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Dyslipidemia: The Expanding Market for Statins and other Lipid Management Products
IMS Health, Aug 2004, Pages: 250
Dyslipidemia, involving levels of cholesterol and other lipids or fats in the blood outside levels deemed to be safe, affects a significant proportion of the world’s population. It is particularly notable in developed countries, being influenced by factors such modern diet and lack of physical exercise, as well as other recognized risk factors. However, the problem is also growing in developing countries and in doing so is increasing the burden of healthcare.
According to WHO estimates, some 16.7m people around the world died of cardiovascular diseases in 2002. Given the continued rise in rates of death from such diseases, the WHO projects that in 2020, some 25m will die of CVD. According to the WHO, over 4 million deaths occurring annually can be attributed to cholesterol problems, with regions such as Europe and the developed nations of Asia Pacific suffering particularly badly from the resulting effects. Data demonstrates that cholesterol levels are significantly high in these regions, as well as in North America. In 2020, some 25m are projected to die as a result of such diseases.
This report focuses on 10 key countries, providing coverage of the market in North America, Europe, Japan and Latin America. These countries accounted for 90% of the global market in 2002-03. The largest market by far is the US, which, at close to $14bn in 2003, was well over six times larger than the second-ranked market, Japan. At around $1bn each, the markets in the UK, France and Germany may be only half the size of that in Japan, but their growth rates have been much quicker, as a result of which they have narrowed the gap on the second-ranked market. The rate of growth in the UK has been particularly rapid. Mexico, too, has also performed well, from a low base. The Brazilian market is very undeveloped in sales terms. As a result of the major economic problems suffered in Brazil in the period under review, this was the only market to post a negative CAGR performance, in terms of dollar sales.
In the light of these statistics and the role played by dyslipidemia in CVD, action is being taken to monitor and control cholesterol levels. This has led to the development of guidelines on safe lipid levels, such as those published by the US National Cholesterol Education Panel (NCEP). These guidelines also provide guidance on appropriate treatment methods, including the role played by diet and exercise, as well as by drugs.
The withdrawal of Baycol (cerivastatin) in 2001 raised concerns about the safety of some statins and has helped increase support for other forms of treatment, including fibrates, bile acid sequestrants and other products. It is also affecting attitudes to the next generation of statins currently coming to market.
Meanwhile, the indications base for statins and other cholesterol management products is being extended by research in other fields. This may extend the scope of the class beyond cholesterol management and cardiovascular health into fields such as diabetes, osteoporosis and Alzheimer’s disease. A range of new types of products are also in development, that will offer new forms of treatment, as well as further options for combinations with statins and other products. However, government cost-containment measures and payer preferences will foster the growth of generic versions of established products. Generics could be favored for long-term primary preventive use, which may offset some of the longer-term costs stemming from inadequate control of cholesterol.
Key Findings
- Dyslipidemia has been proven to play an important role in the development of cardiovascular disease (CVD)
- The largest market by far is the US, which was well over six times larger than the secondranked market, Japan
- The market is heavily consolidated, with three companies accounting for 80% of sales. Statins dominate this market, led by the world’s leading pharma brand, Lipitor (Pfizer) with sales of some $10bn in 2003
- The range of products in the lipid management class currently is relatively limited
- This includes HMG-CoA reductase inhibitors (statins), fibrates, bile acid sequestrants and
nicotinic acid-based products
- This range is being extended by the arrival of the first in a new sub-class, the cholesterol
absorption inhibitor, Zetia (ezetimibe)
- The market formed by such products totaled close to $24bn in 2002-03
The market for products for dyslipidemia and related indications is set to double in size over the coming decade. But the market faces unprecedented change in terms of:
- New guidelines and trials highlighting the need for a more aggressive approach to dyslipidemia
- Intense competition from generic statins including simvastatin, pravastatin and, later, atorvastatin
- The arrival of new so-called 'super statins'
- Impact of alternative treatments including cholesterol absorption inhibitors and PPAR agonists
- Entry of combination therapies offering targeted forms of treatment
- Extension of indications into other areas including Alzheimer’s disease and osteoporosis
- Payers' increasing resistance to rapidly increasing healthcare costs
Comprehensive coverage including:
- Detailed profiles of top six manufacturers and the position of dyslipidemia in their portfolios
- Analysis of sub-classes, including discussion of past, current and future performance
- HMG-CoA reductase inhibitors (statins) assessed in terms of their massive impact on the market
- The historical and ongoing role played by fibrates, bile acid sequestrants and other products in the broader lipid management market
- The impact of other products including nicotinic acid-based treatments and new cholesterol absorption inhibitors
- Detailed profiles of 12 leading products – including clinical data, licensing, competition, lifecycle management, analyst comment, prospects
- Compounds in R&D - with drug profiles and analysis
- Impact of patent expiries
Plus background information on dyslipidemia and associated cardiovascular problems:
- Epidemiology of dyslipidemia by region, selected countries, type, age, sex, ethnic group
- Disease overview: definitions, classifications, risk factors, diagnosis and treatment guidelines, costs of dyslipidemia and CVD
The Dyslipidemia Report uses proven methodologies to indicate likely outcomes in dyslipidemia and related cardiovascular and other therapy areas:
- Analysis of key market drivers
- Forecasts for dyslipidemia market in selected markets to 2012
- Likely performance of statins as well as other products
- Analysis of all products types - history, competition, future performance
- Plus the researched opinions of physicians in each of the top markets:
- Interviews with leading stakeholders: Payers, Industry, Academics, Healthcare policymakers, Market strategists
This major study comprises:
- Approx 250 pages organised in 19 sections
- Over 70 indexed tables, including 40 offering detailed, national data
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