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The Global Diabetes Market: Therapeutics, Diagnostics and Complications

Published by: Arrowhead Publishers

Published: Aug. 1, 2006 - 218 Pages


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

Abstract

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
Who Should Buy This Report:
  • Companies interested in understanding the wider opportunities and challenges in the markets for diabetes therapeutics, diagnostics and products for diabetic complications
  • Pharma/biotech companies wishing to identify opportunities and threats to products in these markets in order to examine a variety of profit maximization strategies
  • Companies interested in understanding the state of R&D in relation to insulin, non-insulin, diagnostics and diabetic complication products


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