Cardiovascular Clinical Trials Market Analysis
Based on phases, the market is segmented into phase I, phase II, phase III and phase IV. The phase III led the market with the largest revenue share of 34.9% in 2022.
- Phase III trials attained dominance in the cardiovascular clinical trials market due to their pivotal role in evaluating treatment efficacy and safety before seeking regulatory approval. It involves the larger patient pool and comprehensive assessments, essential for confirming a therapy's benefits and potential risks. For instance, as per ICTRP data, more than 320 phase III studies are registered for cardiovascular clinical research, projecting considerable opportunities, and anticipating positive study outcomes in the years ahead.
- Thus, the significance of phase III trials in determining a treatment's success and subsequent market entry, coupled with their adherence to regulatory standards, solidified their prominence in shaping the landscape of market.
Based on study designs, the cardiovascular clinical trials market is classified into interventional, observational, and expanded access. The interventional study design holds the largest share of 60.6% in the market, witnessing its dominance throughout the analysis period.
- These studies categorize interventions into drugs or biologics, behavioral, surgical procedures, and devices.
- Over time, there has been a substantial increase in conducted interventional studies, representing 75 to 80% of registered studies as of May 2022, mostly comprising drug or biologics, followed by behavioral, clinical procedure, and device interventions. Interventions are preferred for their heightened precision and relevance compared to observational studies.
- Additionally, in cardiovascular clinical trials, the medical device interventional studies are considered as the gold standard for assessing the accuracy and effectiveness of the devices under investigation, thus contributing to their significant market share.
Based on indication, the global cardiovascular clinical trials market is segmented into cerebrovascular disease, coronary artery disease, hypertensive heart disease, cardiac arrhythmia inflammatory heart disease, pulmonary arterial hypertension syndrome, ischemic heart disease, heart failure and other indications. The cerebrovascular disease segment is projected to account USD 2.3 billion by 2032.
- The dominance is attributed due to the growing number of cerebrovascular diseases. According to the National Center for Health Statistics data, one out of every six cardiovascular disease-related deaths was attributed to stroke, in 2021. Approximately 87% of all strokes are ischemic strokes, characterized by a blockage in blood flow to the brain. Stroke stands as a primary cause of enduring disabilities. Among stroke survivors aged 65 and above, more than half experience reduced mobility due to its impact.
- Thus, surge in the demand for cerebrovascular related clinical studies is expected to augment the market development.
Based on the end users, the global cardiovascular clinical trials market is segmented into biotechnology & pharmaceutical companies, medical devices manufacturers, contract research organization (CRO), and other end users. In 2022, the CROs sector held the largest market share at 49.1%.
- CROs dominate the market due to their specialized expertise, efficient trial management, and regulatory compliance. Their capability in handling diverse trial aspects, solidifies their pivotal role in advancing cardiovascular research.
- Additionally, CROs offer state-of-the-art services, making them preferred partners for the researchers, government organizations, biopharmaceutical and pharmaceutical companies seeking project outsourcing. For instance, in August 2023, Dr. Vince Clinical Research (DVCR) has formed a strategic partnership with Clario to provide cardiac assessments in clinical trials. This alliance is expected to expand access to Clario's Early Precision QT (EPQT) methodology.
- Thus, such collaboration aims to assist biopharmaceutical companies in obtaining accurate and cost-effective cardiac safety data in the initial phases of clinical development.
In 2022, North America held the highest revenue share in the market and is poised to maintain dominance, projecting a lucrative CAGR of 5.6% throughout the analysis period.
- The region's prominence is attributed to the presence of well-established CROs with expertise in cardiovascular clinical trials, including Worldwide Clinical Trials, ICON plc, Caidya, and several others. U.S holds a leading position in the number of conducted cardiovascular clinical trials. For instance, the U.S. has recorded around 11,585 cardiovascular clinical trials on the WHO International Clinical Trials Registry Platform (ICTRP) from 1999 to 2022. The huge number of clinical studies reflects a significant volume of research activities in the country.