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【 英文市場調査報告書 】
非インスリン糖尿病治療薬の開発動向
Pipeline Insight: Non-insulin Antidiabetics - Type 2 diabetes unlikely to develop into a switch market
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※この商品は英文にてご提供いたします。 |
Abstract
Overview
Introduction
Datamonitor expects the continuously growing prevalence of diabetes to drive
growth in diabetes drug spending, benefiting market uptake of newly developed,
efficacious therapies. A variety of novel, non-insulin antidiabetic agents are
poised to become available to patients in the next decade, with two DPP-4
inhibitors likely to launch in 2007 and two GLP-1 agonists entering the market
by 2010.
Scope
- Assessment of the patient potential for developmental non-insulin agents
in the type 2 diabetes setting of over the period 2006-15
- Overview of the non-insulin antidiabetics R&D pipeline, with detailed
information on the classes in development and comparator drugs
- Commercial analysis of key compounds in development regarding their
ability to satisfy key unmet needs, supported by the views of key opinion
leaders
- Sales forecasts for key late-stage developmental non-insulin antidiabetics
in the seven major markets to 2015
Highlights
The diabetes market is worthy of investment because of the endemic size of its
patient pool which is set to grow further, and the nature of its unmet
clinical needs. This situation is reflected in the R&D pipeline for
non-insulin antidiabetics, comprising a diverse collection of 76 novel agents
in clinical development.
Datamonitor has identified five late-stage candidate drugs likely to be
launched in the diabetes market within the next five years. These are the
DPP-4 inhibitors Galvus and Januvia, the GLP-1 agonists Byetta LAR and
liraglutide, the PPAR-gamma modulator metaglidasen. Apart from metaglidasen,
all four agents have blockbuster potential.
Despite the fact that pipeline products will impact the diabetes market
greatly in the next five years, there are currently no agents in late-stage
clinical development that are likely to fully replace current mainstays of
antidiabetic therapy. Type 2 diabetes is therefore likely to remain an add-on
market rather than develop into a switch market.
Reasons to Purchase
- Understand the key factors that will contribute to the success of the next
generation of anti-diabetes drugs
- View independent sales forecasts for products in late stage development
for therapy of type 2 diabetes
- Understand physician sentiment on clinical trial endpoints and late-stage
candidate drugs for the diabetes market
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the market for non-insulin antidiabetic
pharmacotherapies
- The R&D pipeline for non-insulin antidiabetics is a
mechanistically diverse collection of 77 novel agents at the clinical
stages of drug development and dominated by a set of five pharmaceutical
companies
- The diabetes market is characterized primarily by significant unmet
clinical needs but also by some unmet market needs
- Datamonitor has identified two unmet market needs in the setting of
diabetes.
- Datamonitor has identified two unmet clinical needs in the setting
of diabetes.
- Datamonitor has identified five late-stage candidate drugs likely to
be launched into the diabetes market within the next five years-the DPP-4
inhibitors Galvus (vildagliptin) and Januvia (sitagliptin), the GLP-1
agonists Byetta LAR (exenatide LAR) and liraglutide, and the specific
PPAR-γ modulatormetaglidasen.
- GLP-1 agonists
- DPP-4 inhibitors
- Metaglidasen
- CHAPTER 2 PIPELINE OVERVIEW
- Pipeline overview
- Non-insulin antidiabetic pipeline is mechanistically diversified
- Non-insulin antidiabetic pipeline is rich in Phase I and Phase II
candidates
- The R&D landscape is dominated by five companies: GSK, Roche,
Sanofi-Aventis, Merck & Co. and Novo Nordisk
- CHAPTER 3 PATIENT 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
- Future prevalence of type 2 diabetes
- 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: 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
- Biguanides
- Other classes
- Classification of pipeline products
- Incretin mimetics
- Gastric inhibitory polypeptide (GIP)
- Glucagon-like peptide-1 (GLP-1)
- Dipeptidyl PeptidaseIV (DPP-4 Inhibition
- PPAR agonists
- PPAR-γ agonists
- Dual PPAR agonists and PPAR pan agonists
- Sodium glucose co-transporter 2 (SGLT2) inhibitors
- Other classes of agents in development
- Inhibitors of glycogenolysis
- Glucokinase activation
- Clinical trial issues in diabetes
- Efficacy
- Control of average blood glucose levels (HbA1c)
- Bioavailability of non-invasive insulin
- Control of postprandial glucose levels
- Safety and side effects
- Incidence of hypoglycemic events
- Delivery-related complications
- Weight gain
- Patient compliance
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: NON-INSULIN
ANTIDIABETICS
- Overview of pharmacotherapies in late-stage development for type 2
diabetes
- DPP-4 inhibitor class
- Januvia (sitagliptin, MK-0431)
- Drug overview
- Clinical data
- Galvus (vildagliptin, LAF-237)
- Drug overview
- Clinical data
- Competitive environment of the DPP-4 inhibitor class
- Comparison with currently marketed oral antidiabetics
- Comparison with other late-stage pipeline agents
- Inter-class comparison of key clinical trial data of sitagliptin
(Januvia) with vildagliptin (Galvus)
- SWOT analysis: Januvia (sitagliptin)
- SWOT analysis: Galvus (vildagliptin)
- Forecast: Galvus and Januvia
- GLP-1 class
- Byetta LAR (exenatide LAR)
- Drug overview
- Parent product: Byetta (exenatide), Byetta BID
- Clinical data
- Liraglutide (NN-2211)
- Drug overview
- Clinical data
- Competitive environment of the GLP-1 class
- Points of consideration: Byetta LAR
- Points of consideration: Liraglutide
- SWOT-Analysis: Byetta LAR (exenatide LAR)
- SWOT-Analysis: Liraglutide
- Forecast: Byetta LAR and liraglutide
- Metaglidasen (MBX-102)
- Drug overview
- Clinical data
- Phase II
- Competitive environment
- SWOT-Analysis: metaglidasen
- Forecast: metaglidasen
- Datamonitor does not believe non-injectable insulins to be able to
compete with non-insulin antidiabetics
- Datamonitor drug assessment summary
- CHAPTER 6 OTHER NON-INSULIN ANTIDIABETICS
- 625019
- 677954
- 825964
- 189075
- Ro-0730699
- DRF-2593 (Balaglitazone)
- PHX-1149
- AMG-221
- APD-668
- Arimoclomol (BRX-345)
- Anti-CD3
- Drug overview
- Phase I/II clinical trials
- AVE-0847
- AVE-2268
- AVE-5376
- AVE-8134
- AZD-6610
- AZD-8677
- AVE-0010 (ZP-10)
- Drug overview
- Clinical data
- BAY-73-7977
- BI-1356-BS
- BIM-51077 (ITM-077)
- BLX-1002
- Drug overview
- Clinical data
- CJC-1134-PC
- CKD-501
- CS-917 (MB-6322)
- Denagliptin (Redona, 823093)
- Drug overview
- Clinical data
- Diamyd (GAD-65)
- Drug overview
- Clinical data
- Phase II: 47 patients with latent autoimmune diabetes in adults
(LADA)
- Phase II: 70 patients with recent onset type 1 diabetes
- Phase II/III: 160 patients with Latent Autoimmune Diabetes in Adults
(LADA)
- DiaPep277 (AVE-0277)
- Drug overview
- Clinical data
- Phase II: 35 patients with newly diagnosed type 1 diabetes
- DIO-901
- DIO-902
- Drug overview
- Clinical data
- EMD-387008
- EN-122004
- GRC-8200
- 716155 (albugon)
- K-111
- KRP-104
- ISIS-113715
- Drug overview
- Clinical data
- MB-07803
- MBX-2044
- MK-0533
- MK-0893
- MK-0941
- MP-513
- Naveglitazar (LY-818, LY519818)
- iPlex (mecasermin rinfabate)
- Drug overview
- Clinical data
- Phase II: type 1 diabetes
- Phase II: type 1 diabetes
- Phase II: type 2 diabetes
- Phase II: type 2 diabetes
- Netoglitazone (MCC-555)
- NN-0606
- NN-9101
- ONO-5129
- PLX-204
- PSN-010
- PSN-357
- PSN-9301 (P93/01)
- Drug overview
- Clinical data
- R-1438
- R-1439
- R-1440
- AVR-118 (reticulose, Product R)
- CS-011 (rivoglitazone)
- Saxagliptin (BMS-477118)
- TS-033
- SGLT2 Inhibitor (lab code undisclosed)
- Solabegron (427353)
- SSR-162369
- CS-872
- SYR-322
- T-1095
- TA-6666
- TAK-654
- TH-0318
- Drug overview
- Clinical data
- TS-021
- TRX-4 (agCD3)
- Drug overview
- Clinical data
- E1-INT
- APPENDIX A
- Datamonitor drug assessment summary
- Bibliography
- Report methodology
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the cardiovascular analysis team
- Disclaimer
- List of Tables
- Table 1: Pipeline of non-insulin antidiabetic agents, 2006
- Table 2: The pipeline for non-insulin antidiabetic agents is
mechanistically diversified: full listing, 2006
- Table 3: The pipeline for non-insulin antidiabetic agents is
mechanistically diversified, 2006
- Table 4: Acute pipeline of non-insulin antidiabetic agents by company,
2006
- Table 5: Collaborative nature of R&D projects among key players in
the non-insulin antidiabetic therapy sector, 2006
- Table 6: Prevalence of diabetes mellitus is forecast to increase by
the International Diabetes Foundation (IDF), 2003-2025
- Table 7: Prevalence rate of type 1 and type 2 diabetes in the seven
major markets (%), 2006-2015
- Table 8: Estimated absolute prevalence of diabetes in the seven major
markets (millions), 2006-2015
- Table 9: Safety of pioglitazone
- Table 10: Comparator Oral Antidiabetics of the TZD Class
- Table 11: Weight gain associated with Actos (kg)
- Table 12: Weight gain associated with Avandia (kg)
- Table 13: Comparator oral antidiabetics of the sulfonylurea class
- Table 14: Metformin is the only representative of the biguanide class
- Table 15: Characteristics of GIP and GLP-1
- Table 16: Key pipeline non-insulin antidiabetic therapies, 2006
- Table 17: Trial data overview: Galvus, June 2006
- Table 18: Trial data overview: Januvia, June 2006
- Table 19: Key adverse event data comparing Januvia and Galvus as
metformin adjuncts, 2006
- Table 20: Sales forecast for Januvia, 2007-15
- Table 21: Sales forecast for Galvus, 2007-15
- Table 22: Comparison of GLP-1 agonists with DPP-4 inhibitors, 2006
- Table 23: Comparative analysis of Byetta BID, Byetta LAR and
liraglutide, 2006
- Table 24: GLP-1 agonist class: Comparison between Byetta LAR and
liraglutide, 2006
- Table 25: Sales forecast for Byetta LAR, 2010-2015
- Table 26: Sales forecast for liraglutide, 2009-15
- Table 27: Sales forecast for metaglidasen, 2011-2015
- Table 28: Research, clinical and commercial attractiveness of key
pipeline non-insulin antidiabetics: basis dataset
- Table 29: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Pipeline of non-insulin antidiabetic drugs, 2006
- Figure 2: The pipeline of non-insulin antidiabetic agents is
mechanistically diverse, 2006
- Figure 3: Pipeline maturity: percentage of R&D products in each
phase of development, 2006
- Figure 4: Collaborative nature of R&D projects among key players
in the non-insulin antidiabetic therapy sector, 2006
- Figure 5: Comparison of glucose testing
- Figure 6: Current NIADs do not address all medical aspects of type 2
diabetes
- Figure 7: Regulation of blood glucose levels by insulin, glucagon and
amylin
- Figure 8: Mechanism of action of TZDs
- Figure 9: Mechanism of action of sulfonylureas and prandial glucose
regulators
- Figure 10: Mechanism of action of metformin
- Figure 11: History of GLP-1, 1930-2006
- Figure 12: Mechanism of action of GLP-1
- Figure 13: GLP-1 effects on β cells
- Figure 14: Functional pancreatic effects of GLP-1
- Figure 15: Mechanism of action of GLP-1 agonists
- Figure 16: Mechanism of action of DPP-4 inhibitors
- Figure 17: Combined theoretical benefits of PPAR pan agonists
- Figure 18: SWOT: Januvia (sitagliptin), 2006
- Figure 19: SWOT: Galvus (vildagliptin), 2006
- Figure 20: Sales forecast for Januvia and Galvus, 2007-2016
- Figure 21: SWOT: Byetta LAR, 2006
- Figure 22: SWOT: Liraglutide, 2006
- Figure 23: Sales forecast for Byetta LAR, 2010-2015
- Figure 24: Sales forecast for liraglutide, 2009-2015
- Figure 25: SWOT: metaglidasen (MBX-102), 2006
- Figure 26: Sales forecast for metaglidasen, 2011-2015
- Figure 27: Overview of sales forecasts for the five pipeline agents
analyzed in the present report, 2006-2015
- Figure 28: Research, clinical and commercial attractiveness of key
pipeline non-insulin antidiabetics: bubble chart
- Figure 29: Research, clinical and commercial attractiveness of
late-stage candidate drugs in diabetes setting: radar plot
- Figure 30: Example of Datamonitor drug assessment scorecard
- Figure 31: Example of Datamonitor drug assessment graph
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※この商品は英文にてご提供いたします。 |
|
【 英文市場調査報告書 】
非インスリン糖尿病治療薬の開発動向
Pipeline Insight: Non-insulin Antidiabetics - Type 2 diabetes unlikely to develop into a switch market
出版日 : 2006/08
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商品コード : 43896 |
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