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Research and Markets: Examine the Opportunities with Dyslipidemia in
Cardiovascular Risk Reduction
(M2 PressWIRE Via Acquire Media NewsEdge)
RDATE:17072008
Dublin - Research and Markets
(http://www.researchandmarkets.com/research/ef268f/dyslipidemia_oppo)
has announced the addition of the "Dyslipidemia: Opportunities in
Cardiovascular Risk Reduction" report to their offering.
This report deals with the market for drugs used to control blood lipid
levels (mainly LDL cholesterol, HDL cholesterol, and triglycerides) in
individuals at risk of developing new or worsening cardiovascular
disease, i.e. in primary and secondary prevention respectively. These
drugs include statins, ezetimibe, fibrates, niacin products, bile acid
sequestrants, and prescription omega-3 products. Many clinical trials
over the past 30 years or so have shown that treatment with these drugs
substantially reduces cardiovascular risk. The report reviews current
approaches to treatment, drugs on the market, marketing strategies,
lessons learnt from landmark clinical trials, biomarkers, surrogates of
atherosclerosis for drug development, and pipeline agents. It also
derives market forecasts (2008-2012) and assesses market potential.
Why buy this report?
Buy this report to gain an insight into the performance of statins and
other lipid-modulating drugs and commercial implications of
post-marketing clinical trials such as ASTEROID and ENHANCE:
1. identify biomarkers and surrogates of atherosclerosis, their
potential and limitations in drug development
2. obtain market forecasts for the dyslipidemia market to 2012 by major
market segments and geographic areas
3. discover why much of the growth in the dyslipidemia market is
forecast to come from non-statin segments, in particular niacins and
fibrates
4. be alerted to opportunities presented by the growing challenges of
mixed dyslipidemias and undertreated patient subpopulations
5. identify companies developing novel lipid-modulating drugs and the
most promising classes of drugs under development
The term "dyslipidemia" refers to abnormal blood lipid values which,
individually or in combination, elevate the risk of atherosclerotic
vascular disease. Most lipid-related abormalities can be corrected or
at least improved by drug therapy, and many clinical trials over the
past 30 years or so have shown that such treatment substantially
reduces the risk of developing new or worsening disease of the
cardiovascular system. Treatment of dyslipidemia is therefore currently
indicated for all patients with cardiovascular disease (secondary
prevention) and for some higher-risk individuals without it (primary
prevention). This report reviews current approaches to treatment, drugs
on the market, marketing strategies, lessons learnt from landmark
clinical trials, biomarkers, surrogates of atherosclerosis for drug
development, and pipeline agents. It also derives market forecasts and
assesses market potential.
We forecast that, if present trends continue, the dyslipidemia market,
dominated by statins, will grow slowly from $36 billion in 2007 to $42
billion in 2012. As a proportion of the market, statins will fall from
67% to 44%: most of this decline will occur at the end of the forecast
period as Pfizer's Lipitor (atorvastatin), still the world's
top-selling medicine, loses patent protection. Generic statins are
currently worth less than 20% of the audited statin market by sales
volume, but their share is increasing. Much of the growth in the market
will come from non-statin segments: niacin, fibrates, and even
prescription omega-3 esters. Important new drug types (e.g. CETP
inhibitors, Lp-PLA2 inhibitors, HDL mimetics) are in development, but
for a variety of reasons are unlikely to be introduced during the
forecast period. However, we believe that there are many opportunities
for market players to maintain or increase sales in the meantime, e.g.
by means of new drug combinations and improved targeting of particular
patient subgroups.
Current guidelines focus primarily on treating elevated "bad" LDL
cholesterol and secondarily on treating reduced "good" HDL cholesterol
and elevated triglycerides. Increasing attention is being paid to
aggressive LDL-C management in high-risk patients. Recent trials such
as REVERSAL and ASTEROID have suggested that atherosclerosis can be
halted, or even reversed, in many patients by such methods. However,
the fact remains that therapy focused mainly on LDL-C fails to prevent
most cardiovascular events. There are other lipid parameters that could
(and arguably should) be targeted as well. Emerging lipid and protein
biomarkers enable more accurate diagnosis of dyslipidemia and risk
stratification, while vascular imaging technologies enable measurement
of atherosclerotic progression and are potentially useful as surrogate
endpoints in clinical trials.
Statins are well established as the primary LDL-lowering intervention.
Merck & Co/Schering-Plough's ezetimibe also primarily lowers LDL-C and
is generally used in combination with statins. We assess the prospects
for ezetimibe in the light of the disappointing ENHANCE study,
published early in 2008. Although they are less well tolerated, bile
acid sequestrants are another alternative or adjunct to statins. Niacin
is the most effective drug for raising HDL-C, and also produces some
additional degree of LDL lowering when used with statins, but side
effects are common. Fibrates are first choice for lowering
triglycerides, despite gastrointestinal side-effects.
There is growing interest in combination therapies, because they can
address multiple aspects of the lipid profile in mixed dyslipidemias,
and there are indications that they produce a synergistic reduction in
cardiovascular events. In this situation, fixed-dose combination pills
have advantages and disadvantages. For example they are easier for
patients to take, but they make dose adjustments more difficult.
Several such products are on the market, with increasing numbers in
development.
Low HDL-C levels are prevalent and constitute an independent risk
factor for CHD. It is increasingly appreciated that raising HDL-C
should not be the only objective, but producing HDL particles with
better functionality is also an important goal. Of the new small
molecule drug categories still in the pipeline, CETP inhibitors appear
to have the most potential despite the recent well-publicised
withdrawal of torcetrapib following the so-called ILLUMINATE clinical
trial. This, however, meansthat niacin will remain the most potent
HDL-raising agent for some time to come, and has led to a renewed
interest in more tolerable niacin formulations and niacin/statin
combinations.
Promising biopharmaceuticals in the pipeline are injectable HDL
mimetics which have produced remarkable effects on the progression and
regression of atherosclerosis in preclinical studies. Other lipid
modulators in development include therapies which show promise for the
treatment of hypertriglyceridemia and mixed dyslipidemias and therapies
that may attenuate inflammation associated with atherosclerosis. Since
obesity is often associated with lipid abnormalities, particularly
hypertriglyceridemia, treatments for obesity that modulate blood lipids
are also of interest and are reviewed.
Key Topics Covered:
- Introduction
- Biomarkers and surrogates of atherosclerosis
- Improving mainstay therapies
- Focus on HDL
- Other lipid modulators in development
- Market outlook
- Market potential
Companies Mentioned:
- 7TM Pharma
- Abbott
- AbGenomics
- Aegerion
- Affiris
- Alnylam
- Amarin
- Amgen
- Angelini
- Arena
- Ark Therapeutics
- Astellas
- AstraZeneca
- AtheroGenics
- Avanir
- Bayer
- Bebaas
- BioInvent
- BioLineRx
- Biovitrum
- Bristol-Myers Squibb
- Celera Genomics
- Cerenis
- Chipscreen Biosciences
- CombinatoRx
- Critical Therapeutics
- CV Therapeutics
- Cytos Biotechnology
- CytRx
- Daiichi Sankyo
- Dainippon Sumitomo Pharma
- Dara Biosciences
- deCODE genetics
- Dr Reddy's Laboratories
- Eisai
- Elan
- Eli Lilly
- Exelixis
- Ferrer
- Forbes Medi-Tech
- GalMed Medical Research
- Genentech
- Genfit
- Genzyme
- Giaconda
- GlaxoSmithKline
- GlycoMimetics
- Hillcrest Therapeutics
- Hollis-Eden Pharmaceuticals
- Isis Pharmaceuticals
- Japan Tobacco
- Johnson & Johnson
- Kalypsys
- Karo Bio
- Kemia
- KineMed
- Kowa
- Kyorin
- Lexicon Pharmaceuticals
- LifeCycle Pharma
- Ligand
- Lipid Sciences
- Liponex
- Martek Biosciences
- Merck & Co
- Merck KGaA
- Metabasis Therapeutics
- Metabolex
- Metabolic Solutions
- Microbia
- Millennium
- Mitsubishi Tanabe Pharma
- Mochida
- Napo Pharmaceuticals
- NicOx
- Nippon Chemiphar
- Nippon Shinyaku
- Nissan Chemical
- Novartis
- Numerate
- Ono
- Orion Pharma
- Paladin Labs
- Perlecan Pharma
- Pfizer
- PheneX
- Phosphagenics
- Pierre Fabre
- Plexxikon
- Poli
- Pronova BioPharma
- Protemix
- QuatRx
- Ranbaxy
- ratiopharm
- Recordati
- Resverlogix
- Sanofi-Aventis
- Santaris Pharma
- Schering-Plough
- Sciele Pharma
- Scotia Pharmaceuticals
- Servier
- Shionogi
- Solvay
- SPA
- Surface Logix
- Takeda
- Targeted Genetics
- Teijin
- Teva
- Theracos
- Titan Pharmaceuticals
- TransTech Pharma
- Vascular Biogenics
- VIA Pharmaceuticals
- Watson
- Wyeth
- Yeda
- Zydus Cadila
For more information visit
http://www.researchandmarkets.com/research/ef268f/dyslipidemia_oppo
CONTACT: Laura Wood, Senior Manager, Research and Markets
Fax: +1 646 607 1907 (US)
Fax: +353 1 481 1716 (Rest of World)
e-mail: press@researchandmarkets.com
((M2 Communications Ltd disclaims all liability for information
provided within M2 PressWIRE. Data supplied by named party/parties.
Further information on M2 PressWIRE can be obtained at
http://www.presswire.net on the world wide web. Inquiries to
info@m2.com)).
Copyright ? 2008 M2 Communications Ltd.
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