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Pipeline Insight: Non-insulin antidiabetics Incretin mimetics leaders in a diverse pipeline
Publication Date May 2008
Publisher Datamonitor
Product Type Report
Pages 294
ISBN Number not applicable
Product Code DAT01486
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Summary
Introduction
Datamonitor expects incretin mimetics to emerge as a major new therapeutic class in non-insulin antidiabetics, driven by an explosion in the patient population, safety fears surrounding established therapies and significant unmet patient needs.
Scope
Comprehensive analysis of the current non-insulin antidiabetic pipeline detailing the broad range of developmental classes. A detailed clinical and commercial assessment of all key emerging therapies. Sales based sales forecasts for key late-stage developmental non-insulin antidiabetics agents in the seven major markets to 2017.
Highlights
Incretin mimetics, GLP-1 agonists and DPP-IV inhibitors, are likely to be the most successful candidates in the pipeline. Pipeline incretin candidates are forecast to generate sales of $7,905m in the seven major markets in 2017 A huge number of molecules are in development as non-insulin antidiabetics to meet the increase in patient population and disease unmet needs. 137 candidates from 60 different mechanisms of action are in development Big Pharma dominate the non-insulin antidiabetic pipeline as the disease is one of the few growth areas in the cardiovascular and metabolic disease areas. Sixteen of the top twenty drug companies have a non-insulin antidiabetic pipeline and between them are developing 52% of the pipeline.
Reasons to Purchase
Quantify the future drugs in the non-insulin antidiabetic market. Identify licensing opportunities based on company portfolio and market needs. Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs.
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Content
- ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the Non-insulin antidiabetics disease market
- Key metrics
- Datamonitor pipeline assessment summary
- Related reports
- Upcoming report
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Non-insulin antidiabetics: a diverse pipeline
- Huge increase in development candidates as Western World focuses on diabetes
- Market dominated by Big Pharma and single candidate companies
- Current leaders - Pipeline management
- Takeda
- GlaxoSmithKline
- Sanofi-Aventis
- Others
- CHAPTER 3 NON-INSULIN ANTIDIABETIC OVERVIEW - MARKET POTENTIAL
- Definition of diabetes
- Segmentation of diabetes
- Type 1 diabetes
- Type 1.5 diabetes
- Type 2 diabetes
- Epidemiology of diabetes
- Current prevalence of type 1 and type 2 diabetes
- Methodology
- Epidemic rise in incidence of Type 2 diabetes
- Etiology
- Mechanisms of development of diabetes
- Genetic or acquired causes
- Risk factors
- Obesity
- Type 2 diabetes epidemic hand-in-hand with obesity epidemic
- Race
- Type 2 diabetes more prevalent in Hispanics and African Americans than in Caucasians
- Family history
- Type 2 diabetes in first-degree relatives is a strong prognostic indicator
- Advanced age
- Gender and other factors
- Gestational diabetes mellitus
- Unmet need in diabetes
- Unmet market needs
- Unmet market need 1: routine screening for the detection of type 2 diabetes mellitus
- Unmet market need 2: greater patient awareness
- Unmet market need 3: greater guideline awareness in physicians
- Unmet clinical needs
- Unmet clinical need 1: greater efficacy of non-insulin antidiabetics
- Unmet clinical need 2: durability of therapy
- Unmet clinical need 3: better tolerability of non-insulin antidiabetics
- CHAPTER 4 R&D APPROACH
- Therapy overview in type 1 and type 2 diabetes
- Type 1 diabetes
- Type 2 diabetes
- Comparator therapies
- Thiazolidinediones
- Weight gain associated with TZD therapy
- Actos (pioglitazone)
- Avandia (rosiglitazone)
- Sulfonylureas
- Amaryl (glimepiride)
- Glucotrol XL (glipizide)
- Biguanides
- Glucophage (metformin)
- Alpha glucosidase inhibitors
- Basen (voglibose)
- Other classes
- Classification of pipeline products
- Incretin mimetics
- Glucagon-like peptide-1 (GLP-1)
- Dipeptidyl peptidase IV (DPP-IV) inhibition
- PPAR agonists
- PPAR-? agonists
- Dual PPAR agonists and PPAR pan agonists
- Sodium glucose co-transporter 2 (SGLT-2) inhibitors
- Other classes of agents in development
- Glucokinase activation
- Inhibitors of glycogenolysis and gluconeogenesis
- 11-Hydroxysteroiddehydrogenase-1 inhibitors
- Non-insulin antidiabetic pipeline
- Incretin mimetics
- DPP-IV inhibitors
- GLP-1 agonists
- GLP-1 fusion proteins
- GPR119 agonist
- Liver and muscle insulin sensitizers
- PPAR system
- Insulin sensitizers
- Glucose excretion
- Sodium dependent glucose transport-2 inhibitor
- Fatty acid digestion and metabolism
- Bile acid sequestrants
- Carnitine palmitoyltransferase inhibitor
- Farnesoid X receptor agonist
- PPAR-a agonist
- PPAR-d agonist
- HM74a agonist
- Phase I candidates
- Glucose metabolism
- Fructose 1,6 bisphosphatase inhibitor
- Glucagon receptor agonist
- Glucokinase activators
- Glucagon receptor antisense oligonucleotide
- Glycogen phosphorylase inhibitor
- Autoimmune dysfunction
- CD-3 monoclonal antibodies
- Recombinant glutamic acid decarboxylase
- Heat shock protein modulators
- Cell adhesion molecule modulator
- Steroid hormones and the stress response
- 11-Hydroxysteroid dehydrogenase type 1 inhibitors
- Glucocorticoid receptor antagonist
- Biotech therapies
- Alginate encapsulated pancreatic islet product
- Human islet allografts
- Plasmid gene therapy
- Cell based therapy
- Insulin vaccine
- Autonomic and central nervous system
- Dopamine D2 agonist
- Cannabinoid (CB) -1 antagonist
- Anti-inflammatory agents
- Vascular cell adhesion molecule -1 (VCAM-1) gene expression inhibitor
- Cyclooxygenase inhibitor
- IL-1 antagonist/TNF-a antagonist/IL-6 antagonist
- IL-1 antagonist
- NF-?B pathway inhibitor
- Insulin release stimulators
- ATP dependent potassium channel inhibitor
- Unknown mechanisms
- Insulin signaling modulators
- Protein tyrosine phosphatase -1B (PTP-1B) antisense oligonucleotide
- Adenosine monophosphate (AMP) protein kinase modulator
- Undisclosed insulin modulator
- Combination therapies
- PPAR-a agonist based therapies
- PPAR-? agonist and statin
- GABA agonist and appetite suppressant
- Gastrin agonist based therapies
- Muscarinic acetyl choline receptor agonist and a mucolytic
- Other therapeutic modes of action
- Angiotensin converting enzyme inhibitors
- NAD dependent deacetylase sirtuin-1 stimulator
- Amyloid protein deposition inhibitor
- Unknown mechanisms
- Clinical trial issues in diabetes
- Efficacy
- Control of average blood glucose levels
- Insulin
- Blood markers
- Weight loss
- Safety and side effects
- Weight gain
- Cardiovascular endpoints
- Comparators: add-on versus replacement therapy
- Future trends
- FDA guidance February 2008
- Safety
- Regulatory divergence - FDA versus EMEA
- Combinations
- Clinical endpoint selection
- CHAPTER 5 NON-INSULIN ANTIDIABETIC LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for non-insulin antidiabetics
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- DPP-IV and SGLT-2 inhibitors
- Saxagliptin
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Alogliptin
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- BI-1356
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Dapagliflozin
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- GLP-1 agonists
- Byetta LAR
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Liraglutide
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- PPAR modulators
- Balaglitazone
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- MBX-102
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Rivoglitazone
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Autoimmune antibody
- Teplizumab
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Intellectual property status
- Other late-stage candidates
- Actoplus Met XR
- Avandamet XR
- Colesevelam
- Completed trials
- Ongoing trials
- Summary
- Cycloset
- Completed trials
- Summary
- Diamyd
- Completed trials
- Ongoing trials
- Summary
- DiaPep277
- Completed trials
- Ongoing trials
- Summary
- Metformin + fenofibrate
- Completed trials
- Ongoing trials
- Summary
- Mitiglinide
- Completed trials
- On going trials
- Summary
- Ramipril
- Ongoing trials
- Summary
- Rimonabant
- Completed trials
- On going trials
- Summary
- Rosiglitazone + simvastatin
- Completed trials
- Summary
- Succinobucol
- Completed trial
- Ongoing trial
- Summary
- Late-stage development compounds recently discontinued
- BIBLIOGRAPHY
- Epidemiology sources
- General and clinical trial data
- APPENDIX
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Key parameters of the diabetes market for the seven major markets, 2007 and 2017
- Table 2: Forecast key pipeline products in diabetes, 2009- 2017 ($m)
- Table 3: R&D pipeline in non-insulin antidiabetics, 2008
- Table 4: Non-insulin antidiabetic pipeline by mechanism of action, 2007
- Table 5: Big Pharma dominates the major mechanisms of action in the non insulin diabetes pipeline, 2008
- Table 6: Big Pharma also dominates key early phase candidates in the non insulin diabetes pipeline, 2008
- Table 7: Big Pharma's non-insulin antidiabetic pipeline, 2008
- Table 8: Prevalence of diabetes mellitus in the seven major markets (millions), 2000 and 2030
- Table 9: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2007-2017
- Table 10: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2007-2017
- Table 11: Safety of pioglitazone
- Table 12: Weight gain associated with Actos (kg)
- Table 13: Weight gain associated with Avandia (kg)
- Table 14: Characteristics of GIP and GLP-1
- Table 15: Key products in late-stage R&D pipeline for non-insulin antidiabetics, 2008
- Table 16: Forecast key pipeline products in Diabetes in 2017 ($m)
- Table 17: Impacting factors on the revenues of saxagliptin, 2008-2017
- Table 18: Ongoing Phase III clinical trials of saxagliptin, 2008
- Table 19: Completed Phase III clinical trials of saxagliptin, 2008
- Table 20: Impacting factors on the revenues of alogliptin, 2008-2017
- Table 21: Ongoing Phase III clinical trials of alogliptin, 2008
- Table 22: Impacting factors on the revenues of BI-1356, 2008-2017
- Table 23: Ongoing Phase III clinical trials of BI-1356, 2008
- Table 24: Impacting factors on the revenues of dapagliflozin, 2008-2017
- Table 25: Ongoing Phase III clinical trials of dapagliflozin
- Table 26: Impacting factors on the revenues of Byetta LAR, 2008-17
- Table 27: Ongoing Phase III clinical trials of Byetta LAR, 2008
- Table 28: Impacting factors on the revenues of liraglutide, 2008-17
- Table 29: Completed Phase III clinical trials of liraglutide, 2008
- Table 30: Ongoing Phase III clinical trials of liraglutide, 2008
- Table 31: Impacting factors on the revenues of balaglitazone, 2008-2017
- Table 32: Ongoing Phase III clinical trial of balaglitazone, 2008
- Table 33: Impacting factors on the revenues of MBX-102, 2008-2017
- Table 34: Ongoing Phase III clinical trial of MBX-102, 2008
- Table 35: Impacting factors on the revenues of rivoglitazone, 2008-2017
- Table 36: On going Phase III clinical trial of rivoglitazone, 2008
- Table 37: Impacting factors on the revenues of teplizumab, 2008-2017
- Table 38: Ongoing clinical trials of teplizumab, 2008
- Table 39: Terminated non-insulin antidiabetes programs, 2008
- List of Figures
- Figure 1: Datamonitor's competitive positioning analysis of oral non-insulin antidiabetics, 2008
- Figure 2: Datamonitor's competitive positioning analysis of GLP-1 agonist non-insulin antidiabetics, 2008
- Figure 3: Datamonitor's competitive positioning analysis of autoimmune antibody non-insulin antidiabetic, 2008
- Figure 4: Non-insulin antidiabetic candidates in development by mechanism of action, 2008
- Figure 5: Breakdown of PPAR mode of action in diabetes, 2008
- Figure 6: Distribution of developmental candidates in the diabetes pipeline by phase, 2008
- Figure 7: Candidate development in the diabetes pipeline split by company, 2008
- Figure 8: Major mechanisms of action in the diabetes pipeline split by company, 2008
- Figure 9: Comparison of glucose testing diagnostic criteria for prediabetes and diabetes
- Figure 10: History of GLP-1, 1930-2006
- Figure 11: Mechanism of action of GLP-1
- Figure 12: GLP-1 effects on -cells
- Figure 13: Functional pancreatic effects of GLP-1
- Figure 14: Mechanism of action of GLP-1 agonists
- Figure 15: Mechanism of action of DPP-IV inhibitors
- Figure 16: Combined theoretical benefits of PPAR pan agonists
- Figure 17: Control of insulin secretion in pancreatic -cells
- Figure 18: Glucose metabolism in hepatocytes
- Figure 19: Datamonitor's competitive positioning analysis of oral non-insulin antidiabetics, 2008
- Figure 20: Datamonitor's competitive positioning analysis of GLP-1 agonist non-insulin antidiabetics, 2008
- Figure 21: Datamonitor's competitive positioning analysis of autoimmune antibody non-insulin antidiabetic, 2008
- Figure 22: Datamonitor forecasts for DPP-IV and SGLT-2 inhibitors across the seven major markets, 2008-2017
- Figure 23: Datamonitor forecasts for GLP-1 agonists across the seven major markets, 2008-2017
- Figure 24: Datamonitor forecasts for PPAR modulators across the seven major markets, 2008-2017
- Figure 25: Datamonitor forecasts for autoimmune antibodies across the seven major markets, 2008-2017
- Figure 26: SWOT analysis of Saxagliptin
- Figure 27: Datamonitor forecast for Saxagliptin in type 2 diabetes across the seven major markets, 2009-2017
- Figure 28: Datamonitor forecast for saxagliptin in type 2 diabetes in the US, Japan and 5EU, 2009-2017
- Figure 29: Datamonitor's competitive positioning analysis of saxagliptin, 2008
- Figure 30: SWOT analysis of alogliptin
- Figure 31: Datamonitor forecast for alogliptin in type 2 diabetes across the seven major markets, 2009-2017
- Figure 32: Datamonitor forecast for alogliptin in type 2 diabetes in the US, Japan and 5EU, 2009-2017
- Figure 33: Datamonitor's competitive positioning analysis of Alogliptin, 2008
- Figure 34: SWOT analysis of BI-1356
- Figure 35: Datamonitor forecast for BI-1356 in type 2 diabetes across the seven major markets, 2012-2017
- Figure 36: Datamonitor forecast for BI-1356 in type 2 diabetes in the US, Japan and 5EU, 2012-2017
- Figure 37: Datamonitor's competitive positioning analysis of BI-1356, 2008
- Figure 38: SWOT analysis of dapagliflozin
- Figure 39: Datamonitor forecast for dapagliflozin in type 2 diabetes across the seven major markets, 2011-2017
- Figure 40: Datamonitor forecast for dapagliflozin in type 2 diabetes in the US, Japan and 5EU, 2011-2017
- Figure 41: Datamonitor's competitive positioning analysis of dapagliflozin, 2008
- Figure 42: SWOT analysis of Byetta LAR
- Figure 43: Datamonitor forecast for Byetta LAR in type 2 diabetes across the seven major markets, 2009-2017
- Figure 44: Datamonitor forecast for Byetta LAR in type 2 diabetes in the US, Japan and 5EU, 2009-2017
- Figure 45: Datamonitor's competitive positioning analysis of Byetta LAR, 2008
- Figure 46: SWOT analysis of liraglutide
- Figure 47: Datamonitor forecast for liraglutide in type 2 diabetes across the seven major markets, 2008-2017
- Figure 48: Datamonitor forecast for liraglutide in type 2 diabetes in the US, Japan and 5EU, 2008-2017
- Figure 49: Datamonitor's competitive positioning analysis of liraglutide, 2008
- Figure 50: SWOT analysis of balaglitazone
- Figure 51: Datamonitor forecast for balaglitazone in type 2 diabetes across the seven major markets, 2011-2017
- Figure 52: Datamonitor forecast for balaglitazone in type 2 diabetes in the US, Japan and 5EU, 2011-2017
- Figure 53: Datamonitor's competitive positioning analysis of balaglitazone, 2008
- Figure 54: SWOT analysis of MBX-102
- Figure 55: Datamonitor forecast for MBX-102 in type 2 diabetes across the seven major markets, 2012-2017
- Figure 56: Datamonitor forecast for MBX-102 in type 2 diabetes in the US, Japan and 5EU, 2012-2017
- Figure 57: Datamonitor's competitive positioning analysis of MBX-102, 2008
- Figure 58: SWOT analysis of rivoglitazone, 2008
- Figure 59: Datamonitor forecast for rivoglitazone in type 2 diabetes across the seven major markets, 2011-2017
- Figure 60: Datamonitor forecast for rivoglitazone in type 2 diabetes in the US, Japan and 5EU, 2011-2017
- Figure 61: Datamonitor's competitive positioning analysis of rivoglitazone, 2008
- Figure 62: SWOT analysis of teplizumab, 2008
- Figure 63: Datamonitor forecast for teplizumab in type 1 diabetes across the seven major markets, 2012-2017
- Figure 64: Datamonitor forecast for teplizumab in type 1 diabetes in the US, Japan and 5EU, 2012-2017
- Figure 65: Datamonitor's competitive positioning analysis of teplizumab, 2008
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