Cardiovascular Clinical Trials Market size was over USD 5 Billion in 2023 and is anticipated to exceed USD 11.7 Billion by the end of 2036, witnessing over 6% CAGR during the forecast period i.e., between 2024-2036. In the year 2024, the industry size of cardiovascular clinical trials is estimated at USD 6 Billion.
The growth of the market is prompted by the rising incidence of cardiac disorders like cardiac arrest, stoke, and coronary artery diseases. According to the World Heart Federation, cardiovascular diseases are ranked among the top diseases causing deaths and the global estimated deaths from cardiovascular diseases in the year 2021 were approximately 205 million. Besides, the enhancement in related government and industrial funding, along with the rising need to achieve greater cost avoidance in Phase III trials, are also driving market growth.
Growth Drivers
Challenges
Base Year |
2023 |
Forecast Year |
2024-2036 |
CAGR |
6% |
Base Year Market Size (2023) |
USD 5 Billion |
Forecast Year Market Size (2036) |
USD 11.7 Billion |
Regional Scope |
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Phase (Phase I, Phase II, Phase III, Phase IV)
Phase IV segment is set to account for more than 32% cardiovascular clinical trials market share by the end of 2036. The segment growth can be attributed to regulatory bodies such as the U.S. FDA and European Union regulatory authorities requiring post-marketing research to ensure the efficacy and safety of cardiovascular devices. Compliance with these criteria drives the conduct of Phase IV trials, boosting the segment’s growth. For instance, PubMed discovered 4,772 Phase IV trials sponsored by the National Institutes of Health, with 330 focusing solely on medication safety and 4,392 assessing both safety and efficacy. Of these trials, 8.2% were canceled or delayed.
In addition, the proliferation of patient data and advances in genomics are increasing research to investigate the benefits of incorporating global data into clinical trials. The intervention model, therapeutic specialty, and principal sponsor were all factors that influenced the use of blinding and randomization. Also, as experts across the industry say, global data are actively integrated with Phase IV clinical trials to obtain payer approvals and evaluation of clinical interventions. Hence, the aforementioned trends are expected to increase the demand for phase IV trials, thereby increasing the growth of the segment in the cardiovascular clinical trials market.
Study Design (Interventional, Observational, Expanded Access)
By 2036, interventional segment is expected to capture over 48% cardiovascular clinical trials market share. Growing interventional research, with chemical or biological including biological, behavioral, surgical techniques, and devices is set to expand the segment’s growth. In a recent study in the New England Journal of Medicine in 2022, of the 10,596 patients presenting to the emergency department with acute myocardial infarction, 7899 patients were eligible for inclusion in the trial. After excluding those who had reasons for not attending the RAPID-HF clinic, 5452 patients were enrolled in the trial (2972 in the control period, 2480 in the intervention period in the 19th century).
There has been a significant increase in the number of interventional studies developed over time. Interventional studies are generally preferred over observational studies because of their greater accuracy and relevance. Furthermore, for clinical trials of a cardiovascular device, interventional research is the gold standard, and supports, the accuracy and efficiency of the medical device under study large share of the market.
Therapeutic Area (Oncology, Cardiology, Neurology)
Cardiology dominates the segment taking 48% of the cardiovascular clinical trials market in the upcoming years. Robust growth in this segment is witnessed due to factors such as the growing incidence of CVD, the aging population globally, as well as the strategic collaboration between the pharma and biotech companies in which the latter is mainly involved in cardiovascular disease (CVD).
According to the World Heart Association Report 2023, more than half a billion people worldwide are affected by cardiovascular disease, including 20.5 million deaths by 2021, approximately one-third of global deaths, and an estimated million-person increase of 121 CVD deaths. This has led to the search for conventional drugs for the treatment of heart failure, which leads to the identification of clinical trial sites for the same.
Our in-depth analysis of the cardiovascular clinical trials market includes the following segments:
Phase |
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Study Design |
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Therapeutic Area |
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North American Market Statistics
North America region in cardiovascular clinical trials market is predicted to capture over 34% revenue share by 2036. The region is home to several established contract research organizations (CROs) that specialize in cardiovascular clinical trials. These CROs have the expertise, infrastructure, and resources necessary to conduct highly complex cardiovascular research.
In addition, pharmaceutical companies in North America are investing heavily in research and development (R&D) to improve health care and develop new treatments. This increase in R&D expenditure drives demand for clinical trials, especially in the cardiovascular field. Moreover, the fusion of real-world data and genomic advances is increasing the demand for evaluating the value of personalized medicine. This trend is most evident in North America, where there is a strong focus on integrating real-world data with phase IV clinical trials for payer adoption and health technology research
The United States represents the largest market for clinical cardiovascular research. Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for 928,741 deaths by 2020. Due to the availability of new resources and technological changes used in clinical research, cardiovascular clinical trials are conducted in the country.
APAC Market Analysis
The Asia Pacific region will also encounter huge growth for the cardiovascular clinical trials market during the forecast period and will hold the second position. Over the past 2 decades, the number of CVD-related deaths in Asia increased from 5.6 million to 1.08 million. Approximately 39% of these CVD deaths were premature, i.e., they occurred in individuals younger than 70 years, which was significantly higher than premature CVD deaths (23%) in the US.
The expansion of independent clinics in the region is increasing the demand for cardiovascular clinical trials. Supportive regulatory developments, particularly in China and India, are making regional trials more affordable and accessible. Telemedicine and the use of wearable devices for monitoring patients undergoing clinical trials enable cost-effective and efficient management of clinical trials, thus supporting market growth. The growing elderly population of the Asia Pacific region is increasing the prevalence of cardiovascular diseases, and there is a need for clinical research.
In 2022, China accounted for 29% of global clinical trial activity, up from 17% a decade ago. Cardiovascular contributed 9% by 2022, compared with 11% over five years and 12% over 10 years.
Furthermore, industries playing vital role in providing clinical trials of cardiovascular facilitating advanced technologies and AI integration to execute smooth and accurate process. Key players dominating cardiovascular clinical trials market include:
Author Credits: Radhika Pawar
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