Cholesterol Reduction Therapies--The Apple of the Doctor's Eye Elicits Fierce Competition Among Market Players
By Vicky Kim, Frost & Sullivan
MARKET OVERVIEW
Statin drugs are cholesterol reducing therapies that have won the widespread approval of managed care organizations, physicians and patients. The benefits of statin drugs have magnified the competition in the U.S. Hypolipidemic Prescription Market, where manufacturers strive to detail the benefits of one product over another.
With clinical trial data to demonstrate an excellent safety and efficacy profile, as well as the ability to reduce the incidence of cardiovascular morbidity and mortality, statins have been able to capture 98 percent of the earnings in the U.S. hypolipidemic market in 1999. Amidst the statins, Lipitor, marketed by Pfizer Inc., has quickly become the market share leader, earning 37.5 percent of the revenues in 1999. Zocor, promoted by Merck & Co., is the immediate runner-up, earning 36.5 percent. Physicians prefer Lipitor or Zocor to other cholesterol reducing therapies for their immense efficacy in reducing low density lipoprotein (LDL) cholesterol.
The largest imminent threat to both Lipitor and Zocor is AstraZeneca's new statin currently in Phase III trials, ZD-4522. Officials at AstraZeneca claim that this new product will have a superior efficacy profile to any other current drug available in its class.
The U.S. Hypolipidemic Prescription market earned $7.5 billion of revenues in 1999. This market is projected to earn $13.2 billion by the year 2006.
MARKET OPPORTUNITIES AND CHALLENGES
The hypolipidemic prescription marketplace, one of the largest in the entire pharmaceutical industry, attracts the largest pharma players to play a heated game of market share confiscation. Competition is fierce, accelerating the arrangement of co- promotion agreements and intensifying the formation of merger and acquisition activities. Companies manipulate these activities to give rise to widespread marketing endeavors to win the largest market share.
With extra capital and resources, companies fund large-scale clinical studies that promise multifaceted benefits. On one level, these clinical trials will improve the credibility of a product or they will be used as tools to identify new customer segments. Most importantly, these studies are essential to target topics of discussion at the meetings of the National Cholesterol Education Program, where experts will write updates of the Adult Treatment Panel (ATP) guidelines. The ATP guidelines are requisite to physicians, who become subject to lawsuits if they fail to adhere to the guidelines. Therefore, companies that sponsor these studies can design clinical trials to not only address the benefits of their products or create new patient targets, but to revolutionize treatment strategies and prescribing patterns. Clinical data provided by industries are the sole source for guideline updates, as governmentally sponsored trials are no longer funded.
While the ultimate goal of cholesterol reduction is to reduce one's risk for heart disease, marketing enterprises have lead others to neglect the fact that the mechanism or risk factors for heart disease are not well understood. As a result, new market entrants or products with a lesser efficacy in reducing LDL cholesterol may run clinical trials to demonstrate the benefits of improving other lipids. Prognostic markers such as apo B-100, apo A-1, or C-reactive proteins have already been identified to predict coronary events. While the benefits of reducing or elevating these factors are yet to be determined, alteration of these factors may prove to reduce the risk of heart disease. This in turn, could identify new patient targets, and solicit opportunities for new research and development activities.
Additionally, new market segments are identified primarily through the use of Direct- to-Consumer advertising, where both patients and physicians receive education on the benefits of hypolipidemic therapies. Manufacturers may also fund mass screening programs to identify new patients, as Medicare does not reimburse for the routine screening of cholesterol levels in its beneficiaries.
FUTURE MARKET ENTRANTS
The exceptional safety and efficacy profile of statin drugs have greatly satisfied physicians and managed care organizations. As a result, emerging therapies must undertake lofty challenges to revolutionize statin therapy. Like statins, new drugs must be proven to reduce cardiovascular morbidity and mortality in a large-scale clinical trial.
If new therapies are able to reduce LDL-cholesterol as effectively as statins, they must also possess the following qualities:
- Longer acting formulations
- Improved efficacy and safety profile
- Low potential for drug interactions
Statin drugs are very difficult to improve, and as a result, companies searching for hyperlipidemic treatments seek to find anti-atherosclerotic properties of their drugs, or search for compounds that will elevate HDL, the good cholesterol.
Frost & Sullivan's new report, U.S. Hypolipidemic Prescription Market (5388-52) discusses the current and emerging products in the market.
Vicky Kim is a pharmaceutical industry analyst with the healthcare group at Frost & Sullivan. She can be reached for further comment via email: [email protected].
Media inquiries can also be sent to:
Nick Mariottini
Healthcare Media Relations
Frost & Sullivan
530-894-2136 phone & fax
[email protected]
RSS