAKE CONSUMER PRODUCTS, INC. 125
MANX HEALTHCARE LIMITED 126
MCM KLOSTERFRAU VERTRIEBS GMBH (KLOSTERFRAU HEALTHCARE GROUP) 126
MEDA AB 126
MELALEUCA, INC. 126
MERCK CORPORATE HEADQUARTERS 127
MERCK CANADA 127
MERCK CHINA 127
MERZ PHARMA 127
MOCHIDA PHARMACEUTICAL CO., LTD. 128
NEPENTES SA/NEPENTES PHARMA SP. Z O.O. 128
NEUTROGENA CORP. 128
NORTHEAST PHARMACEUTICAL GROUP CO. LTD 128
NOVARTIS INTERNATIONAL AG 129
NOW FOODS 129
PERRIGO PLC 129
PFIZER INC. 130
PGT HEALTHCARE (DIVISION OF PROCTER and GAMBLE) 130
PHARMAVITE LLC 130
PIERRE FABRE PHARMACEUTICALS INC. 130
PIRAMAL HEALTHCARE LTD 131
PRESTIGE BRANDS HOLDINGS, INC. 131
RECKITT BENCKISER PLC. 132
RECKITT BENCKISER (NORTH AMERICA) INC. 132
RECORDATI PHARMA GMBH 132
REVOLYMER (U.K.) LTD 132
SAGE PRODUCTS LLC 133
SANOFI 133
SATO PHARMACEUTICAL CO., LTD. 133
SHAKLEE CORPORATION 134
STADA ARZNEIMITTEL AG 134
SWISSE WELLNESS PTY LTD. 134
TAISHO PHARMACEUTICAL HOLDINGS 135
TAKEDA PHARMACEUTICALS LTD. 135
TISSO NATURPRODUKTE GMBH 135
WELLSPRING PHARMACEUTICAL CORPORATION 136
ZEAVISION, LLC 136

CHAPTER 11 APPENDIX I 138
MARKET DEFINITIONS 138
OTC DRUGS 138
DIETARY SUPPLEMENTS (VMS) 139
COMMON ADMINISTRATION METHODS FOR OTC DRUGS 140
TOPICAL ADMINISTRATION 140
Lotion 140
Cream 140
Ointment 141
Gel 141
Transdermal Patch 141
ORAL ADMINISTRATION 141
Tablets 141
Capsules 142
Medicinal Syrups 142
Medicated Chewing Gums 142

CHAPTER 12 APPENDIX II 144
SMOKING CESSATION INITIATIVES 144
HIGH RATE OF SMOKERS QUITTING IN DEVELOPED COUNTRIES 144
DECREASE IN SMOKING RATES AT SATURATION POINT IN DEVELOPED MARKETS 144
SMOKING RATES ARE INCREASING IN DEVELOPING MARKETS 144
STRATEGIC INITIATIVES TO INCREASE SMOKING CESSATION IN DEVELOPING COUNTRIES 145
DEVELOPING AND POOR COUNTRIES SIGN WHO FCTC TREATY 145
WHO FCTC PROGRESS REPORT 2012 145
TABLE 41 ARTICLES REPORTED TO HAVE HIGHEST IMPLEMENTATION RATES IN 2012 WHO FCTC PROGRESS REPORT (%) 146
TABLE 42 ARTICLES REPORTED MODERATE IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) 146
TABLE 43 ARTICLES REPORTED LOWEST IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) 147
FIGURE 2 GLOBAL IMPLEMENTATION OF ARTICLES OF 2012 WHO FCTC PROGRESS REPORT (%) 147
TABLE 44 GLOBAL IMPLEMETATION OF FCTC ARTICLES: 2012 REPORT 148
Implementation of Article 14 in 2012 150
TABLE 45 GLOBAL IMPLEMENTATION OF ARTICLE 14 OF FCTC 150
Political and Legal Interventions Influence Markets 151
TABLE 46 INITIATIVES IMPLEMENTED BY PARTIES TO FCTC TREATY IN 2012 (%) 152
Socioeconomic Factors of Smoking 153
TABLE 47 PROJECTED GLOBAL CAUSE OF DEATH BY DISEASE (%) 155
TABLE 48 PUBLIC HEALTH BURDEN DUE TO SMOKING-RELATED DISEASES ($ BILLIONS) 155
Technological Developments Concerning Smoking 155
FIGURE 3 ONGOING STUDIES, BY REGION (NO. OF STUDIES) 156

CHAPTER 13 APPENDIX III 159
OTC MARKETS 2013 THROUGH 2018 159
TABLE 49 GLOBAL MARKET FOR OTC DRUGS AND DIETARY SUPPLEMENTS THROUGH 2018 ($ MILLIONS) 159
FIGURE 4 GLOBAL MARKET FOR OTC DRUGS AND DIETARY SUPPLEMENTS, 2011-2018 ($ MILLIONS) 159
HIGHLIGHTS OF THE YEAR 2012 160
TRENDS IN OTC DRUGS AND DIETARY SUPPLEMENTS THROUGH 2018 161
FORECAST TRENDS IN OTC DRUGS BY THERAPEUTIC CLASS THROUGH 2018 162

LIST OF TABLES
SUMMARY TABLE A GLOBAL THERAPEUTIC MARKETS FOR OTC DRUGS, BY SEGMENT, THROUGH 2021 ($ MILLIONS) 8
SUMMARY TABLE B REGIONAL MARKETS FOR DIETARY SUPPLEMENTS, THROUGH 2021 ($ MILLIONS) 10
TABLE 1 GLOBAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS, THROUGH 2021 ($ MILLIONS) 27
TABLE 2 REGIONAL MARKETS FOR OTC DRUGS AND DIETARY SUPPLEMENTS THROUGH 2021 ($ MILLIONS) 28
TABLE 3 GLOBAL MARKET FOR OTC DRUGS, BY THERUPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 29
TABLE 4 OTC DRUGS REVENUE BY LOCATION OF SALES, THROUGH 2021 ($ MILLIONS) 30
TABLE 5 DIETARY SUPPLEMENTS REVENUE BY LOCATION OF SALES, THROUGH 2021 ($ MILLIONS) 31
TABLE 6 NORTH AMERICA OTC DRUG MARKETS, THROUGH 2021 ($ MILLIONS) 34
TABLE 7 NORTH AMERICA DIETARY SUPPLEMENT MARKETS, THROUGH 2021 ($ MILLIONS) 34
TABLE 8 NORTH AMERICA MARKETS BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 35
TABLE 8 NORTH AMERICA MARKETS BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 36
TABLE 9 UPDATED LIST OF RX-TO-OTC SWITCHES IN THE U.S. FROM 2001 TO 2016 39
TABLE 10 THE U.S. OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 43
TABLE 11 BRAZIL OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 46
TABLE 12 EUROPEAN OTC DRUG MARKETS, THROUGH 2021 ($ MILLIONS) 52
TABLE 13 EUROPEAN OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 53
TABLE 14 U.K. POM TO P RECLASSIFICATIONS UP TO OCTOBER 2016 56
TABLE 15 P TO GSL RECLASSIFICATIONS UP TO OCTOBER 2016 58
TABLE 16 RECENT POM TO P RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS: U.K., 2010-2015 59
TABLE 17 RECENT P TO GSL RECLASSIFICATIONS AND NONPRESCRIPTION MARKETING AUTHORIZATIONS - U.K., 2011-2015 59
TABLE 18 THE U.K. OTC DRUG MARKET, BY THERAPEUTIC CLASSIFICATION, THROUGH 2021 ($ MILLIONS) 61
TABLE 19 OTC DRUG SWITCHES IN GERMANY FROM 2005 TO 2016 62
TABLE 20 GERMANY OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 64
TABLE 21 FRANCE OTC DRUG MARKETS BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 65
TABLE 22 CCE OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFCATIONS, THROUGH 2021 ($ MILLIONS) 66
TABLE 23 RUSSIAN OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 67
TABLE 24 POLISH OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 69
TABLE 25 APAC OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 72
TABLE 26 REVIEWS CONDUCTED FOR OTC DRUGS IN JAPAN, BY FISCAL YEAR, 2011-2015 74
TABLE 27 UPDATED LIST OF OTC TO FIRST KIND PHARMACEUTICAL DRUGS IN JAPAN, NOV. 2007-MARCH 2016 74
TABLE 28 JAPAN OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 77
TABLE 29 CHINA OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 79
TABLE 30 INDIA OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 82
TABLE 31 AUSTRALIA AND NEW ZEALAND OTC DRUG MARKETS, BY THERAPEUTIC CLASSIFICATIONS, THROUGH 2021 ($ MILLIONS) 86
TABLE 32 GLOBAL MARKET FORECAST FOR OTC ANALGESICS AND ANTIPYRETICS, THROUGH 2021 ($ MILLIONS) 90
TABLE 33 GLOBAL MARKET FORECAST FOR OTC ANTIHISTAMINE AND COUGH AND COLD, THROUGH 2021 ($ MILLIONS) 93
TABLE 34 GLOBAL MARKET FORECAST FOR OTC GASTROINTESTINAL PRODUCTS, THROUGH 2021 ($ MILLIONS) 95
TABLE 35 GLOBAL MARKET FORECAST FOR OTC DERMATOLOGICAL DRUGS, THROUGH 2021 ($ MILLIONS) 97
TABLE 36 GLOBAL MARKET FORECAST FOR OTC ORAL MEDICAL CARE PRODUCTS THROUGH 2021 ($ MILLIONS) 99
TABLE 37 GLOBAL MARKET FORECAST FOR OTC EYE CARE PRODUCTS, THROUGH 2021 ($ MILLIONS) 101
TABLE 38 GLOBAL MARKET FORECAST FOR OTC SMOKING CESSATION PRODUCTS, BY REGION, THROUGH 2021 ($ MILLIONS) 105
TABLE 39 GLOBAL MARKET FORECAST FOR OTC DIETARY SUPPLEMENT PRODUCTS, BY REGION, THROUGH 2021 ($ MILLIONS) 107
TABLE 40 SWOT ANALYSIS OF THE OTC DRUG AND DIETARY SUPPLEMENT INDUSTRY 113
TABLE 41 ARTICLES REPORTED TO HAVE HIGHEST IMPLEMENTATION RATES IN 2012 WHO FCTC PROGRESS REPORT (%) 146
TABLE 42 ARTICLES REPORTED MODERATE IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) 146
TABLE 43 ARTICLES REPORTED LOWEST IMPLEMENTATION RATES: 2012 WHO FCTC PROGRESS REPORT (%) 147
TABLE 44 GLOBAL IMPLEMETATION OF FCTC ARTICLES: 2012 REPORT 148
TABLE 45 GLOBAL IMPLEMENTATION OF ARTICLE 14 OF FCTC 150
TABLE 46 INITIATIVES IMPLEMENTED BY PARTIES TO FCTC TREATY IN 2012 (%) 152
TABLE 47 PROJECTED GLOBAL CAUSE OF DEATH BY DISEASE (%) 155
TABLE 48 PUBLIC HEALTH BURDEN DUE TO SMOKING-RELATED DISEASES ($ BILLIONS) 155
TABLE 49 GLOBAL MARKET FOR OTC DRUGS AND DIETARY SUPPLEMENTS THROUGH 2018 ($ MILLIONS) 159

LIST OF FIGURES
SUMMARY FIGURE A GLOBAL THERAPEUTIC MARKETS FOR OTC DRUGS, BY SEGMENT, 2015-2021 ($ MILLIONS) 9
SUMMARY FIGURE B REGIONAL MARKETS FOR DIETARY SUPPLEMENTS, 2015-2021 ($ MILLIONS) 10
FIGURE 1 KEY GROWTH FACTORS FOR OTC DRUGS 15
FIGURE 2 GLOBAL IMPLEMENTATION OF ARTICLES OF 2012 WHO FCTC PROGRESS REPORT (%) 147
FIGURE 3 ONGOING STUDIES, BY REGION (NO. OF STUDIES) 156
FIGURE 4 GLOBAL MARKET FOR OTC DRUGS AND DIETARY SUPPLEMENTS, 2011-2018 ($ MILLIONS) 159

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