Commercial Insight: Antidiabetics


Patent expiries and cost containment initiatives balanced by pipeline products

Pages: 216

Publisher: Datamonitor

Date Published: August 2006

Format: PDF, Data-Pack

Price: $15200

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Overview

Introduction
The diabetes epidemic has contributed to growth in the antidiabetics market over 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 2006-15 in the US, Japan, France, Germany, Italy, Spain and the UK, and a Global overview
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 the role that novel agents are likely to play and the balance between issues and opportunities in the diabetes market

Highlights
Demographic trends will lead to increasing patient population. The antidiabetics market is set to continue increasing, driven by the dramatic increase in the prevalence of diabetes in the major markets. Additionally, the rising age of the population across all developed regions is creating an increased burden on health service providers and payers.

The highest selling drug classes in the antidiabetics market are heavily genericized and thus will not generate the revenues needed for growing the market. Additionally, TZDs, one of the most lucrative classes, will face patent expiries in the coming decade. These events are expected to be counterbalanced by the introduction of novel agents.

The diabetes market is characterized by high unmet need and treatment issues. However, these issues along with radical changes on the understanding of diabetes, have created an environment rich in opportunity. We expect that the growth of the diabetes market will be driven by the exchange of older, cheaper drugs for new more expensive agents.

Reasons to Purchase
Quantify the 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

ABOUT DATAMONITOR HEALTHCARE

About the Cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the antidiabetics market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

National markets

The insulin market

Lantus

Humalog

NovoRapid/NovoLog

NovoLin

Humulin

Levemir

Apidra

Outlook

The oral antidiabetics (OADs) market

Thiazolidinediones

Actos

Avandia

Sulfonylureas

Biguanides

Prandial glucose regulators (PGRs)

Alpha-glucosidase inhibitors (AGIs)

Outlook

Incretin mimetics

Exenatide

Outlook

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Current and future opportunities and threats in the antidiabetics market

Global 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

CHICAGO and PERISCOPE

DREAM

ACCORD

ADOPT

ORIGIN

NAVIGATOR

New product launches

Byetta LAR

Liraglutide (NN-2211)

Januvia (sitagliptin, MK-0431)

Galvus (vildagliptin, LAF-237)

Metaglidasen (MBX-102)

Exubera

AIR inhalable insulin

AERx-iDMS inhalable insulin

Technosphere inhalable insulin

Oral-lyn (Generex)

Patent expiries

Limitations of data

Forecasts

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Case study 1 – Will changes in diabetes therapy outweigh the issues currently surrounding it?

Issues with the current treatment of diabetes

Current treatment is suboptimal

Inappropriate definitions/monitoring

Failing to address/prevent cardiovascular complications

Unclear how best to treat Type 2 diabetes

Compliance/polypharmacy/secondary drug failure

Weight gain

Changes in diabetes therapy

Understanding of the pathophysiology of diabetes

Awareness of insulin resistance and metabolic syndrome

Insulin sensitizers versus insulin secretagogues

Increased treatment with combination therapy

Holistic approach

Overlap between cardiology and endocrinology

Proposed paradigm shift towards prevention

Conclusions

Diabetes could drive the primary care market

New intervention points could create big new markets

New understanding leads to new drug markets

Biotechnology is potentially a big winner

Case study 2 – A rich and diverse diabetes pipeline is expected to drive growth

GLP-1 Agonists

Mechanism of action

Advantages

Disadvantages

Market potential

DPP-4 inhibitors

Mechanism of action

Advantages

Disadvantages

Market potential

Inhaled insulin

Advantages

Disadvantages

Market potential

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

US forecasts

Japan forecasts

France forecasts

Germany forecasts

Italy forecasts

Spain forecasts

UK forecasts

M5EU forecasts

Global forecasts

About Datamonitor

About Datamonitor Healthcare

About the Cardiovascular Disease analysis team

Disclaimer

List of Tables

Table 1: Global sales in the antidiabetic market by drug class, 2005

Table 2: Global sales of the leading branded insulin families, 2004-05

Table 3: Global sales of the leading branded TZDs, 2004-05

Table 4: Global sales of the leading branded sulfonylureas, 2004-05

Table 5: Global sales of the leading branded biguanide, 2004-05

Table 6: Global sales of the leading branded PGRs, 2004-05

Table 7: Global sales of the leading branded AGIs, 2004-05

Table 8: Prevalence of obesity in the seven major markets by age (000s), 2005

Table 9: US sales and growth of drug classes

Table 10: Japan sales and growth of drug classes

Table 11: EU5 sales and growth of drug classes

Table 12: French sales and growth of drug classes

Table 13: German sales and growth of drug classes

Table 14: Italian sales and growth of drug classes

Table 15: Spanish sales and growth of drug classes

Table 16: UK sales and growth of drug classes

Table 17: The ten clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005

Table 18: Patent expiry dates used in forecasting antidiabetics market

Table 19: Humulin: key facts

Table 20: Humalog: key facts

Table 21: NovoLin: key facts

Table 22: NovoLog: key facts

Table 23: Lantus: key facts

Table 24: Actos: key facts

Table 25: Avandia: key facts

Table 26: Amaryl: key facts

Table 27: Glucotrol XL: key facts

Table 28: Glucophage and Glucophage XR: key facts

Table 29: US antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 30: Japanese antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 31: French antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 32: German antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 33: Italian antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 34: Spanish antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 35: UK antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 36: M5EU antidiabetic sales forecasts ($m; 2005 figures are actuals)

Table 37: Global antidiabetic sales forecasts ($m; 2005 figures are actuals)

List of Figures

Figure 1: Sales and growth for antidiabetic drug classes in the seven major markets, 2004-05

Figure 2: Share of antidiabetics market represented by each of the seven major markets in 2005

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

Figure 4: Proportion of population 20-39 years of age, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 5: Proportion of population 40-59 years of age, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 6: Proportion of population 60-79 years of age, 2003 and 2015 and prevalence of diabetes in this age group, 2003

Figure 7: Annual US sales of the antidiabetic drug classes, 2002-05

Figure 8: Annual Japan sales of the antidiabetic drug classes, 2002-05

Figure 9: Annual EU5 sales of the antidiabetic drug classes, 2002-05

Figure 10: Annual French sales of the antidiabetic drug classes, 2002-05

Figure 11: Annual German sales of the antidiabetic drug classes, 2002-05

Figure 12: A fall in reference prices is likely to lead to greater use of generics

Figure 13: Annual Italian sales of the antidiabetic drug classes, 2002-05

Figure 14: Annual Spanish sales of the antidiabetic drug classes, 2002-05

Figure 15: Although generic sales and volume use have increased over the last ten years, the generics market only accounts for a small proportion of the Spanish pharmaceutical market

Figure 16: Annual UK sales of the antidiabetic drug classes, 2002-05

Figure 17: Summary of global and EU specific opportunities and threats affecting the diabetes market, 2006

Figure 18: Summary of US and Japan-specific opportunities and threats affecting the diabetes market, 2006

Figure 19: Summary of country-specific opportunities and threats affecting the diabetes market, 2006