Coronary artery disease (CAD), also called ischemic heart disease, occurs due to the narrowing of coronary arteries that supply oxygen-rich blood to the heart. A waxy substance called plaque builds up inside these arteries, leading to atherosclerosis. Plaque builds up within the coronary artery walls until the flow of oxygen-rich blood to the heart muscle is limited. This condition is also called ischemia, which may be chronic or acute. In chronic ischemia, the coronary artery narrows over time, limiting the blood flow to part of the heart muscle, while acute ischemia occurs due to a sudden rupture of plaque and formation of a blood clot. These blood clots can completely or mostly block the flow of blood through the artery, leading to acute myocardial ischemia, which further results in acute coronary syndromes. These include unstable angina, non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment elevation MI (STEMI). If the oxygen-rich blood flow to the heart is blocked or reduced, heart attack or angina can occur.

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were approximately 327.9 million prevalent cases of coronary artery disease worldwide, and forecasts that number to increase to 365.9 million prevalent cases by 2026.
• Coronary artery disease has a male predominance. Globally, Datamonitor Healthcare estimates that in 2017, 58.65% of cases aged 15 years and over were male.
• Datamonitor Healthcare estimates that in 2017, there were approximately 9.5 million incident cases of acute coronary syndrome worldwide, and forecasts that number to increase to 10.7 million incident cases by 2026.
• Acute coronary syndrome has a male predominance. Globally, Datamonitor Healthcare estimates that in 2017, 63.78% of cases aged 25 years and over were male.
• The approved drugs in the coronary artery disease space target angiotensin converting enzyme, amyloid beta/amyloid plaques, calcium channel, and coagulation factor X. The majority of marketed drugs are administered via the oral route, with one product being available in an intravenous formulation.
• Industry-sponsored drugs in active clinical development for coronary artery disease are spread evenly across Phase I and Phase II.
• Therapies in development for coronary artery disease focus on a variety of targets. These drugs are administered via the oral, subcutaneous, and percutaneous catheter/injection routes.
• The overall likelihood of approval of a Phase I cardiovascular disease asset is 6.7%, and the average probability a drug advances from Phase III is 53.6%. Drugs, on average, take 10.0 years from Phase I to approval in the overall cardiovascular space.
• There have been 13 licensing and asset acquisition deals involving coronary artery disease drugs during 2015–20. The $151.5m marketing partnership agreement signed in 2020 between Zhittya and Regenerative Medicine, for the exclusive rights to market and sell all biological drugs developed by Zhittya during a 30-year time period to treat a variety of disorders and diseases, including coronary artery disease, was the largest deal.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for coronary artery disease have been in the late phases of development, with 52% of trials in Phase III–IV, and 48% in Phase I–II.
• The US has a substantial lead in the number of coronary artery disease clinical trials globally. Germany leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the coronary artery disease space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for coronary artery disease, with 98 trials.
• Pfizer leads industry sponsors with the highest overall number of clinical trials for coronary artery disease