Cardiac Safety Services Market

Cardiac Safety Services are an essential aspect of drug development and clinical research. These services focus on monitoring the potential cardiac effects of a drug on patients during clinical trials, as well as evaluating the safety of drugs that are already on the market. Cardiac safety assessments help to identify potential cardiovascular risks associated with a drug, and provide critical information for regulatory approval.

Cardiac safety services typically include a range of tests, including electrocardiograms (ECGs), echocardiography, and cardiac imaging. These tests help to monitor changes in heart rate, rhythm, and function, as well as assess any potential cardiovascular risks associated with a drug.

Cardiac safety assessments are an essential component of the drug development process, and are required by regulatory agencies such as the FDA and EMA. Failure to adequately assess cardiac safety can result in delays in drug approval, or even the withdrawal of a drug from the market.

At a basic level, cardiac safety services involve the identification and monitoring of potential cardiovascular risks associated with a drug. This can include monitoring for changes in heart rate, rhythm, and function, as well as evaluating the effects of a drug on blood pressure, vascular function, and other key indicators of cardiovascular health.

In addition to monitoring the cardiovascular effects of a drug, cardiac safety services may also involve the development and implementation of risk management strategies. These strategies may include the use of specific patient populations or dosage regimens, as well as the development of monitoring plans to detect any potential cardiac adverse events.

Cardiac Safety Services Market Dynamics

Drivers in Cardiac Safety Services Market

The cardiac safety services market is influenced by several factors, including drivers and opportunities. One of the key drivers of the market is the increasing R&D expenditure in the pharmaceutical and biopharmaceutical industry. Pharmaceutical companies invest heavily in R&D to deliver high-quality and innovative products to the market. This has resulted in the growth of preclinical and clinical services, including cardiac safety evaluation, to ensure the safety and efficacy of the therapeutic drug before launching in the market.

Collaborative R&D efforts and heavy R&D investments by top pharmaceutical companies have contributed to the growth of the market. For example, ERT has launched a Phase I QT Center of excellence to provide cardiac safety assessment in Phase I studies. The company also offers an integrated ECG analysis platform, EPQT, to provide sponsors with actionable and reliable information about the cardiac safety profiles of their compounds at the earliest stage of the drug development process.

Opportunities in Cardiac Safety Services Market

Another driver of the market is the growth in the biosimilars and biologics markets. With more than half of the drug candidates in the discovery stage being biologics, pharmaceutical and biopharmaceutical companies are heavily investing in R&D to develop these molecules. Biosimilars are cost-effective compared to small molecules, and specialized testing services are required for their safety assessment. This presents opportunities for safety assessment providers to expand their portfolios and capabilities.

Clinical trials are vital for discovering and developing new drugs for disease treatment. They are the most effective way to ensure the safety and efficacy of therapeutic drugs before they are launched in the market and consumed by humans. Thus, cardiac safety evaluation is an essential part of the drug development process, and the growth in the number of drug launches would help the industry flourish during the forecast period. For instance, ERT has announced a new alert service called Rapid ECG, which expedites analysis of screening and other ECGs to optimize patient enrollment and ensure patient safety in large, complex global clinical trials.

Restraints in Cardiac Safety Services Market

The costly nature of cardiac safety services poses a significant challenge to the development of new drugs, contributing to the decline in the number of drugs approved in the US and posing a threat to public health. Conducting evaluations of off-target drug effects can be time-consuming and expensive, often resulting in the termination of many new drug candidates. The economic crisis brought about by the COVID-19 pandemic has had adverse effects on the healthcare system, with up to a 70% drop in revenue reported from March 2020. Small healthcare facilities have been forced to shut down, and delayed elective surgical procedures due to social distancing and localized curfews have negatively impacted healthcare services. As a result, proper assessment and reporting of clinical cardiac safety data are critical, as it is essential for product approval and recall. Failure to conduct cardiac safety evaluations according to legal procedures may result in delayed product approval and hinder market growth.

In the market for cardiac safety services, the integrated services segment is expected to dominate during the forecast period. These services offer a comprehensive suite of cardiac safety services, including imaging, TQT and profile QT studies, and monitoring of off-target cardiovascular liability. Certified nurses conduct onsite multichannel telemetry to assess heart rate and rhythm in real-time, which expedites clinical trials in the pharmaceutical and biopharmaceutical development cycle.

During the forecast period, the largest regional market for cardiac safety services is expected to be North America. The market has been segmented into major regions, which include North America, Europe, the Asia Pacific, and the Rest of World. North America is considered a mature market for cardiac safety services and is projected to grow at the highest compound annual growth rate (CAGR) during the forecast period. The increasing number of clinical trials being conducted in the region is driving the demand for cardiac safety services, which is contributing to this growth.

The industry is expected to receive a boost in the coming years due to an increase in the number of mergers and acquisitions. For example, in December 2017, ERT acquired iCardiac Technologies, a company known for its cardiac safety services for clinical studies. This acquisition came just three months after ERT bought Biomedical Systems, a company that has been providing clinical cardiac solutions since 1975. iCardiac Technologies has introduced several innovative methodologies over the past decade, including High Precision QT and Early Precision QT, which have helped to further advance the field of cardiac safety services.

One major development in the cardiac safety services market is the increasing adoption of digital technologies for cardiac safety monitoring. This includes the use of wearable devices and remote monitoring solutions, which enable real-time tracking of cardiac function and can improve patient outcomes. Another development in the market is the growing focus on personalized medicine and precision cardiology. As our understanding of cardiovascular diseases improves, there is a greater emphasis on tailoring treatments to individual patients based on their unique cardiac profiles. This requires advanced cardiac safety testing solutions that can provide detailed insights into a patient's cardiac function and help guide treatment decisions. In response to this trend, several companies in the cardiac safety services market have developed new, more sophisticated testing technologies. Finally, there is a growing demand for integrated drug development solutions that can provide end-to-end support for cardiac safety testing and other aspects of the drug development process. This includes the use of advanced data analytics and artificial intelligence to streamline clinical trial operations and improve patient outcomes. Companies that can provide these integrated solutions are likely to be well-positioned for growth in the coming years.

Dominating Companies in Cardiac Safety Services Market

• LABORATORY CORPORATION OF AMERICA HOLDINGS
• Koninklijke Philips N.V.
• CLARIO
• BANOOK GROUP
• IQVIA
• BIOTRIAL
• CERTARA
• CELERION
• MEDPACE
• NCARDIA
• RICHMOND PHARMACOLOGY
• PHYSIOSTIM
• SHANGHAI MEDICILON Inc
• PHARMACEUTICAL PRODUCT DEVELOPMENT LLC.
• SGS S.A
• Eurofins
• NEXEL Co., Ltd
• PPD, Inc.

Recent Developments in Cardiac Safety Services Market

• iCardiac Technologies and ERT - In May 2021, it was announced that iCardiac Technologies, a provider of cardiac safety assessment services, had been acquired by ERT. The acquisition would allow ERT to expand its cardiac safety assessment services and provide customers with a more comprehensive suite of solutions.
• ERT and Bioclinica - In November 2019, it was announced that ERT had acquired Bioclinica's cardiac safety services division. The acquisition would allow ERT to expand its cardiac safety services and provide customers with a more comprehensive suite of solutions.
• BioTelemetry and Geneva Healthcare - In September 2019, BioTelemetry, a provider of remote cardiac monitoring services, announced that it had acquired Geneva Healthcare, a provider of cardiac monitoring services for clinical trials. The acquisition would allow BioTelemetry to expand its services and provide customers with a more comprehensive suite of solutions.
• LabCorp and Evidera - In June 2019, it was announced that LabCorp had acquired Evidera, a provider of clinical research services. The acquisition would allow LabCorp to expand its capabilities in the area of clinical trial design and execution, including cardiac safety assessment services.
• Cardiovascular Systems Inc. and Gardia Medical - In February 2019, it was announced that Cardiovascular Systems Inc. had acquired Gardia Medical, a medical device company that develops solutions for treating cardiovascular disease. The acquisition would allow Cardiovascular Systems Inc. to expand its product portfolio and provide customers with a more comprehensive suite of solutions.
• PPD and ECG Scienion - In January 2021, PPD, a global contract research organization, announced that it had partnered with ECG Scienion, a provider of cardiac safety assessment services. The partnership would allow PPD to expand its capabilities in the area of cardiac safety assessment for clinical trials.
• QPS and Xpansa - In November 2020, it was announced that QPS, a global contract research organization, had acquired Xpansa, a provider of data analytics and artificial intelligence solutions. The acquisition would allow QPS to expand its capabilities in the area of cardiac safety assessment, including the use of AI and machine learning to analyze cardiac data.
• Premier Research and Synteract - In June 2020, it was announced that Premier Research and Synteract had merged to form a new contract research organization. The merger would allow the new company to expand its capabilities in a range of areas, including cardiac safety assessment for clinical trials.
• BioTelemetry and Telcare - In May 2018, BioTelemetry announced that it had acquired Telcare, a provider of cellular-enabled blood glucose monitoring solutions. The acquisition would allow BioTelemetry to expand its offerings in the area of remote monitoring for chronic conditions, including cardiovascular disease

Overall, cardiac safety services are an essential aspect of drug development and clinical research, helping to ensure the safety and efficacy of drugs for patients. If you are involved in drug development or clinical research, it is important to work with a provider that offers comprehensive cardiac safety services to help ensure the success of your project.