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The Pharmaceutical Market: Mexico, Business Monitor International
Published on January 2013

                                                                                                           Report Summary

Espicom market intelligence, brought to you by Business Monitor International


OVERVIEW OF THE PHARMACEUTICAL MARKET IN MEXICO
The improving regulatory environment and the increasing foreign direct investment make Mexico's pharmaceutical market more
attractive to multinational drugmakers. We project an increase in government healthcare spending to further boost the number of
procedures and expand access to medicines in its national health insurance programme. However, the potential deceleration of the
country's macroeconomic growth may dampen the country's pharmaceutical market prospects. Generic drug competition and
counterfeit medicines are also key concerns for multinationals pharmaceutical companies.


Headline Expenditure Projections


Pharmaceuticals: MXN161.45bn (US$12.99bn) in 2011 to MXN175.82bn (US$13.47bn) in 2012; +8.9% in local currency terms and
+3.7% in US dollar terms. Forecasts increase from Q4 12 due to macroeconomic factors.


Healthcare: MXN872.57bn (US$70.21bn) in 2011 to MXN951.98bn (US$72.95bn) in 2012; +9.1% in local currency terms and +3.9 %
in US dollar terms. F orecasts increase from Q4 12 due to macroeconomic factors.


Medical devices: MXN52.05bn (US$4.19bn) in 2011 to MXN57.85bn (US$4.43bn) in 2012; +11.1% in local currency terms and
+5.9% in US dollar terms. F orecasts increase from Q4 12 due to macroeconomic factors.



Risk/Reward Rating: The Pharmaceutical and Healthcare Risk/Reward Rating (RRR) in Q113 for Mexico remains the same (58.4)
as in Q412. Mexico still ranks the fourth out of the 17 Americas markets surveyed in our proprietary regional RRR rating system
above Brazil, indicating a more optimistic outlook for Mexican market.



Competitive Landscape


The competitive landscape section provides comparative company analyses and rankings by US$ sales and % share of total sales -
for the total pharmaceutical sector, as well as the OTC, generics, and distribution sub-sectors.




                                                                                                            Table of Content

Table of Contents


Executive Summary 8
SWOT Analysis 10
Mexico Pharmaceuticals And Healthcare Industry SWOT 10



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Mexico Political SWOT 11
Mexico Economic SWOT 11
Mexico Business Environment SWOT 12
Pharmaceutical Risk/Reward Ratings 13
Table: Americas Pharmaceutical And Healthcare Risk/Reward Ratings, Q113                   13
Rewards 15
Risks 15
Mexico ' Market Summary 17
Regulatory Regime 19
Marketing Registration 20
Table: Legal Pharmaceutical Registration Requirements 21
Table: Legal Pharmaceutical Registration Requirements 21
Import Regulation 22
Table: Import Fees 23
Table: Registration Renewal Requirements 23
Release Of Manufacturing Requirements 23
Regulation Of Antibiotics 24
Post-Marketing 24
Advertising 25
Biologics And Biosimilar Guideline 26
Research & Development 29
Table: NOM-177-SSA1-1998's Generic Tests 32
Intellectual Property Rights 32
Intellectual Property Environment 34
IP Shortcomings 35
Table: Mexican Marketing Applications In Alleged Violation Of Patent Rights              36
Counterfeit Drugs 37
Pricing & Reimbursement 38
Reimbursement 40
Pricing Issues 41
Pricing Developments 43
Reimbursement Issues 44
Other Regulatory Developments                     44
Industry Trends and Developments 46
Epidemiology 46
Non-Communicable Diseases 47
Healthcare Sector 47
Health Insurance 48
Healthcare Sector Funding 50
Medical Tourism 50
Research & Development 51
Clinical Trials 53
Table: Clinical Trial Regulation In Mexico 54
Table: Clinical Studies, 2003-09 56
Medical Devices 57
Industry Forecast Scenario                58
Overall Market Forecast 58
Table: Pharmaceutical Sales Indicators 2008-2016                            59



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Key Growth Drivers ' Industry 60
Table: Healthcare Expenditure Indicators 2008-2016 61
Table: Healthcare Governmental Indicators 2008-2016 62
Table: Healthcare Private Indicators 2008-2016 62
Key Growth Drivers ' Macroeconomic 64
Table: Mexico Macro Indicators 69
Prescription Drug Market Forecast 70
Table: Prescription Drug Sales Indicators 2008-2016 71
Patented Drug Market Forecast                    72
Table: Patented Drug Market Indicators 2008-2016 73
Generic Drug Market Forecast 74
Table: Generic Drug Sales Indicators, 2008-2016 76
Associations 76
Table: Members of AMEGI, 2011 77
Members of ANAFAM, 2011 78
OTC Medicine Market Forecast                    80
Table: OTC Medicine Sales Indicators 2008-2016 82
Pharmaceutical Trade Forecast 83
Table: Exports and Imports Indicators 2008-2016 84
Medical Device Market Forecast 86
Table: Medical Devices Sales Indicators, 2008-2016 86
Other Healthcare Data 87
Key Risks To BMI's Forecast Scenario 87
Competitive Landscape                89
Pharmaceuticals Industry 89
Pharmaceutical Company Activity 90
Foreign Competition 90
Table: Members of AFAMELA, 2012 90
Table: Members of AMIIF, 2012 91
Table: Members of CANIFARMA, 2012                           93
Table: AstraZeneca's Sales, 2005-10 96
Pharmaceutical Distribution Sector 104
Wholesale 104
DIPROFAR 104
Grupo Casa Saba 104
Marzam 105
NADRO 106
Pharmaceuticals Retail Sector 107
Table: IMSS Pharmacies, 2000-11                       107
Table: IMSS Financial Indicators, 2000-11 (MXNmn)                              109
Table: Leading Pharmaceutical Suppliers to IMSS, 2010-12 (MXNmn) 110
Table: IMSS Expenditure on Disease & Maternity Insurance by State, 2011 (MXNmn) 110
ISSSTE 112
Table: ISSSTE's Pharmaceutical Expenditure, 2006-12 112
Seguro Popular 113
Table: SPSS Budget, 2004-11 (MXNmn) 114
Table: FPGC Disease Groups, 2011                       115
Table: FPGC Cases & Cost By Disease, Authorised In 2011, Validated And Paid By December 31 2011 116



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Associations of Independent Pharmacies 118
Table: Members of ANADIM, 2012 119
Members of ANEFAR, 2012 120
Pharmacy Chains 121
Farmacias del Ahorro 121
Farmacias Benavides 121
Table: Farmacias Benavides' Key Indicators, 2003-11 122
Farmacias El Fenix 122
Corporativo Fragua 123
Table: Corporativo Fragua's Key Indicators, 2005-11 123
Farmacias Similares 124
Walmart 125
Company Profiles 127
Local Company Profiles 127
Genomma Labs              127
Multinational Companies 131
Pfizer 131
GlaxoSmithKline (GSK) 133
Sanofi 135
Eli Lilly    138
Bristol-Myers Squibb             140
Novartis 142
Bayer 145
Boehringer Ingelheim 147
Merck KGaA 150
Roche Syntex 152
Demographic Outlook 155
Mexico - Population By Age Group 156
Mexico - Population By Age Group 157
Mexico - Key Population Ratios 158
Mexico - Rural and Urban Population 158
Glossary 159
BMI Methodology 161
How We Generate Our Pharmaceutical Industry Forecasts                                 161
Pharmaceutical Risk/Reward Ratings Methodology 162
Ratings Overview 162
Table: Pharmaceutical Risk/Reward Indicators 163
Weighting 164
Table: Weighting Of Components 164
Sources        164




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The Pharmaceutical Market: Mexico, Business Monitor International

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! The Pharmaceutical Market: Mexico, Business Monitor International Published on January 2013 Report Summary Espicom market intelligence, brought to you by Business Monitor International OVERVIEW OF THE PHARMACEUTICAL MARKET IN MEXICO The improving regulatory environment and the increasing foreign direct investment make Mexico's pharmaceutical market more attractive to multinational drugmakers. We project an increase in government healthcare spending to further boost the number of procedures and expand access to medicines in its national health insurance programme. However, the potential deceleration of the country's macroeconomic growth may dampen the country's pharmaceutical market prospects. Generic drug competition and counterfeit medicines are also key concerns for multinationals pharmaceutical companies. Headline Expenditure Projections Pharmaceuticals: MXN161.45bn (US$12.99bn) in 2011 to MXN175.82bn (US$13.47bn) in 2012; +8.9% in local currency terms and +3.7% in US dollar terms. Forecasts increase from Q4 12 due to macroeconomic factors. Healthcare: MXN872.57bn (US$70.21bn) in 2011 to MXN951.98bn (US$72.95bn) in 2012; +9.1% in local currency terms and +3.9 % in US dollar terms. F orecasts increase from Q4 12 due to macroeconomic factors. Medical devices: MXN52.05bn (US$4.19bn) in 2011 to MXN57.85bn (US$4.43bn) in 2012; +11.1% in local currency terms and +5.9% in US dollar terms. F orecasts increase from Q4 12 due to macroeconomic factors. Risk/Reward Rating: The Pharmaceutical and Healthcare Risk/Reward Rating (RRR) in Q113 for Mexico remains the same (58.4) as in Q412. Mexico still ranks the fourth out of the 17 Americas markets surveyed in our proprietary regional RRR rating system above Brazil, indicating a more optimistic outlook for Mexican market. Competitive Landscape The competitive landscape section provides comparative company analyses and rankings by US$ sales and % share of total sales - for the total pharmaceutical sector, as well as the OTC, generics, and distribution sub-sectors. Table of Content Table of Contents Executive Summary 8 SWOT Analysis 10 Mexico Pharmaceuticals And Healthcare Industry SWOT 10 The Pharmaceutical Market: Mexico, Business Monitor International (From Slideshare) Page 1/6
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Mexico Political SWOT 11 Mexico Economic SWOT 11 Mexico Business Environment SWOT 12 Pharmaceutical Risk/Reward Ratings 13 Table: Americas Pharmaceutical And Healthcare Risk/Reward Ratings, Q113 13 Rewards 15 Risks 15 Mexico ' Market Summary 17 Regulatory Regime 19 Marketing Registration 20 Table: Legal Pharmaceutical Registration Requirements 21 Table: Legal Pharmaceutical Registration Requirements 21 Import Regulation 22 Table: Import Fees 23 Table: Registration Renewal Requirements 23 Release Of Manufacturing Requirements 23 Regulation Of Antibiotics 24 Post-Marketing 24 Advertising 25 Biologics And Biosimilar Guideline 26 Research & Development 29 Table: NOM-177-SSA1-1998's Generic Tests 32 Intellectual Property Rights 32 Intellectual Property Environment 34 IP Shortcomings 35 Table: Mexican Marketing Applications In Alleged Violation Of Patent Rights 36 Counterfeit Drugs 37 Pricing & Reimbursement 38 Reimbursement 40 Pricing Issues 41 Pricing Developments 43 Reimbursement Issues 44 Other Regulatory Developments 44 Industry Trends and Developments 46 Epidemiology 46 Non-Communicable Diseases 47 Healthcare Sector 47 Health Insurance 48 Healthcare Sector Funding 50 Medical Tourism 50 Research & Development 51 Clinical Trials 53 Table: Clinical Trial Regulation In Mexico 54 Table: Clinical Studies, 2003-09 56 Medical Devices 57 Industry Forecast Scenario 58 Overall Market Forecast 58 Table: Pharmaceutical Sales Indicators 2008-2016 59 The Pharmaceutical Market: Mexico, Business Monitor International (From Slideshare) Page 2/6
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Key Growth Drivers ' Industry 60 Table: Healthcare Expenditure Indicators 2008-2016 61 Table: Healthcare Governmental Indicators 2008-2016 62 Table: Healthcare Private Indicators 2008-2016 62 Key Growth Drivers ' Macroeconomic 64 Table: Mexico Macro Indicators 69 Prescription Drug Market Forecast 70 Table: Prescription Drug Sales Indicators 2008-2016 71 Patented Drug Market Forecast 72 Table: Patented Drug Market Indicators 2008-2016 73 Generic Drug Market Forecast 74 Table: Generic Drug Sales Indicators, 2008-2016 76 Associations 76 Table: Members of AMEGI, 2011 77 Members of ANAFAM, 2011 78 OTC Medicine Market Forecast 80 Table: OTC Medicine Sales Indicators 2008-2016 82 Pharmaceutical Trade Forecast 83 Table: Exports and Imports Indicators 2008-2016 84 Medical Device Market Forecast 86 Table: Medical Devices Sales Indicators, 2008-2016 86 Other Healthcare Data 87 Key Risks To BMI's Forecast Scenario 87 Competitive Landscape 89 Pharmaceuticals Industry 89 Pharmaceutical Company Activity 90 Foreign Competition 90 Table: Members of AFAMELA, 2012 90 Table: Members of AMIIF, 2012 91 Table: Members of CANIFARMA, 2012 93 Table: AstraZeneca's Sales, 2005-10 96 Pharmaceutical Distribution Sector 104 Wholesale 104 DIPROFAR 104 Grupo Casa Saba 104 Marzam 105 NADRO 106 Pharmaceuticals Retail Sector 107 Table: IMSS Pharmacies, 2000-11 107 Table: IMSS Financial Indicators, 2000-11 (MXNmn) 109 Table: Leading Pharmaceutical Suppliers to IMSS, 2010-12 (MXNmn) 110 Table: IMSS Expenditure on Disease & Maternity Insurance by State, 2011 (MXNmn) 110 ISSSTE 112 Table: ISSSTE's Pharmaceutical Expenditure, 2006-12 112 Seguro Popular 113 Table: SPSS Budget, 2004-11 (MXNmn) 114 Table: FPGC Disease Groups, 2011 115 Table: FPGC Cases & Cost By Disease, Authorised In 2011, Validated And Paid By December 31 2011 116 The Pharmaceutical Market: Mexico, Business Monitor International (From Slideshare) Page 3/6
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Associations of Independent Pharmacies 118 Table: Members of ANADIM, 2012 119 Members of ANEFAR, 2012 120 Pharmacy Chains 121 Farmacias del Ahorro 121 Farmacias Benavides 121 Table: Farmacias Benavides' Key Indicators, 2003-11 122 Farmacias El Fenix 122 Corporativo Fragua 123 Table: Corporativo Fragua's Key Indicators, 2005-11 123 Farmacias Similares 124 Walmart 125 Company Profiles 127 Local Company Profiles 127 Genomma Labs 127 Multinational Companies 131 Pfizer 131 GlaxoSmithKline (GSK) 133 Sanofi 135 Eli Lilly 138 Bristol-Myers Squibb 140 Novartis 142 Bayer 145 Boehringer Ingelheim 147 Merck KGaA 150 Roche Syntex 152 Demographic Outlook 155 Mexico - Population By Age Group 156 Mexico - Population By Age Group 157 Mexico - Key Population Ratios 158 Mexico - Rural and Urban Population 158 Glossary 159 BMI Methodology 161 How We Generate Our Pharmaceutical Industry Forecasts 161 Pharmaceutical Risk/Reward Ratings Methodology 162 Ratings Overview 162 Table: Pharmaceutical Risk/Reward Indicators 163 Weighting 164 Table: Weighting Of Components 164 Sources 164 The Pharmaceutical Market: Mexico, Business Monitor International (From Slideshare) Page 4/6
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