Brugada Syndrome Market Size, Share & Trends Analysis Report By Diagnosis (Electrocardiogram, Electrophysiology (EP) Test, Genetic Testing, Others), By Treatment (Implantable Cardioverter-Defibrillator, Drug Therapy), By End-User (Hospitals and Clinics, Surgical Centers, Diagnostic Centers, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global brugada syndrome market size was valued at USD 1.21 billion in 2022. It is estimated to reach USD 1.97 billion by 2031, growing at a CAGR of 5.58% during the forecast period (2023–2031). The market is anticipated to be influenced by several factors during the forecast period. The primary aspect boosting the market expansion is the surging prevalence of Brugada syndrome worldwide. Moreover, the growing awareness and diagnosis of Brugada syndrome, which can help prevent sudden cardiac death, is anticipated to drive the growth of the global market.

Brugada syndrome (BrS) is a hereditary condition characterized by channelopathy, which causes abnormal electrical activity of the heart. Abnormal heart rhythms and sudden cardiac death are complications that may arise as a result. Andrea Nava and Bortolo Martini were the first to characterize the condition in Padova in 1989. However, it is named after Pedro and Josep Brugada, two Catalan cardiologists who described it in 1992. Abnormal cardiac rhythms are common during periods of rest in individuals diagnosed with Brugada syndrome.

An estimated 25% of individuals affected by Brugada syndrome have a family member who also possesses the disorder. Certain cases might result from a novel genetic mutation or specific medications. The cardiac sodium channel-encoding SCN5A gene is the most frequently involved. Although electrocardiograms (ECGs) are commonly used for diagnosis, abnormalities may not always be evident. Ajmaline and other similar medications may be administered to detect ECG changes.

Market Dynamics

Market Drivers

Increasing Prevalence of Brugada Syndrome

An important factor contributing to the expansion of the Brugada syndrome market is the rising incidence of the condition. According to an article published in NLM, Brugada Syndrome affects an estimated 3 to 5 per 10,000 individuals worldwide. Southeast Asia had the greatest recorded prevalence in the world, while North Africa had the lowest (0 per 1,000). The prevalence of BrS in Asians was ninefold higher than in Caucasians and 36-fold higher than in Hispanics.

According to an article published in PubMed, the disease is more common in males than females. The clinical phenotype becomes apparent in adulthood. Furthermore, recent data indicate that Brugada syndrome may account for nearly 20% of cases of sudden death in individuals with structurally normal hearts. Therefore, the surge in the prevalence of Brugada syndrome is anticipated to expedite the market expansion over the forecast period.

Rising Diagnosis and Awareness of Brugada Syndrome

The increasing diagnosis and awareness of the Brugada syndrome, which can aid in averting sudden cardiac death and enhancing the prognosis of patients, is expected to stimulate the expansion of the global market. Brugada syndrome is frequently not accurately identified or mistakenly diagnosed, as the electrocardiogram (ECG) alterations can be temporary or concealed by other influences. However, the progress in diagnostic methods, including genetic testing, pharmacological challenges, and electrophysiological studies, has enhanced the precision and dependability of detecting and confirming Brugada syndrome.

In addition, the growing educational initiatives and awareness campaigns, such as the Brugada Foundation and the Brugada Dravet Syndrome Awareness Day, have effectively enhanced the general understanding and acknowledgment of the syndrome among the public and professionals. This, in turn, can contribute to the enhanced diagnosis and intervention of the illness.

Market Restraint

Lack of Safe and Efficient Treatment

The dearth of efficacious and safe therapies and equipment for treating Brugada syndrome poses a significant obstacle to expanding its market. The prevailing medical practice for treating Brugada syndrome involves the insertion of an Implantable Cardioverter-Defibrillator (ICD), which is capable of monitoring and rectifying irregular heart rhythms, hence averting instances of sudden cardiac demise. Nevertheless, ICDs are subject to several limits and problems, including infection, lead fracture, incorrect shocks, battery depletion, and psychological discomfort.

In addition, ICDs are costly, require invasive procedures, and have limited accessibility, particularly in low- and middle-income nations, which are the primary sites for Brugada syndrome occurrences. Hence, there is a requirement for alternative and pioneering medicines and technology that may efficiently address Brugada syndrome with low adverse effects and expenses.

Market Opportunities

Development of Innovative Treatment Solutions

There has been a rise in the advancement of innovative medicines and technology that can address the illness's root cause and deliver improved patient results. For instance, the subcutaneous ICD (S-ICD) is a less intrusive device with better cosmetic appeal. It is capable of administering shocks without the need for transvenous leads.

In addition, gene therapy has been suggested as a viable remedy for Brugada syndrome, as it can rectify the flawed sodium channel gene. In June 2022, researchers at the Lerner Research Institute of the Cleveland Clinic created a gene therapy that effectively treats Brugada syndrome in mice. This therapy targets and corrects abnormalities in the heart muscle cells, which are responsible for causing irregular heart rhythms. These developing therapies and devices have the potential to provide new opportunities and choices for patients with Brugada syndrome, hence stimulating the expansion of the market.

Regional Analysis

Based on region, the global Brugada syndrome market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Brugada syndrome market size is expected to expand substantially during the forecast period. The North American market for Brugada syndrome is primarily influenced by the extensive awareness and diagnosis of the disease, which plays a crucial role in preventing sudden cardiac death and enhancing the prognosis of patients. Antzelevitch et al. conducted a study that found that the occurrence of Brugada syndrome in North America is estimated at 0.02%, indicating a lower rate than the worldwide average. However, this still signifies a noteworthy number of instances. In addition, the North American market for Brugada syndrome is bolstered by prominent players and research institutes, including Boston Scientific, Medtronic, Abbott, and the Brugada Foundation. These entities actively contribute to advancing and creating innovative therapies and devices for the syndrome. Moreover, the North American market for Brugada syndrome benefits from advantageous reimbursement rules that alleviate financial burdens and enhance the accessibility and affordability of medicines and equipment for patients.

Furthermore, there has been a surge in R&D to develop novel treatment approaches. For instance, a recently published study conducted by LIMR in collaboration with Scientists from Simon Fraser University (SFU) has provided insights into a potential pharmacological method for addressing irregular heart rhythms caused by JWS. The J Wave syndromes (JWS), including Brugada syndrome and early repolarization syndromes, are linked to severe cardiac arrhythmias, which are complications affecting the heart's rate or rhythm and can be life-threatening. ARumenamide-787 also referred to as AR-787, was developed by Abdelsayed in a laboratory at SFU under the leadership of Ruben. AR-787 has demonstrated efficacy in laboratory trials conducted at LIMR and SFU. AR-787 was specifically engineered to directly engage with the cardiac sodium channel, a crucial protein in the heart responsible for facilitating the transmission of electrical signals that initiate the contraction of the heart muscle. Moreover, it exerted its effect by interfacing with the transient outward current channels in the heart, thereby inhibiting the arrhythmic activity linked to JWS. Thus, such factors boost market expansion.

The Asia-Pacific region is projected to experience the most rapid expansion in the global market for Brugada syndrome, primarily due to the elevated prevalence and incidence of the disease, particularly in Southeast Asia, where it is known as Sudden Unexplained Nocturnal Death Syndrome (SUNDS). Chen et al. conducted a study that found that the occurrence of Brugada syndrome in Southeast Asia varies between 0.14% and 0.42%, significantly above the worldwide average of 0.05%. In addition, Thailand had the highest prevalence of this disease globally.

Furthermore, the elevated occurrence of Brugada syndrome in this region is due to the genetic predisposition of the population, along with the environmental and lifestyle elements that can incite the illness, including fever, drugs, alcohol, and cocaine. The Brugada syndrome market in Southeast Asia is anticipated to expand due to the rising population and urbanization in the region. The Asia-Pacific market is also influenced by the advancing healthcare infrastructure and accessibility, which can augment the diagnosis and treatment of the syndrome. Moreover, the market is impacted by the surging awareness and education about the syndrome, which can allow early intervention and prevention. All these factors drive the regional market growth.

Segmental Analysis

The global Brugada syndrome market is bifurcated into diagnosis, treatment, and end-user.

Based on diagnosis, the global Brugada syndrome market is segmented into electrocardiogram (ECG), genetic testing, electrophysiological tests, and others. 

The electrocardiogram (ECG) segment is the largest contributor to the market. An electrocardiogram is a medical test that captures and records the electrical impulses of the heart. This routine and non-invasive test efficiently identifies cardiac issues and monitors the heart's well-being. An ECG consists of three primary elements, i.e., the P wave, which signifies atrial depolarization; the QRS complex, which signifies ventricular depolarization; and the T wave, which signifies ventricular repolarization. An electrocardiogram, or ECG or EKG, is typically performed in a healthcare facility such as a provider's office, clinic, or hospital room. ECG machines are essential apparatus found in both operating rooms and ambulances. ECG monitoring is available on certain personal devices, such as smartwatches.

Based on treatment, the global Brugada syndrome market is segmented into implantable cardioverter-defibrillator (ICD) and drug therapy. 

An implantable cardioverter-defibrillator (ICD) is a medical machine implanted in the body to deliver defibrillation, and in some cases, cardioversion and pacing, to the heart. The ICD serves as the initial treatment and preventive measure for patients who are susceptible to sudden cardiac death caused by ventricular fibrillation and ventricular tachycardia. The ICD comprises a single chamber with a right ventricular lead connected to the header. In addition, the lead includes a tip and adjacent first ring, which are used to sense the heart's electrical activity and stimulate the right ventricle. There is also a coil and two rings for atrial sensing. The average lifespan of current device batteries ranges from six to ten years. Technological advancements, such as high-capacity or rechargeable batteries, can extend battery lifespan to over a decade.

Based on end-users, the global Brugada syndrome market is bifurcated into hospitals and clinics, diagnostic centers, surgical centers, and others. 

The hospital and clinic segment dominates the global market. Hospitals and clinics are projected to dominate the market due to their ability to provide the most extensive and cutting-edge care for patients with Brugada syndrome, encompassing diagnosis, treatment, and post-treatment monitoring. Moreover, the growing number of hospitals across several countries positively impacts the demand for lithotripsy devices. For instance, as per the American Hospital Association Annual Survey 2021, in the United States, there were 1,805 rural community hospitals, 3,336 urban community hospitals, and 3,453 community hospitals in a system in 2019. In addition, effective reimbursement policies offered in hospitals in certain countries around the world, which ease the medical cost burden on the patient, contribute to the growth of the hospital segment.

Recent Developments

• May 2023- Samsung Electronics announced that the Irregular Heart Rhythm Notification (IHRN) feature of the Samsung Health Monitor app has been granted clearance by the FDA.
• October 2023- Vektor Medical, a leading company in the field of arrhythmia treatment and creator of vMap®, the first technology in the world to precisely map arrhythmias using the patient's 12-lead ECG data, announced that the American Medical Association (AMA) CPT Editorial Panel has officially approved a new Category III CPT code for the utilization of vMap's noninvasive arrhythmia analysis.