The Diabetes Market Outlook To 2014: Market dynamics, competitive landscape, emerging therapies

Published by: Business Insights

Published: Sep. 1, 2009 - 155 Pages

Table of Contents

Table of Contents

The Diabetes Market Outlook to

Executive summary

Patient potential

Global market analysis

Pipeline analysis

Leading players of the global diabetes market

Chapter 1 Scope and methodology

Scope

Methodology

Scope of IMS data

Chapter 2 Patient potential

Summary

Introduction

What is diabetes?

Types of diabetes

Type 1 diabetes

Type 2 diabetes

Gestational diabetes mellitus

Impaired glucose tolerance

Diabetic complications

Epidemiology

Diagnosis

How is diabetes measured?

Treatment algorithm

Chapter 3 Global market analysis

Summary

Introduction

Market analysis by country

Licensing trends

Key events/trends in the diabetes market

FDA’s revised guidelines on longer, larger cardiovascular risk studies for diabetes drugs

Newer agents recommended by NICE in diabetes treatment

A prophylactic treatment for children at high risk

GSK discontinued development of remogliflozin

Takeda’s Phase II loss of TAK-379

Novo Nordisk’s Prandin lawsuit

Market analysis by drug class

Diabetes drug classes

The insulin landscape

Human insulins

Animal insulins

Drugs targeting underlying causes

Glitazones

Sulfonylurea

Biguanides

DPP-IV inhibitors

Alpha-glucosidase inhibitors

Glinides

Glucagon-like peptide-1 agonists

DPP-IV and GLP-1 differences

Insulin devices

Insulin pump therapy

Therapy area sales forecast

Leading brands of the diabetes market

Generic erosion among the leading brands

Leading brands sales forecast

Chapter 4 Pipeline analysis

Summary

Introduction

Emerging trends/key events in diabetes R&D

Emerging therapies in the diabetes market

Inhaled insulin still a distant reality

Hitherto unexplored avenues in diabetes R&D: magnesium, chromium and vanadium

SGLT-2 inhibitors yet to prove their potential

Other novel mechanisms under development

Profiles of key pipeline products

Drugs under registration/recently approved

Victoza (liraglutide): Novo Nordisk

Onglyza (saxagliptin): BMS/AstraZeneca

SYR322 (alogliptin): Takeda

Byetta LAR (exenatide long-acting release): Eli Lilly, Amylin,

Alkermes

Syncria (albiglutide): GlaxoSmithKline

Ondero (linagliptin): Boehringer Ingelheim

R1583 (taspoglutide): Roche/Ipsen

AVE0010/ZP10: Sanofi-Aventis

BMS-512148 (dapagliflozin): AstraZeneca/BMS

Teplizumab: Eli Lilly/MacroGenics

Competitive dynamics of the investigational drugs

Key pipeline compounds sales forecast

Chapter 5 Leading players of the global diabetes market

Summary

Introduction

Detailed analysis of the diabetes market players

Novo Nordisk

Overview

Drug class focus

Marketed product portfolio

R&D pipeline analysis

Novo Nordisk: strategic growth analysis

Takeda

Overview

Drug class focus

Marketed product portfolio

R&D pipeline analysis

Takeda: strategic growth analysis

Sanofi-Aventis

Overview

Drug class focus

Marketed products portfolio

R&D pipeline analysis

Sanofi-Aventis: strategic growth analysis

Eli Lilly

Overview

Drug class focus

Marketed products portfolio

R&D pipeline analysis

Eli Lilly: strategic growth analysis

Merck & Co.

Overview

Drug class focus

Marketed products portfolio

R&D pipeline analysis

Merck: Strategic growth analysis

Other major players in the diabetes market

GSK

Boehringer Ingelheim

Leading players' outlook through to 2014

Chapter 6 Appendix

IMS data

Glossary

Index

List of Figures

Figure 2.1: Production of insulin and its action

Figure 2.2: Diabetes treatment algorithm

Figure 3.3: Global market sizes, 2008

Figure 3.4: Global sales of types of diabetes brands ($m), 2008

Figure 3.5: Relative positions of different types of insulins in the insulin market, 2008

Figure 3.6: Relative positions of different diabetes drug classes, 2008

Figure 4.7: Leading late-stage R&D products in the diabetes market, 2009

Figure 5.8: Competitive dynamics of the top 10 diabetes players, 2007-08

Figure 5.9: Drug class focus of Novo Nordisk, 2008

Figure 5.10: Drug class focus of Takeda, 2008

Figure 5.11: Drug class focus of Sanofi-Aventis, 2008

Figure 5.12: Drug class focus of Eli Lilly, 2008

Figure 5.13: Drug class focus of Merck, 2008

List of Tables

Table 2.1: Estimated prevalence of diabetes mellitus across the seven major markets, 2008

Table 2.2: Forecast prevalence of diabetes mellitus across the seven major markets, 2008-14

Table 3.3: USA diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.4: French diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.5: German diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.6: Italian diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.7: Japanese diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.8: Spanish diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.9: UK diabetes drug sales by ATC3 class, 2008 US$ millions

Table 3.10: Distribution of the global diabetes market by drug class, 2007-08

Table 3.11: Characteristics of different types of insulin

Table 3.12: Leading brands in the fast-acting insulin category, 2008

Table 3.13: Characteristics of NovoRapid

Table 3.14: Characteristics of Humalog

Table 3.15: Leading brands in the long-acting insulin category, 2008

Table 3.16: Characteristics of Lantus

Table 3.17: Leading brands in the intermediate-acting insulin category, 2008

Table 3.18: Characteristics of Protaphane HM

Table 3.19: Leading brands in the intermediate- and fast-acting insulin category, 2008

Table 3.20: Characteristics of NovoMix

Table 3.21: Leading brands in the intermediate- and long-acting insulin category, 2008

Table 3.22: Leading brands of the glitazones drug class, 2008

Table 3.23: Leading brands of the sulfonylureas drug class, 2008

Table 3.24: Leading brands of the biguanides drug class, 2008

Table 3.25: Leading brands of the DPP-IV drug class, 2008

Table 3.26: Strategic growth analysis of Januvia

Table 3.27: Leading brands of the AGI drug class, 2008

Table 3.28: Leading brands of the glinides drug class, 2008

Table 3.29: Leading brands of the GLP-1 agonists drug class, 2008

Table 3.30: Major differences between GLP-1 agonists and DPP-IV inhibitors

Table 3.31: Diabetes market sales forecast by drug classes ($m),

Table 3.32: Leading brands of the global diabetes market, 2008

Table 3.33: Generic erosion index of key diabetes brands

Table 3.34: Top 10 brands of the diabetes market, sales forecast 2008-14

Table 4.35: Select late-stage diabetes R&D pipeline, 2008

Table 4.36: An overview of Victoza

Table 4.37: An overview of Onglyza

Table 4.38: An overview of alogliptin

Table 4.39: An overview of Byetta LAR

Table 4.40: An overview of Syncria

Table 4.41: An overview of Ondero

Table 4.42: An overview of taspoglutide

Table 4.43: An overview of AVE0010/ZP10

Table 4.44: Ongoing Phase III trials of AVE0010/ZP10

Table 4.45: An overview of dapagliflozin

Table 4.46: Reduction in HbA1c on administering dapagliflozin

Table 4.47: An overview of teplizumab

Table 4.48: Key diabetes pipeline compounds sales forecast, 2008-14

Table 5.49: Leading players of the diabetes market, 2008

Table 5.50: Leading brands of Novo Nordisk, 2008

Table 5.51: Key pipeline compounds of Novo Nordisk, 2008

Table 5.52: Leading brands of Takeda, 2008

Table 5.53: Key pipeline compounds of Takeda, 2008

Table 5.54: Leading brands of Sanofi-Aventis, 2008

Table 5.55: Key pipeline compounds of Sanofi-Aventis, 2008

Table 5.56: Leading brands of Eli Lilly, 2008

Table 5.57: Key pipeline compounds of Eli Lilly, 2008

Table 5.58: Leading brands of Merck, 2008

Table 5.59: Key pipeline compounds of Merck, 2008

Table 5.60: Leading players in the diabetes market, sales forecast 2008-14

Abstract

• Epidemiological analysis of the therapy area and forecast prevalence over the period 2009-14 .
• Forecasts and analysis of the key products in the diabetes market over the period 2009-14 spread across the major classes of treatments.
• Overview of key events in the global diabetes market that have impacted treatment trends and sales potential.
• Strategic and growth analysis of leading pharmaceutical corporations based on sales focus by drug class, currently marketed products and R&D product portfolios.

• Biguanides, mainly comprised of metformin, are the core first line therapy in diabetes care. These drugs have been used in diabetes therapy for over a decade. Some of their advantages include, efficacy, low cost, extensive experience, lack of incidences of hypoglycemia and weight neutrality. Metformin lost patent protection in 2002 and the class is now much genericized and has been ceding market share to other therapies.
• Insulin captured the largest market share (45%) among available diabetes treatments and is likely to dominate the market in the forecast period. However, though insulin analogs have become well established in the market, inhaled insulin is yet to make its mark.
• Significant R&D has been observed in the pre-insulin market leading to the development of several novel and safer therapies. The comparative performance of these therapies, such as the DPP-IV inhibitors and GLP-1 analogs would shape the diabetes market landscape through 2014 and in the long term.

• Revised FDA guidelines make the regulatory environment challenging
In December 2008, the FDA announced that the companies developing diabetes drugs will be required to conduct longer and larger studies to avoid any “unacceptable” cardiovascular risk. Companies are now required to conduct meta analyses for cardiovascular safety in the Phase II and III trials and rule out the possibility of an increased cardiovascular disease risk by 80% or more.
• Inhaled insulin still a distant reality
Insulin therapy takes up the biggest share of diabetes treatment and has been an area of extensive research. While several different purer forms of insulin have emerged over a period of time, nasally administered insulin is still a distant reality. Inhaled insulin may aid compliance, leading to superior long term outcomes. Pfizer/Nektar’s Exubera was the first to be launched inhaled insulin but it had a troubled launch and was subsequently discontinued in October 2007. The only inhaled insulin which is still under development is Technosphere, being developed by Mannkind/Afresa. This insulin uses a technology that facilitates absorption of proteins and peptides through the pulmonary route.

• Which companies were the leading players in the diabetes therapy area in 2008?
• How have recent major launches from the key market players performed?
• Which companies will become the key players in the diabetes market over the period 2009-14?
• Which products will be impacted by generic competitors over the period 2009-14?

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