脂質異常症治療薬：ブランド・戦略

Abstract

Introduction

In 2006, the dyslipidemia market, valued at $27.7 billion in the US, Europe, and Japan, reached its peak for the near future. Dominated by the statin drug class, specifically Pfizer' s Lipitor, this highly lucrative market faced significant generic erosion with the 2006 US patent expiration of Merck' s Zocor and Bristol-Myers Squibb' s Pravachol. Of the seven drug classes in the dyslipidemia market, five are highly genericized. Moreover, more than 20 drugs are currently marketed for dyslipidemia, representing a crowded and competitive landscape. However, unmet clinical need still exists and provides an attractive commercial opportunity for new treatments that demonstrate greater efficacy over existing treatment options.

From 2007 to 2011, two major events will occur in the dyslipidemia market: Lipitor' s US and European patents will expire in 2010 and 2011, respectively; and five new fixed dose combination (FDC) therapies will launch. In total, seven emerging drugs are expected to launch before the end of 2011, including the highly anticipated Cordaptive (extended-release niacin/laropiprant) from Merck. Although a number of these emerging therapies are forecast for blockbuster status, their revenues will not replace those lost to genericization of the statins (specifically Lipitor) and the dyslipidemia market will decline to a total market value of $22.0 billion in 2011.

Questions Answered in This Report

• Pfizer dominated the dyslipidemia market in 2006, with a market share in excess of 45%; more than double that of the next leading competitor. With generic simvastatin pressuring Lipitor, will Pfizer maintain its dominant share? What strategies will the company employ to sustain their leading position over the forecast period?
• Merck experienced a detrimental impact to their overall revenue with the US patent expiration of Zocor in 2006. Nonetheless, by 2011 they will surpass Pfizer as the leading company in revenue for dyslipidemia. How did Merck sustain the blow of Zocor' s patent expiration and what strategies will the company employ to surpass Pfizer?
• The dyslipidemia market is very lucrative, but competition for market share is fierce. Thus, understanding current physician opinion continues to be critical for companies to maintain or grow their share. We surveyed 64 cardiologists and primary care physicians on a range of topics influencing the dyslipidemia market. Who do physicians think are the top companies and brands in dyslipidemia? Which brand attributes are most important? What channels do doctors use to find information about dyslipidemia and what messaging in dyslipidemia do they find the most appealing?
• Statins dominate the dyslipidemia market; however, the drug class is facing increasing generic erosion, which will peak in 2010 and 2011 when Lipitor' s patent is set to expire in the US and Europe, respectively. The genericization of the statin market will represent the biggest challenge to companies seeking to retain significant earnings in this market, putting even more pressure on companies to develop drug therapies that offer greater efficacy than the current market leading statins. What products are major competitors developing in their pipelines? How will the emerging drugs perform if approved? Finally, which emerging drugs do physicians think will be the most influential?

Scope

• Markets Covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Detailed discussion of major competitors including Pfizer, Merck, Schering-Plough, Abbott, AstraZeneca, Novartis, and, Bristol-Myers Squibb as well as the emerging competitors, Takeda and Isis Pharmaceuticals. Included is an analysis of each company' s cardiovascular product portfolio, strategic positioning, and development pipeline in dyslipidemia. The report features an in-depth discussion of leading brands including approval history, sales and market position, SWOT analysis, ongoing postmarketing clinical trials, and strategic initiatives.

• Physician Perception of Key Brands: Analysis of physician perceptions of the dyslipidemia market based on a custom survey of 64 US-based primary care physicians and cardiologists. The survey is brand-focused and examines physician perceptions of key competitors, brand attributes and messaging, and uptake of emerging agents.
• Epidemiology: Total prevalent and diagnosed cases for each of the major markets are presented in an annualized forecast from 2006 to 2011.
• Market Forecast: Annualized sales forecasts for branded agents, including the uptake of new agents, presented by region, drug class, molecule, and brand for 2006 to 2011.

Table of Contents

Brands & Strategies: Dyslipidemia

Table of Contents

Table of Exhibits

Executive Summary

• Market Summary
• Competitive Landscape
• Brand Overview
• Physician Perspectives

Section 1: Dyslipidemia Disease Dynamics

• Disease Background
• Patient Population
• Prevaence and Diagnosis
  • US Prevalence and Diagnosis
  • Europe Prevalence and Diagnosis
  • Japan Prevalence and Diagnosis
• Prescribers
• Treatment Dynamics
• Market Summary
• Reimbursement Issues

Section 2: Competitive Analysis

• Overview of Competitive Landscape
• Research and Development Spending
• Promotional Spending
• Dyslipidemia Market Messaging
• Physician Perceptions

Pfizer

• Cardiovascular and Metabolic Diseases Product Portfolio
• Goals in Cardiovascular and Metabolic Diseases Treatment
• Current Positioning
• Market Strategy
• Outlook
• Lipitor
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Caduet
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Other Pfizer Dyslipidemia Products
  • Lopid (Gemfibrozil)

Merck

• Cardiovascular Product Portfolio
• Goals in Cardiovascular Treatment
• Current Positioning
• Market Strategy
• Outlook
• Zocor
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Zetia
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Vytorin
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Exhibit 2-58:
  • Future Positioning
• Cordaptive
• MK-0524B

Schering-Plough

• Cardiovascular Product Portfolio
• Goals in Cardiovascular Treatment
• Current Positioning
• Market Strategy
• Outlook

Abbott

• Cardiovascular Product Portfolio
• Goals in Cardiovascular Treatment
• Current Positioning
• Market Strategy
• Outlook
• Tricor
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Niaspan
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning
• Other Abbott Dyslipidemia Products
  • Advicor (lovastatin + ER niacin)
• Rosuvastatin/ABT-335

AstraZeneca

• Cardiovascular Product Portfolio
• Goals in Cardiovascular Treatment
• Current Positioning
• Market Strategy
• Outlook
• Crestor
  • Development and Commercial Overview
  • Current Positioning and Physician Perception
  • Key Brand Strategies
  • Future Positioning

Novartis

• Lescol

Bristol-Myers Squibb

• Pravachol

Emerging Competitors:

Takeda

• Lapaquistat

ISIS Pharmaceuticals Inc.

• ISIS-301012

Section 3: Market Forecast

• Market Overview
  • Drug Sales by Region
  • Drug Sales by Class
• Dyslipidemia Market Forecast
  • Statin Market
  • FDC Market
  • Cholesterol Absorption Inhibitor Market
  • Fibrate Market
  • Niacin Market
  • Bile Acid Sequestrants Market
  • Omega-3 Acid Ethyl Esters Market

Section 4: Appendix

• Acronyms and Abbreviations
• Methodology
  • Epidemiological Forecast Methodology
  • Market Forecast Methodology
  • Competitive Analysis Methodology
  • Survey Methodology

Table of Exhibits

Executive Summary

• Exhibit ES-1: Key Parameters of the Dyslipidemia Market
• Exhibit ES-2: Dyslipidemia Branded Market, ($US), Major Markets, 2006-2011
• Exhibit ES-3: Dyslipidemia Market Competitive Position, 2006 and 2011
• Exhibit ES-4: Statin Market Share, by Brand, 2006 and 2011
• Exhibit ES-5: Dyslipidemia Brand Sales ($US), by Brand, 2006 and 2011
• Exhibit ES-6: Physician Rankings of Companies in Dyslipidemia Treatment

Section 1: Dyslipidemia Disease Dynamics

• Exhibit 1-1: Manifestation of Dyslipidemia
• Exhibit 1-2: Prevalent and Diagnosed Dyslipidemia Cases, Major Markets
• Exhibit 1-3: Prevalent and Diagnosed Dyslipidemia Cases, US
• Exhibit 1-4: Prevalence of Dyslipidemia, Europe, 2006-2011 (Table)
• Exhibit 1-5: Prevalence of Dyslipidemia, Europe, 2006-2011 (Graph)
• Exhibit 1-6: Prevalent and Diagnosed Dyslipidemia Cases, Japan
• Exhibit 1-7: Unmet Needs in Dyslipidemia Treatment
• Exhibit 1-8: Physician Perceptions of Most Appealing Antidyslipidemic FDCs
• Exhibit 1-9: NCETP ATP III Guidelines for Cholesterol, TG, LDL and HDL Levels
• Exhibit 1-10: Major Markets Guidelines for Dyslipidemia
• Exhibit 1-11: General Treatment Algorithm for Dyslipidemia
• Exhibit 1-12: Agents Approved for the Treatment of Dyslipidemia, by Drug Class
• Exhibit 1-13: Emerging Dyslipidemia Drugs, by Drug Class
• Exhibit 1-14: Dyslipidemia Sales ($US), by Country, 2006
• Exhibit 1-15: Dyslipidemia Sales ($US), by Drug Class, 2006
• Exhibit 1-16: Dyslipidemia, Sales ($US), Market Share, by Brand, 2006
• Exhibit 1-17: Formulary Status of Antidyslipidemics in Key Plans
• Exhibit 1-18: Formulary Status of Antidyslipidemics in Key Plans (Continued)

Section 2: Competitive Landscape

• Exhibit 2-1: Physician Perception on Branded Antidyslipidemic Drugs Following the Availability of Generic Simvastatin
• Exhibit 2-2: Dyslipidemia Market Competitive Position, 2006 and 2011
• Exhibit 2-3: Dyslipidemia Market ($US), by Company, 2006-2011
• Exhibit 2-4: Dyslipidemia Market Share ($US), by Company, 2006-2011
• Exhibit 2-5: Top Six Companies in the Dyslipidemia Market, 2006 Financials
• Exhibit 2-6: Promotional Spend for Dyslipidemia Therapies, by Company, 2006
• Exhibit 2-7: Branded Statins Promotional Spending
• Exhibit 2-8: Promotional Spending for FDCs and Branded Nonstatins
• Exhibit 2-9: Various Promotional Spending for Dyslipidemia Therapies, by Brand, 2006
• Exhibit 2-10: Physician Perception of Most Influential Messaging in the Dyslipidemia Market
• Exhibit 2-11: Physician Perception of Most Influential Branded-Drug Messaging in the Dyslipidemia Market
• Exhibit 2-12: Physician Perception of Most Influential FDC Messaging in the Dyslipidemia Market
• Exhibit 2-13: Physician Perception: Most Influential Companies in Dyslipidemia
• Exhibit 2-14: Physician Ranking of Dyslipidemia Companies
• Exhibit 2-15: Influencing Factors Among Physician' s Perception of a Company in Dyslipidemia
• Exhibit 2-16: Physician Ranking of Preference for First-Line Antidyslipidemics
• Exhibit 2-17: Physician Ranking of Information Channels for Dyslipidemia Drug Treatment
• Exhibit 2-18: Physician Ranking of the Most Popular Information Sources Sought by Patients
• Exhibit 2-19: Summary of Pfizer' s Cardiovascular Portfolio
• Exhibit 2-20: Physician Perception of Pfizer in Dyslipidemia
• Exhibit 2-21: Lipitor' s Key Facts
• Exhibit 2-22: Lipitor' s Expanded Indications
• Exhibit 2-23: Timeline of Lipitor' s Development
• Exhibit 2-24: Physician Perception of Lipitor
• Exhibit 2-25: Physician Response to the Label Expansion of Lipitor
• Exhibit 2-26: Ongoing and Emerging Clinical Trials with Lipitor
• Exhibit 2-27: Lipitor Market ($US), 2006-2011
• Exhibit 2-28: Lipitor Market ($US), by Country, 2006-2011
• Exhibit 2-29: Price to Treat per Day ($US), Lipitor, by Country, 2006
• Exhibit 2-30: Caduet' s Key Facts
• Exhibit 2-31: Timeline of Caduet' s Development
• Exhibit 2-32: Physician Perception of Caduet
• Exhibit 2-33: Ongoing Trials with Caduet
• Exhibit 2-34: Caduet Market ($US), 2006-2011
• Exhibit 2-35: Caduet Market ($US), by Country, 2006-2011
• Exhibit 2-36: Price to Treat per Day ($US), Caduet, by Country
• Exhibit 2-37: Summary of Merck' s Cardiovascular Portfolio
• Exhibit 2-38: Merck Royalties from Astra AP Joint Venture
• Exhibit 2-39: Physician Perception of Merck in Dyslipidemia
• Exhibit 2-40: Zocor' s Key Facts
• Exhibit 2-41: Zocor' s Expanded Indications
• Exhibit 2-42: Timeline of Zocor' s Development
• Exhibit 2-43: Physician Perception of Zocor
• Exhibit 2-44: Zocor Market ($US), 2006-2011
• Exhibit 2-45: Zocor Market ($US), by Country, 2006-2011
• Exhibit 2-46: Price to Treat per Day ($US), Zocor, by Country, 2006
• Exhibit 2-47: Zetia' s Key Facts
• Exhibit 2-48: Timeline of Zetia' s Development
• Exhibit 2-49: Physician Perception of Zetia
• Exhibit 2-50: Emerging Cholesterol Absorption Inhibitors
• Exhibit 2-51: Zetia Market ($US), 2006-2011
• Exhibit 2-52: Zetia Market ($US), by Country, 2006-2011
• Exhibit 2-53: Price to Treat per Day ($US), Zetia, by Country, 2006
• Exhibit 2-54: Vytorin' s Key Facts
• Exhibit 2-55: Timeline of Vytorin' s Development
• Exhibit 2-56: Physician Perception of Vytorin
• Exhibit 2-57: Ongoing Clinical Trials for Vytorin
• Exhibit 2-58: Ongoing Clinical Trials for Vytorin (Continued)
• Exhibit 2-59: Vytorin Market ($US), 2006-2011
• Exhibit 2-60: Vytorin Market ($US), by Country, 2006-2011
• Exhibit 2-61: Price to Treat per Day ($US), Vytorin, by Country, 2006
• Exhibit 2-62: PCPs Perception on the Impact of Cordaptive in the Dyslipidemia Market
• Exhibit 2-63: Cardiologists' Perception on the Impact of Cordaptive in the Dyslipidemia Market
• Exhibit 2-64: Physician Ranking of Emerging Drugs
• Exhibit 2-65: Cordaptive Market ($US), 2006-2011
• Exhibit 2-66: Cordaptive Market ($US), by Country, 2006-2011
• Exhibit 2-67: Expected Price to Treat per Day ($US), Cordaptive, by Country
• Exhibit 2-68: PCPs Perception of MK-0524B
• Exhibit 2-69: Cardiologists Perception of MK-0524B
• Exhibit 2-70: MK-0524B Market ($US), 2006-2011
• Exhibit 2-71: MK-0524B Market ($US), by Country, 2006-2011
• Exhibit 2-72: Expected Price to Treat per Day ($US), MK-0524B, by Country
• Exhibit 2-73: Summary of Schering-Plough' s Cardiovascular Portfolio
• Exhibit 2-74: Physician Perception of Schering-Plough
• Exhibit 2-75: Summary of Abbott' s Cardiovascular Portfolio
• Exhibit 2-76: Physician Perception of Abbott' s Cholesterol Franchise
• Exhibit 2-77: Tricor' s Key Facts
• Exhibit 2-78: Timeline of Tricor' s Development
• Exhibit 2-79: Physician Perception of Tricor
• Exhibit 2-80: Ongoing Clinical Trials for Tricor
• Exhibit 2-81: Tricor Market ($US), 2006-2011
• Exhibit 2-82: Tricor Market ($US), by Country, 2006-2011
• Exhibit 2-83: Price to Treat per Day ($US), Tricor, by Country
• Exhibit 2-84: Niaspan' s Key Facts
• Exhibit 2-85: Timeline of Niaspan' s Development
• Exhibit 2-86: Physician Perception of Niaspan
• Exhibit 2-87: Ongoing Clinical Trials for Niaspan
• Exhibit 2-88: Niaspan Market ($US), 2006-2011
• Exhibit 2-89: Niaspan Market ($US), by Country, 2006-2011
• Exhibit 2-90: Price to Treat per Day ($US), Niaspan, by Country
• Exhibit 2-91: Advicor Market ($US), 2006-2011
• Exhibit 2-92: Advicor Market ($US), by Country, 2006-2011
• Exhibit 2-93: Price to Treat per Day ($US), Advicor, by Country
• Exhibit 2-94: Simcor Market ($US), 2006-2011
• Exhibit 2-95: Simcor Market ($US), by Country, 2006-2011
• Exhibit 2-96: Expected Price to Treat per Day ($US), Simcor, by Country
• Exhibit 2-97: PCPs Perception on the Impact of Crestor/ABT-335 in the Dyslipidemia Market
• Exhibit 2-98: Cardiologists Perception on the Impact of Crestor/ABT-335 in the Dyslipidemia Market
• Exhibit 2-99: Crestor/ABT-335 Market ($US), 2006-2011
• Exhibit 2-100: Crestor/ABT-335 Market ($US), by Country, 2006-2011
• Exhibit 2-101: Expected Price to Treat per Day ($US), Crestor/ABT-335, by Country
• Exhibit 2-102: Summary of AstraZeneca' s Cardiovascular Portfolio
• Exhibit 2-103: Physician Perception of AstraZeneca in Dyslipidemia
• Exhibit 2-104: Crestor' s Key Facts
• Exhibit 2-105: Timeline of Crestor' s Development
• Exhibit 2-106: Physician Perception of Crestor
• Exhibit 2-107: Summary of Completed and Ongoing Studies Investigating Crestor' s Efficacy
• Exhibit 2-108: Summary of Ongoing Trials in the Galaxy Program Targeted to Determine Crestor' s Safety
• Exhibit 2-109: Summary of Completed Trials in the Galaxy Program Targeting Atherosclerosis
• Exhibit 2-110: Summary of Ongoing Galaxy Program Trials Focused in Risk Reduction of CVD
• Exhibit 2-111: Crestor Market ($US), 2006-2011
• Exhibit 2-112: Crestor Market ($US), by Country, 2006-2011
• Exhibit 2-113: Price to Treat per Day ($US), Crestor, by Country
• Exhibit 2-114: Summary of Novartis' s Cardiovascular Portfolio
• Exhibit 2-115: Physician Perception of Novartis in Dyslipidemia
• Exhibit 2-116: Lescol Market ($US), 2006-2011
• Exhibit 2-117: Lescol Market ($US), by Country, 2006-2011
• Exhibit 2-118: Price to Treat per Day ($US), Lescol, by Country
• Exhibit 2-119: Summary of BMS' s Cardiovascular Portfolio
• Exhibit 2-120: Physician Perception of BMS in Dyslipidemia
• Exhibit 2-121: Physician Perception of Pravachol
• Exhibit 2-122: Pravachol Market ($US), 2006-2011
• Exhibit 2-123: Pravachol Market ($US), by Country, 2006-2011
• Exhibit 2-124: Price to Treat per Day ($US), Pravachol, by Country
• Exhibit 2-125: Site of Squalene Synthase Inhibition
• Exhibit 2-126: Lapaquistat Market ($US), 2006-2011
• Exhibit 2-127: Lapaquistat Market ($US), by Country, 2006-2011
• Exhibit 2-128: Expected Price to Treat per Day ($US), Lapaquistat, by Country
• Exhibit 2-129: PCPs Perception on the Impact of ISIS-301012 in Dyslipidemia
• Exhibit 2-130: Cardiologists Perception on the Impact of ISIS-301012 in Dyslipidemia
• Exhibit 2-131: ISIS-301012 Market ($US), 2006-2011
• Exhibit 2-132: ISIS-301012 Market ($US), by Country, 2006-2011
• Exhibit 2-133: Expected Price to Treat per Day ($US), ISIS-301012, by Country

Section 3: Market Forecast

• Exhibit 3-1: Dyslipidemia Market ($US), Major Markets, 2006-2011 (Tabular Format)
• Exhibit 3-2: Dyslipidemia Market ($US), Major Markets, 2006-2011 (Graphical Format)
• Exhibit 3-3: Key Events in Dyslipidemia Market, 2006-2011
• Exhibit 3-4: Dyslipidemia Market ($US), by Country, 2006-2011
• Exhibit 3-5: Dyslipidemia ($US), by Drug Class, 2006-2011
• Exhibit 3-6: Dyslipidemia ($US), by Drug Class, 2006-2011 (Continued)
• Exhibit 3-7: Dyslipidemia Market, by Drug Class, as a % of Total, 2006 and 2011
• Exhibit 3-8: Statin Market ($US), by Drug, 2006-2011
• Exhibit 3-9: Statin Market ($US), by Country, 2006-2011
• Exhibit 3-10: Stain Market ($US), by Brand, 2006-2011
• Exhibit 3-11: Stain Market ($US), by Brand, 2006-2011 (Continued)
• Exhibit 3-12: FDC ($US), by Drug, 2006-2011
• Exhibit 3-13: FDC Market ($US), by Country, 2006-2011
• Exhibit 3-14: FDC Market ($US), by Brand, 2006-2011
• Exhibit 3-15: FDC ($US), by Brand, 2006-2011 (Continued)
• Exhibit 3-16: Zetia Market ($US), 2006-2011
• Exhibit 3-17: Zetia Market ($US), by Country, 2006-2011
• Exhibit 3-18: Fibrate Market ($US), 2006-2011
• Exhibit 3-19: Fibrate Market ($US), by Country, 2006-2011
• Exhibit 3-20: Fibrate Market ($US), by Brand, 2006-2011
• Exhibit 3-21: Fibrate Market ($US), by Brand, 2006-2011 (Continued)
• Exhibit 3-22: Niacin Market ($US), 2006-2011
• Exhibit 3-23: Niacin Market ($US), by Country, 2006-2011
• Exhibit 3-24: Bile Acid Sequestrants ($US), by Drug, 2006-2011
• Exhibit 3-25: Bile Acid Sequestrants Market ($US), by Country, 2006-2011
• Exhibit 3-26: Bile Acid Sequestrants Market ($US), by Brand, 2006-2011
• Exhibit 3-27: Bile Acid Sequestrants Market ($US), by Brand, 2006-2011 (Continued)
• Exhibit 3-28: Omega-3 Acid Ethyl Esters Market ($US), 2006-2011
• Exhibit 3-29: Omega-3 Acid Ethyl Esters Market ($US), by Country, 2006-2011

Section 4: Appendix

• Exhibit 4-1: Adjusted Price of Zocor, 2006-2011
• Exhibit 4-2: Adjusted Price of Lipitor 2006-2011
• Exhibit 4-3: Adjusted Price of Lescol, 2006-2011
• Exhibit 4-4: Surveyed Physicians' Years of Practice
• Exhibit 4-5: Surveyed Physicians' Patients per Month