Snapshot: Coronary Artery Disease Global Clinical Trials 201113 May 2011
An estimated 17 million people die of coronary artery disease worldwide every year, and numbers are rising. While pharmaceutical efforts to find a cure have always been fiercely competitive, few contenders have emerged to challenge time-tested drugs and their generics. But, as this special report snapshot shows, a host of new trials and targeted therapeutics are beginning to show serious dividends.
Coronary artery disease (CAD) is a condition in which plaque (cholesterol or fatty material) builds along the wall of the arteries. This plaque restricts the supply of oxygen-rich blood to the heart muscle and may even block the arteries completely. The plaque makes the artery narrow and less flexible, and can be the result of a number of sources including smoking, high cholesterol, high blood pressure or high sugar levels due to diabetes.
Overall, the World Health Organisation estimates that around 17 million people die of coronary diseases each year. In the UK, coronary heart disease (CHD) is the biggest killer, affecting one in five men and one in seven women, resulting in 94,000 deaths every year.
While current competition in the CAD therapeutics market is strong, mainly due to the market being governed by branded and generic drugs that have comparable safety and efficacy profiles, three major patent expiries and the entry of new therapeutics are expected to pump new blood into an already competitive environment.
Based on GlobalData's clinical trial report, "Coronary Artery Disease Global Clinical Trials Review, Q1, 2011", this snapshot provides comprehensive information about the coronary artery disease clinical trials conducted by key players, compiled from information taken from 70 registries across the globe, from 1982 to January 2011.
Moderate growth to 2017
The CAD therapeutics market is highly competitive and is expected to become more competitive by 2017. Three major patent expiries are expected during the forecast period – Plavix and Lipitor by 2012, and Crestor by 2016.
The patent expiries of these blockbuster drugs will trigger generic competition in the CAD therapeutics market, making it more competitive. However, an increase in the number of CAD patients and the entry of novel therapies will be responsible for the stable growth predicted between 2013 and 2017.
The present market products for the treatment of CAD have overall high efficacy and safety standards. The market also has two other modes of treatment – coronary artery bypass grafting (CABG) and angioplasty. The CAD mortality rate is very high compared with other diseases, due to the coronary events associated with CAD, which include myocardial infarction (MI), angina and stroke. Therefore, the prevention of such events remains an untapped area of research and development (R&D) for pharmaceutical companies to bring novel drugs into the market.
It would be sufficient for newer entrants to demonstrate a superior efficacy and safety profile in order to capture value in the market from the current-use branded and generic treatments.
Europe the leading destination
In total, 438 CAD clinical trials had been conducted by January 2011, of these, 157 clinical trials were in Europe. More than 35% of the clinical trials were conducted in Europe followed by 31% in North America.
Among the European countries, Germany had the highest number of coronary artery disease clinical trials, followed by the Netherlands.
In a geographical analysis, the US has the highest number of coronary artery disease clinical trials followed by Germany. In the Asia-Pacific region, China has the highest number of coronary artery disease clinical trials followed by the Republic of Korea. In North America, the US has the highest number of coronary artery disease clinical trials followed by Canada. Israel has the highest number of coronary artery disease clinical trials followed by Iran in the Middle East and Africa.
Majority of trials are ongoing
As of January 2011, there were 269 clinical trials in progress and 151 trials had been completed. 18 trials had been terminated / suspended or withdrawn due to the lack of efficacy, safety or accrual of subjects.
Success rates of the trials were based on completed versus uncompleted (terminated, suspended or withdrawn) trials.
As of January 2011, Cordis Corporation had sponsored the highest number of coronary artery disease clinical trials, followed by Boston Scientific and Johnson & Johnson.
New entrants: a paradigm shift
GlobalData has found that that the presently available treatment options are successful in meeting the market demand but that newer classes of drugs like aliskiren would bring much needed efficacy in the reduction of progression of atherosclerosis in CAD patients.
Ticagrelor and vorapaxar, an antiplatelet, are likely to have improved efficacy over other antiplatelets and effient which was been approved in 2009 has more inhibition of platelet activation compared to already approved platelet inhibitor clopidogrel.
Similarly, darapladib, a new class of therapeutic agent, is a selective lipoprotein associated phospholipase A2 (Lp-PLA2) inhibitor, and dalcetrapib and anacetrapib are being studied for long-term tolerability and efficacy in patients with CAD or other equivalent diseases. All of these drugs are believed to present a more favorable risk-benefit ratio than the current multidrug therapies. They may offer more comprehensive and effective methods to tackle CAD. A paradigm shift is therefore predicted in this market.
Novel class of therapeutic drugs
The current competition in the CAD therapeutics market is strong, as the market is mainly governed by branded and generic drugs that have comparable safety and efficacy profiles. This apart, major revenue for this market is generated by statins, antiplatelet and anticoagulants, which are prescribed in addition to beta-blockers, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to achieve superior treatment for patients. The antiplatelet and renin inhibitor (a new class of molecule) market is in itself set to witness a remarkable growth rate with the approval of newer drugs. The entry of these newer classes of drugs will undoubtedly accelerate the growth of the overall CAD market and also offset the negative impact of the patent expiry of major products. Merck & Co. is expected to lead sales in the CAD therapeutics market with the introduction of anacetrapib, dalcetrapib, ticagrelor and vorapaxar in the next few years.
However, other products, such as darapladib and aliskiren, are also likely to propel the growth of the market.
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