胰島素以外的抗糖尿病藥市場

Introduction

• 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 TZDs, AGIs and PGRs, there are still important unmet needs in the treatment of diabetes. As a result, a great surge of activity towards the discovery and development of new agents has been recently noted.

Scope of this report

• Evaluation of patient potential for developmental antidiabetics over the period 2004-2012
• Scrutiny of key impacts on the R&D approach and cost, evaluation of optimal clinical trial end points and identification of suitable comparators.
• Evaluation of key players in the antidiabetics market and opposing company approaches to development and commercialization
• Analysis of key antidiabetic drugs in development and their ability to satisfy major unmet needs and compete with existing agents

Research and analysis highlights

• One of the most exciting classes of agents in development is GLP-1 agonists. There have been suggestions that these agents will exhibit efficacy over an extended period of time and that they will offer some effect on beta-cell preservation. However, these findings need to be conclusively proven through specifically designed trials.
• DPPIV inhibitors are expected to enter the market in the following years. Their main advantage is their mode of administration. They will be available as pills or capsules, contrary to GLP-1 agonists that will be injectable. This makes them far more attractive and is likely to help their faster uptake and increased patient compliance.
• Dual PPAR agonists were once hailed as the next big development in the diabetes treatment. 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 such compounds. This development will severely delay the progress of dual PPAR analogs.

Key reasons to read this report

• View independent forecasts of sales in late stage development for treatment of diabetes in novel classes
• Understand physicians views on incretin mimetics as the potential next big development in the diabetes treatment
• Identify early stage antidiabetic compounds with high potential being developed by companies seeking a marketing partner

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