脂質代謝異常薬の商業的見通し

INTRODUCTION

Due to the maturing of the anti-dyslipidemics market, evidenced by the increasing availability of generic statins, growth in this market has slowed in recent years. However, increasing prevalence of dyslipidemia and the launch of novel adjunctive therapies and statin single-pill combinations will drive future growth

SCOPE OF THE REPORT

• Evaluation of lifecycle management strategies employed to maximize revenue potential and brand life of agents in all anti-dyslipidemic classes
• Analysis of the impacts of patent expiries from 2003 to 2011 in the US, EU and Japan on all 1st and 2nd generation statins
• Evaluation of the initial uptake of Crestor vs. Zetia and the longer term potential of these agents over the forecast period to 2011
• Assessment of the expanding use of combination therapy, following the launch of novel adjunctive therapies and single-pill combination therapies

REPORT HIGHLIGHTS

In order to minimize the impact of Zocor losing patent protection in the major markets, Johnson & Johnson MSD Consumer Pharmaceuticals has applied for OTC status for Zocor in the UK. However, this strategy is unlikely to maintain Zocor's revenues.

Combination therapy will enable more patients to achieve target cholesterol goals. As a result, the development of statin single-pill combinations is an active lifecycle-management strategy for many statin manufacturers.

Zetia and Crestor represent the newest anti-dyslipidemics to reach the US and EU, and both agents have been aggressively marketed. The benefit of using Zetia in combination with statins has led to rapid initial uptake. However, Crestor has encountered a number of setbacks since launch and concerns over safety have led to slower initial uptake.

KEY REASONS TO BUY THIS REPORT

• To prioritize sales and marketing efforts to effectively counter competitive threats
• To select best product lifecycle management strategies to counter generic competition and expand a drug's commercial potential
• To optimize licensing decisions based on market potential for inline products and identify optimal R&D development strategies

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the anti-dyslipidemics market

Key metrics

Evolution of the anti-dyslipidemics market

CHAPTER 2 MARKET SEGMENTATION & DEFINITION

Key findings

Strategic scoping and focus

Market definition

Therapy classes covered

Disease indications

Dyslipidemia

Cardiovascular indications

Markers for dyslipidemia

Main types of dyslipidemia

Epidemiology overview

Prevalence of dyslipidemia

Methodology

US

Japan

France

Germany

Italy

Spain

UK

Lipitor: the gold standard in the treatment of dyslipidemia

Associated pharmaceutical markets and indications

CHAPTER 3 GLOBAL MARKET OVERVIEW

Key findings

Global anti-dyslipidemic market analysis

Overview of global anti-dyslipidemic market

Initial uptake of Zetia versus Crestor

Dyslipidemia pipeline overview

Global market forecast

CHAPTER 4 STATINS

Key findings

Overview of the global statin market

Current statin indications

Statins market performance

Statins market forecast

Statin brand analysis

Lipitor (atorvastatin) – the gold-standard statin

Zocor (simvastatin) – HPS results may be too late

Pravachol (pravastatin) – strategies to slow the decline in sales

Mevalotin (pravastatin) – MEGA study holds the future

Lescol (fluvastatin) – to be replaced by pitavastatin?

Mevacor (lovastatin) – increasing erosion from genericization

Advicor (lovastatin/ER niacin) – the first combination statin

Crestor (rosuvastatin) – additional safety data required

Livalo (pitavastatin) – not so 'superstatin' ?

CHAPTER 5 FIBRATES

Key findings

Overview of the global fibrate market

Fibrates market forecast

Fibrate brand analysis

Lipanthyl and TriCor (fenofibrate) – US generic threat

Cedur and Bezatol (bezafibrate) – triglyceride reductions not enough to ensure success

CHAPTER 6 'OTHER'  ANTI-DYSLIPIDEMICS

Key findings

Overview of the global 'others'  market

'Others'  market forecast

'Others'  brand analysis

Zetia (ezetimibe) – revenue protection for Zocor

WelChol (colesevelam) – difficult-to-treat patients hold the highest potential

Niaspan (niacin) – EU roll-out set to boost sales

Epadel (ethyl icosapentate) – confined to the Japanese market

Questran (cholestyramine) – alternative to fibrates in combination with statins

Bibliography

Epidemiology

Clinical trial data

Report methodology

Pricing sources

Disclaimer

List of Tables

Table 1: Future prevalence of dyslipidemia across the seven major markets, 2003–11

Table 2: Current and future global sales for the leading anti-dyslipidemics ($m), 2002–11

Table 3: Key changes to lipid levels between the NCEP II and NCEP III guidelines

Table 5: Mean number and volume of gadolimium-enhancing (Gd) lesions pre-treatment and post-treatment with simvastatin

Table 6: Global sales in the anti-dyslipidemic market by drug class, 2001–02

Table 7: Key developmental compounds in the anti-dyslipidemic market, 2003

Figure 5: Global anti-dyslipidemic market forecasts, 2003–11

Table 8: Anti-dyslipidemic global sales forecasts, 2003–11

Table 9: Statins fact file

Table 10: Summary of statin indications, 2003

Table 11: Global sales of the leading branded statins, 2001–02

Table 12: Comparison of global sales forecasts for the statins ($m), 2003–11

Table 13: Lipitor: key facts

Table 14: Comparison of US drug prices for Lipitor and Zocor, 2003

Table 15: Key clinical trials for Lipitor, 2003

Table 16: Major Lipitor events, 2002–03

Table 17: Endpoint results from ASCOT-LLA, 2003

Table 18: Results of the REVERSAL trial

Table 19: Impacting factors on the revenues of Lipitor, 2003–11

Table 20: Zocor: key facts

Table 21: Key clinical trials for Zocor

Table 22: Major Zocor events, 2002–03

Table 23: Absolute effects of simvastatin allocation on five-year rates of first major vascular event among participants with diabetes, occlusive arterial disease, or both

Table 24: CHESS trial results

Table 25: Impacting factors on the revenues of Zocor, 2003–11

Table 26: Pravachol: key facts

Table 27: Key clinical trials: Pravachol

Table 28: Major Pravachol events, 2002–03

Table 29: PROSPER trial results

Table 30: Results of pilot trial evaluating atenolol versus nebivolol

Table 31: Results of pilot trial evaluating the combinations of atenolol/pravastatin and nebivolol/pravastatin

Table 32: Impacting factors on the revenues of Pravachol, 2003–11

Table 33: Mevalotin: key facts

Table 34: Impacting factors on the revenues of Mevalotin, 2003–11

Table 35: Lescol: key facts

Table 36: Lescol: key clinical trials

Table 37: Major Lescol events, 2002–03

Table 38: Impacting factors on the revenues of Lescol, 2003-11

Table 39: Mevacor: key facts

Table 40: Mevacor: key clinical trials

Table 41: Major Mevacor events, 2002–03

Table 42: Attempted OTC switching in the US

Table 43: Impacting factors on the revenues of Mevacor, 2003–11

Table 44: Advicor: key facts

Table 45: Advicor: key clinical trials

Table 46: Major Advicor events, 2002–03

Table 47: ADVOCATE trial results

Table 48: Impacting factors on the revenues of Advicor, 2003–11

Table 49: Crestor: key facts

Table 50: Crestor: key clinical trials

Table 51: Major Crestor events, 2002–03

Table 52: Comparison of US drug prices for Lipitor and Crestor, 2003

Table 53: GALAXY program summary

Table 54: Impacting factors on the revenues of Crestor, 2003–11

Table 55: Livalo: key facts

Table 56: Key clinical trials: Livalo

Table 57: Major Livalo events, 2002–03

Table 58: Impacting factors on the revenues of Livalo, 2003–11

Table 59: Fibrates fact file

Table 60: Global sales of the leading branded fibrates, 2001–02

Table 61: Triglyceride-lowering effects of statins

Figure 31: Fibrate market forecasts, 2003–11

Table 62: Comparison of fibrate global sales forecasts ($m), 2003–11

Table 63: Lipanthyl & TriCor: key facts

Table 64: Key clinical trials for fenofibrate

Table 65: Major Lipanthyl and TriCor events, 2002–03

Table 66: Impacting factors on the revenues of TriCor, 2003–11

Table 67: Impacting factors on the revenues of Lipanthyl, 2003–11

Table 68: Bezafibrate: key facts

Table 69: Other anti-dyslipidemics fact file

Table 70: Global sales of the leading branded 'others' , 2001–02

Table 71: Cost of 'other'  anti-dyslipidemics in the US

Figure 36: 'Other'  anti-dyslipidemics market forecasts, 2003–11

Table 72: Comparison of 'others'  anti-dyslipidemics class global sales forecasts ($m), 2003–11

Table 73: Zetia: key facts

Table 74: Zetia: key clinical trials

Table 75: Major Zetia events, 2002–03

Table 76: Anti-dyslipidemic clinical trials assessing CRP reductions

Table 77: Results of the Add-On trial

Table 78: LDL cholesterol reduction obtained with ezetimibe alone versus simvastatin alone and ezetimibe plus simvastatin

Table 79: Impacting factors on the revenues of Zetia, 2003–11

Table 80: WelChol: key facts

Table 81: WelChol: key clinical trials

Table 82: Major WelChol events, 2002–03

Table 83: LDL cholesterol reductions with colesevelam alone and in combination versus ezetimibe alone and in combination

Table 84: Impacting factors on the revenues of WelChol, 2003–11

Table 85: Niaspan: key facts

Table 86: Niaspan: key clinical trials

Table 87: Major Niaspan events, 2002–03

Table 88: Roll-out of EU launches of Niaspan

Table 89: Impacting factors on the revenues of Niaspan, 2003–11

Table 90: Epadel: key facts

Table 91: Use of combination therapy involving fish oil derivatives in Japan

Table 92: Questran: key facts

List of Figures

Figure 1: Scope and coverage of Datamonitor' s 2003 dyslipidemia reports

Figure 2: Evolution of the anti-dyslipidemics market, 1987–2011

Figure 3: Growth and market share of the anti-dyslipidemic drug classes, 2001–02

Figure 4: Proportion of overall drug-treated dyslipidemia patients expected to be prescribed Zetia and Crestor by the end of their first year on the market in the seven major markets

Figure 6: Timeline for statin launches

Figure 7: Growth and class market share of the leading statins, 2001–02

Figure 8: Global sales for the leading statins by quarter, 2002

Figure 9: Availability of generic statins in the seven major markets in 2003

Figure 10: Statin market forecasts, 2003–11

Figure 11: SWOT analysis for Lipitor

Figure 12: Global sales forecasts for Lipitor, 2003–11

Figure 13: Sales of Zocor versus Lipitor, Q1 2001 to Q4 2002

Figure 14: SWOT analysis for Zocor

Figure 15: Global sales forecasts for Zocor, 2003–11

Figure 16: SWOT analysis for Pravachol

Figure 17: Global sales forecasts for Pravachol, 2003–11

Figure 18: SWOT analysis for Mevalotin

Figure 19: Global sales forecasts for Mevalotin, 2003–11

Figure 20: Lescol SWOT analysis

Figure 21: Global sales forecasts for Lescol, 2003–11

Figure 22: SWOT analysis for Mevacor

Figure 23: Global sales forecasts for Mevacor, 2003–11

Figure 24: SWOT analysis: Advicor

Figure 25: Global sales forecasts for Advicor, 2003–11

Figure 26: SWOT analysis for Crestor

Figure 27: Global sales forecasts for Crestor, 2003–11

Figure 28: SWOT analysis for Livalo

Figure 29: Global sales forecasts for Livalo, 2003–11

Figure 30: Growth and class market share of the leading fibrates, 2001–02

Figure 32: SWOT analysis for Lipanthyl and TriCor

Figure 33: Global sales forecasts for TriCor, 2003–11

Figure 34: Global sales forecasts for Lipanthyl, 2003–11

Figure 35: Growth and class market share of the leading 'others' , 2001-2002

Figure 37: SWOT analysis for Zetia

Figure 38: Global sales forecasts for Zetia, 2003–11

Figure 39: SWOT analysis for WelChol

Figure 40: Global sales forecasts for WelChol, 2003–11

Figure 41: SWOT analysis for Niaspan

Figure 42: Global sales forecasts for Niaspan, 2003–11

Figure 43: SWOT analysis for Epadel