Commercial Insight: Antithrombotics

Content

• 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 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: