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Executive Summary

The use of pharmaceuticals to treat cardiovascular conditions will rise sharply in the next 10 years compared to use of equipment/device treatment modalities, SRI Internatl. Senior Consultant Frank von Richter predicted at an Oct. 10-11 conference sponsored by the research/consulting firm in Menlo Park, California. By 1995, the ratio of pharmaceutical use to equipment/device use for treating cardiovascular disease will be 2-to-1, von Richter said, noting that the current ratio is 1.3-to-1. Greater demand for the most cost effective treatment modalities in the cardiovascular area will spark a 15.5% annual growth rate in cardiovascular drug sales, with the total volume in drugs used to treat heart conditions reaching $17.3 bil. in 1995, von Richter estimated. By comparison, the overall cardiovascular products market, including equipment and devices, will increase annually by 14.5%, with total sales of $27.1 bil. in 1995, the SRI specialist said. Cost containment pressure, exemplified by the move by the federal govt. to prospective reimbursement through the DRG system, which von Richter said is "heralding a more restrictive approach to reimbursement," will result in greater reliance on chemical therapies to treat cardiovascular disease, he said. Mechanical approaches to cardiovascular therapy, including bypass surgery and pacemakers, have been popular in America where a "quick fix mentality" and the "historic availability of inexpensive, broad-coverage insurance" made the more expensive treatments feasible, von Richter declared. But he said that the availability of broad-based insurance coverage will decline, making cost efficient treatments more important. To illustrate what can be expected to happen, he noted that in Europe, where insurance coverage is not as broad as in the U.S., the ratio of chemical to mechanical treatments is 6-to-1. Von Richter said that in Europe that ratio will increase to 7-to-1 by 1995. He predicted that the cardiovascular product market will grow at an annual rate exceeding the growth rate of the overall U.S. health care market during the next decade. He noted that the cardiovascular market is already the "largest single category of disease products, representing 12%-13%" of the $432 bil. U.S. health care market. SRI Health & Food Industries Center Director George von Haunalter predicted that U.S. health care expenditures will grow at an average annual rate of 10% to reach $670 bil. by 1990. Consumer expenditures, the largest segment, will grow most rapidly at a rate of 12% as the market becomes "more consumer/patient driven," von Haunalter said. At the same time, private insurance expenditures are only expected to grow at a 7% average annual rate, according to his estimates. The aging population is another factor which will significantly enlarge the market, von Richter said. Noting that the "over-65 population accounts for some 47% of cardiovascular disease in the U.S.," he estimated that by the year 2000, "we will have some 10 mil. (people over age 65) and we may well be faced with treating two generations with a similar problem." Despite cost containment pressures, new technologies will continue to make a significant impact on the cardiovascular disease market, von Richter said. For example, a group of new products which were "not available in 1980," will continue to grow in market share. The group includes calcium antagonists, tissue plasminogen activators, new inotropic agents, novel imaging products, and ambulatory blood pressure monitors. The annual growth rate for this group of new technological developments "is about 23% per year," von Richter said. With $1.2 bil. in sales for 1985, the group holds a 17% share of the cardiovascular disease market: By 1995, SRI expects this share to grow to 38%, or $10.2 bil. Von Richter's predictions are based on information gathered for three SRI Internatl. multi-client studies on cardiovascular disease management in the U.S. and Europe. The effects of preemerging technologies - those in early developmental stages -- on the market were also investigated as part of the studies. Drugs To Limit Myocardial, Cerebral, and Vascular Infarcts May Reach Market By 1990s - SRI Pre-emerging technologies that SRI expects will yield breakthroughs in the next 10 years fall into six different areas: (l) computer-assisted drug design, (2) modification of sodium/calcium transport, (3) self-regulated drug delivery, (4) genetic modification, (5) biotechnology, and (6) artificial implants. Among these technologies, SRI has identified five areas where breakthroughs will "most likely" occur in the near future. One such area is "tissue protection." Work with enzymes and prostaglandins showing promising results have given SRI analysts reason to expect commercially viable products which can help "limit myocardial, cerebral, vascular infarcts" by the mid 1990's. "Smart" anti-arrhythmic drugs, which are not as broad in impact as the ones currently available, are another expected breakthrough. Von Richter noted that the method of designing such products to react "only on biological command" is currently available. As a focus of attention for Harvard researchers and small entrepeneurs, synthetic blood vessels are another area where breakthroughs are anticipated shortly. In the area of biotechnology, research is expected to yield tissue plasminogen activators that will operate at the site of the clot, rather than systemically, von Richter said. Advances in molecular biology are also expected to improve our understanding of atherosclerosis and facilitate the search for methods of earlier detection or prevention. Calling all of the categories "strategic opportunities," von Richter said a breakthrough in any one of them would probably result in a minimum $1 bil. worldwide market, or possibly $2 bil. Von Richter expects the eventual impact of the new technologies to be four-fold. They will focus more attention on detection and maintenance, have a dramatic effect on chronic mortality/ morbidity, lower the overall cost of managing the disease, and bring in many new participants, such as biotechnology companies, small entrepeneurs, and offshore companies. Peptide research is one "pre-emerging technology" expected to yield improved cardiovascular agents "in the next five to 10 years. SRI Internatl. Life Sciences Div. Senior Pharmacologist, Richard Jensen, PhD, indicated that the area to watch now in peptide research is renin inhibitors. Noting that three generations of renin inhibitors have been developed, Jensen said that some are now ready to start human trials. Ciba-Geigy's CGP 29 287 is one he has particularly "been paying a lot of attention to." The test drug "is very interesting in that it overcomes some of the major problems with peptide drugs," such as duration of action and multiple activity, Jensen said. He predicted the drug "may not make it to the clinic," but that Ciba-Geigy "will come along with something that is an improvement on this drug." Peptide research is also unraveling the secrets of the body's endogenous sodium regulating systems such as the atrial natriuretic factor, endogenous digitalis, and renal natriuretic hormones. The atrial peptides now being synthesized by peptide chemists "may be important drugs in the future in treating hypertension that's related to high sodium retention and also water retention," Jensen said. Those forms of hypertension are currently being treated by diuretics. A calcitonin gene-related peptide, touted as the most potent vasoactive peptide known, is also under investigation. The use of peptides to limit the spread of damage from myocardial infarction is another area where work is starting to yield.exciting results, Jensen said.

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