GOLDMINE!
Cardiovascular diseases, the world's top killers, are also the pharmaceutical industry's top moneymakers. However, only a small percentage of the potential market for CV drugs is actually reached.
By Jin Paul S. de Guzman
Associate Editor
Every year millions of diagnoses are made, millions of prescriptions written, and tens of thousands of surgical procedures ordered--all in an attempt to stave off deaths resulting from cardiovascular causes. Yet people continue to die of diseases of the cardiovascular system and related conditions.
In 2002 the World Health Organization recorded 16.7 million global deaths resulting from cardio- and cerebrovascular diseases. In the country, latest Department of Health data (1998) show cardio- and cerebrovascular diseases occupying the two top spots on the list of killer diseases, resulting in a combined 97,000 deaths.
Despite their being the deadliest conditions--or perhaps because of their being so--they have helped bring about a market for cardiovascular products and services that is among the most competitive in the pharmaceutical industry.
Worth the GDP of a transition economy
The global pharmaceutical market, based on data provided by IMS Health was only US$8 billion dollars shy of reaching the half-trillion-dollar mark. This is staggering, because in 1998, the global drug market was estimated at about US$306.7 billion. That translates to a 62.4-percent jump in five years, or an average annual growth of 12.5 percent. This is higher than the gross domestic products of transition economies (those moving from the "developing" to "newly industrialized" categories); the growth rate will be unmatched by any other economy in the world. For example, the Philippine GDP in 1998 was estimated at US$270.5 billion, with an annual growth rate of between three and five percent.
Drugs for the cardiovascular system cover 21 percent of the 10 best-selling therapeutic categories. In the 12 months leading to February 2005, as much as US$68.9 billion worth of cardiovascular drugs were sold, as reported by IMS Health. These include lipid-lowering, antihypertensive, antiangina, antiplatelet, and antiarrhythmia agents. This is a slight increase from February 2003 - February 2004 purchases worth US$62.1 billion.
The United States remains the key market for cardiovascular products, accounting for 47 percent of global purchases. This is only a little higher than the combined expenses for CV drugs in the six other leading countries (Japan, Germany, France, Italy, Britain, and Canada).
The United States has a very high prevalence of cardiovascular diseases. In 2004 the American Heart Association estimated a 61.8 million CV-disease prevalence--practically one out of every four Americans. Assuming all of them contribute equally to CV-drug purchases in the United States--which, admittedly, probably does not mirror the actual situation--each CV patient spends about US$100 monthly on medication alone.
Lipitor, Zocor, Plavix, Norvasc
In 2003, the 10 top-selling drugs raked in US$48.3 billion in total sales. Fifty-one percent of it came from four drugs for the cardiovascular system--two are lipid-lowering agents, one an antihypertensive, and another an antiplatelet.
Pfizer's Lipitor (atorvastatin) and Merck Inc.'s Zocor (simvastatin) occupied the two top spots, posting sales of US$10.3 billion and US$6.1 billion. The difference between the two is that Lipitor grew by 14 percent from 2002, while Zocor suffered a four-percent decrease in sales, resulting from what IMS Health reports to be a loss in "exclusivity in a number of European markets."
Occupying the fourth spot was Norvasc (amlodipine, Pfizer), the leading calcium-channel blocker and antihypertensive in the global market. It registered 2003 sales of US$4.5 billion.
Plavix (clopidogrel, Sanofi-Synthélabo/Bristol-Myers Squibb), an antiplatelet, occupied the eighth spot. It brought in sales that reached US$3.7 billion, with a tremendous 12-month growth of 40 percent.
As of February 2005, four of the five top products are CV drugs. Lipitor remains the market leader, bringing along with it US$10.75 billion in sales and a growth rate of 14.3 percent. Zocor has remained second, while Plavix has surged to the fourth spot (with a still-impressive growth of 29 percent) and Norvasc has gone down to number five.
High blood pressure, high sales
Essential-hypertension management has been one of the most dynamic--and debate-riddled--medical issues. Wide-scale drug trials are generously financed and closely observed; treatment guidelines are modified with regularity to accommodate the results of these trials. Of course, none of these is free of criticism--certain methodological decisions made in trials are questioned, certain statements made in practice-guideline revisions lead to massive discussions.
The implications, of course, are not purely scientific. Every new randomized, controlled trial could spell the ascent of a new agent, and lead to the end of the profitability of an old one. For instance, the fate of the cyclooxygenase-2-specific inhibitor Vioxx was practically sealed by a clinical trial that showed the cardiovascular risks it put chronic users in. Of course, clinical trials are just one of the forces that determine the viability of any agent. If that were not so, the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT, 2003) could have brought thiazide-type diuretics--which the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) declared "virtually unsurpassed in preventing the cardiovascular complications of hypertension"-straight to the top.
In the past 10 years the popularity of calcium-channel blockers has been practically unchallenged. IMS Health reports that in 2000, CCBs comprised 31 percent of prescriptions. These are followed by angiotensin-converting-enzyme inhibitors (ACEIs), which retained their 19-percent share in 2000 with the help of such landmark trials as HOPE (Heart Outcomes Prevention Evaluation) and PROGRESS (Perindopril Protection against Recurrent Stroke Study)--despite the growing popularity of angiotensin-receptor blockers, which were first introduced in 1994 and enjoyed four percent of total prescriptions written. However, ARBs are the only antihypertensives to register significant growth--35 percent for the plain ARBs, and 58 percent for the ARB/diuretic combination--in June 2001.
Beta blockers and diuretics each accounted for 11 percent of all antihypertensive prescriptions in 2000.
The Pinoy market
The Philippines is the world's 33rd largest pharmaceutical market, accounting for about 0.27 percent (US$1.06 billion) of the global market in 2001. There is no clear trend in the industry's growth in the country--in 1997 it was worth US$1.2 billion, but never reached that level again in the intervening years. Still, the Philippines remains the top drug market in Southeast Asia.
The Pharmaceutical and Healthcare Association of the Philippines (PHAP) reports that in 2002, cardiovascular drugs controlled 13.8 percent of the national drug market, and was estimated to be worth PhP9.1 billion. This class of drugs ranked third, closely following drugs for the alimentary tract and systemic antiinfectives.
Diseases of the cardiovascular system are also fairly common in the country. In 2001 the DOH showed that hypertension and diseases of the heart ranked fifth and seventh in the leading causes of morbidity. The Philippine Heart Association, meanwhile, estimated that eight million Filipino adults are hypertensive.
CCBs and renin-angiotensin-system agents (ACEIs, beta-blockers, and ARBs) together sold PhP4.9 billion in 2002, with a combined market share of 7.4 percent. The PHAP report did not give any figures on diuretics.
Three of the 10 best-selling drugs in the country are CV drugs. Pfizer's Norvasc ranked third overall, showing a considerable rise since its launch in 1992--from being 56th in 1996, 18th in 1998, and 12th in 2000. Another CCB, AstraZeneca's Plendil (felodipine), found itself sixth on the list, while Pfizer's Lipitor ranked ninth.
Untapped potential
Based on PHA data, only 21 percent--or 1.75 million--of an estimated eight million hypertensive Filipinos take any medication at all for their condition. Only 770,000--or 9.6 percent of the total--are compliant to their treatment regimen.
If the total value of the national antihypertensive market is PhP5.387 billion (assuming that the diuretic market is valued at PhP500 million), each of the patients who take any medicines at all is spending about PhP8.55 daily, or PhP256.50 monthly, to control their condition. In other words, antihypertensives reach only about 21 percent of their potential market, which could be worth PhP24.6 billion.
Now if the worth of the entire antihypertensive market depended mostly on those who comply to their treatment regimen, each of the patients is spending about PhP19.40 daily, or PhP583 monthly. However, this would imply that the available drugs are reaching only 9.8 percent of its potential market, which could be worth a staggering PhP55.97 billion.
It goes without saying that these are ideal scenarios. The high cost of health care--and medicines in particular--remains a serious roadblock to most Filipinos. In addition, only about half of Pinoys who are compliant to their treatment regimen--about 385,000, or 4.8 percent of all hypertensives--actually achieve blood-pressure control.
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