Global Pharmaceutical Market Forecast

Global Pharmaceutical Market Forecast to 2012

The global pharmaceutical market is expected to earn over a trillion dollar in revenues by 2012 and according to “Global Pharmaceutical Market Forecast to 2012”, our new research report, the market will witness a number of changes impacting its course of growth. These include the shift of growth from the developed markets to the emerging ones, increasing focus on biotech-based drugs, fewer new drug approvals, and a strong growth in the prevalence of generics. ( http://www.bharatbook.com/Market-Research-Reports/Global-Pharmaceutical-Market-Forecast-to-2012.html )

This report, an updated and far more exhaustive and analytical version of our popular 2006 study, provides a comprehensive analysis of every major pharmaceutical market worldwide. Thirty-four major pharmaceutical markets from North America, Latin America, Europe, Asia-Pacific and Africa have been selected as the most important regions to be presented in this report. Factual insight, supplemented with statistical overview on the past, present and future, together with statistics and analysis pertaining to market size, growth, segmentation, government policies, healthcare indicators, key players, health coverage, new developments and future prospects has been provided for each market.

“Global Pharmaceutical Market Forecast to 2012” acts as a valuable tool for pharmaceutical manufactures/investors/consultants who are studying the global pharmaceutical market as it helps in identifying and analyzing market opportunities that will suit their business needs and profiles.

Key Research Findings

§ Growing at a CAGR of around 8%, the global pharmaceutical market is forecasted to reach US$ 1043.4 Billion in 2012.
§ North America remains the largest pharmaceutical market constituting 42.8% of the global sales in 2007. Growth in the region is however expected to slow down in near future owing to patent expiration of key drugs and increased prevalence of generics.
§ In Europe, growth in the top five markets is expected to remain sluggish in next five years. Emerging markets in Central and Eastern Europe is however expected to drive growth in future.
§ A large untapped population and strong economic growth in major countries is expected to make Asia-Pacific the most lucrative pharmaceutical market in future.
§ Growth in the Latin American markets is expected to be strong with Brazil and Mexico amongst the most emerging pharmaceutical markets in the world.
§ Dwindling drug pipelines and patent expiration of a number of blockbuster drugs may challenge the growth of global pharmaceutical market in future.

Key Players Discussed in the Report

This section provides the overview, key facts, strengths and weaknesses, and financial information of prominent players in the global pharmaceutical market like Pfizer Inc, Sanofi-Aventis, GlaxoSmithKline Plc and AstraZeneca Plc.

Key Issues and Facts Analyzed in the Report

§ What are the emerging trends in the global pharmaceutical sector?
§ What are the future prospects of the pharmaceutical industry in various regions across the world?
§ What opportunities exist for the industry?
§ What challenges are being faced by the industry?
§ Who are the key players in the global pharmaceutical market?

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

Japan has been an industrially active nation ever since it adopted Western technology and gained industrial supremacy in the early years of the 20th century. In 2008, the services sector (72.1%) contributed the major portion of GDP growth in Japan followed by industries (26.4%) and agriculture (1

The regulatory environment that shaped the Japanese pharmaceutical market has changed significantly over the past decade. Many of the Japanese pharma companies had a considerable experience from a string of recent high profile acquisitions. Moreover, with strong cash reserves and the recent dramatic increase in the value of the yen (particularly against euro), this appetite for international acquisitions looks set to continue in the coming years.

Foreign companies are now increasingly developing a presence in Japan mostly in the field of R&D and marketing. In terms of domestic sales of prescription drugs, foreign companies have boosted their market share with Pfizer, Roche, Novartis and GSK making it to the top 10 list. This expansion into the Japanese pharmaceutical market has suffered occasional reversals such as Pfizer and Merck & Co. decision to close research facilities in 2006. Moreover in 2008, US biotech giant Amgen (in a $1.2bn deal with Takeda) also handed over the rights of 13 drugs to Takeda. But more recently, foreign multinationals are seeking to expand their presence in Japan mostly by retaining Japanese rights that formerly would have gone to domestic firms.

Key features of this report

• The macroeconomic environment in Japan includes the population profile, disease burden, economic landscape and healthcare spending

• Japanese healthcare system involving the recent developments in healthcare sector, health insurance system, Japanese drug regulatory system (covering IP protection, pricing and reimbursement, drug approval system and healthcare reforms) and future prospects of pricing & reimbursement system in Japan

• Overview of the Japanese pharmaceutical market covering Japanese domestic pharmaceutical market, generic drug market, biotechnological challenges, key mergers & acquisitions and pipeline attractions through 2014

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

Scope of this report

• Develop insights for the Japanese pharmaceutical market, pricing & regulation and detailed epidemiological status of the common indications/risk factors in the country

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

• 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 Japanese pharmaceutical market

• Understand which indications have the greatest potential to provide franchise growth, and how pharmaceutical companies are attempting to exploit these opportunities in Japan

Key Market Issues

• Somatropin BS formed the first biosimilar to launch in Japan
Novartis’s generic division Sandoz became the first company to launch a therapeutic biosimilar Somatropin BS (a recombinant form of human growth hormone Genotropin) in Japan. Initially approved in June 2009 in Japan, for the treatment of growth hormone deficiency in children, growth disturbance associated with Turner’s syndrome and chronic renal insufficiency, Sandoz already markets this product as Omnitrope in the EU, the US and a number of other markets.

• Cervarix, Prevenar and Januvia formed the most awaited drugs to receive Japanese approval in 2009
In October 2009, GSK’s Cervarix (cervical cancer vaccine), Wyeth/Pfizer’s Prevenar (a pediatric pneumococcal conjugate vaccine) and Merck & Co’s DPP-IV inhibitor Januvia (sitagliptin) received the final marketing approval in Japan. Moreover, Cervarix also formed the first vaccine product to receive Japanese approval against human papillomavirus (HPV). Januvia was notable among the ministry’s other clearances, which will be co-marketed by Ono as Glactiv in Japan.

Key findings from this report

• The Japanese pharmaceutical market was valued at $68.6bn in 2008, registering sales growth of 17.2% over 2007, and is forecast to grow at a CAGR of 4.8% during 2008–14. According to Business Insights estimates, targeted therapies and antineoplastics & immunomodulating agents will have the highest growth with CAGR of 19.8% and 10.1%, respectively, over the forecast period.

• Cardiovascular disorders, alimentary canal & metabolism and general anti-infectives remained the top selling therapeutic categories in Japan, registering 2008 sales of $14.6bn, $9.6bn and $6.5bn respectively.

• The leading brands in the Japanese pharmaceutical market had a predominance of cardiovascular drugs (with as many as 6 products in top 10). The top 10 products in this market constituted a very small portion of the market with only 11.4% share in 2008. Takeda’s angiotensin-II inhibitor drug Blopress led the market with 2008 sales of $1.1bn, a growth of 13.3% over 2007.

Key questions answered

• Which indications will see major growth in the Japanese pharmaceutical market over the period 2008–14?

• Which companies (both multinational and domestic) will become the key players in the Japanese pharma 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 Japanese pharmaceutical market?

• Which therapeutic categories are forecast to have the highest levels of commercial potential over the period 2008–14
 
 
Table of Contents
The Japanese Pharmaceutical Market Outlook to 2014
Executive summary 10
The macroeconomic environment in Japan 10
The Japanese healthcare system 11
The Japanese pharmaceutical market analysis 12
Competitive landscape of the Japanese pharmaceutical market 13
Scope and methodology 14
Scope 14
Methodology 14
Chapter 1 The macroeconomic environment in Japan 16
Summary 16
Introduction 17
Economic scenario 17
Environmental scenario 20
Population profile 20
Disease burden 22
Healthcare spending 24
Chapter 2 The Japanese healthcare system 28
Summary 28
Introduction 29
Health insurance system 30
Japanese drug regulatory system 32
Intellectual property rights 33
Pricing and reimbursement 36
Reforming the healthcare system in Japan 41
Future prospects of pricing and reimbursement in Japan 41
Increase in the uptake of generic drugs 41
Changes to the type of drugs that are reimbursable 42
Reference pricing may become more restrictive 42
The government should aim to make it easier for innovative drug makers 42
Chapter 3 The Japanese pharmaceutical market analysis 44
Summary 44
Introduction 45
Domestic pharmaceutical market in Japan 46
Japanese generic drug market 47
Biotechnological challenges in Japan 49
Key mergers and acquisitions in Japan 50
M&A deals in 2007 and 2008 52
Key deals and alliances in 2009 53
Pipeline attractions of Japanese pharmaceutical market 53
Key drugs to enter the Japanese market during 2009–10 55
Therapy area analysis 57
Unmet medical needs in Japan 60
Therapy area sales forecast 61
Leading product dynamics 62
Blopress – Takeda 63
Diovan – Novartis 64
Norvasc – Pfizer 64
Lipitor – Pfizer 65
Aricept – Eisai 65
Mohrus – Hisamitsu 66
Takepron – Takeda 66
Leuplin – Takeda 66
Micardis – Boehringer Ingelheim 67
Amlodin – Dainippon Sumitomo 67
Leading product sales forecast 68
Chapter 4 Competitive landscape of the Japanese pharmaceutical market 70
Summary 70
Introduction 71
Competitive positioning of top players in the Japanese pharma market 72
Detailed analysis of key players in the Japanese pharmaceutical market 74
Takeda 74
Overview 74
Sales focus by leading therapeutic area 75
Marketed product portfolio 77
Takeda’s pipeline focus 80
Strategic growth analysis 83
Daiichi Sankyo 85
Overview 85
Sales focus by leading therapeutic area 86
Marketed product portfolio 88
Daiichi Sankyo’s pipeline focus 90
Strategic growth analysis 91
Pfizer 94
Overview 94
Sales focus by leading therapeutic area 94
Marketed product portfolio 96
Pfizer’s pipeline focus 98
Strategic growth analysis 100
Mitsubishi Tanabe 103
Overview 103
Sales focus by leading therapeutic area 103
Marketed product portfolio 104
Mitsubishi Tanabe’s pipeline focus 107
Strategic growth analysis 108
Roche 110
Overview 110
Sales focus by leading therapeutic area 110
Marketed product portfolio 112
Roche’s pipeline focus 114
Strategic growth analysis 115
Otsuka 117
Overview 117
Sales focus by leading therapeutic area 118
Marketed product portfolio 119
Otsuka’s pipeline focus 121
Strategic growth analysis 123
Novartis 125
Overview 125
Sales focus by leading therapeutic area 125
Marketed product portfolio 127
Novartis’ pipeline focus 129
Strategic growth analysis 130
Chapter 5 Appendix 133
Anatomical therapeutic classification (ATC) 133
A: Alimentary tract and metabolism 133
B: Blood and blood-forming organs 133
C: Cardiovascular system 133
D: Dermatologicals 134
G: Genitourinary system and sex hormones 134
H: Systemic hormonal preparations 134
J: General anti-infectives systemic 134
K: Hospital solutions 134
L: Antineoplastic and immunomodulating agents 134
M: Musculoskeletal system 135
N: Nervous system 135
P: Parasitology 135
R: Respiratory system 135
S: Sensory organs 135
T: Diagnostic agents 135
V: Various 135
Forecast factors 136
Glossary 137
Index 138

List of Figures
Figure 1.1: Japanese GDP distribution across different sectors, 2008 19
Figure 1.2: Comparison of healthcare expenditure across the seven major pharmaceutical markets 25
Figure 2.3: Healthcare provision in Japan 29
Figure 2.4: Organization of MHLW 33
Figure 2.5: Number of patent applications and registrations during the in Japan, 2003–08 35
Figure 2.6: Approval process for pricing and reimbursement of new drugs 40
Figure 3.7: Top 10 drug classes in the Japanese pharma market ($m), 2008 60
Figure 3.8: Unmet medical needs by key therapeutic areas in Japan 61
Figure 4.9: Takeda’s Japanese market sales by therapy area ($m), 2008 76
Figure 4.10: Daiichi Sankyo’s Japanese market sales by therapy area ($m), 2008 87
Figure 4.11: Pfizer’s Japanese market sales by therapy area ($m), 2008 95
Figure 4.12: Mitsubishi Tanabe’s Japanese market sales by therapy area ($m), 2008 104
Figure 4.13: Roche’s Japanese market sales by therapy area ($m), 2008 111
Figure 4.14: Otsuka’s Japanese market sales by therapy area ($m), 2008 119
Figure 4.15: Novartis’ Japanese market sales by therapy area ($m), 2008 126

List of Tables
Table 1.1: Key economic metrics in Japan, 2008 18
Table 1.2: Japanese demographic scenario 21
Table 1.3: Forecast epidemiology of common risk factors/disorders in Japan, 2008–14 23
Table 2.4: Latest developments on drug pricing-related laws in Japan 38
Table 2.5: Revision rates of product reimbursement prices during 2000–08 in Japan 39
Table 3.6: Key mergers and acquisitions involving Japanese pharmaceutical companies in 2007 and 2008 52
Table 3.7: Key deals and alliances involving Japanese pharmaceutical companies in 2009 53
Table 3.8: List of key drugs to enter Japanese market during 2009–10 56
Table 3.9: Japanese pharmaceutical sales by therapy area, 2008 58
Table 3.10: Japanese pharmaceutical market sales forecast by ATC code, 2008–2014 62
Table 3.11: Leading brands in the Japanese pharmaceutical market, 2008 63
Table 3.12: Leading products sales forecast, 2008–14 68
Table 4.13: Leading companies in the Japanese pharmaceutical market, 2008 73
Table 4.14: Takeda’s leading brands in the Japanese market, 2008 78
Table 4.15: Takeda’s pipeline compounds in Japan, July 2009 82
Table 4.16: Daiichi Sankyo’s leading brands in the Japanese market, 2008 89
Table 4.17: Daiichi Sankyo’s pipeline compounds in Japan, July 2009 91
Table 4.18: Pfizer’s leading brands in the Japanese market, 2008 97
Table 4.19: Mitsubishi Tanabe’s leading brands in the Japanese market, 2008 105
Table 4.20: Mitsubishi Tanabe’s pipeline products in Japan, July 2009 108
Table 4.21: Roche’s leading brands in the Japanese market, 2008 112
Table 4.22: Roche/Chugai’s pipeline products in Japan, July 2009 115
Table 4.23: Otsuka’s leading brands in the Japanese market, 2008 120
Table 4.24: Otsuka/Taiho’s pipeline products in Japan, 2009 122
Table 4.25: Novartis’ leading brands in the Japanese market, 2008 127
 
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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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The Specialty Pharmaceutical Market Outlook

The Specialty Pharmaceutical Market Outlook: Key players, opportunities and future trends

The Specialty Pharmaceuticals Market Outlook reveals market dynamics, leading players and key therapy areas of opportunity for specialty pharma companies. Market drivers include increasing reimbursement from national health bodies and governments, industry consolidation, big pharma divestments and biotech growth. Resistors including increased competition, big pharma entry to specialty markets and the financial crisis are also examined in the context of industry strategies of licensing deals, product acquisitions and orphan drug development. Ten leading players are profiled including an analysis of current products, drug pipelines and threats from patent expiries. ( http://www.bharatbook.com/detail.asp?id=133984&rt=The-Specialty-Pharmaceutical-Market-Outlook-Key-players-opportunities-and-future-trends.html )

The effects of industry trends such as rising costs, and generic erosion are analyzed and developed into an outlook for the future of the specialty sector, including strategies for future success.

Key features of this report

• Sizes the specialty pharmaceutical market and makes quantitative forecasts to 2014
• Details market drivers and resistors against the background of pharmaceutical market dynamics.
• Profiles the ten largest specialty pharma companies, including recent deals, product pipelines and key patent expiries.
• Analyzes the effects of wider pharmaceutical industry trends on specialty players.
• Details strategies for success in the future specialty pharma market.

Scope of this report

• Assess leading players in the specialty sector.
• Understand the drivers and resistors of the specialty pharmaceutical market.
• Understand key market strategies such as in-licensing, acquisitions and orphan drug development.
• Determine therapy areas of rich opportunity which are well suited to the specialty pharma business model.
• Develop strategies for success in the future specialty pharma market.

Key Market Issues

• Which therapy areas and indications have suitable dynamics for the specialty pharmaceutical business model?
• How is the financial crisis affecting the specialty pharma industry?
• Competition for licensing deals is increasing as big pharma companies rush to fill their pipelines.
• Healthcare reform is set to have wide ranging effects on the largest pharmaceutical market in the world.
• A further round of pharma industry consolidation will impact the specialty pharmaceutical industry.

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The Future Of The Biologicals Market: Market Overview, Innovations And Company Profiles

Biopharmaceutical products are the key to the future of the pharmaceutical market. Even before the market stagnation seen in 2009 due to the recession, conventional pharmaceuticals were facing drastic consequences from the loss of patent cover for many blockbusters, and the continued failure of the R&D departments in big pharma to produce replacement candidates.
Although the conventional, small-molecule segment of the market will continue to hold a larger share, their growth is expected to be in low single figures, while biopharma products are forecast to grow at rates up to 10% per annum.
This report analyses the three main components of the biopharma market – monoclonal antibodies, therapeutic proteins and vaccines – to show why these groups have such a positive future. It provides the most up-to-date discussion of the whole biopharma market and explores new clinical indications beyond those already targeted.

Key features of this report

• Monoclonal antibodies will build on recent market growth as new product candidates come onstream and new indications are confirmed, extending the usefulness of Mabs beyond cancers and autoimmune disease to CNS conditions, infections and others.
• The Therapeutic Proteins class will continue to be dominated by hematopoietic growth factor products for cancer-related neutropenia and anemia.
• Cytokines are another important contributor to the Therapeutic Proteins sector, and new uses for them are under investigation, including cancers, benign prostatic hyperplasia, gout, wound healing and inflammatory diseases such as Crohn’s.
• Buoyancy in the Vaccines sector is driven by anxiety over bioterrorism, the ongoing risk of a global influenza pandemic and new targets for prevention.
• The prospect of therapeutic vaccines, especially against cancers, is another major driver in the vaccines market.

Scope of this report

• The report gives a realistic picture of the strengths and limitations of the biopharma marketplace, indicating those product groups whose strengths are set to last while avoiding over-optimistic forecasts of growth over the next five years.
• In terms of R&D activity, the report aims to give the reader a perspective on the important research avenues now being pursued, while updating the reader with an overview of recent R&D developments .
• By covering all the three major segments of the biopharma market, the report gives a better perspective of the contribution of biopharma to the management of some major diseases than would be gleaned from studying only a single product type.

Key Market Issues

• Monoclonal antibodies are forecast to grow at a CAGR approaching 10% over the next five years, driven largely by good results in the clinic
• Cancers and immune-related inflammatory diseases will continue to be leading iuses of Mabs during the five-year forecast period
• New indications offer the prospect of major market growth for cytokines; these include cancers and inflammatory diseases
• Other therapeutic proteins such as growth factors, coagulation factors and erythropoietins, have limited opportunities for growth through excpanding indications, and depend instead on product improvements

Key findings from this report

• In terms of market size, therapeutic proteins are the leaders, but monoclonal antibodies (MAbs) are the fastest growing sector
• Cancer still ranks high among targets for new MAb development, along with treatments for inflammation/immune related diseases including rheumatoid arthritis and multiple sclerosis
• Cytokines in advanced development include treatments for cancers, benign prostatic hyperplasia, gout and inflammatory conditions such as Crohn’s disease.
• By the end of 2009 there were 29 monoclonal antibodies approved and marketed for therapeutic use. This product class is now approaching maturity.
• Therapeutic protein products which have been success stories include insulin, erythropoietin, growth hormone, the interferons, and the fusion protein Enbrel (etanercept)

Key questions answered

• What indications will be the main market drivers for Mabs during the next five years?
• What are the most important market trends in the vaccines market?
• Will the biopharma market perform any better than the overall pharma market during the next five years, and why?
• Which segments of the therapeutic protein market are likely to see the best growth?
• What are the major drivers for M&A activity in the biopharma market?

Table of Contents
The future of the biologicals market
Executive Summary 10
Introduction to biopharmaceuticals 10
Developments in technology and clinical applications 11
Market analysis 12
The biopharmaceutical industry 13

Chapter 1 Introduction to biopharmaceuticals 16
Summary 16
Introduction 17
Definition 18
Main product classes 19
Monoclonal antibodies (MAbs) 19
Therapeutic proteins 21
Hemopoietic growth factors 22
Cytokines 23
Blood factors 24
Vaccines 25
Traditional vaccines 25
Novel vaccine technologies 25
Current status: uses and markets 26
Monoclonal antibodies 26
Anti-cancer 27
Anti-TNF 30
Market status of mAbs 31
Therapeutic proteins 33
Insulin 33
Erythropoietin 33
Growth hormone 34
Cytokines 35
Blood factors 37
Market status of therapeutic proteins 37
Vaccines 39

Chapter 2 Developments in technology and clinical applications 42
Summary 42
Introduction 43
Monoclonal antibodies 43
Technology 43
Human antibodies 44
Antibody fragments 44
Conjugated antibodies 45
Antibodies in advanced development 46
Pipeline activity 47
Oncology 47
Abagovomab 47
Anyara 48
Humax EGFr 48
Rencarex 49
Ipilimumab 49
Others 50
Inflammation and immunology 52
Benlysta 52
Epratuzumab 53
Ocrelizumab 53
Reslizumab 54
Others 55
Other indications 55
Bapineuzumab 56
Otelixizumab 57
Pagibaximab 58
Tanezumab 58
Others 58
Therapeutic proteins 59
Technology 59
Multikine 60
Cintredekin Besudotox 61
Rilonacept (IL-1 Trap) 62
Prevascar 63
PRX302 63
Hemopoietic growth factors 64
Recent pipeline activity 65
Replagal 66
Joulferon 68
CYT107 68
Talactoferrin 69
Taspoglutide 70
Vaccines 71
Technology 72
Heterologous prime-boost schemes 72
New adjuvants 73
New vaccines against existing targets 74
Vaccines against new targets 76
HIV vaccines 76
Cancer vaccines 77
Malaria 78
Tuberculosis 79
Vaccines pipeline 80
Menveo 81
Cervarix 81
Ixiaro/Jespect 82
Stimuvax 82

Chapter 3 Market analysis 86
Summary 86
Introduction 87
Market status by product group 88
Monoclonal antibodies 88
Therapeutic proteins 90
Cytokines 91
Anti-hemophilia products 92
Growth hormones 93
Vaccines 93
Production issues 94
Opportunities in emerging markets 94
Adjuvant developments 95
Therapeutic vaccines 95
Influenza 96
Market by geographic region 97
The threat from biosimilars 98
Rationale for biosimilar development 99
Selected biosimilar developments and introductions 100
EPO 100
G-CSF 101
Interferons 101
HGH 101
Monoclonal antibodies 102

Chapter 4 The biopharmaceutical industry 104
Summary 104
Evolution 105
Amgen, Biogen and Genentech 106
Involvement of big pharma 108
Biopharma specialist companies 110
M&A activity 110
Key findings 111
Future M&A trends 113

Chapter 5 Company profiles 116
Introduction 116
Companies marketing/researching Monoclonal Antibodies: 116
Industry leaders 116
Abbott Laboratories 116
Bayer Schering Pharma Ag 117
Biogen Idec Inc. 118
Genzyme Corporation 118
Imclone Systems Inc. 120
UCB S.A. 121
F. Hoffmann-La Roche Ltd 122
Medarex Inc. 123
Other companies involved in MAb research 124
Amgen Inc 124
Apogenix GmbH 125
Bioinvent International AB 126
Celldex Therapeutics Inc 127
Debiopharm Group 128
Genmab A/S 129
Glycotope GmbH 130
ImmunoGen Inc 131
Innate Pharma 132
Pfizer Inc. 133
Seattle Genetics Inc. 134
Tolerx Inc. 135
Trubion Pharmaceuticals Inc. 136
Wilex AG 137
Companies involved in Therapeutic Proteins 138
Industry Leaders 138
CSL Behring 138
Eli Lilly & Co. 139
Ipsen 140
Merck Serono S.A. 140
Novartis AG 141
Novo Nordisk A/S 143
Baxter International Inc 144
Other companies involved in Therapeutic Protein research 144
Agennix AG 144
Akebia Therapeutics, Inc. 145
Biovitrum AB 146
Cytheris SA 147
Dyax Corp 147
ERYtech Pharma 148
Helix BioPharma Corp. 149
Human Genome Sciences Inc. 149
Immutep S.A. 150
H. Lundbeck A/S 152
Octapharma AG 152
Phosphagenics Limited 153
Proteon Therapeutics, Inc. 154
Shire plc 154
Teva Pharmaceutical Industries Ltd 155
ThromboGenics NV 156
ZymoGenetics, Inc. 157
Companies involved in Vaccines 158
Industry Leaders 158
Merck & Co Inc. 158
GlaxoSmithKline plc 159
Sanofi-Aventis 160
Other companies involved in Vaccine Research 161
Advaxis Inc 161
Hawaii Biotech, Inc. 162
ImmunoVaccine Technologies Inc. 163
Intercell AG 164
Soligenix, Inc. 165
Stallergenes 166
Tripep AB 167
Vical Inc 167
Xcellerex, Inc 169
Index 170

List of Figures
Figure 1.1: Global biopharmaceutical market ($bn), 2009 19
Figure 1.2: Diagram of typical antibody structure 20
Figure 1.3: MAb market 2009, market share by use 26
Figure 1.4: Therapeutic proteins market, 2009 market, sales by class, $bn 38
Figure 3.5: Evolution of the biologics market 2009-2015 87
Figure 3.6: Geographic breakdown of the global biopharmaceutical market 98

List of Tables
Table 1.1: Marketed Anti-TNF MAbs 31
Table 1.2: Global market forecast for mAbs, 2009-2015, $bn 32
Table 1.3: mAb market leaders, 2009 32
Table 1.4: Human growth hormone products 35
Table 1.5: Approved cytokines 36
Table 1.6: Blood factors for hemophilia treatment 37
Table 1.7: Global therapeutic proteins market and forecast, $bn 38
Table 1.8: Leading vaccine product sales, 2009; $bn 40
Table 1.9: Global vaccines market and forecast, 2009-2015, $bn 40
Table 2.10: MAbs near to market launch, 2010 46
Table 2.11: Anti-cancer monoclonal antibody products in Phase III trials 47
Table 2.12: Immune system related monoclonal antibody products in Phase III trials 52
Table 2.13: mAb products in clinical development for novel indications 56
Table 2.14: Therapeutic proteins in development 65
Table 2.15: Therapeutic proteins in development (continued) 66
Table 2.16: Vaccines in late stage development 80
Table 3.17: Biopharmaceutical market, estimated value and forecast 2009-2015; $bn 87
Table 3.18: Leading monoclonal antibody products in 2009 89
Table 3.19: Hemopoietic growth factors 90
Table 3.20: Cytokines sales. 2009 91
Table 3.21: Anti-hemophilia products sales, 2009 92
Table 3.22: Growth factor product sales, 2008 93
Table 3.23: Leading vaccine products, sales 2009, $bn 97
Table 3.24: Biologics facing the launch of biosimilars 100
Table 4.25: Company dependence on biopharmaceuticals 109
Table 4.26: Leading specialist biotech companies 110

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