CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Published: July 2014
No. of Pages: 246
   

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

In 2013, the population of Saudi Arabia was estimated at 29.9 million and was growing at an annual rate of 3%. In 2012, 32.1% of the population of Saudi Arabia were non-native. These were mostly immigrant workers from South Asia and other Muslim countries. The total population is expected to reach approximately 36.8 million in 2020, growing at a Compound Annual Growth Rate (CAGR) of 3%. The value of the pharmaceutical market in Saudi Arabia was $4 billion in 2013, and it is expected to increase at a CAGR of 5.8% to reach approximately $5.9 billion in 2020. The major market share is garnered by imports of over-the-counter drugs and patented products.

The positive trend in the healthcare market of Saudi Arabia can be attributed primarily to government initiatives for the prevention and management of chronic diseases and an improved and updated regulatory environment.

Scope

This report provides information on the healthcare, regulatory, and reimbursement landscape in Saudi Arabia and includes the following -

  • An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
  • Profiles and SWOT analyses of major players in the pharmaceutical market (GlaxoSmithKline, Pfizer, Novartis, SPIMACO and Tabuk)
  • Profiles and SWOT analyses of major players in the medical device market (Siemens Healthcare, GE Healthcare, F. Hoffmann-La Roche, Philips Healthcare and Abbott Laboratories)
  • An insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies, and 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 based on a sound understanding of the trends shaping and driving the healthcare market in Saudi Arabia
  • Generate revenue based upon knowledge of key trends, reimbursement and regulatory policies, pharmaceutical market segments, and the companies likely to impact the healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize sales and marketing efforts by identifying the market categories and segments that present the greatest opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize upon the opportunities and challenges in the Saudi Arabia healthcare market

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Table of Contents

1 Table of Contents 7
1.1 List of Tables 10
1.2 List of Figures 14

2 Introduction 18
2.1 GlobalData Report Guidance 18

3 Overview of the Pharmaceutical and Medical Device Market 19
3.1 Pharmaceutical Market 19
3.1.1 Market Overview 19
3.1.2 Pharmaceutical Exports and Imports 23
3.1.3 Supply Channels 24
3.1.4 Market Segments 24
3.1.5 Major Diseases 28
3.1.6 Major Players 29
3.2 Medical Device Market 65
3.2.1 Market Overview 65
3.2.2 Overview of the Top Five Segments 67
3.2.3 Diagnostics Market 80
3.2.4 Major Players 83
3.3 Market Drivers and Barriers 118
3.3.1 Drivers 118
3.3.2 Barriers 119

4 Market Access 121
4.1 Reimbursement and Payer Landscape 121
4.1.1 Overview of Healthcare system 121
4.1.2 Reimbursement Process 122
4.1.3 Overview of Insurance Providers 124
4.1.4 Patient Share in Healthcare Spending 126
4.1.5 Price Trends in the Healthcare Sector 127
4.1.6 Pricing Policies 127
4.2 Regulatory Landscape 131
4.2.1 Overview of Regulatory Agencies 131
4.2.2 Market Authorization Procedure for Pharmaceutical Products 132
4.2.3 New Medical Device Approval Process 138
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 142
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 143
4.2.6 Intellectual Property Rights 144
4.2.7 Clinical Trial Regulations 150
4.2.8 Pharmaceutical Advertising Regulations 152
4.2.9 Pharmacy Regulations 154
4.2.10 Labeling and Packaging Regulations 155

5 Country Analysis 158
5.1 Political Environment 158
5.1.1 Political Structure 158
5.1.2 Analysis of Current Political Environment 159
5.1.3 Healthcare Policy Initiatives 160
5.2 Economic Landscape 161
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 Fiscal Surplus/Deficit 180
5.3.9 General Government Gross Debt 181
5.3.10 Major Industries 182
5.4 Demographics 184
5.4.1 Population 184
5.4.2 Education and Literacy 204
5.4.3 Employment 205
5.4.4 Disease Burden 207
5.5 Healthcare Infrastructure 209
5.5.1 Healthcare Facilities 209
5.5.2 Healthcare Parameters 213
5.5.3 Environmental Health 215
5.5.4 Healthcare Personnel 219
5.6 Healthcare Expenditure 221
5.6.1 Overview 221
5.6.2 Share of Public and Private Sector 222
5.7 Trade Associations 223
5.7.1 Saudi Pharmaceutical Society 223
5.7.2 Saudi Dental Society 223
5.7.3 Gulf Pharmaceutical Industries Association 223
5.7.4 Middle East Medical Devices and Diagnostics Trade Association 224
5.7.5 Middle East Generic Association 224
5.8 Trade fairs 224

6 Opportunities and Challenges 225
6.1 Opportunities 225
6.2 Challenges 226

7 Appendix 227
7.1 Abbreviations 227
7.2 Bibliography 233
7.3 Research Methodology 243
7.3.1 Coverage 243
7.3.2 Secondary Research 244
7.3.3 Forecasts 244
7.3.4 Expert Panel 244
7.4 Disclaimer 245

List of Tables

Table 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008-2013 21
Table 2: Pharmaceutical Market, Saudi Arabia, Revenue Forecast ($bn), 2014-2020 22
Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008-2013 23
Table 4: Pharmaceutical Market, Saudi Arabia, Supply Chain Margin, 2008 24
Table 5: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 2008-2013 26
Table 6: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 2008-2013 27
Table 7: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 30
Table 8: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 31
Table 9: Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 38
Table 10: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 39
Table 11: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 46
Table 12: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014-2018 47
Table 13: SPIMACO, Major Products, 2012 57
Table 14: Tabuk, Major Products, 2012 62
Table 15: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008-2013 66
Table 16: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 2014-2020 66
Table 17: Medical Device Market, Saudi Arabia, Major Segments, Revenue ($m) and Share (%), 2013 67
Table 18: Medical Device Market, Saudi Arabia, In Vitro Diagnostics, Revenue ($m), 2008-2013 69
Table 19: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, In Vitro Diagnostics, 2012 70
Table 20: Medical Device Market, Saudi Arabia, Diagnostic Imaging, Revenue ($m), 2008-2013 71
Table 21: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Diagnostic Imaging, 2012 72
Table 22: Medical Device Market, Saudi Arabia, Ophthalmic Devices Market, Revenue ($m), 2008-2013 73
Table 23: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Ophthalmic Devices, 2012 75
Table 24: Medical Device Market, Saudi Arabia, Cardiovascular Devices Market, Revenue ($m), 2008-2013 76
Table 25: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Cardiovascular Devices, 2012 77
Table 26: Medical Device Market, Saudi Arabia, Nephrology and Urology Devices Market, Revenue ($m), 2008-2013 78
Table 27: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Nephrology and Urology Devices, 2012 80
Table 28: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 2008-2013 81
Table 29: Medical Device Market, Saudi Arabia, Revenue Forecast ($m), 2014-2020 82
Table 30: Medical Device Market, Saudi Arabia, Major Players, Revenue ($m), 2012 83
Table 31: Siemens Healthcare, Global, Major Products, 2014 84
Table 32: Roche, Global, Major Products, 2013 101
Table 33: Medical Device Market, Roche, Global, Late-stage Pipeline, 2014 101
Table 34: Abbott, Global, Major Products, 2014 112
Table 35: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 113
Table 36: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (%), 2008-2013 127
Table 37: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2008-2013 166
Table 38: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 2014-2020 167
Table 39: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008-2013 168
Table 40: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2014-2020 169
Table 41: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 2008-2013 170
Table 42: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008-2013 172
Table 43: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2014-2020 172
Table 44: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 2008-2013 173
Table 45: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008-2013 174
Table 46: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008-2013 176
Table 47: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008-2013 177
Table 48: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008-2013 178
Table 49: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008-2013 179
Table 50: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008-2012 180
Table 51: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008-2013 181
Table 52: Economic Indicators, Saudi Arabia, Major Industries, Gross Domestic Product ($bn), 2012-2013 183
Table 53: Demographics, Saudi Arabia, Population (million), 2008-2013 185
Table 54: Demographics, Saudi Arabia, Population Forecast (million), 2014-2020 185
Table 55: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 2008-2013 187
Table 56: Demographics, Saudi Arabia, Population, Urban and Rural Population Forecast Share (%), 2014-2020 188
Table 57: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2008-2013 189
Table 58: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 2008-2013 190
Table 59: Demographics, Saudi Arabia, Births (per 1,000 Population), 2008-2013 191
Table 60: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 2008-2013 192
Table 61: Demographics, Saudi Arabia, Major Causes of Mortality (%), 2012 194
Table 62: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008-2013 195
Table 63: Demographics, Saudi Arabia, Immunization Rate (%), 2008-2012 196
Table 64: Demographics, Saudi Arabia, Major Causes of Male Mortality (‘000), 2008 198
Table 65: Demographics, Saudi Arabia, Major Causes of Female Mortality (‘000), 2008 199
Table 66: Demographics, Saudi Arabia, Gender Ratio (M/F), 2008-2013 200
Table 67: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008-2013 202
Table 68: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2014-2020 203
Table 69: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008-2013 205
Table 70: Demographics, Saudi Arabia, Unemployment Rate (%), 2008-2013 206
Table 71: Demographics, Saudi Arabia, Major Diseases, Health Center Visits (million), 2011 207
Table 72: Demographics, Saudi Arabia, Major Diseases, DALYs (per 100,000 Population), 2004 209
Table 73: Healthcare Infrastructure, Saudi Arabia, Hospitals, 2008-2013 210
Table 74: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2012 211
Table 75: Healthcare Infrastructure, Saudi Arabia, Primary Health Centers, 2008-2013 213
Table 76: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 2008-2013 214
Table 77: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 2008-2013 215
Table 78: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 2008-2013 216
Table 79: Environmental Health, Saudi Arabia, PM10 (µgm/m³), 2008-2013 217
Table 80: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 2008-2013 220
Table 81: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008-2013 221
Table 82: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2018-2013 222
Table 83: Major Healthcare Trade Fairs, Saudi Arabia, 2014 224

List of Figures

Figure 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008-2013 21
Figure 2: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2014-2020 22
Figure 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008-2013 23
Figure 4: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 2008-2013 25
Figure 5: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 2008-2013 27
Figure 6: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008-2013 65
Figure 7: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 2014-2020 66
Figure 8: Medical Device Market, Saudi Arabia, Major Segments, Revenue ($m), 2013 67
Figure 9: Medical Device Market, Saudi Arabia, In Vitro Diagnostics, Revenue ($m), 2008-2013 68
Figure 10: Medical Device Market, Saudi Arabia, Sales Trends for Major Players, In Vitro Diagnostics, 2008-2012 69
Figure 11: Medical Device Market, Saudi Arabia, Diagnostic Imaging, Revenue ($m), 2008-2013 71
Figure 12: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Diagnostic Imaging, 2008-2012 72
Figure 13: Medical Device Market, Saudi Arabia Ophthalmic Devices Market, Revenue ($m), 2008-2013 73
Figure 14: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Ophthalmic Devices, 2008-2012 74
Figure 15: Medical Device Market, Saudi Arabia, Cardiovascular Devices Market, Revenue ($m), 2008-2013 76
Figure 16: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Cardiovascular Devices, 2008-2012 77
Figure 17: Medical Device Market, Saudi Arabia, Nephrology and Urology Devices Market, Revenue ($m), 2008-2013 78
Figure 18: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Nephrology and Urology Devices, 2008-2012 79
Figure 19: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 2008-2013 81
Figure 20: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 2014-2020 82
Figure 21: Medical Device Market, Saudi Arabia, Major Players, Revenue ($m), 2012 83
Figure 22: Healthcare Market, Saudi Arabia, Drivers and Barriers, 2014 120
Figure 23: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (%), 2008-2013 126
Figure 24: Healthcare System, Saudi Arabia, Saudi Food and Drug Authority Structure, 2014 132
Figure 25: Healthcare System, Saudi Arabia, Drug Licensing Approval Process, 2014 134
Figure 26: Healthcare System, Saudi Arabia, Patent-Approval Process, 2014 147
Figure 27: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2008-2013 166
Figure 28: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 2014-2020 167
Figure 29: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008-2013 168
Figure 30: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth Forecast (%), 2014-2020 169
Figure 31: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 2008-2013 170
Figure 32: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008-2013 171
Figure 33: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2014-2020 172
Figure 34: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 2008-2013 173
Figure 35: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008-2013 174
Figure 36: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008-2013 175
Figure 37: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008-2013 177
Figure 38: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008-2013 178
Figure 39: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008-2013 179
Figure 40: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008-2012 180
Figure 41: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008-2013 181
Figure 42: Economic Indicators, Saudi Arabia, Major Industries, Industrial Sector, Gross Domestic Product ($bn), 2012-2013 183
Figure 43: Demographics, Saudi Arabia, Population (million), 2008-2013 184
Figure 44: Demographics, Saudi Arabia, Population Forecast (million), 2014-2020 185
Figure 45: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 2008-2013 186
Figure 46: Demographics, Saudi Arabia, Population, Urban and Rural Population Share Forecast (%), 2014-2020 187
Figure 47: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2008-2013 189
Figure 48: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 2014-2020 190
Figure 49: Demographics, Saudi Arabia, Births (per 1,000 Population), 2008-2013 191
Figure 50: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 2008-2013 192
Figure 51: Demographics, Saudi Arabia, Major Causes of Mortality (%), 2012 193
Figure 52: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008-2013 195
Figure 53: Demographics, Saudi Arabia, Immunization Rate (%), 2008-2013 196
Figure 54: Demographics, Saudi Arabia, Major Causes of Male Mortality (‘000), 2008 197
Figure 55: Demographics, Saudi Arabia, Major Causes of Female Mortality (‘000), 2008 199
Figure 56: Demographics, Saudi Arabia, Gender Ratio (M/F), 2008-2013 200
Figure 57: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008-2013 202
Figure 58: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2014-2020 203
Figure 59: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008-2013 204
Figure 60: Demographics, Saudi Arabia, Unemployment Rate (%), 2008-2013 206
Figure 61: Demographics, Saudi Arabia, Major Diseases, Health Center Visits (million), 2011 207
Figure 62: Demographics, Saudi Arabia, Major Diseases, DALYs (per 100,000 Population), 2004 208
Figure 63: Healthcare Infrastructure, Saudi Arabia, Hospitals, 2008-2013 210
Figure 64: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2012 211
Figure 65: Healthcare Infrastructure, Saudi Arabia, Primary Health Centers, 2008-2013 212
Figure 66: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 2008-2013 213
Figure 67: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 2008-2013 214
Figure 68: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 2008-2013 216
Figure 69: Environmental Health, Saudi Arabia, PM10 (µgm/m³), 2008-2013 217
Figure 70: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 2008-2013 220
Figure 71: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008-2013 221
Figure 72: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2018-2013 222
Figure 73: Healthcare Market, Saudi Arabia, Opportunities and Challenges, 2014 226

Published By: GlobalData
Product Code: GlobalData30009


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