Market Report Source

Overview

This TriMark Publications report describes the specific market segment of the pharmaceutical market for diabetes and two of its related diseases, metabolic syndrome and cardiovascular disease. It begins with a textbook explanation of the biology underlying diabetes, and then it reviews and evaluates widely accepted pharmaceutical approaches to diabetes that are currently in use. Finally, market forecasts and an analysis of products in the worldwide prescriptions market will help the reader understand the significance of past developments and speculate on future possibilities about the market of diabetes therapies as an area of research and investment. The principal objectives of this report are to: 1) identify viable technology drivers through a comprehensive look at various platform technologies for diabetes, metabolic syndrome and cardiovascular disease; 2) provide a complete understanding of the leading diabetes tests that are used for disease prediction, screening, prognosis and monitoring, encompassing their basic principles and applications; 3) discover feasible market opportunities via an identification of high-growth applications in different therapeutic areas, with a focus on the largest and most rapidly expanding markets for diabetes, metabolic syndrome and cardiovascular disease; 4) focus on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including forecasts for growth; and 5) summarize the blood glucose testing market, including definitions, processes and trends. Market figures regarding the current value of the diabetes drug market are taken from the most recently available data of the global pharmaceutical industry. The following categories of diabetes drugs will be covered herein: 1) rapid-acting insulin; 2) short-activity insulin; 3) intermediate-acting insulin; 4) long-acting insulin; 5) ultra-long-acting insulin; 6) insulin mixtures; 7) sulfonylureas; 8) meglitinides; 9) biguanides; 10) thiazolidinediones; and 11) alpha-glucosidase inhibitors.

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 Facts

4. Current Treatment Paradigms
4.1 The Worldwide Pharmaceutical Industry
4.1.1 Total Diabetes Drug Market Size and Growth
4.1.2 Sales of Anti-diabetic Drugs Continue to Rise
4.1.3 Epidemiology/Cost of Treatment
4.2 Diabetic Medications Overview
4.2.1 Recent Trends in Diabetic Drug Usage
4.2.2 Factors that are Likely to Influence the Market
4.2.3 Anti-Diabetic Drug Therapy Overview
4.2.3.1 Sulfonylureas
4.2.3.2 Meglitinides
4.2.3.3 Biguanides
4.2.3.4 Thiazolidinediones (TZD’s)
4.2.3.5 a-Glucosidase Inhibitors
4.2.3.6 Combination Therapy
4.2.3.7 Drivers and Trends
4.2.3.8 Market Share of Anti-Diabetic Drugs
4.2.4 Forecasts for Anti-Diabetic Drugs
4.2.4.1 Sales Forecast for the Global Diabetes Market
4.2.4.2 The Future
4.2.4.2.1 Practice Patterns
4.2.4.2.2 New Products in Pipeline
4.2.5 Anti-Diabetic Drug Patent Expiry
4.2.6 Regulatory Issues
4.3 Sulfonylureas and Meglitinides
4.3.1 First-generation Sulfonylurea Agents
4.3.2 Second-generation Sulfonylurea Agents
4.4.1 Thiazolidinediones
4.4.2 PPAR Agonists
4.5 a-Glucosidase Inhibitors
4.6 Insulin Markets
4.6.1 Major Players and Market Share
4.6.2 Rapid-Acting Insulin
4.6.3 Intermediate-Acting Insulin
4.6.4 Long-Acting Insulin
4.6.5 Ultra Long-Acting Insulin
4.6.6 Insulin Mixtures
4.6.7 Newly Approved Insulin
4.6.8 Pipeline Insulin
4.6.9 Insulin in Development
4.6.9.1 Inhaled Insulin Overview
4.6.9.2 Inhaled Insulin Pipeline
4.6.9.3 Oral insulin
4.6.9.4 Barriers for Non-Injected Insulin
4.6.9.5 Patient Potential for Non-Injected Insulin
4.7 Other Anti-diabetic Therapy Drug Candidates
4.7.1 Lipid Abnormalities
4.7.2 High Blood Pressure
4.7.3 Anticoagulants
4.8 Biguanides
4.9 Drugs Used “Off-Label”
4.9.1 Glucagon-Like Insulinotropic Peptide (GLP-1)
4.9.2 Pramlintide (Symlin)
4.9.3 Niacin Derivatives
4.9.4 Benfluorex
4.9.5 D-Chiro-Inositol
4.9.6 Exendin-4
4.10 Investigational New Agents
4.11 New Medicines in Development

5. Emerging Oral Anti-diabetes Products
5.1 Novel Oral Medications
5.2 PPAR agonists
5.3 Insulin Mimetics
5.4 GLP-1
5.5 Immune Modulators
5.6 Artificial Pancreas
5.6.1 Pancreatic Transplantation
5.6.1.1 Pancreatic Organ Transplantation
5.6.1.2 Allo-Islet Transplantation
5.6.1.3 Transplantation of Encapsulated Pancreatic Cells
5.6.1.4 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells
5.6.2 Current Status
5.7 Other Type Drugs
5.8 New Pipeline Diabetic Drug Candidates
5.9 Drug Research Overview

6. Projections for the Anti-diabetes Drug Market
6.1 Implantable Insulin Pumps
6.1.1 Market Share
6.1.2 Drivers of Demand for Pumps
6.2 Insulin Pills
6.3 Transdermal Insulin
6.4 Oral Spray Insulin
6.5 Inhaled Insulin
6.5.1 Important Players
6.6 Insulin-Producing Cells
6.7 Transplantation Procedures
6.8 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes

7. Diagnosing Diabetes Using In Vitro Laboratory Tests
7.1 New Diagnostic Guidelines
7.2 Diabetes Tests
7.2.1 Fasting Plasma Glucose (FPG) Test
7.2.2 Glucose Tolerance Test
7.2.3 Test for Glycosylated Hemoglobin
7.2.4 Fructosamine
7.3 Glucose Monitoring
7.3.1 Overview of Market Segment
7.3.2 Competitive Strategies
7.3.3 Analyses of the Current Market Conditions, Competition and Product Mix
7.3.3.1 First-Generation Monitors
7.3.3.2 Second-Generation Monitors
7.3.3.3 Third-Generation SMBG Technologies
7.3.3.4 Product Overview
7.3.3.4.1 LifeScan
7.3.3.4.2 Roche Diagnostics
7.3.3.3 Bayer Diagnostics (Ames Division)
7.3.3.3.1 Abbott Diagnostics
7.3.3.3.2 Other Players
7.3.4 Adjacent Markets
7.3.5 What Are the Advantages of Using a Continuous Glucose-Monitoring Device?

8. Insulin Delivery Technologies
8.1 Lancets and Lancing Devices
8.2 Insulin Pens
8.3 Injections Aids
8.3.1 Automatic Injectors
8.3.2 Syringe Magnifiers
8.3.3 Insulin Infusers
8.4 Insulin Jet Injectors
8.5 External Insulin Pumps
8.6 Implantable Insulin Pumps
8.7 Artificial Pancreas
8.8 Insulin Patches
8.9 Market Forecasts for Insulin Administration Technologies
8.9.1 Insulin Inhalers
8.9.2 Mouth Sprays
8.9.3 Pills
8.9.4 The Patch

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-Essential, 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

Appendix 1

INDEX OF FIGURES

Figure 1: Demographic Changes in Diabetes Populations in 2010, 2025, 2050
Figure 2: Annual Number of New Cases of Diagnosed Diabetes Among Adults Aged 18 to 79 Years, U.S., 1997-2002
Figure 3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, U.S., 1997-2002
Figure 4: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Age, U.S., 1997-2002
Figure 5: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex, U.S., 1997-2002
Figure 6: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex and Age, U.S., 1997-2002
Figure 7: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Race, U.S., 1997-2002
Figure 8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, U.S., 2002
Figure 9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, U.S., 1980-2001
Figure 10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, U.S., 1980-2001
Figure 11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, U.S., 2002
Figure 12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002
Figure 13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002
Figure 14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002
Figure 15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-2002
Figure 16: How Diabetes Dollars Are Spent in the U.S.
Figure 17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the U.S. Adult Population
Figure 18: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA criteria) or the Two Hour Glucose Value (WHO Criteria)
Figure 19: Sales Forecast for the Global Diabetes Market
Figure 20: Utilization: Compliance by Class
Figure 21: Analysis of Diabetes Pipeline by Company, 2000
Figure 22: Relative Risk of Diabetes Complications by Mean HbA1c
Figure 23: Worldwide Diabetes Market, 2000, 2001, 2002 and 2007

INDEX OF TABLES

Table 1: Total of People with Diabetes in the World and in Selected Nations, 2000 and 2030
Table 2: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 1997-2002
Table 3: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002
Table 4: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-2002
Table 5: Annual Estimated Cost of Diabetes Care, U.S.
Table 6: Impacts of Diabetes on Americans
Table 7: Leading Ten Diagnoses by Total U.S. Patient Visits, 2001
Table 8: U.S. Incidence of Diabetes by Age, 2005
Table 9: Prevalence, Cost and Medicines for Major Diseases in the U.S., 2005
Table 10: Top Ten Causes of Death in the U.S., 2003
Table 11: Per-Event Costs of Diabetes Complications (Estimated)
Table 12: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications
Table 13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease In Type 2 Diabetes Mellitus
Table 14: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
Table 15: Worldwide Market for Cardiac Care Therapeutics
Table 16: Major Causes of End Stage Renal Disease
Table 17: Worldwide Clinical Development Costs for Drugs, 2003
Table 18: Pharmaceutical R&D Expenditures by World Region, 1990-2003
Table 19: U.S. Listed Pharmaceutical Companies Ranked by 2001 R&D Expenditures
Table 20: Global Pharmaceutical Sales
Table 21: World Pharmaceutical Sales Share by Region 2003
Table 22: The World’s Top-Selling Drugs 2003
Table 23: Pharmaceutical Product Sales by Country Market
Table 24: Top Pharmaceutical Companies by Market Capitalization
Table 25: Leading Therapy Classes Global Pharmaceutical Sales 2000 and 2003
Table 26: Leading Ten Therapeutic Classes by U.S. Sales, 2002
Table 27: Top Ten Drug Classes by Retail Dollars
Table 28: Top Ten Drugs by Retail Dollars
Table 29: Top Ten Pharmaceutical Firms by Retail Dollars
Table 30: Worldwide Anti-Diabetes Drug Market
Table 31: Oral Anti-Diabetic Therapy Major World Markets, 2003
Table 32: Worldwide Market Share of Anti-Diabetic Drugs by Type, 2003 and 2007
Table 33: The Leading Five Oral Anti-diabetics For 2004
Table 34: Oral Hypoglycemic Drugs Used to Treat Type 2 Diabetes
Table 35: Worldwide Sales of Avandia
Table 36: Worldwide Sales of Actos
Table 37: Worldwide Sales of Glucophage
Table 38: Worldwide Sales of Starlix
Table 39: World Diabetes Pharmaceutical Market
Table 40: Trends In Prescription Drug Use Among Patients with Type 2 Diabetes, 1997-2002
Table 41: Classes of Oral Hypoglycemic Agents
Table 42: Clinical Efficacy of Oral Hypoglycemic Agents
Table 43: Average Dose and Cost Comparison of Hypoglycemic Agents
Table 44: Average Dose and Cost Comparison of Hypoglycemic Agents
Table 45: Relative Efficacy of Oral Agents for Diabetes
Table 46: Thiazolidinediones Available for Type 2 Diabetes Mellitus
Table 47: Therapeutic Comparison of the Available Thiazolidinediones
Table 48: Oralin Sales Forecast Through 2008
Table 49: AERx Sales Forecast Through 2008
Table 50: HIM 2 Sales Forecast Through 2008
Table 51: Oral Anti-diabetic Agents and Their Approved Indications and Uses
Table 52: Brand and Generic Names for the Sulfonylureas Sold in the U.S.
Table 53: Preparations of Sulfonylurea Tablets
Table 54: Worldwide Insulin Sales
Table 55: Worldwide Insulin Sales and Market Share by World Region 2003
Table 56: Worldwide Insulin Sales and Market Share by Company, 2003
Table 57: U.S. Insulin Sales and Market Share by Company, 2003
Table 58: U.S. Insulin Sales, 2000-2009
Table 59: Worldwide Recombinant Human Insulin Sales and Market Share by Company, 2005
Table 60: Pharmacokinetics of Available Insulins
Table 61: Action Times for Each Insulin
Table 62: Key Drivers of the Type 2 Diabetes Insulin Market to 2012
Table 63: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes
Table 64: Agents for Lowering Lipid Levels in Patients with Dyslipidemia
Table 65: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes
Table 66: New Drugs in Human Clinical Trials by Disease Type
Table 67: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-1
Table 68: Cells of the Pancreas
Table 69: Selected Mid-2004 Press Releases on Emerging Anti-diabetes Agents
Table 70: Diabetes Agents in the Pipeline
Table 71: Control Averages by Treatment
Table 72: Reduced Risk for Various Diseases When Blood Glucose is Near Normal
Table 73: Worldwide Diabetes Market, through 2007 ($ Millions)
Table 74: Types of Insulin Pumps on the Market
Table 75: Laboratory Assessment of Diabetic Vascular Disease
Table 76: The Global Population of Persons with Diabetes
Table 77: The Glucose Market for OTC Testing in the U.S., 1996-2007
Table 78: The Glucose Market for OTC Testing Worldwide, 2000-2007
Table 79: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
Table 80: Lancet Characteristics
Table 81: Lancing Device Characteristics
Table 82: Worldwide Insulin Injector Pen Dollar Volume, 1998-2006
Table 83: Insulin Delivery Systems Percent Retail Market Share
Table 84: Insulin Delivery Systems Percent Retail Market Share by Company, 2003
Table 85: Summary of Inhaled Insulin Products
Table 86: Worldwide Diabetes Drugs in Pipeline, 2004
Table 87: Top Therapeutic Drug Categories Worldwide, 2004
Table 88: Top Therapeutic Categories in U.S. Development, 2003
Table 89: Pharmaceutical Companies Number of Products in Development
Table 90: Pharmaceutical Companies Number of Diabetes Products in Development
Table 91: Drugs in Preclinical Testing, 2004
Table 92: New Diabetes Drugs in Pipeline without Major Pharma Alliances