[Report] Pipeline Insight Non-insulin Antidiabetics Market Research, Trends, Analysis TOC

ABOUT DATAMONITOR HEALTHCARE

About the Cardiovascular and Diabetes pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis
Datamonitor insight into the diabetes market
- Despite the presence of well tried and liked compounds for the treatment of diabetes, such as insulin, metformin and sulfonylureas and the recent introduction of new classes such as thiazolidinediones (TZDs), alpha glucosidase inhibitors (AGIs) and prandial glucose regulators (PGRs), there are still important unmet needs in the treatment of diabetes.
- One of the most exciting classes of agents in development is GLP-1 agonists, these aim to address two of the main unmet needs in diabetes treatment, prolonged efficacy and the potential to act on the underlying cause of the disease rather than on its symptoms.
- Another class of agents expected to enter the market in the following years are DPPIV inhibitors, these are targeting the same biochemical pathway as GLP-1 agonists, but instead of supplementing the natural pool of GLP-1, they attempt to inhibit the enzyme responsible for its breakdown.
- Dual PPAR agonists were once hailed as the next big development in the treatment of diabetes. However the recent withdrawal of many leading agents following safety concerns has prompted the FDA to request additional safety data before considering the approval of any such compounds. This development will severely delay the progress of dual PPAR analogs
- Summary
Key metrics

CHAPTER 2 PATIENT POTENTIAL

Definition of diabetes
Segmentation of diabetes
- Type 1 diabetes
- Type 1.5 diabetes
- Type 2 diabetes
- Complications of diabetes
  - Nephropathy
  - Retinopathy
  - Neuropathy
  - Macrovascular complications
  - Economic Impact of Diabetes
  - Low diagnosis rates remain an unresolved issue
Epidemiology of diabetes
- Current prevalence of type 1 and type 2 diabetes
- Future prevalence of type 2 diabetes
  - Methodology
  - Future trends in the incidence and prevalence of diabetes
Unmet need in diabetes

CHAPTER 3 R&D APPROACH

The gold standard in type 1 and type 2 diabetes
- Type 1 diabetes
- Type 2 diabetes
Classification of pipeline products
- Incretin mimetics
  - GIP
  - Current Status of Drugs in Development
  - GLP-1
  - Dipeptidyl Peptidase IV Inhibition
- PPAR agonists
  - PPAR-gamma agonists
  - Dual PPAR agonists and PPAR pan agonists
  - Other classes of agents in development
Clinical trial issues in diabetes

CHAPTER 4 DIABETES PIPELINE ANALYSIS

Pipeline overview
Key companies involved in the diabetes pipeline
- Novo Nordisk
  - Marketed products
  - R&D Compounds
  - Overall comments
- BMS
  - Marketed products
  - R&D compounds
  - Overall Comments
- Eli Lilly
  - Marketed products
  - R&D Compounds
  - Overall Comments
- GlaxoSmithKline
  - Marketed products
  - R&D compounds
  - Overall comments

CHAPTER 5 INCRETIN MIMETICS

Pipeline summary
GLP-1 agonists
- Pipeline summary
Pre-reg compounds
Exenatide
- Profile
  - Clinical trial data
  - Unmet needs and forecast
Phase II compounds
Exenatide LAR
- Clinical trial data
- Unmet needs and forecast
Liraglutide
- Profile
  - Clinical trial data
  - Unmet needs and forecast
CJC-1131
- Profile
  - Clinical trial data
  - Datamonitor opinion
AVE-0010
- Profile
  - Clinical trial data
BIM-51077
- Profile
  - Preclinical data
Overall comments
DPPIV inhibitors
- Pipeline summary
Phase III compounds
LAF-237
- Profile
  - Clinical trial data
  - Unmet needs and forecast
MK-431
- Clinical trial data
- Unmet needs and forecast
Phase II compounds
PSN-9301
- Profile
  - Clinical trial data
Overall comments

CHAPTER 6 PPAR AGONISTS

Pipeline summary
PPAR-gamma agonists
- Pipeline summary
Phase II compounds
Rivoglitazone (CS-011)
- Profile
  - Clinical trial data
T-131
- Profile
  - Clinical trial data
MBX-102
- Profile
  - Clinical trial data
R-483
- Profile
Phase I and earlier compounds
CLX-0921
- Profile
Overall Comments
Dual PPAR agonists and PPAR pan agonists
- Pipeline summary
Phase III compounds
Galida (tesaglitazar)
- Profile
  - Clinical trial data
  - Unmet needs and forecast
Muraglitazar
- Profile
  - Clinical trial data
  - Unmet needs and forecast
Naveglitazar (LY-818)
- Profile
  - Clinical trial data
  - Unmet needs and forecast
TAK-559
- Profile and Clinical trial data
Overall Comments
Phase II compounds
Netoglitazone
- Profile
  - Preclinical data
GW-677594
- Profile
Overall Comments
Phase I compounds
LY-929
- Profile and Clinical trial data

CHAPTER 7 OTHER KEY COMPOUNDS IN THE DIABETES PIPELINE

Pipeline summary
Symlin (pramlintide)
- Profile
- Regulatory issues
  - Clinical trial data
  - Additional clinical trial data
  - Unmet needs and forecast
Sodium Glucose co Transporter (SGLT) inhibitors
- Pipeline summary
T-1095
- Profile
AVE-2268
- Profile
869682 (KGT-1251)
- Profile and Clinical trial data

APPENDIX A

Contributing experts
Bibliography
- Epidemiology
- Clinical trial data
Report methodology

APPENDIX B

About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcares research and analysis methodologies
Datamonitor Healthcares therapy area capabilities
- About the Cardiovascular and Diabetes analysis team
- Disclaimer
List of Tables
- Table 1: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2004
- Table 2: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12
- Table 3: Forecast key products in diabetes pipeline ($m), 2005-12
- Table 4: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2004
- Table 5: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12
- Figure 4: Unmet needs in diabetes, 2004
- Table 6: Characteristics of GIP and GLP-1
- Table 7: R&D pipeline in diabetes, 2004
- Table 8: Key GLP-1 agonists in development, 2004
- Table 9: Assumptions and factors influencing exenatides sales forecast
- Table 10: Assumptions and factors influencing exenatide LARs sales forecast
- Table 11: Assumptions and factors influencing liraglutides sales forecast
- Table 12: Key DPPIV inhibitors in development, 2004
- Table 13: Assumptions and factors influencing LAF-237s sales forecast
- Table 14: Assumptions and factors influencing MK-431s sales forecast
- Table 15: Key PPAR agonists in development, 2004
- Table 16: Key dual and pan PPAR agonists in development, 2004
- Table 17: Assumptions and factors influencing Galidas sales forecast
- Table 18: Assumptions and factors influencing muraglitazars sales forecast
- Table 19: Assumptions and factors influencing naveglitazars sales forecast
- Table 20: Key products the R&D pipeline for human amylin analogs, 2004
- Table 21: Assumptions and factors influencing Symlins sales forecast
- Table 22: Key products in late-stage R&D pipeline for sodium glucose cotransporter inhibitors, 2004
List of Figures
- Figure 1: Impacts on the global antidiabetics market to 2012
- Figure 2: Comparative forecast sales of all key developmental compounds in the diabetes pipeline, 2005-2012
- Figure 3: Comparison of glucose testing
- Figure 5: History of GLP-1, 1930-2004
- Figure 6: Mechanism of action of GLP-1
- Figure 7: GLP-1 effects on beta cells
- Figure 8: Functional pancreatic effects of GLP-1
- Figure 9: Mechanism of action of GLP-1 agonists
- Figure 10: Mechanism of action of DPPIV inhibitors
- Figure 11: Mechanism of action of TZDs
- Figure 12: Combined benefits of PPAR pan agonists
- Figure 13: Key products in the R&D pipeline for incretin mimetics, 2004
- Figure 14: Satisfaction of unmet needs by exenatide in comparison to insulin
- Figure 15: Global sales forecast for exenatide ($m), 2005-12
- Figure 16: Satisfaction of unmet needs by exenatide LAR in comparison to insulin
- Figure 17: Global sales forecast for exenatide LAR ($m), 2007-12
- Figure 18: Satisfaction of unmet needs by liraglutide in comparison to insulin
- Figure 19: Global sales forecast for liraglutide ($m), 2007-12
- Figure 20: Satisfaction of unmet needs by the leading GLP-1 agonists
- Figure 21: Comparative forecasted sales of the leading GLP-1 agonists
- Figure 22: Satisfaction of unmet needs by LAF-237 in comparison to TZDs
- Figure 23: Global sales forecast for LAF-237 ($m), 2007-12
- Figure 24: Satisfaction of unmet needs by MK-431 in comparison to TZDs
- Figure 25: Global sales forecast for MK-431 ($m), 2009-12
- Figure 26: Satisfaction of unmet needs by the leading DPPIV inhibitors
- Figure 27: Comparative forecasted sales of the leading DPPIV inhibitors
- Figure 28: Key products in the R&D pipeline for PPAR agonists, 2004
- Figure 29: Satisfaction of unmet needs by Galida in comparison to TZDs
- Figure 30: Global sales forecast for Galida ($m), 2009-12
- Figure 31: Satisfaction of unmet needs by muraglitazar in comparison to TZDs
- Figure 32: Global sales forecast for muraglitazar ($m), 2006-12
- Figure 33: Satisfaction of unmet needs by naveglitazar in comparison to TZDs
- Figure 34: Global sales forecast for naveglitazar ($m), 2010-12
- Figure 35: Satisfaction of unmet needs by the leading dual PPAR agonists
- Figure 36: Comparative forecasted sales of the leading dual PPAR agonists
- Figure 37: Regulation of blood glucose levels by insulin, glucagon and amylin
- Figure 38: Satisfaction of unmet needs by Symlin in comparison to Insulin
- Figure 39: Global sales forecast for Symlin ($m), 2005-12

Pipeline Insight: Non-insulin Antidiabetics - Three New Classes Compete for Market Control