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Middle Eastern

The Middle Eastern Pharmaceutical Market Outlook To 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities-Aarkstore

Egypt, Turkey, Saudi Arabia, Israel, Jordan, United Arab Emirates, Lebanon and Kuwait are the major countries of the Middle East with a total population of around 213m. Turkey, one of the key pharmerging markets of the world, is a strong proponent of liberal trade and investment policies. It has an open trading system, especially with countries in the EU, with which it forged a customs union agreement in 1996. Among the Gulf countries, Saudi Arabia is considered as the most attractive healthcare market in the Gulf which is mainly because of its rapidly growing population, enormous economic resources.

The Middle East pharmaceutical market is diverse, with a significant presence of leading global players alongside domestic pharmaceutical companies such as Ibrahim, Bilim and Deva. The market dynamics are further shaped by the presence of several leading suppliers of branded generics and APIs (active pharmaceutical ingredients) such as Teva, Hikma, Ibrahim, etc. Although, Middle East countries were a late entrant to the biotech sector, countries like Turkey, Saudi Arabia, UAE and Israel has made a dramatic progress in recent years, which was mainly due to several government initiatives. Moreover, several public-private partnerships also boosted the growth of pharmaceutical sector in the Middle East region.

Key findings

• The Middle East pharmaceutical market was valued at $14.8bn in 2008, registering a y-o-y sales growth of 12.6%, and is forecast to return at a CAGR of 8.1% between 2008 and 2014 to reach a total value of 23.5bn in 2014. The general anti-infective market is expected to generate the highest sales of $3.9bn in 2014, followed by alimentary canal & metabolic disorders at $3.7bn.

• General anti-infectives, alimentary canal & metabolism and cardiovascular disorders remained as top selling therapeutic categories in the Middle East, while registering 2008 sales of $2.6bn, $2.3bn and $1.9bn respectively.

• The leading brands in the Middle East pharmaceutical market had a predominance of respiratory and cardiovascular drugs. However, the top 10 brands constituted a very small fraction of the Middle East market, with other drugs making up 94.1% of the total market in 2008. GSK's asthma and COPD drug Seretide dominated the market with 2008 sales of $134m, a strong growth of 21% over 2007.

Key features of this report

• The macroeconomic environment in the Middle East countries includes the population profile, disease burden and macroeconomic comparison (involving economic landscape and healthcare spending) for all the major Middle East markets

• Profiles of the healthcare system across the 8 markets (Egypt, Turkey, Saudi Arabia, Israel, Jordan, UAE, Lebanon and Kuwait) of the Middle East region

• Overview of key recent events in the Middle East pharmaceutical market that have impacted treatment trends and sales potential across all the Middle East countries

• Forecasts and analysis of the leading products in the Middle East market over the period 2008–14 spread across the major indications and classes of treatments

Use this report to

• Develop insights for the Middle East pharmaceutical market, pricing & regulation and detailed epidemiological status of the common indications/risk factors across 8 major countries of the Middle East region

• Quickly understand how recent events are affecting the performance of major products, and how their marketers are confronting competitive challenges in the Middle East market place

• Gain up-to-date competitive intelligence across a wide-range of marketed products, R&D pipeline, market share data, sales forecast and competitive landscape for the major players in the Middle East market

Discover

• What will be the major growth indications in the Middle East pharmaceutical market over the period 2008–14?

• Which companies (both multinational and domestic) will become the key players in the Middle East market over the period 2008–14?

• Which products will be impacted by generic competition over the period 2008–14?

• Which products will be the future growth drivers for the Middle East pharmaceutical market?

Which therapeutic categories are predicted to offer substantial commercial opportunity in the forecast period from 2008–14

Table of Contents :
Introduction

Diabetes mellitus is a chronic metabolic disorder that results due to a failure of the body to produce the hormone insulin and/or an inability of the body to respond adequately to circulating insulin. Type 1 diabetes, previously referred to as insulin-dependent diabetes mellitus (IDDM), occurs most commonly in children or young adults and constitutes 5–10% of the diagnosed diabetes patient population. Type 2 diabetes, previously known as adult-onset diabetes or non-insulin-dependent diabetes mellitus (NIDDM), accounts for 90–95% of diagnosed diabetes cases globally and typically develops in middle-aged adults. The 2008 prevalence of diabetes mellitus, together in the seven major markets, was 8.5% with Germany having the highest prevalence rate at 11.8%. But the disease has been growing at epidemic proportions, a fact that has driven extensive R&D in this therapy area.

The global diabetes market was worth $27.3bn in 2008 and was led by insulin analogs which captured 45.0% of the market followed by glitazones that captured a share of 22.8%. US is the largest diabetes market globally with sales of $12.9b in 2008 and a market share of 47.6%. However the highest growth in sales y-o-y was exhibited by several early emerging economies such as UAE at 59.7%.

Scope of this report

• Epidemiological analysis of the therapy area and forecast prevalence over the period 2009-14 .

• Forecasts and analysis of the key products in the diabetes market over the period 2009-14 spread across the major classes of treatments.

• Overview of key events in the global diabetes market that have impacted treatment trends and sales potential.

• Strategic and growth analysis of leading pharmaceutical corporations based on sales focus by drug class, currently marketed products and R&D product portfolios.

Key findings from this report

• Biguanides, mainly comprised of metformin, are the core first line therapy in diabetes care. These drugs have been used in diabetes therapy for over a decade. Some of their advantages include, efficacy, low cost, extensive experience, lack of incidences of hypoglycemia and weight neutrality. Metformin lost patent protection in 2002 and the class is now much genericized and has been ceding market share to other therapies.

• Insulin captured the largest market share (45%) among available diabetes treatments and is likely to dominate the market in the forecast period. However, though insulin analogs have become well established in the market, inhaled insulin is yet to make its mark.

• Significant R&D has been observed in the pre-insulin market leading to the development of several novel and safer therapies. The comparative performance of these therapies, such as the DPP-IV inhibitors and GLP-1 analogs would shape the diabetes market landscape through 2014 and in the long term.

Key issues

• Revised FDA guidelines make the regulatory environment challenging
In December 2008, the FDA announced that the companies developing diabetes drugs will be required to conduct longer and larger studies to avoid any "unacceptable" cardiovascular risk. Companies are now required to conduct meta analyses for cardiovascular safety in the Phase II and III trials and rule out the possibility of an increased ardiovascular disease risk by 80% or more.

• Inhaled insulin still a distant reality
Insulin therapy takes up the biggest share of diabetes treatment and has been an area of extensive research. While several different purer forms of insulin have emerged over a period of time, nasally administered insulin is still a distant reality. Inhaled insulin may aid compliance, leading to superior long term outcomes. Pfizer/Nektar's Exubera was the first to be launched inhaled insulin but it had a troubled launch and was subsequently discontinued in October 2007. The only inhaled insulin which is still under development is Technosphere, being developed by Mannkind/Afresa. This insulin uses a technology that facilitates absorption of proteins and peptides through the pulmonary route.

Use this report to:

• Which companies were the leading players in the diabetes therapy area in 2008?

• How have recent major launches from the key market players performed?

• Which companies will become the key players in the diabetes market over the period 2009-14?

• Which products will be impacted by generic competitors over the period 2009-14?

"Table of Contents
The Middle Eastern Pharmaceutical Market Outlook to 2014
Executive Summary 12
The macroeconomic environment in the Middle East 12
Healthcare systems in the Middle East 13
Pharmaceutical market analysis of the Middle East 14
Competitive landscape of the Middle Eastern pharmaceutical market 15
Scope and Methodology 18
Scope 18
Methodology 18
Chapter 1 The macroeconomic environment in the Middle East 20
Summary 20
Introduction 21
Population profile 22
Disease burden 24
Macroeconomic comparison of the Middle East 30
Economic landscape of key Middle Eastern countries 32
Egypt 32
Turkey 33
Saudi Arabia 34
Israel 35
Jordan 36
UAE 36
Lebanon 38
Kuwait 38
Healthcare spending 39
Chapter 2 Healthcare systems in the Middle East 42
Summary 42
Introduction 43
Profiles of the healthcare systems across Middle Eastern countries 43
Egypt 43
Healthcare system 43
Intellectual property rights 44
Pricing and reimbursement 45
Key recent events 46
Turkey 47
Healthcare system 47
Intellectual property rights 49
Pricing and reimbursement 50
Key recent events 52
Saudi Arabia 53
Healthcare system 53
Intellectual property rights 54
Pricing and reimbursement 55
Key recent events 57
Israel 58
Healthcare system 58
Intellectual property rights 58
Pricing and reimbursement 59
Key recent events 61
Jordan 62
Healthcare system 62
Intellectual property rights 63
Pricing and reimbursement 63
Key recent events 64
UAE 65
Healthcare system 65
Intellectual property rights 66
Pricing and reimbursement 67
Key recent events 68
Lebanon 68
Healthcare system 68
Intellectual property rights 69
Pricing and reimbursement 70
Key recent events 71
Kuwait 71
Healthcare system 71
Intellectual property rights 72
Pricing and reimbursement 72
Key recent events 73
Chapter 3 Pharmaceutical Market analysis in the Middle East 76
Summary 76
Introduction 77
Pharmaceutical market overview 77
Therapy area analysis 80
Therapy area sales forecast 81
Therapy area analysis by country 82
Egypt 82
Turkey 85
Saudi Arabia 88
Israel 90
Jordan 93
UAE 94
Lebanon 97
Kuwait 100
Leading brands analysis 103
Seretide (GSK) 104
Lipitor (Pfizer) 104
Augmentin (GSK/MUP) 104
Glivec (Novartis) 105
Co-Diovan (Novartis) 105
Spiriva (Boehringer Ingelheim) 106
Plavix (Sanofi-Aventis) 106
Cipralex (Lundbeck) 107
Lansor (Sanovel) 107
Symbicort (AstraZeneca) 108
Leading brands sales forecast 108
Key brand analysis by country 110
Egypt 110
Flumox and Cefotax (Eipico) 110
Amaryl (Sanofi-Aventis) 111
Cataflam (Novartis) 111
Augmentin (MUP) 111
Turkey 112
Foradil Combi (Novartis) 113
Taxotere (Sanofi-Aventis) 113
Herceptin (Roche) 114
Saudi Arabia 114
Augmentin (GSK) 115
Snafi (Spimaco) 116
(Pfizer) 116
Nexium (AstraZeneca) 116
Israel 116
Norditropin (Novo Nordisk) 117
Seretide (GSK) 118
Tritace (Sanofi-Aventis) 118
Jordan 118
Amoclan (Hikma) 119
Similac Gain and Similac Advance (Abbott Nutrition) 119
Cerelac (Nestle) 120
United Arab Emirates 121
(Eli Lilly) 121
Plavix (Sanofi-Aventis) 122
Zinnat (GSK) 122
Lebanon 122
Pariet (J&J) 123
Concor (Merck KGaA) 123
Crestor (AstraZeneca) 124
Kuwait 124
Rocephin (Roche) 125
Xenical (Roche) 125
Yasmin (Bayer) 126
Chapter 4 Competitive landscape of the Middle Eastern pharmaceutical market 128
Summary 128
Introduction 129
Leading players 129
Analysis of key players in the Middle East 133
Novartis 133
Overview 133
Sales focus by leading drug class 133
Marketed product portfolio 135
Novartis' pipeline focus 138
Strategic growth analysis 139
GSK 142
Overview 142
Sales focus by leading drug class 142
Marketed product portfolio 144
GSK's pipeline focus 146
Strategic growth analysis 147
Sanofi-Aventis 150
Overview 150
Sales focus by leading drug class 150
Marketed product portfolio 152
Sanofi-Aventis pipeline focus 154
Strategic growth analysis 155
Pfizer 157
Overview 157
Sales focus by leading drug class 157
Marketed product portfolio 159
Pfizer's pipeline focus 161
Strategic growth analysis 162
Ibrahim 165
Overview 165
Sales focus by leading drug class 166
Marketed product portfolio 167
Ibrahim's pipeline focus 169
Strategic growth analysis 169
Leading players analysis by country 171
Egypt 171
Turkey 172
Saudi Arabia 174
Israel 176
Jordan 178
UAE 180
Lebanon 182
Kuwait 183
Chapter 5 Appendix 186
Anatomical therapeutic classification (ATC) 186
A: Alimentary tract and metabolism 186
B: Blood and blood-forming organs 186
C: Cardiovascular system 186
D: Dermatologicals 187
G: Genitourinary system and sex hormones 187
H: Systemic hormonal preparations 187
J: General anti-infectives systemic 187
K: Hospital solutions 187
L: Antineoplastic and immunomodulating agents 187
M: Musculoskeletal system 188
N: Nervous system 188
P: Parasitology 188
R: Respiratory system 188
S: Sensory organs 188
T: Diagnostic agents 188
V: Various 189
Forecast factors 189
Glossary 190
Index 191

List of Figures
Figure 1.1: GDP composition by sector in key Middle East countries, 2008 32
Figure 1.2: Comparison of healthcare expenditure across major Middle Eastern countries 39
Figure 3.3: Middle East pharmaceutical market share by countries, 2008 79
Figure 3.4: Top 10 drug classes in the Egyptian pharmaceutical market, 2008 ($m) 85
Figure 3.5: Top 10 drug classes in the Turkish pharmaceutical market, 2008 ($m) 87
Figure 3.6: Top 10 drug classes in the Saudi Arabian pharmaceutical market, 2008 ($m) 90
Figure 3.7: Top 10 drug classes in the Israel pharmaceutical market, 2008 ($m) 92
Figure 3.8: Top 10 drug classes in the Jordanian pharmaceutical market, 2008 ($m) 94
Figure 3.9: Top 10 drug classes in the UAE pharmaceutical market, 2008 ($m) 97
Figure 3.10: Top 10 drug classes in the Lebanese pharmaceutical market, 2008 ($m) 100
Figure 3.11: Top 10 drug classes in the Kuwaiti pharmaceutical market, 2008 ($m) 102
Figure 4.12: Market share of top 10 and other players in the Middle East pharmaceutical market, 2008 132
Figure 4.13: Novartis' Middle East pharmaceutical market sales by therapy area, 2008 134
Figure 4.14: GSK's Middle East pharmaceutical market sales by therapy area, 2008 143
Figure 4.15: Sanofi-Aventis' Middle East pharmaceutical market sales by therapy area, 2008 151
Figure 4.16: Pfizer's Middle East pharmaceutical market sales by therapy area, 2008 158
Figure 4.17: Ibrahim's Middle East pharmaceutical market sales by therapy area, 2008 166

List of Tables
Table 1.1: Demographic profile of key Middle East countries 23
Table 1.2: Forecast epidemiology of common risk factors in Egypt, 2008–14 25
Table 1.3: Forecast epidemiology of common risk factors in Turkey, 2008–14 25
Table 1.4: Forecast epidemiology of common risk factors in Saudi Arabia, 2008–14 26
Table 1.5: Forecast epidemiology of common risk factors in Israel, 2008–14 27
Table 1.6: Forecast epidemiology of common risk factors in Jordan, 2008–14 27
Table 1.7: Forecast epidemiology of common risk factors in UAE, 2008–14 28
Table 1.8: Forecast epidemiology of common risk factors in Lebanon, 2008–14 29
Table 1.9: Forecast epidemiology of common risk factors in Kuwait, 2008–14 30
Table 1.10: Key economic metrics of Middle East countries, 2008 31
Table 3.11: Pharmaceutical sales in major Middle East countries, 2008 78
Table 3.12: Middle East pharmaceutical sales by therapy area, 2008 81
Table 3.13: Middle East pharmaceutical market sales forecast by ATC code, 2008–14 82
Table 3.14: Egypt's pharmaceutical market by therapy area sales, 2008 83
Table 3.15: Turkey's pharmaceutical market by therapy area sales, 2008 86
Table 3.16: Saudi Arabia's pharmaceutical market break-down by therapy area sales, 2008 89
Table 3.17: Israel's pharmaceutical market by therapy area sales, 2008 91
Table 3.18: Jordan's pharmaceutical market breakdown by therapy area sales, 2008 93
Table 3.19: UAE's pharmaceutical market by therapy area sales, 2008 96
Table 3.20: Lebanon's pharmaceutical market by therapy area sales, 2008 98
Table 3.21: Kuwait's pharmaceutical market by therapy area sales, 2008 101
Table 3.22: Leading brands in the Middle East pharmaceutical market, 2008 103
Table 3.23: Leading brand sales forecast, 2008–14 109
Table 3.24: Leading brands in the Egyptian pharmaceutical market, 2008 110
Table 3.25: Leading brands in the Turkish pharmaceutical market, 2008 112
Table 3.26: Leading brands in the Saudi Arabian pharmaceutical market, 2008 115
Table 3.27: Leading brands in the Israeli pharmaceutical market, 2008 117
Table 3.28: Leading brands in the Jordanian pharmaceutical market, 2008 119
Table 3.29: Leading brands in the UAE pharmaceutical market, 2008 121
Table 3.30: Leading brands in the Lebanese pharmaceutical market, 2008 123
Table 3.31: Leading brands in the Kuwaiti pharmaceutical market, 2008 125
Table 4.32: Leading companies in the Middle East pharmaceutical market, 2008 130
Table 4.33: Novartis' leading brands in the Middle East market, 2008 136
Table 4.34: GSK's leading brands in the Middle East market, 2008 145
Table 4.35: Sanofi-Aventis' leading brands in the Middle East market, 2008 152
Table 4.36: Pfizer's leading brands in the Middle East market, 2008 159
Table 4.37: Ibrahim's leading brands in the Middle East market, 2008 168
Table 4.38: Leading companies in the Egyptian pharmaceutical market, 2008 171
Table 4.39: Leading companies in the Turkish pharmaceutical market, 2008 173
Table 4.40: Leading companies in the Saudi Arabian pharmaceutical market, 2008 175
Table 4.41: Leading companies in the Israeli pharmaceutical market, 2008 177
Table 4.42: Leading companies in the Jordanian pharmaceutical market, 2008 179
Table 4.43: Leading companies in the UAE pharmaceutical market, 2008 181
Table 4.44: Leading companies in the Lebanese pharmaceutical market, 2008 182
Table 4.45: Leading companies in the Kuwaiti pharmaceutical market, 2008 184

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