Overview

Diabetes is one of the largest therapeutic segments of global pharmaceutical sales and during the last 10 years it has grown by a compound average growth rate of nearly 20% from around US$4 billion in 1995 to over US$17 billion in 2005. Overall, anti-diabetic drugs sales are expected to grow dramatically over the next five years to over US$22 billion in 2012 as the addressable patient population continues to increase and new, oral, injectable and pulmonary premium priced products enter the market to address high unmet clinical needs.

The Global Diabetes Market assesses the markets for diabetes therapeutics, as well as the markets for diagnostic products and those that treat diabetic complications. This new report from Arrowhead Publishers incorporates new clinical findings presented at the 2006 conference of the American Diabetes Association into our product outlooks and financial forecasts. This report also analyzes, clinically and financially, the leading products on the market, the major players, as well as the groundbreaking new products in clinical development.
Financial forecasts are also provided for individual products as well as for product classes.

Key Features of This Report:

• A thorough global market breakdown of key products and players in the non-insulin, insulin, diagnostic and diabetic neuropathy areas

• Individual chapters outlining the drivers of and resistors on this growing market

• Clinical evaluations of products and product classes in both the insulin and non-insulin markets

• Financial forecasts through 2012 for products and product classes in the areas of insulin, non-insulin, alternative therapies and diabetic complications

• Thorough analysis of products in clinical development, including coverage of safety, efficacy, market potential and filing timelines

• 96 tables/figures illustrating scientific and market aspects of the global diabetes market

About the Author
Dr. Cheryl Lee Barton graduated from Queens University in Belfast in 1993 with a doctorate from the department of Biochemistry and Biology. This three year project involved the characterization of novel proteins in parasites and hosts as potential targets for drug development.

Dr. Barton served a sabbatical at Merck Sharp and Dohme’s Neuroscience Centre to develop assays for protein identification. In 1999, Dr Barton was head hunted away from the industry into the Dutch Investment Bank ABN Armro N.V to join their team of Pharmaceutical researchers as a senior equity analyst in London. Whilst there, Cheryl became the lead analyst on AstraZeneca, Roche and Sanofi-Synthelabo and was responsible for writing thematic research notes, evaluating new drugs in development and assessing their potential impact on Pan European stocks.

In 2002 Dr Barton established the consultancy Pharmavision.co.uk to provide independent, tailor made, pharmaceutical thematic research to Investment Houses, Competitive Intelligence Specialists and Pharmaceutical Companies. The research reports combine independent analysis with patient based models to forecast the potential sales growth of key drugs in clinical development.

Table of Contents

1 Summary

2 The Diabetes Market
2.1 Current Market Size
2.1.1 The Insulin Market
2.1.2 The Non-Insulin Market
2.1.3 Sales of Diabetes Products Could Double by 2012
2.1.4 The Diabetic Neuropathy Market
2.1.5 The Glucose Monitoring Market
2.2 Key Players in the Diabetes Market � Winners & Losers
2.2.1 Key Players in the Insulin Market
2.2.2 The Key Players in the Non-Insulin Market
2.2.3 The Key Players in the Treatment of Diabetic Neuropathy
2.2.4 The Key Players in the Glucose Monitoring Market
2.2.5 Major players in the Diabetes Market in 2012

3 The Facts about Diabetes
3.1 What is Diabetes?
3.1.1 Type 1 Diabetes
3.1.2 Type 2 Diabetes
3.2 How is it Diagnosed?
3.3 What are the Current Treatment Goals?
3.4 The Financial Burden of Diabetes

4 Patient Statistics
4.1 Type 1 Diabetes Statistics
4.2 Type 2 Diabetes Statistics
4.3 Type 2 Pre-Diabetes
4.4 Diabetes Complications

5 Market Drivers
5.1 Patient Dynamics
5.2 Improvements in Diagnosis
5.3 Improvements in Glucose Monitoring
5.4 Changes in Guidelines
5.5 Launch of New Treatments & Combinations
5.6 Increased Use of Pen Devices
5.7 Off-Label Use

6 Market Resistors
6.1 More Economic Use of Insulin
6.2 Patent Expiration
6.3 Drug Safety Issues
6.4 Health Insurance/Reimbursement

7 Non-Insulin Agents: Attributes, Efficacy & Financial Forecasts
7.1 Oral Anti-Diabetic Agents (OADs)
7.1.1 Insulin Secretion Promoting Agents
7.1.1.1 Sulfonylureas (SUs) are Cost Effective in Early Type 2 Diabetes
7.1.1.1.1 Advantages and Disadvantages of Sus
7.1.1.1.2 Sales Forecast of Leading SUs 2005A-2012E
7.1.1.2 Meglitinides (MGs) Have Limited Uptake in the Market
7.1.1.2.1 Advantages and Disadvantages of MGs
7.1.1.2.2 Sales forecast of leading MGs 2005A-2010E
7.1.2 Insulin Sensitizing Agents
7.1.2.1 Biguanides (BGs) are First-Line Therapy for Obese Diabetics
7.1.2.1.1 Advantages and Disadvantages of BGs
7.1.2.1.2 Sales Forecasts of Leading BGs 2005A-2012E
7.1.2.2 Thiazolidinediones (TZDs) Extensively Used in the Second-Line Setting
7.1.2.2.1 Advantages and Disadvantages of TZDs
7.1.3 Combination Therapy
7.1.3.1 Advantages of Combination Therapies
7.1.3.2 Sales Forecast of Leading TZD Therapies 2005A-2012E
7.1.4 Glucose Absorption Inhibitors
7.1.4.1 Alpha-GIs are First Line Treatment in Japan
7.1.4.1.1 Advantages and Disadvantages of Alpha Gis
7.1.4.1.2 Sales Forecasts of Leading Alpha GIs 2005A-2012E
7.2 Insulin Secretion Promoting Agents
7.2.1 Byetta is the First in Class
7.2.1.1 Advantages and Disadvantages of Byetta
7.2.1.2 Sales Forecasts of Approved Insulin Secretion Promoting Agents 2005A-2012E
7.3 Amylinomimetic Agents
7.3.1 Symlin is the First Approved Amylinomimetic
7.3.1.1 Advantages and Disadvantages of Symlin
7.3.1.2 Sales Forecasts of Approved Amylinomimetic Agents 2005A-2012E
7.4 Prescription Trends in the Non-Insulin Market
7.5 Sales Forecast for Approved Non-Insulin Agents 2005A-2012E

8 Insulin Agents
8.1 Injectable Insulin
8.1.1 Short Acting Insulin versus Rapid Acting Analogues
8.1.1.1 Advantages and Disadvantages of Rapid Acting Insulin
8.1.2 Rapid-Acting Analogues
8.1.2.1 Humalog (Eli Lilly)
8.1.2.2 Novolog (Novo Nordisk)
8.1.2.3 Apidra (Sanofi Aventis)
8.1.3 Sales Forecast of Leading Short and Rapid Acting Insulin 2005A-2012E
8.1.4 Intermediate Acting Insulin vs Long Acting Analogues
8.1.4.1 Advantages and Disadvantages of Intermediate-Acting Insulin
8.1.4.2 Humulin (Eli Lilly)
8.1.4.3 Novolin (Novo Nordisk)
8.1.4.4 Insuman (Sanofi-Aventis)
8.1.4.5 Sales Forecast of Intermediate Insulin 2005A-2012E
8.1.5 Pre-Mixes
8.1.5.1 Sales Forecast of Insulin Mixes 2005A-2012E
8.1.6 Long Acting Insulin Analogues
8.1.6.1 Lantus (Sanofi Aventis)
8.1.6.2 Levemir (Novo Nordisk)
8.1.6.3 Sales Forecast of Leading Long-Acting Analogues 2005A-2012E
8.2 Pulmonary Insulin
8.2.1 Exubera (Pfizer/Nektar)
8.2.1.1 Exubera�s Unique Pharmacokinetic Profile
8.2.1.2 Advantages and Disadvantages of Exubera
8.2.1.3 Exubera due for launch July 2006
8.2.2 Sales Forecast of Pulmonary Insulin 2005A-2012E
8.3 Prescription Trends In The Insulin Market
8.4 Sales Forecast for Approved Insulin Agents 2005A-2012E

9 Future Treatments: Non-Insulin
9.1 More Efficacious Medicine
9.2 Safer Anti-Diabetic Agents
9.3 Insulin-Secretion Promoting Agents
9.3.1 Advantages and Disadvantages of Insulin Secretion Promoting Agents
9.3.2 New GLP-1 Analogues
9.3.2.1 Liraglutide (Novo Nordisk)
9.3.2.1.1 Efficacy
9.3.2.1.2 Safety
9.3.2.1.3 Development and Filing
9.3.2.1.4 Forecasts
9.3.2.2 AVE-OO10 (Sanofi Aventis)
9.3.2.2.1 Efficacy
9.3.2.2.2 Safety
9.3.2.2.3 Development and Filing
9.3.2.2.4 Forecasts
9.3.2.3 Byetta LAR (Eli Lilly)
9.3.2.3.1 Efficacy
9.3.2.3.2 Safety
9.3.2.3.3 Development and Filing
9.3.2.3.4 Forecasts
9.3.3 Other GLP-1 Analogues in Early Stage Clinical Development
9.3.3.1 BIM 51077
9.3.3.2 CS-872
9.3.3.3 CJC-113
9.3.3.4 GSK716155
9.3.4 New DPP IV inhibitors
9.3.4.1 Galvus (Novartis)
9.3.4.1.1 Efficacy
9.3.4.1.2 Safety
9.3.4.1.3 Development and Filing
9.3.4.1.4 Forecasts
9.3.4.2 Januvia (Merck & Co.)
9.3.4.2.1 Efficacy
9.3.4.2.2 Safety
9.3.4.2.3 Development and Filing
9.3.4.2.4 Forecasts
9.3.4.3 Saxagliptin (Bristol-Myers Squibb)
9.3.4.3.1 Efficacy
9.3.4.3.2 Safety
9.3.4.3.3 Development and Filing
9.3.4.3.4 Forecasts
9.3.5 Other DPP IV Inhibitors in Clinical Development
9.3.5.1 SYR322 (Takeda)
9.3.5.2 Denaglipitin (GSK)
9.3.5.3 PSN9301 (Prosidion)
9.3.5.4 Sales Forecasts of New Insulin-Secretion Promoting Agents 2005A-2010E
9.3.6 New Insulin Sensitizing Agents
9.3.6.1 Advantages and Disadvantages of Dual Acting PPAR Agonists and PPAR Pan Agonists
9.3.7 New Dual Acting PPAR Agonists
9.3.7.1 Pargluva (Bristol-Myers Squibb)
9.3.7.1.1 Efficacy
9.3.7.1.2 Safety
9.3.7.1.3 Development and Filing
9.3.7.1.4 Forecasts
9.3.7.2 Naveglitazar (Eli Lilly/Ligand)
9.3.7.2.1 Efficacy
9.3.7.2.2 Safety
9.3.7.2.3 Development and Filing
9.3.7.2.4 Forecasts
9.3.8 Other dual acting PPAR agonists
9.3.8.1 AVE-0847 (Sanofi Aventis)
9.3.8.2 TAK-654 (Takeda)
9.3.8.3 ONO-5129 (ONO Pharma)
9.3.9 New PPAR Pan Agonists
9.3.9.1 GW677954 (GSK)
9.3.9.2 PLX204 (Plexxikon)
9.3.10 New PPAR Gamma Agonists
9.3.10.1 Rivoglitazone (Daiichi-Sankyo)
9.3.10.2 Balaglitazone (Dr Reddy)
9.3.10.3 CLX-0921 (Calyx Pharmaceuticals)
9.3.10.4 Metaglidasen (Metabolex)
9.3.10.5 AMG 131 (Amgen)
9.3.11 New PPAR agonist combinations
9.3.12 Sales Forecasts of New Insulin Sensitizing Agents 2005A-2012E

10 Future Treatments: Insulin
10.1 Pulmonary Insulin
10.1.1 AERx iDMS (Novo Nordisk/Paradigm)
10.1.1.1 Efficacy
10.1.1.2 Safety
10.1.1.3 Development and Filings
10.1.1.4 Forecasts
10.1.2 TechnoSphere Inhaled Insulin (MannKind Corporation)
10.1.2.1 Efficacy
10.1.2.2 Safety
10.1.2.3 Development and filings
10.1.2.4 Forecasts
10.1.3 AIR inhaled Insulin (Eli Lilly/Alkermes)
10.1.3.1 Efficacy
10.1.3.2 Safety
10.1.3.3 Development and Filings
10.1.3.4 Forecasts
10.1.4 Other Pulmonary Insulin in Clinical Development
10.1.4.1 Kos Pharmaceuticals
10.1.4.2 QDose Pharmaceuticals
10.1.4.3 Coremed Inc
10.2 Oral Insulin
10.2.1 Oral-Lyn/Oralgen/Oralin (Generex)
10.2.2 Oral Insulin (Hubei Huagong Biochemical Engineering)
10.3 Transoral Patch Insulin
10.3.1 ALT 1391 (Altea Therapeutics)
10.3.2 Transoral Insulin Patch (Noven Pharmaceuticals)
10.4 Sales Forecasts of New Insulin Formulations

11 Alternative Approaches to the Treatment of Diabetes
11.1 The Sodium-Dependent Glucose Transporter Inhibitors (SGLT inhibitors)
11.1.1 The SGLT 1 inhibitors
11.1.2 The SGLT 2 inhibitors
11.2 Protein Tyrosine Phosphatase Inhibitors (PTP ase)
11.3 The Glycogenolysis/Gluconeogenesis Modulators
11.3.1 Glycogen phosphorylase inhibitors
11.3.2 Fructose-biphosphatase inhibitors
11.3.3 Glucagon receptor antagonists
11.3.4 Glucokinase activators
11.4 Sales Forecasts of Alterative Diabetes Therapies

12 Treatments for Diabetes Complications
12.1 Diabetic Retinopathy
12.2 Diabetic Nephropathy
12.3 Diabetic Neuropathy
12.4 Current Treatments for Diabetic Complications
12.4.1 Antihypertensive use in Diabetic Nephropathy
12.4.2 Anticonvulsant use in Diabetic Neuropathy
12.4.3 Antidepressant use in Diabetic Neuropathy
12.5 New Treatments for Diabetic Complications
12.5.1 Arxxant (Eli Lilly)
12.5.1.1 Efficacy
12.5.1.2 Safety
12.5.1.3 Development & Filing
12.5.1.4 Forecasts
12.5.2 Avosentan (Speedel)
12.5.2.1 Efficacy
12.5.2.2 Safety
12.5.2.3 Development and Filing
12.5.2.4 Forecasts
12.5.3 Candesartan (Takeda/AstraZeneca)
12.5.4 Fidarestat (Sankyo/Sanwa Kagaku Kenkyusho)
12.5.5 Neurodex (Avanir)
12.5.5.1 Efficacy
12.5.5.2 Safety
12.5.5.3 Development and filing
12.5.6 Perzinfotel (Wyeth)
12.5.7 Ranirestat (Dainippon Sumitomo/Eisai)
12.5.8 Rasilez (Novartis/Speedel)
12.5.8.1 Efficacy
12.5.8.2 Safety
12.5.8.3 Development & Filing
12.5.8.4 Forecasts
12.5.9 Sulonex (Keryx)
12.5.9.1 Efficacy
12.5.9.2 Safety
12.5.9.3 Development & Filing
12.5.9.4 Sales forecasts and Assumptions
12.5.10 Sativex (GW Pharma)
12.5.11 TAK 428 (Takeda)
12.5.12 V3381 (Vernalis)
12.6 Drugs in Early Phase Clinical Development For Diabetic Complications
12.6.1 ABT-894 (Abbott)
12.6.2 AV-101 (VistaGen)
12.6.3 CNS 5161 (CeNeS)
12.6.4 SB-509 (Sangamo BioSciences)
12.7 Sales forecasts of Key Drugs to Treat Diabetic Complications

13 The Diabetes Diagnostic Market
13.1 The Glucose Monitoring Market
13.1.1 Self-Monitoring of Blood Glucose
13.1.2 Glucose Meters
13.1.3 Non-Invasive Testing
13.1.4 Continuous Blood Glucose Monitoring
13.2 The Insulin Delivery Market

14 Company Profiles
Abbott Laboratories
Amylin Pharmaceuticals Inc
Bristol-Myers Squibb
Bayer Group
Eli Lilly and Company
F. Hoffman-La Roche Ltd
GlaxoSmithKline plc
Keryx Biopharmaceuticals
LifeScan Inc
Medtronic Inc.
Merck & Co.Inc
Novartis Pharmaceuticals
Novo Nordisk A/S
Pfizer
Sanofi-Aventis
Takeda Pharmaceutical Company Ltd

Glossary of Terms

Figures
Figure 2.1 Diabetes Market US$15bn � Regional Sales Split (2005)
Figure 2.2 Diabetes Market US$15bn � Drugs Sales Split (2005)
Figure 2.3 Insulin Market US$7.2 billion � Drug Class Sales Split (2005)
Figure 2.4 Insulin Market US$7.2 billion�Regional Sales Split (2005)
Figure 2.5 Non-Insulin Market US$7.5 billion - Drug Class Split (2005)
Figure 2.6 Non-Insulin Market US$7.5 billion � Regional Sales Split (2005)
Figure 2.7 Diabetic Neuropathy Market US$1.0 billion � Drugs Sales Split (2005)
Figure 2.8 Glucose Monitoring Market US$ 6.1bn - Regional Sales Split (2005)
Figure 2.9 Key Players in the Diabetes Market (2005)
Figure 2.10 Key Players in the Insulin Market by Revenue (2005)
Figure 2.11 Key Players in the Non-Insulin Market by Revenues (2005)
Figure 2.12 Key Players in the Diabetic Neuropathy Market (2005)
Figure 2.13 Key Players in the Glucose Monitoring Market US$6bn (2005)
Figure 3.1 Glycosylated hemoglobin levels versus blood glucose
Figure 7.1 Schematic of Glycaemic Control in Non-Diabetics and Diabetics
Figure 7.2 Treatment Algorithm for Type2 Diabetics
Figure 7.3 Treatment Mechanisms for Type 2 Diabetes Drugs
Figure 7.4 Secondary Endpoint for PROactive Study
Figure 7.5 The Effect of Oral Combination Therapies on Hb1Ac Levels
Figure 7.6 Schematic Depicting GLP-1 Mechanism of Action
Figure 7.7 Schematic Depicting Amylin�s Mechanism of Action
Figure 8.1 Profile of Short-Acting and Rapid Acting Insulin
Figure 8.2 Profile of Intermediate-Acting Insulin Given Once and Twice Daily
Figure 8.3 Profile of Pre-Mixed Insulin
Figure 8.4 Profile of Long-Acting Insulin
Figure 8.5 The Effect of Pulmonary Insulin Versus SC Insulin on Hb1AC levels
Figure 9.1 Liraglutide Molecular Structure
Figure 9.2 Denagliptin (�093) Phase 2a Data
Figure 13.1 Schematic of Medtronic�s MiniMed Paradigm REAL-Time System

Tables
Table 2.1 Global Sales Forecasts of Anti Diabetic Products 2005A-2012E
Table 2.2 Major Players Within the Diabetes Market (2005)
Table 2.3 Historical Sales of Leading Insulin Brands* (2001-2005)
Table 2.4 Historical Sales of Leading Non-Insulin Brands* (2001-2005)
Table 2.5 Major Players within the Diabetes Market (2012E)
Table 3.1 Criteria for the Diagnosis of Diabetes
Table 3.2 Criteria for the Diagnosis of Pre-Diabetes
Table 4.1 Estimated Number of People with Diabetes Globally (2005A & 2030E)
Table 7.1 Treatment Options for Diabetics
Table 7.2 Classes of OADs
Table 7.3 Approved SUs
Table 7.4 Advantages and Disadvantages of SUs
Table 7.5 Sales Forecasts of Leading SUs 2005A � 2012E
Table 7.6 Approved MGs
Table 7.7 Advantages and Disadvantages of MGs
Table 7.8 Sales Forecasts of Leading MGs 2005A � 2012E
Table 7.9 Approved BGs
Table 7.10 Advantages and Disadvantages of BGs
Table 7.11 Sales Forecasts of Leading BGs 2005A � 2012E
Table 7.12 Approved TZDs
Table 7.13 Advantages and Disadvantages of TZDs
Table 7.14 Approved Combination Therapies
Table 7.15 Advantages of Combination Therapies
Table 7.16 Sales Forecasts of Leading TZDs Therapies 2005A � 2012E
Table 7.17 Approved Alpha-glucosidase inhibitors (Alpha Gis)
Table 7.18 Advantages and Disadvantages of Alpha GIs
Table 7.19 Sales Forecasts of Leading Alpha Gis 2005A-2012E
Table 7.20 Advantages and Disadvantages of Byetta
Table 7.21 Sales Forecasts of Approved Insulin Secretion Promoting Agents 2005A � 2012E
Table 7.22 Advantages and Disadvantages of Symlin
Table 7.23 Sales Forecasts of Approved Amylinomimetics 2005A � 2012E
Table 7.24 Sales Forecasts of Approved Non-Insulin Drugs 2005A � 2012E
Table 8.1 Types of Injectable Insulin
Table 8.2 Pharmokinetic Profile of Types of Injectable Insulin
Table 8.3 Injectable Short Acting Insulin & Rapid Acting Insulin Analogues
Table 8.4 Advantages and Disadvantages of Rapid Acting Insulin Analogues
Table 8.5 Sales Forecasts of Rapid Acting Analogues and Short Acting Insulin (2005A � 2012E)
Table 8.6 Intermediate and Long Acting Insulin
Table 8.7 Advantages and Disadvantages of Intermediate-Acting Insulin
Table 8.8 Sales Forecasts of Intermediate Human Insulin 2005A � 2012E
Table 8.9 Approved Pre-Mixes
Table 8.10 Sales Forecasts of Pre-Mixed Insulin 2005A � 2012E
Table 8.11 Advantages and Disadvantages of Long-Acting Insulin
Table 8.12 Sales Forecasts of Long-Acting Insulin�s 2005A � 2012E
Table 8.13 Pharmokinetic Profile of Pulmonary Insulin
Table 8.14 Advantages and Disadvantages of Pulmonary Insulin
Table 8.15 Sales Forecasts of Pulmonary Insulin 2005A � 2012E
Table 8.16 Sales Forecasts of Approved Insulin Drugs 2005A � 2012E
Table 9.1 Anti-Diabetes Agents in Late-Stage Clinical Development
Table 9.2 Risks Raised by HbA1c 1% Change
Table 9.3 Insulin Secretion Promoting Drugs in Clinical Development
Table 9.4 Advantages and Disadvantages of GLP-1Analogues and DPP IV Inhibitors
Table 9.5 Sales Forecasts of New Insulin Secretion Promoting Agents 2006E � 2010E
Table 9.6 New Insulin Sensitizing Drugs in Clinical Development
Table 9.7 PPAR Isoforms
Table 9.8 Advantages and Disadvantages of Dual Acting PPAR Agonists and PPAR Pan Agonists
Table 9.9 Sales Forecasts of New Insulin Sensitizing Agents 2006E � 2012E
Table 10.1 New Formulations of Insulin in Clinical Development
Table 10.2 Sales Forecasts of New Insulin Formulations 2006E - 2012E
Table 11.1 SGLT Isoforms
Table 12.1 Current Approved Treatments for Diabetic Complications
Table 12.2 New Treatments in Development for Diabetic Complications
Table 12.3 Sales Forecasts for New Treatments for Diabetic Complications (2006E-2012E)
Table 13.1 Glucose Monitoring Device Manufacturers and Products
Table 13.2 Key Features of Some Leading Glucose Meters
Table 13.4 Insulin Pump Suppliers
Table 13.3 Developmental Continuous Monitoring Devices

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