Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the hypertension market
- Contributing experts
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Definition of drug classes included
- Current market situation
- The antihypertensives market segmented by class
- The antihypertensives market segmented by country
- Antihypertensive market landscape
- Market growth and market restraint
- Factors driving growth of the antihypertensives market
- Factors restraining growth of the antihypertensives market
- Strategic scope and report focus
- US antihypertensives market dynamics
- Consideration of market unmet needs
- Conflicting evidence from clinical trials and guideline alterations
- Paradigm shift in antihypertensive R&D
- Defining the unmet need in the antihypertensives market
- Need beyond cosmetic blood pressure reduction
- Improved diagnosis
- Improved blood pressure management
- Increased uptake of fixed-dose combination therapies
- Targeting global cardiovascular risk and target organ damage
- Patient and primary care physician education
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Seven major market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Demographic and lifestyle trends continue to dominate the agenda,
and have the potential to increase the hypertensive patient population
- Big Pharma cannot ignore the emerging markets of India and China
- Novel products are expected, but innovation is lacking in
antihypertensive R&D
- Growing awareness of the metabolic syndrome
- Increasing co-operation between regulatory bodies
- Threats
- Increased generic competition
- Parallel trade
- 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: market level assessment, opportunities and threats
- Market level assessment
- 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
- Price of drugs
- Threats
- The changing healthcare environment in the US will drive future
generic use
- Medicare Part D is expected to lead to greater generic use
- Patient power
- Pharmaceutical re-importation issues continue to dog Big Pharma
- Formularies promote quality, but restrict choice
- Pricing and reimbursement issues
- Curbing of DTC advertising will lead to greater emphasis on risk of
products
- Wal-Mart $4 a day generic program introduces further cost competition
- Japan: market level assessment, opportunities and threats
- Market level assessment
- 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
- Reduced product approval time
- Harmonization of approval process
- The Internet is an effective means to reach out to patients
- 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
- France: market level assessment, opportunities and threats
- Market level assessment
- 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
- 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
- Market level assessment
- Opportunities
- Pricing freedom which 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: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Single agency holds regulatory authority
- Negligible impact of generics is set to continue
- Threats
- Stringent reference pricing system
- Restructured reimbursement categories
- Intellectual property to conform with rest of EU
- Spain: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- Underdeveloped generics market both an opportunity and a threat
- Threats
- R&D activity expected to decline
- Reference pricing systems (RPS) likely to have an impact on branded
revenues
- UK: market level assessment, opportunities and threats
- Market level assessment
- Opportunities
- NICE guidance advises against the use of beta-blockers
- GMS contact improvements
- Threats
- Pharmaceutical Price Regulation Scheme (PPRS) implements periodic
price cuts
- Cost containment measures encourage continued high use of generics
- Summary of environmental issues affecting antihypertensive market size
- CHAPTER 4 PIPELINE DYNAMICS ANALYSIS
- Outlook for developmental antihypertensives
- Pipeline overview
- Pipeline agents by phase of development
- Pipeline antihypertensives segmented by mechanism of action
- Pipeline activity segmented by company
- Companies developing key novel antihypertensive agents
- Novartis
- Daiichi Sankyo
- Gilead
- Takeda
- CHAPTER 5 COMPARATIVE ASSESSMENT OF KEY PIPELINE PRODUCTS
- Overview
- Key pipeline product positioning
- Darusentan
- Mechanism of action
- Clinical assessment
- Commercial assessment
- Exforge (valsartan/amlodipine)
- Mechanism of action
- Clinical assessment
- Commercial Assessment
- Olmesartan/amlodipine
- Mechanism of action
- Clinical assessment
- Commercial Assessment
- Zanipress (enalapril/lercanidipine)
- Mechanism of action
- Clinical assessment
- Commercial assessment
- CYT006-AngQb
- Mechanism of action
- Clinical assessment
- Commercial assessment
- CHAPTER 6 FORECAST ANALYSIS
- Overview
- Changes in medical practice
- Increased use of ambulatory BP monitoring and home BP monitoring
- Assessment of overall cardiovascular risk
- Physician incentives to control blood pressure
- Pressure to increase compliance through the use of single-pill
combination products
- Major clinical trials
- ONTARGET
- DREAM
- TROPHY
- Outcomes program for Rasilez: ALTITUDE, AVIATOR
- New product launches
- Tekturna/Rasilez (aliskiren) marketed by Novartis
- Exforge (valsartan+ amlodipine) marketed by Novartis
- Additional indications
- Irbesartan gains congestive heart failure indication
- Valsartan gains additional diabetes indication
- Micardis (telmisartan) gains type 2 diabetic nephropathy indication
- Patent expiries
- ARB patent expiries
- CCB patent expiries
- Betablocker patent expiries
- ACE inhibitor patent expiries
- Other patent expiries
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecasts
- Forecast methodology
- CHAPTER 7 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Case Study 1: Aliskiren - up to the hype?
- Introduction
- Mechanism of action
- Aliskiren
- Clinical development of aliskiren
- Key Phase III Trials with aliskiren
- Aliskiren in combination with a diuretic
- Aliskiren versus CCB and their combination
- Aliskiren versus ACEI and their combination
- Efficacy - As good, but no better
- Benign side-effect profile - Not good enough
- Long duration of action - The saving grace?
- The negative-feedback conundrum
- End organ protection
- Prevention of organ damage with ACEIs and ARBs
- Additional benefit from renin inhibition?
- Summary of key advantages:
- Can Novartis justify price premium?
- Datamonitor assessment
- Case study 2: ESC/ESH GUIDELINES
- Emphasis on the assessment of total cardiovascular risk
- Consideration of absolute risk versus relative cardiovascular risk
- Targeting end-organ damage
- Recommendation for lifestyle modification
- First-line treatment strategy
- Managing hypertension and comorbidities
- Treatment of specific patient groups
- Opinion leader SWOT analysis
- Strengths:
- Weaknesses:
- Potential barriers to uptake:
- Commercial implications and further work
- Implication for clinical trial design
- CHAPTER 8 BIBLIOGRAPHY AND REFERENCES
- APPENDIX A - MARKET DATA AND MAJOR BRAND FACTS
- Mechanisms of action
- Beta blockers
- Calcium channel blockers
- Diuretics
- Angiotensin converting enzyme inhibitors
- Angiotensin-II receptor blockers (ARBs)
- Seven major market antihypertensive market data
- Segmentation by country
- Segmentation by class
- Major brand facts
- C7 Betablockers
- C8 Calcium channel blockers
- C9 Angiotensin converting enzyme inhibitors
- C9 Angiotensin II receptor blockers
- Anatomical Therapeutic Chemical (ATC) classification
- APPENDIX B - MARKET FORECAST DATA
- US Forecasts
- Japan Forecasts
- France Forecasts
- Germany Forecasts
- Italy Forecasts
- Spain Forecasts
- UK Forecasts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the cardiovascular disease analysis team
- Disclaimer
- List of Tables
- Table 1: Seven major market antihypertensive sales ($m), 2006.
- Table 2: Sales of antihypertensives across the seven major markets by
country Sales of Antihypertensives by Country($m), 2006.
- Table 3: Seven major market sales and market share of the 10
top-selling antihypertensives, 2006
- Table 4: Prevalence of obesity in the seven major markets by age
(000s), 2003 (all totals have been rounded where applicable)
- Table 5: US antihypertensive sales, 2006
- Table 6: Five generics companies are among the top 10 companies in
terms of prescriptions filled under Medicare Part D, 2006
- Table 7: The actual generic fill rate varies between therapeutic
classes, 2006
- Table 8: Wal-Mart is selling many generic antihypertensives for less
than the mean price per standard unit in the US in 2006
- Table 9: Japan antihypertensive sales, 2006
- Table 10: An example of the savings to be realized by using generic
drugs in the Japanese market, 2006
- Table 11: France antihypertensive sales, 2005
- Table 12: Germany antihypertensive sales, 2005
- Table 13: Italy antihypertensive market, 2006
- Table 14: Spain antihypertensive market, 2006
- Table 15: UK antihypertensive market, 2006
- Table 16: The 10 clinical areas of the Quality Outcome Framework, as
outlined in the GMS contract, 2005
- Table 17: Summary of macro-environmental issues affecting the
antihypertensive market, 2007
- Table 18: The antihypertensive R&D pipeline, 2007
- Table 19: Patent expiry dates used in forecasting the antihypertensive
market across the seven major markets, 2007-2016
- Table 20: Effects of Circulating RAS and Tissue RASe
- Table 21: Kredex: key facts
- Table 22: Toprol-XL: key facts
- Table 23: Tenormin; key facts
- Table 24: Inderal: key facts
- Table 25: Norvasc: key facts
- Table 26: Plendil: key facts
- Table 27: Cardizem LA: key facts
- Table 28: Adalat: key facts
- Table 29: Altace: key facts
- Table 30: Aceon: key facts
- Table 31: Accupro: key facts
- Table 32: Atacand; key facts
- Table 33: Teveten: key facts
- Table 34: Avapro: key facts
- Table 35: Cozaar: key facts
- Table 36: Benicar: key facts
- Table 37: Micardis: key facts
- Table 38: Diovan: key facts
- Table 39: Antihypertensive classifications
- Table 40: US Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 41: Japan Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 42: France Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 43: Germany Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 44: Italy Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 45: Spain Antihypertensives $ (000s)Sales Forecast 2006-2016
- Table 46: US Antihypertensives $ (000s)Sales Forecast 2006-2016
- List of Figures
- Figure 1: Growth in the antihypertensives market by country, 2003-06
- Figure 2: Proportion of population aged 20-39 years, 2004 and 2015,
and prevalence of hypertension in this age group in the seven major
markets, 2004
- Figure 3: Proportion of population aged 40-59 years, 2004 and 2015,
and prevalence of hypertension in this age group in the seven major
markets, 2004
- Figure 4: 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 5: The growing prevalence of obesity in the US, 2005-2015
- Figure 6: Generalized distribution chain for parallel traded
pharmaceutical products
- Figure 7: JNC6 and JNC7 compared: classification of blood pressure
levels
- Figure 8: Compelling indications for individual drug classes
- Figure 9: More than half of all prescriptions dispensed in the US are
generics, 1994-2005
- Figure 10: Generic companies dominate the US pharmaceutical market in
terms of prescriptions
- Figure 11: Generic use in the US is promoted through a number of
channels
- Figure 12: The generic fill rates in the US for 2003 varied
considerably by state
- Figure 13: The tiered co-payment system will lead to greater use of
generics
- Figure 14: Key pressures facing drug developers, 1990-2004
- Figure 15: Wal-Mart' s $4 generic drug program web-page
- Figure 16: The Japanese generic market is underdeveloped because of a
number of factors
- Figure 17: Pipeline antihypertensive agents segmented by phase of
development, 2007
- Figure 18: Pipeline antihypertensive agents segmented by mechanism of
action, 2007
- Figure 19: The nature of the compounds in the antihypertensives
pipeline, 2006
- Figure 20: Nature of antihypertensive developmental compounds
according to company type, 2007
- Figure 21: Pipeline maturity index for antihypertensive agents, 2007
- Figure 22: Comparative assessment of pipeline antihypertensive agents
- Figure 23: Segmentation of the antihypertensives market by country,
2007
- Figure 24: Segmentation of the antihypertensives market by class, 2007
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