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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Mexico

Summary

GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Mexico". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Mexico. It identifies the key trends in the country’s healthcare market and provides insights into its healthcare infrastructure and demographic, regulatory and reimbursement landscape. Most importantly, the report provides valuable insights into the trends and segmentation of its pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

The population of Mexico was approximately 121 million in 2015, and is estimated to grow at a Compound Annual Growth Rate (CAGR) of 1.2%, to approximately 128.6 million in 2020. This is due to a positive balance between the birth and mortality rates. The government has been successful in implementing the steps necessary for achieving universal healthcare coverage, such as reforms in the System of Social Protection in Health (Sistema de Protección Social en Salud). The value of the Mexican pharmaceutical market amounted to $19.4 billion, in 2015, and is expected to increase at a CAGR of 8.7% to reach approximately $29.4 billion in 2020. The medical device market was worth $4.9 billion in 2015 and is projected to reach $6.5 billion in 2020, at a CAGR of 4.9%. These positive growth trends can be attributed primarily to government initiatives in the public healthcare sector and an improved and updated regulatory environment.

Scope

The report provides information on the healthcare, regulatory and reimbursement landscape in Mexico, and includes -
- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical market and medical devices market. The key players covered for the pharmaceutical market are Bayer de Mexico, Genomma Lab, Pfizer, Merck and Roche. The key players covered for the medical devices market are Fresenius Medical Care, Baxter, DePuy, Johnson & Johnson and Medtronic.
- Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
- Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An overview of the opportunities for and challenges facing growth in the healthcare market

Reasons to buy

This report will enhance your decision-making capability by allowing you to -
- Develop business strategies by understanding the trends shaping and driving Mexico’s healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect Mexico’s healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and being informed of the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investment, and strategic partnership
- Identify, understand and capitalize on the opportunities and challenges in Mexico’s healthcare market

Table Of Contents

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Mexico
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 13
2 Introduction 17
2.1 GlobalData Report Guidance 17
3 Overview of the Pharmaceutical and Medical Device Markets 18
3.1 Pharmaceutical Market 18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical Exports and Imports 20
3.1.3 Supply Channels 22
3.1.4 Market Segments 22
3.1.5 Major Disease Areas 23
3.1.6 Major Players 25
3.2 Medical Device Market 64
3.2.1 Market Overview 64
3.2.2 Overview of Top Five Segments 66
3.2.3 Diagnostics Market 77
3.2.4 Major Players 80
3.3 Market Drivers and Barriers 124
3.3.1 Drivers 124
3.3.2 Barriers 124
4 Market Access 126
4.1 Reimbursement and Payer Landscape 126
4.1.1 Overview of Healthcare system 126
4.1.2 Reimbursement Process 128
4.1.3 Overview of Insurance Providers 131
4.1.4 Patient Share in Healthcare Spending 133
4.1.5 Price Trends in Healthcare Sector 134
4.1.6 Pricing Policies 135
4.2 Regulatory Landscape 136
4.2.1 Overview of Regulatory Agencies 136
4.2.2 Market Authorization Procedure for Pharmaceutical Products 138
4.2.3 New Medical Device Approval Process 140
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 143
4.2.5 Exports and Imports 144
4.2.6 Intellectual Property Rights 147
4.2.7 Clinical Trial Regulations 151
4.2.8 Pharmaceutical Advertising Regulations 154
4.2.9 Pharmacy Regulations 156
4.2.10 Labeling and Packaging Regulations 157
5 Country Analysis 159
5.1 Political Environment 159
5.1.1 Political Structure 159
5.1.2 Analysis of the Current Political Environment 160
5.1.3 Healthcare Policy Initiatives 162
5.2 Economic Landscape 164
5.3 Economic Indicators 165
5.3.1 Gross Domestic Product 165
5.3.2 Gross National Income 169
5.3.3 Inflation 171
5.3.4 Currency Exchange Rate 174
5.3.5 Foreign Direct Investment 175
5.3.6 Foreign Exchange Reserves 176
5.3.7 Trade Balance 178
5.3.8 General Government Structural Balance 180
5.3.9 General Government Net Debt 182
5.3.10 Major Industries 185
5.4 Demographics 186
5.4.1 Population 186
5.4.2 Education and Literacy 205
5.4.3 Employment 206
5.4.4 Disease Burden 207
5.5 Healthcare Infrastructure 210
5.5.1 Healthcare Facilities 210
5.5.2 Healthcare Parameters 215
5.5.3 Environmental Health 218
5.5.4 Healthcare Personnel 221
5.6 Healthcare Expenditure 224
5.6.1 Overview 224
5.6.2 Major Components of Healthcare Spending 225
5.6.3 Public and Private Sector Share 226
5.6.4 Spending in Healthcare RandD 227
5.7 Trade Associations 229
5.7.1 Mexican Association of Pharmaceutical Research 229
5.7.2 National Association of Pharmaceutical Manufacturers 229
5.7.3 Mexican Association of Pharmaceutical Laboratories 229
5.7.4 National Chamber of the Pharmaceutical Industry 229
5.8 Trade Fairs 230
6 Opportunities and Challenges 231
6.1 Opportunities 231
6.2 Challenges 231
7 Appendix 233
7.1 Abbreviations 233
7.2 Bibliography 236
7.3 Research Methodology 247
7.3.1 Coverage 247
7.3.2 Secondary Research 248
7.3.3 Forecasts 248
7.3.4 Expert Panel 248
7.4 Disclaimer 249

1.1 List of Tables
Table 1: Pharmaceutical Market, Mexico, Revenue ($bn), 2008-2015 19
Table 2: Pharmaceutical Market, Mexico, Revenue Forecast ($bn), 2016-2020 20
Table 3: Pharmaceutical Market, Mexico, Exports and Imports ($bn), 2008-2015 21
Table 4: Pharmaceutical Market, Bayer de Mexico, Major Products, 2014 26
Table 5: Pharmaceutical Market, Bayer de Mexico, Global, Late-Stage Pipeline, 2014 28
Table 6: Pharmaceutical Market, Mexico, Genomma Lab, Major Products, 2014 34
Table 7: Pharmaceutical Market, Pfizer, Global, Major Products by Revenue ($bn) and Annual Growth (%), Revenue, 2014 39
Table 8: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2015 40
Table 9: Pharmaceutical Market, Merck, Global, Major Products, 2014 48
Table 10: Pharmaceutical Market, Merck, Global, Late-Stage Pipeline, 2016 50
Table 11: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($m) and Annual Growth (%), 2013 57
Table 12: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2013 58
Table 13: Medical Device Market, Mexico, Revenue ($bn), 2008-2015 65
Table 14: Medical Device Market, Mexico, Revenue ($bn), 2016-2020 66
Table 15: Medical Device Market, Mexico, Revenue by Segment, 2015 67
Table 16: Medical Device Market, Mexico, Orthopedic Revenue ($m), 2008-2015 69
Table 17: Medical Device Market, Mexico, Orthopedic Market Share (%), 2014 69
Table 18: Medical Device Market, Mexico, Nephrology and Urology Revenue ($m), 2008-2015 70
Table 19: Medical Device Market, Mexico, Nephrology and Urology Market Share (%), 2012 71
Table 20: Medical Device Market, Mexico, Ophthalmic Revenue ($m), 2008-2015 72
Table 21: Medical Device Market, Mexico, Orthopedic Sales Trend for Major Players, 2012 73
Table 22: Medical Device Market, Mexico, Wound Care Management Revenue ($m), 2008-2015 74
Table 23: Medical Device Market, Mexico, Wound Care Management Sales Trend for Major Players, 2012 75
Table 24: Medical Device Market, Mexico, IVD Revenue ($m), 2008-2015 76
Table 25: Medical Device Market, Mexico, IVD Market Share (%), 2014 77
Table 26: Medical Device Market, Mexico, Diagnostics Revenue ($bn), 2008-2015 78
Table 27: Medical Device Market, Mexico, Diagnostic Revenue ($bn), 2016-2020 79
Table 28: Medical Device Market, Mexico, Revenue ($m) and Share (%) of Major Companies, 2012 80
Table 29: Medical Device Market, Fresenius Medical Care, Major Products, 2014 82
Table 30: Medical Device Market, Baxter, Major Products, 2014 91
Table 31: Medical Device Market, DePuy Synthes, Major Market Share (%), 2014 100
Table 32: Medical Device Market, Medtronic, Major Products, 2013 114
Table 33: Market Access, Mexico, OOP Expenditure as a Percentage of Private Expenditure (%), 2008-2015 133
Table 34: Price of Healthcare Products, Mexico, Change in Average Price of Healthcare Services (%), 2008-2014 135
Table 35: Regulatory Fee Structure, Mexico, Pharmaceutical Products, 2014 140
Table 36: Market Access, Mexico, Medical Device Approval Timelines, 2014 143
Table 37: Regulatory Fee Structure, Mexico, Medical Devices, 2014 143
Table 38: Economic Indicators, Mexico, GDP per Capita ($), 2008-2015 166
Table 39: Economic Indicators, Mexico, GDP per Capita ($), 2016-2020 167
Table 40: Economic Indicators, Mexico, GDP Annual Growth (%), 2008-2015 168
Table 41: Economic Indicators, Mexico, GDP Annual Growth (%), 2016-2020 169
Table 42: Economic Indicators, Mexico, GNI per Capita ($), 2008-2015 170
Table 43: Economic Indicators, Mexico, Consumer Price Index, 2008-2015 171
Table 44: Economic Indicators, Mexico, Consumer Price Index, 2016-2020 172
Table 45: Economic Indicators, Mexico, Consumer Price Annual Change (%), 2008-2015 173
Table 46: Economic Indicators, Mexico Currency Exchange Rate (MXN/$), 2008-2015 174
Table 47: Economic Indicators, Mexico, Foreign Direct Investment ($bn), 2008-2015 176
Table 48: Economic Indicators, Mexico, Foreign Exchange Reserves ($bn), 2008-2015 177
Table 49: Economic Indicators, Mexico, Imports of Goods and Services ($bn), 2008-2015 179
Table 50: Economic Indicators, Mexico, Exports of Goods and Services ($bn), 2008-2015 180
Table 51: Economic Indicators, Mexico, Government Structural Balance ($bn), 2008-2015 181
Table 52: Economic Indicators, Mexico, General Government Net Debt ($bn), 2008-2015 183
Table 53: Economic Indicators, Mexico, General Government Net Debt Forecast ($bn), 2016-2020 184
Table 54: Major Industries, Mexico, Gross Value Added to Economy ($bn), 2015 186
Table 55: Demographics, Mexico, Population (million), 2008-2015 187
Table 56: Demographics, Mexico, Population Forecast (million), 2016-2020 188
Table 57: Demographics, Mexico, Urban and Rural Population Share (%), 2008-2015 189
Table 58: Demographics, Mexico, Urban and Rural Population Share (%), 2016-2020 190
Table 59: Demographics, Mexico, Population Distribution by Age Group (%), 2008-2015 192
Table 60: Demographics, Mexico, Population Distribution by Age Group (%), 2016-2020 192
Table 61: Demographics, Mexico, Births (per 1,000 population), 2008-2015 194
Table 62: Demographics, Mexico, Mortality (per 1,000 Population), 2008-2015 195
Table 63: Demographics, Mexico, Major Causes of Mortality (number of deaths), 2014 196
Table 64: Demographics, Mexico, Mortality Rate of Children under Five (per 1,000 live births), 2008-2015 198
Table 65: Demographics, Mexico, Immunization Rate (%), 2008-2013 199
Table 66: Demographics, Mexico, Major Causes of Male Mortality (‘000), 2015 201
Table 67: Demographics, Mexico, Major Causes of Female Mortality (‘000), 2015 202
Table 68: Demographics, Mexico, Gender Ratio (M/F), 2008-2015 203
Table 69: Demographics, Mexico, Life Expectancy at Birth (years), 2008-2015 204
Table 70: Demographics, Mexico, Gross Enrollment by Level of Education (%), 2008-2015 206
Table 71: Demographics, Mexico, Unemployment Rate (%), 2008-2015 207
Table 72: Demographics, Mexico, Number of Deaths by Disease, 2014 208
Table 73: Demographics, Mexico, Major Diseases, DALYs (‘000), 2012 209
Table 74: Healthcare Infrastructure, Mexico, Hospitals, 2008-2015 211
Table 75: Healthcare Infrastructure, Mexico, Public and Private Hospitals, 2008-2015 212
Table 76: Healthcare Infrastructure, Mexico, Hospital Beds by Type of Service (per 1,000 population), 2008-2015 213
Table 77: Healthcare Infrastructure, Mexico, Diagnostic Equipment (per 1,000,000 population), 2008-2015 214
Table 78: Healthcare Infrastructure, Mexico, Hospital Beds (per 1,000 population), 2008-2015 216
Table 79: Healthcare Infrastructure, Mexico, Doctors (per 1,000 population), 2008-2015 217
Table 80: Healthcare Infrastructure, Mexico, PM2.5 (µg per m3), 2008-2015 219
Table 81: Healthcare Infrastructure, Mexico, CO2 Emissions (metric tons per capita), 2008-2015 221
Table 82: Healthcare Infrastructure, Mexico, Nurses (per 1,000 population), 2008-2015 222
Table 83: Healthcare Infrastructure, Mexico, Dentists (per 1,000 population), 2008-2015 223
Table 84: Healthcare Expenditure, Mexico, Healthcare Expenditure (% of GDP), 2008-2015 225
Table 85: Public Healthcare Expenditure, Mexico, Share of Major Components (%), 2013 226
Table 86: Healthcare Expenditure, Mexico, Public-Private Share (%), 2008-2015 227
Table 87: Healthcare Expenditure, Mexico, RandD Expenditure ($m), 2008-2015 228
Table 88: Pharmaceutical Market,, Mexico, Major Trade Fairs, 2016 230

1.2 List of Figures
Figure 1: Pharmaceutical Market, Mexico, Revenue ($bn), 2008-2015 19
Figure 2: Pharmaceutical Market, Mexico, Revenue Forecast ($bn), 2016-2020 20
Figure 3: Pharmaceutical Market, Mexico, Exports and Imports ($bn), 2008-2015 21
Figure 4: Medical Device Market, Mexico, Revenue ($bn), 2008-2015 65
Figure 5: Medical Device Market, Mexico, Revenue ($bn), 2016-2020 66
Figure 6: Medical Device Market, Mexico, Revenue by Segment ($m), 2015 67
Figure 7: Medical Device Market, Mexico, Orthopedic Revenue ($m), 2008-2015 68
Figure 8: Medical Device Market, Mexico, Orthopedic Market Share (%), 2014 69
Figure 9: Medical Device Market, Mexico, Nephrology and Urology Revenue ($m), 2008-2015 70
Figure 10: Medical Device Market, Mexico, Nephrology and Urology Market Share (%), 2012 71
Figure 11: Medical Device Market, Mexico, Ophthalmic Revenue ($m), 2008-2015 72
Figure 12: Medical Device Market, Mexico, Ophthalmic Market Share (%), 2012 73
Figure 13: Medical Device Market, Mexico, Wound Care Management Revenue ($m), 2008-2015 74
Figure 14: Medical Device Market, Mexico, Wound Care Management Market Share (%), 2012 75
Figure 15: Medical Device Market, Mexico, IVD Revenue ($m), 2008-2015 76
Figure 16: Medical Device Market, Mexico, IVD Market Share (%), 2014 77
Figure 17: Medical Device Market, Mexico, Diagnostics Revenue ($bn), 2008-2015 78
Figure 18: Medical Device Market, Mexico, Diagnostic Revenue ($bn), 2016-2020 79
Figure 19: Medical Device Market, Mexico, Revenue of Major Companies ($m), 2012 80
Figure 20: Healthcare Market, Mexico, Drivers and Barriers, 2016 125
Figure 21: Market Access, Mexico, Overview of Healthcare system 128
Figure 22: Market Access, Mexico, OOP Expenditure as a Percentage of Private Expenditure (%), 2008-2015 133
Figure 23: Price of Healthcare Products, Mexico, Change in Average Price of Healthcare Services (%), 2008-2014 134
Figure 24: Market Access, Mexico, Marketing Authorization Procedure, 2015 140
Figure 25: Market Access, Mexico, Licensing Process for Manufacture of Pharmaceuticals and Medical Devices, 2015 144
Figure 26: Market Access, Mexico, Patent Approval Process, 2014 149
Figure 27: Market Access, Mexico, Trademark Approval Process, 2014 151
Figure 28: Market Access, Mexico, Clinical Trial Approval Process, 2014 153
Figure 29: Economic Indicators, Mexico, GDP per Capita ($), 2008-2015 166
Figure 30: Economic Indicators, Mexico, GDP per Capita ($), 2016-2020 167
Figure 31: Economic Indicators, Mexico, GDP Annual Growth (%), 2008-2015 168
Figure 32: Economic Indicators, Mexico, GDP Annual Growth (%), 2016-2020 169
Figure 33: Economic Indicators, Mexico, GNI per Capita ($), 2008-2015 170
Figure 34: Economic Indicators, Mexico, Consumer Price Index, 2008-2015 171
Figure 35: Economic Indicators, Mexico, Consumer Price Index, 2016-2020 172
Figure 36: Economic Indicators, Mexico, Consumer Price Annual Change (%), 2008-2015 173
Figure 37: Economic Indicators, Mexico, Currency Exchange Rate (MXN/$), 2008-2015 174
Figure 38: Economic Indicators, Mexico, Foreign Direct Investment ($bn), 2008-2015 176
Figure 39: Economic Indicators, Mexico, Foreign Exchange Reserves ($bn), 2008-2015 177
Figure 40: Economic Indicators, Mexico, Imports of Goods and Services ($bn), 2008-2015 178
Figure 41: Economic Indicators, Mexico, Exports of Goods and Services ($bn), 2008-2015 180
Figure 42: Economic Indicators, Mexico, Government Structural Balance ($bn), 2008-2015 181
Figure 43: Economic Indicators, Mexico, General Government Net Debt ($bn), 2008-2015 183
Figure 44: Economic Indicators, Mexico, General Government Net Debt Forecast ($bn), 2016-2020 184
Figure 45: Major Industries, Mexico, Gross Value Added to Economy ($bn), 2015 185
Figure 46: Demographics, Mexico, Population (million), 2008-2015 187
Figure 47: Demographics, Mexico, Population Forecast (million), 2016-2020 188
Figure 48: Demographics, Mexico, Urban and Rural Population Share (%), 2008-2015 189
Figure 49: Demographics, Mexico, Urban and Rural Population Share (%), 2016-2020 190
Figure 50: Demographics, Mexico, Population Distribution by Age Group (%), 2008-2015 191
Figure 51: Demographics, Mexico, Population Distribution by Age Group (%), 2016-2020 192
Figure 52: Demographics, Mexico, Births (per 1,000 population), 2008-2015 193
Figure 53: Demographics, Mexico, Mortality (per 1,000 population), 2008-2015 194
Figure 54: Demographics, Mexico, Major Causes of Mortality (number of deaths), 2014 196
Figure 55: Demographics, Mexico, Mortality Rate of Children under Five (per 1,000 live births), 2008-2015 198
Figure 56: Demographics, Mexico, Immunization Rate (%), 2008-2015 199
Figure 57: Demographics, Mexico, Major Causes of Male Mortality (‘000), 2015 200
Figure 58: Demographics, Mexico, Major Causes of Female Mortality (‘000), 2015 201
Figure 59: Demographics, Mexico, Gender Ratio (M/F), 2008-2015 203
Figure 60: Demographics, Mexico, Life Expectancy at Birth (years), 2008-2015 204
Figure 61: Demographics, Mexico, Gross Enrollment by Level of Education (%), 2008-2015 205
Figure 62: Demographics, Mexico, Unemployment Rate (%), 2008-2015 206
Figure 63: Demographics, Mexico, Number of Deaths by Disease, 2014 207
Figure 64: Demographics, Mexico, Major Diseases, DALYs (‘000), 2012 209
Figure 65: Healthcare Infrastructure, Mexico, Hospitals, 2008-2015 211
Figure 66: Healthcare Infrastructure, Mexico, Public and Private Hospitals, 2008-2015 212
Figure 67: Healthcare Infrastructure, Mexico, Hospital Beds by Type of Service (per 1,000 population), 2008-2015 213
Figure 68: Healthcare Infrastructure, Mexico, Diagnostic Equipment (per 1,000,000 population), 2008-2015 214
Figure 69: Healthcare Infrastructure, Mexico, Hospital Beds (per 1,000 population), 2008-2015 215
Figure 70: Healthcare Infrastructure, Mexico, Doctors (per 1,000 population), 2008-2015 217
Figure 71: Healthcare Infrastructure, Mexico, PM2.5 (µg per m3), 2008-2015 219
Figure 72: Healthcare Infrastructure, Mexico, CO2 Emissions (metric tons per capita), 2008-2015 221
Figure 73: Healthcare Infrastructure, Mexico, Nurses (per 1,000 population), 2008-2015 222
Figure 74: Healthcare Infrastructure, Mexico, Dentists (per 1,000 population), 2008-2015 223
Figure 75: Healthcare Expenditure, Mexico, Healthcare Expenditure (% of GDP), 2008-2015 225
Figure 76: Public Healthcare Expenditure, Mexico, Share of Major Components (%), 2013 226
Figure 77: Healthcare Expenditure, Mexico, Public-Private Share (%), 2008-2015 227
Figure 78: Healthcare Expenditure, Mexico, RandD Expenditure ($m), 2008-2015 228
Figure 79: Healthcare Market, Mexico, Opportunities and Challenges, 2016 232

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