Strategic Perspectives: Antidyslipidemics Current market is not conducive for growth

Published by: Datamonitor

Published: Oct. 22, 2008 - 223 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION

Market definition for this report

CHAPTER 3 MARKET OVERVIEW

US

Current market assessment

Future market assessment

Opportunities

Price of drugs

Leveraging the NCEP ATP III guidelines

Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates

Threats

High-profile generic entrants into the statin class could slow growth

Medicare and Medicaid

Drug importation

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

The FDA's increasing safety focus

Changes in the US patent law may weaken the position of Pharma

Japan

Current market assessment

Future market assessment

Opportunities

Aging population

An underdeveloped generics market slows brand erosion

Multiple Patent Extensions and Labeling Regulations

Harmonization of approval process and opening up the Japanese market

Drug approval lag-time being targeted by the Japanese Ministry of Health, Labour and Welfare

Reduced product approval time

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

Biennial price cuts still threaten market growth

Complex regulatory process

New healthcare reforms under debate

Flat-sum reimbursement discourages physicians from prescribing highly priced medicines

France

Current market assessment

Future market assessment

Opportunities

Innovation encouraged in the pharmaceutical industry

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

Reference price system

Formulary access

Take-off of generic sector

Pharmacists are being mandated to drive generic dispensing

Germany

Current market assessment

Future market assessment

Opportunities

Pricing freedom which supports innovation

Reimbursement is granted to almost all drugs

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

Current market assessment

Future market assessment

Opportunities

Single agency holds regulatory authority

Negligible impact of generics

Innovative drug development rewarded with premium price and 100% reimbursement

Threats

Ongoing cost-containment measures

Restructured reimbursement categories

Intellectual property to conform with rest of EU

Spain

Current market assessment

Future market assessment

Opportunities

New initiatives to improve prevention

Traditionally underdeveloped generics market

Threats

Complex pricing system

Increased scrutiny of new drugs

Compulsory patient co-payments

Government awareness campaign promotes generic use

UK

Current market assessment

Future market assessment

Opportunities

Attractiveness of market

Supplementary and expanded prescribing powers

Taking the GMS contract to the next level

Fast-track drug assessment process speeds up time between licensing and NICE recommendations

Threats

The National Institute for Health and Clinical Excellence (NICE)

2009 PPRS is expected to be more stringent than 2005 PPRS

Cost-containment measures encourage continued high use of generics

Rest of World snapshot

Current market assessment

CHAPTER 4 BRAND DYNAMICS

Overview of competitive landscape

Drivers of prescription choice

Cost becoming more important than efficacy and safety: generics

Cost playing a role in the brand choice: formulary status

Lipitor - the would-be gold standard

Drug profile

Product positioning

Brand forecast to 2017

Strategic recommendations

Vytorin - the success of an SPC

Drug profile

Product positioning

Vytorin's sales plateau

Brand forecast to 2017

Strategic recommendations

Crestor - the newest statin is on the rise

Drug profile

Product positioning

Brand forecast to 2017

Strategic recommendations

Pipeline - making it to the top 10?

TriLipix - joining the list

Development overview

Product positioning

Drug forecast to 2017

The rest of the pipeline - the reasons behind the lack of blockbuster

Livalo - not fitting into the overcrowded market

Dalcetrapib and anacetrapib - CETP inhibitors still under scrutiny

Mipomersen - the niche success?

Fenoglide - what does the new fenofibrate have to offer?

Cordaptive - more tolerable, but is it worth the risks?

Statin SPCs - waging the battle with generics unarmed?

CHAPTER 5 KEY PLAYERS

Strategic overview

Trends in corporate strategy

Pfizer

Corporate strategy

Antidyslipidemic portfolio assessment

Merck & Co.

Corporate strategy

Antidyslipidemic portfolio assessment

AstraZeneca

Corporate strategy

Antidyslipidemic portfolio assessment

Abbott

Corporate strategy

Antidyslipidemic portfolio assessment

CHAPTER 6 CASE STUDIES AND FORECAST SCENARIOS

TriLipix - will fenofibrate stay evergreen?

TriLipix - will Abbott's fenofibrate continue the domination?

Surrogate end points in dyslipidemia - a matter of the past?

ILLUMINATE puts HDL cholesterol into the spotlight

Torcetrapib's fiasco

The future of anacetrapib and dalcetrapib still in the dark

ENHANCE undermines trust in LDL cholesterol

Vytorin - is lower still better?

Potential impact of ENHANCE

Surrogate end points in dyslipidemia - an out of date concept?

Impact of ILLUMINATE and ENHANCE on drug development

SPCs - conquering the new horizons?

The first SPC - Vytorin

SPCs - aggressive marketing and significant advantages required

Development of the SPCs in the future

IMPROVE-IT - waiting for the new perspective on Zetia and Vytorin

Overview and importance of the study

IMPROVE-IT - worst and best case scenarios

Worst case scenario

Best case scenario

CETP Inhibitors

CETP inhibitors: the past and the future; what will be needed for successful launch?

Overview of the mechanism of action

HDL raising is one of the most important unmet needs

Torcetrapib - the most promising agent in development in 2006

CETP inhibition in general

Hypertension as a side effect of torcetrapib

Failure of torcetrapib - potential reasons

Anacetrapib and dalcetrapib - same mechanism of action, same outcome?

CETP inhibitors - what can be done to ensure successful launch?

CETP Inhibitors - worst and best case scenarios

Cordaptive and the FDA

Cordaptive/Tredaptive: the improved niacin not good enough for the FDA

Reasons for the non-approval and what it says about the FDA

Potential consequences may make Europe a more attractive market for launch

THRIVE: the light at the end of the tunnel?

UK: NICE recent guidelines - a nice surprise?

NICE Lipid Modification Guidelines - the driver of market expansion

NICE-led expansion of the market - an opportunity for Pharma?

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX A - MARKET ASSUMPTIONS

New product launches

Patent expiries

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Forecast methodology

APPENDIX B

Contributing experts

Experts contributing to this report

Experts contributing to previous reports

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the cardiovascular analysis team

Disclaimer

List of Tables

Table 1: US sales and growth of drug classes in the antidyslipidemic market, 2007

Table 2: Japan sales and growth of drug classes in the antidyslipidemic market, 2007

Table 3: An example of the savings to be realized by using generic drugs in Japan, 2006

Table 4: France sales and growth of drug classes in the antidyslipidemic market, 2007

Table 5: Germany sales and growth of drug classes in the antidyslipidemic market, 2007

Table 6: Italy sales and growth of drug classes in the antidyslipidemic market, 2007

Table 7: Spain sales and growth of drug classes in the antidyslipidemic market, 2007

Table 8: UK sales and growth of drug classes in the antidyslipidemic market, 2007

Table 9: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005

Table 10: Formulary status in the US for leading brands in dyslipidemia, 2007

Table 11: Lipitor: key facts, 2008

Table 12: Sales forecast ($m) for Lipitor in the seven major markets ($m), 2007-2017

Table 13: Impacting factors on Lipitor revenues, 2008-2017

Table 14: Vytorin: key facts, 2008

Table 15: Sales forecast for Vytorin in the seven major markets ($m), 2008-2017

Table 16: Impacting factors on Vytorin, revenues, 2007-2017

Table 17: Crestor: key facts, 2008

Table 18: Sales forecast for Crestor in the seven major markets ($m), 2007-2017

Table 19: Impacting factors on Crestor revenues, 2008-2017

Table 20: Summary of pipeline antidyslipidemic agents that are likely to launch with the forecast period, 2008-2017

Table 21: Sales forecast ($m) for TriLipix for dyslipidemia in the 7MM, 2007-2017

Table 22: Impacting factors on the revenues of TriLipix, 2007-2017

Table 23: Leading 10 companies in the seven major markets dyslipidemia market, 2007-2017

Table 24: Strategic importance of antidyslipidemic drugs to leading companies' portfolios, 2007

Table 25: Summary of statin-containing SPCs that are likely to launch within the forecast period, 2007-2017

Table 26: Phase II trial results for the atorvastatin + torcetrapib combination

Table 27: Mean percentage increase in HDL-C

Table 28: Mean percentage decrease in LDL-C

Table 29: Patient discontinuation results

Table 30: Summary of torcetrapib's late-stage clinical development, 2006

Table 31: Datamonitor's launch dates for antidyslipidemics in the 5EU and US, 2008-2017

Table 32: Patent expiry dates for the approved antidyslipidemics in the seven major markets, 2008-2017

List of Figures

Figure 1: Annual US sales ($m)of the antidyslipidemic drug classes, 2004-07

Figure 2: Performance of the key antidyslipidemic therapies in the US ($m), 2006-07

Figure 3: Market share of antidyslipidemic drugs in the US, 2007 versus 2017

Figure 4: New US Patent and Trademark Office (PTO) rules are unfavorable for Pharma and biotech

Figure 5: Annual Japan sales of the antidyslipidemic drug classes, 2004-07

Figure 6: Performance of the key antidyslipidemic therapies in Japan ($m), 2006-07

Figure 7: Market share of antidyslipidemic drugs in Japan, 2007 versus 2017

Figure 8: Annual France sales of the antidyslipidemic drug classes, 2004-07

Figure 9: Performance of the key antidyslipidemic therapies in France ($m), 2006-07

Figure 10: Market share of antidyslipidemic drugs in France, 2007 versus 2017

Figure 11: Annual Germany sales of the antidyslipidemic drug classes, 2004-07

Figure 12: Performance of the key antidyslipidemic therapies in Germany ($m), 2006-07

Figure 13: Market share of antidyslipidemic drugs in Germany, 2007 versus 2017

Figure 14: Annual Italy sales of the antidyslipidemic drug classes, 2004-07

Figure 15: Performance of the key antidyslipidemic therapies in Italy ($m), 2006-07

Figure 16: Market share of antidyslipidemic drugs in Italy, 2007 versus 2017

Figure 17: Annual Spain sales of the antidyslipidemic drug classes, 2004-07

Figure 18: Performance of the key antidyslipidemic therapies in Spain ($m), 2006-07

Figure 19: Market share of antidyslipidemic drugs in Spain, 2007 versus 2017

Figure 20: Annual UK sales of the antidyslipidemic drug classes, 2004-07

Figure 21: Performance of the key antidyslipidemic therapies in the UK ($m), 2006-07

Figure 22: Market share of antidyslipidemic drugs in the UK, 2007 vs. 2017

Figure 23: Rest of World versus seven major market sales in the antidyslipidemic market ($ billion and %), 2007

Figure 24: Global antidyslipidemic sales growth by region (%), 2004-07

Figure 25: Top 10 cardiovascular brands in the seven major markets by sales, 2004-2017

Figure 26: Sales of top 10 brands in the seven major markets, 2004-17

Figure 27: Sales forecast for Lipitor in the seven major markets ($ billion), 2007-2017

Figure 28: The relationship between the pricing advantage and the market share of Vytorin, 2007

Figure 29: Sales forecast for Vytorin in the seven major markets ($ billion), 2008-2017

Figure 30: Sales forecast for Crestor in the seven major markets ($ billion), 2008-2017

Figure 31: Leading 4 companies as proportion of the whole market, 2007 versus 2017

Figure 32: Forecasted sales of Zetia, three scenarios, $m

Figure 33: Forecasted sales of Vytorin, three scenarios, $m

Figure 34: HDL-C metabolism and the role of CETP

Figure 35: HDL-C levels in male and female residents of the USA

Figure 36: Forecast sales of dalcetrapib across the seven major markets - three scenarios ($m), 2008-2017

Figure 37: Forecast sales of anacetrapib across the seven major markets - three scenarios ($m), 2008-2017

Abstract

• Description of the competitive landscape in antidyslipidemics market with detailed overview of main challenges for launched and novel agents.
• Event-driven updated sales forecasts for 2008-17 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan.
• Analysis of major events and brand dynamics affecting the antidyslipidemics market, including the overview of the pipeline drugs.

• Quantify the future size and understand the background of the antidyslipidemic market
• Quantify the impact of the recent ENHANCE results on the dynamics of the market
• Size up the potential for the market expansion and revenue increases that recent guidelines, initiatives and regulatory changes may bring.

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