Lipid Regulators

Published by: Global Industry Analysts

Published: Aug. 1, 2006 - 275 Pages

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability And Reporting Limitations

Disclaimers

Data Interpretation & Reporting Level

Quantitative Techniques & Analytics

Product Definitions And Scope Of Study

II. EXECUTIVE SUMMARY

1. Global Market Overview and Analysis

2. Industry Overview

Evolution of Statins Market

Growth of Cholesterol Drug Market

US Spearheads Statin Market

Statins Market is Under Prescribed

Potent Statins Embrace Wider Scopes for Market Expansion

Lipids Gets Center-Stage in Biomedical Research

Scientists Discover Gene Mutation Key for Lipid Control

3. Trends and Issues

Growth Drivers

Novel Drug Classes Energizes the Statins Market

Advent of Single-Pill Combination

Increased Promotional Spending Fuels Up the Statin Market

Revised Treatment Guidelines Sparks Up the Lipid-Lowering Drugs

Development of New Uses of Statins

Generic Substitution to Bring Down Statin Therapy Costs

Statin Therapy to Become Standard Practice in Hospitals

Generics and New Combinations Erode the Profitability of Branded Products

Aging Population Growth to Augment Statins Market

New Therapies and Indications Leverage Statins Market

Challenges Faced

Low Awareness Restrains Market Potential

Physicians Hold Back on Prescribing Statins

Non-Observance of NCEP Guidelines by Physicians Restrains Market Growth

Poor Patient Compliance with Lipid-Lowering Therapy

Baycol Withdrawal Tightens the Drug Approval Process of FDA

Expanding Cholesterol Drug Market Leads to Increased Health Plan Costs

4. Product Overview

What is Cholesterol?

Reverse Lipid Pathway (RLT)

Lipid-Lowering Drugs

Statins

Drug Selection by Lipoprotein Profile

Non-Statins

Complementary Products

Ezetimibe (Zetia)

Combination Therapy

Future Lipid Regulators

5. Branded Statins - A Competitive Analysis

Lipitor, Zocor & Pravachol Dominate Statins Market

Erosion of Blockbuster Drug Sales

Review of Available Branded Statins

Mevacor (Lovastatin)

Pravachol (Pravastatin Sodium)

Zocor (Simvastatin)

Lescol (Fluvastatin Sodium)

Lipitor (Atorvastatin Calcium)

Crestor (Rosuvastatin Calcium)

Vytorin (Ezetimibe/Simvastatin)

Pitavastatin

Table 1: Worldwide Leading Branded Statins: A Synopsis

Table 2: Leading Statins Brands Worldwide (2003-2005E): Market Share by Sales for Lipitor, Zocor, Pravachol, Mevacor, Lescol, and Crestor (Includes Corresponding Graph /Chart)

Lipitor from Pfizer Remains the Highest Selling Brand

Table 3: Preferred Statins of HMO Formularies (Includes Corresponding Graph/Chart)

Advicor to Overtake Lipitor and Zocor

Cost Comparison of Statins

6. Statins & Its Significance

Use of Statins for Treating Dyslipidemia

Role of Statins in Hyperlipidemia

Statin Therapy for Children with Familial Hypercholesterolaemia

Statin Therapy for Treating Familial Hypercholesterolaemia

Statins Help to Prevent Cardiovascular Diseases

Role of Statins Therapy for Treating Atherosclerosis

Statin Therapy for Postmenopausal Women

Statins Helpful for Osteoporosis Treatment

Statins Indicate Evidence of Preventing Cancer

Role of Statins in Preventing Multiple Sclerosis

Efficacy of Statins to Lessen Risk of CHD in Diabetes

Statins Shows Efficacy for Treating Hyperlipidemia in Older Patients

Efficacy of Statins & Aspirins to Prevent Heart Attacks

Statins Help to Reduce the Progression of Aortic Stenosis

Statins Help to Abstain Alzheimer’s Disease

Role of Statin on DVT

Statins Substitute Cyclosporin for Organ Transplantation

Statins Lowers Fracture Risk in Elderly

Statins Found Unsafe Concurrently with Protease Inhibitors

7. Types of Non-Statins

Bile Acid Sequestrants

Colesevelam HCl (WelChol)

CholestaGel

Nicotinic Acid (Niacin)

Fibric-Acid Derivatives (Fibrates)

Clofibrate (Atromid-S)

Fenofibrate (Lipidil)

TriCor

Gemfibrozil (Lopid)

Fish Oil

Estrogen Therapy

Various Benefits of Non-Statins

Significance of Fenofibrate in Reduction of Increased Plasma Homocysteine Levels

Gemfibrozil in Combination with Niacin Augments HDL Levels

Gemfibrozil Alleviates Chances of Coronary Attack

Low-Dose Nicotinic Acid Beneficial for Type 2 Diabetics

Combination Therapeutic Products

Impact of Zetia with Statins in Treatment for Cholesterol Reduction

Zetia with Simvastatin Doubles CRP Reduction Level

Lipitor and Norvasc Combination for Coronary Events with Hypertension

Combination of Simvastatin and Niacin Useful for CAD Patients

Advicor (Niacin & Lovastatin) Helpful to Reduce Cholesterol Levels

Atorvastatin and Fenofibrate Combo Reduce Lipid Levels in Type 2 Diabetes with CHD

Mevacor and Aspirin Combination Reduces Risk of Colon Cancer

WelChol & Lipitor Combination Lessens LDL Cholesterol Level

Cholestagel & Statins Combination Therapy Helps to Reduce LDL Cholesterol

8. Regulatory Environment

NCEP Guidelines for Lipid Abnormalities

Revised NCEP Guidelines for Adult Treatment Panel III (ATP III)

Revised NCEP Guidelines for Adult Treatment Panel II (ATP II)

American Diabetes Association (ADA) Clinical Guidelines

FDA Stiffens Stand on the Generic Availability of Statins

9. Recent Industry

IMPAX Obtains FDA Grant for Generic Version of Colestid®

Merck/Schering-Plough Obtains FDA Approval for New Indication of ZETIA®

Novartis to Acquire NeuTec Pharma

Sankyo Pharma, Daiichi Pharma, Daiichi Medical Merge to form Daiichi Sankyo

Teva Obtains FDA Nod for Generic Pravastatin

Abbott Teams Up with AstraZeneca for Combination Cholesterol Pill

Merck, Schering-Plough Collaborate Over Combination Cholesterol Drug

Yamanouchi Pharmaceutical Merges with Fujisawa Pharmaceutical

Teva Acquires Dorom S.r.l of Pfizer

Merck/Schering-Plough Receives Approval for Inegy™ in Europe

Industry Activity in Recent Past

Micro Labs Introduces Statin Molecule

AstraZeneca Sets Up Bulk Drug Manufacturing Plant

Merck/Schering-Plough Receives EU Approval for EZETROL™ (ezetimibe)

AstraZeneca Introduces Crestor in Canada and the Netherlands

AstraZeneca Launches Crestor in the US Market

AstraZeneca Offers Crestor in the UK, Holland and Sweden

Merck/Schering-Plough Launches ZETIA™

Alpharma Unveils Simvastatin Tablets

AstraZeneca Receives Canadian Approval for Crestor

Merck Obtains FDA Approval for Zocor 40mg Dosage

Novartis Receives FDA Approval for Lescol & Lescol XL

AstraZeneca Bags European Approval for Crestor

Pfizer Obtains FDA Approval for Lipitor

Bristol-Myers Squibb Receives FDA Approval for Pravachol® 80 mg Dosage

Merck/Schering-Plough Bags FDA Approval for Zetia (ezetimibe)

Andrx Obtains FDA Approval for Altocor

Teva Pharmaceutical Receives FDA Approval for Micronized Fenofibrate Capsules

IMPAX Obtains Temporary FDA approval for Generic Fenofibrate Capsules

Teva Pharmaceutical Receives Indefinite FDA Approval for Generic Pravastatin

Nymox Obtains US Patent for Statin Drugs for Treating Alzheimer's Disease

Kos Introduces its Dual Component Therapy Advicor™ in the US

Bal Pharma Launches Simvofix

Biocon Receives FDA Approval for Manufacturing Lovastatin in India

Laboratorios Belmac Receives Spanish Approval to Market Generic Simvastatin

Mylan Gets FDA Approval for Lovastatin Tablets

Purepac Pharmaceutical Receives FDA Approval for Lovastatin Tablets

Cipher Obtains FDA and Canadian Approval to Conduct Trials of Finofibrate

Sankyo Pharma Launches WelChol in the US

Novartis Introduces Lescol XL

Warner-Lambert Bags Marketing Approval for Lipitor in Japan

Fournier Releases Supralip Tablets for Hyperlipidaemia

Merck Introduces High Dosage Zocor

10. Focus on Select Players

Abbott Laboratories (USA)

Andrx Corporation (USA)

AstraZeneca (UK)

Astellas Pharma,Inc.(Japan)

Bentley Pharmaceuticals (USA)

Bristol-Myers Squibb (USA)

Daiichi Sankyo, Inc. (USA)

Kos Pharmaceuticals (USA)

Merck (USA)

Merck/Schering-Plough Pharmaceuticals (USA)

Novartis AG (Switzerland)

Pfizer (USA)

Teva Pharmaceutical (Israel)

11. Global Market Perspective

Table 4: World Recent Past, Current & Future Analysis for Lipid Regulators (Statins) by Geographic Region/Country - US, Canada, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

Table 5: World 11-Year Perspective for Lipid Regulators (Statins) by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, and Rest of World Markets for Years 2000, 2005 & 2010.(Includes Corresponding Graph/Chart)

III. MARKET

1. The United States

A.Market Analysis

Statins Market in the US

Table 6: PBM Drug Expenditures by Therapeutic Category in 2004 in the US (Includes Corresponding Graph/Chart)

Current and Upcoming Statins in the US- A Profile

Table 7: Price of Statins in the US Market

Table 8: Leading Players in US Lipid Regulators Market (2003-2005E): Market Share of Merck, Pfizer, Astra, BMS, Abbott, Novartis, KOS, and Others (Includes Corresponding Graph/Chart)

Table 9: Statin Prescriptions by Brand in the US (2003- 2005E): Percentage Share Breakdown for Lipitor (Atorvastatin), Zocor (Simvastatin), Pravachol (Pravastatin), Mevacor (Lovastatin), Lescol (Fluvastatin) and Others (Includes Corresponding Graph/Chart)

Table 10: Branded Statins Market in the U.S (2003-2005E): Market Share of Leading Players- Pfizer, Merck, AstraZeneca, BMS, and Novartis (Includes Corresponding Graph/Chart)

Table 11: Branded Statins Market in the U.S (2003-2005E): Market Share of Leading Brands by Value Sales for Lipitor, Zocor, Crestor, Pravachol, Lescol, and Mevacor (Includes Corresponding Graph/Chart)

Market Trends

Increasingly Aggressive Guidelines Fuel up Statins Market

Physicians Switch to Higher and More Costly Starting Dose of Statins

Expansion of Treatment Population Charges the Statin Market

Merck’s Zocor to Become Leading Selling Prescription

Improved Patient Compliance Energizes the Statins Market

Marketer’s Increased Promotional Spending Sparks Up Statin Sales

New Clinical Studies Outcome Fuels the Expansion of Statin Market

Lipitor Dominates the Lipid-Lowering Drugs Market

Crestor Launch Jeopardize Market Players

Generics, New Combination Therapies Gaining Momentum

Government to Boost the Growth of Generics Industry

Aging Population Drives the Statin Market Growth

US Non Statins Market: A Profile of Select Products

Table 12: Leading Brands of Statin Combinations in the U.S (2004&2005E): Percentage Share Breakdown for Advicor and Zocor/Zetia (based on number of prescriptions).

Table 13: Leading Products of Generic Statins in the U.S (2005E): Market Share by Value Sales for Lovastatin, Simvastatin and Pravastatin (Includes Corresponding Graph/Chart)

Table 14: Leading Product Types in the US Non- Statins Market (2003-2005E): Percentage Share Breakdown for Fibrates, Nicotinic Acid Derivative, Bile-Acid Sequestrant, and New Products (Includes Corresponding Graph/Chart)

List of Major Players in US Market for Lipid Regulators by Product Type

Strategic Corporate Developments

Product Innovations/Introductions in Recent Past

Leading Players/Market Leaders

B.Market Analytics

Table 15: US Recent Past, Current & Future Analysis for Lipid Regulators (Statins and Non-Statins) by Product Segments - Statins and Non-Statins Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/ Chart)

Table 16: US 11-Year Perspective for Lipid Regulators (Statins and Non-Statins) by Product Segment -Percentage Breakdown of Dollar Sales for Statins and Non-Statins Markets for 2000, 2005 & 2010

2. Canada

A.Market Analysis

Strategic Corporate Developments in Recent Past

Product Innovation/Introduction in Recent Past

B.Market Analytics

Table 17: Canadian Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

3. Japan

A.Market Analysis

Current and Upcoming Statins in Japan- A Profile

Strategic Corporate Development

Strategic Corporate Developments in Recent Past

Product Innovation/Introduction in Recent Past

Leading Players

B.Market Analytics

Table 18: Japanese Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4. Europe

A.Market Analysis

Current and Upcoming Statins and their Patent Expiration Years in the EU

Growth of Generics to Control Health Care Costs in Europe

Strategic Corporate Developments in Recent Past

Product Innovation/Introduction in Recent Past

B.Market Analytics

Table 19: European Recent Past, Current & Future Analysis for Lipid Regulators (Statins) by Geographic Region/Country - France, Germany, UK, Italy, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

Table 20: European 11-Year Perspective for Lipid Regulators (Statins) by Geographic Region/Country - Percentage Breakdown of Dollar Sales for France, Germany, UK, Italy, Spain, and Rest of Europe Markets for Years 2000, 2005 & 2010. (Includes Corresponding Graph/Chart)

4a. France

A.Market Analysis

Statins in France: A Brand Profile

B.Market Analytics

Table 21: French Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4b. Germany

A.Market Analysis

Patent Expiry Fuels Up Generic Competition in German Statins Market

Statins in Germany: A Brand Profile

Strategic Corporate Developments

B.Market Analytics

Table 22: German Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4c. The United Kingdom

A.Market Analysis

Generic Substitute Fuels Up the UK Statins Market

Statins in the UK: A Brand Profile

UK Encourages Generic Status for Statins

Strategic Corporate Developments

Leading Player/Market Leader

B.Market Analytics

Table 23: UK Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4d. Italy

Market Analysis

Table 24: Italian Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4e. Spain

A.Market Analysis

Strategic Corporate Development in Recent Past

B.Market Analytics

Table 25: Spanish Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

4f. Rest of Europe

A.Market Analysis

Product Innovation/Introduction in Recent Past

Leading Player/Market Leader

B.Market Analytics

Table 26: Rest of Europe Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 ( Includes Corresponding Graph/Chart)

5. Rest of World

A.Market Analysis

Australia

Australian Drug Market

Drug Approval Process in Australia

India

Market Overview

Table 27: Market Potential of Select Statins in Generics Market in India- Atorvastatin, Pravastatin, Simvastatin and Lovastatin (In INR Billion) (Includes Corresponding Graph/Chart)

Efforts of Pharmaceutical Industry Paying Off

Growth Drivers

Exploring Other Growth Opportunities

Competitive Landscape

Outlook

Product Innovation/Introduction in Recent Past

Strategic Corporate Developments

Strategic Corporate Developments in Recent Past

Historic Review

Leading Players/Market Leaders

B.Market Analytics

Table 28: Rest of World Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart)

IV. COMPETITION

1. Abbott Laboratories (USA)

Table 29: First Quarter Sales Analysis: 2005-2006 (In US$ billion)

Table 30: Annual Sales Analysis: 2003-2005 (In US$ billion)

2. Andrx Corporation (USA)

Table 31: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 32: First Quarter Sales Analysis by Business Segment: 2005-2006 (In US$ million)

Table 33: Annual Sales Analysis: 2004-2005 (In US$ million)

Table 34: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 35: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million)

3. Astellas Pharma, Inc. (Japan)

4. AstraZeneca PLC (UK)

Table 36: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 37: First Quarter Sales Analysis by Geographic Region: 2005-2006 (In US$ million)

Table 38: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 39: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Astrazeneca Pharmaceuticals LP (USA)

5. Bentley Pharmaceuticals, Inc. (USA)

Table 40: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 41: Annual Sales Analysis: 2003-2005 (In US$ million)

6. Biocon India Limited (India)

Table 42: Annual Sales Analysis: 2004-2005 (In INR million)

7. Bristol-Myers Squibb Company (USA)

Table 43: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 44: Annual Sales Analysis: 2003-2005 (In US$ million)

8. Daiichi Sankyo Co., Ltd. (Japan)

Daiichi Sankyo Pharma, Inc. (USA)

9. Ethypharm SA (France)

10. Fournier Pharma, Inc. (Canada)

11. GlaxoSmithKline PLC (UK)

Table 45: Annual Sales Analysis: 2003-2005 (In £ million)

Table 46: Annual Sales Analysis by Segment: 2004-2005 (In £ million)

Table 47: Annual Sales Analysis by Segment: 2003-2004 (In £ million)

12. Impax Laboratories, Inc. (USA)

13. Johnson & Johnson (USA)

Table 48: First Quarter Sales Analysis: 2005-2006 (In US$ billion)

Table 49: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ billion)

Table 50: First Quarter Sales Analysis by Geographic Region: 2005-2006 (In US$ billion)

14. Kos Pharmaceuticals, Inc. (USA)

Table 51: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 52: Annual Sales Analysis: 2004-2005 (In US$ million)

15. Krka, Tovarna Zdravil, d.d., Novo Mesto (Slovenia)

Table 53: Annual Sales Analysis: 2004-2005 (In SIT million)

Table 54: Annual Sales Analysis by Geographic Region: 2004-2005 (In SIT million)

16. Merck & Co., Inc. (USA)

Table 55: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 56: First Quarter Sales Analysis by Product Segment: 2005-2006 (In US$ million)

Table 57: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 58: Annual Sales Analysis by Product: 2004-2005 (In US$ million)

Table 59: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

17. Merck Frost Canada Ltd. (Canada)

18. Merck Frosst/Schering Pharmaceuticals (Canada)

Merck/Schering-Plough Pharmaceuticals (USA)

19. Metkinen Oyj (Finland)

20. Novartis AG (Switzerland)

Table 60: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 61: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)

Table 62: Annual Sales Analysis: 2004-2005 (In US$ million)

Table 63: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 64: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

Novartis Pharmaceuticals Corporation (USA)

Novartis Pharmaceuticals Canada, Inc. (Canada)

21. Pfizer, Inc. (USA)

Table 65: Annual Sales Analysis: 2003-2005 (In US$ billion)

Pfizer Canada, Inc. (Canada)

Pfizer GmbH (Germany)

Pfizer Ireland Pharmaceuticals (Ireland)

Pfizer Japan, Inc. (Japan)

22. Pharmac (New Zealand)

23. QUATRx Pharmaceuticals Co. (USA)

24. Ranbaxy Laboratories Ltd. (India)

Table 66: Annual Sales Analysis: 2003-2005 (In INR billion)

25. Reliant Pharmaceuticals, Inc. (USA)

26. Schering-Plough Corporation (USA)

Table 67: Annual Sales Analysis: 2004-2005 (In US$ million)

Table 68: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 69: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

Table 70: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

27. Sopharma Jsc (Bulgaria)

28. Strides Arcolabs Limited (India)

29. Teva Pharmaceutical Industries Ltd. (Israel)

Table 71: First Quarter Sales Analysis: 2005-2006 (In US$ billion)

Table 72: Annual Sales Analysis: 2003-2005 (In US$ billion)

30. Zentiva AS Praha (Czech Republic)

31. Zydus Cadila (India)

Table 73: Annual Sales Analysis: 2004-2005 (In INR million)

Abstract

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