The worldwide prevalence of cardiac diseases is increasing at a rapid pace. Hypertension is the most common cause of heart failure and is caused by a rise in blood pressure in the arteries. It is the most dangerous condition causing serious risk of heart disease or stroke. Also, the rising incidence of diabetes is increasing the prevalence of cardiovascular diseases (CVDs) globally. The rising prevalence of such chronic conditions is necessitating the need for diagnosis and treatment in order to keep track of the patient's daily medical condition and maintain medical records. This, coupled with rising hospitalization of the older population for the treatment of cardiac diseases, has increased the need for electrocardiograph (ECG) diagnosis. As a result, the global diagnostic ECG market is projected to grow by USD 4.5 billion at a CAGR of 8.93% during the forecast period 2021 to 2026.

These are the latest findings of Technavio Research (London, UK), a technology research and advisory company.

The introduction of advanced technologies in CVD testing has led to higher sales of diagnostic ECG devices. The development of new monitoring technologies has helped improve disease diagnosis and treatment of cardiac diseases. Technological advances have also enabled better flexibility and portability of these systems. To improve workflows, companies are striving to incorporate sophisticated technologies in diagnostic ECG devices. The continuous advances in wireless data systems have allowed medical examination rooms to provide a more flexible placement of individuals and equipment. Instead of tethering individuals to the machine, physicians can place their workstations in any convenient location while the patient is doing exercises. The product eliminates remote ECG detection delays with improved verification and diagnosis using remote cardiac monitoring. In addition, it offers better responsiveness to cardiac events. Thus, technological advances in ECG devices and their integration with other compatible technologies will positively impact the growth of the diagnostic ECG market globally.

However, stringent approval processes and safety regulations for ECG products make it difficult for manufacturers to launch new products in the market. The US FDA has imposed stringent labeling standards and regulatory frameworks for cardiac diagnostic devices, also known as cardiac monitors. The ECG software applications used to record and monitor the heart are classified as Class III devices, whereas traditional diagnostic ECG devices are categorized as Class II devices. Before being approved by the US FDA, cardiac diagnostic ECG devices need to be carefully examined through clinical studies, besides undergoing safety examinations to demonstrate their medical efficacy. Hence, these devices are categorized as Class II devices based on the risk factor. The US FDA prevents the market entry of unsafe and ineffective devices. This has resulted in many devices not being approved or still in the process of approval. Mobile applications are considered Class III devices as they can adversely affect the interpretation of radiological images, owing to the small screen size, low contrast ratio, and uncontrolled light of the mobile platform. Applications that do not fall under the 'mobile medical applications' category must undergo a stringent evaluation.

Based on end-user, the hospitals, clinics, and cardiac centers segment accounted for the largest share of the global diagnostic ECG systems market. Factors such as the increasing number of CVD cases, rising number of heart specialty hospitals, and business strategies adopted by end-users and vendors are fueling the adoption of diagnostic ECG. The segment’s growth is also driven by the growing presence of large multi-specialty hospitals and heart specialty hospitals, availability of reimbursements, and government initiatives to offer diagnostic ECG fees.

Geographically, North America accounted for the major share of the global diagnostic ECG market, mainly due to technological advances and product launches, rapid growth in the number of cardiac specialty centers, and favorable reimbursement scenario in the region. The increasing number of diagnostic procedures to detect CVDs being performed in hospitals and clinics in North America is also fueling the adoption of diagnostic ECG. 

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