Cardiac Safety Services Market Size, Share & Trends

Updated on : September 24, 2024

Overview of the Cardiac Safety Services Market

Cardiac safety services market forecasted to transform from $739 million in 2023 to 1,282 million by 2028, driven by a CAGR of 11.6%. Key drivers of this growth include the rising incidence of cardiovascular diseases, which boosts demand from pharmaceutical companies and CROs. However, challenges such as inadequate cardiotoxicity testing and high evaluation costs are notable constraints. Opportunities are emerging through new methods to detect cardiotoxicity, such as digital twin technology and non-invasive imaging. North America is anticipated to lead the market, supported by a strong pharmaceutical sector and extensive clinical trials. Major players include Laboratory Corporation of America Holdings, Medpace, and IQVIA.

The growth of this market is majorly driven by the rising pace of R&D and growing expenditure. On the other hand, inadequacy of cardiotoxicity testing is a major factor restraining market growth to a certain extent.

Cardiac Safety Services Market Trends

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Cardiac Safety Services Market Dynamics

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.

CHALLENGE: High cost of cardiac safety evaluation services

The US FDA’s Critical Path Initiative emerged with the general recognition that the rising costs of drug development and the decline in the number of new drugs approved in the US are significant problems that threaten public health. For example, cardiac safety evaluations of off-target drug effects are generally expensive, time-consuming, and contribute to the termination of many new molecular entities. cardiac safety evaluation thus constitutes an area that fits the core mission of the FDA’s Critical Path. However, the high cost remains a challenge for pharmaceutical & biopharmaceutical companies, as conducting the usual stand-alone Thorough QT (TQT) can cost USD 2–4 million, a huge investment before the commercialization of a new molecule/drug. This cost challenge encompasses several aspects of cardiac safety assessment, including the need for specialized equipment, extensive data analysis, and compliance with stringent regulatory requirements. Some cardiac safety evaluations entail the continuous monitoring of patients, particularly in clinical trials for drugs with potential cardiovascular side effects. This ongoing monitoring involves dedicated staffing and resources, further contributing to overall expenditure. For instance, in a clinical trial for a novel hypertension treatment, the continuous monitoring of participants' blood pressure and heart rate is essential, necessitating the deployment of dedicated personnel and equipment.

Cardiac Safety Services Market Ecosystem

The cardiac safety services market is a complex ecosystem involving various stakeholders, including supply side i.e companies providing cardiac safety services and demand side i.e.  pharmaceutical & biopharmaceutical companies and contract research organization (CROs).

Several key companies provide cardiac safety services . For example, Laboratory Corporation of America Holdings (US) is the leading market player. LabCorp has built its expertise in entering new markets and successfully impacting them. The company has pursued competitive strategies such as acquisitions and expansions to solidify its market presence.  The company provides cardiac safety services through its LabCorp Drug Development or DD segment. This segment provides end-to-end drug development, medical device, and companion diagnostic development solutions from early-stage research to clinical development and commercial market access. Other service providers include Medpace (US), Koninklijke Philips N.V. (Netherland), Clario (US), Ncardia (Netherlands), and others.

The integrated services segment dominated cardiac safety services industry by type

Integrated cardiac safety services refer to a comprehensive collection of clinical & medical services that help monitor and assessing the potential effects of a drug in the cardiovascular system. Integrated services are provided as a bundle of services to pharmaceutical & biopharmaceutical companies. These include cardiac safety services, such as cardiovascular imaging services, blood pressure measurement, ECG/ Holter measurement TQT studies, and profile QT studies. Integrated services offer multiple benefits as compared to standalone services. For instance, TQT services of MedPace monitor off-target cardiovascular liability and onsite multichannel telemetry conducted by certified nurses to aid in the real-time assessment of heart rate and rhythm. As a result, these services help enhance and expedite clinical trials in the pharmaceutical and biopharmaceutical development cycle.

The ECG/Holter measurement services segment dominated cardiac safety services industry by service type

ECG is a widely used diagnostic tool for assessing cardiac arrhythmias, acute & old cardiac ischemia, and left ventricular hypertrophy. Further analysis allows differentiating between physiological & pathological bradycardia & tachycardia and changes in conduction times (QT time or bundle branch block). As such, ECG continues to plays a critical role in many clinical trials studying the cardiac safety of a drug across all clinical study phases. Holter measurements are continuous ECG measurements that allow for extended analysis outside the pre-specified windows, including arrhythmia analysis, trends assessment, and enhanced quality metrics. These services help in the R&D of novel methods for clinical trials and drug discovery. For instance, ECG/ Holter data can serve as sources for identifying novel biomarkers associated with cardiac health or specific disease conditions.

North America region of the cardiac safety services industry is estimated to register the highest CAGR during the forecast period.

North America offers lucrative growth potential for the cardiac safety services market. This can be attributed to the presence of a well-established pharmaceutical industry, many ongoing clinical trial studies, high R&D expenditure, growth in the biosimilars and generics market, and rising outsourcing of preclinical, clinical, and laboratory testing services by pharmaceutical and biopharmaceutical companies.

According to ClinicalTrials.gov, as of December 2022, around 31% of registered and 33% of recruiting clinical studies are conducted in the US. This can be attributed to the presence of world-class facilities for conducting clinical trials in the country and the significant investments in R&D for drug development. Moreover, North America is the largest pharmaceutical market in the world with many global pharmaceutical and medical device giants, such as Pfizer (US), AbbVie (US), Abbott Laboratories (US), and Johnson & Johnson (US), headquartered in the region.

Some of the major players operating in the North American cardiac safety services market are IQVIA (US), Laboratory Corporation of America Holdings (US), ICON (US), and PPD, Inc. (US)

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Key players in the cardiac safety services  market include Laboratory Corporation of America Holdings (US), Medpace (US), Koninklijke Philips N.V. (Netherland), Clario (US), Ncardia (Netherlands), IQVIA (US), Certara (US), PPD Inc. (Part of Thermo Fisher Scientific, Inc.) (US), SGS S.A. (Switzerland), ICON Plc (Ireland), WuXi AppTec (China), Charles River Laboratories (US), Eurofins Scientific (Luxembourg), Frontage Labs (US), Banook Group (France), Biotrial (France), Celerion (US), Richmond Pharmacology (UK), PhysioStim (France), Shanghai Medicilon Inc. (China), ACM Global Laboratories (India), Worldwide Clinical Trials (US), Nova Research Laboratories LLC (US), Biobeat (Israel), and CRS. Experts. Early Phase. (Germany).

Scope of the Cardiac Safety Services Industry:

This report categorizes the Cardiac Safety Services Market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Integrated Services
• Standalone Services

By Service Type

• ECG/Holter Measurement Services
• Blood Pressure Measurement Services
• Cardiovascular Imaging Services
• Thorough QT Studies Services
• Other Cardiac Safety Services

By End User

• Pharmaceutical & Biopharmaceutical Companies
• Contract Research Organization (CROs)

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • Rest of Latin America (RoLATAM)
• Middle East
• Africa

Recent Developments of Cardiac Safety Services Industry

• 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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