Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

REF ER EN CE CO DE GDH C0064CH R | PU BLIC AT IO N D AT E JULY 2014
HEALTHCARE, REGULATORY AND

REIMBURSEMENT LANDSCAPE SAUDI ARABIA
Executive Summary
A high burden of chronic diseases, improving Patented drugs have a dominant position in the
regulatory guidelines and the launch of new pharmaceutical market. In 2012, the share of
products will provide the necessary impetus patented drugs was XX% of the pharmaceutical
for the growth of the pharmaceutical market in market. In 2013, the generic market was worth
Saudi Arabia $XX million. The OTC drug market had a low
market share of XX% of the pharmaceutical
The Saudi pharmaceutical market is one of the
market. The OTC drugs market expanded at a
largest markets in the Middle East and the largest
CAGR of XX% during the 20082013 (Shaikh,
among the Gulf Co-operation Council (GCC)
2011).
members. It was valued at approximately $XX
billion in 2013 and is projected to reach $XX billion The major multi-national pharmaceutical
in 2020 at a Compound Annual Growth Rate companies in Saudi Arabia are GlaxoSmithKline
(CAGR) of XX% (Shaikh, 2011). (GSK), Pfizer and Novartis. Saudi Pharmaceutical
Industries and Medical Appliances Corporation
The incidence of heart diseases has been
(SPIMACO) and Tabuk are the major local players.
increasing annually. The major risk factors for
Imports accounted for XX%, or $XX billion, of the
cardiovascular disease are a lack of physical
pharmaceutical market in 2012.
activity, unhealthy diet, and tobacco use.
Approximately XX% of deaths from non- The price of pharmaceuticals was less expensive
communicable disease were due to cardiovascular compared with other GCC member countries.
diseases in 2010. In 2010, XX men and XX women These low prices enhance the affordability of
with cardiovascular disease visited primary pharmaceuticals, boosting the pharmaceutical
healthcare centers (MOH, 2013). market.
Increasing access to medicines, increasing

affordability and increasing general awareness of
common diseases are the other factors that will
drive the pharmaceutical market.
Healthcare, Regulatory and Reimbursement Landscape Saudi Arabia

2
GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Executive Summary
Pharmaceutical Market, Saudi Arabia, Revenue Medical Device Market, Saudi Arabia, Revenue
Forecast ($bn), 20082020 Forecast ($bn), 20082020
CAGR (20082020): XX%

CAGR (20082020): XX%
Revenue ($bn)
Revenue ($bn)
2008 2013* 2015 2020 2008 2013 2015 2020
Source: Shaikh, 2011 Source: Medical eTrack [accessed May 21, 2014]
*Estimated figures
The government is working to ease

The size of the medical device market was
cumbersome regulatory processes in order to
approximately $XX billion in 2013. The market is
accelerate the approval of pharmaceuticals and
projected to reach approximately $XX billion by
medical devices, which will positively influence
2020 at a projected CAGR of XX%. In vitro
the healthcare market
diagnostics (XX%), diagnostic imaging (XX%) and
ophthalmic devices (XX%) were the major The Saudi Food and Drug Authority (SFDA) is
segments in the medical device market in 2013. responsible for ensuring the safety of food and
The key challenges faced by the medical device drugs as well as biological and chemical
industry are low expenditure on Research and substances. The main task of SFDA is to regulate,
Development (R&D) by the domestic sector. manage and control food, drug, medical devices as
well as setting up of compulsory standard
specifications, whether they are imported or locally
manufactured.

3
Table of Contents
1 Table of Contents
1 Table of Contents ....................................................................................................................... 7
1.1 List of Tables .................................................................................................................... 11
1.2 List of Figures ................................................................................................................... 15
2 Introduction ............................................................................................................................... 19
2.1 GlobalData Report Guidance ............................................................................................ 19
3 Overview of the Pharmaceutical and Medical Device Market .................................................... 20
3.1 Pharmaceutical Market ..................................................................................................... 20
3.1.1 Market Overview ........................................................................................................... 20
3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24
3.1.3 Supply Channels ........................................................................................................... 25
3.1.4 Market Segments .......................................................................................................... 25
3.1.5 Major Diseases ............................................................................................................. 29
3.1.6 Major Players ................................................................................................................ 30
3.2 Medical Device Market ...................................................................................................... 66
3.2.1 Market Overview ........................................................................................................... 66
3.2.2 Overview of the Top Five Segments .............................................................................. 68
3.2.3 Diagnostics Market ........................................................................................................ 81
3.2.4 Major Players ................................................................................................................ 84
3.3 Market Drivers and Barriers ............................................................................................ 119
3.3.1 Drivers......................................................................................................................... 119
3.3.2 Barriers ....................................................................................................................... 120

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Table of Contents
4 Market Access ........................................................................................................................ 122
4.1 Reimbursement and Payer Landscape ........................................................................... 122
4.1.1 Overview of Healthcare system ................................................................................... 122
4.1.2 Reimbursement Process ............................................................................................. 123
4.1.3 Overview of Insurance Providers ................................................................................. 125
4.1.4 Patient Share in Healthcare Spending ......................................................................... 127
4.1.5 Price Trends in the Healthcare Sector ......................................................................... 128
4.1.6 Pricing Policies ............................................................................................................ 128
4.2 Regulatory Landscape .................................................................................................... 132
4.2.1 Overview of Regulatory Agencies................................................................................ 132
4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 133
4.2.3 New Medical Device Approval Process ....................................................................... 139
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 143
4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 144
4.2.6 Intellectual Property Rights.......................................................................................... 145
4.2.7 Clinical Trial Regulations ............................................................................................. 151
4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 153
4.2.9 Pharmacy Regulations ................................................................................................ 155
4.2.10 Labeling and Packaging Regulations .......................................................................... 156
5 Country Analysis ..................................................................................................................... 159
5.1 Political Environment....................................................................................................... 159
5.1.1 Political Structure ........................................................................................................ 159
5.1.2 Analysis of Current Political Environment .................................................................... 160

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Table of Contents
5.1.3 Healthcare Policy Initiatives......................................................................................... 161
5.2 Economic Landscape ...................................................................................................... 162
5.3 Economic Indicators ........................................................................................................ 166
5.3.1 Gross Domestic Product ............................................................................................. 166
5.3.2 Gross National Income ................................................................................................ 170
5.3.3 Inflation ....................................................................................................................... 172
5.3.4 Currency Exchange Rate ............................................................................................ 175
5.3.5 Foreign Direct Investment ........................................................................................... 176
5.3.6 Foreign Exchange Reserves ....................................................................................... 177
5.3.7 Trade Balance ............................................................................................................. 179
5.3.8 Fiscal Surplus/Deficit ................................................................................................... 181
5.3.9 General Government Gross Debt ................................................................................ 182
5.3.10 Major Industries........................................................................................................... 183
5.4 Demographics ................................................................................................................. 185
5.4.1 Population ................................................................................................................... 185
5.4.2 Education and Literacy ................................................................................................ 205
5.4.3 Employment ................................................................................................................ 206
5.4.4 Disease Burden........................................................................................................... 208
5.5 Healthcare Infrastructure ................................................................................................. 210
5.5.1 Healthcare Facilities .................................................................................................... 210
5.5.2 Healthcare Parameters ............................................................................................... 214
5.5.3 Environmental Health .................................................................................................. 216
5.5.4 Healthcare Personnel .................................................................................................. 220

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Table of Contents
5.6 Healthcare Expenditure................................................................................................... 222
5.6.1 Overview ..................................................................................................................... 222
5.6.2 Share of Public and Private Sector .............................................................................. 223
5.7 Trade Associations ......................................................................................................... 224
5.7.1 Saudi Pharmaceutical Society ..................................................................................... 224
5.7.2 Saudi Dental Society ................................................................................................... 224
5.7.3 Gulf Pharmaceutical Industries Association ................................................................. 224
5.7.4 Middle East Medical Devices and Diagnostics Trade Association ............................... 225
5.7.5 Middle East Generic Association ................................................................................. 225
5.8 Trade fairs....................................................................................................................... 225
6 Opportunities and Challenges ................................................................................................. 226
6.1 Opportunities .................................................................................................................. 226
6.2 Challenges ...................................................................................................................... 227
7 Appendix................................................................................................................................. 228
7.1 Abbreviations .................................................................................................................. 228
7.2 Bibliography .................................................................................................................... 234
7.3 Research Methodology ................................................................................................... 244
7.3.1 Coverage .................................................................................................................... 244
7.3.2 Secondary Research ................................................................................................... 245
7.3.3 Forecasts .................................................................................................................... 245
7.3.4 Expert Panel................................................................................................................ 245
7.4 Disclaimer ....................................................................................................................... 246

10
Table of Contents
1.1 List of Tables
Table 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 20082013 .................................................. 22
Table 2: Pharmaceutical Market, Saudi Arabia, Revenue Forecast ($bn), 20142020 .................................... 23
Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 20082013 ................................. 24
Table 4: Pharmaceutical Market, Saudi Arabia, Supply Chain Margin, 2008 ................................................... 25
Table 5: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 20082013 .......................... 27
Table 6: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 20082013 ............................... 28
Table 7: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013.................. 31
Table 8: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 ................................... 32
Table 9: Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 .................................. 39
Table 10: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 .................................................. 40
Table 11: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013............................. 47
Table 12: Pharmaceutical Market, Novartis, Global, Planned Filings, 20142018 ........................................... 48
Table 13: SPIMACO, Major Products, 2012 ................................................................................................... 58
Table 14: Tabuk, Major Products, 2012.......................................................................................................... 63
Table 15: Medical Device Market, Saudi Arabia, Revenue ($bn), 20082013 ................................................. 67
Table 16: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 20142020................................... 67
Table 17: Medical Device Market, Saudi Arabia, Major Segments, Revenue ($m) and Share (%), 2013 ......... 68
Table 18: Medical Device Market, Saudi Arabia, In Vitro Diagnostics, Revenue ($m), 20082013 .................. 70
Table 19: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, In Vitro Diagnostics, 2012 . 71
Table 20: Medical Device Market, Saudi Arabia, Diagnostic Imaging, Revenue ($m), 20082013................... 72
Table 21: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Diagnostic Imaging, 2012 . 73
Table 22: Medical Device Market, Saudi Arabia, Ophthalmic Devices Market, Revenue ($m), 20082013...... 74
Table 23: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Ophthalmic Devices, 2012 76

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Table 24: Medical Device Market, Saudi Arabia, Cardiovascular Devices Market, Revenue ($m), 20082013 77
Table 25: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Cardiovascular Devices,
2012............................................................................................................................................ 78
Table 26: Medical Device Market, Saudi Arabia, Nephrology and Urology Devices Market, Revenue ($m),
20082013 .................................................................................................................................. 79
Table 27: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Nephrology and Urology
Devices, 2012 ............................................................................................................................. 81
Table 28: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 20082013................... 82
Table 29: Medical Device Market, Saudi Arabia, Revenue Forecast ($m), 20142020 ................................... 83
Table 30: Medical Device Market, Saudi Arabia, Major Players, Revenue ($m), 2012 .................................... 84
Table 31: Siemens Healthcare, Global, Major Products, 2014 ........................................................................ 85
Table 32: Roche, Global, Major Products, 2013 ........................................................................................... 102
Table 33: Medical Device Market, Roche, Global, Late-stage Pipeline, 2014 ................................................ 102
Table 34: Abbott, Global, Major Products, 2014 ........................................................................................... 113
Table 35: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 ............................................... 114
Table 36: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (%), 20082013 ......................... 128
Table 37: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 20082013 .............. 167
Table 38: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 20142020 168
Table 39: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 20082013 ...... 169
Table 40: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 20142020 ...... 170
Table 41: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 20082013 ................ 171
Table 42: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 20082013.......................... 173
Table 43: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 20142020.......................... 173
Table 44: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 20082013 .... 174
Table 45: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 20082013 ...................... 175

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Table 46: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 20082013 ......................... 177
Table 47: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 20082013 ..................... 178
Table 48: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 20082013 ................. 179
Table 49: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 20082013 ................. 180
Table 50: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 20082012 .............................. 181
Table 51: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 20082013 .... 182
Table 52: Economic Indicators, Saudi Arabia, Major Industries, Gross Domestic Product ($bn), 20122013 184
Table 53: Demographics, Saudi Arabia, Population (million), 20082013 ..................................................... 186
Table 54: Demographics, Saudi Arabia, Population Forecast (million), 20142020 ....................................... 186
Table 55: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 20082013 ..... 188
Table 56: Demographics, Saudi Arabia, Population, Urban and Rural Population Forecast Share (%), 2014
2020.......................................................................................................................................... 189
Table 57: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 20082013 ................... 190
Table 58: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 20082013 ..... 191
Table 59: Demographics, Saudi Arabia, Births (per 1,000 Population), 20082013....................................... 192
Table 60: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 20082013 .................................. 193
Table 61: Demographics, Saudi Arabia, Major Causes of Mortality (%), 2012............................................... 195
Table 62: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008
2013.......................................................................................................................................... 196
Table 63: Demographics, Saudi Arabia, Immunization Rate (%), 20082012 ............................................... 197
Table 64: Demographics, Saudi Arabia, Major Causes of Male Mortality (000), 2008................................... 199
Table 65: Demographics, Saudi Arabia, Major Causes of Female Mortality (000), 2008............................... 200
Table 66: Demographics, Saudi Arabia, Gender Ratio (M/F), 20082013 ..................................................... 201
Table 67: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 20082013 .................................. 203
Table 68: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 20142020 .................................. 204

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Table 69: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 20082013 ...... 206
Table 70: Demographics, Saudi Arabia, Unemployment Rate (%), 20082013 ............................................. 207
Table 71: Demographics, Saudi Arabia, Major Diseases, Health Center Visits (million), 2011....................... 208
Table 72: Demographics, Saudi Arabia, Major Diseases, DALYs (per 100,000 Population), 2004 ................ 210
Table 73: Healthcare Infrastructure, Saudi Arabia, Hospitals, 20082013..................................................... 211
Table 74: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2012..................................... 212
Table 75: Healthcare Infrastructure, Saudi Arabia, Primary Health Centers, 20082013 ............................... 214
Table 76: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 20082013 ........ 215
Table 77: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 20082013 ............... 216
Table 78: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 20082013 ............................ 217
Table 79: Environmental Health, Saudi Arabia, PM10 (gm/m), 20082013 ................................................ 218
Table 80: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 20082013 .... 221
Table 81: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 20082013 .............. 222
Table 82: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 20182013 ............................... 223
Table 83: Major Healthcare Trade Fairs, Saudi Arabia, 2014 ....................................................................... 225

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Table of Contents
1.2 List of Figures
Figure 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 20082013 ................................................. 22
Figure 2: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 20142020 ................................................. 23
Figure 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 20082013 ................................ 24
Figure 4: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 20082013 ......................... 26
Figure 5: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 20082013.............................. 28
Figure 6: Medical Device Market, Saudi Arabia, Revenue ($bn), 20082013 .................................................. 66
Figure 7: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 20142020 ................................... 67
Figure 8: Medical Device Market, Saudi Arabia, Major Segments, Revenue ($m), 2013 ................................. 68
Figure 9: Medical Device Market, Saudi Arabia, In Vitro Diagnostics, Revenue ($m), 20082013 ................... 69
Figure 10: Medical Device Market, Saudi Arabia, Sales Trends for Major Players, In Vitro Diagnostics, 2008
2012............................................................................................................................................ 70
Figure 11: Medical Device Market, Saudi Arabia, Diagnostic Imaging, Revenue ($m), 20082013 ................. 72
Figure 12: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Diagnostic Imaging, 2008
2012............................................................................................................................................ 73
Figure 13: Medical Device Market, Saudi Arabia Ophthalmic Devices Market, Revenue ($m), 20082013 ..... 74
Figure 14: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Ophthalmic Devices, 2008
2012............................................................................................................................................ 75
Figure 15: Medical Device Market, Saudi Arabia, Cardiovascular Devices Market, Revenue ($m), 20082013
................................................................................................................................................... 77
Figure 16: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Cardiovascular Devices,
20082012 .................................................................................................................................. 78
Figure 17: Medical Device Market, Saudi Arabia, Nephrology and Urology Devices Market, Revenue ($m),
20082013 .................................................................................................................................. 79
Figure 18: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Nephrology and Urology
Devices, 20082012 .................................................................................................................... 80

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Figure 19: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 20082013 ................. 82
Figure 20: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 20142020 ................. 83
Figure 21: Medical Device Market, Saudi Arabia, Major Players, Revenue ($m), 2012 ................................... 84
Figure 22: Healthcare Market, Saudi Arabia, Drivers and Barriers, 2014 ...................................................... 121
Figure 23: Healthcare Spending, Saudi Arabia, Out-of-Pocket Expenditure (%), 20082013 ........................ 127
Figure 24: Healthcare System, Saudi Arabia, Saudi Food and Drug Authority Structure, 2014 ..................... 133
Figure 25: Healthcare System, Saudi Arabia, Drug Licensing Approval Process, 2014 ................................. 135
Figure 26: Healthcare System, Saudi Arabia, Patent-Approval Process, 2014 .............................................. 148
Figure 27: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 20082013 ............. 167
Figure 28: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 20142020
................................................................................................................................................. 168
Figure 29: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 20082013 ..... 169
Figure 30: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth Forecast (%), 2014
2020.......................................................................................................................................... 170
Figure 31: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 20082013 ............... 171
Figure 32: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 20082013 ........................ 172
Figure 33: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 20142020 ........................ 173
Figure 34: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 20082013... 174
Figure 35: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 20082013..................... 175
Figure 36: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 20082013 ........................ 176
Figure 37: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 20082013 .................... 178
Figure 38: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 20082013 ................ 179
Figure 39: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 20082013 ................ 180
Figure 40: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 20082012 ............................. 181
Figure 41: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 20082013 ... 182

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Figure 42: Economic Indicators, Saudi Arabia, Major Industries, Industrial Sector, Gross Domestic Product
($bn), 20122013 ...................................................................................................................... 184
Figure 43: Demographics, Saudi Arabia, Population (million), 20082013 .................................................... 185
Figure 44: Demographics, Saudi Arabia, Population Forecast (million), 20142020 ..................................... 186
Figure 45: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 20082013 .... 187
Figure 46: Demographics, Saudi Arabia, Population, Urban and Rural Population Share Forecast (%), 2014
2020.......................................................................................................................................... 188
Figure 47: Demographics, Saudi Arabia, Population Distribution by Age Group (%), 20082013 .................. 190
Figure 48: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 20142020.... 191
Figure 49: Demographics, Saudi Arabia, Births (per 1,000 Population), 20082013 ..................................... 192
Figure 50: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 20082013 ................................. 193
Figure 51: Demographics, Saudi Arabia, Major Causes of Mortality (%), 2012 ............................................. 194
Figure 52: Demographics, Saudi Arabia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008
2013.......................................................................................................................................... 196
Figure 53: Demographics, Saudi Arabia, Immunization Rate (%), 20082013 .............................................. 197
Figure 54: Demographics, Saudi Arabia, Major Causes of Male Mortality (000), 2008 ................................. 198
Figure 55: Demographics, Saudi Arabia, Major Causes of Female Mortality (000), 2008 ............................. 200
Figure 56: Demographics, Saudi Arabia, Gender Ratio (M/F), 20082013.................................................... 201
Figure 57: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 20082013 ................................. 203
Figure 58: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 20142020 ................................. 204
Figure 59: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 20082013 ..... 205
Figure 60: Demographics, Saudi Arabia, Unemployment Rate (%), 20082013............................................ 207
Figure 61: Demographics, Saudi Arabia, Major Diseases, Health Center Visits (million), 2011...................... 208
Figure 62: Demographics, Saudi Arabia, Major Diseases, DALYs (per 100,000 Population), 2004 ............... 209
Figure 63: Healthcare Infrastructure, Saudi Arabia, Hospitals, 20082013 ................................................... 211

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Table of Contents
Figure 64: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2012 ................................... 212
Figure 65: Healthcare Infrastructure, Saudi Arabia, Primary Health Centers, 20082013 .............................. 213
Figure 66: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 20082013 ....... 214
Figure 67: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 20082013 .............. 215
Figure 68: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 20082013 ........................... 217
Figure 69: Environmental Health, Saudi Arabia, PM10 (gm/m), 20082013 .............................................. 218
Figure 70: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 20082013 ... 221
Figure 71: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 20082013............. 222
Figure 72: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 20182013.............................. 223
Figure 73: Healthcare Market, Saudi Arabia, Opportunities and Challenges, 2014 ....................................... 227

18
Introduction
2 Introduction
2.1 GlobalData Report Guidance
The report begins with an executive summary, which provides an overview of the healthcare
market in Saudi Arabia and the key factors driving its development. It also includes a snapshot
of Saudi Arabias demographic, regulatory and reimbursement landscape, as well as its
healthcare infrastructure.
Chapter three provides an overview of the pharmaceutical and medical device markets in
Saudi Arabia, covering market size; generics, Over-the-Counter (OTC) drugs,
biologic/biosimilar product shares and key drivers and barriers. It also includes profiles and
SWOT assessments of the major players in Saudi Arabias healthcare market.
Chapter four covers the reimbursement and payer landscape and provides details of the
reimbursement process, insurance providers, pricing policies and drug price trends in Saudi
Arabia. It also looks at the regulatory landscape and provides an overview of the regulatory
agencies and approval processes for new drugs and medical devices. In addition, this chapter
covers the licensing process for the manufacture, export and import of pharmaceuticals; details
the regulations in place for pharmaceutical advertising, labeling, packaging, and clinical trials;
and provides an overview of Saudi Arabias legal framework for intellectual property rights.
Chapter five provides detailed analysis of the political and economic environment in Saudi
Arabia, as well as economic indicators, demographics, and healthcare infrastructure and
expenditure.
Chapter six provides an overview of the opportunities for and challenges facing the growth of
the healthcare market.

19
Overview of the Pharmaceutical and Medical Device Market
3.1.2 Pharmaceutical Exports and Imports
Pharmaceutical exports were valued at approximately $XX billion in 2008 and $XX billion in 2013,
while pharmaceutical imports were valued at approximately $XX billion in 2008 and $XX billion in
2013 (Shaikh, 2011).
Figure 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 20082013
Revenue ($bn)
Exports
Imports
2008 2009 2010 2011 2012 2013*
Source: Shaikh, 2011
Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 20082013
Year 2008 2009 2010 2011 2012 2013*
Exports
Imports
Source: Shaikh, 2011
*Estimated figures

24
Appendix
7 Appendix
7.1 Abbreviations
gm/m: micrograms per cubic meter
ACPE: American Council for Pharmacy Education
ADHD: Attention Deficit Hyperactivity Disorder
ALK: Anaplastic Lymphoma Kinase
ARAMCO: Arabian American Oil Company
CAB: Conformity Assessment Body
CAGR: Compound Annual Growth Rate
CCHI: Council of Cooperative Health Insurance
CCS: CO2 Capture and Storage
CD: Crohns Disease
CDM: Clean Development Mechanism
CE: Conformit Europenne
CEO: Chief Executive Officer
CER: Certified Emission Reductions
CHD: Coronary Heart Disease
CIF: Cost, Insurance and Freight
CIS: Commonwealth of Independent States
CMPI: Center for Medicine in the Public Interest
CNS: Central Nervous System
COPD: Chronic Obstructive Pulmonary Disease
CPI: Consumer Price Index
CPS: Counts per Second

228
Appendix
CRL: Complete Response Letter
CT/NG: Chlamydia trachomatis/Neisseria gonorrhoeae
CT: Computed Tomography
CTMC: Clinical Trial Monitoring Center
CVD: Cardiovascular Disease
CVIS: Cardiovascular Information Management System
DALY: Disability Adjusted Life Year
DOTS: Directly Observed Treatment System
DPT: Diphtheria, Pertussis and Tetanus
DRG: Diagnostic Related Groups
DTC: Drug and Therapeutics Committee
EC: Ethics Committee
EFTA: European Free Trade Association
EMA: European Medical Agency
EMAP: Emerging Markets Asia-Pacific
EMEA: Europe, Middle East, Africa
ENT: Ear, Nose and Throat
FDA: Food and Drug Administration
FDI: Foreign Direct Investment
GAD: Generalized anxiety disorder
GAFTA: Greater Arab Free Trade Area
GCC: Gulf Co-operation Council
GDP: Gross Domestic Product
GFCF: Gross Fixed Capital Formation

229
Appendix
GHTF: Global Harmonization Task Force
GMP: Good Manufacturing Practices
GNI: Gross National Income
GOIC: Gulf Organization for Industrial Consulting
GOSI: General Organization for Social Insurance
GPIA: Gulf Pharmaceutical Industries Association
GSK: GlaxoSmithKline
HBV: Hepatitis B Virus
HCV: Hepatitis C Virus
HPV: Human Papillomavirus
HTA: Health Technology Assessment
IMF: International Monetary Fun
IMI: Innovative Medicines Initiative
IND: Investigational New Drug
IPCC: Intergovernmental Panel on Climate change
IPU: Inter-Parliamentary Union
IRB: Institutional Review Board
ISE: International Society of Electrochemistry
ITE: In-the-Ear
IVD: In Vitro Diagnostics
KACST: King Abdulaziz City for Science and Technology
KAUST: King Abdullah University of Science and Technology
LIS: Laboratory Information System
MAA: Market Authorization Application

230
Appendix
MDD: Medical Device Directives
MDG: Millennium Development Goals
MDIR: Medical Devices Interim Regulation
MDMA: Medical device marketing authorization
MDNR: Medical Devices National Registry
MDS: Medical Devices Sector
MECOMED: Middle East Medical Devices and Diagnostics Trade Association
MENA: Middle East and North Africa
MHLW: MOH, Labor and Welfare
MNC: Multi-National Company
MOC: Ministry of Commerce
MOH: Ministry of Health
MoU: Memorandum of Understanding
MRI: Magnetic Resonance Imaging
NDA: New Drug Application
NIBR: Novartis Institutes for Biomedical Research
NME: New Molecular Entity
NMHRS: National Medical and Health Research Strategy
NSCLC: Non-Small-Cell Lung Cancer
OBS: Obstetrics
OOP: Out-of-Pocket
OPEC: Organization of the Petroleum Exporting Countries
OTC: Over-the-Counter
PACS: Picture Archiving and Communications System

231
Appendix
PAD: Peripheral Arterial Disease
PCR: Polymerase Chain Reactions
PEPFAR: Presidents Emergency Plan for AIDS Relief
PET: Positron Emission Tomography
PHC: Primary Healthcare Centers
PhRMA: Pharmaceutical Research Manufacturers of America
PIL: Patient Information Leaflet
PTC: Pharmacy and Therapeutics Committee
QC: Quality Control
QMS: Quality Management System
R&D: Research and Development
RIS: Radiology Information System
SAMA: Saudi Arabian Monetary Agency
SAR: Saudi Arabian Riyal
SET: Signal Extraction Technology
SFDA: Saudi Food and Drug Authority
SMF: Site Master File
SPC: Summary of Product Characteristics
SPECT: Single-Photon Emission Computed Tomography
SPIMACO: Saudi Pharmaceutical Industries and Medical Appliances Corporation
SPS: Saudi Pharmaceutical Society
SRA: Stringent Drug Regulatory Authority
STD: Sexually Transmitted Diseases
TRIPS: Trade-Related Aspects of Intellectual Property Rights

232
Appendix
UNFCCC: United Nations Framework Convention on Climate Change
UNICEF: United Nations International Childrens Emergency Fund
USP: Unique Selling Proposition
WHO: World Health Organization
WIPO World Intellectual Property Organization
WTO: World Trade Organization
Y-o-Y: Year-on-Year

233
Appendix
7.2 Bibliography
Abbott (2013). 2013 Investor Relations. Abbott. Available from:

http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irol-irhome [Accessed on February,
27, 2014].
Alghasham A (2009). Generic Drug Prescribing in Central Saudi Arabia: Perceptions and
Attitudes of Physicians. Annals of Saudi medicine; 29(1): 2429. Available from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2813610/.
Alkahtani A (2008). The Experience of Mandatory Health Insurance in Kingdom of Saudi

Arabia. Council of Cooperative Health Insurance. Available from:
http://www.eventscom.net/bia/pr2.pdf
Al-Oufi Law Firm (2012). Patents. Al-Oufi Law Firm. Available from:
http://www.aloufilawfirm.com/pate.htm [Accessed on May 2, 2014].
Aluwaisheg AA (2013). Saudi budget 2014 and economic performance, Arab News,
December 29, 2013. Available from: http://www.arabnews.com/news/500101 [Accessed April
14, 2014].
Bawazir SA et al. (2012). Pharmaceutical policies used by private health insurance companies
in Saudi Arabia. Saudi Pharmaceutical Journal; 2013 (21): 267-276.
Brockmeyer C and Woollett G (2012). Biosimilars in Emerging Markets. Brockmeyer-

Biopharma. Available from: http://www.brockmeyer-
biopharma.com/_downloads/Biosimilars_in_emerging_markets_CB_GW_2012.pdf
Brown D (2006). Crash of 86 Left Permanent Scars. American Association of Petroleum

Geologists. Available from: http://www.aapg.org/explorer/2006/01jan/crash.cfm [Accessed on
May 27, 2014].
CCHI (2014). Cooperative Health Insurance. Council of Cooperative Health Insurance.

Available from: http://www.cchi.gov.sa/en/Magazine/Pages/default.aspx [Accessed on May 19,
2014].
CDSI (2014). National accounts statistics. Central Department of Statistics and Information.
Available from: http://www.cdsi.gov.sa/english/index.php?option=com_docman&Itemid=151
[Accessed April 14, 2014].

234
Appendix
WIPO (2002). Law of Trademarks. World Intellectual Property Organization. Available from:
http://www.wipo.int/wipolex/en/text.jsp?file_id=129518 [Accessed on May 27, 2014].
WIPO (2012). Law of Patents, Layout-Designs of Integrated Circuits, Plant Varieties, and
Industrial Designs. World Intellectual Property Organization. Available from:
http://www.wipo.int/wipolex/en/text.jsp?file_id=206401#LinkTarget_990 [Accessed on May 27,
2014].
WIPR (2012). Border measures: a solution in Saudi Arabia. World Intellectual Property Review.
Available from: http://www.worldipreview.com/article/border-measures-a-solution-in-saudi-
arabia [Accessed on May 2, 2014].
World Bank (2014a). Out-of-pocket health expenditure (% of total expenditure on health).

World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.TO.ZS
World Bank (2014b). GNI per capita, Atlas method (current US$). World Bank. Available from:
http://data.worldbank.org/indicator/NY.GNP.PCAP.CD [Accessed April 14, 2014].
World Bank (2014c). Foreign direct investment, net inflows (BoP, current US$). World Bank.
Available from: http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD [Accessed April 2,
2014].
World Bank (2014d). Total reserves (includes gold, current US$). World Bank. Available from:
http://data.worldbank.org/indicator/FI.RES.TOTL.CD [Accessed April 2, 2014].
World Bank (2014e). Imports of goods and services (current US$). World Bank. Available from:
http://data.worldbank.org/indicator/NE.IMP.GNFS.CD [Accessed April 2, 2014].
World Bank (2014f). Exports of goods and services (current US$). World Bank. Available from:
http://data.worldbank.org/indicator/NE.EXP.GNFS.CD [Accessed April 2, 2014].
World Bank (2014g). Population density (people per sq. km of land area). World Bank.
Available from: http://data.worldbank.org/indicator/EN.POP.DNST [Accessed April 2, 2014].
World Bank (2014h). Urban population (% of total). World Bank. Available from:
http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS/countries/1W-SA?display=graph

242
Appendix
World Bank (2014i). Literacy rate, adult total (% of people ages 15 and above). World Bank.
Available from: http://data.worldbank.org/indicator/SE.ADT.LITR.ZS [Accessed April 2, 2014].
World Bank (2014j). CO2 emissions (kt). World Bank. Available from:
http://data.worldbank.org/indicator/EN.ATM.CO2E.KT/countries/1W-SA?display=graph
World Bank (2014k). PM10, country level (micrograms per cubic meter). World Bank. Available
from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3/countries/1W-
SA?display=graph [Accessed April 2, 2014].
World Bank (2014l). Health expenditure, total (% of GDP). World Bank. Available from:
http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS/countries/1W-SA?display=graph
World Bank (2014m). Health expenditure, public (% of total health expenditure). World Bank.
Available from: http://data.worldbank.org/indicator/SH.XPD.PUBL/countries/1W-
SA?display=graph [Accessed April 2, 2014].
World Health Organization (2009). Global Burden of Disease (GBD). World Health
Organization. Available from: http://www.who.int/healthinfo/global_burden_disease/en/
[Accessed on April 9, 2012].

243
Appendix
7.3 Research Methodology
GlobalDatas dedicated research and analysis teams consist of experienced professionals with
advanced statistical expertise and marketing, market research and consulting backgrounds in the
pharmaceutical industry.
GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and
Strategic and Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research
methodology is followed for all databases and reports.
7.3.1 Coverage
The objective of updating GlobalDatas coverage is to ensure that it represents the most up-to-date
vision of the industry possible.
Changes to the industry taxonomy are built on the basis of extensive research of company,
association and competitor sources.
Company coverage is based on three key factors: revenue; products; and media attention,
innovation and market potential.
The estimated revenue of all major companies, including private and governmental, are gathered
and used to prioritize coverage.
Companies that are making the news or are of particular interest due to their innovative approach
are prioritized.
GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated
on a daily basis.
The coverage is further streamlined and strengthened with additional input from GlobalDatas
expert panel (see below).

244
Appendix
7.3.2 Secondary Research
The research process begins with extensive secondary research using internal and external
sources to gather qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and
SEC filings
Industry trade journals, scientific journals and other technical literature
Internal proprietary databases
Relevant patent and regulatory databases
National government documents, statistical databases and market reports
Procedure registries
News articles, press releases and web-casts specific to the companies operating in the market
Saudi Arabia focus reports are largely based on secondary research and use reliable and
authoritative sources such as the IMF, World Bank, OECD, WHO, UNICEF, UNStats, BEA, MHLW
and NHS, among others.
7.3.3 Forecasts
Saudi Arabia focus reports use the data available from the secondary sources to forecast and
validate the future trends for a countrys healthcare market, as well as parameters related to the
economy and healthcare infrastructure and expenditure.
7.3.4 Expert Panel
GlobalData uses a panel of experts to cross-verify its databases and forecasts.
GlobalDatas expert panel comprises marketing managers, product specialists, international sales
managers from pharmaceutical companies, academics from research universities, consultants from
venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.
Historic data and forecasts are relayed to GlobalDatas expert panel and adjusted in accordance
with their feedback.

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Appendix
7.4 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.

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REF ER EN CE CO DE GDH C0064CH R | PU BLIC AT IO N D AT E JULY 2014

HEALTHCARE, REGULATORY AND

Increasing access to medicines, increasing

Healthcare, Regulatory and Reimbursement Landscape Saudi Arabia

CAGR (20082020): XX%

The government is working to ease

Healthcare, Regulatory and Reimbursement Landscape Saudi Arabia

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 11

1.2 List of Figures ................................................................................................................... 15

2.1 GlobalData Report Guidance ............................................................................................ 19

3 Overview of the Pharmaceutical and Medical Device Market .................................................... 20

3.1 Pharmaceutical Market ..................................................................................................... 20

3.1.1 Market Overview ........................................................................................................... 20

3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24

3.1.3 Supply Channels ........................................................................................................... 25

3.1.4 Market Segments .......................................................................................................... 25

3.1.5 Major Diseases ............................................................................................................. 29

3.1.6 Major Players ................................................................................................................ 30

3.2 Medical Device Market ...................................................................................................... 66

3.2.1 Market Overview ........................................................................................................... 66

3.2.2 Overview of the Top Five Segments .............................................................................. 68

3.2.3 Diagnostics Market ........................................................................................................ 81

3.2.4 Major Players ................................................................................................................ 84

3.3 Market Drivers and Barriers ............................................................................................ 119

3.3.1 Drivers......................................................................................................................... 119

3.3.2 Barriers ....................................................................................................................... 120

Healthcare, Regulatory and Reimbursement Landscape Saudi Arabia

4 Market Access ........................................................................................................................ 122

4.1 Reimbursement and Payer Landscape ........................................................................... 122

4.1.1 Overview of Healthcare system ................................................................................... 122

4.1.2 Reimbursement Process ............................................................................................. 123

4.1.3 Overview of Insurance Providers ................................................................................. 125

4.1.4 Patient Share in Healthcare Spending ......................................................................... 127

4.1.5 Price Trends in the Healthcare Sector ......................................................................... 128

4.1.6 Pricing Policies ............................................................................................................ 128

4.2 Regulatory Landscape .................................................................................................... 132

4.2.1 Overview of Regulatory Agencies................................................................................ 132

4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 133

4.2.3 New Medical Device Approval Process ....................................................................... 139

4.2.6 Intellectual Property Rights.......................................................................................... 145

4.2.7 Clinical Trial Regulations ............................................................................................. 151

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 153

4.2.9 Pharmacy Regulations ................................................................................................ 155

4.2.10 Labeling and Packaging Regulations .......................................................................... 156

5 Country Analysis ..................................................................................................................... 159

5.1 Political Environment....................................................................................................... 159

5.1.1 Political Structure ........................................................................................................ 159

5.1.2 Analysis of Current Political Environment .................................................................... 160

Healthcare, Regulatory and Reimbursement Landscape Saudi Arabia

5.1.3 Healthcare Policy Initiatives......................................................................................... 161

5.2 Economic Landscape ...................................................................................................... 162

5.3 Economic Indicators ........................................................................................................ 166

5.3.1 Gross Domestic Product ............................................................................................. 166

5.3.2 Gross National Income ................................................................................................ 170

5.3.3 Inflation ....................................................................................................................... 172

5.3.4 Currency Exchange Rate ............................................................................................ 175

5.3.5 Foreign Direct Investment ........................................................................................... 176

5.3.6 Foreign Exchange Reserves ....................................................................................... 177

5.3.7 Trade Balance ............................................................................................................. 179

5.3.8 Fiscal Surplus/Deficit ................................................................................................... 181

5.3.9 General Government Gross Debt ................................................................................ 182

5.3.10 Major Industries........................................................................................................... 183