Diabetes, a disorder in which the body does not produce or properly use the hormone insulin (which is needed to convert sugar, starches, and other food into energy), affects 16 million Americans, 5 million of whom are unaware that they have the disorder.  Diabetes is the sixth-leading cause of death by disease in the U.S.  Important growth markets in diabetes include:  glucose monitoring, insulin delivery, and bioartificial pancreas technology, which would essentially enable diabetics to live a normal life.  Device companies, anxious to cash in on this very lucrative and growing market opportunity, have recently developed and introduced many new technologies into the diabetes market—and more are on the way.

This report details the current markets for diabetes management technology, including:  pharmacological treatments, glucose monitoring systems, and insulin delivery systems, as well as therapies that are soon to come, including alternative drug delivery technology, advanced glucose monitoring devices, gene therapy, cell replacement therapy, and bioartificial implantable pancreas technology.  Market analysis is provided by device 
market segment, along with a procedure volume forecast, an analysis of the suppliers and products, and share by supplier.  The markets for these products are forecast from 2000 to 2010 and key players in this exciting market are profiled.

TABLE OF CONTENTS

SECTION 1: EXECUTIVE SUMMARY

1.1 Pharmaceuticals Market Segment

1.2 Diabetes Self-Testing Market Segment

1.3 Insulin Delivery Market Segment

1.4 Emerging Diabetes Management Technologies

1.4.1 Pharmacologic Therapy

1.4.2 Noninvasive Glucose Monitoring Devices

1.4.3 Cell Replacement Therapy

SECTION 2: CLINICAL AND STATISTICAL OVERVIEW OF DIABETES

2.1 Introduction to Diabetes

2.1.1 Type 1 Diabetes

2.1.2 Type 2 Diabetes

2.1.3 Gestational Diabetes

2.1.4 Impaired Glucose Tolerance/ Secondary Forms of Diabetes

2.2 Epidemiology/Diabetes Prevalence

2.2.1 Trends in Diabetes Prevalence in the United States

2.2.2 Sharp Increase in Reported Cases of Type 2 Diabetes in Children

2.3 Signs and Symptoms of Diabetes

2.4 Diagnosing Diabetes

2.4.1 Diagnostic Methods in Research

2.5 Diabetes Complications

2.5.1 Hyperglycemia

2.5.2 Hypoglycemia

2.5.3 Ketoacidosis

2.6 Diabetes-Related Long-Term Complications

2.6.1 Microvascular Complications

2.6.1.1 Diabetic Retinopathy

2.6.1.2 Diabetic Neuropathy

2.6.1.2.1 Lower Limb Amputations

2.6.1.3 Nephropathy

2.6.2 Macrovascular Complications

2.6.2.1 Cardiovascular Disease

2.6.3 Other Complications

2.6.3.1 Influenza and Pneumonia

2.6.3.2 Pregnancy Complications

2.6.3.3 Skin Conditions

2.6.3.4 Bacterial Infections         

2.6.3.5 Foot Ulcers

2.6.3.6 Fungal Infections  

2.6.3.7 Impotence

2.7 Diabetes Management and Treatment Standards

2.7.1 Overall Goals of Treatment

2.7.2 Clinical Practice Recommendations for Managing Diabetes

2.7.3 Screening Recommendations

2.7.4 Key Treatment Strategies

2.7.4.1 The National Standards for Diabetes Self-Management Education Programs

2.7.4.2 New Multidisciplinary Credential: The Advanced Diabetes Manager

SECTION 3: CURRENT DIABETES TREATMENT TECHNOLOGIES

3.1 Overview

3.2 Pharmacological Treatments

3.2.1 Insulin

3.2.1.1 Rapid-Acting Insulin Analogues

3.2.1.2 Intermediate- and Long-Acting Insulin Analogues

3.2.2 Oral Diabetes Therapies

3.2.2.1 Sulfonylureas

3.2.2.2 Meglitinides

3.2.2.3 Biguanides

3.2.2.4 Thiazolidinediones

3.2.2.5 Alpha-Glucosidase Inhibitor

3.2.2.6 Combination Therapy

3.2.3 New Diabetes Pharmaceuticals

3.2.3.1 Lantus

3.2.3.2 NovaLog

3.2.3.3 Actos and Avandia

3.2.3.4 Glucophage XR

3.2.3.5 Glucovance

3.2.3.6 Starlix

3.3 Diabetes Self-Testing Technology and Insulin Delivery Devices

3.3.1 Glucose Monitoring Systems

3.3.1.1 Self-Testing of Blood Glucose Vital to Treatment Plan

3.3.1.2 Noninvasive Monitors      

3.3.1.3 Selected New, Technologically Advanced Glucose Monitors

3.3.1.4 Lancets and Lancing Devices

3.3.2 Insulin Delivery Devices

3.3.2.1 Syringes

3.3.2.2 Insulin Pens

3.3.2.3 Insulin Jet Injectors

3.3.2.4 External Insulin Pumps

3.3.2.4.1 New Pumps on the Market

SECTION 4: THE U.S. MARKET FOR DIABETES MANAGEMENT

4.1 Overview

4.2 Diabetes Management and Treatment Market

4.2.1 U.S. Insulin Products Market

4.2.1.1 Leading Competitors and Market Share  

4.2.2 U.S. Oral Diabetes Therapeutics Market

4.2.2.1 Leading Competitors and Market Share

4.2.2.1.1 Market Share Lost to Generics 

4.2.3 Future Growth Areas in Pharmacological Treatments

4.3 Diabetes Device Market

4.3.1 Diabetes Self-Testing Market

4.3.1.1 Leading Glucose Monitoring Competitors and Market Share

4.3.1.2 Noninvasive Glucose Monitoring Devices on the Market

4.3.1.3 Continuous Glucose Monitoring: A Future Growth Area

4.3.2 Insulin Delivery Device Market

4.3.2.1 Leading External Insulin Pump Competitors and Market Share

4.3.2.2 Implanted Insulin Pumps: A Future Growth Area

4.3.2.3 Leading Syringe Competitors and Market Share

4.3.2.4 Leading Injector Pen Competitors and Market Share

4.3.2.5 Leading Jet Injector Competitors and Market Share

SECTION 5: EMERGING DIABETES MANAGEMENT TECHNOLOGIES

5.1 Overview

5.1.1 Pharmacologic Therapy    

5.1.2 Future Blood Glucose Monitors

5.1.3 Islet Transplantation and Artificial Pancreas       

5.2 Drug Delivery Technology Drives Development of New Treatments

5.2.1 Oral Insulin

5.2.2 Inhaled/Pulmonary Insulin

5.2.3 Transdermal Delivery of Insulin

5.2.4 Pharmaceuticals in Research and Development

5.3 Noninvasive Glucose Monitoring Devices Under Development

5.3.1 Near-Infrared Light Spectroscopy

5.3.2 Far-Infrared Radiation Spectroscopy

5.3.3 Radio Wave Impedance Technology

5.3.4 Optical Rotation of Polarized Light Technology

5.3.5 Fluid Extraction From Skin/Reverse Iontophoresis

5.3.6 Interstitial Fluid Harvesting Technology

5.4 Cell Replacement Therapy

5.4.1 Islet Transplantation Research Progress to Date

5.5 Bioartificial Implantable Pancreas        

SECTION 6: COMPANY PROFILES

6.1 ABBOTT LABORATORIES

6.2 AEROGEN, INC.

6.3 ALKERMES, INC.

6.4 ANIMAS CORPORATION

6.5 ANTARES PHARMA, INC.

6.6 ARADIGM CORPORATION

6.7 AVENTIS, S.A.   

6.8 BAYER CORPORATION

6.9 BECTON, DICKINSON & COMPANY

6.10 BIOJECT MEDICAL TECHNOLOGIES, INC.

6.11 BRISTOL-MYERS SQUIBB COMPANY

6.12 CYGNUS, INC.

6.13 DISETRONIC MEDICAL SYSTEMS, INC.

6.14 DOR BIOPHARMA, INC.

6.15 EMISPHERE TECHNOLOGIES, INC.

6.16 EQUIDYNE SYSTEMS, INC.

6.17 GENEREX BIOTECHNOLOGY CORPORATION    

6.18 GLAXOSMITHKLINE PLC

6.19 HELIX BIOPHARMA CORPORATION

6.20 INHALE THERAPEUTIC SYSTEMS, INC.

6.21 INSMED INCORPORATED

6.22 LIFESCAN, INC.

6.23 ELI LILLY AND COMPANY        

6.24 MEDTRONIC MINIMED

6.25 NOVO NORDISK PHARMACEUTICALS, INC.     

6.26 PFIZER, INC.    

6.27 ROCHE DIAGNOSTICS CORPORATION

6.28 THERASENSE, INC.

APPENDIX A: COMPANY LISTING  

LIST OF EXHIBITS

Exhibit 1-1:    Diabetes Reaching Epidemic Proportions in the U.S.

Exhibit 1-2:    Risk Factors for Type 2 Diabetes    

Exhibit 1-3:    U.S. Diabetes Management and Treatment Products Market, 2000-2010E 

Exhibit 1-4:    U.S. Insulin Products Market, 2000-2010   

Exhibit 1-5:    U.S. Oral Diabetes Therapies Market, 2000-2010E

Exhibit 1-6:    Selected Glucose Monitors Currently on the U.S. Market, 2002

Exhibit 1-7:    U.S. Diabetes Self-Testing Market, 2000-2010E   

Exhibit 1-8:    U.S. Insulin Delivery Device Market, 2000-2010E  

Exhibit 1-9:    Selected Insulin Pumps Currently on the U.S. Market, 2002

Exhibit 1-10:  A Selection of Pharmaceutical Products in Research and Development for the Treatment of Diabetes, 2002

Exhibit 1-11:  Selected Noninvasive Glucose Monitors or Technology in Development, 2002  

Exhibit 1-12:  Selected Competitors Developing Bioartificial Pancreas Technologies, 2002

Exhibit 2-1:    Diabetes Characteristics

Exhibit 2-2:    Risk Factors for Type 2 Diabetes    

Exhibit 2-3:    A Classification of Impaired Glucose Tolerance or Secondary Forms of Diabetes       

Exhibit 2-4:    Diabetes Reaching Epidemic Proportions in the U.S.        

Exhibit 2-5:    U.S. Diabetes Prevalence, by Gender, 1990-1998 

Exhibit 2-6:    Obesity in the U.S., by Selected Characteristics, 1991-2000

Exhibit 2-7:    Characteristics of Participants in the Behavioral Risk Factor Surveillance System, 1990 and 1998

Exhibit 2-8:    Changes in U.S. Diabetes Prevalence from 1990 to 1998, by Selected Characteristics

Exhibit 2-9:    Changes in U.S. Diabetes Prevalence from 1998 to 1999, by Selected Characteristics        

Exhibit 2-10:  Prevalence of Overweight Children and Adolescents in the U.S. Age 6-19 Years       

Exhibit 2-11:  Estimates of the Magnitude of Type 2 Diabetes in North American Children        

Exhibit 2-12:  Signs and Symptoms of Diabetes    

Exhibit 2-13:  Symptoms and Possible Causes of Hyperglycemia  

Exhibit 2-14:  Symptoms and Possible Causes of Hypoglycemia  

Exhibit 2-15:  U.S. Diabetic Retinopathy Procedures, 2000        

Exhibit 2-16:  Definitions of Abnormalities in Albumin Excretion

Exhibit 2-17:  Adjuvant Treatments to Treat or Prevent Diabetic Vascular Complications

Exhibit 2-18:  Effect of Improved Glycemic Control on Reducing Diabetic Complications

Exhibit 2-19:  Glycemic Control for People with Diabetes  

Exhibit 2-20:  Suggested Management of Major Conditions Associated with Cardiovascular Disease in Patients with diabetes  

Exhibit 2-21   Proven Benefits of Treatment Aimed at Lowering Blood Glucose to or Near Normal Levels

Exhibit 3-1:    Insulin Products Currently on the U.S. Market, 2002       

Exhibit 3-2:    Clinical Efficacy of Oral Hypoglycemic Agents       

Exhibit 3-3:    Oral Diabetes Therapies Currently on the U.S. Market, 2002

Exhibit 3-4:    Major New Diabetes Pharmaceuticals Launched in the U.S., Including Oral Therapies, 1999-2002

Exhibit 3-5:    Selected Glucose Monitors Currently on the U.S. Market, 2002

Exhibit 3-6:    Selected Lancets and Lancet Devices Currently on the U.S. Market, 2002

Exhibit 3-7:    Selected Insulin Syringes and Needles Currently on the U.S. Market, 2002  

Exhibit 3-8:    Selected Insulin Injector Pens Currently on the U.S. Market, 2002

Exhibit 3-9:    Selected Insulin Jet Injectors Currently on the U.S. Market, 2002

Exhibit 3-10:  Selected Insulin Pumps Currently on the U.S. Market, 2002

Exhibit 4-1:    U.S. Diabetes Management and Treatment Products Market, 2000-2010E 

Exhibit 4-2:    U.S. Diabetes Management and Treatment Products Market, Share by Segment, 2000        

Exhibit 4-3:    U.S. Insulin Products Market, 2000-2010E 

Exhibit 4-4:    U.S. Insulin Products Market, Share by Supplier, 2000 and 2001E

Exhibit 4-5:    U.S. Oral Diabetes Therapies Market, 2000-2010E

Exhibit 4-6:    U.S. Oral Diabetes Therapies Market, Share by Supplier, 2000 and 2001E 

Exhibit 4-7:    U.S. Oral Diabetes Therapies Market, Share by Supplier, 2000 and 2001E 

Exhibit 4-8:    U.S. Diabetes Self-Testing Market, 2000-2010E   

Exhibit 4-9:    U.S. Diabetes Self-Testing Market, Share by Product, 2000 and 2001E  

Exhibit 4-10:  U.S. Glucose Monitoring Market, 2000-2010E

Exhibit 4-11:  U.S. Glucose Monitoring Market, Share by Supplier, 2000 and 2001E     

Exhibit 4-12:  U.S. Insulin Delivery Device Market, 2000-2010E  

Exhibit 4-13:  U.S. Insulin Delivery Device Market, Share by Product, 2000 and 2001E 

Exhibit 4-14:  U.S. Insulin Pump Market, 2000-2010E      

Exhibit 4-15:  U.S. External Insulin Pump Market, Share by Supplier, 2000 and 2001E  

Exhibit 4-16:  U.S. Insulin Syringe Market, Share by Supplier, 2000 and 2001E

Exhibit 4-17:  U.S. Insulin Injector Pen Market, Share by Supplier, 2000 and 2001E     

Exhibit 4-18:  U.S. Insulin Jet Injector Market, Share by Supplier, 2000 and 2001E     

Exhibit 5-1:    A Selection of Pharmaceutical Products in Research and Development for the Treatment of Diabetes, 2002

Exhibit 5-2:    Selected Noninvasive Glucose Monitors or Technology in Development, 2002

Exhibit 5-3:    Selected Competitors Developing Bioartificial Pancreas Technologies, 2002