CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Mexico

Publisher Name:
Published Date: 11-May-2016
No. of pages: 250

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 For This Report

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 R&D 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

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, R&D Expenditure ($m), 2008-2015 228

Table 88: Pharmaceutical Market,, Mexico, Major Trade Fairs, 2016 230

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, R&D Expenditure ($m), 2008-2015 228

Figure 79: Healthcare Market, Mexico, Opportunities and Challenges, 2016 232

Get Updates

Share This Post

Latest Reports from Life Sciences category

© 2016 Market optimizer. All rights reserved.