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
- Cardiovascular market
- 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
- Intellectual property risk assessment
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- 5EU opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- Summary of environmental issues affecting the cardiovascular market size
- Global opportunities and threats
- 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
- New product launches
- 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'
