Commercial Insight: Antithrombotics - Market Expands As Disease Management Focuses On Prevention

Published by: Datamonitor

Published: Oct. 12, 2007 - 236 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the antithrombotics market

Key Opinion Leaders Interviewed for this report

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Disease definition

Definition of the antithrombotics market

Current market situation

Anticoagulants market

Heparins

Unfractionated Heparin

Low molecular weight heparin (LMWH)

Parenteral non-heparinoid anticoagulants

Direct Thrombin Inhibitors (DTIs)

Oral anticoagulants

Antiplatelets market

ADP receptor antagonists

Gp 2b/3a inhibitors

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

National markets

Anticoagulants

Antiplatelets

Current and future opportunities and threats in the antithrombotics market

Global opportunities and threats

Opportunity: increasing patient pool due to changes in demography and lifestyle

Opportunity :Big Pharma cannot ignore the emerging markets of India and China

Opportunity: Increasing co-operation between regulatory bodies

Threat: cost-conscious pricing and reimbursement environment

Threat: Mandatory registration of all clinical trial results

Threat: Increasingly conservative regulatory environments

Threat: Ongoing cost-containment measures

Threat: Parallel trade

Increasing generic competition

US

US opportunities

Price of drugs

Direct-to-consumer advertising

US threats

The changing healthcare environment in the US will drive future generic use

Healthcare expenditure is a concern for many Americans

There is a variety of generic substitution policies in place

Healthcare providers are implementing a range of incentives to boost generic use

Medicare Part D is expected to lead to greater generic use

The growing role of the patients in their healthcare choices will drive generic use

Pharmaceutical reimportation

Formularies promote quality, but restrict choice

Pricing and reimbursement issues

Curbing of DTC advertising will lead to greater emphasis on risk of products

Japan

Japan opportunities

Ageing population

An underdeveloped generics market slows brand erosion

Possible introduction of direct-to-consumer advertising

Multiple patent extensions and labeling regulations

Opening up the Japanese market

Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare

Harmonization of approval process

The Internet is an effective means to reach out to patients

Japan Threats

Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future

Flat sum reimbursement

Complex regulatory process

Biannual price cuts still threaten market growth

New healthcare reforms under debate

EU5: opportunities and threats

EU5 Opportunities

EU5 Threats

France: opportunities and threats

France opportunities

France threats

Germany: opportunities and threats

Germany opportunities

Germany Threats

Italy: opportunities and threats

Italy opportunities

Italy Threats

Spain: opportunities and threats

Spain opportunities

Spain threats

UK: opportunities and threats

UK opportunities

UK threats

SUMMARY of environmental issues affecting the antithrombotic market size

CHAPTER 4 FORECAST ANALYSIS

Key clinical trials

Key clinical trials in the anticoagulant category

Lovenox (enoxaparin)

Angiomax (bivalirudin)

Arixtra (fondaparinux)

Key clinical trials in the antiplatelet category

Plavix (clopidogrel)

Key assumptions and events

New products

Novel Anticoagulants

Xarelto (Bayer's rivaroxaban)

Rendix (Boehringer Ingelheim's dabigatran etexilate)

Apixaban (BMS and Pfizer)

Novel Antiplatelet Agents

Prasugrel

Cangrelor (The Medicines Company)

Ticagrelor (Astra Zeneca)

Datamonitor Comment on Emerging Antiplatelet Agents

Future outlook on key marketed products

Lovenox (enoxaparin)

Angiomax (bivalirudin)

Arixtra (fondaparinux)

Gp 2b/3a inhibitors

Generic incursion: patent expiries and marketing exclusivity

Limitations of data

Forecasts

CHAPTER 5 CASE STUDIES

Case study A - Clinical unmet need demands a replacement for warfarin

The limitations of warfarin

The market opportunity

Unmet Need 1: An oral anticoagulant that is more efficacious than warfarin in the real-life clinical setting

Unmet Need 2: An oral anticoagulant with no monitoring requirement

Unmet Need 3: An oral anticoagulant with less complex dosing than warfarin

The key contenders in development

The commercial potential of oral anticoagulants

Patient potential of oral anticoagulants

Sales forecast of the two most advanced oral anticoagulants

Forecast to 2016

Datamonitor comments

Rivaroxaban (BAY-597939)

Forecasts to 2016

Datamonitor comments

Conclusions

Case study B - Review of Legal Arguments Surrounding the BMS/Sanofi-Aventis versus Apotex Trial over generic Plavix

The Importance of Intellectual Property

Patent protection of Plavix (clopidogrel)

BMS/Sanofi-Aventis versus Apotex

Apotex had Three Main Positions at Trial

Argument 2 - Inequitable Conduct

Argument 3 - Double Patenting

Verdict

Market Impact

Datamonitor Assessment of Potential Market Impact

APPENDIX A

Bibliography

Report methodology

Standard units

Japanese market data

APPENDIX B - MARKET FORECAST DATA

US forecasts

Japan forecasts

France forecasts

Germany forecasts

Italy forecasts

Spain forecasts

UK forecasts

M5EU forecasts

7MM forecasts

About Datamonitor

About Datamonitor Healthcare

About the Cardiovascular Disease analysis team

Disclaimer

List of Tables

Table 1: Sales of antithrombotics in the seven major markets by drug category, 2005-06

Table 2: Sales of anticoagulants in the seven major markets by drug class, 2006

Table 3: The heparin market is dominated by LMWHs, 2006

Table 4: Growth and market share of the LMWHs in the seven major markets, 2006

Table 5: Growth and market share within the DTI subsegment of the parenteral non-heparinoid segment, 2006

Table 6: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2006

Table 7: Warfarin sales in the seven major markets, 2006

Table 8: Sales of antiplatelets in the seven major markets by drug class, 2006

Table 9: Sales of thienopyridines in the seven major markets by drug class, 2006

Table 10: Gp 2b/3a receptor properties: overview

Table 11: Growth and market share within the Gp2b/3a inhibitors, 2006

Table 12: Antithrombotics market in the seven major markets by country, 2006

Table 13: Anticoagulant market in the seven major markets by country, 2006

Table 14: Antiplatelet market in the seven major markets by country, 2006

Table 15: The ageing population in the seven major markets, 2006-2015

Table 16: Prevalence of obesity in six major markets by age (000s), 2005

Table 17: Prevalence of overweight in the six of the seven major markets by age (000s), 2005

Table 18: Patient dynamics in cardiovascular conditions in the seven major markets, 2005-2015 (000s)

Table 19: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D, 2006

Table 20: An example of the savings to be realized by using generic drugs in the Japanese market, 2006

Table 21: Key results of CURE substudy

Table 22: COMMIT/CCS-2 trial: efficacy endpoints

Table 23: COMMIT/CCS-2 trial: safety endpoints

Table 24: COMMIT/CCS-2 trial: time to treatment

Table 25: COMMIT/CCS-2 trial: thrombolytic background therapy

Table 26: ARMYDA-2: number of events at 30 days

Table 27: ARMYDA-2: postprocedural peak biomarker levels

Table 28: ARMYDA-2: percentage of patients with an elevation of CKMB/troponin I

Table 29: ARMYDA-2: number of bleeding events at 30 days

Table 30: Generic incursion in the sales of key products within the forecasting period, 2006-2016

Table 31: Phase III anticoagulants (long-term indications), 2006

Table 32: US antithrombotic forecasts ($m), 2006-2016

Table 33: Japan antithrombotic forecasts ($000s), 2006-2016

Table 34: France antithrombotic forecasts ($000s), 2006-2016

Table 35: Germany antithrombotic forecasts ($000s), 2006-2016

Table 36: Italy antithrombotic forecasts ($000s), 2006-2016

Table 37: Spain antithrombotic forecasts ($000s), 2006-2016

Table 38: UK antithrombotic forecasts ($000s), 2006-2016

Table 39: M5EU antithrombotic forecasts ($ m), 2006-2016

Table 40: 7MM antithrombotic forecasts ($ m), 2006-2016

List of Figures

Figure 1: Sales of antithrombotics in the seven major markets, 2006

Figure 2: Sales of anticoagulants in the seven major markets by drug class, 2006

Figure 3: The heparin market is dominated by LMWHs, 2006

Figure 4: The broad indication roll-out of Lovenox (enoxaparin) is a barrier to market entry and penetration of novel anticoagulants

Figure 5: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2006

Figure 6: Risk of stroke increases with age

Figure 7: Sales of antiplatelets in the seven major markets by drug class, 2006

Figure 8: Antithrombotics market in the seven major markets by country, 2006

Figure 9: Anticoagulant market in the seven major markets by country, 2006

Figure 10: Antiplatelet market in the seven major markets by country, 2006

Figure 11: Increase in obese and overweight adults in the US, 1976-2000

Figure 12: Generalized distribution chain for parallel traded pharmaceutical products

Figure 13: More than half of all prescriptions dispensed in the US are generics, 1994-2005

Figure 14: Generic companies dominate the US pharmaceutical market in terms of prescriptions

Figure 15: Generic use in the US is promoted through a number of channels

Figure 16: The tiered co-payment system will lead to greater use of generics

Figure 17: Key pressures facing drug developers, 1990-2004

Figure 18: The Japanese generic market is underdeveloped because of a number of factors

Figure 19: 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 20: Summary of global and EU specific opportunities and threats affecting the antithrombotics market, 2006

Figure 21: Summary of country-specific opportunities and threats affecting the US and Japanese antithrombotics markets, 2006

Figure 22: Summary of country-specific opportunities and threats affecting the EU5 antithrombotics markets, 2006

Figure 23: COMMIT/CCS-2 trial: dual antiplatelet therapy in AMI

Figure 24: ARMYDA-2: trial design

Figure 25: Datamonitor's projected sales for Rendix (dabigatran etexilate, BIBR-1048) in across the seven major markets ($m), 2007-2016.

Figure 26: Datamonitor's projected sales for rivaroxaban (BAY-59-7939) in across the seven major markets ($m), 2007-2016

Figure 27: Apotex's argument on obviousness

Figure 28: Apotex's argument on inequitable conduct

.Figure 29: Market share garnered by generic clopidogrel

Figure 30: Forecast generic erosion of the Plavix brand

Figure 31:

Abstract

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