Commercial Insight: Antithrombotics - Market expands as disease management focuses on prevention

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: