CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Published: July 2016
No. of Pages: 238
   

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 on the healthcare, regulatory and reimbursement landscape in Saudi Arabia. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Saudi Arabia. Most importantly, the report provides valuable insights into the trends and segmentation of the 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.

In 2015, Saudi Arabia's population was approximately at 31.5 million. The government of Saudi Arabia has been making continuous efforts to strengthen the economy to ensure long-term growth, and the pharmaceutical market is seen as a key industry for the country's future growth. To support this industry, the government has improved regulatory guidelines and initiatives to develop the domestic pharmaceutical market. The Saudi pharmaceutical market is one of the largest in the Middle East and the largest of the Gulf Co-operation Council (GCC) members, estimated to be worth $4.5 billion in 2015 and expected to reach $6 billion by 2020. The market grew nominally at a Compound Annual Growth Rate (CAGR) of 7.4% over the 2008-2020 period. The medical device market was valued at $1.3 billion in 2008 and is expected to reach approximately $1.8 billion by 2020, at a projected CAGR of 4.6%.

These positive trends can primarily be attributed to -

  • An increasing elderly population in Saudi Arabia, leading to increases in disease incidence and prevalence as well as higher need for long-term care and medical devices
  • Increasing awareness in the medical community and the general population regarding early disease detection and diagnosis, leading to higher rates of adoption of treatments and healthcare

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Saudi Arabia, 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 (GlaxoSmithKline, Pfizer, Novartis, SPIMACO, Tabuk Pharmaceuticals) and the medical device market (Siemens Healthcare, GE Healthcare, Roche, Philips Healthcare, Abbott Laboratories)
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the 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 to growth in the Saudi Arabian 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 Saudi Arabian healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and 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 your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in Saudi Arabian healthcare market

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Table of Contents

1 Table of Contents 6
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 Market 18
3.1 Pharmaceutical Market 18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical Exports and Imports 21
3.1.3 Supply Channels 22
3.1.4 Market Segments 23
3.1.5 Major Diseases 26
3.1.6 Major Players 27
3.2 Medical Device Market 63
3.2.1 Market Overview 63
3.2.2 Overview of the Top Five Segments 64
3.2.3 Major Players 74
3.3 Market Drivers and Barriers 108
3.3.1 Drivers 108
3.3.2 Barriers 110

4 Market Access 112
4.1 Reimbursement and Payer Landscape 112
4.1.1 Overview of Healthcare system 112
4.1.2 Reimbursement Process 114
4.1.3 Overview of Insurance Providers 116
4.1.4 Patient Share in Healthcare Spending 118
4.1.5 Price Trends in the Healthcare Sector 118
4.1.6 Pricing Policies 119
4.2 Regulatory Landscape 122
4.2.1 Overview of Regulatory Agencies 122
4.2.2 Market Authorization Procedure for Pharmaceutical Products 124
4.2.3 New Medical Device Approval Process 131
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 134
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 135
4.2.6 Intellectual Property Rights 136
4.2.7 Clinical Trial Regulations 142
4.2.8 Pharmaceutical Advertising Regulations 143
4.2.9 Pharmacy Regulations 146
4.2.10 Labeling and Packaging Regulations 146

5 Country Analysis 150
5.1 Political Environment 150
5.1.1 Political Structure 150
5.1.2 Analysis of Current Political Environment 151
5.1.3 Healthcare Policy Initiatives 152
5.2 Economic Landscape 154
5.3 Economic Indicators 160
5.3.1 Gross Domestic Product 160
5.3.2 Gross National Income 164
5.3.3 Inflation 165
5.3.4 Currency Exchange Rate 168
5.3.5 Foreign Direct Investment 169
5.3.6 Foreign Exchange Reserves 170
5.3.7 Trade Balance 171
5.3.8 Fiscal Surplus/Deficit 174
5.3.9 General Government Gross Debt 175
5.3.10 Major Industries 176
5.4 Demographics 178
5.4.1 Population 178
5.4.2 Education and Literacy 194
5.4.3 Employment 195
5.4.4 Disease Burden 196
5.5 Healthcare Infrastructure 199
5.5.1 Healthcare Facilities 199
5.5.2 Healthcare Parameters 202
5.5.3 Environmental Health 204
5.5.4 Healthcare Personnel 208
5.6 Healthcare Expenditure 209
5.6.1 Overview 209
5.6.2 Share of Public and Private Sector 210
5.7 Trade Associations 211
5.7.1 Saudi Pharmaceutical Society 211
5.7.2 Saudi Dental Society 211
5.7.3 Gulf Pharmaceutical Industries Association 211
5.7.4 Middle East Medical Devices and Diagnostics Trade Association 211
5.7.5 Middle East Generic Association 212
5.8 Trade Fairs 212

6 Opportunities and Challenges 213
6.1 Opportunities 213
6.2 Challenges 214

7 Appendix 217
7.1 Abbreviations 217
7.2 Bibliography 220
7.3 Research Methodology 235
7.3.1 Coverage 235
7.3.2 Secondary Research 235
7.3.3 Forecasts 236
7.3.4 Expert Panel 236
7.4 Disclaimer 237

List of Tables

Table 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008-2015 20
Table 2: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2016-2020 21
Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008-2014 22
Table 4: Pharmaceutical Market, Saudi Arabia, Generic Market Revenue ($m), 2008-2014 24
Table 5: Pharmaceutical Market, Saudi Arabia, OTC Market Revenue ($m), 2008-2014 25
Table 6: GlaxoSmithKline, Global, Major Products Revenue ($m) and Annual Growth (%), 2015 29
Table 7: Pharmaceutical Market, GlaxoSmithKline, Late-Stage Pipeline, 2016 30
Table 8: Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2015 37
Table 9: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016 38
Table 10: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2015 45
Table 11: Pharmaceutical Market, Novartis, Planned Filings, 2014-2018 46
Table 12: SPIMACO, Major Products, 2015 55
Table 13: Tabuk, Major Products, 2015 60
Table 14: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008-2015 63
Table 15: Medical Device Market, Saudi Arabia, Revenue ($bn), 2016-2020 64
Table 16: Medical Device Market, Saudi Arabia, Revenue ($m) and Share (%) of Major Segments, 2015 65
Table 17: Medical Device Market, Saudi Arabia, In Vitro Diagnostic Revenue ($m), 2008-2015 66
Table 18: Medical Device Market, Saudi Arabia, Diagnostic Imaging Revenue ($m), 2008-2015 67
Table 19: Medical Device Market, Saudi Arabia, Sales Trends for Major Diagnostic Imaging Players (%), 2011 68
Table 20: Medical Device Market, Saudi Arabia, Ophthalmic Device Revenue ($m), 2008-2015 69
Table 21: Medical Device Market, Saudi Arabia, Sales Trends for Major Ophthalmic Device Players, 2012 70
Table 22: Medical Device Market, Saudi Arabia, Cardiovascular Device Revenue ($m), 2008-2015 71
Table 23: Medical Device Market, Saudi Arabia, Sales Trends for Major Cardiovascular Device Players, 2011 72
Table 24: Medical Device Market, Saudi Arabia, Nephrology and Urology Device Revenue ($m), 2008-2015 73
Table 25: Medical Device Market, Saudi Arabia, Sales Trends for Major Nephrology and Urology Device Players, 2012 74
Table 26: Medical Device Market, Saudi Arabia, Revenue ($m) and Share (%) of Major Players, 2015 75
Table 27: Siemens Healthcare, Global, Major Products, 2015 76
Table 28: Roche, Global, Major Products, 2016 90
Table 29: Medical Device Market, Roche, Global, Late-stage Pipeline, 2016 91
Table 30: Philips Healthcare, Global, Major Products, 2016 97
Table 31: Abbott, Global, Major Products, 2016 103
Table 32: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (% of Total Healthcare Expenditure), 2008-2014 118
Table 33: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2008-2015 161
Table 34: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2016-2020 162
Table 35: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008-2015 163
Table 36: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2016-2020 164
Table 37: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 2008-2015 165
Table 38: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008-2015 166
Table 39: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2016-2020 167
Table 40: Economic Indicators, Saudi Arabia, Consumer Price Annual Change (%), 2008-2015 168
Table 41: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008-2015 169
Table 42: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008-2014 170
Table 43: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008-2014 171
Table 44: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008-2014 172
Table 45: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008-2014 173
Table 46: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008-2014 174
Table 47: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008-2015 175
Table 48: Economic Indicators, Saudi Arabia, GDP of Major Industrial Sectors ($bn), 2014-2015 177
Table 49: Demographics, Saudi Arabia, Population (million), 2008-2015 178
Table 50: Demographics, Saudi Arabia, Population (million), 2016-2020 179
Table 51: Demographics, Saudi Arabia, Urban and Rural Population Share (%), 2008-2015 180
Table 52: Demographics, Saudi Arabia, Urban and Rural Population Share (%), 2016-2020 181
Table 53: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2008-2015 182
Table 54: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2016-2020 183
Table 55: Demographics, Saudi Arabia, Births (per 1,000 population), 2008-2014 184
Table 56: Demographics, Saudi Arabia, Mortality (per 1,000 population), 2008-2014 185
Table 57: Demographics, Saudi Arabia, Major Causes of Mortality, 2013 186
Table 58: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 live births), 2008-2014 187
Table 59: Demographics, Saudi Arabia, Immunization Rate (%), 2008-2014 188
Table 60: Demographics, Saudi Arabia, Major Causes of Male Mortality (‘000), 2008 189
Table 61: Demographics, Saudi Arabia, Major Causes of Female Mortality (‘000), 2008 191
Table 62: Demographics, Saudi Arabia, Gender Ratio (M/F), 2008-2014 192
Table 63: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008-2014 193
Table 64: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2016-2020 194
Table 65: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008-2014 195
Table 66: Demographics, Saudi Arabia, Unemployment Rate (%), 2008-2014 196
Table 67: Demographics, Saudi Arabia, Health Center Visits by Major Diseases (million), 2011 197
Table 68: Demographics, Saudi Arabia, DALYs by Major Diseases (per 1,000 population), 2009 199
Table 69: Healthcare Infrastructure, Saudi Arabia, Hospitals, 2008-2013 200
Table 70: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2014 201
Table 71: Healthcare Infrastructure, Saudi Arabia, Primary Healthcare Centers, 2008-2014 202
Table 72: Healthcare Infrastructure, Saudi Arabia, Hospital Beds (per 10,000 population), 2008-2014 203
Table 73: Healthcare Infrastructure, Saudi Arabia, Doctors (per 10,000 population), 2008-2014 204
Table 74: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 2008-2014 205
Table 75: Environmental Health, Saudi Arabia, PM2.5 (µgm/m³), 2008-2014 206
Table 76: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 10,000 population), 2008-2014 209
Table 77: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008-2014 209
Table 78: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2008-2014 210
Table 79: Major Healthcare Trade Fairs, Saudi Arabia, 2016 212

List of Figures

Figure 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008-2015 20
Figure 2: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2016-2020 21
Figure 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008-2014 22
Figure 4: Pharmaceutical Market, Saudi Arabia, Generic Market Revenue ($m), 2008-2014 24
Figure 5: Pharmaceutical Market, Saudi Arabia, OTC Market Revenue ($m), 2008-2014 25
Figure 6: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008-2015 63
Figure 7: Medical Device Market, Saudi Arabia, Revenue ($bn), 2016-2020 64
Figure 8: Medical Device Market, Saudi Arabia, Revenue by Major Segment ($m), 2015 65
Figure 9: Medical Device Market, Saudi Arabia, In Vitro Diagnostic Revenue ($m), 2008-2015 66
Figure 10: Medical Device Market, Saudi Arabia, Diagnostic Imaging Revenue ($m), 2008-2015 67
Figure 11: Medical Device Market, Saudi Arabia, Sales Trends for Major Diagnostic Imaging Players (%), 2011 68
Figure 12: Medical Device Market, Saudi Arabia, Ophthalmic Device Revenue ($m), 2008-2015 69
Figure 13: Medical Device Market, Saudi Arabia, Sales Trends for Major Ophthalmic Device Players (%), 2012 70
Figure 14: Medical Device Market, Saudi Arabia, Cardiovascular Device Revenue ($m), 2008-2015 71
Figure 15: Medical Device Market, Saudi Arabia, Sales Trends for Major Cardiovascular Device Players (%), 2011 72
Figure 16: Medical Device Market, Saudi Arabia, Nephrology and Urology Device Revenue ($m), 2008-2015 73
Figure 17: Medical Device Market, Saudi Arabia, Sales Trends for Major Nephrology and Urology Device Players (%), 2012 74
Figure 18: Medical Device Market, Saudi Arabia, Revenue of Major Players ($m), 2015 75
Figure 19: Healthcare Market, Saudi Arabia, Drivers and Barriers, 2016 111
Figure 20: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (% of Total Healthcare Expenditure), 2008-2014 118
Figure 21: Healthcare System, Saudi Arabia, Saudi Food and Drug Authority Structure, 2016 124
Figure 22: Healthcare System, Saudi Arabia, Drug Licensing Approval Process, 2014 126
Figure 23: Healthcare System, Saudi Arabia, Drug Licensing - Market Authorization, 2014 130
Figure 24: Healthcare System, Saudi Arabia, Patent-Approval Process, 2016 139
Figure 25: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2008-2015 161
Figure 26: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2016-2020 162
Figure 27: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008-2015 163
Figure 28: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2016-2020 164
Figure 29: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 2008-2015 165
Figure 30: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008-2015 166
Figure 31: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2016-2020 167
Figure 32: Economic Indicators, Saudi Arabia, Consumer Price Annual Change (%), 2008-2015 168
Figure 33: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008-2015 169
Figure 34: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008-2014 170
Figure 35: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008-2014 171
Figure 36: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008-2014 172
Figure 37: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008-2014 173
Figure 38: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008-2014 174
Figure 39: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008-2015 175
Figure 40: Economic Indicators, Saudi Arabia, GDP of Major Industrial Sectors ($bn), 2014-2015 177
Figure 41: Demographics, Saudi Arabia, Population (million), 2008-2015 178
Figure 42: Demographics, Saudi Arabia, Population (million), 2016-2020 179
Figure 43: Demographics, Saudi Arabia, Urban and Rural Population Share (%), 2008-2015 180
Figure 44: Demographics, Saudi Arabia, Urban and Rural Population Share (%), 2016-2020 181
Figure 45: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2008-2015 182
Figure 46: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 2016-2020 183
Figure 47: Demographics, Saudi Arabia, Births (per 1,000 population), 2008-2014 184
Figure 48: Demographics, Saudi Arabia, Mortality (per 1,000 population), 2008-2014 185
Figure 49: Demographics, Saudi Arabia, Major Causes of Mortality, 2013 186
Figure 50: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 live births), 2008-2014 187
Figure 51: Demographics, Saudi Arabia, Immunization Rate (%), 2008-2014 188
Figure 52: Demographics, Saudi Arabia, Major Causes of Male Mortality (‘000), 2008 189
Figure 53: Demographics, Saudi Arabia, Major Causes of Female Mortality (‘000), 2008 190
Figure 54: Demographics, Saudi Arabia, Gender Ratio (M/F), 2008-2014 191
Figure 55: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008-2014 193
Figure 56: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2016-2020 194
Figure 57: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008-2014 195
Figure 58: Demographics, Saudi Arabia, Unemployment Rate (%), 2008-2014 196
Figure 59: Demographics, Saudi Arabia, Health Center Visits by Major Diseases (million), 2011 197
Figure 60: Demographics, Saudi Arabia, DALYs by Major Diseases (per 1,000 population), 2009 198
Figure 61: Healthcare Infrastructure, Saudi Arabia, Hospitals, 2008-2014 200
Figure 62: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2014 201
Figure 63: Healthcare Infrastructure, Saudi Arabia, Primary Healthcare Centers, 2008-2014 202
Figure 64: Healthcare Infrastructure, Saudi Arabia, Hospital Beds (per 10,000 population), 2008-2014 203
Figure 65: Healthcare Infrastructure, Saudi Arabia, Doctors (per 10,000 population), 2008-2014 204
Figure 66: Environmental Health, Saudi Arabia, CO2 Emissions (million metric tons), 2008-2014 205
Figure 67: Environmental Health, Saudi Arabia, PM2.5 (µgm/m³), 2008-2014 206
Figure 68: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 10,000 population), 2008-2014 208
Figure 69: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008-2014 209
Figure 70: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2008-2014 210
Figure 71: Healthcare Market, Saudi Arabia, Opportunities and Challenges, 2016 216

Published By: GlobalData
Product Code: GlobalData34951


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