抗血栓剤

Abstract

Overview

Introduction

The ageing of the population will result in an increased incidence of coronary artery disease, heart failure and stroke. In addition to these epidemiological forces, the antithrombotics market will be sustained by the forthcoming launch of innovative novel agents whose sales revenue is expected to dampen the commercial impact of generic incursion in blockbuster proceeds.

Scope

• Country specific event-driven sales forecasts for the period 2006-15 for the US, Japan, France, Germany, Italy, Spain and the UK.
• Discussion of recent trials and market-shaping 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 evaluating the commercial impact of two developmental agents with blockbuster potential.

Report Highlights

Demographic trends lead to an increase in the patient population requiring antithrombotic therapy. However, the rising age of the population across all developed regions is increasing the fiscal burden on healthcare payors which are likely to respond by limiting the reimbursement potential of therapies and put pricing pressure on all agents.

The highest selling brands in the antidiabetics market are Lovenox (enoxaparin) and Plavix (clopidogrel), but these agents are subject to forthcoming genericization and will thus not contribute to the growth of the antithrombotics market in the medium-to-long term. Pipeline agents are expected to become significant drivers in the market.

The antithrombotics market is characterized by pockets of high unmet need and a broad spectrum of similarly efficacious therapeutic strategies. There is regional bias in the choice and popularity of therapeutic strategies driven by cultural reasons as well as infrastructural confines.

Reasons to Purchase

• Quantify future size and scope of the antithrombotics market and potential for new products
• Analyze options to expand commercial potential through pursuit of new indications
• Formulate successful launch strategies in a highly competitive mature market

Table of Contents

• ABOUT HEALTHCARE
  • About the Cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
• CHAPTER 2 MARKET DEFINITION AND OVERVIEW
  • Market definition for this report
  • Current market situation
    • Antithrombotics market: overview
    • Anticoagulants market
      • Heparins
      • Low molecular weight heparin (LMWH)
      • Parenteral non-heparinoid anticoagulants
      • Oral anticoagulants
    • Antiplatelets market
      • ADP receptor antagonists
      • cAMP enhancing platelet aggregation inhibitors
      • GP 2b/3a inhibitors
      • Other antiplatelets
    • Thrombolytics market
    • National markets
      • Anticoagulants
      • Antiplatelets
      • Thrombolytics
  • 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 clinical trials in the thrombolytics category
      • TNK (tenecteplase)
      • Actilyse (tPA, alteplase)
• CHAPTER 3 COUNTRY MARKET ASSESSMENTS
  • 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
      • Threat: cost-conscious pricing and reimbursement environment
    • US
      • US opportunities
      • US threats
    • Japan
      • Japan opportunities
      • Japan threats
    • 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 assumptions and events
    • New products
    • Future outlook on key marketed products
      • Lovenox (enoxaparin)
      • Angiomax (bivalirudin)
      • Arixtra (fondaparinux)
      • Plavix (clopidogrel)
      • GP 2b/3a inhibitors and thrombolytics
    • Generic incursion: patent expiries and marketing exclusivity
  • Limitations of data
  • Forecasts
• CHAPTER 5 CASE STUDIES: KEY PIPELINE AGENTS
  • Case study A - What commercial potential does the oral anticoagulant market segment harbor?
    • The market opportunity
      • Warfarin' s monitoring requirement and dosing complexity generates an opening in the market for novel oral anticoagulants
      • Oral antiplatelets are unlikely to threaten commercial potential of emerging oral anticoagulants
      • The key competitors in development
    • The commercial potential of oral anticoagulants
      • Patient potential of oral anticoagulants
      • Sales forecast of the two most advanced oral anticoagulants
    • Conclusions
  • Case study B - Will prasugrel capture the antiplatelet market?
    • The market opportunity
      • The unmet need profile of the antiplatelet market indicates opportunities for novel antiplatelets.
    • Commercial potential of prasugrel
      • Drug overview: prasugrel (CS-747)
      • Sales forecast of prasugrel
• 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
  • Global forecasts
    • Disclaimer
  • List of Tables
    • Table 1: Sales of antithrombotics in the seven major markets by drug category, 2004-05
    • Table 2: Sales of anticoagulants in the seven major markets by drug class, 2005
    • Table 3: The heparin market is dominated by LMWHs, 2005
    • Table 4: Growth and market share of the LMWHs in the seven major markets, 2005
    • Table 5: Growth and market share of the "other LMWHs" in the seven major markets, 2005
    • Table 6: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2005
    • Table 7: Growth and market share within the DTI subsegment of the parenteral non-heparinoid segment, 2005
    • Table 8: Warfarin sales in the seven major markets, 2005
    • Table 9: Sales of antiplatelets in the seven major markets by drug class, 2005
    • Table 10: Sales of thienopyridines in the seven major markets by drug class, 2005
    • Table 11: Platelet cAMP enhancers are heavily prescribed in Japan, 2005
    • Table 12: Sales of platelet cAMP enhancers in the seven major markets by value, 2005
    • Table 13: GP 2b/3a receptor properties: overview
    • Table 14: Sales of GP 2b/3a inhibitors in the seven major markets by value, 2005
    • Table 15: Sales of "COX inhibitors and other antiplatelets" in the seven major markets by value, 2005
    • Table 16: Sales of thrombolytics in the seven major markets by drug class, 2005
    • Table 17: Comparison of tPA-based thrombolytics
    • Table 18: Antithrombotics market in the seven major markets by country, 2005
    • Table 19: Anticoagulant market in the seven major markets by country, 2005
    • Table 20: Antiplatelet market in the seven major markets by country, 2005
    • Table 21: Thrombolytics market in the seven major markets by country, 2005
    • Table 22: Key results of CURE substudy
    • Table 23: COMMIT/CCS-2 trial: efficacy endpoints
    • Table 24: COMMIT/CCS-2 trial: safety endpoints
    • Table 25: COMMIT/CCS-2 trial: time to treatment
    • Table 26: COMMIT/CCS-2 trial: thrombolytic background therapy
    • Table 27: ARMYDA-2: number of events at 30 days
    • Table 28: ARMYDA-2: postprocedural peak biomarker levels
    • Table 29: ARMYDA-2: percentage of patients with an elevation of CKMB/troponin I
    • Table 30: ARMYDA-2: number of bleeding events at 30 days
    • Table 31: The ageing population in the seven major markets, 2006-2015
    • Table 32: Prevalence of obesity in six major markets by age (000s), 2005
    • Table 33: Prevalence of overweight in the six of the seven major markets by age (000s), 2005
    • Table 34: Patient dynamics in cardiovascular conditions in the seven major markets, 2005-2015 (000s)
    • Table 35: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005
    • Table 36: Generic incursion in the sales of key products within the forecasting period, 2006-2015
    • Table 37: Phase III anticoagulants (long-term indications), 2006
    • Table 38: Comparison of antiplatelet, antithrombotic, and antihemostatic effects of prasugrel, clopidogrel and ticlopidine
    • Table 39: Number of adverse events in Phase IIa prasugrel dose-ranging study
    • Table 40: JUMBO-TIMI 26: patient characteristics
    • Table 41: JUMBO-TIMI 26: primary endpoint (significant bleeding)
    • Table 42: JUMBO-TIMI 26: TIMI major bleeding
    • Table 43: JUMBO-TIMI 26: total bleeding episodes (TIMI major/minor and minimal)
    • Table 44: JUMBO-TIMI 26: secondary endpoint (MACE)
    • Table 45: JUMBO-TIMI 26: MACE components
    • Table 46: US antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 47: Japan antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 48: France antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 49: Germany antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 50: Italy antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 51: Spain antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 52: UK antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 53: 5MEU antithrombotic sales forecasts ($m; 2005 figures are actuals)
    • Table 54: Global antithrombotic sales forecasts ($m; 2005 figures are actuals)
  • List of Figures
    • Figure 1: Sales of antithrombotics in the seven major markets, 2005
    • Figure 2: Sales of anticoagulants in the seven major markets by drug class, 2005
    • Figure 3: The heparin market is dominated by LMWHs, 2005
    • Figure 4: Growth and market share of the LMWHs in the seven major markets, 2005
    • Figure 5: The broad indication roll-out of Lovenox (enoxaparin) is a barrier to market entry and penetration of novel anticoagulants
    • Figure 6: Growth and market share of parenteral non-heparinoid anticoagulants in the seven major markets, 2005
    • Figure 7: Risk of stroke increases with age
    • Figure 8: Sales of antiplatelets in the seven major markets by drug class, 2005
    • Figure 9: Sales of platelet cAMP enhancers in the seven major markets by value, 2005
    • Figure 10: Majority of the sales in "Other platelet cAMP enhancers" segment are confined to Japan, 2005
    • Figure 11: Sales of GP 2b/3a inhibitors in the seven major markets by value, 2005
    • Figure 12: Sales of "COX inhibitors and other antiplatelets" in the seven major markets by value, 2005
    • Figure 13: Sales of thrombolytics in the seven major markets by drug class, 2005
    • Figure 14: Antithrombotics market in the seven major markets by country, 2005
    • Figure 15: Anticoagulant market in the seven major markets by country, 2005
    • Figure 16: Antiplatelet market in the seven major markets by country, 2005
    • Figure 17: Thrombolytics market in the seven major markets by country, 2005
    • Figure 18: COMMIT/CCS-2 trial: dual antiplatelet therapy in AMI
    • Figure 19: ARMYDA-2: trial design
    • Figure 20: Increase in obese and overweight adults in the US, 1976-2000
    • Figure 21: A fall in reference prices is likely to lead to greater use of generics
    • Figure 22: 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 23: Summary of global and EU specific opportunities and threats affecting the antithrombotics market, 2006
    • Figure 24: Summary of country-specific opportunities and threats affecting the US and Japanese antithrombotics markets, 2006
    • Figure 25: Summary of country-specific opportunities and threats affecting the EU5 antithrombotics markets, 2006
    • Figure 26: Sales forecasts for Rendix in the seven major markets, 2008-2015
    • Figure 27: Sales forecasts for rivaroxaban in the seven major markets, 2008-2015
    • Figure 28: Randomized two-way cross-over study in healthy subjects
    • Figure 29: Randomized, partially blind, parallel group dose-ranging study
    • Figure 30: JUMBO-TIMI 26: prasugrel in the setting of PCI
    • Figure 31: TRITON-TIMI-38: trial design
    • Figure 32: Sales forecasts for prasugrel in the seven major markets, 2008-2015