Cardiac Safety Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (ECG/Holter Monitors, Blood Pressure Monitors, Cardiovascular Imaging, Others), By Type (Integrated and Standalone), By End Use (Pharma & Biopharma Companies, CROs, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 883.13 Million
CAGR (2026-2031)	8.32%
Fastest Growing Segment	ECG/Holter Monitors
Largest Market	North America
Market Size (2031)	USD 1426.52 Million

Market Overview

The Global Cardiac Safety Services Market will grow from USD 883.13 Million in 2025 to USD 1426.52 Million by 2031 at a 8.32% CAGR. Cardiac safety services encompass the specialized monitoring, collection, and analysis of cardiovascular data—such as electrocardiograms and blood pressure readings—conducted by dedicated vendors during clinical trials to detect potential adverse drug reactions. The market is fundamentally driven by stringent regulatory mandates from health authorities like the FDA and EMA, which require rigorous cardiovascular risk assessments for new therapeutics, alongside the escalating global burden of heart-related ailments that necessitates safer drug profiles. According to the World Heart Federation, in 2025, cardiovascular conditions claim nearly 18 million lives annually, a statistic that underscores the critical urgency for developing robust safety monitoring protocols in pharmaceutical development.

Despite this strong demand, the market faces a significant impediment regarding the prohibitive costs and logistical complexities associated with implementing centralized safety monitoring across multinational trial sites. The financial strain of deploying specialized equipment and standardizing data across diverse regulatory jurisdictions often burdens small to mid-sized biopharmaceutical sponsors, potentially delaying study timelines. Consequently, while the necessity for granular safety data remains acute, high operational expenses and the intricate nature of global compliance continue to hinder the seamless expansion of these services.

Key Market Drivers

The accelerated outsourcing of clinical trial operations to specialized Contract Research Organizations (CROs) has become a primary catalyst for the cardiac safety services market. As clinical studies become increasingly complex and geographically dispersed, biopharmaceutical sponsors—particularly small to mid-sized entities—lack the internal infrastructure to manage intricate cardiovascular monitoring requirements across multiple regulatory jurisdictions. Consequently, these sponsors rely on CROs to access established global networks of cardiac safety experts and centralized data platforms to ensure patient safety. According to Contract Pharma, in August 2025, emerging biopharma companies were responsible for 63% of all clinical trial starts in 2024, a dynamic that forces these smaller entities to depend heavily on external partners for specialized safety oversight. This structural shift ensures a steady stream of demand for third-party cardiac monitoring services, as these dedicated vendors are essential for maintaining compliance and data integrity in outsourced trials.

Concurrently, rising R&D investments in biopharmaceutical development are significantly expanding the pipeline of therapeutics requiring rigorous cardiovascular assessment. Pharmaceutical companies are channeling record capital into discovering novel modalities, such as gene therapies and biologics, which often carry unknown cardiac risk profiles that necessitate continuous, high-fidelity monitoring. According to the IQVIA Institute, in March 2025, global biopharma R&D funding reached a ten-year high of $102 billion in 2024, fueling a surge in active clinical programs. This financial intensification is further exemplified by major industry players aggressively scaling their research capabilities; for instance, according to Fierce Biotech, in March 2025, AbbVie increased its R&D budget by 66% compared to the previous year to accelerate its developmental pipeline. Such robust investment directly translates into a higher volume of clinical trials, thereby amplifying the necessity for comprehensive cardiac safety testing throughout the drug development lifecycle.

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Key Market Challenges

The prohibitive costs and logistical complexities associated with implementing centralized safety monitoring across multinational trial sites constitute a formidable barrier to the growth of the Global Cardiac Safety Services Market. As pharmaceutical sponsors expand clinical studies into diverse regulatory jurisdictions, the financial burden of standardizing data collection and deploying specialized equipment becomes increasingly unsustainable. This strain is particularly damaging to small and mid-sized biopharmaceutical organizations, which often lack the capital to navigate the intricate nature of global compliance. Consequently, these operational hurdles frequently lead to extended study timelines and reduced budget allocation for granular safety data, directly hindering the seamless adoption of comprehensive cardiac monitoring services.

The magnitude of this operational challenge is substantiated by recent industry data. According to the Association of Clinical Research Professionals (ACRP), in 2025, 35% of clinical research sites identified increasing trial complexity as their leading operational challenge. This statistic highlights the profound difficulty vendors face in executing robust safety protocols amidst varying local requirements. As the logistical burden of managing these complex trials grows, sponsors are forced to consolidate resources, often at the expense of expanding specialized safety services, thereby stifling the overall market momentum.

Key Market Trends

The proliferation of medical-grade wearable continuous monitoring devices is fundamentally reshaping cardiac safety protocols by enabling high-fidelity, real-world data collection beyond traditional clinical sites. Unlike episodic ECG snapshots, these biosensors provide longitudinal insight into arrhythmogenic risks, allowing sponsors to detect intermittent cardiac anomalies that would otherwise go unnoticed during standard site visits. This shift towards patient-centric remote monitoring is rapidly scaling to meet the need for comprehensive safety profiles in complex therapeutic indications. According to iRhythm Technologies, January 2025, in the 'Preliminary Fourth Quarter 2024 Highlights' report, the company served over 2 million patients in 2024 with its Zio ambulatory cardiac monitoring platform, underscoring the decisive move towards continuous, ambulatory validation of cardiovascular health.

Simultaneously, the integration of AI-driven ECG interpretation is becoming essential for managing the massive datasets generated by these continuous monitoring technologies. Advanced machine learning algorithms are being deployed to automate the analysis of cardiovascular safety endpoints, significantly enhancing diagnostic precision while reducing the manual burden on central review teams. These tools are critical for filtering signal noise and minimizing false positives, ensuring that adverse events are identified with greater reliability. According to PMcardio, October 2025, in the 'AI-Powered Electrocardiogram Improves Heart Attack Detection' announcement, its Queen of Hearts AI algorithm correctly identified 92% of true acute cardiac events compared to only 71% via standard triage methods, while achieving a fivefold reduction in false alarms.

Segmental Insights

The ECG/Holter Monitors segment is emerging as the fastest-growing category within the Global Cardiac Safety Services Market, driven by the critical need for continuous cardiovascular data in drug development. This surge is primarily attributed to the industry transition toward decentralized clinical trials, where ambulatory devices enable effective remote patient monitoring outside traditional clinical settings. Furthermore, rigorous safety guidelines from regulatory bodies, such as the U.S. Food and Drug Administration (FDA), compel pharmaceutical sponsors to utilize these continuous monitoring solutions to detect intermittent arrhythmias that snapshot assessments may miss. Consequently, the capacity of Holter monitors to ensure comprehensive safety profiling supports their rapid adoption.

Regional Insights

North America holds a dominant position in the global cardiac safety services market, primarily driven by the substantial presence of major pharmaceutical and biotechnology firms investing heavily in research and development. This leadership is further reinforced by stringent regulatory frameworks established by the U.S. Food and Drug Administration, which mandates rigorous cardiac safety evaluation for new drug approvals to mitigate cardiovascular risks. Additionally, the increasing prevalence of cardiovascular conditions in the region accelerates the volume of clinical trials, thereby sustaining the high demand for comprehensive cardiac safety monitoring and specialized service providers.

Recent Developments

• In July 2025, Royal Philips announced a collaboration with Epic to integrate its ambulatory cardiac monitoring services directly into the electronic health record (EHR) system. This integration utilizes the Aura platform to streamline the workflow for healthcare providers by allowing them to order and review ECG results from Philips' monitoring devices directly within the patient’s existing records. The partnership was established to reduce the administrative burden on cardiac care teams and enhance the speed of diagnosis and treatment. By improving data interoperability, the initiative aimed to support more proactive management of patient populations requiring cardiac safety monitoring.
• In November 2024, SmartCardia received FDA clearance for its mobile outpatient cardiac telemetry (OCT/MCT) software, which operates with its 7-lead ECG patch. This regulatory approval expanded the company's service offerings, allowing its cable-free, waterproof wearable patch to be used for real-time remote monitoring of patients’ cardiac activity. The system utilizes a cloud-based platform to analyze live ECG data and immediately notify clinicians of significant arrhythmias, such as atrial fibrillation. This clearance positioned the company to provide a complete range of cardiac safety monitoring services, from Holter to mobile telemetry, within a single solution.
• In September 2024, iRhythm Technologies entered into a strategic partnership with BioIntelliSense to advance its capabilities in the ambulatory cardiac monitoring space. Through this collaboration, the company licensed advanced multiparameter sensor technologies, including pulse oximetry and accelerometry, to enhance its existing Zio cardiac monitoring platform. The agreement aimed to integrate these medical-grade signals into iRhythm’s solutions, allowing for broader clinical insights and improved detection of cardiac arrhythmias. This development was intended to support more comprehensive patient monitoring and drive operational efficiencies for healthcare providers utilizing cardiac safety services.
• In June 2024, Clario obtained FDA 510(k) clearance for its SpiroSphere device integrated with the wireless COR-12 electrocardiogram (ECG) sensor. This product launch was designed to streamline clinical trials by enabling the consecutive collection of spirometry and cardiac safety data during a single site visit. By consolidating these assessments into one unified database, the enhanced platform eliminates the need for separate ECG devices, thereby improving the site and patient experience. The wireless capability facilitates flexible trial designs, including hybrid and remote modalities, while maintaining high-quality data collection for respiratory and cardiac safety studies.

Key Market Players

• Medpace, Inc.
• IQVIA Holdings Inc.
• Thermo Fisher Scientific Inc.
• Charles River Laboratories International, Inc.
• WuXi AppTec Co., Ltd.
• Nova Research Laboratories LLC
• Laboratory Corporation of America Holdings
• Koninklije Philips N.V.
• ICON Plc
• Richmond Pharmacology Limited

By Service	By Type	By End Use	By Region
ECG/Holter Monitors Blood Pressure Monitors Cardiovascular Imaging Others	Integrated and Standalone	Pharma & Biopharma Companies CROs Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cardiac Safety Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cardiac Safety Services Market, By Service:

• ECG/Holter Monitors
• Blood Pressure Monitors
• Cardiovascular Imaging
• Others

• Cardiac Safety Services Market, By Type:

• Integrated and Standalone

• Cardiac Safety Services Market, By End Use:

• Pharma & Biopharma Companies
• CROs
• Others

• Cardiac Safety Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE