Forecast Insight: Antidiabetics - Diabetes market growth driven by epidemiological trends and rich pipeline

Introduction

Datamonitor expects the antidiabetics market to grow to $34.8 billion in 2019 for the seven major markets. Januvia will become the leading franchise from 2012 after patent expiry of Actos, with franchise sales reaching nearly $6 billion by 2019. Pipeline candidates will make up 30% of sales in 2019, with once-weekly GLP-1 agonists and new long-acting insulin analogs meeting success.

Scope

* Description of the competitive landscape in antidiabetics across seven major markets with market definition and overview
* Event-driven updated sales forecasts for 2010-19 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan
* Analysis of major events and brand dynamics affecting the diabetes market
* Understand the barriers to uptake for novel antidiabetics agents and quantify the shift away from older therapies like glitazones and sulfonylureas

Highlights

The antidiabetics market in the seven major markets is expected to grow from $22,806 million in 2009 to $34,820 million in 2019, with a 4% CAGR. Growth is driven by the epidemiological expansion of the market, fuelled by the obesity epidemic and improved diagnosis rates.

Januvia will be the leading oral antidiabetic agent after the patent expiry of Actos. Its relatively benign safety profile has led to rapid growth since launching in 2006, despite a poorer efficacy than other oral antidiabetics. Marketed and pipeline class competitors are seen as "me-too" drugs and will struggle to attract share away from Januvia.

New products launched from the highly active antidiabetic pipeline will command 30% ($10,570m) of the market in 2019. Highest growth will be seen for the GLP-1 agonists, with the first once-weekly product, Bydureon, expected to take share from within the class, insulins and oral antidiabetics.

Reasons to Purchase

* Quantify the future size of the antidiabetics market from 2010-2019 and identify opportunities for new products
* Examine the future performance of leading antidiabetic brands and the growth of generics and insulin biosimilars
* Understand the barriers to uptake for novel antidiabetic agents

Report Highlights
The antidiabetics market in the seven major markets is expected to grow from $22,806 million in 2009 to $34,820 million in 2019, with a 4% CAGR. Growth is driven by the epidemiological expansion of the market, fuelled by the obesity epidemic and improved diagnosis rates.

Januvia will be the leading oral antidiabetic agent after the patent expiry of Actos. Its relatively benign safety profile has led to rapid growth since launching in 2006, despite a poorer efficacy than other oral antidiabetics. Marketed and pipeline class competitors are seen as "me-too" drugs and will struggle to attract share away from Januvia.

New products launched from the highly active antidiabetic pipeline will command 30% ($10,570m) of the market in 2019. Highest growth will be seen for the GLP-1 agonists, with the first once-weekly product, Bydureon, expected to take share from within the class, insulins and oral antidiabetics.
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TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Cardiovascular and diabetes pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Upcoming related reports 4

1. MARKET DEFINITION AND OVERVIEW 10
Market definition for this report 10
Countries and regions included in this report 10
Seven major market assessment 11
Rest of the World snapshot 31

2. EPIDEMIOLOGY OF DIABETES 35
Introduction 35
Key points 35
Disease definition, classification and diagnosis criteria 36
Strengths and weaknesses of our epidemiologic projections 38
Risk factors of type 1 diabetes 38
Global variation and temporal trends of incidence and prevalence of diabetes mellitus 40
Epidemiologic forecasting of type 1 diabetes mellitus 41
Results for type 1 diabetes incidence 43
Risk factors of type 2 diabetes 45
Co-morbidities of type 2 diabetes 46
Epidemiologic forecasting of type 2 diabetes mellitus 47
Results for type 2 diabetes prevalence 51
Discussion 59

3. BRAND DYNAMICS 61
Overview of the competitive landscape in antidiabetics 61
Basal insulins 63
Fast-acting insulins 69
Premixed insulins 78
Glitazones 80
DPP-4 inhibitors 87
GLP-1 agonists 96
Other classes 103

Bibliography 108
Journal papers 108
Websites 108
Datamonitor reports 109
Type 1 diabetes epidemiology references 109
Type 2 diabetes epidemiology references 111
Appendix A – Market Assumptions 115
New product launches 115
Patent expiries 117
Data definitions, limitations and assumptions 117
Forecast methodology 119
Appendix B 120
Contributing experts 120
Conferences attended 120
Report methodology 120
About Datamonitor 120
Disclaimer 124

TABLE OF FIGURES
Figure 1: Antidiabetics sales ($m) by type of product (marketed versus pipeline) in the seven major markets, 2006–2019 13
Figure 2: Antidiabetics sales (SUm) by type of product (marketed versus pipeline) in the seven major markets, 2006–2019 14
Figure 3: Antidiabetics sales ($m) by type of product (branded versus generic) in the seven major markets, 2006–2019 15
Figure 4: Antidiabetics sales (SUm) by type of product (branded versus generic) in the seven major markets, 2006–2019 16
Figure 5: Antidiabetics sales ($m) by country in the seven major markets, 2006–2019 18
Figure 6: Antidiabetics sales (SUm) by country in the seven major markets, 2006–2019 19
Figure 7: Antidiabetics sales ($m) and historical and forecast growth (% CAGR) by region in the seven major markets, 2006–2019 20
Figure 8: Regional sales performance in the seven major diabetes markets, 2008–09 21
Figure 9: Antidiabetics sales ($m) by class in the seven major markets, 2006–2019 22
Figure 10: Antidiabetics sales (SUm) by class in the seven major markets, 2006–2019 23
Figure 11: Insulin sales ($m) for diabetes by class in the seven major markets, 2006–2019 24
Figure 12: Performance of the antidiabetic drug classes across the seven major markets, 2006–09 25
Figure 13: Performance of antidiabetic drug classes including pipeline drugs across the seven major markets, 2010–19 26
Figure 14: Leading antidiabetic brand revenues ($m) share of antidiabetics market across the seven major markets (%), 2009 and 2019 27
Figure 15: Sales of the top five antidiabetics (2009) and their generics in the seven major markets ($m), 2006–2019 29
Figure 16: Top five antidiabetic brands in the seven major markets and by region ($m), in 2006, 2009 and 2019 31
Figure 17: Seven major market, BRIC nations and the Rest of World sales ($m) for the antidiabetics market, 2009 33
Figure 18: Indexed annual sales for the antidiabetic market in the seven major markets, BRIC nations and the Rest of World, 2005–09 34
Figure 19: Indexed annual growth rate of the antidiabetic market in the seven major markets, BRIC nations and the Rest of World, 2005–09 35
Figure 20: Number of prevalent cases of type 2 diabetes in those aged 20–79 in the seven major markets, 2010–2020 54
Figure 21: Sales of the long-acting insulins class in the seven major markets, 2006–2019 65
Figure 22: Sales of Lantus for diabetes in the seven major markets, 2009–2019 69
Figure 23: Sales of fast-acting insulins for diabetes in the seven major markets, 2006–2019 72
Figure 24: Sales of NovoRapid for diabetes in the seven major markets, 2009–2019 75
Figure 25: Sales of Humalog for diabetes in the seven major markets, 2009–2019 78
Figure 26: Sales of premixed insulins for diabetes in the seven major markets, 2006–2019 80
Figure 27: Sales of the glitazone class for diabetes by franchise in the seven major markets, 2006–2019 82
Figure 28: Sales of the Actos franchise for diabetes in the seven major markets, 2009–2019 87
Figure 29: Sales of marketed and pipeline products in the DPP-4 inhibitor class for diabetes in the seven major markets, 2006–2019 90
Figure 30: Sales of the Januvia franchise (including pipeline combinations) for diabetes in the seven major markets, 2009–2019 96
Figure 31: Sales of GLP-1 agonists for diabetes in the seven major markets, 2006–2019 100
Figure 32: Sales of Byetta for diabetes in the seven major markets, 2009–2019 103
Figure 33: Alpha-glucosidase inhibitor sales for diabetes by country, 2006–2019 105

TABLE OF TABLES
Table 1: Leading branded antidiabetic drug sales ($m) in the seven major markets, 2009 and 2019 28
Table 2: 1999 World Health Organization definitions of diabetes mellitus and pre-diabetes 38
Table 3: Summary of sources used to forecast incidence of type 1 diabetes mellitus in those aged 0-14, published between 1993 and 2008 43
Table 4: Incident cases of type 1 diabetes mellitus in those aged 0–14 in the seven major markets, 2010–2020 45
Table 5: Incidence rates per 100,000 of type 1 diabetes mellitus in those aged 0–14 in the seven major markets, 2010–2020 46
Table 6: Summary of sources used in analyses of type 2 diabetes mellitus, published between 1999 and 2009 48
Table 7: Diagnosed prevalent cases of type 2 diabetes mellitus in those aged 20–79, in the seven major markets, 2010–2020 52
Table 8: Percent of population aged 20–79 with type 2 diabetes mellitus in the seven major markets, 2010–2020 (%) 53
Table 9: Percent of type 2 diabetes cases in the United States by age group, 2010–2020 (%) 55
Table 10: Percent of type 2 diabetes cases in Japan by age group, 2010–2020 (%) 55
Table 11: Percent of type 2 diabetes cases in France by age group, 2010–2020 (%) 56
Table 12: Percent of type 2 diabetes cases in Germany by age group, 2010–2020 (%) 56
Table 13: Percent of type 2 diabetes cases in Italy by age group, 2010–2020 (%) 57
Table 14: Percent of type 2 diabetes cases in Spain by age group, 2010–2020 (%) 57
Table 15: Percent of type 2 diabetes cases in the UK by age group, 2010–2020 (%) 58
Table 16: Percent of undiagnosed diabetes in those aged 20-79 in the seven major markets, 2010 (%) 58
Table 17: Prevalence of impaired glucose tolerance in those aged 20–79 in the seven major markets in those aged 20–79 years, 2010–2020 59
Table 18: Prevalence rates of impaired glucose tolerance in those aged 20–79 in the seven major markets in those aged 20-79, 2010–2020 (%) 59
Table 19: Lantus – drug profile, 2010 66
Table 20: Sales forecast for Lantus in diabetes in the seven major markets ($m), 2009–2019 70
Table 21: NovoRapid – drug profile, 2010 73
Table 22: Sales forecast for NovoRapid for diabetes in the seven major markets ($m), 2009–2019 74
Table 23: Humalog – drug profile, 2010 76
Table 24: Sales forecast for Humalog for diabetes in the seven major markets ($m), 2009–2019 79
Table 25: Actos – drug profile, 2010 83
Table 26: Actoplus Met – drug profile, 2010 84
Table 27: Duetact – drug profile, 2010 84
Table 28: Sales forecast for Actos franchise for diabetes in the seven major markets ($m), 2009–2019 88
Table 29: Januvia – drug profile, 2010 91
Table 30: Janumet – drug profile, 2010 92
Table 31: Sales forecast for Januvia franchise for diabetes in the seven major markets ($m), 2009–2019 97
Table 32: Byetta – drug profile, 2010 101
Table 33: Sales forecast for Byetta for diabetes in the seven major markets ($m), 2009–2019 104
Table 34: Datamonitor’s estimated launch dates for diabetes products in the seven major markets, 2010–19116
Table 35: Patent expiry or loss of market exclusivity dates for approved diabetes drugs in the seven major markets, 2010–19
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