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Innovations in The Management of Diabetes - Next generation treatments and market dynamics

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Report Summary

Innovations in the Management of Diabetes
Next generation treatments and market dynamics

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Some key findings from this report

• The global diabetes market value was $24,275mn in 2007, having increased by 13.8% since 2006. The market has maintained steady growth in recent years, with a CAGR of 13.2% over 2003-07.
• OAD drugs and non-invasive insulin drug delivery technologies continue to offer significant potential for market expansion, despite several innovative introductions within new drug classes, such as GLP-1 agonists and DDP-IV inhibitors.
• A number of pharma companies are re-focusing on co-morbidities such as hypertension, dyslipidemia and obesity for innovative product development. Sanofi-Aventis’ Acomplia (rimonabant) is a first-in-class CB-1 antagonist indicated for the treatment of overweight patients with associated Type 2 diabetes or dyslipidemia risk factors.
• Metabolic syndrome has become a focal area for drug developers. The syndrome refers to a clustering of CVD risk factors whose underlying pathophysiology is related to insulin resistance.
• The FDA is considering the implementation of stricter standards when testing diabetes drugs for related cardiovascular risks. The possibility of stricter controls in diabetes drugs development will be a difficult obstacle for several emerging agents.

Innovations in the Management of Diabetes
Diabetes has become the fifth leading cause of death across developed markets, and cases of the disease are forecast to grow by 7.1% across the globe by 2013. The market for innovative diabetes treatments will be driven by this projected rise in prevalence, together with the substantial unmet need for drugs that can effectively halt or reverse disease progression. Although extended lifecycle management for existing antidiabetic therapies may offer sales growth in the short term, the development of new drugs from novel classes will become increasingly important in the future. However, the potential introduction of stricter regulations for diabetes drug development and recent setbacks for novel products have increased speculation about the potential of innovative treatments.
‘Innovations in the Management of Diabetes: Next generation treatments and market dynamics’ is a new report that analyzes the emerging drug classes, novel drug delivery technologies and future growth drivers of the diabetes market. This report explores the major trends and issues affecting the development of novel products and assesses the future potential of leading innovations. The major areas of unmet need in the market are identified and the currently marketed portfolios and developmental compounds of key companies operating within the sector are assessed. This report also examines recent concerns about the safety profiles of marketed products and the possible implementation of stricter FDA regulations.
Explore the latest trends and innovations in diabetes treatments, assess the currently marketed portfolios and pipelines of leading players and identify future market opportunities with this report...

Top five reasons to order your copy today
• Forecast sales growth for the global diabetes market to 2012 and assess the epidemiology and prevalence rates of Type 1/ Type 2 diabetes with this report’s detailed analysis across Japan, France, Germany, Italy, Spain, the UK and the US.
• Examine the major unmet needs within the global diabetes market, identify the latest key events and understand the most important trends and issues affecting major companies operating in this sector.
• Discover which innovations and new compounds have the greatest potential to catalyze portfolio growth by gaining insights into future growth drivers, emerging drug classes and novel delivery technologies.
• Compare the currently marketed portfolios and product pipelines of key players in the diabetes market and understand how competitive dynamics will change with this report’s assessment of companies including Novo Nordisk, Takeda, Sanofi-Aventis, GSK and Lilly.
• Evaluate the potential of leading competitive strategies with this report’s examination of lifecycle management, diversification, franchise development and new market entry.

Key issues examined in this report...
• The diagnosis/treatment gap. With prevalence rates of diabetes continuing to increase globally, it is estimated that only 50% of Type 2 diabetes patients across the seven major markets have been diagnosed, with only 80% of these patients receiving treatment.
• Inhaled insulin failure. The market withdrawal of SanofiAventis/Pfizer’s Exubera has been compounded by the suspension of NovoNordisk’s AERx iDMS, following claims that the product lacks the potential to offer significant benefits over injected formulas. Lilly/Alkermes ceased development of AIR in March 2008 on the same grounds.
• New drug classes. The diabetes treatment paradigm may potentially be altered following the introduction of several new drugs that target the underlying causes of diabetes rather than the symptoms.
• Potential for innovatives. The global diabetes market is forecast to grow significantly over the next five years, driven by an increasing global prevalence creating expanded patient populations and the continued launch of novel drugs. Immense market potential exists for companies who address combined risk factors effectively.

Your questions answered...
• Which markets will experience an increase in the prevalence of diabetes?
• What are the latest technological developments in this field?
• Which treatment areas have become the focus of R&D investment?
• Are currently marketed innovatives satisfying demand?
• What are the drivers and resistors to growth for new products?
• Which pharma companies are implementing lifecycle management strategies for their diabetes portfolios?
• What are the implications of stricter FDA regulations for product approvals?
• How can companies most effectively prepare for impending changes to the market for innovative treatments?

Table of Contents

Table of Contents
Innovations in the Management of Diabetes
Executive Summary 8
Introduction 8
Currently marketed innovatives 9
Future drivers of growth and innovation 10
Key companies and pipelines 11
Future trends and implications 12
Chapter 1 Introduction 14
Summary 14
Introduction 15
Disease description 15
Type 1 diabetes 15
Type 2 diabetes 16
An increasing global health concern 17
Increasing patient population 17
Underdiagnosed and undertreated 17
Economic burden 18
Chapter 2 Currently marketed innovatives 20
Summary 20
Introduction 21
Current growth drivers 21
Insulins 23
Leading marketed innovatives within insulin 23
Exubera 26
Oral anti-diabetics (OADs) 28
Leading marketed innovatives in OADs 29
Other diabetic drugs 31
Leading marketed innovatives in other diabetic drugs 32
Chapter 3 Future drivers of growth and
innovation 38
Summary 38
Introduction 39
Unmet need 39
Key events in the global diabetes market 41
ACCORD trial halted 18 months early 41
Inhaled insulins fail to impact market 42
FDA considers stricter rules for diabetes drugs 42
Toward the prevention and further treatment of diabetes 43
Non-invasive forms of insulin via new drug delivery technologies 43
Inhaled insulins 43
Future potential of inhaled insulins 44
Oral insulins 47
Future potential of oral insulins 47
Insulin patches 49
Future potential of insulin patches 49
Emerging new drug classes: targeting underlying causes 50
Incretin mimetics: GLP-1 agonists and DDP-IV inhibitors 51
GLP-1 agonists in development 52
Novel GLP-1 agonists addressing unmet need 56
DDP-IV inhibitors in development 57
Novel DDP-IV inhibitors addressing unmet need 59
PPAR agonists 60
PPAR agonists in development 62
Novel PPAR agonists addressing unmet need 64
Sodium glucose co-transporter (SGLT) inhibitors 65
SGLT inhibitors in development 66
Cannabinoid-1 (CB1) receptor antagonists 67
CB-1 receptor antagonists in development 67
Glucokinase activators (GKA) 68
Glucokinase activators in development 69
Other novel drugs in development 70
Protein tyrosine phosphatase 1B (PT1B) inhibitors 70
Glycogen synthase kinase-3 (GSK-3) inhibitors 71
11-beta-hydroxysteroid dehydrogenase (11beta-HSD1) inhibitors 71
GPR119 agonists 72
Cell transplantation and innovative therapies 73
Chapter 4 Key companies and pipelines 76
Summary 76
Introduction 77
Leading competitive strategies 77
Lifecycle management 77
Diversification 78
Franchise development 78
New market entry 79
Leading players 79
Novo Nordisk 82
Currently marketed innovatives profile 82
R&D/innovatives profile 83
Takeda 85
Currently marketed innovatives profile 85
R&D/innovatives profile 86
Sanofi-Aventis 87
Currently marketed innovatives profile 87
R&D/innovatives profile 88
GSK 90
Currently marketed innovatives profile 90
R&D/innovatives profile 91
Lilly 93
Currently marketed innovatives profile 93
R&D/innovatives profile 94
Merck. 96
Currently marketed innovatives profile 96
R&D/innovatives profile 97
Chapter 5 Future trends and implications 100
Summary 100
Introduction 101
Future market growth 101
Competitive strategy and future potential 104
Chapter 6 Appendix 108
IMS data 108
Index 109
List of Figures
Figure 3.1: Unmet needs in diabetes, 2008 40
Figure 3.2: Innovative diabetes pipeline, 2007 51
Figure 3.3: Addressing unmet need of novel GLP-1 agonists versus insulin 56
Figure 3.4: Addressing unmet need of novel DDP-IV inhibitors versus TZDs 59
Figure 3.5: Addressing unmet need of novel PPAR agonists* versus TZDs 64
Figure 4.6: Competitive dynamics of the leading players in the diabetes market, 2007 81
Figure 5.7: Drivers and resistors of growth in the innovative diabetes market, 2007 102
Figure 5.8: Forecast sales growth for the global diabetes market, 2007-12 103
Figure 5.9: Outlook for leading pharmaceutical companies in the innovative diabetes market 104
List of Tables
Table 2.1: Breakdown of the global diabetes market by drug class, 2003-07 22
Table 4.2: Leading diabetes companies*, 2006-07 79
Table 4.3: Novo Nordisk’s currently marketed innovative diabetes profile, 2003-07 82
Table 4.4: Novo Nordisk’s diabetes R&D/innovatives profile 83
Table 4.5: Takeda’s currently marketed innovative diabetes profile, 2003-07 85
Table 4.6: Takeda’s diabetes R&D/innovatives profile 86
Table 4.7: Sanofi-Aventis’ currently marketed innovative diabetes profile, 2003-07 87
Table 4.8: Sanofi-Aventis’ diabetes R&D/innovatives profile 88
Table 4.9: GSK’s currently marketed innovative diabetes profile, 2003-07 90
Table 4.10: GSK’s diabetes R&D/innovatives profile 91
Table 4.11: Lilly’s currently marketed diabetes innovative diabetes, 2003-07 93
Table 4.12: Lilly’s diabetes R&D/innovatives profile 95
Table 4.13: Merck’s currently marketed innovative diabetes profile, 2003-07 96
Table 4.14: Merck’s diabetes R&D/innovatives profile 97