抗血栓剤市場

Abstract

Overview

Introduction

Datamonitor expects the antithrombotics market to peak at just over $20 billion in 2012, across the seven major markets. The growth will be driven by the uptake of the novel oral anticoagulants - Bayer' s Xarelto and BI' s Rendix - which are expected to launch simultaneously, in 2008.

Scope

• Event-driven sales forecasts for 2007-16 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan.
• Country and market specific issues that will impact sales opportunities and market landscape, including key patent expiries and product launches.
• Case studies assessing the possibility that a novel, oral anticoagulant may replace warfarin; and detailing the Plavix patent dispute with Apotex.
• Analysis of the main antithrombotics drugs, with a qualitative assessment of their future market potential, backed-up by thought-leader opinion.

Highlights

The antithrombotics market is mature, however, the possibility of engineering a replacement for warfarin, or a side-effect free, oral anticoagulant suitable for chronic anticoagulation does represent an attractive opportunity for R&D expenditure. The simultaneous launch of FXa inhibitor Xarelto, and DTI, Rendix, will occur in 2008.

Cost containment initiatives, promoting the prescription of generic drugs, are being introduced across the seven major markets and will constrain growth. However, a paradigm shift towards thrombosis prophylaxis, will expand the oral anticoagulant markets in terms of stroke prevention in atrial fibrillation and post-surgical patient populations.

Sanofi-Aventis' s Lovenox (enoxaparin) is the dominant LMWH, generating sales of $3.0 billion in 2006 and thereby accounting for 72% of the overall heparin market and 80% of the LMWH market. However, the Lovenox patent expires in 2012 and so Lovenox revenues will be subject to generic erosion over the forecast period.

Reasons to Purchase

• Quantify the future size of the antithrombotics market and identify opportunities for new products.
• Learn how the premature expiry of the Plavix patent would have shaped the market and understand why Apotex chose to launch a generic "at risk".
• Understand the barriers to uptake that novel anticoagulants may experience in attempting to replace warfarin.

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
    • 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: