(From January 2007 MedMarkets; subscribers only)
MedMarket Outlook: Cardiovascular Disease Outlook
Cardiovascular Disease continues to represent a major source of morbidity and mortality globally, as illustrated in recent CDC data on the U.S. The prevalence of heart disease and its direct involvement in 232,000 deaths in 2003 (see Exhibit 1, below), combined with de facto growth in the forces driving caseload in heart disease — the ageing population, increasing rates of obesity and other risk factors — lead to an unmistakable conclusion that future for development of cardiovascular technologies remains very bright.
One might argue that a good reason for the size and relative stability of the cardiovascular disease market is that the development of interventional cardiology techniques and products, particularly for those in the treatment of ischemic heart disease (angioplasty and drug-eluting or bare stents), has produced relatively effective options for dealing with the acute aspect of the disease. (It should be noted that the CDC data points up that the most common cause of death from cardiovascular disease is due to ischemic heart disease, accounting for 45% of all deaths from CV disease.) Interventional cardiology avoids coronary artery bypass and its associated costs and trauma, provides rapid recanalization, and can allow rapid return of patients to their lives. This effectiveness of interventional cardiology, as an alternative to bypass, therefore takes away some of the pressure on patients for dealing more preemptively with the risk factors — sedentary lifestyle, cholesterol intake, management of stress, etc. — that lead to coronary heart disease in the first place. It may be a bit of an over-simplification that patients may prefer to live life as they please and view interventional cardiology as a sort of “rejuventation” of their vasculature, but there may well be some truth in this.
Is the Future Defined by Late Stage Thrombosis or New Innovations?
The recent preliminary data indicating that there is an increased risk of late stage thrombosis associated with the drug-eluting stents of Johnson & Johnson and Boston Scientific, and the FDA panel hearings to evaluate the issue, has unquestionably put a damp blanket on the enbridled enthusiasm for drug-eluting stents. As discussed in previous issues of MedMarkets, neither J&J nor Boston Scientific demonstrated outward concern about the thrombosis risk of their CYPHER and TAXUS stents, but it is reasonable to assume that, given the $5 billion market that hangs in the balance, the internal concern is much greater for both companies. Be that as it may, neither J&J nor Boston Scientific needed the late stage thromobosis risk to prod them to think innovatively about future DES developments. With new drug-eluting stent versions pending from Medtronic, Abbott (including the PROMUS everolimus eluting stent made by Abbott and already distributed by Boston Scientific in Europe) and a cadre of others, all players recognize the continued potential in this market as well as the risk that thromobosis, which has not been adequately elucidated with short term data, may become a rate-limiting factor when long term data is generated.
Age, Race and Other Factors in CVD
In the January issue of Health Affairs, the data described above is presented in the paper entitled, “The CVD Burden And Trends In The United States.” An area of tremendous room for improvement that is noted is the need to address the wide disparities that exist in the management of cardiovascular disease within and between different age, race/ethnicity and even state groups. While presenting the data at face value, showing that, for example, there is a 2.5-fold difference in coronary heart disease mortality between black and white women aged 45-54, the study does not make assertions about whether the difference appears to be due to differences in economics or other correlating cause. Simarly, three fold differences in mortality were seen for women of similar age in different states.
It is imperative for manufacturers to discern what factors may point to opportunities for product development that will address these disparities. And, while it may be noble to do so, one cannot fault manufacturers for their interest in pursuing age-specific, gender-specific or other segment-specific developments that may enable them to increase caseload and product sales. The end result (a reduction in CVD mortality), whether through noble or self-serving intentions, may well be the same.
With the introduction in 2006 of gender-specific knee implants by Zimmer and Stryker, the door seems to have been opened, or the potential demonstrated, for developments based on disparities such as gender that have not been previously pursued (i.e., other than for those more overtly different in gender, such as gynecology). So, too, are there potential considerations for CVD treatment technologies that capitalize on other differences, such as the innate difference between pediatrics and adult medicine that go beyond issues of the “size” of products.
Manufacturers may see the differences in CVD risk based on these factors as eminently too nuanced to pursue, but with health care costs becoming transparent and evidently different for different populations, the savvy manufacturer is one who can capitalize on such differences.
The CVD Outlook
Coronary vascular disease has seen dramatic reductions in morbidity and mortality over the past few decades as the diseases have become the target of health-conscious patients, cost-conscious health care systems, and opportunity-conscious manufacturers. As significant as those reductions have been, CVD still represents the single largest cause of death from disease in the United States. Moreover, the CDC data and authors point to potential for those reductions to dissipate in light of the persistence and potential impact of risk factors — aging populations, prevalence of obesity and even the declining prevalence of adults who have no known major CVD risk factors of their own (“those with favorable levels of measured blood cholesterol and blood pressure who do not smoke and do not have diagnosed diabetes, myocardial infarction, or electrocardiographic abnormalities”).
Ironically, in the face of the risk from these factors, the CDC study authors point up that spiraling costs may ensue from programs that may seek to aggressively target CVD risk through the use of expensive cardiac catheterization and other diagnostics. Consequently, there remains considerable room for cost-effective improvement.