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Diabetes, Metabolic Syndrome and Cardiovascular Disease

Published by: Trimark Publications

Published: Apr. 1, 2009 - 265 Pages


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 a-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-Label”

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—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

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 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—Fasting 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

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.

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