Diabetes, Metabolic Syndrome and Cardiovascular Disease

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