The Diabetes Market Outlook To 2014: Market dynamics, competitive landscape, emerging therapies - 2009/09/01 - Business Insights

Report title: The Diabetes Market Outlook To 2014: Market dynamics, competitive landscape, emerging therapies

from Business Insights
155 page report published Sep 01, 2009

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IntroductionDiabetes 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 challengingIn December 2008, the FDA announced that the companies developing diabetes drugs will be required to conduct longer and larger studies to avoid any 'unacceptableâ? 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 cardiovascular disease risk by 80% or more.
- Inhaled insulin still a distant realityInsulin 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

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Business Insights

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rbhc0242

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Biotechnology

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Pharmaceutical

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Title	Starting Page	Number of Pages
Sections
Table of Contents The Diabetes Market Outlook to 2014 Executive summary 10 Patient potential 10 Global market analysis 10 Pipeline analysis 11 Leading players of the global diabetes market 12 Chapter 1 Scope and methodology 16 Scope 16 Methodology 16 Scope	0	1
Table of Contents	0	1
The Diabetes Market Outlook to 2014	0	1
Executive summary 10	0	1
Patient potential 10	0	1
Global market analysis 10	0	1
Pipeline analysis 11	0	1
Leading players of the global diabetes market 12	0	1
Chapter 1 Scope and methodology 16	0	1
Scope 16	0	1
Methodology 16	0	1
Scope of IMS data 16	0	1
Chapter 2 Patient potential 20	0	1
Summary 20	0	1
Introduction 20	0	1
What is diabetes? 20	0	1
Types of diabetes 22	0	1
Type 1 diabetes 22	0	1
Type 2 diabetes 24	0	1
Gestational diabetes mellitus 25	0	1
Impaired glucose tolerance 26	0	1
Diabetic complications 26	0	1
Epidemiology 28	0	1
Diagnosis 29	0	1
How is diabetes measured? 31	0	1
Treatment algorithm 32	0	1
Chapter 3 Global market analysis 38	0	1
Summary 38	0	1
Introduction 39	0	1
Market analysis by country 39	0	1
Licensing trends 43	0	1
Key events/trends in the diabetes market 43	0	1
FDAâ€™s revised guidelines on longer, larger cardiovascular risk studies for diabetes drugs 43	0	1
Newer agents recommended by NICE in diabetes treatment 44	0	1
A prophylactic treatment for children at high risk 45	0	1
GSK discontinued development of remogliflozin 45	0	1
Takedaâ€™s Phase II loss of TAK-379 46	0	1
Novo Nordiskâ€™s Prandin lawsuit 46	0	1
Market analysis by drug class 47	0	1
Diabetes drug classes 47	0	1
The insulin landscape 49	0	1
Human insulins 52	0	1
Animal insulins 61	0	1
Drugs targeting underlying causes 61	0	1
Glitazones 62	0	1
Sulfonylurea 67	0	1
Biguanides 69	0	1
DPP-IV inhibitors 71	0	1
Alpha-glucosidase inhibitors 74	0	1
Glinides 76	0	1
Glucagon-like peptide-1 agonists 78	0	1
DPP-IV and GLP-1 differences 80	0	1
Insulin devices 81	0	1
Insulin pump therapy 81	0	1
Therapy area sales forecast 82	0	1
Leading brands of the diabetes market 82	0	1
Generic erosion among the leading brands 84	0	1
Leading brands sales forecast 85	0	1
Chapter 4 Pipeline analysis 88	0	1
Summary 88	0	1
Introduction 89	0	1
Emerging trends/key events in diabetes R&D 89	0	1
Emerging therapies in the diabetes market 89	0	1
Inhaled insulin still a distant reality 90	0	1
Hitherto unexplored avenues in diabetes R&D: magnesium, chromium and vanadium 91	0	1
SGLT-2 inhibitors yet to prove their potential 91	0	1
Other novel mechanisms under development 92	0	1
Profiles of key pipeline products 93	0	1
Drugs under registration/recently approved 94	0	1
Victoza (liraglutide): Novo Nordisk 94	0	1
Onglyza (saxagliptin): BMS/AstraZeneca 97	0	1
SYR322 (alogliptin): Takeda 98	0	1
Byetta LAR (exenatide long-acting release): Eli Lilly, Amylin,	0	1
Alkermes 100	0	1
Syncria (albiglutide): GlaxoSmithKline 102	0	1
Ondero (linagliptin): Boehringer Ingelheim 103	0	1
R1583 (taspoglutide): Roche/Ipsen 105	0	1
AVE0010/ZP10: Sanofi-Aventis 106	0	1
BMS-512148 (dapagliflozin): AstraZeneca/BMS 108	0	1
Teplizumab: Eli Lilly/MacroGenics 110	0	1
Competitive dynamics of the investigational drugs 112	0	1
Key pipeline compounds sales forecast 114	0	1
Chapter 5 Leading players of the global diabetes market 116	0	1
Summary 116	0	1
Introduction 117	0	1
Detailed analysis of the diabetes market players 119	0	1
Novo Nordisk 119	0	1
Overview 119	0	1
Drug class focus 119	0	1
Marketed product portfolio 120	0	1
R&D pipeline analysis 123	0	1
Novo Nordisk: strategic growth analysis 124	0	1
Takeda 127	0	1
Overview 127	0	1
Drug class focus 127	0	1
Marketed product portfolio 128	0	1
R&D pipeline analysis 129	0	1
Takeda: strategic growth analysis 130	0	1
Sanofi-Aventis 131	0	1
Overview 131	0	1
Drug class focus 131	0	1
Marketed products portfolio 132	0	1
R&D pipeline analysis 135	0	1
Sanofi-Aventis: strategic growth analysis 136	0	1
Eli Lilly 137	0	1
Overview 137	0	1
Drug class focus 137	0	1
Marketed products portfolio 138	0	1
R&D pipeline analysis 140	0	1
Eli Lilly: strategic growth analysis 141	0	1
Merck & Co. 142	0	1
Overview 142	0	1
Drug class focus 142	0	1
Marketed products portfolio 143	0	1
R&D pipeline analysis 145	0	1
Merck: Strategic growth analysis 146	0	1
Other major players in the diabetes market 147	0	1
GSK 147	0	1
Boehringer Ingelheim 148	0	1
Chapter 6 Appendix 152	0	1
IMS data 152	0	1
Glossary 153	0	1
Index 154	0	1
List of Figures	0	1
Figure 2.1: Production of insulin and its action 21	0	1
Figure 2.2: Diabetes treatment algorithm 34	0	1
Figure 3.3: Global market sizes, 2008 40	0	1
Figure 3.4: Global sales of types of diabetes brands ($m), 2008 43	0	1
Figure 3.5: Relative positions of different types of insulins in the insulin market, 2008 51 Figure 3.6: Relative positions of different diabetes drug classes, 2008 62 Figure 4.7: Leading late-stage R&D products in the diabetes market, 2009 93 Figure 5.8:	0	1

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