Commercial Insight: Cardiovascular Market Overview - Raft Of Patent Expires Threaten Blockbusters

Published by: Datamonitor

Published: Oct. 24, 2007 - 262 Pages

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'

Abstract

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