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MarketVIEW: Cholesterol (PCSK9) vaccines

Published: February 2015

Cardiovascular disease(s) (CVD) are prominent within the 10 leading causes of death in high-income countries. The most common manifestations of CVD are coronary heart disease (CHD), ischaemic stroke, and peripheral arterial disease (PAD). Raised low-density lipoprotein cholesterol (LDL-C), smoking, and uncontrolled hypertension are major risk factors the development of CVD. By 2030 almost 24.3M people/year globally are predicted to die from CVD.

Currently Statins (HMG-CoA reductase inhibitors) are the most effective drug class for reducing LDL-C but differ in their LDL-C lowering capacity. In addition, several novel therapies are in development to reduce LDL-C levels in patients with severe hypercholesterolemia. These include PCSK9 inhibitors (monoclonals) of which Sanofi's SAR236553 (REGN727) PRALUENT and Amgen's evolocumab RAPATHA have now been filed for registration in both the US and EU. Both monoclonals were shown to reduce LDL-C levels by 40 to 60% in combination with statins/ezetimibe in high-risk patients and those with homozygous familial hypercholesterolaemia. CVD outcomes studies are now ongoing.

Some companies (Pfizer and AFFiRiS AG) are also investigating the possibility of preclinical PCSK9 vaccines that could help reduce LDL-C levels in high-risk patients who cannot achieve guideline LDL-C treatment goals. Vaccines could have the added benefit of lower cost and less frequency of administration than monoclonals.

This MarketVIEW product contains a comprehensive MS Excel-based model + summary presentation which forecasts the potential commercial value of PCSK9 (cholesterol) vaccines + monoclonals across major Western markets until 2030. The model contains value ($ m) and volume (mio doses) predictions per product type along with timeframe, pricing and penetration estimates for all target populations. The product also includes an in depth review of latest epidemiological trends, lipid lowering treatments/guidelines and latest developments in R&D.

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