世界の糖尿病動向：治療、診断および合併症

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.

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