cardiac safety services market, valued at $739 million in 2023, is on track to reach $1,282 million by 2028, with a CAGR of 11.6%. This growth is supported by extensive research that includes analysis of industry trends, pricing strategies, and patent reviews, as well as insights from industry events like conferences and webinars. The research also identifies key market stakeholders and examines purchasing behaviors. The market’s expansion is primarily driven by the accelerating pace of R&D and increasing expenditures, though the limited effectiveness of cardiotoxicity testing is a notable restraint on growth.
DRIVER: Rising incidence of cardiovascular diseases
The increasing incidence of cardiovascular diseases directly amplifies the demand for cardiac safety services by pharmaceutical companies and Contract Research Organizations (CROs) in various ways. For instance, According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives annually. Similarly, according to AstraZeneca report (UK) around 523 million people live with CVD globally. Moreover, according to the Centers for Disease Control and Prevention (CDC), heart disease is the leading cause of death for men, women, and people of most racial & ethnic groups in the US, about 695,000 people in the US died from heart disease in 2021—that’s one in every five deaths. Therefore, the rising incidence of cardiovascular diseases ensures the critical role of cardiac safety services in ensuring patient safety, regulatory compliance, and the success of cardiovascular drug development initiatives.
RESTRAINT: Inadequacy of cardiotoxicity testing
Inadequacy of cardiotoxicity testing represents a critical bottleneck in the market, with far-reaching implications. Patient safety is compromised when potential cardiac risks associated with drugs or treatments go undetected, potentially resulting in severe health consequences. For instance, when cardiotoxicity testing is not properly done, it can lead to the approval of drugs that later show serious cardiovascular side effects. For example, the FDA approved Vioxx, but it was later withdrawn from the market due to concerns about its heart-related risks. Such occurrences can cause delays in new drug approvals as regulatory agencies become more cautious. Regulatory hurdles become pronounced, as regulatory agencies like the FDA and EMA demand comprehensive cardiac safety evaluations for drug approvals. Thus, an inadequacy in testing can lead to delays in drug development and market entry. Furthermore, the repercussions extend to research & development, with companies hesitant to invest in drugs that may carry cardiac side effects, stifling innovation. Moreover, this situation can tarnish the reputation of pharmaceutical companies and CROs, affecting their competitiveness.
OPPORTUNITY: Emergence of new methods to curb cardiotoxicity
The evolution of mechanistic preclinical strategies for the detection of drug-induced electrophysiological and structural cardiotoxicity, mainly using in vitro human ion channel assays, human-based in silico reconstructions, and human stem cell-derived cardio¬myocytes. New methods such as digital twin technology, non-invasive electrocardiographic imaging (ECGI), high-throughput screening assays are gaining popularity in the market, and it presents a paradigm shift from traditional approaches that rely on simplistic in vitro assays. These new strategies can improve sensitivity and specificity in the early detection of genuine cardiotoxicity risks, thereby reducing the likelihood of mistakenly discarding viable drug candidates and expediting the progression of worthy drugs to the clinical trial stage. The introduction of these new methods, given their high efficiency and their growing usage, will provide significant opportunities for cardiac safety services to expand in the coming years. Furthermore, these methods encompass advancements in drug formulations, delivery systems, and targeted therapies, as well as more sensitive biomarkers and in vitro models for early cardiotoxicity detection. For cardiac safety services providers, these new methods represent a vital role in offering specialized guidance to pharmaceutical companies and researchers by facilitating comprehensive cardiac safety assessments, including monitoring during clinical trials, data analysis, and adherence to regulatory standards.
The integrated services segment accounted for the largest share, by type in the cardiac safety services market in 2022.
By type, the cardiac safety services market has been further categorized as integrated services and standalone services. The integrated services segment held the largest share of the global cardiac safety services market in 2022. This can be attributed to benefits associated with integrated services. Integrated services offer benefits such as comprehensive data integration and improved data quality. Additionally, these services help enhance and expedite clinical trials in the pharmaceutical and biopharmaceutical development cycle. These advantages make integrated services as preferable option against standalone cardiac safety services.
The ECG/ Holter measurement services segment accounted for the largest share of the service type segment in the cardiac safety services market in 2022.
Based on service type, the global cardiac safety services market has been segmented into ECG/Holter measurement services, blood pressure measurement services, cardiovascular imaging services, thorough QT studies, and other cardiac safety services. The ECG/ Holter measurement services segment held the largest market share in 2022. The large share of this segment can be attributed to the low cost of ECG/Holter services and rigorous regulations for drug safety, increasing research & development activities to develop effective and innovative drugs.
The North America region catered the largest share of the cardiac safety services market in 2022.
The cardiac safety services market in North America has experienced significant growth in recent years, showcasing a robust expansion trajectory, owing to large pharmaceutical & biopharmaceutical industry in the region, the rising R&D expenditure, stringent regulations, and the presence of major providers of cardiac safety services in the US and Canada. Additionally, growth of the North American cardiac safety services market is driven by significant factors such as a multitude of ongoing clinical trials, the expansion of the biosimilars and generics sector, and the increasing adoption of outsourcing preclinical, clinical, and laboratory testing services by pharmaceutical and biopharmaceutical companies.
Key Market Players
Key players in the cardiac safety services market include Laboratory Corporation of America Holdings (US), Koninklijke Philips N.V. (Netherlands), Clario (US), Banook Group (France), IQVIA (US), Biotrial (France), Certara (US), Celerion (US), Medpace (US), Ncardia (Netherlands), Richmond Pharmacology (UK), PhysioStim (France), Shanghai Medical (China), Pharmaceutical Product Development, Inc. (US), and SGS S.A. (Switzerland).
Recent Developments
- In August 2023, Clarion (US) collaborated with Dr. Vince Clinical Research (DVCR) (US). The strategic collaboration helps Clario (US) deliver accurate and cost-efficient cardiac safety data in the early clinical development stages.
- In October 2022, IQVIA (US) launched its first self-collection safety lab panel for US clinical trial participants by a leading global clinical trial laboratory.
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