Lipitor Market analysis and forecasts Report, 2007-2012, 2017 & 2023

Table of Contents

1 Executive Summary

• 1.1 Lipitor Was the World' s Best Selling Drug In 2006
• 1.2 Lipitor Will Face Strong Competition After Patent Expiration In Key Markets
• 1.3 Lipitor Is Embroiled In Patent Challenges With Ranbaxy

2 Overview of Lipitor (Atorvastatin)

• 2.1 Lipitor (Atorvastatin) - The Cholesterol Reducing Drug
  • 2.1.1 Pfizer Acquires Lipitor After Merging With Warner-Lambert
  • 2.1.2 Dyslipidemia
    • 2.1.2.1 Classification of Dyslipidaemia
  • 2.1.3 Dyslipidaemia - a Major Risk Factor In Developing Coronary Heart Disease In The Western Population
  • 2.1.4 Aetiology of Dyslipidaemia
    • 2.1.4.1 Primary Causes of Dyslipidemia
    • 2.1.4.2 Secondary Causes of Dyslipidaemia
    • 2.1.4.3 Diabetes A Leading Cause of Secondary Dyslipidaemia
• 2.2 Obesity Is a Major Environmental Factor Associated With Dyslipidaemia
  • 2.2.1 Strong Link Between Diabetes And Obesity
  • 2.2.2 Diet Remains An Important Component In Regulating Lipid levels
  • 2.2.3 Behaviour
  • 2.2.4 Regular Physical Exercise
• 2.3 Symptoms and Signs of Dyslipidaemia
• 2.4 Diagnosis, Screening and Markers of Dyslipidaemia
  • 2.4.1 Direct Measurement of Total cholesterol, Triglycerides, And HDL
  • 2.4.2 Estimation of Low-density Lipoprotein (LDL) And Very Low-Density Lipoprotein (VLDL)
  • 2.4.3 Fasting Lipid Profile
  • 2.4.4 Screening Patients Under 20 Years For Atherosclerotic Risk Factors
  • 2.4.5 Screening For Lipoprotein(a) levels

3 Treatment of Dyslipidaemia

• 3.1 Lipid Regulating Drugs Are Central To Treating Dyslipidaemia
  • 3.1.1 Statins are First Choice Lipid-Regulating Drugs
  • 3.1.2 Statin Drugs Are Significant Market for Leading Pharmaceutical Companies
  • 3.1.3 Lipitor A Second-Generation 3-hydroxy-3-methygulutaryl coenzyme A (HMGCoA) Reductase Inhibitor Gold Standard Drug
• 3.2 Posology And Method of Administration of Lipitor
  • 3.2.1 Primary Hypercholesterolaemia and Combined (Mixed) Hyperlipidaemia In Adults And Children aged 10-17 years
    • 3.2.1.1 Heterozygous Familial Hypercholesterolaemia in Adults and Children aged 10-17 years
    • 3.2.1.2 Homozygous Familial Hypercholesterolaemia in Adults and Children aged 10-17 years
    • 3.2.1.3 Lipitor Dosage in Patients With Renal Insufficiency
    • 3.2.1.4 Lipitor Dosage in Patients With Hepatic Dysfunction
    • 3.2.1.5 Lipitor Dosage in Geriatric

4 Lipitor World Market Analysis

• 4.1 Lipid-regulating/ Anti-Atheroma Preparations Is The Largest In Cardiovascular System Market
  • 4.1.1 Pfizer Is The Leader In Cardiovascular Pharmaceuticals
  • 4.1.2 Cholesterol And Triglycerides Reduction Drugs Generate Highest Individual Sales
  • 4.1.3 The US Market For Cholesterol and Triglyceride Drugs Sees The largest Sales
• 4.2 Lipitor (Atorvastatin) Revenue Dominates all Cholesterol & Triglyceride Drugs
  • 4.2.1 Lipitor Sales in North America, Europe, Africa, Asia & Australasia and Latin America
    • 4.2.1.1 Lipitor Sales are Most Significant In US
    • 4.2.1.2 Lipitor Drives Sales For Cholesterol & Triglyceride Reducers In The EU Market
    • 4.2.1.3 UK is Lipitor' s Largest Market In Europe
    • 4.2.1.4 Lipitor Sales Decline in France
    • 4.2.1.5 Lipitor Sales Grow By 10% In 2006
    • 4.2.1.6 Lipitor Experiences Strong Market Growth In Italy
    • 4.2.1.7 Lipitor Year-on-Year Sales Decline Continued In Germany
    • 4.2.1.8 Japan is Lipitor' s Strongest Market in Africa, Asia & Australasia
• 4.3 Lipitor' s Faces Competitions From Key Rivals In Major Markets
  • 4.3.1 Lipitor' s Prescription Volume Eroded Steeply Due To Generic Statins
  • 4.3.2 AstraZeneca' s Crestor, Merck & Co and Schering Plough' s Vytorin Dampens Lipitor' s Market Share
  • 4.3.3 Head-to-Head Clinical Study Proves Lipitor to Be More Potent Than Crestor
  • 4.3.4 Vytorin A Strong Contender For Market Share With Lipitor During Near-Term
• 4.4 Pfizer' s Lipitor Challenge With Ranbaxy Will Have Significant Implications On Future Sales
• 4.5 US WellPoint Demonstrates Generic Statins- Lovastatin, Simvastatin And Pravastatin To Elicit Cardiovascular Benefits
• 4.6 Lipitor Global Sales Forecast 2008-2023
  • 4.6.1 Lipitor' s Five New Indications Will Be key To Sales Growth After Patent Expiration
  • 4.6.2 Lipitor Major Market Sales Forecast 2008-2023
  • 4.6.3 US Lipitor Market Forecasts 2008-2023
  • 4.6.4 Japan Lipitor Market Forecast 2008-2023
  • 4.6.5 EU Lipitor Market Forecast 2008-2023
  • 4.6.6 UK Lipitor Market Forecast 2008-2023
  • 4.6.7 France Lipitor Market Forecast 2008-2023
  • 4.6.8 Spain Lipitor Market Forecast 2008-2023
  • 4.6.9 Italy Lipitor Market Forecast 2008-2023
  • 4.6.10 Germany Lipitor Market Forecast 2008-2023
• 4.7 Lipitor Competes With Other Non-Statin Drugs
  • 4.7.1 Bristol Myers Questran Is leading Anion Exchange Resin
  • 4.7.2 MSD and Schering-Plough' s Ezetrol An Adjunct Therapy for Inhibiting Absorption of Cholesterol
  • 4.7.3 Fibrates Constitute A Significant Market
  • 4.7.4 Niaspan Is Key Nicotinic Acid Competitor To Lipitor
  • 4.7.5 Simcor- Niaspan And Generic Simivastatin Will Increase Lipitor Competition
  • 4.7.6 US National Heart, Lung and Blood Institute Sponsors Niaspan And Simvastatin AIM-HIGH Study
  • 4.7.7 Fish Oils Industry A Growing Market and A deterrent To Lipitor Growth
• 4.8 Pfizer Has Large Resources To Promo

5. Lipitor' s Key Patent Challenges

• 5.1 Patent Expiration is the Major Driver in All Generic Markets
• 5.2 The US Has The Largest Generics Market
• 5.3 The US and European Regulation of Generic Drugs
• 5.4 Pfizer' s Lipitor Patent Protection Sets Benchmark In Pharmaceutical Industry For Protecting Brands
• 5.5 Pfizer Struggles To Block Early Generic Lipitor Market Entry
• 5.6 The Hatch-Waxman Act, Patent Expiration and the Promotion of Generic Drugs: Title I of the Act
  • 5.6.1 Ranbaxy To Benefit From The Hatch-Waxman Title I
  • 5.6.2 US First To Market 180-Day Exclusivity Period Incentive Will Be Key To Rambaxy' s Initial Sales Success of Generic Atorvastatin
• 5.7 Ranbaxy Receives Favourable Lipitor Decisions in Key EU Markets
  • 5.7.1 Federal Patent Court of Germany Revokes Lipitor Patent
• 5.8 Lipitor Expanding Patent Contention
  • 5.8.1 Pfizer Versus Teva Pharmaceuticals' ANDA For Generic Atorvastatin
  • 5.8.2 Pfizer Versus Cobalt Pharmaceuticals For Atorvastatin Sodium A Potentially Marketable Product
  • 5.8.3 Pfizer Vs Apotex Generic Atorvastatin In Canada
• 5.9 Ranbaxy Will Cover Cost of Legal Challenges From Sales of Atorvastatin in Key Markets

6 Lipitor- Product Life Cycle Management (PML)

• 6.1 Pfizer To Use Product Lifecycle Management to Drive Sales of Lipitor
• 6.2 Pfizer' s Prominent PLM Is Caduet- "uber-pill", a combination of Lipitor And Norvasc
  • 6.2.1 Caduet Sales Rises Significantly By 99% in 2006
• 6.3 Pfizer' s Torcetrapib- The Lipitor Follow-Up Drug Fails To Deliver
• 6.4 Pfizer Lipitor and Peripheral Vascular Diseases
• 6.5 Pfizer' s LEAD Trial investigates Lipitor in Combination with Aricept in AD patients
• 6.6. Other Lipitor Significant Clinical Studies
  • 6.6.1 Lipitor Pre-Clinical Data
    • 6.6.1.1 Atorvastatin Proves to be More Liver Selective Than Pravastatin
  • 6.6.2 Atorvastastin Clinical Data
    • 6.6.2.1 Atorvastatin Was Tolerated in Healthy Volunteers
• 6.7 Cardiovascular Disease
  • 6.7.1 Ten milligram (10 mg) of Atorvastatin Has Significant Effect Lipid-Lowering Ability
  • 6.7.2 Coronary Artery Disease-AVERT (Atorvastatin Versus Revascularization Treatment)
  • 6.7.3 Ten milligram (10 mg) Atorvastatin is Effective in Australian Atorvastatin Assessment Study
  • 6.7.4 Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study
  • 6.7.5 ASCOT trial Demonstrates Atorvastatin to Reduce Risk of Heart Attack Induced by Hypertension
  • 6.7.6 Head-To-Head REVERSAL Trial Demonstrates that Highest Dose of Atorvastatin, Halted Atherosclerosis
  • 6.7.7 Post-Hoc Analysis in Treating New Targets (TNT ) Trial Demonstrates Atorvastatin 80 mg with Less Cardiovascular Events Than 10 mg dose
  • 6.7.8 Atorvastatin - Incremental Decrease in Endpoints Through Aggressive Lipid Lowering (IDEAL) Trial Reveals Significantly Fewer Risk of Secondary Heart Attacks
  • 6.7.9 CARDS study (Collaborative AtoRvastatin Diabetes Study)-Shows Marked Reduction in Percentages Risk of Cardiovascular Events in Diabetes Patients
  • 6.7.10 SPARCL study (Stroke Prevention by Aggressive Reduction in Cholesterol Study)
  • 6.7.11 Atorvastatin Lowers Cardiovascular Disease By a Significant Percentage
• 6.8 Paediatric Studies Demonstrated Significant Therapeutic benefits of Lipitor
• 6.9 Lipitor Post Marketing Studies

7 Lipitor Competitor Studies & Pipeline

• 7.1 Lipitor worldwide clinical studies
• 7.2 Competitor Agents in Development
  • 7.2.1 Abbott And AstraZeneca' s Developmental Fibrate /Cholesterol reducing Agent Shows Significant Potential
  • 7.2.2 First Horizon' s Fenofibrate (Triglide) And Aegerion' s MTP Inhibitor (AEGR 733)

8 Lipitor SWOT Analysis

• 8.1 Lipitor First Drug of Choice For Cholesterol Treatment
• 8.2 Lipid Regulator Market Will Continue to Generate High Revenues
• 8.3 An Expanding Patient Population Constitutes the Principal Driver in the Statins Market
• 8.4 Changes to Treatment Guidelines in US and Europe Can Benefit Sales Of Lipitor
• 8.5 The US Market Will Continue To Be Key for Lipitor' s Sales Growth
• 8.6 Generic Rivals Will Drive The Erosion of Lipitor' s Market Share
  • 8.6.1 The US has the Largest Generics Market
  • 8.6.2 Generic Statins A Growing Presence In The US Market
  • 8.6.3 Rising Generic Uptake in Key EU Markets Will Impact On Lipitor Sales
  • 8.6.4 Generic Statins Potential Threat To Lipitor Growth As They Become Mainstay In Japan
• 8.7 Pfizer And Astellas Reach Lipitor Settlement In Japan
• 8.8 US and EU Two -Year Statin Approval Timelines Increase Competitiveness
• 8.9 Lipitor A Testimony of The Crumbling Blockbuster Business Model
• 8.10 Pfizer Will Need Strategies That Will Yield High ROI After Lipitor' s Patent Expiration
• 8.11 New Reformulation Will be Significant To Drive Lipitor' s Long-Term Revenues
• 8.12 Liptor Still Has Significant Developmental Possibilities
• 8.13 Lipitor' s Prominent Indications For Diverse Cardiovascular and Metabolic Areas Will be Significant For Future Sales
• 8.14 Lipitor Significant Trial Results Will Drive Sales
• 8.15 Is Pfizer' s Lipitor Success Repeatable?
• 8.16 US House of Democrats Investigate Lipitor' s Director-To-Customer Advertisement Campaign
• 8.17 OTC Simvastatin Adds To Lipitor' s Competition
• 8.18 Anti-Counterfeiting Initiatives Will Safeguard Lipitor in Emerging Markets
• 8.19 Lipitor Will Face Pricing Competition From Generic Statins

9 Conclusion

• 9.1 Lipitor (Atorvastatin) - The Cholesterol Reducing Drug
• 9.2 Lipid-regulating Drugs Generate The Highest Revenues In Cardiovascular Market
• 9.3 Statin Drugs Are Significant Market for Leading Pharmaceutical Companies
• 9.4 Lipitor (Atorvastatin) Is The World' s Highest Selling Drug
• 9.5 Lipitor Sales Are Most Significant In the US Market
  • 9.5.1 Lipitor Sales in other Key Markets
  • 9.5.2 Lipitor Global Sales Forecast 2008-2023
• 9.6 Lipitor' s Faces Competition From Key Rivals
• 9.7 Non-Statin Drug Therapies Market Expands
• 9.8 Pfizer Using Product Lifecycle Management to Drive Sales of Lipitor
• 9.9 Caduet Positioned To Experience Strong Sales After Lipitor Expiration
• 9.10 Ranbaxy' s Successsful Patent Lawsuits Against Pfizer In Key Markets Will Be Costly To Lipitor' s Future Sales
• 9.11 Visiongain Concludes that Loyalty from Pfizer and Brand "Lipitor' s" Key Stakeholders Will Confer Future Sales

List of Tables

• Table 2.1 Lipoprotein Patterns (Fredrickson Phenotypes)
• Table 2.2 Genetic Variations In Dyslipidaemia
• Table 2.3 Obese Population in Major Countries by Percentage (%)
• Table 4.1 Sales Distribution of Cardiovascular Disease Market, 2006
• Table 4.2 Leading Companies in Cardiovascular Market, 2006
• Table 4.3 Sales Distribution of Leading Anti-Atheroma Therapies, 2006
• Table 4.4 Leading Markets In Cholesterol and Triglyceride Drugs
• Table 4.5 Global Sales of Top Ten Leading Statin Drugs, 2006
• Table 4.6 Market Share of Lipitor in leading Markets, 2003-2006
• Table 4.7 Lipitor Sales in Key EU Markets, 2003-2006
• Table 4.8 Comparison of Effects on Cholesterol Levels
• Table 4.9 Comparison of Dose Effects on LDL Cholesterol (LDL-C)
• Table 4.10 Lipitor (Atorvastatin) Patents Expiration In Major Markets
• Table 4.11 Lipitor Global Sales Forecast 2008-2023
• Table 4.12 US Lipitor Global Sales Forecast 2008-2023
• Table 4.13 Japan Lipitor Global Sales Forecast 2008-2023
• Table 4.14 UK Lipitor Global Sales Forecast 2008-2023
• Table 4.15 France Lipitor Global Sales Forecast 2008-2023
• Table 4.16 Spain Lipitor Market Forecasts 2008-2023
• Table 4.17 Italy Lipitor Market Forecasts 2008-2023
• Table 4.18 Lipitor Sales In Germany, 2003-2006
• Table 4.19 Germany Lipitor Market Forecasts 2008-2023
• Table 4.20 Leading Fibrate Drugs, 2006
• Table 4.21 Leading Anti-atheroma Preparations Of Natural Origin (Fish Oil Products), 2006
• Table 5.1 The Top Ten US Generic Drugs by Revenue ($m) and Units, 2006
• Table 5.2 US Top Ten Generic Drugs as a Function of Combined Branded and Generic Drugs by Prescription Number (m) and Revenues ($m),2006
• Table.5.3 Prescription Number (m), 2004 Top 10 Generic Drugs, Dispensed by Prescriptions in the US, 2006
• Table 5.4 Lipitor (Atorvastatin) Patents In Major Markets
• Table 5.5 Ranbaxy /Pfizer (Atorvastatin) Patents Challenges In Other Markets
• Table 6.1 Pfizer Post Marketing Lipitor Studies
• Table 6.2 Pfizer' s Lipitor Phase III Studies
• Table 7.1 Competitors Post Marketing Cardiovascular Agents Studies Including Lipitor
• Table 7.2 Competitors Comparative Phase III Cardiovascular Agents Including Lipitor
• Table 7.3 Competitors Comparative Phase II Cardiovascular Agents Including Lipitor
• Table 7.4 Competitors Comparative Phase I Cardiovascular Agents Including Lipitor
• Table 7.5 Competitors Other Comparative Cardiovascular Agents Including Lipitor
• Table 8.1 Lipitor Market SWOT Analysis

List of Figures

• Figure 1.1 Market Shares of Leading Statin Drugs, 2006
• Figure 1.2 Lipitor Sales in key leading markets, 2003-2006
• Figure 1.3 Lipitor Market Share in key leading markets, 2003-2006
• Figure 4.1 Sales Distribution of Cardiovascular Disease Market, 2006
• Figure 4.2 Leading Companies in Cardiovascular Market, 2006
• Figure 4.3 Sales Distribution of Leading Anti-Atheroma Therapies, 2006
• Figure 4.4 Leading Markets Share In Cholesterol and Triglyceride Drugs
• Figure 4.5 Sales Distribution of Top Ten Leading Statin Drugs, 2006
• Figure 4.6 Sales Distribution of Top Five Leading Statin Drugs, 2006
• Figure 4.7 Market Share of Lipitor in leading Markets, 2006
• Figure 4.8 Lipitor Sales in Key EU Market, 2006
• Figure 4.9 Market Share of Lipitor in Key EU Market, 2006
• Figure 4.10 Lipitor Global Sales Forecast 2008-2023
• Figure 4.11 US Lipitor Market Forecasts 2008-2023
• Figure 4.12 Japan Lipitor Market Forecasts 2008-2023
• Figure 4.13 UK Lipitor Market Forecasts 2008-2023
• Figure 4.14 France Lipitor Market Forecasts 2008-2023
• Figure 4.15 Spain Lipitor Market Forecasts 2008-2023
• Figure 4.16 Italy Lipitor Market Forecasts 2008-2023
• Figure 4.17 Lipitor Sales In Germany, 2003-2006
• Figure 4.18 Germany Lipitor Market Forecasts 2008-2023

Organisations mentioned in this report:

• Abant Izzet Baysal University
• Abbott
• Actavis
• Aegerion Pharmaceuticals
• American College of Clinical Pharmacy
• American Heart Association
• and Cardiovascular Health
• Apotex
• ASKA Pharmaceutical
• Astellas
• AstraZeneca
• Basic GmbH
• Beside Health
• Beth Israel Deaconess Medical Centre
• Biovail
• Boston University
• Bristol Myers Squibb
• Buddhist Tzu Chi General Hospital
• Canadian Heart Research Centre
• Cardiovascular Institute and Fuwai Hospital
• Chiesi
• Children' s Hospital of Philadelphia
• Children' s Mercy Hospital Kansas City
• Cipla
• CNAM (Conservatoire National des Arts et Métiers)
• Cobalt Pharmaceuticals
• Daiichi Sankyo
• Damon Runyon Cancer Research Foundation
• DiObex
• Emory University
• FDA Office of Orphan Products Development
• First Horizon
• Gedeon Richter
• GlaxoSmithKline
• Global Pharmaceuticals
• Hartford Hospital,CT USA
• Hospital de Clinicas de Porto Alegre
• Japan Foundation for the Promotion of International Medical Research Cooperation
• Kaken
• Korea University Anam Hospital
• Kos Pharmaceuticals
• LifeCycle Pharma
• Lupin
• M.D. Anderson Cancer Centre
• Maine Centre for Lipids
• Masaryk University
• Mayo Clinic
• McGill University Health Centre
• Medical College of Wisconsin
• Medical Research Council
• Medical University of South Carolina
• Memorial Sloan-Kettering
• Merck & Co
• Merck KGaA
• Ministry of Science and Higher Education, Poland
• MSD
• National Cancer Institute (NCI)
• National Centre for Research Resources (NCRR)
• National Heart, Lung and Blood Institute (NHLBI)
• National Institute of Allergy and Infectious Disease (NIAID)
• National Institutes of Health (NIH)
• National Science Council, Taiwan
• National Taiwan University Hospital
• New York University School of Medicine
• NHS Greater Glasgow and Clyde
• Nobel
• Novartis
• Ontario Association of Optometrists
• Ontario Thoracic Society
• OrbusNeich
• Par Pharmaceuticals
• Park-Davis
• Penn State University
• Pfizer
• Pharma Nord
• Queen' s University
• Queen' s University
• R&D Cardiologie UMC Utrecht
• Radboud University
• Ranbaxy
• Rikshospitalet-Radiumhospitalet
• Roche
• Samsung Medical Centre
• Sanofi-Aventis
• Schering Plough
• Sciele
• Servier
• Seven Seas
• Shenyang Northern Hospital
• Shenyang Northern Hospital
• Silesian School of Medicine
• SkyePharm
• Solvay
• St Vincent' s University Hospital, Ireland
• St. Michael' s Hospital, Toronto
• Stanford University
• Sun Pharma
• Tanabe
• Teijan
• Teofarma
• Teva Pharmaceuticals
• The Centre for Rheumatic Disease Allergy, & Immunology Saint Luke' s Hospital
• The Cleveland Clinic
• The Gustavus and Louise Pfeiffer Research Foundation
• The Hospital of Vestfold
• The Netherlands Organisation for Health Research and Development
• The Physicians' Services Incorporated Foundation
• Toronto Ophthalmological Society
• Università degli Studi dell' Insubria
• University Hospital, Brest
• University Hospital, Motol
• University of Calgary Heart and Stroke Foundation of Ontario
• University of California
• University of Campinas
• University of Chicago
• University of Florida
• University of Glasgow
• University of North Carolina
• University of Oslo
• University of Oslo School of Pharmacy
• University of Toronto
• University of Wisconsin, Madison
• VU University Medical Centre
• Warner-Lambert
• WellPoint
• Yokohama City University Medical Centre