Analysts: New Cholesterol Treatment Guidelines Present Challenges

  • Updated guidelines could substantially boost the statin market
  • Meanwhile, drugs in alternative therapeutic classes ‘could well experience greater difficulty in gaining physician uptake and patient shares,’ says analyst

New Cholesterol Treatment Guidelines ‘Hard to Swallow’ for Non-Statin Manufacturers in Cardiovascular Drug Market, say GlobalData Analysts

LONDON, UK (GlobalData), 27 November 2013 - Updated guidelines for the treatment of hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) could well give the statin market a substantial boost over the coming years, but they will pose a significant challenge to developers of other drug classes in the cardiovascular marketplace, according to analysts with research and consulting firm GlobalData.

The new guidelines, released by a task force from the American College of Cardiology (ACC) and the American Heart Association (AHA), promote the use of statins alone for the reduction of low-density lipoprotein cholesterol (LDL-C), or “bad cholesterol.”

Eric J. Dimise, Ph.D., and Rebecca C. Wong, MSc, GlobalData's Analysts covering Cardiovascular & Metabolic Disorders, say that these guidelines will prove particularly “hard to swallow” for manufacturers of other lipid-lowering drug classes, such as Zetia (ezetimibe/Merck) and Trilipix (fenofibric acid/AbbVie), as the new recommendations all but discredit the usefulness of these products.

Conversely, the analysts believe that the support received from statin suppliers is not at all surprising. AstraZeneca, for instance, is leveraging the new guidelines to promote Crestor (rosuvastatin), which will remain under patent protection into 2016. 

Rebecca C. Wong says: “Now that statins are officially recommended as the go-to therapy, drugs such as Lipitor (atorvastatin), Crestor, and Zocor (simvastatin) are likely to retain market dominance for the treatment of ASCVD. Meanwhile, drugs in alternative therapeutic classes could well experience greater difficulty in gaining physician uptake and patient shares.”

Instead of employing a “treat-to-target” approach to cholesterol reduction, the new guidelines promote a more opaque goal of “treat to reduce risk,” with an increased emphasis on healthy lifestyles.

However, prescribing physicians are far from achieving a consensus regarding these directions. Eric J. Dimise believes that physicians will not necessarily break from what they perceive to be the tried-and-true, “treat-to-target” approach.

As such, Dimise concludes: “It is risky to say that the statin market will double in size between November 2013 and the patent expiry of Crestor in 2016 as a result of these guidelines. However, suggesting that it will experience a boost is a reasonable and well-founded proposition that GlobalData can support.”



- Comments to be attributed to Eric J. Dimise, Ph.D., and Rebecca C. Wong, MSc, GlobalData's Analysts covering Cardiovascular & Metabolic Disorders.

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Posted: December 2013

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