Market Report Source

Overview

Introduction
The diabetes epidemic has contributed in the growth of the antidiabetics market the past few years. Since the prevalence of diabetes continues to increase, the market will further expand. While early therapy is dominated by generically available agents, and the later stages by insulin, the number of unmet needs in the diabetes treatment, warrants that novel agents will have a place in the market.

Scope
Country specific event-driven sales forecasts for the period 2007-16 for the US, Japan, France, Germany, Italy, Spain and the UK. Patient potential and prescribing trends overview of the antidiabetics market based on historical sales data and future key events. Profiles of the country and market specific issues which will impact future sales in the market including generic erosion and class switching. Case studies presenting safety issues and the role that novel agents are likely to play in the balance of issues and opportunities in the market

Highlights
Insulin class dominates the market with a 40.9% share of its overall seven major market sales and the US market accounts for 66% of the value of the seven major markets with 13% CAGR 200306. Although insulin, sulfonylureas and biguanides remain the highest selling drug classes (number of units sold) in the antidiabetics market a strong need for new drugs with fewer side effects and better tolerability have created a potential niche for companies to compete for. Patients with Type 2 diabetes who are poorly controlled with metformin and/or sulfonylureas are subjects to second-line therapy with TZDs. For a number of years this class was in dispute due to its safety concerns.

Reasons to Purchase

• Quantify future size and scope of the diabetes market and potential for new products
• Analyze options to expand commercial potential through pursuit of new indications
• Formulate successful launch strategies in a highly competitive market

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the antidiabetics market

Contributing experts

Related reports

Upcoming reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

National markets

The insulin market in the seven major markets

Lantus

NovoRapid/NovoLog

Humalog

NovoLin

Humulin

Levemir

Apidra

Exubera

Outlook

The oral antidiabetics (OADs) market

Thiazolidinediones

Actos

Avandia

Sulfonylureas

Biguanides

Prandial glucose regulators (PGRs)

Alpha-glucosidase inhibitors (AGIs)

Outlook

Incretin mimetics

Exenatide

Sitagliptin

Outlook

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Current and future opportunities and threats in the antidiabetics market

Seven Major Markets opportunities and threats

Opportunities

Threats

US: current market assessment

Overview

US opportunities

US threats

Japan: current market assessment

Overview

Japan opportunities

Japan threats

EU5: current market assessment

Overview

EU5: opportunities and threats

EU5 opportunities

EU5 threats

France: current market assessment

Overview

France: opportunities and threats

France opportunities

France threats

Germany: current market assessment

Overview

Germany: opportunities and threats

Germany opportunities

Germany threats

Italy: current market assessment

Overview

Italy: opportunities and threats

Italy opportunities

Italy threats

Spain: current market assessment

Overview

Spain: opportunities and threats

Spain opportunities

Spain threats

UK: current market assessment

Overview

UK: opportunities and threats

UK opportunities

UK threats

Summary of environmental issues affecting the antidiabetic market size

CHAPTER 4 FORECAST ANALYSIS

Assumptions and events

Ongoing trends

Increasing market size

Trial results

RECORD

CHICAGO and PERISCOPE

DREAM

ACCORD

ADOPT

NAVIGATOR

New product launches

Byetta LAR

Liraglutide (NN-2211)

Januvia (sitagliptin, MK-0431)

Galvus (vildagliptin, LAF-237)

Saxagliptin

Metaglidasen (MBX-102)

AIR inhalable insulin

AERx-iDMS inhalable insulin

Technosphere inhalable insulin

Patent expiries

Limitations of data

Forecasts

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Case study 1 – The Avandia story: Mass hysteria or common sense?

Introduction

History of TZDs and their contribution to diabetes treatment

Avandia milestones

The meta-analysis

The interim data from RECORD

The Oversight and Reform Committee hearing

FDA vs. EMEA – did FDA drop the ball?

FDA restructuring – the true political motive?

Avandia sales analysis

Views of key opinion leaders

Potential outcomes

Conclusion: following the meeting

Case study 2 – DPP-4s’ market dynamics affected by the delay of Galvus launch

Introduction

Incretin mimetics overview

DPP-4 inhibitors

Problems with Galvus and its milestones

How did Merck leapfrog Novartis

Analysis of Januvia sales and its success

Januvia versus Galvus

Caution required

Future scenarios for the DPP-4 market

Conclusion

APPENDIX A – MAJOR BRAND KEY FACTS

Insulin market data

Humulin

Humalog

NovoLin

NovoRapid/NovoLog

Lantus

TZDs market data

Actos

Avandia

Sulfonylureas market data

Amaryl

Glucotrol XL

Biguanide market data

Glucophage and Glucophage XR

APPENDIX B

Bibliography

Epidemiology

Clinical trial data

Report methodology

Standard units

Japanese market data

APPENDIX C – MARKET FORECAST DATA

Market Forecast, US

Market Forecast, Japan

Market Forecast, France

Market Forecast, Germany

Market Forecast, Italy

Market Forecast, Spain

Market Forecast, UK

ABOUT DATAMONITOR

About Datamonitor Healthcare

About the Cardiovascular Disease analysis team

Disclaimer

List of Tables

Table 1: Seven major market sales in the antidiabetic market by drug class, 2006

Table 2: Seven major market sales of the leading branded insulin families, 2005-06

Table 3: Seven major market sales of the leading branded TZDs, 2005-06

Table 4: Seven major market sales of the leading branded sulfonylureas, 2005-06

Table 5: Seven major market sales of the leading branded biguanide, 2005-06

Table 6: Seven major market sales of the leading branded PGRs, 2005-06

Table 7: Seven major market sales of the leading branded AGIs, 2005-06

Table 8: Seven major market sales of the leading branded incretin mimetics, 2005-06

Table 9: Prevalence of obesity in the seven major markets by age group (000s), 2005

Table 10: US sales and growth of drug classes in the antidiabetics market, 2006

Table 11: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D, 2006

Table 12: Japan sales and growth of drug classes in the antidiabetics market, 2006

Table 13: EU5 sales and growth of drug classes in the antidiabetics market, 2006

Table 14: French sales and growth of drug classes in the antidiabetics market, 2006

Table 15: Germany sales and growth of drug classes in the antidiabetics market, 2006

Table 16: Italy sales and growth of drug classes in the antidiabetics market, 2006

Table 17: Spanish sales and growth of drug classes in the antidiabetics market, 2006

Table 18: UK sales and growth of drug classes in the antidiabetics market, 2006

Table 19: The ten clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005

Table 20: Avandia’s historical timeline

Table 21: Interim RECORD data summary

Table 22: Timeline of Merck’s development of Januvia

Table 23: Humulin: key facts

Table 24: Humalog: key facts

Table 25: NovoLin: key facts

Table 26: NovoLog: key facts

Table 27: Lantus: key facts

Table 28: Actos: key facts

Table 29: Avandia: key facts

Table 30: Amaryl: key facts

Table 31: Glucotrol XL: key facts

Table 32: Glucophage and Glucophage XR: key facts

List of Figures

Figure 1: Sales and growth for antidiabetic drug classes in the seven major markets, 2005-06

Figure 2: Share of antidiabetics market represented by each of the seven major markets, 2006

Figure 3: Pioglitazone’s effects on triglyceride and HDL cholesterol levels

Figure 4: Population in seven major markets aged 20-39, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 5: Population in seven major markets aged 40-59, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 6: Population in seven major markets aged 60-79, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 7: The growing prevalence of obesity in the US, 2005-2015

Figure 8: Generalized distribution chain for parallel traded pharmaceutical products

Figure 9: Annual US sales of the antidiabetic drug classes, 2003-06

Figure 10: More than half of all prescriptions dispensed in the US are generics, 1994-2005

Figure 11: Generic companies dominate the US pharmaceutical market in terms of prescriptions

Figure 12: Generic use in the US is promoted through a number of channels

Figure 13: The tiered co-payment system will lead to greater use of generics

Figure 14: Annual Japan sales of the antidiabetic drug classes, 2003-06

Figure 15: The Japanese generic market is underdeveloped because of a number of factors

Figure 16: Annual EU5 sales of the antidiabetic drug classes, 2003-06

Figure 17: Annual French sales of the antidiabetic drug classes, 2003-06

Figure 18: Annual German sales of the antidiabetic drug classes, 2003-06

Figure 19: A fall in reference prices is likely to lead to greater use of generics

Figure 20: Annual Italian sales of the antidiabetic drug classes, 2003-06

Figure 21: Annual Spanish sales of the antidiabetic drug classes, 2003-06

Figure 22: Although generic sales and volume use have increased over the last 10 years, the generics market only accounts for a small proportion of the Spanish pharmaceutical market

Figure 23: Annual UK sales of the antidiabetic drug classes, 2003-06

Figure 24: Summary of opportunities and threats affecting the diabetes markets in the seven major pharmaceutical markets and the EU, 2006

Figure 25: Summary of opportunities and threats affecting the diabetes markets in the US and Japan 2006

Figure 26: Summary of country-specific opportunities and threats affecting the diabetes market in the EU5, 2006

Figure 27: Patent expiry dates used in forecasting antidiabetics market, 2007-2016

Figure 28: Avandia sales forecast across the seven major markets, 2006-2016

Figure 29: Mechanism of action of GLP-1 agonists

Figure 30: Mechanism of action of DPP-4 inhibitors

Figure 31: Januvia sales forecast across the seven major markets, 2006-2016