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Diabetes, Metabolic Syndrome and Cardiovascular Disease
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Abstract
There has been a dramatic increase in the incidence of diabetes worldwide,
which has been exacerbated by the growing obesity problem across the globe.
Once thought of as primarily a childhood disease--sometimes referred to as
juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to
the adoption of a high-fat, high-carbohydrate, high-calorie American diet has
resulted in skyrocketing rates of diabetes among adults across the world. To
compound the global diabetes epidemic, health professionals are witnessing an
alarming increase in inflammatory diseases resulting from adult onset (i.e.,
Type 2) diabetes. This phenomenon is referred to as “metabolic
syndrome” where a confluence of inflammatory conditions occur along with
the diabetes. As a result, growing evidence appears to show that metabolic
syndrome makes the diabetic patient susceptible to degenerative health
conditions such as cardiovascular disease, stroke and, now believed,
Alzheimer' s disease. As the diabetes epidemic escalates, a new sense of
urgency has taken hold. Proactive strategies for prevention of the disease are
being put in place by international health organizations such as the World
Health Organization (WHO), as well as by the health departments of
industrialized and developing countries, and even at the local level where
food ingredients regulations are being passed. This TriMark Publications
report charts the changing landscape of the global diabetic population and
explores the added health concerns resulting from the metabolic syndrome
phenomenon and one of its major risk factors: cardiovascular disease
(CVD). Furthermore, this study evaluates widely-accepted therapeutic
approaches to diabetes that are currently in use, while providing an in-depth
analysis of emerging technologies that will be used to treat diabetes and
other inflammatory diseases in the future.
Report Statistics:- Pages: 265
- Format: PDF document
Table of Contents
1. Overview
- 1.1 Statement of Report
- 1.2 About this Report
- 1.3 Scope of the Report
- 1.4 Methodology
- 1.5 Executive Summary
2. Introduction
- 2.1 Demographics of Diabetes
- 2.1.1 Worldwide Diabetes
- 2.1.2 U.S. Diabetes
- 2.2 Economics of Diabetes
3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes
- 3.1 Pre-Diabetes Syndrome
- 3.2 Metabolic Syndrome
- 3.3 Diabetes and Inflammation
- 3.4 Progression of Diabetes
- 3.5 Complications and Co-Morbidities in Type 2 Diabetes
- 3.6 Hypoglycemia and Treatment
- 3.7 Risk Factors and Diabetes
- 3.8 Cardiovascular Disease (CVD) Facts
4. Pharmaceutical Industry and the Anti-Diabetes Market
- 4.1 The Worldwide Pharmaceutical Industry
- 4.2 Total Diabetes Drug Market Size and Growth
- 4.2.1 Sales of Anti-Diabetic Drugs Continue to Rise
- 4.3 Epidemiology/Cost of Treatment
- 4.4 Diabetic Medications Overview
- 4.4.1 Recent Trends in Diabetic Drug Usage
- 4.4.2 Market Influence Factors
5. Non-Insulin Anti-Diabetes Products
- 5.1 Anti-Diabetic Drug Therapy Overview
- 5.1.1 Sulfonylureas
- 5.1.2 Meglitinides
- 5.1.3 Biguanides
- 5.1.4 Thiazolidinediones (TZDs)
- 5.1.5 £¥-Glucosidase Inhibitors
- 5.1.6 Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analog
- 5.1.7 Amylin Analog
- 5.1.8 DPP-IV Inhibitors
- 5.1.9 Other Classes
- 5.1.10 Combination Therapy
- 5.2 Drivers and Trends
- 5.2.1 Market Share of Anti-Diabetic Drugs
- 5.2.2 Forecasts for Anti-Diabetic Drugs
- 5.2.3 Sales Forecast for the Global Diabetes Market
- 5.3 The Future
- 5.3.1 Practice Patterns
- 5.3.2 New Products in Pipeline
- 5.4 Anti-Diabetic Drug Patent Expiry
- 5.5 Regulatory Issues
6. Insulin
- 6.1 Insulin Markets
- 6.1.1 Major Players and Market Share
- 6.2 Insulin and Analogs
- 6.2.1 Rapid-Acting Insulin
- 6.2.2 Intermediate-Acting Insulin
- 6.2.3 Long-Acting Insulin/Ultra Long-Acting Insulin
- 6.2.4 Insulin Mixtures
- 6.3 Insulin Analogs
- 6.4 Non-Insulins in Development
- 6.5 Pipeline Insulin
- 6.6 Non-Invasive Insulin Delivery
- 6.6.1 Inhaled Insulin
- 6.6.1.1 Inhaled Insulin Overview
- 6.6.2 Oral Insulin
- 6.6.3 Transdermal Insulin
- 6.6.4 Oral Spray Insulin
- 6.7 Barriers for Non-Injected Insulin
- 6.8 Patient Potential for Non-Injected Insulin
- 6.9 Insulin Delivery Devices
- 6.9.1 Lancets and Lancing Devices
- 6.9.2 Insulin Pens
- 6.9.3 Injections Aids
- 6.9.3.1 Automatic Injectors
- 6.9.3.2 Syringe Magnifiers
- 6.9.3.3 Insulin Infusers
- 6.9.4 Insulin Jet Injectors
- 6.9.5 Insulin Pumps
- 6.9.5.1 External Insulin Pumps
- 6.9.5.2 Implantable Insulin Pumps
- 6.9.5.3 Insulin Pump Market Share
- 6.9.5.4 Drivers of Demand for Pumps
- 6.10 Market Forecasts for Insulin Administration Technologies
7. Emerging Anti-Diabetes Products
- 7.1 Projections for the Anti-Diabetes Drug Market
- 7.2 Artificial Pancreas
- 7.3 Insulin-Producing Cells
- 7.3.1 Cell Therapy Companies for Diabetes
- 7.4 Transplantation Procedures
- 7.4.1 Pancreatic Transplantation
- 7.4.1.1 Pancreatic Organ Transplantation
- 7.4.1.2 Allo-Islet Transplantation
- 7.4.1.3 Transplantation of Encapsulated Pancreatic Cells
- 7.4.1.4 Implantation of Genetically Engineered-Cells or Embryonic Stem
Cells
- 7.4.2 Current Status
- 7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes
- 7.6 Immune Modulators
- 7.7 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2
Diabetes
- 7.8 Other Anti-Diabetic Therapy Drug Candidates
- 7.8.1 Lipid Abnormalities
- 7.8.2 High Blood Pressure
- 7.8.3 Anticoagulants
- 7.9 Drugs Used Off-Labeli
- 7.9.1 Niacin Derivatives
- 7.9.2 Benfluorex
- 7.9.3 D-Chiro-Inositol
- 7.9.4 Warfarin Sodium
- 7.10 Pipeline Diabetic Drug Candidates
- 7.11 Drug Research Overview
- 7.12 Future Anti-Diabetic Drugs in Late-Stage Development
8. Diagnosing Diabetes Using In Vitro Laboratory Tests
- 8.1 New Diagnostic Guidelines
- 8.2 Diabetes Tests
- 8.2.1 Fasting Plasma Glucose (FPG) Test
- 8.2.2 Glucose Tolerance Test
- 8.2.3 Test for Glycosylated Hemoglobin
- 8.2.4 Fructosamine
- 8.3 Glucose Monitoring
- 8.3.1 Overview of Market Segment
- 8.3.2 Competitive Strategies
- 8.3.3 Analyses of the Current Market Conditions, Competition and Product
Mix
- 8.3.3.1 First-Generation Monitors
- 8.3.3.2 Second-Generation Monitors
- 8.3.3.3 Third-Generation SMBG Technologies
- 8.3.3.4 Product Overview
- 8.3.3.4.1 LifeScan
- 8.3.3.4.2 Roche Diagnostics
- 8.3.3.4.3 Bayer Diagnostics
- 8.3.3.4.4 Abbott Diagnostics
- 8.3.3.4.5 Other Players
- 8.3.4 What Are the Advantages of Using a Continuous Glucose-Monitoring
Device?
- 8.3.5 Other Monitoring Device Advancements
- 8.3.6 Future of Non-Invasive Glucose Technology
9. Market Trends, Challenges and Strategic Options
- 9.1 Overview
- 9.2 Diabetes Drug Market Trends
- 9.2.1 Overview
- 9.2.2 Emergence of Therapeutics with Improved Administration
Characteristics
- 9.2.3 Increasing Prevalence of Obesity
- 9.3 Diabetes Mellitus Market Challenges
- 9.3.1 Overview
- 9.3.2 Diabetic Pain Therapeutics
- 9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish
Safety Levels
- 9.3.4 Changing Consumer Preference Drives Product Development in
Invasive Technology Segment
- 9.3.5 Non-Invasive Technology for Revenue Potential
- 9.3.6 Developing Countries Emerging as Key Markets for Diabetes
Monitoring Devices
- 9.3.7 Consumer-Driven Marketing Campaigns!XEssential, though Expensive
- 9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation
- 9.3.9 Market Size Predictions
- 9.3.10 Major Competitors
- 9.4 Strategic Options
- 9.4.1 Overview
- 9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery
- 9.4.3 Diabetes Drugs in Pipeline
- 9.5 FDA Therapeutic Targets
- 9.5.1 FDA Targets Cardiotoxicity
- 9.5.2 Avandia FDA Warning
- 9.6 Outlook to Anti-Diabetes Drugs
- 9.7 Outlook for Cardiovascular Drugs
10. Company Profiles
- 10.1 A. Menarini
- 10.2 Abbott Laboratories
- 10.3 Amgen
- 10.4 AstraZeneca
- 10.5 Bayer
- 10.6 BodyMedia
- 10.7 Cybermedical
- 10.8 Debiotech
- 10.9 DexCom
- 10.10 Echo Therapeutics
- 10.11 Elixir Pharmaceuticals
- 10.12 Eksigent
- 10.13 Flamel Technologies
- 10.14 GlaxoSmithKline
- 10.15 GlucoLight
- 10.16 Insulet
- 10.17 iSense Corporation
- 10.18 Isis Pharmaceuticals, Inc.
- 10.19 Johnson & Johnson
- 10.20 KYORIN
- 10.21 M-Biotech
- 10.22 Medtronic
- 10.23 Merck & Co.
- 10.24 Merck KGaA
- 10.25 MicroIslet
- 10.26 Mitsubishi Tanabe Pharma Corporation
- 10.27 Nipro Diabetes Systems
- 10.28 Novartis
- 10.29 Novo Nordisk
- 10.30 Novocell
- 10.31 ONO Pharmaceutical
- 10.32 Orexigen Therapeutics
- 10.33 Pfizer
- 10.34 ReNeuron
- 10.35 Roche Diagnostics
- 10.36 Sanofi-Aventis
- 10.37 Sensors for Medicine and Science
- 10.38 Siemens
- 10.39 Smiths Medical
- 10.40 Servier
- 10.41 SOOIL Development
- 10.42 Takeda
- 10.43 TheraFuse
- 10.44 Teco Diagnostics
- 10.45 Transition Therapeutics
- 10.46 U.S. Diagnostics
- 10.47 VeraLight
- 10.48 Vivus
- 10.49 Ypsomed Holding
APPENDIX:
- Appendix 1: Contact Information for Companies Profiled
- Appendix 2: Prescribing Patterns for Anti-Hyperglycemic Drugs
- Appendix 3: Detailed List of Insulins Available
- Appendix 4: The History of Insulin
- Appendix 5: Diabetes and Obesity Drugs in Development
- Appendix 6: Pharmaceutical Sampling Practices
INDEX OF FIGURES
- Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2025
- Figure 2.2: Prevalence of Diabetes by Age in the U.S, 2007
- Figure 2.3: New Adult Cases of Diabetes Diagnosed in the U.S., 2007
- Figure 2.4: Distribution of Duration of Diabetes among Adults Aged 18 to
79 Years in the U.S., 2005
- Figure 2.5: Number of Persons with Diagnosed Diabetes in the U.S.,
1980-2007
- Figure 2.6: Treatment with Insulin or Oral Medication among Adults
Diagnosed with Diabetes, 2007
- Figure 2.7: Rate of New Diabetes Cases among Children in the U.S., 2007
- Figure 2.8: Expenditure Associated with Diabetes Complications in the
U.S., 2007
- Figure 2.9: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006
- Figure 3.1: Prevalence of Complications in Diabetics vs. People with
Normal Blood Sugar Levels, 2007
- Figure 3.2: Per Capita Costs for Diabetes-related Complications per Year,
2007
- Figure 3.3: Total Spending on Healthcare in the U.S., 1960-2008
- Figure 3.4: Percentage Breakdown of U.S. Healthcare Spending, 2008
- Figure 3.5: Percentage of U.S. Population that Smokes, 1965-2005
- Figure 3.6: Heart Disease Death Rate by Race and Sex in the U.S., 1979-2006
- Figure 3.7: Hypertension Drugs Newly Prescribed or Continued in the U.S.,
1994-2007
- Figure 3.8: Annual Death Rate of U.S. Population from Strokes, 1950-2008
- Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 2008
- Figure 3.10: Annual Death Rate of U.S. Population from Heart Disease,
1950-2008
- Figure 3.11: Percentage of U.S. Population that is Overweight, 1976-2004
- Figure 4.1: Medical Research in the U.S. Outpaces the Rest of the World
- Figure 4.2: Cost of Diabetes in the U.S., 2007
- Figure 4.3: Top Therapeutic Classes Contributing to Drug Trend, 2007
- Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2006
- Figure 5.1: Comparison of the Effects of the Pioglitazone and
Rosiglitazone on Lipids
- Figure 5.2: U.S. Non-Insulin Anti-Diabetes Sales, 2006
- Figure 5.3: Sales Forecast for the Global Diabetes Market, 1992-2012
- Figure 6.1: Insulin Pump Market Share, 2007
- Figure 6.2: Relative Risk of Diabetes Complications by Mean HbA1c
- Figure 9.1: Relationship between Diabetes Therapy and the Proposed Timeline
- Figure A3.1: Novo Nordisk' s Rising Market Share in the U.S. Insulin
Market, 1982-2008
INDEX OF TABLES
- Table 1.1: Criteria for the Diagnosis of Diabetes
- Table 2.1: Top Ten Countries in Number of Diabetics (20 to 79 Age Group)
in the World, 2007 and 2025
- Table 2.2: Annual Estimated Cost of Diabetes Care in the U.S., 2007
- Table 2.3: Impact of Diabetes on Americans
- Table 2.4: How Diabetes Dollars are Spent in the U.S., 2007
- Table 3.1: Percentage of GDP Healthcare Spending by Country, 2008
- Table 3.2: Life Expectancy Rate by Country, 2008
- Table 3.3: Normal Glucose Values!XFasting State
- Table 3.4: Percentage of Adults Smokers by Country, 2008
- Table 3.5: Worldwide Market for Cardiac Care Therapeutics, 2003-2010
- Table 3.6: Death Rate from Cardiovascular Diseases by Country, 2008
- Table 4.1: Leading Therapy Classes for R&D, 2008
- Table 4.2: Pharmaceutical R&D Expenditures by World Region, 1990-2007
- Table 4.3: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2007
- Table 4.4: Global Pharmaceutical Sales, 2007
- Table 4.5: World Pharmaceutical Sales Share by Region, 2007
- Table 4.6: The World' s Top-Selling Drugs (Audited Market), 2007
- Table 4.7: Pharmaceutical Product Sales by Country Market, 2007
- Table 4.8: Top Ten Global Pharmaceutical Companies by Global Sales, 2007
- Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales (Audited
Market), 2007
- Table 4.10: Leading Ten Therapeutic Classes by U.S. Sales, 2003-2007
- Table 4.11: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions,
2006 and 2007
- Table 4.12: Top Ten Brand Drugs by U.S. Retail, 2007
- Table 4.13: Worldwide Anti-Diabetes Drug Market, 2006-2012
- Table 4.14: Oral Anti-Diabetic Therapy Major World Markets, 2006
- Table 4.15: The Leading Ten Anti-Diabetics by Sales, 2007
- Table 4.16: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes,
2008
- Table 4.17: Summary of Glucose-Lowering Interventions as Monotherapy
- Table 5.1: Classes of Non-Insulin Hypoglycemic Agents
- Table 5.2: Average Dose and Cost Comparison of Hypoglycemic Agents
- Table 5.3: Relative Efficacy of Diabetes Drugs
- Table 5.4: Thiazolidinediones Available for Type 2 Diabetes Mellitus
- Table 5.5: Fixed Drug Combinations
- Table 5.6: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-1
- Table 5.7: DPP-IV Inhibitor Pipeline
- Table 6.1: Available Therapeutic Insulin Alternatives
- Table 6.2: Worldwide Insulin Sales, 2005-2012
- Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2007
- Table 6.4: Worldwide Insulin Sales and Market Share by Company, 2007
- Table 6.5: U.S. Insulin Sales and Market Share by Company, 2007
- Table 6.6: U.S. Retail Insulin Sales, 2006-2009
- Table 6.7: Comparison of Rapid-Acting Insulins
- Table 6.8: Comparison of Long-Acting Insulins
- Table 6.9: Pharmacokinetics of Available Insulins
- Table 6.10: Status of Inhaled Insulin Products, 2009
- Table 6.11: Key Drivers of the Type 2 Diabetes Insulin Market, 2012
- Table 6.12: A Comparison of Existing Insulin Delivery Devices
- Table 6.13: Lancet Characteristics
- Table 6.14: Lancing Device Characteristics
- Table 6.15: Insulin Pens
- Table 6.16: Worldwide Demand for Insulin Injector Pens by Volume, 2006-2010
- Table 6.17: Injection Aids
- Table 6.18: Jet Injectors
- Table 6.19: Leading Insulin Pump Manufacturers
- Table 6.20: External Insulin Pumps
- Table 6.21: Comparison of Current Insulin Pumps on the Market
- Table 6.22: Control Averages by Treatment
- Table 6.23: Reduced Risk for Various Diseases When Blood Glucose is Near
Normal
- Table 6.24: Worldwide Diabetes Market, 2008
- Table 6.25: Types of Insulin Pumps on the Market
- Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies
- Table 7.2: Cells of the Pancreas
- Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients
with Diabetes
- Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia
- Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in
Patients with Diabetes
- Table 7.6: Selected Mid-2008 Press Releases on Emerging Anti-Diabetes
Agents
- Table 7.7: Diabetes Agents in the Pipeline
- Table 7.8: Future Anti-Diabetic Drugs in Late-Stage Development
- Table 8.1: Laboratory Assessment of Diabetic Vascular Disease
- Table 8.2: Worldwide Market for Diabetes Self-Testing (Meters, Strips and
Lancets), 2004-2012
- Table 8.3: Market for Glucose Self-Testing in the U.S., 2004-2012
- Table 8.4: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007
- Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008
- Table 9.2: Selected Licensing Deals in the Diabetes Arena, 2003-2008
- Table 9.3: Top Therapeutic Categories in U.S. Development, 2008
- Table 9.4: Pharmaceutical Companies by Number of Products in R&D Pipeline,
2007
- Table 9.5: Pharmaceutical Companies by Number of Diabetes Products in
Development
- Table 9.6: Selected New Diabetes Drugs in Pipeline, 2007
- Table 9.7: Comparison of New Molecular Entity Outcomes for FDA and EMEA
(Jan 2006 to October 2008)
- Table 9.8: Upcoming Milestones for Selected Diabetes Drugs
- Table 9.9: Overview of Blockbuster Drugs Coming Off-Patent, 2008 to 2012
- Table A1.1: Company Headquarters Contact Information
- Table A3.1: Current Insulins
- Table A4.1: Select Archived Press Release Excerpts
- Table A5.1: The Diabetes/Obesity Pipeline by Developmental Stage, 2009
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