Dyslipidemia Therapeutics - Global Strategic Business Report

This report analyzes the worldwide markets for Dyslipidemia Therapeutics in US$ Million by the following segments - Statins, and Non-Statins.

The report provides separate comprehensive analytics for US, Japan, Europe, and Rest of World.

Annual estimates and forecasts are provided for each region for the period 2006 through 2015.

The report profiles 41 companies including many key and niche players worldwide such as Abbott Laboratories, AstraZeneca, PLC, GlaxoSmithKline, Inc., Merck & Co., Inc., Mylan, Inc., Novartis AG, Pfizer, Inc., and Teva Pharmaceutical Industries Ltd.

Market data and analytics are derived from primary and secondary research.

Company profiles are mostly extracted from URL research and reported select online sources.

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Statins I-3
Non-Statins I-4

II. Executive Summary

1. GLOBAL MARKET OVERVIEW II-1
Outlook II-1
Global Market Analysis II-1
Plummeting Growth for Statins II-1
Non-Statin Drug Segment to Drive Future Growth II-2
Major Drugs Face Patent Expiry II-2
Major Dyslipidemia Drugs & Patent Expiry II-3
Key Challenges Faced by Dyslipidemia Market II-3
Patents Expiry II-3
Generic Penetration II-3
Table 1: Increasing Penetration of Generics in the US and
European Dyslipidemia Therapeutics Market by Volume
(2005-2009) (includes corresponding Graph/Chart) II-3
Strict FDA Regulations II-4
Pipeline Drugs: Focused on Unmet Needs II-4
List of Select Pipeline Drugs for Treatment of Dyslipidemia
(2009) II-4
Novel Combination Products and Future Therapies to Change
Landscape II-5
Fixed-Dose Combination Therapies II-5
Simcor - The Foremost Fixed-Dose Combination II-5
CERTRIAD II-5
Combination Therapy - Treatment for Diabetic Dyslipidemia II-6
Market Competition and Brand Dynamics II-6
Lipitor - Top Selling Statin II-6
Table 2: Lipitor Sales Worldwide (2004-2008) (In US$
Billion) (includes corresponding Graph/Chart) II-7
Crestor - The Rising Statin II-7
Table 3: Crestor Sales Worldwide (2004-2008) (In US$
Billion) (includes corresponding Graph/Chart) II-8
Vytorin (Ezetimibe/Simvastatin) II-8
Lovaza - The Leading Non-Statin II-8
Trilipix -The Foremost Combination Therapy Drug II-8
Table 4: Leading Non-Statin Brands in the US and Europe
(2009): Percentage Breakdown of Value Sales for Tricor,
Niaspan, Lovaza, Antara, Triplix and Others (includes
corresponding Graph/Chart) II-9

2. DYSLIPIDEMIA - AN INSIGHT II-10
Introduction to Dyslipidemia II-10
Classification II-10
Causes II-10
Hereditary Dyslipidemia II-11
Types II-11
Familial Combined hyperlipidemia II-11
Familial Hypertriglyceridemia II-11
Familial Dysbetalipoproteinemia II-11
Hypoalphalipoproteinemia II-11
Symptoms of Dyslipidemia II-11
Co-morbid Disorders and Risk Factors II-11
Diagnosis II-12
Treatment Strategies II-12
Drug Therapy II-13

3. TREATMENT OF DYSLIPIDEMIA II-14
Classes of Antidyslipidemic Drugs II-14
Statins II-14
Types of Statins II-14
Various Types of Statins Along With Their Brand Names and
Availability in Market as Prescription Generic Drugs II-14
Growth Drivers for Statins II-15
Impediments to Growth II-15
Non-Statins II-15
Types of Non-Statins II-15
Fibric Acid Derivatives II-15
Bile Acid Sequestrants II-15
Cholesterol Absorption Inhibitors II-16
Potential Growth Drivers for Non-Statins II-16
Market Opportunities II-16
Non-Statin Products in Pipeline II-16
Select Non -Statin Drugs in Pipeline (2009) II-16
Lipoprotein Synthesis Inhibitor II-17
Fat Supplements II-17

4. PRODUCT APPROVALS AND CLINICAL TRIALS II-18
Kowa Pharmaceuticals America Receives FDA Approval for Livalo II-18
Aegerion Pharmaceuticals Releases Final Data for Lomitapide (
AEGR-733) Phase II Trials II-18
Dr Reddys Laboratories Obtains Approval for Two Drugs II-19
Arena Pharmaceuticals Commences Phase II Clinical Trial for
Niacin Receptor Agonist II-19
Abbott Laboratories and Solvay Pharmaceuticals Receives FDA
Approval for Trilipix II-19
AstraZeneca and Abbott Submit NDA for CERTRIAD™ II-19
Amarin Secures FDA Approval for AMR101 Phase III Trials II-20
Abbotts Receives Approval for using TRILIPIX® as a
Combination Therapy II-20
Takeda Commences Phase III Trial for ATL-962 II-21
AAIPharma Licenses ProCR Oral Drug Delivery Technology to Cortria II-21
Essentialis Finishes Patient Enrolment Process II-21
Metabolex Releases Results from Phase II Clinical Trial for
MBX-8025 II-21
Karo Bio Releases Phase II Study Results for Eprotirome II-22
Merck Sharp & Dohme Receives Approval for Tredaptive II-22
Merck Obtains Patent Approval for Two Drugs II-22
Resverlogix Completes Phase 1a Trials for RVX-208 II-23
Abbott Obtains Approval from FDA for Simcor II-23
Surface Logix Releases Results of Phase 2a Clinical Trial for
SLx-4090 II-23
Merck’s Cholesterol Pill to Receive FDA Approval in 2013 II-24
Schering-Plough Obtains Approval for Marketing ZETIA® II-24

5. RECENT INDUSTRY ACTIVITY II-25
Abbott and Solvay Group Enter into Definitive Agreement II-25
Daiichi Sankyo Establishes New Subsidiary II-25
AstraZeneca Introduces Crestor II-25
Kowa Takes Over ProEthic Pharmaceuticals II-26
Ore Pharmaceuticals Acquires Exclusive Rights from Roche to
Develop Romazarit II-26
AstraZeneca Enters into Agreement with Abbott II-26
Pfizer Sells Esperion Therapeutics II-27
Merck Establishes New Biotechnology Division II-27
GlaxoSmithKline Acquires Reliant Pharmaceuticals II-27

6. FOCUS ON SELECT GLOBAL PLAYERS II-29
Abbott Laboratories (US) II-29
AstraZeneca, PLC (UK) II-29
GlaxoSmithKline, Inc. (US) II-29
Merck & Co., Inc. (US) II-30
Mylan, Inc. (US) II-30
Novartis AG (Switzerland) II-30
Pfizer, Inc. (US) II-31
Teva Pharmaceutical Industries Ltd. (Israel) II-31

7. GLOBAL MARKET PERSPECTIVE II-32
Table 5: World Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Geographic Region/Country - US,
Japan, Europe, and Rest of World Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2006 through 2015 (includes corresponding Graph/Chart) II-32

Table 6: World 10-Year Perspective for Dyslipidemia
Therapeutics by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for US, Japan, Europe, and Rest of
World Markets for Years 2006, 2009 & 2015 (includes
corresponding Graph/Chart) II-33

Table 7: World Recent Past, Current & Future Analysis for
Statins by Geographic Region/Country - US, Japan, Europe, and
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) II-34

Table 8: World 10-Year Perspective for Statins by Geographic
Region/ Country - Percentage Breakdown of Dollar Sales for US,
Japan, Europe, and Rest of World Markets for Years 2006, 2009 &
2015 (includes corresponding Graph/Chart) II-35

Table 9: World Recent Past, Current & Future Analysis for
Non-Statins by Geographic Region/Country - US, Japan, Europe,
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2015
(includes corresponding Graph/Chart) II-36

Table 10: World 10-Year Perspective for Non-Statins by
Geographic Region/ Country - Percentage Breakdown of Dollar
Sales for US, Japan, Europe, and Rest of World Markets for
Years 2006, 2009 & 2015 (includes corresponding Graph/Chart) II-37

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
Demographics III-1
Dyslipidemia in Elderly Population III-1
Market Share Statistics III-2
Table 11: The US Market for Antidyslipidemic Drugs (2007):
Percentage Share Breakdown of Leading Brands by
Prescription - Lipitor, Vytorin, Zetia, Crestor, Tricor,
Niaspan and, Others (includes corresponding Graph/Chart) III-2
Product Approvals And Clinical Trials III-2
Strategic Corporate Developments III-7
Key Players III-10
B.Market Analytics III-12
Table 12: US Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-12

Table 13: US 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment -- Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-12

2. JAPAN III-13
A.Market Analysis III-13
Strategic Corporate Developments III-13
B.Market Analytics III-14
Table 14: Japanese Recent Past, Current & Future Analysis
for Dyslipidemia Therapeutics by Product Segment - Statins
and Non-Statins Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2015
(includes corresponding Graph/Chart) III-14

Table 15: Japanese 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-14

3. EUROPE III-15
A.Market Analysis III-15
Strategic Corporate Developments III-15
B.Market Analytics III-16
Table 16: European Recent Past, Current & Future Analysis
for Dyslipidemia Therapeutics by Geographic Region - France,
Germany, Italy, UK, Spain, & Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2015 (includes corresponding
Graph/Chart) III-16

Table 17: European 10-Year Perspective for Dyslipidemia
Therapeutics by Geographic Region -Percentage Breakdown of
Dollar Sales for France, Germany, Italy, UK, Spain, & Rest
of Europe Markets for 2006, 2009, and 2015 (includes
corresponding Graph/Chart) III-17

Table 18: European Recent Past, Current & Future Analysis
for Dyslipidemia Therapeutics by Product Segment - Statins
and Non-Statins Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2015
(includes corresponding Graph/Chart) III-18

Table 19: European 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-18

3a. FRANCE III-19
Market Analysis III-19
Table 20: French Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-19

Table 21: French 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-19

3b. GERMANY III-20
Market Analysis III-20
Table 22: German Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-20

Table 23: German 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-20

3c. ITALY III-21
Market Analysis III-21
Table 24: Italian Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-21

Table 25: Italian 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-21

3d. THE UNITED KINGDOM III-22
Market Analysis III-22
Table 26: UK Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-22

Table 27: UK 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-22

3e. SPAIN III-23
Market Analysis III-23
Table 28: Spanish Recent Past, Current & Future Analysis for
Dyslipidemia Therapeutics by Product Segment - Statins and
Non-Statins Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) III-23

Table 29: Spanish 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-23

3f. REST OF EUROPE III-24
Market Analysis III-24
Table 30: Rest of Europe Recent Past, Current & Future
Analysis for Dyslipidemia Therapeutics by Product Segment -
Statins and Non-Statins Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2006 through
2015 (includes corresponding Graph/Chart) III-24
Table 31: Rest of Europe 10-Year Perspective for
Dyslipidemia Therapeutics by Product Segment - Percentage
Breakdown of Dollar Sales for Statins and Non-Statins
Markets for 2006, 2009, and 2015 III-24

4. REST OF WORLD III-25
A.Market Analysis III-25
China III-25
Outlook III-25
Key Players III-25
Strategic Corporate Developments III-26
B.Market Analytics III-27
Table 32: Rest of World Recent Past, Current & Future
Analysis for Dyslipidemia Therapeutics by Product Segment -
Statins and Non-Statins Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2006 through
2015 (includes corresponding Graph/Chart) III-27

Table 33: Rest of World 10-Year Perspective for Dyslipidemia
Therapeutics by Product Segment - Percentage Breakdown of
Dollar Sales for Statins and Non-Statins Markets for 2006,
2009, and 2015 III-27

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 41 (including Divisions/Subsidiaries - 43)
---------
Region/Country Players
---------
The United States 23
Canada 2
Japan 4
Europe 10
France 1
The United Kingdom 2
Italy 1
Rest of Europe 6
Asia-Pacific (Excluding Japan) 3
Middle-East 1

- Abbott Laboratories (US)
- AstraZeneca, PLC (UK)
- GlaxoSmithKline, Inc. (US)
- Merck & Co., Inc. (US)
- Mylan, Inc. (US)
- Novartis AG (Switzerland)
- Pfizer, Inc. (US)
- Teva Pharmaceutical Industries Ltd. (Israel)