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Therapeutic Market Outlooks

Diabetes
Publication Date: October 2007
Updated: July 2008 (Removed inhaled insulin products, updated model)

Table of Contents

Disease Etiology................................................................... 7
Epidemiology & Patient Population Estimates........................... 8
Screening and Diagnosis ................................................. 8
Theoretical Patient Population.......................................... 9
Addressable Patient Population ........................................ 9
Treated Patient Population .............................................. 9
Patient-Years of Therapy................................................. 9
U.S. Anti-Diabetes Market Model, 2004-2013......................... 12
Disease & Market Definitions ......................................... 12
OAD/GLP-1 Market ................................................. 12
Biguanides and Sulfonylureas ............................. 12
PPARγ Agonists ................................................ 13
DPP-IV Inhibitors .............................................. 13
Meglitinides...................................................... 13
Β-Glucosidase Inhibitors .................................... 13
Fixed-Dose Combinations................................... 13
Insulin Market ........................................................ 13
Forecasting Methodology............................................... 14
Market Revenue Forecasts............................................. 19
AVOS Physician Panel Results .............................................. 20
Physician Treatment Patterns for Type 1 Diabetes............ 20
Physician Treatment Patterns for Type 2 Diabetes............ 20
Patient Compliance ....................................................... 21
Asymptomatic Nature of Type 2 Diabetes .................. 21
Side-Effects ........................................................... 21
Patient Sentiments/Attitudes.................................... 21
Patient Demographics ............................................. 21
Physician Product Selection Criteria ................................ 21
HbA1c Reduction Efficacy ........................................ 21
Side-Effect Profile ................................................... 21
Cardiovascular Risk ........................................... 21

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Weight Gain ..................................................... 22
Hypoglycemia................................................... 22
Cost ...................................................................... 22
Convenience of Use ................................................ 22
Other Criteria ......................................................... 22
Physician Product Ratings and Forecasts of Market
Trends ........................................................................ 22
Market Overview ................................................................ 26
Leading Products.......................................................... 27
Market History ............................................................. 27
Current Market Environment.......................................... 28
Oral Anti-Diabetes Drugs/GLP-1 Analogues ................ 28
Insulin................................................................... 28
Marketed Product Profiles
Actos (Takeda/Eli Lilly).................................................. 29
U.S. Perspective ..................................................... 29
Worldwide Perspective ............................................ 30
AVOS Physician Panel Discussions ............................ 31
Avandia (GlaxoSmithKline) ............................................ 32
U.S. Perspective ..................................................... 32
Worldwide Perspective ............................................ 33
AVOS Physician Panel Discussions ............................ 33
Januvia (Merck) ........................................................... 35
U.S. Perspective ..................................................... 35
Worldwide Perspective ............................................ 36
AVOS Physician Panel Discussions ............................ 36
Byetta (Amylin Pharmaceuticals/Eli Lilly) ......................... 37
U.S. Perspective ..................................................... 37
Worldwide Perspective ............................................ 38
AVOS Physician Panel Discussions ............................ 38
Prandin/NovoNorm (Novo Nordisk) ................................. 39
U.S. Perspective ..................................................... 39
Worldwide Perspective ............................................ 40
AVOS Physician Panel Discussions ............................ 40
Exubera (Pfizer) ........................................................... 41
U.S. Perspective ..................................................... 41
Worldwide Perspective ............................................ 42

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AVOS Physician Panel Discussions ............................ 42
Lantus (sanofi-aventis)/Levemir (Novo Nordisk) ............... 44
U.S. Perspective ..................................................... 44
Worldwide Perspective ............................................ 45
AVOS Physician Panel Discussions ............................ 45
Humalog (Eli Lilly)/NovoLog (Novo Nordisk)/Apidra
(sanofi-aventis) ............................................................ 46
U.S. Perspective ..................................................... 47
Worldwide Perspective ............................................ 47
AVOS Physician Panel Discussions ............................ 47
Humulin (Eli Lilly)/Novolin (Novo Nordisk) ....................... 49
U.S. Perspective ..................................................... 49
Worldwide Perspective ............................................ 50
AVOS Physician Panel Discussions ............................ 50
Pipeline Product Profiles
Byetta LAR (Amylin Pharmaceuticals/Eli Lilly)/
Liraglutide (Novo Nordisk) ............................................. 51
U.S. Perspective ..................................................... 51
Worldwide Perspective ............................................ 52
AVOS Physician Panel Discussions ............................ 52
Saxagliptin (BMS)/SYR-322 (Takeda)/Galvus
(Novartis) .................................................................... 53
U.S. Perspective ..................................................... 53
Worldwide Perspective ............................................ 54
AVOS Physician Panel Discussions ............................ 54
AIR (Alkermes/Eli Lilly)/AERx (Novo Nordisk)/
Technosphere Insulin (MannKind)/Oral-lyn
(Generex Biotechnology) ............................................... 55
U.S. Perspective ..................................................... 55
Worldwide Perspective ............................................ 56
AVOS Physician Panel Discussions ............................ 56
Drugs in Development ........................................................ 57
R&D Overview ............................................................. 57
Dipeptidyl Peptidase-IV (DPP-IV) Inhibitors ............... 57
GLP-1 Analogues .................................................... 57
Peroxisome Proliferator-Activated Receptor (PPAR)
Agonists ................................................................ 57
Sodium-Dependent Glucose Transporter-2 (SGLT-2)
Inhibitors............................................................... 57

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Protein Tyrosine Phosphatase 1b (PTP1b) Inhibitors ... 57
11-β Hydroxysteroid Dehydrogenase-1 (11 β-HSD-1)
Inhibitors............................................................... 57
Commercial Prospects for Key Drug Classes..................... 57
Products in the Pipeline................................................. 60
Phase III (25 Agents).............................................. 60
Phase II (65 Agents)............................................... 62

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