Cardiac Safety Services Market

Market Definition

Cardiac safety services are specialized preclinical and clinical testing services designed to assess the cardiovascular risks of pharmaceutical compounds, medical devices, or biologics. 

They evaluate drug-induced effects on heart rate, blood pressure, QT interval, arrhythmia, and other cardiac parameters to ensure patient safety and regulatory compliance. The  market encompasses a broad range of offerings, including ECG/Holter monitoring, blood pressure monitoring and cardiovascular imaging.

Cardiac Safety Services Market Overview

The global cardiac safety services market size was valued at USD 846.5 million in 2024 and is projected to grow from USD 941.9 million in 2025 to USD 2,039.6 million by 2032, exhibiting a CAGR of 11.55% during the forecast period.

Expanding drug development pipelines across multiple therapeutic areas are fueling the demand for cardiac safety assessments to meet regulatory and safety requirements. The rising prevalence of cardiovascular diseases globally is creating a significant demand for advanced cardiac safety services to ensure patient well-being during clinical trials.

Key Highlights:

1. The cardiac safety services industry size was recorded at USD 846.5 million in 2024.
2. The market is projected to grow at a CAGR of 11.55% from 2025 to 2032.
3. North America held a share of 34.09% in 2024, valued at USD 288.5 million.
4. The integrated segment garnered USD 526.1 million in revenue in 2024.
5. The blood pressure monitoring segment is expected to reach USD 560.3 million by 2032.
6. The contract research organizations segment is anticipated to witness the fastest CAGR of 11.67% through the projection period.
7. Asia Pacific is anticipated to grow at a CAGR of 12.58% over the forecast period.

Major companies operating in the cardiac safety services market are ICON plc, Clario, IQVIA Inc, Medpace, Inc, Charles River Laboratories, Eurofins Discovery Services LLC, Certara, Inc, Biotrial, Celerion, Richmond Pharmacology Limited, Ncardia Services B.V, Koninklijke Philips N.V, NEXEL Co., Ltd., Clario, and Laboratory Corporation of America Holdings.

Increasing investment by market players in AI-powered cardiac diagnostics is enabling earlier and more accurate detection of complex heart conditions. This advancement is improving patient outcomes and fueling the adoption of advanced cardiac safety services. In addition, AI-driven platforms are streamlining data interpretation, reducing human error, and accelerating decision-making in clinical trials.

• In July 2025, Ultromics raised USD 55 million in Series C funding to expand its FDA-cleared EchoGo AI platform for early detection of heart failure across the U.S. The platform enhances diagnosis of HFpEF and cardiac amyloidosis through AI-powered echocardiogram analysis, improving accuracy, scalability, and proactive cardiac care.

Market Driver

Increasing Prevalence of Chronic Diseases

A key factor propelling the growth of the cardiac safety services market is the increasing prevalence of chronic diseases such as diabetes, hypertension, and obesity, which elevate the risk of cardiovascular complications. Pharmaceutical companies are prioritizing the development of safer therapies for these high-risk populations, prompting regulatory authorities to mandate comprehensive cardiac safety assessments during drug development. 

Clinical trials are increasingly incorporating advanced monitoring technologies such as electrocardiogram (ECG) monitoring, Holter monitoring, and cardiac biomarker analysis to detect potential side effects early, reduce adverse events, and ensure patient safety. This growing focus on cardiovascular risk mitigation is boosting demand for specialized cardiac safety services.

• The International Diabetes Federation (IDF) reported that approximately 589 million adults (20–79 years) are living with diabetes globally in 2024, with the number projected to rise to 853 million by 2050. This increasing prevalence increases cardiovascular risks, thereby boosting demand for cardiac safety assessments in drug development to ensure safer therapies for high-risk populations.

Market Challenge

High Cost of Cardiac Safety Evaluation Services

A key challenge impeding the growth of the cardiac safety services market is the high cost of cardiac safety evaluation services. These assessments require advanced monitoring equipment, sophisticated data analysis tools, and highly skilled professionals to ensure accurate and reliable results. 

Extended trial durations, integration of multiple study endpoints, and large patient populations further increase operational expenses for cardiac safety evaluation services. Additionally, compliance with stringent regulatory standards adds to financial and administrative burdens, creating barriers for smaller companies and limiting broader adoption.

To address this challenge, market players are increasingly investing in advanced digital platforms, AI-driven analytics, and centralized monitoring solutions to streamline study processes and reduce operational expenses. 

They are also forming strategic partnerships, collaborations, and acquisitions to share resources and expertise, enabling more efficient trial execution. Additionally, they are adopting remote and wearable cardiac monitoring technologies, which minimize the need for frequent patient visits and extensive on-site infrastructure.

Market Trend

Growing Adoption of Artificial Intelligence and Predictive Analytics in Cardiac Care

A key trend influencing the cardiac safety services market is the growing adoption of artificial intelligence and predictive analytics in cardiac care. AI-powered tools are enabling healthcare providers to predict cardiovascular risks with greater accuracy, facilitate early interventions, and deliver more personalized patient management. 

These technologies are streamlining clinical decision-making, enhancing the efficiency of cardiac monitoring, and improving patient outcomes in both clinical trials and routine care.

• In August 2025, Apollo Hospitals launched an Apollo AI-powered cardiovascular disease risk prediction tool (AICVD) to support early detection and intervention. The tool processes patient data with high speed and accuracy, enabling proactive and preventive care for at-risk individuals.

Cardiac Safety Services Market Report Snapshot

Market Segmentation

• By Type (Integrated and Standalone): The integrated segment earned USD 526.1 million in 2024, mainly due to its ability to offer comprehensive, streamlined cardiac safety assessments with reduced operational complexity.
• By Service Type (ECG / Holter Measurement, Blood Pressure Monitoring, Cardiovascular Imaging, and Thorough QT (TQT) Studies): The blood pressure monitoring segment held a share of 27.44% in 2024, propelled by its widespread use in early cardiovascular risk detection and routine trial monitoring.
• By End Use (Pharma & Biopharma Companies, Contract Research Organizations, and Others): The pharma & biopharma companies segment is projected to reach USD 816.8 million by 2032, owing to increasing drug development pipelines and mandatory regulatory cardiac safety assessments.

Cardiac Safety Services Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America cardiac safety services market share stood at 34.09% in 2024, valued at USD 288.5 million. This dominance is reinforced by the rising prevalence of chronic diseases such as diabetes, hypertension, and obesity, which significantly increases the risk of cardiovascular complications. 

Increasing regulatory scrutiny from agencies such as the U.S. Food and Drug Administration (FDA) is further compelling pharmaceutical companies to conduct comprehensive cardiac safety evaluations during drug development. Expanding drug development pipelines and a high volume of clinical trials across therapeutic areas are also fueling demand for specialized cardiac monitoring solutions.

The rapid adoption of advanced technologies, including electrocardiogram (ECG) analysis, wearable cardiac sensors, and in silico modeling, is enhancing the accuracy and efficiency of cardiac safety assessments. Additionally, growing investments in clinical trial services are strengthening service provider’s capabilities, enabling integrated, data-driven solutions for complex trials, thereby fueling regional market expansion.

• In May 2025, Clario acquired WCG’s electronic clinical outcome assessment (eCOA) business to strengthen its leadership in digital endpoint data collection. The acquisition expands Clario’s capabilities in clinical outcomes assessments, study design, centralized image analysis, and regulatory guidance.

The Asia-Pacific cardiac safety services industry is set to grow at a robust CAGR of 12.58% over the forecast period. This growth is attributed to the increasing cardiovascular disease prevalence, fueled by rapid urbanization and aging populations. Increasing government investments in healthcare infrastructure and clinical research initiatives to expand access to advanced medical technologies and strengthen trial capabilities are further boosting the need for cardiac safety services.

Additionally, the adoption of innovative cardiac care and monitoring platforms such as AI-powered risk prediction tools, wearable ECG devices, and advanced ablation systems is enhancing procedural accuracy and safety. This is leading to the widespread adoption of advanced cardiac safety services across the region, thereby fostering regional market growth.

• In July 2025, Johnson & Johnson MedTech launched the VARIPULSE Platform in Asia-Pacific, the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO 3 electroanatomical mapping system. The platform is designed to enhance efficiency, reproducibility, and procedural accuracy in atrial fibrillation treatment.

Regulatory Frameworks

• In the U.S., the Food and Drug Administration (FDA) oversees the safety, efficacy, and quality of drugs, biologics, and medical devices, including cardiac safety evaluations in clinical trials. The agency enforces regulations such as ICH E14 for thorough QT studies, monitors adverse cardiac events, approves trial protocols, and ensures compliance with Good Clinical Practice (GCP) standards to protect patient safety.
• In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices, including cardiac safety services in clinical trials. It reviews trial protocols, mandates cardiovascular safety assessments, monitors adverse cardiac events, enforces GCP compliance, and ensures that trial data for drugs or devices are scientifically robust and patient-safe before market authorization.
• In China, the National Medical Products Administration (NMPA) regulates the approval, clinical testing, and post-market surveillance of drugs and medical devices, including cardiac safety assessments. It mandates ECG, blood pressure, and QT studies, monitors adverse cardiovascular events during trials, and ensures clinical trial data meet national safety and quality standards for regulatory submissions.
• In India, the Central Drugs Standard Control Organization (CDSCO) oversees clinical trials, drug approvals, and medical device regulations, including cardiac safety evaluations. It mandates assessment of cardiovascular risks, compliance with Good Clinical Practice (GCP), adverse event monitoring, and reporting, ensuring patient safety and reliability of cardiac safety data submitted for new drug or device approvals.

Competitive Landscape

Major players operating in the cardiac safety services industry are expanding their capabilities through partnerships with digital health technology providers to integrate wearable ECG devices into clinical trials. They are enhancing remote monitoring solutions to improve patient compliance, streamline data collection, and ensure accurate detection of cardiac events. 

Additionally, market participants are advancing the use of AI-driven analytics, extended monitoring technologies, and digital endpoints to deliver high-quality cardiac safety data, improve trial efficiency, and reinforce their competitive market positioning.

• In April 2025, HeartcoR Solutions partnered with Wellysis for exclusive rights to the FDA-cleared S-Patch wearable ECG device in global cardiac safety trials, enhancing remote monitoring capabilities and patient-centric trial outcomes.

Key Companies in Cardiac Safety Services Market:

• ICON plc
• Clario
• IQVIA Inc
• Medpace, Inc
• Charles River Laboratories
• Eurofins Discovery Services LLC
• Certara, Inc
• Biotrial
• Celerion
• Richmond Pharmacology Limited
• Ncardia Services B.V
• Koninklijke Philips N.V
• NEXEL Co., Ltd.
• Clario
• Laboratory Corporation of America Holdings.

Recent Developments (M&A/Product Launch)

• In April 2025, CardioOne acquired CardioDiagnostics, a provider of advanced ECG and remote patient monitoring technologies. The acquisition strengthens CardioOne’s capabilities in delivering integrated cardiology care, enhancing real-time insights and early detection.
• In March 2024, Stryker launched the LIFEPAK CR2 automated external defibrillator (AED) at the Criticare National Conference in Kolkata, India. The device improves sudden cardiac arrest management through faster electrode placement, advanced ECG-based shock advisory, and real-time CPR coaching, supporting both adult and pediatric resuscitation.