Market Report Source

Overview

Diabetes mellitus is a chronic metabolic disorder that is caused by a failure of the body to produce insulin and/or an inability of the body to respond adequately to circulating insulin; type 1 diabetes occurs most often in children or young adults and accounts for 5-10% of the diagnosed diabetes patient population. Type 2 diabetes, or adult-onset diabetes, accounts for 90–95% of diagnosed diabetes cases worldwide, typically developing in middle-aged adults. There are several risk factors associated with type 2 diabetes including age, obesity, high blood pressure, genetics, level of exercise, and a history of cardiac disease. Type 2 diabetes is more prevalent than type 1 and is growing at a faster rate across the 7 major markets, with a forecast prevalence of 49.2m people in 2011, compared to 39.4m people in 2005. Drivers for increased type 2 prevalence include the aging demographic profile and an increase in obesity. Diabetes is the sixth leading cause of death in the US (based on number of death certificates, NIDDK). The global diabetes market was worth $18.6bn in 2005, which was an 11.5% increase from 2004 sales of $16.6bn. The US has the dominant share in the global diabetes market, with 49.6% of 2005 global sales. The large US market share is mainly due to the large population and the high prevalence of diabetes, the increasing incidence of diabetes associated with Western diets and an aging population. OADs represent 58% of the global diabetes market in 2005, with the remainder of sales being from insulins and analogs (40.1%) and other drugs with 1.9%. However, insulins and analogs have seen the largest sales growth at 17.3% in 2005. There has been a high level of innovation in drug delivery technology within the diabetes market during 2005-6. Key events include advances in inhaled insulins, funding into insulin pills, patch technology and pain free needles for injection. The top 10 leading antidiabetic brands consist of 6 OADs (Actos, Avandia, Amaryl, Basen, metformin HCl, and Avandamet) and 4 insulins (Lantus, Humalog, NovoLog/NovoRapid and Novolin 70/30/actraphane).

Table of Contents

Table of Contents

The Diabetes Market Outlook to

Executive Summary

Patient potential

Global market analysis

Analysis of potential future blockbusters

Leading players in the global diabetes market

Chapter 1 Patient potential

Summary

Introduction

Disease description

Type 1 diabetes

Type 2 diabetes

Diabetic complications

Prevalence of diabetes

Type 1

Type 2

Incidence

Mortality

Diagnosis

Treatment

Chapter 2 Global market analysis

Summary

Introduction

Market analysis by country

Anti-diabetic licensing trends

iv

Antidiabetic drug classes

Leading brands in the global diabetes market

Key events in the global diabetes market, 2005-6

Introduction

Product launches and discontinued products

Reported side effects of marketed drugs

Innovation in glucose testing

Cell transplantation and innovative therapies

Innovation in drug delivery technology

The insulin market

Human insulins

Fast-acting insulin analogs

Intermediate insulin analogs

Long-acting insulin analogs

Intermediate and fast-acting insulin analogs

Intermediate and long-acting insulin analogs

Animal insulins

Insulin devices

Sales forecast for human insulin and analogs

Oral anti-diabetics (OADs)

Thiazolidiniones (TZDs)

Sulfonylureas

Biguanides

Combined sulphonylurea and biguanide antidiabetics

Alpha-glucosidase inhibitors

Thiozolidiniones (TZDs) and other oral antidiabetics

Other oral antidiabetics

Sales forecast for OADs

Other drugs

Chapter 3 Analysis of potential future blockbusters

Summary

Introduction

Key trends in R&D

Non-invasive human insulin

New drug classes in the OAD market

Profiles of key insulin pipeline compounds

Inhaled Insulins

Exubera

AERx iDMS

AIR

Oral insulin

Oralin

v

Emisphere Oral insulin

HIM2

Insulin patches

Profiles of key OAD pipeline products

Dual PPAR agonists

Pargluva

GLP-1 agonists and DPP IV agonists

Byetta

Galvus

Sitagliptin

Amylinomimetic agents

Product forecasts

Factors affecting forecasts

New product launches

Patent expiry dates

Clinical trial results

Human insulin sales forecasts

OAD’s sales forecasts

Chapter 4 Leading players in the global diabetes market

Summary

Introduction

Novo Nordisk

Antidiabetic sales focus

Marketed product portfolio

NovoRapid/ NovoLog

Novolin/Insulatard/Actrapid/Mixtard

Prandin/NovoNorm

Levemir

R&D pipeline analysis

NovoMix 50 & 70

AERx iDMS/ NN1998

Strategic analysis

Drivers of growth

Resistors of growth

Takeda

Antidiabetic sales focus

Marketed diabetes product portfolio

Actos

Basen

TCV-116

TAK-428

TAK-128

Strategic analysis

vi

Drivers of growth

Resistors of growth

Sanofi-Aventis

Antidiabetic sales focus

Marketed diabetes product portfolio

Lantus

Amaryl

R&D pipeline analysis

Acomplia

Exubera

Strategic analysis

Drivers of growth

Resistors of growth

GlaxoSmithKline

Antidiabetic sales focus

Marketed product portfolio

Avandia

Avandamet

R&D pipeline analysis

Strategic analysis

Drivers of growth

Resistors of growth

Eli Lilly

Antidiabetic sales focus

Marketed product portfolio

Humalog

Humulin

Actos

R&D pipeline analysis

Arxxant

Pulmonary insulin (AIR)

Strategic analysis

Drivers of growth

Resistors of growth

Servier

Antidiabetic sales focus

Marketed product portfolio

Diamicron

R&D pipeline analysis

S-15261

Glufast

Strategic analysis

Drivers of growth

Resistors of growth

Merck KGaA

Antidiabetic sales focus

Marketed product portfolio

Glucophage

Glucophage XR

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Glucovance

R&D pipeline analysis

Strategic analysis

Drivers of growth

Resistors of growth

Bayer

Antidiabetic sales focus

Marketed product portfolio

Precose

R&D pipeline analysis

Strategic analysis

Drivers of growth

Resistors of growth

Novartis

Antidiabetic sales focus

Marketed product portfolio

Starlix

Metformin HCl

R&D pipeline analysis

Galvus

Strategic analysis

Drivers of growth

Resistors of growth

Bristol-Myers Squibb

Antidiabetic sales focus

Marketed product portfolio

R&D pipeline analysis

Pargluva

Strategic analysis

Drivers of growth

Resistors of growth

Chapter 5 Appendix

IMS data

Index

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List of Figures

Figure 1.1: Estimated number of new cases of diagnosed type 2 diabetes in people aged 20 or

over, by age group in the US, 2005

Figure 1.2: Diabetes mortality in the US, 1999-2003

Figure 2.3: Global diabetes market share by geography, 2005

Figure 2.4: Sales of types of antidiabetic brands, 2004-5

Figure 2.5: Breakdown of global diabetes sales by drug class, 2004-5

Figure 2.6: Competitive dynamics of the leading 10 brands in the global diabetes market, 2004-

Figure 2.7: Innovation in drug delivery technology, 2005-6

Figure 2.8: Competitive dynamics of the global insulin market, 2004-5

Figure 2.9: Competitive dynamics of OADs in the global diabetes

Figure 3.10: Positive and negative factors affecting forecasted sales of antidiabetics

Figure 3.11: Expected patent expiry dates for major antidiabetics in the US, Japan and EU, 2006-

2015

Figure 4.12: Competitive dynamics of the leading players in the global diabetes market, 2005

Figure 4.13: Novo Nordisk’s antidiabetic sales, 2005

Figure 4.14: Takeda’s antidiabetic sales, 2005

Figure 4.15: Sanofi-Aventis’ antidiabetic sales, 2005

Figure 4.16: GSK’s antidiabetic sales, 2005

Figure 4.17: Lilly’s antidiabetic sales, 2005

Figure 4.18: Servier’s antidiabetic sales, 2005

Figure 4.19: Merck KGaA’s antidiabetic sales, 2005

Figure 4.20: Bayer’s antidiabetic sales, 2005

Figure 4.21: Novartis’s antidiabetic sales, 2005

Figure 4.22: Bristol-Myers Squibb’s antidiabetic sales, 2005

List of Tables

Table 1.1: Prevalence of overweight and obese adults by country, 2005-11

Table 1.2: Prevalence of Type 1 & 2 diabetes in the 7 major markets, 2004-5

Table 1.3: Prevalence of Type 1 diabetes in the 7 major markets, 2005-11

Table 1.4: Prevalence of Type 2 diabetes in the 7 major markets, 2005-11

Table 2.5: Global diabetes market sales by country/region, 2001-5

Table 2.6: Leading brands in the global diabetes market, 2004-5

Table 2.7: Characteristics of the key types of insulin

Table 2.8: Fast-acting insulin analogs in the global diabetes market, 2004-5

Table 2.9: Intermediate insulin analogs in the global diabetes market, 2004-5

Table 2.10: Long-acting insulin analogs in the global diabetes market, 2004-5

Table 2.11: Intermediate and fast-acting insulin analogs in the global diabetes market, 2004-5

Table 2.12: Intermediate and long-acting insulin analogs in the global diabetes market, 2004-5

Table 2.13: Insulin devices in the global diabetes market, 2004-5

Table 2.14: Human insulin and analogs sales forecast, 2005-11

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Table 2.15: Thiazolidiniones in the global diabetes market, 2004-5

Table 2.16: Sulfonylureas in the global diabetes market, 2004-5

Table 2.17: Biguanides in the global diabetes market, 2004-5

Table 2.18: Combined sulphonylurea and biguanide antidiabetics in the global diabetes market,

2004-5

Table 2.19: Alpha-glucosidase inhibitors in the global diabetes market, 2004-5

Table 2.20: Glitazone and other oral antidiabetics in the global diabetes market, 2004-5

Table 2.21: Other oral antidiabetics in the global diabetes market, 2004-5

Table 2.22: OAD sales forecast, 2005-11

Table 2.23: Other drugs in the global diabetes market, 2004-5

Table 3.24: Expected product launch dates, 2005-11