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Launch of Promising Late-stage Anti-hypertensive Drugs to Drive Growth of Branded ACS Therapeutics
This research service offers an assessment for marketed and pipeline products for the global ACS therapeutics market. Segmentation by drug class is provided along with additional supporting information such as clinical trial timelines and results, historical and projected launch timelines, and epidemiology. The marketed and pipeline products are broadly segmented into anti-platelet therapeutics, anti-hypertensives and cholesterol lowering drugs, anti-thrombins, and others. Other upcoming therapies include anti-inflammatories. The forecast period is 2015–2025.
Executive Summary—Key Findings
- The ACS therapeutics market is comprised of both branded and generics drugs, the latter of which registers the most revenue.
- The market is driven by the ageing population and a prevalence of conditions associated with unhealthy living such as obesity and metabolic disorders such as diabetes.
- There are approximately key marketed branded drugs and hundreds of generics indicated for the treatment of ACS. The current treatments increasingly focus on targeting novel orphan pathways for treatment of ACS and to augment the existing class of therapeutics.
- These new drug classes are being evaluated to merge various unmet gaps among patients such as statin intolerance, bleeding risks associated with existing blood thinning drugs, and an effective treatment of atherosclerotic plaques.
- Among the various classes of ACS therapeutics, anti-hypertensives and cholesterol lowering drugs are currently dominating the ACS therapeutics market with an influx of new drugs targeting novel pathways.
The key drug targets include the proprotein convertase subtilisin/kexin type 9 (PCSK9) and cholesteryl ester transfer protein (CETP).
- The next 5 years are expected to witness the launch of the key drugs Losmapimod (GSK), Praluent (Sanofi & Regeneron), Anacetrapib (Merck & Co.), Evacetrapib (Eli Lilly and Co.), and Evolocumab (Amgen), which will boost market share for branded drugs to approximately %.
o Losmapimod from GSK’s drug portfolio is an anti-inflammatory drug which inhibits the p38 mitogen activated protein kinase (MAPK) and is being evaluated in Phase clinical trials (LATITUDE-TIMI 60).
o Amgen’s Repatha (Evolocumab) Phase 3 clinical trial program PROFICIO has engaged patients for testing the LDL-C and cardiovascular outcomes following inhibition of PCSK9 in different populations. Nearly 10 clinical phase trials are being conducted under this Phase 3 trial program.
- The drug was designed to inhibit PCSK9 from binding to LDL receptors on the liver’s surface. In the absence of PCSK9, enough LDL receptors will not be present on the surface of the liver to remove LDL-C from the blood.
o GSK has so far recruited patients for this trials to evaluate the safety of the drug in reducing the risk of cardiovascular events such as death, heart attack, or near heart attack that require urgent treatment. The enzyme p38 kinase is known for its role in inflammation and its inhibition is expected to stabilize atherosclerotic plaques and reduce plaque rupture thereby preventing thrombosis.
o The drug Evolocumab combined with the standard care treatment benefitted the patients by reducing the LDL-c by % when compared to standard of care treatment alone.
o Sanofi and Regeneron has recently received a priority review certificate for its lead drug Praluent (alirocumab) an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). So far, ten Phase 3 clinical trials, including ODYSSEY OUTCOMES, will include over patients.
o Anacetrapib is being developed by Merck for treatment of hypercholesterolemia and prevention of cardiovascular disease. It has engaged over 30,000 participants in a randomized double-blinded, placebo-controlled trial code named REVEAL and DEFINE Phase 3 trials. The drug is a CETP inhibitor.
- The market size of the ACS therapeutics was approximately $ billion in 2014 and is expected to reach $ billion in 2019 growing at a CAGR of %.
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