Table of Contents

Commercial Insight: Antithrombotics - An analysis of the current status and future potential of the marketed antithrombotics drug classes across the seven major markets. Drug classes covered include antiplatelets, anticoagulants and thrombolytics.

Product Code: dmhc1998

Publication Date: 23-Dec-2004

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Overview

Introduction

Commercial Insight: Antithrombotics explores current and future trends in the drug classes used in the management of conditions such as venous thromboembolism and stroke prevention. Case studies are also used to highlight possible strategies to maximise future growth potential of key products.

Scope

· Country specific event-driven sales forecasts for the period 2004-14 for the US, Japan, France, Germany, Italy, Spain and the UK and Global overview.

· Patient potential and prescribing trends overview of the antithrombotics 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 discussing potential causes for Arixtra's slower than expected uptake and whether Exanta will revolutionize the antithrombotics market.

Report Highlights

Patent expiries will be the greatest factor to influence the antithrombotics markets. A few key products dominate, but key patents will be lost in the forecast period, eg Plavix and Lovenox. Pipeline agents, excluding Exanta, are not expected to become significant drivers in the market and may find it difficult to compete with generics.

The range of approved indications is vital to both marketed and developmental antithrombotics to maximize physician uptake and compete effectively with other agents. Astra Zeneca chose to file for the approval of Exanta in the US in three indications including the prevention of stroke in AF patients, with the greatest potential.

Novel agents such as Sanofi-Aventis' idraparinux and Eli Lilly/Sankyo's CS-747 are expected to further drive sales of antithrombotic agents. The design of Phase III clinical trials and the choice of launch indication(s) will be crucially important for maximizing the uptake of these new compounds.

Reasons to Purchase

· View independent, event-driven forecasts for key antithrombotics products and classes across the seven major markets.

· Identify possible future strategy to maximise product potential and minimize risks for the antithrombotics market.

· Redesigned report template presents executive summary in an accessible powerpoint format allowing rapid access to the key insights.

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ABOUT DATAMONITOR HEALTHCARE	2
About the Cardiovascular pharmaceutical analysis team	2
CHAPTER 1 EXECUTIVE SUMMARY	3
Objective of the analysis	3
Datamonitor insight into the antithrombotics market	3
CHAPTER 2 MARKET DEFINITION AND OVERVIEW	9
Market definition for this report	9
Current market situation	9
Antiplatelet agents	13
ADP receptor antagonists	14
Cyclo-oxygenase inhibitors	24
cAMP enhancing platelet aggregation inhibitors	27
GPIIb/IIIas	36
Other antiplatelets	48
Anticoagulants	54
Heparins	55
Oral anticoagulants	66
Other anticoagulants	71
Thrombolytics	86
Strategic scoping and focus	96
CHAPTER 3 COUNTRY MARKET ASSESSMENTS	98
Current and future opportunities and threats in the antithrombotics market	98
Global opportunities and threats	98
Opportunities	98
Threat	102
US: opportunities and threats	103
Opportunities	103
Opportunity/threat	108
Threats	109
Japan: opportunities and threats	112
Opportunities	112
Threats	113
Europe: opportunities and threats	114
Opportunity/threat	114
Threats	122
Summary of environmental issues affecting antithrombotics market size	128
CHAPTER 4 FORECAST ANALYSIS	130
Key assumptions and events	130
Patent expiries	130
Lovenox	130
Plavix	131
Additional indications	132
Exanta gains SPAF indication	132
European indication in PCI for Integrilin	132
Fragmin and Innohep are approved for use in cancer patients	132
Arixtra gains an indication for use in UA and NSTEMI patients	133
New products	133
Exanta	133
Angiomax in Europe	134
Plavix in Japan	134
Novel compounds	135
Limitations of data	136
Forecasts	136
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES	137
Introduction	137
Case study 1	137
Arixtra - potential causes for slower-than-expected uptake	137
Commercial activity	138
Patient potential	141
Case study 2	144
Will Exanta revolutionize the antithrombotics market?	144
Patient potential	148
Marketing factors	153
Ximelagatran: performance against benchmark criteria	154
APPENDIX	156
Bibliography	156
Clinical trial data	156
Report methodology	158
Standard units	158
Japanese market data	159
B1C1 class	159
Additional information	159
About Datamonitor	160
About Datamonitor Healthcare	160
About the Cardiovascular analysis team	161
Key therapy team members	162
Allison Fleetwood, Director Cardiovascular analysis team	162
Disclaimer	163
List of Tables
Table 1: Antithrombotic sales in the seven major markets by drug class, 2002-03	10
Table 2: Key players in the antithrombotics market	12
Table 3: Sales of antiplatelet drug classes across the seven major markets in 2002-03	13
Table 4: Sales of the leading ADP receptor antagonists in the seven major markets during 2002-03	16
Table 5: Key results of CURE sub-study	19
Table 6: Plavix (clopidogrel): key US patents	23
Table 7: Sales of the leading cyclo-oxygenase inhibitors in the seven major markets during 2002-03	25
Table 8: Sales of the leading cAMP enhancers in the seven major markets during 2002-03	29
Table 9: Sales of the leading GPIIb/IIIas across the seven major markets in 2002-03 ($000s)	38
Table 10: Sales of the leading "other" antiplatelets across the seven major markets in 2002-03	50
Table 11: Sales of anticoagulant drug classes across the seven major markets, 2002-03	54
Table 12: Global sales of the leading brands of heparins, 2002-03	57
Table 13: Sales of the leading oral anticoagulants in the seven major markets during 2002-03	67
Table 14: Sales of the leading "other" anticoagulants in the seven major markets during 2002-03	72
Table 15: Sales of the leading thrombolytics across the seven major markets in 2002-03	87
Table 16: Prevalence of obesity in the seven major markets by age (000s), 2003	99
Table 17: Epidemiology of major antithrombotic indications for the seven major markets, 2003-11	100
Table 18: Exanta: elevated liver enzyme levels	145
Table 19: Exanta: anticipated market development	146
Table 20: Proportion of AF patients receiving antithrombotic therapy by level of risk of experiencing stroke	149
Table 21: Perception of Exanta compared to warfarin in SPAF	150
Table 22: AF patients receiving Exanta	150
List of Figures
Figure 1: Growth and market share of the antithrombotics drug classes, 2002-03	11
Figure 2: Growth and market share of the anticoagulant drug classes, 2002-03	14
Figure 3: Growth and market share of the leading ADP receptor antagonists, 2002-03	17
Figure 4: Growth and market share of the leading cyclo-oxygenase inhibitors, 2002-03	26
Figure 5: Growth and market share of the leading cAMP enhancers, 2002-03	30
Figure 6: Growth and market share of the leading GPIIb/IIIa inhibitors, 2002-03	39
Figure 7: Growth and market share of the leading "other" antiplatelets, 2002-03	51
Figure 8: Growth and market share of the anticoagulant drug classes, 2002-03	55
Figure 9: Growth and market share of the leading heparins in 2003	58
Figure 10: Growth and market share of the leading LMWHs in 2003	59
Figure 11: Growth and market share of the leading oral anticoagulants, 2002-03	68
Figure 12: Growth and market share of the leading "other" anticoagulants, 2002-03	73
Figure 13: Growth and market share of the thrombolytics drug class in 2003	88
Figure 14: Proportion of population over the age of 65, 1991 and 2000	98
Figure 15: Antithrombotic pipeline summary	102
Figure 16: Summary of regional opportunities and threats	129
Figure 17: Ximelagatran: performance against benchmark criteria	155

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