The Outlook for Medical Devices in the Middle East

Report Summary

Attractive macro-environmental conditions

In spite of recent political unrest, economic, social and demographic changes are making the pharmaceutical markets in the Middle East & North Africa (MENA) region more attractive. The Economist Intelligence Unit (EIU) forecasts that the five MENA markets covered in this collection will represent a combined GDP of US$2.5 trillion in 2016, led by Turkey and Saudi Arabia. Economic development is changing the epidemiological health profile in the region, with the increasing prevalence of communicable diseases. In demographic terms, the population in these five MENA markets is still young and is expected to reach 246.2 million in 2016, headed by Egypt and Turkey. Nevertheless, there is a sizeable elderly population that will increase demand for healthcare services.

Healthcare development towards privatisation

The population has different levels of expectations in each national healthcare system. The healthcare system in Egypt, for instance, is in a transitory phase, characterised by progress towards privatisation. While access to free healthcare exists, private services are appearing as a result of the decline in the standard of public sector care. There is a need for considerable investment in order to continue the modernisation of programmes and maintain the existing facilities. There are two main areas of reform: primary healthcare and the provision of a national health insurance scheme. In Morocco, the health insurance system is in a transitional phase. Overall, opportunities exist, particularly in Turkey and Egypt, as combined health expenditure in these five markets is projected at US$153.2 billion in 2016.

Increasing pharmaceutical demand

International companies recognise the value and potential of these five MENA pharmaceutical markets. Sanofi, for instance, is the largest pharmaceutical operation in Morocco, whilst GlaxoSmithKline is the leader in Saudi Arabia. Some local producers, such as Hikma from Jordan and SPIMACO from Saudi Arabia, aim to become regional leaders. The projected CAGR for the region is very attractive compared to mature markets or other emerging markets. In fact, pharmaceutical sales in these five MENA markets are expected to amount to a combined value of US$35.8 billion at retail prices in 2016, including pharmacy and hospital sales. The region is headed by Turkey, followed by Egypt and Saudi Arabia. Local manufacturing production is fragmented and geared towards branded generics, but reliance on imports remains. Biotechnology is still in its infancy.

HIGHLIGHTS FROM THE REGION

EGYPT

Egypt is expected to be the second leading pharmaceutical market in the MEA region in 2016. Providing the political situation stabilises and the economy continues to perform well, the Egyptian pharmaceutical market at retail prices is expected to rise by a high CAGR in US dollar terms between 2011 and 2016. Espicom estimates that the market increased by nearly five times between 1995 and 2010. Nevertheless, per capita consumption is still low. In spite of recent production problems, production is expected to rise as the healthcare system continues its transition towards modernisation. Considering opportunities beyond BRIC pharmaceutical markets, Egypt is becoming a very attractive market for multinational pharmaceutical companies focused on emerging markets.

JORDAN

Jordan has a relatively strong level of domestic production; however, the majority is exported, resulting in a market still dependent on imports. Most imported pharmaceuticals are retail medicaments from countries located in Western Europe, such as Switzerland and Germany, while exports are primarily semi-finished and retail medicaments destined for other countries in the MENA region. The largest pharmaceutical company in Jordan is Hikma Pharmaceuticals, with a market share of over 10%. The company has a number of manufacturing facilities in Jordan, as well as R&D facilities. In October 2010, Hikma announced it was to acquire an injectables business from a US company, which will significantly enhance the scope of the company’s injectables business worldwide. Previously, Hikma acquired an Algerian company in April 2010 and a Tunisian company in March 2010, strengthening its presence in the MENA region.

MOROCCO

Although the Moroccan pharmaceutical market is small in global terms, per capita spending on pharmaceutical products is comparatively high for an African country. The pharmaceutical market, which was stagnating prior to the launch of the universal health insurance scheme in 2006, is expected to grow by a moderate CAGR between 2011 and 2016. Over 50% of the pharmaceutical companies operating in the country are owned by foreign interests, and these companies are responsible for more than half of industry turnover. Multinationals with a strong presence in the Moroccan pharmaceutical market include Sanofi, GlaxoSmithKline and Pfizer. Hikma is also expected to increase its market penetration, following its acquisition of 63.9% of Promopharm, announced in October 2011. Independent local manufacturers primarily manufacture under licence or produce generics. Leading indigenous producers include Cooper Pharma, Laprophan and Sothéma.

SAUDI ARABIA

The Saudi pharmaceutical market is the richest in the Gulf region and is expected to rise by a CAGR in the high single digits during the 2011-2016 period. The private pharmacy sector tends to favour branded pharmaceuticals but is marked by tight price controls. The leading companies operating in the sector are GlaxoSmithKline and SPIMACO. The public sector, more generic-led, is dependent on oil revenues and is characterised by cost-containment and late payments for tenders. There is little domestic production in Saudi Arabia, therefore the vast majority of the market is provided by imports. There are only a few major domestic manufacturers in the country. Locally made pharmaceuticals supply only around 15% of the market, and the rest of the output is mainly exported to other Gulf Cooperation Council (GCC) countries.

TURKEY

Turkey is the largest MENA pharmaceutical market, due to the size of its population and GDP. The Turkish pharmaceutical market is expected to grow by a high single digit CAGR in US dollar terms between 2011 and 2016. While the overall pharmaceutical market size is amongst the top 30 largest in the world, per capita spending on pharmaceuticals in Turkey remains low, especially when compared with a European country. Given the possible accession to the EU, though this is still at least a few years away, the potential for growth is very promising, compared to more established and mature markets in Western Europe. There is a strong generics industry; according to the Pharmaceutical Manufacturers’ Association of Turkey (IEIS), generics account for over a third of the market in value terms and just over half in volume terms. There is room for this sector to expand as physicians are not actively encouraged to prescribe generic drugs and there are no incentives for pharmacists to dispense them.

THESE REPORTS ANALYSE THE ISSUES

The Outlook for Pharmaceuticals in the Middle East and North Africa is a unique collection of management reports from Espicom Business Intelligence. Each report provides individual and highly-detailed analysis of each market, looking at the key regulatory, political, economic and corporate developments in the wider context of market structure, service and access. The reports are available individually, or as a discounted collection, and prices include 4 completely updated reports sent quarterly, together with a comprehensive statistical appendix. There are over 60 markets covered in the worldwide series.

Use these original and insightful reports to...

• Assess future market values with our unique and regularly reviewed independent 5-year market forecasts.
• Track the latest developments with the news service that is included for every country.
• Understand the critical issues and drivers which are shaping the market.
• Evaluate the environment for branded and generic operators and stay in touch with the fast growing biologic sector.
• Shape and support business plans and decisions with reliable business data.
• Benchmark key market performance with Espicom’s standardised data.

Table Of Contents

EXECTIVE SUMMARY  1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections  .3
MACROENVIRONMENT  4
POLITICAL4
ECONOMIC 5
Projections .5
LEGAL.6
Intellectual Property Rights.6
DEMOGRAPHIC 7
Projections .7
Demographic Indicators.8
EPIDEMIOLOGY . 9
DISEASE BURDEN.9
DISEASE PREVALENCE.9
Communicable Diseases.9
Non-Communicable Diseases 9
Cancer. 9
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS  10
ORGANISATION 10
Government Sector (Ministry of Health).10
Public Sector 10
Private Sector.10
Healthcare Reforms.11
Healthcare Sector Reform Project. 11
EXPENDITURE.12
Projections .12
Health Insurance .13
Health Insurance Bill 13
Health Insurance Systems Development Project. 13
Health Insurance Beneficiaries  13
INFRASTRUCTURE14
SERVICES15
Hospital Inpatient Services 15
WORKFORCE.15
Projections .15
REGULATORY AFFAIRS . 16
PHARMACEUTICAL REGISTRATION.16
NATIONAL DRUGS POLICY17
Essential Drugs List .17
PRICING & REIMBURSEMENT. 18
PRICING18
New Drug Pricing Decree18
DISTRIBUTION CHANNELS. 19
WHOLESALING .19
Public Wholesalers 19
Egydrug 19
El-Gomhouria .20
Private Wholesalers 20
Multipharma  20
PharmaOverseas 20
UCP20
RETAILING21
Pharmacy Chains .21
El-Ezaby Pharmacy Chain     21
Misr Pharmacies . 21
Seif Pharmacies. 21
MARKET ANALYSIS 22
SIZE 22
Projections .22
Historical Market Figures25
Current Structure.26
PRODUCT DEVELOPMENT26
MANUFACTURING27
TRADE . 29
Exports .29
Imports.31
Balance of Trade 36
COMPETITION 37
TRADE ASSOCIATIONS 37
AUPAM37
FEI .37
TRADE FAIR .37
COMPANY INTELLIGENCE 38
Public Sector Producers 38
ADCO.40
Alexandria .40
CID. 41
El-Nasr  41
Kahira .42
Memphis 42
Misr .43
Nile43
Local Private Producers 44
ACDIMA44
Amoun44
EIPICO .45
Minapharm .46
MultiApex  .47
October Pharma  47
Pharco Corporation47
SEDICO48
Foreign Private Producers 48
AstraZeneca 48
Eli Lilly.48
GlaxoSmithKline 48
Hikma .48
Novartis .49
Sanofi49
Competitive Strategies .49
OTC PHARMACEUTICALS 50
GENERIC PHARMACEUTICALS . 51
PRICING51
New Drug Pricing Decree51
MARKET.51
BIOLOGICS & BIOSIMILARS . 52
REGULATION.52
DISTRIBUTION 52
PRODUCT DEVELOPMENT52
COMPETITION.53
Company Intelligence.53
Arab Company for Medical Appliances53
EIPICO .53
Nile53
Rhein Minapharm Biogenetics 54
CONCLUSIONS: OPPORTUNITIES & CHALLENGES . 55
Strategic Espicom Analysis.55
MACROENVIRONMENT55
EPIDEMIOLOGY55
HEALTHCARE55
REGULATORY AFFAIRS.56
PRICING & REIMBURSEMENT56
DISTRIBUTION CHANNELS 57
MARKET 57
COMPETITION 58
OTC PHARMACEUTICALS.58
GENERIC PHARMACEUTICALS.58
BIOLOGICS & BIOSIMILARS.58
Radar Analysis . 60
SWOT Analysis. 60
DIRECTORY  61
GOVERNMENT ORGANISATIONS.61
PRODUCERS61
Local Public Holding61
Local Private Producers 61
Foreign Private Producers 62
TRADE ASSOCIATIONS . 62

List of TabLes

Espicom Analysis of the Pharmaceutical Market, 2011. 2
Summary of Key Data Projections, 2011-2016 3
Political Landscape, 2011  4
Regional Ranking of Projected Economies, 2016 5
Projected Economy, 2011-2016 . 5
Regional Ranking of Projected Demographics, 2016 7
Projected Demographics, 2011-2016 7
Demographic Indicators, 2000-2007 . 8
Regional Ranking of Projected Health Expenditure, 2016.12
Projected Health Expenditure, 2011-201612
Beneficiaries from Health Insurance System, 1999-200813
Hospital Beds, 2000-2009. 14
Public & Village Hospitals and Rural Health Units, 2000-2008 14
Regional Ranking of Projected Physicians, 201615
Projected Physicians, 2011-201615
Egydrug’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million) 19
El-Gomhouria’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million). 20
Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 2016 23
Projected Pharmaceutical Market at Retail Prices, 2011-2016 (US$ Million) 24
Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Million) 25
Pharmacy Sector by Origin, 2004/2008 (LE Million). 26
Pharmacy Sector by Origin, 2004/2008 (Million Units) 26
Pharmaceutical Producers, 2006 28
Pharmaceutical Exports by Category, 2005-2009 (US$000s). 29
Pharmaceutical Exports by Country/Region, 2009 (US$000s).30
Pharmaceutical Imports by Category, 2005-2009 (US$000s) 31
Imports of Raw Materials by Country/Region, 2009 (US$000s). 33
Imports of Antisera & Vaccines by Country/Region, 2009 (US$000s). 34
Imports of Medicaments by Country/Region, 2009 (US$000s) 35
Pharmaceutical Balance of Trade, 2005-2009 (US$000s) 36
HOLDIPHARMA’s Affiliated Companies, 2010. 38
HOLDIPHARMA’s Joint-Ventures, 2010 . 38
HOLDIPHARMA’s Financial Indicators, FY 2006/2007-FY2009/2010 (LE Million)  39
HOLDIPHARMA’s Net Operating Revenue by Affiliate, FY 2009/2010 (LE Million)  39
ADCO’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million).40
Alexandria’s Financial Indicators, FY2006/2007-FY2008/2010 (LE Million)40
CID’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million) 41
El-Nasr’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million) 41
Kahira’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million). 42
Memphis’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million) 42
Misr’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million). 43
Nile’s Financial Indicators, FY2006/2007-FY2009/2010 (LE Million). 43
Amoun’s Financial Indicators, 2008-QI 2010 (LE Million).44
Pharco Corporation’s Indicators by Subsidiary, 2009 47
Espicom Analysis of the Pharmaceutical Market, 2011. 59
SWOT Analysis of the Pharmaceutical Market, 2011.6

List of Charts

Regional Comparison of Projected Pharmaceutical Markets at Retail Prices, 2016  23
Regional Comparison of Projected Pharmaceutical Market Share at Retail Prices, 2016 . 24
Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Million) 25
Pharmaceutical Exports, 2003-2009 (US$ Millions). 29
Pharmaceutical Imports, 2003-2009 (US$ Millions). 31
Pharmaceutical Imports by Country/Region, 2009 (%). 32
Pharmaceutical Balance of Trade, 2003-2009 (US$ Millions). 36
Radar Graph of the Pharmaceutical Market, 2011 .60

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections 3

MACROENVIRONMENT  4
POLITICAL4
ECONOMIC 5
Projections .5
LEGAL.6
DEMOGRAPHIC 6
Projections .6
Latest Figures.7
Demographic Indicators.8
Births. 8
Deaths  8
Infant Deaths. 8
Life Expectancy at Birth  8
EPIDEMIOLOGY . 9
DISEASE BURDEN.9
Leading Causes of Mortality 9
DISEASE PREVALENCE.9
Communicable Diseases.9
HIV/AIDS. 10
Non-Communicable Diseases 11
Cancer Incidence  11
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS  12
ORGANISATION 12
EXPENDITURE.15
Projections .15
Latest Figures.15
INFRASTRUCTURE16
Hospital Infrastructure .16
Ambulatory Infrastructure.16
SERVICES17
Hospital Inpatient Services 17
Outpatient Services.17
WORKFORCE.18
Projections .18
Physicians.18
Visiting Doctor Programme . 19
Nurses.19
Dentists 19
Pharmacists20
REGULATORY AFFAIRS . 21
NATIONAL AUTHORITY .21
Ministry of Health21
MARKETING REGISTRATION.21
National Procedures21
IMPORT REGULATIONS  . 2
PRICING & REIMBURSEMENT. 24
DISTRIBUTION CHANNELS. 25
DRUG RETAILING. 25
MARKET ANALYSIS 26
SIZE.26
Projections .26
Historical Figures.28
Current Structure.29
PRODUCT DEVELOPMENT. 29
MANUFACTURING. 30
Domestic Production 30
TRADE 31
Exports .31
Imports.34
Balance of Trade 39
COMPETITION 40
TRADE ASSOCIATION 40
Jordanian Association of Manufacturers of Pharmaceuticals & Medical Appliances .40
TRADE FAIRS.41
Phar/MedExpo 2011. 41
AUPAM Conference 41
COMPANY INTELLIGENCE.41
Domestic Producers 41
Arab Centre for Pharmaceuticals and Chemicals . 41
Dar Al Dawa. 41
Hayat Pharmaceutical Industries  41
Hikma Pharmaceuticals 42
Jordanian Pharmaceuticals Manufacturing46
Jordan River Pharmaceutical Industries 46
Jordan Sweden Medical and Sterilisation Company.46
Middle East Pharmaceutical Manufacturing Company46
Pharma International 46
United Pharmaceutical Manufacturing .46
BIOLOGICS & BIOSIMILARS . 47
PRODUCT DEVELOPMENT47
COMPETITION.47
Company Intelligence.47
Al-Kindi Pharmaceutical Industries 47
AraGen Biotechnology47
MONOJO 47
Competitive Strategies .48
CONCLUSIONS: OPPORTUNITIES & CHALLENGES . 49
Strategic Espicom Analysis 49
MACROENVIRONMENT49
EPIDEMIOLOGY49
HEALTHCARE49
REGULATORY AFFAIRS.50
PRICING & REIMBURSEMENT50
DISTRIBUTION CHANNELS 50
MARKET 51
COMPETITION 51
OTC PHARMACEUTICALS.52
GENERIC PHARMACEUTICALS.52
BIOLOGICS & BIOSIMILARS.52
Radar Analysis . 54
SWOT Analysis. 54
DIRECTORY  55
GOVERNMENT ORGANISATIONS.55
PHARMACEUTICAL PRODUCERS .55
Biologic Companies.55
Domestic Producers 55
TRADE ORGANISATIONS.55

List of TabLes

Espicom Analysis of the Pharmaceutical Market, 2011. 2
Key Data Projections, 2011-2016. 3
Political Landscape, 2011  4
Regional Ranking of Projected Economies, 2016 5
Projected Economy, 2011-2016 . 5
Regional Ranking of Projected Demographics, 2016 6
Projected Demographics, 2011-2016 7
Population by Governorate, 2008 (000s) 7
Demographic Indicators, 2003-2008 8
Notifiable Communicable Diseases & Conditions, 2004-2008 . 9
HIV/AIDS Patients, 1986-2008 10
Cancer Incidence by Sex, 200711
Regional Ranking of Projected Health Expenditure, 2016.15
Projected Health Expenditure, 2011-201615
Ministry of Health (MoH) Budget, 2004-2008 (JOD Millions) .15
MoH Health Centres, 2004-2008 16
MoH Hospital Activity, 2000-2008.17
Regional Ranking of Projected Physicians, 2016. 18
Projected Physicians, 2011-2016. 18
Physicians by Sector, 2008  18
Nursing Staff by Category & Sector, 2008. 19
Dentists by Sector, 2008 19
Pharmacists by Sector, 2008. 20
Pharmacies, 2001-2008 25
Pharmacies by Governorate, 2005-2008 25
Regional Ranking of Projected Pharmaceutical Markets, 2016 26
Projected Pharmaceutical Market at Retail Prices, 2011-2016 27
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 28
Expenditure on Pharmaceuticals, 2000-2007 (JOD). 29
Pharmaceutical Exports by Category, 2005-2009 (US$000s). 32
Pharmaceutical Exports by Country/Region, 2009 (US$000s). 33
Pharmaceutical Imports by Category, 2005-2009 (US$000s) 35
Imports of Raw Materials by Country/Region, 2009 (US$000s). 36
Imports of Antisera & Vaccines by Country/Region, 2009 (US$000s). 37
Imports of Medicaments by Country/Region, 2009 (US$000s) 38
Balance of Pharmaceutical Trade, 2005-2009 (US$000s) 39
Sales from 10 Jordanian Pharmaceutical Companies, 2007-2008 (JOD Millions) 40
Members of JAPM, 201040
Hikma’s Product Portfolio, 2010 . 43
Hikma’s Product Pipeline, 2010. 43
Hikma Pharmaceuticals’ Results, 2009-2010 (US$ Millions)  .44
Hikma Pharmaceuticals’ Results by Region, 2009-2010 (US$ Millions) .44
Espicom Analysis of the Pharmaceutical Market, 2011. 53
SWOT Analysis of the Pharmaceutical Market, 2011. 54

List of Charts

Regional Comparison of Projected Pharmaceutical Markets at Retail Prices, 2016  26
Regional Comparison of Projected Pharmaceutical Market Share, 2016 . 27
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 28
Pharmaceutical Exports, 2000-2009 (US$ Millions). 31
Change in Pharmaceutical Exports, 2001-2009 (%). 31
Pharmaceutical Exports by Country/Region, 2009 (%) 32
Pharmaceutical Imports, 2000-2009 (US$ Millions) 34
Change in Pharmaceutical Imports, 2001-2009 (%) 34
Pharmaceutical Imports by Country/Region, 2009 (%). 35
Pharmaceutical Balance of Trade, 2000-2009 (US$ Millions) 39
Radar Graph of the Pharmaceutical Market, 2011 . 54

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections  .3
MACROENVIRONMENT  4
POLITICAL4
ECONOMIC 5
Projections .5
LEGAL.6
Intellectual Property Rights.6
DEMOGRAPHIC 6
Projections .6
Demographic Indicators.7
Birth Rate . 7
Death Rate. 7
Infant Mortality  7
Maternal Mortality. 8
Life Expectancy at Birth  8
EPIDEMIOLOGY . 9
DISEASE BURDEN.9
Leading Causes of Mortality 9
DISEASE PREVALENCE.9
Communicable Diseases.9
HIV/AIDS. 10
Tuberculosis  10
Non-Communicable Diseases 10
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS .11
ORGANISATION 11
Five Year Action Plan for the Health Sector (2008-2012)12
New Planning Tools.12
EXPENDITURE.13
Projections .13
Latest Figures.14
Ministry of Health Budget, 2009 . 14
Health Insurance .15
Compulsory Health Insurance Scheme 15
RAMED Scheme 16
INFRASTRUCTURE17
Hospital Infrastructure .17
Capital Investment Programme, 2009. 17
Ambulatory Infrastructure.18
Public Ambulatory Infrastructure. 18
Private Ambulatory Infrastructure . 19
SERVICES. 20
Hospital Inpatient Services 20
WORKFORCE.21
Projections .21
Latest Figures.21
Physicians  21
Dentists 22
Nurses.22
Pharmacists.22
REGULATORY AFFAIRS . 23
Pharmaceutical Regulation. 23
New Pharmaceutical Law23
PRICING & REIMBURSEMENT. 24
PRICING24
New Pharmaceutical Pricing System.24
Parliamentary Drug Pricing Report.24
Pharmaceutical Pricing System25
Pharmaceutical Cost Structure 25
REIMBURSEMENT.26
DISTRIBUTION CHANNELS. 27
MOH SUPPLIES DIVISION27
WHOLESALING .27
Cooper Pharma.27
Sophasud.27
RETAILING. 28
MARKET ANALYSIS 29
SIZE 29
Projections .29
Historical Figures.31
Current Structure.32
Private Pharmacy Sales.33
CNOPS Pharmacy Sales .35
PRODUCT DEVELOPMENT35
MANUFACTURING. 36
TRADE . 38
Exports .38
Imports.40
Balance of Trade 44
COMPETITION 45
TRADE ASSOCIATIONS . 45
AMIP45
MIS 46
TRADE FAIR  46
Médical Expo.46
COMPANY INTELLIGENCE.47
Local Manufacturers .47
 Afric-Phar 47
Bottu.47
Cooper Pharma.47
Laboratoire Galenica .48
Iberma48
Laprophan .48
Pharmaceutical Institute.48
Polymedic48
Promopharm.49
Sothéma.49
Multinational Manufacturers.50
Bayer Pharma Maroc50
GlaxoSmithKline.50
Pfizer.50
sanofi-aventis50
Servier  51
Competitive Strategies .51
GENERIC PHARMACEUTICALS . 52
PRICING52
New Pharmaceutical Pricing System.52
MARKET.53
BIOLOGICS & BIOSIMILARS . 54
REGULATORY AFFAIRS . 54
Regulation of Biosimilars .54
MARKET SIZE 54
Biosimilar Market 54
CONCLUSIONS: OPPORTUNITIES & CHALLENGES . 55
Strategic Espicom Analysis.55
MACROENVIRONMENT55
EPIDEMIOLOGY55
HEALTHCARE55
REGULATORY AFFAIRS.56
PRICING & REIMBURSEMENT56
DISTRIBUTION CHANNELS 57
MARKET 57
COMPETITION 58
OTC PHARMACEUTICALS.58
GENERIC PHARMACEUTICALS.58
BIOLOGICS & BIOSIMILARS.58
Radar Analysis . 60
SWOT Analysis. 60
DIRECTORY  61
GOVERNMENT ORGANISATIONS.61
PRODUCERS61
Local Producers .61
Multinational Producers.61
TRADE ASSOCIATIONS 61

List of TabLes

Espicom Analysis of the Pharmaceutical Market, 2011. 2
Summary of Key Data Projections, 2011-2016 3
Political Landscape, 2011  4
Regional Ranking of Projected Economies, 2016 5
Projected Economy, 2011-2016 . 5
Regional Ranking of Projected Demographics, 2016 6
Projected Demographics, 2011-2016 7
Principal Demographic Indicators, 2002-2007. 8
Reported Communicable Diseases, 2000-2007 9
Regional Ranking of Projected Health Expenditure, 2016.13
Projected Health Expenditure, 2011-201613
Hospitals & Beds, 2007.17
Outpatient Facilities in the Public Sector, 2000-2007. 18
Outpatient Facilities in the Private Sector, 2003-2007 19
Public Hospital Activity, 2001-2007  20
Activity of Public Hospital Surgical & Maternity Units, 2001-2007. 20
University Hospital Activity, 2007 . 20
Regional Ranking of Projected Physicians, 2016. 21
Projected Physicians, 2011-2016. 21
Medical Personnel, 2000-2007. 22
Retail Pharmacies by Region, 2006-2007. 28
Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 2016 29
Projected Pharmaceutical Market at Retail Prices, 2011-2016 29
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 31
Pharmaceutical Market by Sector at Retail Prices, 2008. 32
Private Pharmacy Sales at Manufacturers’ Prices, 1998-2009. 33
CNOPS Pharmacy Sales, 2000-2008. 35
CNOPS Branded & Generic Pharmacy Sales, 2006-2008 (DH Million) 35
Production Units & Direct Employees, 1965-2008 36
Pharmaceutical Production, 1999-2005. 36
Pharmaceutical Production by Type, 2003/2005 37
Key Figures for Pharmaceutical Producers, 2003-2005 37
Pharmaceutical Exports by Category, 2006-2010 (US$000s). 38
Pharmaceutical Exports by Country/Region, 2010 (US$000s) 39
Pharmaceutical Imports by Category, 2006-2010 (US$000s) 40
Imports of Raw Materials by Country/Region, 2010 (US$000s). 41
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s). 42
Imports of Medicaments by Country/Region, 2010 (US$000s)  43
Balance of Pharmaceutical Trade, 2006-2010 (US$000s) 44
Members of AMIP, 2010 45
Members of MIS, 2010 46
Espicom Analysis of the Pharmaceutical Market, 2011. 59
SWOT Analysis of the Pharmaceutical Market, 2011.60

List of Charts

Ministry of Health’s Budget by Sector, 1995-2009 (DH 000s). 14
Regional Comparison of Projected Pharmaceutical Markets at Retail Prices, 2016  30
Regional Comparison of Projected Pharmaceutical Market Share, 2016 (%). 30
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 32
Private Pharmacy Sales at Manufacturers’ Prices, 1998-2009 (DH Millions). 33
Private Pharmacy Sales Value by Principal Therapeutic Categories, 2007 (%)  34
Private Pharmacy Sales Volume by Principal Therapeutic Categories, 2007 (%). 34
Pharmaceutical Exports, 1995-2010 (US$ Millions) 38
Pharmaceutical Imports, 1995-2010 (US$ Millions).40
Pharmaceutical Imports by Leading Country/Region, 2010 (%) 41
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions).44
Branded & Generic Pharmacy Sales Volume, 2001-2007. 53
Radar Graph of the Pharmaceutical Market, 2011 .60

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections  .3
MACROENVIRONMENT  4
POLITICAL4
ECONOMIC 5
Projections .5
LEGAL.6
Intellectual Property Rights.6
IPR Protection . 6
USTR Position 7
Exclusive Marketing Rights for Certain Pharmaceuticals . 7
DEMOGRAPHIC 8
Projections .8
Demographic Indicators.10
Birth Rate . 10
Death Rate. 10
Infant Mortality  10
Life Expectancy at Birth  10
EPIDEMIOLOGY 11
DISEASE BURDEN.11
Leading Causes of Mortality 11
DISEASE PREVALENCE.12
Communicable Diseases.12
Non-Communicable Diseases 12
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS  13
REGIONAL ORGANISATION.13
NATIONAL ORGANISATION 14
Public Providers.14
Armed Forces  14
General Organisation of Social Insurance . 14
National Guard 14
Ministry of the Interior  14
Pilgrim Health. 14
Red Crescent Society . 14
University/Specialist Hospitals  15
Private Sector.15
Development Plans .15
Seventh Development Plan 15
Eighth Development Plan. 16
EXPENDITURE.18
Projections .18
Latest Figures.19
Health Insurance .19
General Organisation of Social Insurance . 19
Private Health Insurance. 19
INFRASTRUCTURE. 20
Hospital Infrastructure .20
Outpatient Infrastructure.21
SERVICES. 22
Inpatient Analysis22
Outpatient Analysis.22
WORKFORCE 23
Projections .23
Latest Figures.24
REGULATORY AFFAIRS . 25
REGIONAL AUTHORITY  25
NATIONAL AUTHORITY  25
PRICING & REIMBURSEMENT. 27
REGIONAL PROCUREMENT 27
 Tender Guidelines for Pharmaceutical Products.28
Definitions .28
Guidelines .28
NATIONAL PROCUREMENT 30
NUPCO 30
PRICING31
National Authority 31
Pricing Concerns31
DISTRIBUTION CHANNELS. 32
DRUG WHOLESALING33
Leading Private Wholesalers33
Abdulrehman Algosaibi33
AMHSCO.33
Banaja Holdings .33
Tamer Group .34
Leading Public Wholesalers .34
NUPCO34
DRUG RETAILING35
Leading Pharmacy Chains 35
NMC 35
MARKET ANALYSIS 36
SIZE 36
Projections .36
Historical Figures.38
Current Structure.39
Pharmacy Sector 39
PRODUCT DEVELOPMENT. 40
Jeddah BioCity  40
KACST .41
KSU41
MANUFACTURING42
TRADE 42
Exports .42
Imports.44
Balance of Trade 48
COMPETITION 49
TRADE ASSOCIATION 49
Regional Trade Association 49
AUPAM49
TRADE FAIRS 49
Regional Trade Fair49
PABME & PHARMA .49
National Trade Fairs 49
SHASH.49
Saudi International Pharmaceutical Conference & Exhibition 49
Saudi Medicare.50
COMPANY INTELLIGENCE 50
Foreign Pharmaceutical Producers .50
GlaxoSmithKline.50
Hikma .50
Local Pharmaceutical Producers51
Deef. 51
Jamjoom  51
PSI 51
Riyadh Pharma . 51
SAJA 51
SPIMACO 52
Tabuk52
Competitive Strategies .53
OTC PHARMACEUTICALS 54
GENERIC PHARMACEUTICALS . 54
MARKET SIZE 54
COMPETITION 54
Regional Conference.54
MEGMC.54
BIOLOGICS & BIOSIMILARS . 55
REGULATION.55
Guidelines for Biologics55
Guidelines for Biosimilars.55
RESEARCH & DEVELOPMENT  56
Jeddah BioCity  56
KACST .57
KSU57
COMPETITION 58
Regional Trade Fair58
PABME & PHARMA .58
Foreign Biologic Producers 58
Genway 58
Local Biologic Producers.58
Arabio.58
NAVPC.58
Competitive Strategies .59
CONCLUSIONS: OPPORTUNITIES & CHALLENGES . 60
Strategic Espicom Analysis 60
MACROENVIRONMENT60
EPIDEMIOLOGY60
HEALTHCARE61
REGULATORY AFFAIRS.61
PRICING & REIMBURSEMENT62
DISTRIBUTION CHANNELS 62
MARKET 62
COMPETITION 63
OTC PHARMACEUTICALS.63
GENERIC PHARMACEUTICALS.63
BIOLOGICS & BIOSIMILARS.63
Radar Analysis . 65
SWOT Analysis. 65
DIRECTORY  66
GOVERNMENT ORGANISATIONS 66
PRODUCERS. 66
Foreign Biologic Producer 66
Foreign Pharmaceutical Producers .66
Local Biologic Producers.66
Local Pharmaceutical Producers67
REGIONAL ORGANISATIONS 67
TRADE ASSOCIATIONS/PROFESSIONAL BODIES.67

List of Tables

Espicom Analysis of the Pharmaceutical Market, 2011.2
Summary of Key Data Projections, 2011-20163
Political Landscape, 2011 4
Regional Ranking of Projected Economies, 20165
Projected Economy, 2011-2016 .5
Regional Ranking of Projected Demographics, 20168
Projected Population, 2011-20168
Population by Health Region, 2006-20089
Principal Demographic Indicators, 2005-2008.10
Deaths Reported in Hospitals Operated by the Ministry of Health, 2003-2008 11
Notifiable Communicable Diseases, 2000-2008. 12
Regional Ranking of Projected Health Expenditure, 201618
Projected Health Expenditure, 2011-2016.18
Health Expenditure, 2000-2010 19
Hospitals by Sector, 2000-2009 20
Outpatient Facilities by Sector, 2002-2008. 21
Private Outpatient Facilities by Type, 2002-2008 . 21
Hospital Inpatient Cases by Sector, 2004-2008 22
Outpatient Visits by Sector, 2004-2008 22
Regional Ranking of Projected Physicians, 2016.23
Projected Physicians, 2011-2016.23
Physicians & Nurses, 2000-2008  24
Pharmacies & Drugstores, 2002-200835
Pharmacies & Drugstores by Region, 2008.35
Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 2016 37
Projected Pharmaceutical Market at Retail Prices, 2011-2016 37
Regional Comparison of Projected Pharmaceutical Markets at Retail Prices, 2016  37
Historical Pharmaceutical Market at Retail Prices, 1995-2010 .38
Pharmaceutical Production, 2000-2006 (SR Billion)42
Pharmaceutical Exports by Category, 2006-2010 (US$000s).43
Pharmaceutical Exports by Country/Region, 2010 (US$000s)43
Pharmaceutical Imports by Category, 2006-2010 (US$000s) 44
Imports of Raw Materials by Country/Region, 2010 (US$000s).46
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s).46
Imports of Medicaments by Country/Region, 2010 (US$000s)  47
Pharmaceutical Balance of Trade, 2006-2010 (US$000s) 48
SPIMACO’s Subsidiaries. 52
Espicom Analysis of the Pharmaceutical Market, 2011.64
SWOT Analysis of the Pharmaceutical Market, 2011. 65

List of Charts

Regional Comparison of Projected Pharmaceutical Market Share, 2016 (%). 38
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 39
Pharmaceutical Exports, 1995-2010 (US$ Millions) 42
Pharmaceutical Imports, 1995-2010 (US$ Billions)44
Pharmaceutical Imports by Country/Region, 2010 (%) 45
Pharmaceutical Balance of Trade, 1995-2010 (US$ Millions).48
Radar Graph of the Pharmaceutical Market, 2011 . 65

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections  .3
MACROENVIRONMENT  4
POLITICAL4
ECONOMIC 5
Projections .5
LEGAL.6
DEMOGRAPHIC 7
Projections .7
Demographic Indicators.8
Births. 8
Deaths  8
Infant Deaths. 8
Life Expectancy at Birth  8
EPIDEMIOLOGY . 9
DISEASE BURDEN.9
Causes of Death .9
DISEASE PREVALENCE.9
Communicable Diseases.9
HIV/AIDS. 9
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS  10
ORGANISATION 10
EXPENDITURE.11
Projections .11
Social Security12
Social Security Institution. 12
Background of Health Insurance. 12
Private Health Insurance. 12
INFRASTRUCTURE13
Hospital Infrastructure .13
Ambulatory Infrastructure.13
SERVICES13
Hospital Inpatient Services 13
WORKFORCE.14
Projections .14
Latest Figures.15
REGULATORY AFFAIRS . 16
MARKETING REGISTRATION.17
Registration Requirements  .17
Section 1: Summary of File . 17
Section 2: Chemical, Pharmaceutical and Biological Information  18
Section 3: Toxicological and Pharmacological Information . 18
Section 4: Clinical Documentation 18
POST-MARKETING SURVEILLANCE .18
PROMOTION .19
Advertising 19
PRICING & REIMBURSEMENT. 20
PRICING  20
REIMBURSEMENT.21
DISTRIBUTION CHANNELS. 22
DRUG WHOLESALING. 22
Leading Wholesalers.22
Hedef Alliance.22
Selçuk Ecza Deposu .22
DRUG RETAILING. 23
Agreement between SGK and TEB over Drug Purchase Contracts .23
New 2D Barcode System for Pharmaceuticals  .23
MARKET ANALYSIS 24
SIZE.24
Projections .24
Historical Figures.26
Current Structure.27
PRODUCT DEVELOPMENT27
MANUFACTURING. 28
TRADE . 28
Exports .28
Imports.30
Balance of Trade 34
COMPETITION 35
TRADE ASSOCIATIONS 35
Association of Research-Based Pharmaceutical Companies (AiFD) .35
Pharmaceutical Manufacturer’s Association (IEIS).36
COMPANY INTELLIGENCE.37
Foreign Producers .37
Bayer 37
Pfizer.37
Polpharma.37
Recordati37
Local Producers .38
Abdi İbrahim .38
Biofarma.38
Deva Holding 39
Eczacıbaşı.39
Embil Pharmaceutical Co40
Mustafa Nevzat Pharmaceuticals40
Turgut Group. 41
Competitive Strategies .41
OTC PHARMACEUTICALS 42
REGULATION.42
Marketing Registration.42
Advertising.42
MARKET.42
GENERIC PHARMACEUTICALS . 43
REGULATION.43
PRICING43
MARKET SIZE 44
COMPETITION 44
Foreign Producers .44
Actavis Turkey.44
Zentiva44
Local Producers .45
Bilim Pharmaceuticals.45
Sanovel.45
BIOLOGICS & BIOSIMILARS . 46
REGULATION 46
RESEARCH .47
CONCLUSIONS: OPPORTUNITIES & CHALLENGES . 48
Strategic Espicom Analysis 48
MACROENVIRONMENT48
EPIDEMIOLOGY48
HEALTHCARE48
REGULATORY AFFAIRS.49
PRICING & REIMBURSEMENT49
DISTRIBUTION CHANNELS 50
MARKET 50
COMPETITION 50
OTC PHARMACEUTICALS.51
GENERIC PHARMACEUTICALS.51
BIOLOGICS & BIOSIMILARS.51
Radar Analysis 53
SWOT Analysis53
DIRECTORY  54
GOVERNMENT ORGANISATIONS 54
PHARMACEUTICAL PRODUCERS  54
Foreign Pharmaceutical Producers .54
Local Pharmaceutical Producers54
Foreign Generic Producers .54
Local Generic Producers .54
TRADE ORGANISATIONS 54

List of Tables

Espicom Analysis of the Pharmaceutical Market, 2011. 2
Key Data Projections, 2011-2016. 3
Political Landscape, 2011  4
Regional Comparison of Projected Economies, 2016 5
Projected Economy, 2011-2016 . 5
Regional Ranking of Projected Demographics, 2016 7
Population Projections by Age Group, 2008-2025 7
Regional Comparison of Projected Health Expenditure, 2016.11
Projected Health Expenditure, 2011-201611
Regional Ranking of Projected Physicians, 2016. 14
Projected Physicians, 2011-2016. 14
Regional Comparison of Projected Pharmaceutical Markets at Retail Prices, 2016  24
Projected Pharmaceutical Market at Retail Prices, 2011-2016 25
Historical Pharmaceutical Market at Retail Prices, 1995-2010 . 26
Pharmaceutical Consumption by Therapeutic Class, 1999-2010 (%). 27
Pharmaceutical Exports by Category, 2005-2009 (US$000s)  29
Pharmaceutical Exports by Country/Region, 2009 (US$000s). 29
Pharmaceutical Imports by Category, 2005-2009 (US$000s) 31
Imports of Raw Materials by Country/Region, 2009 (US$000s). 32
Imports of Antisera & Vaccines by Country/Region, 2009 (US$000s). 32
Imports of Medicaments by Country/Region, 2009 (US$000s) 33
Pharmaceutical Balance of Trade, 2005-2009 (US$000s) 34
Top-Ten Pharmaceutical Manufacturers by Value & Market Share, 2009 . 35
Members of the AiFD, 2011 . 35
Members of IEIS, 2011. 36
Data Required for Marketing Authorisation in Turkey 43
Guidelines for Biosimilar Product Registration, 2008.46
Espicom Analysis of the Pharmaceutical Market, 2011. 52
SWOT Analysis of the Pharmaceutical Market, 2011. 53

List of Charts

Projected Demographics, 2011-20167
Key Demographic Indicators & Projections, 2004-2025.8
Regional Comparison of Top 7 Projected Pharmaceutical Markets at Retail Prices, 2016  24
Regional Comparison of Projected Pharmaceutical Market Share at Retail Prices, 2016 .25
Historical Pharmaceutical Market at Retail Prices, 1995-2010 .26
Pharmaceutical Exports, 1999-2009 (US$ Millions).28
Change in Pharmaceutical Exports, 2000-2009 (%)28
Pharmaceutical Imports, 1999-2009 (US$ Millions).30
Change in Pharmaceutical Imports, 2000-2009 (%).30
Pharmaceutical Imports by Country/Region, 2009 (%). 31
Pharmaceutical Balance of Trade, 1999-2009 (US$000s)34
Radar Graph of the Pharmaceutical Market, 2011 .53