心血管疾患治療薬市場概要

Abstract

Overview

Introduction

Datamonitor expects the cardiovascular market to remain stable with sales only showing negligible growth between 2006 and 2016, below the 3% growth predicted for the SU sold. Generic products will become increasingly important as the majority of products will have lost IP protection, accounting for 30% of cardiovascular sales and 65% of SU sold in 2016.

Scope

• Comprehensive analysis of the cardiovascular market by disease area in each of the seven major markets
• An assessment of trends within the cardiovascular market between 2003 and 2006.
• Intellectual Property risk assessment for Top 10 brands in each market.
• Forecast models for key brands, active agents and pipeline products up to 2016.

Report Highlights

The cardiovascular market in the seven major markets is a mature market with negligible sales growth between 2006 and 2016. Growth of SU sold in the cardiovascular market is expected to increase by 3%, driven by population growth, leaving an effective cardiovascular sales growth of -3%.

Use of generics will increase as key products lose patent protection and healthcare providers push for greater cost containment. Patent expiries during the pivotal 2010-13 window expose $30.9 billion worth of branded drugs to generic competition.

Cardiovascular pipeline products are unlikely to make a significant impact on the market with only 16% ($11.9 billion) of 2016 sales generated from the current pipeline. A number of blockbuster products are likely to be launched but the sales are likely to be greatly reduced from the levels seen in 2006.

Reasons to Purchase

• Understand market specific drivers and predict the future potential of key cardiovascular brands
• Quantify the impact of key patent expiries and product launches and gain a valuable insight into the market dynamics
• Consider, assess and react to opportunities and risks influencing the leading cardiovascular brands

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the cardiovascular market
  • Related reports
  • Upcoming reports
• CHAPTER 2 MARKET OVERVIEW AND DYNAMICS
  • Cardiovascular market
    • Seven major markets
  • Cardiovascular market by disease area
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • The Top 25 cardiovascular active agents
  • The Top 25 cardiovascular brands
  • Geographical variations
    • Top 25 active agents
    • Top 25 brands
    • Disease areas
      • Hypertension
      • Dyslipidemia
      • Diabetes
      • Thrombosis
• CHAPTER 3 MARKET ANALYSIS
  • Intellectual property risk assessment
    • Seven major markets
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • Key patent expiries
    • Patent challenges
  • Company portfolio assessment
    • The Top 25 cardiovascular companies
    • The Top 10 cardiovascular companies profiles
      • Pfizer
      • Sanofi-Aventis
      • Merck & Co
      • Amgen
      • Novartis
      • Takeda
      • GlaxoSmithKline
      • Bristol-Myers Squibb
      • AstraZeneca
      • Novo Nordisk
    • Company vulnerability
    • Sales - winners and losers
    • SUs sold - winners and losers
  • Drug pricing
  • The generic threat
    • Major brands facing generic erosion during forecast period
    • Reformulations and evergreening
    • Biosimilars
• CHAPTER 4 COUNTRY MARKET ASSESSMENTS
  • Global opportunities and threats
    • Opportunities
      • Demographic and lifestyle trends continue to dominate the agenda, and have the potential to increase the hypertensive patient population
      • Large patient population and low treatment goals in dyslipidemia
      • Development of novel compounds
      • Growing awareness of the metabolic syndrome
      • Increasing co-operation between regulatory bodies
      • The emerging markets of India and China cannot be ignored
    • Threats
      • Increased generic competition
      • Parallel trade
      • New EU states may lead to a flood of cheap drug exports
      • Ongoing cost-containment measures
      • Increasingly conservative regulatory environments
      • Restrictive pricing and reimbursement policies
      • Reduced periods of market exclusivity
      • Mandatory registration of all clinical trial results
  • US: opportunities and threats
    • Opportunities
      • Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates
      • Leveraging the JNC7 guidelines to maximize pharmacotherapy
      • Leveraging the NCEP ATP III guidelines
      • Lower targets will intensify the treatment of diabetes
      • Price of drugs
    • Threats
      • The changing healthcare environment in the US will drive future generic use
      • Generics
      • Medicare Part D is expected to lead to greater generic use
      • Patient power
      • Pharmaceutical re-importation issues continue to dog Big Pharma
      • Further genericization encouraged by new legislation and public programs
      • Formularies promote quality, but restrict choice
      • Pricing and reimbursement issues
      • $10 billion cut planned in Medicaid between 2005 and 2010
      • Curbing of DTC advertising will lead to greater emphasis on risk of products
      • Wal-Mart $4 a day generic program introduces further cost competition
      • The obesity epidemic
  • Japan: opportunities and threats
    • Opportunities
      • Ageing population
      • Separation of manufacturing and marketing entities benefits both Japanese and foreign companies
      • Fewer outsourcing restrictions enhances manufacturing efficiency
      • 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
      • Reduced product approval time
      • Harmonization of approval process
    • Threats
      • Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future
      • Generic drug use is expected to increase
      • Flat-sum reimbursement
      • Complex regulatory process
      • Biannual price cuts still threaten market growth
      • New healthcare reforms under debate
  • 5EU: opportunities and threats
    • 5EU opportunities
      • Revisions to EU pharmaceutical laws
      • Extra year of marketing protection
    • 5EU threats
      • Single European pricing
      • Facilitated entry of generics
      • Generic substitution
      • Finalization of biosimilar legislation
      • Parallel trade
      • Formulary changes
  • France: opportunities and threats
    • Opportunities
      • Innovation encouraged in the pharmaceutical industry
      • Demographic changes provide opportunity for market expansion of chronic illnesses
      • Consumers in France readily recognize the Internet as a source of high-quality medical information
      • Generic consumption in France is particularly low
    • Threats
      • Attractiveness of French market hit by higher taxes, lower prices and a shorter reimbursement list
      • Continuation of cost-control measures
      • Formulary access
      • Take-off of generic sector
      • Limitations on prescriptions dispensed from hospitals to patients in the community
      • Pharmacists are being mandated to drive generic dispensing
  • Germany: opportunities and threats
    • Opportunities
      • Pricing freedom supports innovation
      • ePharmacy and mail-order drugs legalized
    • Threats
      • Cost-containment measures in Germany have led to a healthy generics market
      • German doctors set to receive bonuses for prescribing generics
  • Italy: opportunities and threats
    • Opportunities
      • Single agency holds regulatory authority
      • Negligible impact of generics is set to continue
      • Innovative drug development rewarded with premium price and 100% reimbursement
    • Threats
      • Single agency holds regulatory authority
      • Ongoing cost-containment measures
      • Stringent reference pricing system
      • Restructured reimbursement categories
      • Further pharmaceutical price cuts planned
      • Intellectual property to conform with rest of EU
  • Spain: opportunities and threats
    • Opportunities
      • Underdeveloped generics market both an opportunity and a threat
      • Electronic prescribing will improve access to treatments and promote the rational use of drugs
    • Threats
      • Increased scrutiny of new drugs
      • R&D activity expected to decline
      • Reference pricing systems (RPS) likely to have an impact on branded revenues
      • Compulsory patient co-payments
      • Government awareness campaign promotes generic use
      • New medicines bill pushes more price cuts and increases pharmaceutical tax
  • UK: opportunities and threats
    • Opportunities
      • Attractiveness of market
      • Supplementary and expanded prescribing powers
      • New fast-track drug assessment process speeds up time between licensing and NICE recommendations
      • NICE guidance advises against the use of betablockers
      • GMS contract improvements
    • Threats
      • The National Institute of Clinical Excellence (NICE)
      • Pricing controls dominate budgetary cost containment strategies
      • The NHS is unreceptive to new treatments compared to the rest of Europe
      • Falling foul of the ABPI, the UK' s Pharma watchdog
      • Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts
      • Cost containment measures encourage continued high use of generics
      • Public space smoking ban
  • Summary of environmental issues affecting the cardiovascular market size
• CHAPTER 5 FORECAST ANALYSIS
  • New product launches
    • Tekturna/Rasilez (Aliskiren) marketed by Novartis
    • Exforge (amlodipine + valsartan) marketed by Novartis
    • Byetta LAR
    • Januvia
    • Zetia (ezetimibe) in Japan
  • Sales forecast 2006-2016
  • Case studies
    • Avandia - FDA negligence or political grandstanding?
    • Pfizer' s sales ' cliff'
  • Where to next?
    • Exit the franchise
    • Cost control
    • R&D productivity
    • Licensing and M&A
    • Blockbuster to nichebuster
    • The rise of Japan
    • Emerging markets
  • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
  • Forecasts
  • Forecast methodology
• APPENDIX A - BIBLIOGRAPHY
  • Journals
  • Press releases
  • Web articles
  • Databases
  • Datamonitor reports
• APPENDIX B - MARKET FORECAST DATA
  • US forecasts
  • Japan forecasts
  • France forecasts
  • Germany forecasts
  • Italy forecasts
  • Spain forecasts
  • UK forecasts
  • 5EU forecasts
  • Seven major market forecasts
• APPENDIX C
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • Disclaimer
  • List of Tables
    • Table 1: Top 25 cardiovascular active agents in the seven major markets, 2003-2016
    • Table 2: Top 25 cardiovascular brands in the seven major markets, 2003-2016
    • Table 3: Key patent expiries during the forecast period, 2006-2016
    • Table 4: Significant Paragraph IV challenges to Top 25 brands in US, September 2007
    • Table 5: Top 25 cardiovascular companies in the seven major markets by sales, 2003-06
    • Table 6: Top 25 cardiovascular companies in the seven major markets by SUs sold, 2003-06
    • Table 7: Prevalence of obesity in six major markets by age (000s), 2005
    • Table 8: Five generics companies are among the Top 10 companies in terms of prescriptions filled under Medicare Part D, 2006
    • Table 9: The actual generic fill rate varies between therapeutic classes, 2006
    • Table 10: Wal-Mart is selling many generic antihypertensives for less than the mean price per standard unit in the US in 2006
    • Table 11: An example of the savings to be realized by using generic drugs in the Japanese market, 2006
    • Table 12: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005
    • Table 13: Sales forecast for the major brands and active agents in the US ($ million), 2006-16
    • Table 14: Sales forecast for the major brands and active agents in the Japan ($ million), 2006-16
    • Table 15: Sales forecast for the major brands and active agents in the France ($ million), 2006-16
    • Table 16: Sales forecast for the major brands and active agents in the Germany ($ million), 2006-16
    • Table 17: Sales forecast for the major brands and active agents in the Italy ($ million), 2006-16
    • Table 18: Sales forecast for the major brands and active agents in the Spain ($ million), 2006-16
    • Table 19: Sales forecast for the major brands and active agents in the UK ($ million), 2006-16
    • Table 20: Sales forecast for the major brands and active agents in the 5 EU ($ million), 2006-16
    • Table 21: Sales forecast for the major brands and active agents in the seven major markets ($ million), 2006-16
  • List of Figures
    • Figure 1: Cardiovascular sales and Standard Units sold in the seven major markets, 2003-06
    • Figure 2: Geographical distribution of cardiovascular sales in the seven major markets by value, 2003 and 2006
    • Figure 3: Geographical distribution of cardiovascular sales in the seven major markets by volume, 2003 and 2006
    • Figure 4: Cardiovascular sales in the seven major markets by value ($ billion), 2003-06
    • Figure 5: Cardiovascular sales in the seven major markets by volume (SUs), 2003-06
    • Figure 6: Cardiovascular sales in the seven major markets by disease area, 2006
    • Figure 7: Cardiovascular sales in the seven major markets by disease area, 2016
    • Figure 8: US cardiovascular sales by disease area, 2003-06
    • Figure 9: Japanese cardiovascular sales by disease area, 2003-06
    • Figure 10: French cardiovascular sales by disease area 2003-06
    • Figure 11: German cardiovascular sales by disease area, 2003-06
    • Figure 12: Italian cardiovascular sales by disease area, 2003-06
    • Figure 13: Spanish cardiovascular sales by disease area, 2003-06
    • Figure 14: UK cardiovascular sales by disease area, 2003-06
    • Figure 15: Top 10 cardiovascular active agents in the seven major markets by sales, 2003-2016
    • Figure 16: Total sales of the top 10 and top 25 active agents in the seven major markets, 2003-2016
    • Figure 17: Top 10 cardiovascular branded/licensed/generic active agents in the seven major markets, 2006
    • Figure 18: Top 10 cardiovascular brands in the seven major markets by sales, 2003-2016
    • Figure 19: Growth of top 10 and top 25 brands by sales in the seven major markets, 2003-16
    • Figure 20: Geographical variations in sales and launch of the Top 25 active agents in the seven major markets, 2006
    • Figure 21: Geographical variations in sales and launch of the Top 25 brands in the seven major markets, 2006
    • Figure 22: Leading mechanisms of action in the hypertension market by SUs sold in the seven major markets, 2003-06
    • Figure 23: National hypertension markets split by main mechanism of action and SUs sold in the seven major markets, 2006
    • Figure 24: Leading mechanisms of action in the hypertension market by sales value in the seven major markets, 2003-06
    • Figure 25: National hypertension markets split by main mechanism of action and sales in the seven major markets, 2006
    • Figure 26: Dyslipidemia market split by main mechanism of action and SUs sold in the seven major markets, 2003-06
    • Figure 27: National dyslipidemia markets split by main mechanism of action and SUs sold in the seven major markets, 2006
    • Figure 28: Dyslipidemia market split by sales of statins and other mechanisms in the seven major markets, 2003-06
    • Figure 29: National dyslipidemia market sales split by main mechanism of action and sales in the seven major markets, 2006
    • Figure 30: Diabetes market split by main mechanisms of action and SUs sold in the seven major markets, 2003-06
    • Figure 31: National diabetes markets split by main mechanisms of action and SUs sold in the seven major markets, 2006
    • Figure 32: Leading mechanisms of action in the diabetes market by sales in the seven major markets, 2003-06
    • Figure 33: National diabetes markets split by main mechanisms of action and sales in the seven major markets, 2006
    • Figure 34: Leading mechanisms of action in the thrombosis market by sales in the seven major markets, 2003--06
    • Figure 35: National thrombosis markets split by main mechanisms of action and SUs sold in the seven major markets, 2006
    • Figure 36: Leading mechanisms of action in the thrombosis market by sales in the seven major markets, 2003-06
    • Figure 37: National thrombolytic markets split by main mechanism of action and sales in the seven major markets, 2006
    • Figure 38: Intellectual property risk assessment - division of risk field
    • Figure 39: Intellectual property risk assessment of Top 10 brands in the seven major markets, weighted by 2006 sales
    • Figure 40: Intellectual property risk assessment of Top 10 US brands, weighted by 2006 sales
    • Figure 41: Intellectual property risk assessment of Top 10 Japanese brands, weighted by 2006 sales
    • Figure 42: Intellectual property risk assessment of Top 10 French brands, weighted by 2006 sales
    • Figure 43: Intellectual property risk assessment of Top 10 German brands, weighted by 2006 sales
    • Figure 44: Intellectual property risk assessment of Top 10 Italian brands, weighted by 2006 sales
    • Figure 45: Intellectual property risk assessment of Top 10 Spanish brands, weighted by 2006 sales
    • Figure 46: Intellectual property risk assessment of Top 10 UK brands, weighted by 2006 sales
    • Figure 47: Vulnerability of Top 10 cardiovascular companies by sales, 2003-06
    • Figure 48: Vulnerability of Top 10 cardiovascular companies by SUs sold, 2003-06
    • Figure 49: IP assessment of Top 10 brands in the seven major markets and their importance to the marketing companies, weighted by 2006 sales
    • Figure 50: Overall sales growth of the 10 best-performing companies out of the Top 25 cardiovascular players in the seven major markets, 2003-06
    • Figure 51: Overall sales performance of the 10 worst-performing companies out of the top 25 cardiovascular players in the seven major markets, 2003-06
    • Figure 52: Cardiovascular sales growth of the 10 best-performing companies out of the Top 25 pharmaceutical companies in the seven major markets, 2003-06
    • Figure 53: Cardiovascular sales growth of the 10 worst-performing of the Top 25 pharmaceutical companies in the seven major markets, 2003-06
    • Figure 54: Overall SUs sold growth of the 10 best-performing of the Top 25 cardiovascular companies in the seven major markets, 2003-06
    • Figure 55: Overall SUs sold growth of the 10 worst-performing of the Top 25 cardiovascular companies in the seven major markets, 2003-06
    • Figure 56: Cardiovascular SUs sold growth of the 10 best-performing of the Top 25 pharmaceutical companies in the seven major markets, 2003-06
    • Figure 57: Cardiovascular SUs sold growth of the 10 worst-performing of the top 25 pharmaceutical companies in the seven major markets, 2003-06
    • Figure 58: National price variations from the mean for the seven major markets, 2006
    • Figure 59: Branded drugs as a proportion of the Top 25 cardiovascular active agents, 2003-06
    • Figure 60: US patent expiries of the Top 10 brands, 2006-2016
    • Figure 61: Proportion of population aged 60-79 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004
    • Figure 62: Generalized distribution chain for parallel traded pharmaceutical products
    • Figure 63: JNC6 and JNC7 compared: classification of blood pressure levels
    • Figure 64: More than half of all prescriptions dispensed in the US are generics, 1984-2005
    • Figure 65: Generic companies dominate the US pharmaceutical market in terms of prescriptions, 2006
    • Figure 66: Generic use in the US is promoted through a number of channels
    • Figure 67: The generic fill rates in the US for 2003 varied considerably by state
    • Figure 68: The tiered co-payment system will lead to greater use of generics
    • Figure 69: Key pressures facing drug developers, 1990-2004
    • Figure 70: Wal-Mart' s $4 generic drug program web-page
    • Figure 71: The Japanese generic market is underdeveloped because of a number of factors
    • Figure 72: Summary of global opportunities and threats affecting the cardiovascular market, 2007
    • Figure 73: Summary of regional opportunities and threats affecting the cardiovascular market, 2007
    • Figure 74: Impact of cardiovascular pipeline on total sales, 2006-2016
    • Figure 75: Sales growth in the main geographical regions, 2003-2016)
    • Figure 76: Growth in cardiovascular sales by disease area, 2006-2016
    • Figure 77: The future is generics - cardiovascular sales, 2006-2016
    • Figure 78: Avandia and Actos sales, 2006-16
    • Figure 79: Pfizer' s cardiovascular sales ' cliff'