Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Published: October 2012
No. of Pages: 189
   

Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

Summary

GlobalData, the industry analysis specialist, has released its new report, “Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia”. An essential source of information and analysis on the Saudi Arabian healthcare, regulatory, and reimbursement landscape, this report identifies the key trends in the healthcare market, and provides insights on the demographic, regulatory, and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts. In 2011, the population of Saudi Arabia was approximately 28.17 million, growing at an annual rate of 3.8%. The mortality rate was almost steady at approximately four deaths per 1,000 population due to advances in the healthcare infrastructure and medical and diagnostic services. The value of the pharmaceutical market was estimated at $3.5 billion in 2011, and is expected to reach $5.6 billion by 2020, increasing at a projected Compound Annual Growth Rate (CAGR) of 5.4%. The medical device market was worth approximately $1.5 billion in 2011, and is expected to reach $2.3 billion by 2020, increasing at a projected CAGR of 4.5%.


The positive trends in the healthcare market of Saudi Arabia can be attributed primarily to -
- Increasing awareness of health and well-being in society
- Increasing affordability and compliance
- Strategic move towards compulsory health insurance

Scope

- An overview of the pharmaceutical and medical device markets, including size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical and medical device markets. The key players covered for the pharmaceutical market are GlaxoSmithKline (GSK), Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO), Pfizer, Tabuk, and Novartis; the key players covered for the medical device market are Siemens Healthcare, F. Hoffmann-La Roche, GE Healthcare, Abbott Laboratories, and Philips Healthcare.
- Insightful review of the reimbursement and regulatory landscape, with details of the reimbursement process, regulatory agencies, and market authorization processes for new drug and medical devices
- Detailed analysis of the political and economic environment, including economic indicators, demographics, healthcare infrastructure, and healthcare expenditures
- An overview of the opportunities and challenges for growth in the healthcare market

Reasons to buy

- Develop business strategies by understanding the trends shaping and driving the healthcare market in Saudi Arabia
- Drive revenues by understanding the key trends, reimbursement, and regulatory policies, pharmaceutical and medical device market segments, and companies likely to impact the healthcare market in Saudi Arabia in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape in Saudi Arabia and analyzing the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments in Saudi Arabia that present the most opportunities for consolidation, investment, and strategic partnerships
- Identify, understand, and capitalize on the opportunities and challenges in the healthcare market in Saudi Arabia

Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 11
2.1 Report Guidance 11
3 Overview of the Pharmaceutical and Medical Device Market 12
3.1 Pharmaceutical Market 12
3.1.1 Market Overview 12
3.1.2 Supply Channels 15
3.1.3 Market Segments 16
3.1.4 Major Diseases 19
3.1.5 Major Players 20
3.2 Medical Device Market 46
3.2.1 Market Overview 46
3.2.2 Overview of the Top Five Segments 49
3.2.3 Major Players 60
3.3 Market Drivers and Barriers 80
3.3.1 Drivers 80
3.3.2 Barriers 81
4 Market Access 83
4.1 Reimbursement and Payer Landscape 83
4.1.1 Overview of Healthcare System 83
4.1.2 Reimbursement Process 84
4.1.3 Overview of Insurance Providers 86
4.1.4 Patient Share in Healthcare Spending 87
4.1.5 Healthcare Price Trend 88
4.1.6 Drug Pricing Policies 88
4.2 Regulatory Landscape 90
4.2.1 Overview of Regulatory Agencies 90
4.2.2 Marketing Authorization Procedure for Pharmaceutical Products 91
4.2.3 New Medical Device Approval Process 97
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 100
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 101
4.2.6 Intellectual Property Rights 103
4.2.7 Clinical Trial Regulations 108
4.2.8 Pharmaceutical Advertising Regulations 109
4.2.9 Pharmacy Regulations 110
4.2.10 Labeling and Packaging Regulations 111
5 Country Analysis 113
5.1 Political Environment 113
5.1.1 Political Structure 113
5.1.2 Analysis of the Current Political Environment 113
5.1.3 Healthcare Policy Initiatives 114
5.2 Economic Landscape 115
5.3 Economic Indicators 118
5.3.1 Gross Domestic Product 118
5.3.2 Inflation 123
5.3.3 Currency Exchange Rate 127
5.3.4 Foreign Direct Investment 128
5.3.5 Foreign Exchange Reserves 129
5.3.6 Trade Balance 130
5.3.7 Government Gross Debt 132
5.3.8 Major Industries 134
5.4 Demographics 136
5.4.1 Population 136
5.4.2 Education and Literacy 152
5.4.3 Employment 154
5.4.4 Disease Burden 155
5.5 Healthcare Infrastructure 157
5.5.1 Healthcare Facilities 157
5.5.2 Healthcare Parameters 161
5.5.3 Environmental Health 163
5.5.4 Healthcare Personnel 168
5.6 Healthcare Expenditure 171
5.6.1 Overview of the Healthcare System 171
5.6.2 Public and Private Sector Shares 172
5.7 Trade Associations 173
5.7.1 Saudi Pharmaceutical Society 173
5.7.2 Saudi Dental Society 173
5.7.3 Gulf Pharmaceutical Industries Association 173
5.7.4 Middle East Medical Devices and Diagnostics Trade Association 173
5.7.5 Middle East Generic Association 173
5.8 Trade Fairs 174
6 Opportunities and Challenges 175
6.1 Opportunities 175
6.2 Challenges 176
7 Appendix 178
7.1 Abbreviations 178
7.2 Bibliography 182
7.3 Methodology 187
7.3.1 Coverage 187
7.3.2 Secondary Research 187
7.3.3 Forecasting 188
7.3.4 Primary Research 188
7.3.5 Expert Panel Validation 188
7.4 Contact Us 188
7.5 Disclaimer 189

1.1 List of Tables
Table 1: Pharmaceutical Market ($bn), Saudi Arabia, 2006-2011 12
Table 2: Pharmaceutical Market ($bn), Saudi Arabia, Forecast, 2012-2020 13
Table 3: Pharmaceutical Sector, Saudi Arabia, 2008-2012 14
Table 4: Pharmaceutical Product Supply Chain Margin, Saudi Arabia, 2008 15
Table 5: Generic Market ($m), Saudi Arabia, 2006-2011 16
Table 6: Generic Market ($m), Saudi Arabia, Forecast, 2012-2020 17
Table 7: OTC Pharmaceutical Market ($m), Saudi Arabia, 2006-2011 18
Table 8: OTC Pharmaceutical Market ($m), Saudi Arabia, Forecast, 2012-2020 19
Table 9: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 21
Table 10: Late-Stage Pipeline, GlaxoSmithKline, 2012 22
Table 11: Major Products, Pfizer, Global, Revenue ($m), 2011 27
Table 12: Late-Stage Pipeline, Pfizer, 2012 28
Table 13: Major Products, Novartis, Global, Revenue ($m), 2011 33
Table 14: Planned Filings, Novartis, 2012 to = 2016 34
Table 15: Major Products, SPIMACO, 2012 39
Table 16: Major Products, Tabuk, 2012 43
Table 17: Medical Device Market ($bn), Saudi Arabia, 2006-2011 47
Table 18: Medical Device Market ($bn), Saudi Arabia, 2012-2020 48
Table 19: Medical Device Market, Saudi Arabia, Segments, Revenue ($m), 2011 49
Table 20: In-Vitro Diagnostics Market ($m), Saudi Arabia, 2006-2011 50
Table 21: Sales Trends for Major Players, In-Vitro Diagnostics, Saudi Arabia, 2010 51
Table 22: Diagnostic Imaging Market ($m), Saudi Arabia, 2006-2011 52
Table 23: Sales Trends for Major Players, Diagnostic Imaging, Saudi Arabia, 2006-2010 53
Table 24: Ophthalmic Devices Market ($m), Saudi Arabia, 2006-2011 54
Table 25: Sales Trends for Major Players, Ophthalmic Devices, Saudi Arabia, 2006-2010 55
Table 26: Cardiovascular Devices Market ($m), Saudi Arabia, 2006-2011 56
Table 27: Sales Trends for Major Players, Cardiovascular Devices, Saudi Arabia, 2006-2010 57
Table 28: Nephrology and Urology Devices Market ($m), Saudi Arabia, 2006-2011 58
Table 29: Sales Trends for Major Players, Nephrology and Urology Devices Market, Saudi Arabia, 2006-2010 59
Table 30: Major Medical Device Companies, Saudi Arabia, Revenue ($m), 2010 60
Table 31: Major Products, Siemens Healthcare, Global, Revenue ($m), 2010 61
Table 32: Major Products, Roche, Global, Revenue ($m), 2010 65
Table 33: Late-stage Pipeline, F. Hoffmann-La Roche, 2012 65
Table 34: Major Products, Abbott, Global, Revenue ($m), 2010 72
Table 35: Late-stage Pipeline, Abbott, 2011 73
Table 36: Major Products, Philips Healthcare, Global, Revenue ($m), 2011 75
Table 37: Healthcare Spending, Saudi Arabia, Patient''s Share (%), 2005-2010 87
Table 38: Medical Device Marketing Authorization (MDMA) Processing Fees, Saudi Arabia, 2012 99
Table 39: GDP Per Capita ($), Saudi Arabia, 2006-2011 118
Table 40: GDP Per Capita ($), Saudi Arabia, Forecast, 2012-2020 119
Table 41: GDP, Saudi Arabia, Annual Growth (%), 2006-2011 120
Table 42: GDP, Saudi Arabia, Annual Growth (%), Forecast, 2012-2020 121
Table 43: GNI Per Capita ($), Saudi Arabia, 2006-2011 122
Table 44: Average Consumer Price Index, Saudi Arabia, 2006-2011 123
Table 45: Average Consumer Price Index, Saudi Arabia, Forecast, 2012-2020 124
Table 46: Average Consumer Price, Saudi Arabia, Annual Change (%), 2006-2011 125
Table 47: Average Consumer Price, Saudi Arabia, Annual Change (%), Forecast, 2012-2020 126
Table 48: Currency Exchange Rate (SAR/$), Saudi Arabia, 2006-2011 127
Table 49: Foreign Direct Investment ($bn), Saudi Arabia, 2006-2011 128
Table 50: Foreign Exchange Reserves ($bn), Saudi Arabia, 2005-2010 129
Table 51: Imports ($bn), Saudi Arabia, 2006-2011 130
Table 52: Exports ($bn), Saudi Arabia, 2006-2011 131
Table 53: General Government Gross Debt ($bn), Saudi Arabia, 2006-2011 132
Table 54: General Government Gross Debt ($bn), Saudi Arabia, Forecast, 2012-2020 133
Table 55: Major Industries, Saudi Arabia, Value Added ($bn), 2010 135
Table 56: Population (millions), Saudi Arabia, 2006-2011 136
Table 57: Population (millions), Saudi Arabia , Forecast, 2012-2020 137
Table 58: Urban and Rural Population, Saudi Arabia, Share (%), 2005-2010 138
Table 59: Urban and Rural Population, Saudi Arabia, Share (%), Forecast, 2011-2020 139
Table 60: Age Groups, Saudi Arabia, Population Distribution (%), 2005-2010 140
Table 61: Age Groups, Saudi Arabia, Population Distribution (%), Forecast, 2011-2020 141
Table 62: Births (per 1,000 Population), Saudi Arabia, 2005-2010 142
Table 63: Mortality (per 1,000 Population), Saudi Arabia, 2005-2010 143
Table 64: Major Causes of Mortality (%),Saudi Arabia, 2010 144
Table 65: Children <5 Years Age, Saudi Arabia, Mortality Rate (per 1,000 Live Births), 2005-2010 145
Table 66: Immunization Rate (%),Saudi Arabia, 2005-2010 146
Table 67: Major Causes of Male Mortality (’000s), Saudi Arabia, 2008 147
Table 68: Major Causes of Female Mortality (’000s), Saudi Arabia, 2008 148
Table 69: Gender Ratio (M/F), Saudi Arabia, 2005-2010 149
Table 70: Life Expectancy at Birth (Years), Saudi Arabia, 2005-2010 150
Table 71: Life Expectancy at Birth (Years), Saudi Arabia, Forecast, 2011-2020 151
Table 72: Students Enrolled (millions), Saudi Arabia, 2005-2010 152
Table 73: Higher Education, Saudi Arabia, Share of Enrolled Students (%) 2009 153
Table 74: Unemployment (%), Saudi Arabia, 2005-2010 154
Table 75: Major Causes of Health Center Visits (millions), Saudi Arabia, 2010 155
Table 76: Major Diseases, Saudi Arabia, DALYs (per 100,000 Population), 2004 156
Table 77: Public and Private Hospitals, Saudi Arabia, 2005-2010 157
Table 78: Primary Health Centers, Saudi Arabia, 2005-2010 158
Table 79: Hospitals by Type of Care, Saudi Arabia, 2009 159
Table 80: General Hospital Beds (’000s), Saudi Arabia, 2005-2010 160
Table 81: Hospital Beds (per 1,000 Population), Saudi Arabia, 2005-2010 161
Table 82: Physicians (per 1,000 Population), Saudi Arabia, 2005-2010 162
Table 83: CO2 Emissions (Million Tons), Saudi Arabia, 2005-2010 163
Table 84: PM-10 Emissions (µgm/cubic meter), Saudi Arabia, 2005-2010 164
Table 85: Treated Sewage Effluent Reuse Potential, Saudi Arabia, 2010 166
Table 86: Waste Handling, Saudi Arabia, Share (%), 2006 167
Table 87: Nurses (per 1,000 Population), Saudi Arabia, 2005-2010 168
Table 88: Pharmacists (per 100,000 Population), Saudi Arabia, 2005-2010 169
Table 89: Dentists (per 100,000 Population), Saudi Arabia, 2005-2010 170
Table 90: Healthcare Expenditure (% of GDP), Saudi Arabia, 2005-2010 171
Table 91: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2005-2010 172
Table 92: Major Healthcare Trade Fairs, Saudi Arabia, 2012-2013 174

1.2 List of Figures
Figure 1: Pharmaceutical Market ($bn), Saudi Arabia, 2006-2011 12
Figure 2: Pharmaceutical Market ($bn), Saudi Arabia, Forecast, 2012-2020 13
Figure 3: Generic Market ($m), Saudi Arabia, 2006-2011 16
Figure 4: Generic Market ($m), Saudi Arabia, Forecast, 2012-2020 17
Figure 5: OTC Pharmaceutical Market ($m), Saudi Arabia, 2006-2011 18
Figure 6: OTC Pharmaceutical Market ($m), Saudi Arabia, Forecast, 2012-2020 19
Figure 7: Medical Device Market ($bn), Saudi Arabia, 2006-2011 47
Figure 8: Medical Device Market ($bn), Saudi Arabia, 2012-2020 48
Figure 9: Medical Device Market, Saudi Arabia, Five Major Segments, Revenue ($m), 2011 49
Figure 10: In-Vitro Diagnostics Market ($m), Saudi Arabia, 2006-2011 50
Figure 11: Sales Trends for Major Players*, In-Vitro Diagnostics, Saudi Arabia, 2006-2010 51
Figure 12: Diagnostic Imaging Market ($m), Saudi Arabia, 2006-2011 52
Figure 13: Sales Trends for Major Players, Diagnostic Imaging, Saudi Arabia, 2006-2010 53
Figure 14: Ophthalmic Devices Market ($m), Saudi Arabia, 2006-2011 54
Figure 15: Sales Trends for Major Players, Ophthalmic Devices, Saudi Arabia, 2006-2010 55
Figure 16: Cardiovascular Devices Market ($m), Saudi Arabia, 2006-2011 56
Figure 17: Sales Trends for Major Players, Cardiovascular Devices, Saudi Arabia, 2006-2010 57
Figure 18: Nephrology and Urology Devices Market ($m), Saudi Arabia, 2006-2011 58
Figure 19: Sales Trends for Major Players, Nephrology and Urology Devices Market, Saudi Arabia, 2006-2010 59
Figure 20: Major Medical Device Companies, Saudi Arabia, Revenue ($m), 2010 60
Figure 21: Drivers and Barriers, Healthcare Market, Saudi Arabia, 2012 82
Figure 22: Addition of a Drug to the Hospital Formulary, Saudi Arabia, 2012 85
Figure 23: Healthcare Spending, Saudi Arabia, Patient Share (%), 2005-2010 87
Figure 24: Structure of the Saudi Food and Drug Authority (SFDA), Saudi Arabia, 2012 91
Figure 25: Drug Submission Process, Saudi Arabia, 2012 92
Figure 26: Marketing Authorization Approval Process (New Chemical Entity), Saudi Arabia, 2012 94
Figure 27: Marketing Authorization Approval Process (Generics), Saudi Arabia, 2012 97
Figure 28: Medical Device Registration Procedure, Saudi Arabia, 2012 100
Figure 29: Licensing Process, Saudi Arabia, 2012 102
Figure 30: Structure of KACST, Saudi Arabia, 2012 103
Figure 31: Patent Approval Process, Saudi Arabia, 2012 106
Figure 32: GDP Per Capita ($), Saudi Arabia, 2006-2011 118
Figure 33: GDP Per Capita ($), Saudi Arabia, Forecast, 2012-2020 119
Figure 34: GDP, Saudi Arabia, Annual Growth (%), 2006-2011 120
Figure 35: GDP, Saudi Arabia, Annual Growth (%), Forecast, 2012-2020 121
Figure 36: GNI Per Capita ($), Saudi Arabia, 2006-2011 122
Figure 37: Average Consumer Price Index, Saudi Arabia, 2006-2011 123
Figure 38: Average Consumer Price Index, Saudi Arabia, Forecast, 2012-2020 124
Figure 39: Average Consumer Price, Saudi Arabia, Annual Change (%), 2006-2011 125
Figure 40: Average Consumer Price, Saudi Arabia, Annual Change (%), Forecast, 2012-2020 126
Figure 41: Currency Exchange Rate (SAR/$), Saudi Arabia, 2006-2011 127
Figure 42: Foreign Direct Investment ($bn), Saudi Arabia, 2006-2011 128
Figure 43: Foreign Exchange Reserves ($bn), Saudi Arabia, 2005-2010 129
Figure 44: Imports ($bn), Saudi Arabia, 2006-2011 130
Figure 45: Exports ($bn), Saudi Arabia, 2006-2011 131
Figure 46: General Government Gross Debt ($bn), Saudi Arabia, 2006-2011 132
Figure 47: General Government Gross Debt ($bn), Saudi Arabia, Forecast, 2012-2020 133
Figure 48: Major Industries, Saudi Arabia, Value Added ($bn), 2010 135
Figure 49: Population (millions), Saudi Arabia, 2006-2011 136
Figure 50: Population (millions), Saudi Arabia, Forecast, 2012-2020 137
Figure 51: Urban and Rural Population, Saudi Arabia, Share (%), 2005-2010 138
Figure 52: Urban and Rural Population, Saudi Arabia, Share (%), Forecast, 2011-2020 139
Figure 53: Age Groups, Saudi Arabia, Population Distribution (%), 2005-2010 140
Figure 54: Age Groups, Saudi Arabia, Population Distribution (%), Forecast, 2011-2020 141
Figure 55: Births (per 1,000 Population), Saudi Arabia, 2005-2010 142
Figure 56: Mortality (per 1,000 Population), Saudi Arabia, 2005-2010 143
Figure 57: Major Causes of Mortality (%),Saudi Arabia, 2010 144
Figure 58: Children <5 Years Age, Saudi Arabia, Mortality Rate (per 1,000 Live Births), 2005-2010 145
Figure 59: Immunization Rate (%),Saudi Arabia, 2005-2010 146
Figure 60: Major Causes of Male Mortality (’000s), Saudi Arabia, 2008 147
Figure 61: Major Causes of Female Mortality (’000s), Saudi Arabia, 2008 148
Figure 62: Gender Ratio (M/F), Saudi Arabia, 2005-2010 149
Figure 63: Life Expectancy at Birth (Years), Saudi Arabia, 2005-2010 150
Figure 64: Life Expectancy at Birth (Years), Saudi Arabia, Forecast, 2011-2020 151
Figure 65: Students Enrolled (millions), Saudi Arabia, 2005-2010 152
Figure 66: Higher Education, Saudi Arabia, Share of Enrolled Students (%) 2009 153
Figure 67: Unemployment (%), Saudi Arabia, 2005-2010 154
Figure 68: Major Causes of Health Center Visits (millions), Saudi Arabia, 2010 155
Figure 69: Major Diseases, Saudi Arabia, DALYs (per 100,000 Population), 2004 156
Figure 70: Public and Private Hospitals, Saudi Arabia, 2005-2010 157
Figure 71: Primary Health Centers, Saudi Arabia, 2005-2010 158
Figure 72: Hospitals by Type of Care, Saudi Arabia, 2009 159
Figure 73: General Hospital Beds (’000s), Saudi Arabia, 2005-2010 160
Figure 74: Hospital Beds (per 1,000 Population), Saudi Arabia, 2005-2010 161
Figure 75: Physicians (per 1,000 Population), Saudi Arabia, 2005-2010 162
Figure 76: CO2 Emissions (Million Tons), Saudi Arabia, 2005-2010 163
Figure 77: PM-10 Emissions (µgm/cubic meter), Saudi Arabia, 2005-2010 164
Figure 78: Waste Handling, Saudi Arabia, Share (%), 2006 167
Figure 79: Nurses (per 1,000 Population), Saudi Arabia, 2005-2010 168
Figure 80: Pharmacists (per 100,000 Population), Saudi Arabia, 2005-2010 169
Figure 81: Dentists (per 100,000 Population), Saudi Arabia, 2005-2010 170
Figure 82: Healthcare Expenditure (% of GDP), Saudi Arabia, 2005-2010 171
Figure 83: Healthcare Expenditure, Saudi Arabia, Public-Private Share (%), 2005-2010 172
Figure 84: Opportunities and Challenges, Healthcare Market, Saudi Arabia, 2012 177

Published By: GlobalData
Product Code: GlobalData26529


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