GDHC0064CHR Healthcare, Regulatory and … 18: Medical Device Market, Saudi Arabia, In Vitro...

REFERENCE CODE GDHC0064CHR | PUBLICATION DATE JULY 2014

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SAUDI ARABIA

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

A high burden of chronic diseases, improving regulatory guidelines and the launch of new products will provide the necessary impetus for the growth of the pharmaceutical market in Saudi Arabia

The Saudi pharmaceutical market is one of the

largest markets in the Middle East and the largest

among the Gulf Co-operation Council (GCC)

members. It was valued at approximately $XX

billion in 2013 and is projected to reach $XX billion

in 2020 at a Compound Annual Growth Rate

(CAGR) of XX% (Shaikh, 2011).

The incidence of heart diseases has been

increasing annually. The major risk factors for

cardiovascular disease are a lack of physical

activity, unhealthy diet, and tobacco use.

Approximately XX% of deaths from non-

communicable disease were due to cardiovascular

diseases in 2010. In 2010, XX men and XX women

with cardiovascular disease visited primary

healthcare centers (MOH, 2013).

Increasing access to medicines, increasing

affordability and increasing general awareness of

common diseases are the other factors that will

drive the pharmaceutical market.

Patented drugs have a dominant position in the

pharmaceutical market. In 2012, the share of

patented drugs was XX% of the pharmaceutical

market. In 2013, the generic market was worth

$XX million. The OTC drug market had a low

market share of XX% of the pharmaceutical

market. The OTC drugs market expanded at a

CAGR of XX% during the 2008–2013 (Shaikh,

2011).

The major multi-national pharmaceutical

companies in Saudi Arabia are GlaxoSmithKline

(GSK), Pfizer and Novartis. Saudi Pharmaceutical

Industries and Medical Appliances Corporation

(SPIMACO) and Tabuk are the major local players.

Imports accounted for XX%, or $XX billion, of the

pharmaceutical market in 2012.

The price of pharmaceuticals was less expensive

compared with other GCC member countries.

These low prices enhance the affordability of

pharmaceuticals, boosting the pharmaceutical

market.



Executive Summary

Pharmaceutical Market, Saudi Arabia, Revenue Forecast ($bn), 2008–2020

2008 2013* 2015 2020

Rev

enue

($bn

)

CAGR (2008–2020): XX%CAGR (2008–2020):

Source: Shaikh, 2011 *Estimated figures

The size of the medical device market was

approximately $XX billion in 2013. The market is

projected to reach approximately $XX billion by

2020 at a projected CAGR of XX%. In vitro

diagnostics (XX%), diagnostic imaging (XX%) and

ophthalmic devices (XX%) were the major

segments in the medical device market in 2013.

The key challenges faced by the medical device

industry are low expenditure on Research and

Development (R&D) by the domestic sector.

Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 2008–2020

2008 2013 2015 2020

Rev

enue

($b

n)

CAGR (2008–2020): XX%

Source: Medical eTrack [accessed May 21, 2014]

The government is working to ease cumbersome regulatory processes in order to accelerate the approval of pharmaceuticals and medical devices, which will positively influence the healthcare market

The Saudi Food and Drug Authority (SFDA) is

responsible for ensuring the safety of food and

drugs as well as biological and chemical

substances. The main task of SFDA is to regulate,

manage and control food, drug, medical devices as

well as setting up of compulsory standard

specifications, whether they are imported or locally

manufactured.


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


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


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


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


Table of Contents


1.1 List of Tables

Table 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008–2013 .................................................. 22

Table 2: Pharmaceutical Market, Saudi Arabia, Revenue Forecast ($bn), 2014–2020 .................................... 23

Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008–2013 ................................. 24

Table 4: Pharmaceutical Market, Saudi Arabia, Supply Chain Margin, 2008 ................................................... 25

Table 5: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 2008–2013 .......................... 27

Table 6: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 2008–2013 ............................... 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, 2014–2018 ........................................... 48

Table 13: SPIMACO, Major Products, 2012 ................................................................................................... 58

Table 14: Tabuk, Major Products, 2012.......................................................................................................... 63

Table 15: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008–2013 ................................................. 67

Table 16: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 2014–2020................................... 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), 2008–2013 .................. 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), 2008–2013................... 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), 2008–2013...... 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), 2008–2013 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),

2008–2013 .................................................................................................................................. 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), 2008–2013................... 82

Table 29: Medical Device Market, Saudi Arabia, Revenue Forecast ($m), 2014–2020 ................................... 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 (%), 2008–2013 ......................... 128

Table 37: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita ($), 2008–2013 .............. 167

Table 38: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 2014–2020 168

Table 39: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008–2013 ...... 169

Table 40: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2014–2020 ...... 170

Table 41: Economic Indicators, Saudi Arabia, Gross National Income per Capita ($), 2008–2013 ................ 171

Table 42: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008–2013.......................... 173

Table 43: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2014–2020.......................... 173

Table 44: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 2008–2013 .... 174

Table 45: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008–2013 ...................... 175


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Table 46: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008–2013 ......................... 177

Table 47: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008–2013 ..................... 178

Table 48: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008–2013 ................. 179

Table 49: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008–2013 ................. 180

Table 50: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008–2012 .............................. 181

Table 51: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008–2013 .... 182

Table 52: Economic Indicators, Saudi Arabia, Major Industries, Gross Domestic Product ($bn), 2012–2013 184

Table 53: Demographics, Saudi Arabia, Population (million), 2008–2013 ..................................................... 186

Table 54: Demographics, Saudi Arabia, Population Forecast (million), 2014–2020 ....................................... 186

Table 55: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 2008–2013 ..... 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 (%), 2008–2013 ................... 190

Table 58: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 2008–2013 ..... 191

Table 59: Demographics, Saudi Arabia, Births (per 1,000 Population), 2008–2013....................................... 192

Table 60: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 2008–2013 .................................. 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 (%), 2008–2012 ............................................... 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), 2008–2013 ..................................................... 201

Table 67: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008–2013 .................................. 203

Table 68: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2014–2020 .................................. 204


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Table 69: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008–2013 ...... 206

Table 70: Demographics, Saudi Arabia, Unemployment Rate (%), 2008–2013 ............................................. 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, 2008–2013..................................................... 211

Table 74: Healthcare Infrastructure, Saudi Arabia, Hospitals by Type of Care, 2012..................................... 212

Table 75: Healthcare Infrastructure, Saudi Arabia, Primary Health Centers, 2008–2013 ............................... 214

Table 76: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 2008–2013 ........ 215

Table 77: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 2008–2013 ............... 216

Table 78: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 2008–2013 ............................ 217

Table 79: Environmental Health, Saudi Arabia, PM10 (µgm/m³), 2008–2013 ................................................ 218

Table 80: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 2008–2013 .... 221

Table 81: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008–2013 .............. 222

Table 82: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2018–2013 ............................... 223

Table 83: Major Healthcare Trade Fairs, Saudi Arabia, 2014 ....................................................................... 225


Table of Contents


1.2 List of Figures

Figure 1: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2008–2013 ................................................. 22

Figure 2: Pharmaceutical Market, Saudi Arabia, Revenue ($bn), 2014–2020 ................................................. 23

Figure 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008–2013 ................................ 24

Figure 4: Pharmaceutical Market, Saudi Arabia, Generic Market, Revenue ($m), 2008–2013 ......................... 26

Figure 5: Pharmaceutical Market, Saudi Arabia, OTC Market, Revenue ($m), 2008–2013.............................. 28

Figure 6: Medical Device Market, Saudi Arabia, Revenue ($bn), 2008–2013 .................................................. 66

Figure 7: Medical Device Market, Saudi Arabia, Revenue Forecast ($bn), 2014–2020 ................................... 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), 2008–2013 ................... 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), 2008–2013 ................. 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), 2008–2013 ..... 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), 2008–2013

................................................................................................................................................... 77

Figure 16: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Cardiovascular Devices,

2008–2012 .................................................................................................................................. 78

Figure 17: Medical Device Market, Saudi Arabia, Nephrology and Urology Devices Market, Revenue ($m),

2008–2013 .................................................................................................................................. 79

Figure 18: Medical Device Market, Saudi Arabia, Sales Trends for Major Players*, Nephrology and Urology

Devices, 2008–2012 .................................................................................................................... 80


Table of Contents


Figure 19: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 2008–2013 ................. 82

Figure 20: Medical Device Market, Saudi Arabia, Diagnostics Market, Revenue ($m), 2014–2020 ................. 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 (%), 2008–2013 ........................ 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 ($), 2008–2013 ............. 167

Figure 28: Economic Indicators, Saudi Arabia, Gross Domestic Product per Capita Forecast ($), 2014–2020

................................................................................................................................................. 168

Figure 29: Economic Indicators, Saudi Arabia, Gross Domestic Product Annual Growth (%), 2008–2013 ..... 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 ($), 2008–2013 ............... 171

Figure 32: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2008–2013 ........................ 172

Figure 33: Economic Indicators, Saudi Arabia, Average Consumer Price Index, 2014–2020 ........................ 173

Figure 34: Economic Indicators, Saudi Arabia, Average Consumer Price Annual Change (%), 2008–2013 ... 174

Figure 35: Economic Indicators, Saudi Arabia, Currency Exchange Rate (SAR/$), 2008–2013..................... 175

Figure 36: Economic Indicators, Saudi Arabia, Foreign Direct Investment ($bn), 2008–2013 ........................ 176

Figure 37: Economic Indicators, Saudi Arabia, Foreign Exchange Reserves ($bn), 2008–2013 .................... 178

Figure 38: Economic Indicators, Saudi Arabia, Imports of Goods and Services ($bn), 2008–2013 ................ 179

Figure 39: Economic Indicators, Saudi Arabia, Exports of Goods and Services ($bn), 2008–2013 ................ 180

Figure 40: Economic Indicators, Saudi Arabia, Budget Surplus/Deficit ($bn), 2008–2012 ............................. 181

Figure 41: Economic Indicators, Saudi Arabia, General Government Gross Debt (% of GDP), 2008–2013 ... 182


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Figure 42: Economic Indicators, Saudi Arabia, Major Industries, Industrial Sector, Gross Domestic Product

($bn), 2012–2013 ...................................................................................................................... 184

Figure 43: Demographics, Saudi Arabia, Population (million), 2008–2013 .................................................... 185

Figure 44: Demographics, Saudi Arabia, Population Forecast (million), 2014–2020 ..................................... 186

Figure 45: Demographics, Saudi Arabia, Population, Urban and Rural Population Share (%), 2008–2013 .... 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 (%), 2008–2013 .................. 190

Figure 48: Demographics, Saudi Arabia, Population Distribution by Age Group Forecast (%), 2014–2020.... 191

Figure 49: Demographics, Saudi Arabia, Births (per 1,000 Population), 2008–2013 ..................................... 192

Figure 50: Demographics, Saudi Arabia, Mortality (per 1,000 Population), 2008–2013 ................................. 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 (%), 2008–2013 .............................................. 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), 2008–2013 .................................................... 201

Figure 57: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2008–2013 ................................. 203

Figure 58: Demographics, Saudi Arabia, Life Expectancy at Birth (years), 2014–2020 ................................. 204

Figure 59: Demographics, Saudi Arabia, Student Enrollment by Level of Education (million), 2008–2013 ..... 205

Figure 60: Demographics, Saudi Arabia, Unemployment Rate (%), 2008–2013............................................ 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, 2008–2013 ................................................... 211


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, 2008–2013 .............................. 213

Figure 66: Healthcare Infrastructure, Saudi Arabia, Hospitals Beds (per 1,000 Population), 2008–2013 ....... 214

Figure 67: Healthcare Infrastructure, Saudi Arabia, Physicians (per 1,000 Population), 2008–2013 .............. 215

Figure 68: Environmental Health, Saudi Arabia, CO2 Emissions (million tons), 2008–2013 ........................... 217

Figure 69: Environmental Health, Saudi Arabia, PM10 (µgm/m³), 2008–2013 .............................................. 218

Figure 70: Healthcare Personnel, Saudi Arabia, Healthcare Personnel (per 1,000 population) 2008–2013 ... 221

Figure 71: Healthcare Expenditure, Saudi Arabia, Healthcare Expenditure (% of GDP), 2008–2013 ............. 222

Figure 72: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2018–2013 .............................. 223

Figure 73: Healthcare Market, Saudi Arabia, Opportunities and Challenges, 2014 ....................................... 227



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 Arabia’s 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 Arabia’s 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 Arabia’s 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.


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), 2008–2013

2008 2009 2010 2011 2012 2013*

Rev

enue

($bn

)

ExportsImports

Source: Shaikh, 2011

Table 3: Pharmaceutical Market, Saudi Arabia, Exports and Imports ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013*

Exports

Imports

Source: Shaikh, 2011 *Estimated figures


Appendix


7 Appendix

7.1 Abbreviations

µgm/m³: 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: Crohn’s Disease

CDM: Clean Development Mechanism

CE: Conformité Européenne

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


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


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


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


Appendix


PAD: Peripheral Arterial Disease

PCR: Polymerase Chain Reactions

PEPFAR: President’s 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


Appendix


UNFCCC: United Nations Framework Convention on Climate Change

UNICEF: United Nations International Children’s 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


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): 24–29. 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].


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



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].


Appendix


7.3 Research Methodology

GlobalData’s 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 GlobalData’s 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 GlobalData’s

expert panel (see below).


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 country’s 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.

GlobalData’s 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 GlobalData’s expert panel and adjusted in accordance

with their feedback.


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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