France Brugada Syndrome Market Analysis

France Brugada Syndrome Market Executive Summary

The France Brugada Syndrome Market is at around $33 Mn in 2023 and is projected to reach $52.3 Mn in 2030, exhibiting a CAGR of 6.8% during the forecast period.

Brugada syndrome is a rare, but potentially threatening, genetic condition that causes abnormal electrical activity in the heart, leading to an increased risk of sudden cardiac death. People with Brugada syndrome have an increased risk of irregular heart rhythms beginning in the lower chambers of the heart, i.e., the ventricles. Common signs and symptoms associated with Brugada Syndrome include dizziness, fainting, gasping and laboured breathing, particularly at night, irregular heartbeats or palpitations, extremely fast and chaotic heartbeat, and seizures. The risk factors for Brugada syndrome include family history of Brugada syndrome, being male, race, and fever.

In France, CVDs contributed to around 43.2 thousand deaths in the 75+ age group. The France Brugada Syndrome Market is driven by significant factors such as growing prevalence of cardiovascular diseases, increased awareness and diagnosis, and technological innovations in treatment. However, complexity of genetic testing, side effects and complications of treatment, and limited R&D restrict the growth and potential of the market.

The major players of the France Brugada Syndrome Market are Abbott Laboratories, Medtronic, Siemens Healthcare, Sanofi, and Abivax, among others.

Market Dynamics

Market Growth Drivers

Growing Prevalence of Cardiovascular Diseases: In 2021, the number of deaths due to cardiovascular disease in France was the highest in the population above 75 years of age with approximately 43,200 deaths in the male population and around 61,800 deaths in the female population. Thus, the rising prevalence of cardiovascular diseases significantly drives the Brugada syndrome market by intensifying the focus on diagnosing and managing related conditions. As cardiovascular problems become more widespread, there is increased attention from healthcare providers and researchers towards genetic disorders such as Brugada syndrome. This heightened focus leads to greater investments in advanced diagnostic tools, treatment options, and research efforts. Consequently, the growing demand for effective Brugada syndrome management contributes to the expansion of the market within the country.

Increased Awareness and Diagnosis: In France, rising awareness of Brugada syndrome greatly contributes to market growth by improving early detection and diagnosis. As both healthcare providers and the public gain more knowledge about the condition, the demand for sophisticated diagnostic tools and treatment options increases. This heightened awareness not only facilitates earlier intervention but also drives investment in research and development, enhancing the availability and effectiveness of therapies for Brugada syndrome.

Technological Innovations in Treatment: Technological advancements in treatment are a major factor driving growth in the Brugada syndrome market. Innovations such as advanced implantable cardioverter defibrillators (ICDs), enhanced genetic testing techniques, and novel drug therapies improve the effectiveness and accessibility of managing Brugada syndrome. These developments not only boost patient outcomes but also promote market expansion by making treatments more viable and attractive, leading to greater adoption and investment in Brugada syndrome care.

Market Restraints

Complexity of Genetic Testing: The complexity of genetic testing significantly hinders the growth of the Brugada syndrome market by limiting its widespread adoption and accessibility. Testing for Brugada syndrome often involves intricate and costly procedures that necessitate specialized facilities and expertise, restricting availability to certain areas and populations. Moreover, the detailed interpretation of genetic results demands advanced clinical knowledge, which can create obstacles for both healthcare providers and patients. This complexity affects market penetration and reduces patient awareness and engagement, thereby impeding the growth potential of treatments and diagnostic tools for Brugada syndrome.

Side Effects and Complications of Treatments: Side effects and complications linked to Brugada syndrome treatments, like implantable cardioverter defibrillators (ICDs), significantly hinder market growth. Patients may face infections, device malfunctions, psychological impacts, and other adverse effects, which can discourage them from opting for these treatments. These potential risks and complications can decrease the acceptance and adoption of advanced therapies, thus restricting market expansion despite the availability of effective treatments.

Limited R&D: Being a relatively rare condition, Brugada syndrome attracts less investment compared to more prevalent cardiovascular diseases, leading to slower progress in understanding the disease, developing new diagnostic tools, and creating innovative treatments. As a result, medical breakthroughs are less frequent, reducing the availability of effective therapies and diagnostic methods, and ultimately restricting market growth for Brugada syndrome. Thus, limited R&D in the field of Brugada syndrome significantly restrains market growth.

Regulatory Landscape and Reimbursement Scenario

The main regulatory body for pharmaceuticals in France is the National Agency for the Safety of Medicines and Health Products (ANSM, Agence nationale de sécurité du médicament et des produits de santé in French). The ANSM is a government organization under the Ministry of Health which ensures the security of health products and facilitates access to innovative therapeutics. The ANSM guarantees the safety, efficacy, accessibility, and appropriate usage of health goods that are sold in France through evaluation, knowledge, and monitoring protocols.

The pharmaceutical companies must submit a completed MAA (Marketing Authorization Application) which can be used for drugs meant for the France market (National Procedure) or for the drugs intended for commercialization throughout the European Union (EU) through the EMA (European Medicines Agency). Through the EMA, products can be authorized through the National Procedure, the Centralised Procedure (CP), Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP). In this case, ANSM acts as a national competent authority (NCA) within the EMA framework. The ANSM then issues a final decision of either approval, conditional approval or refusal after conducting a review and evaluation of the MAA based on safety, efficacy, quality, and risk-benefit ratio. The Medical Device and Technology Evaluation Committee (CNEDiMTS) is the agency which examines the medical devices and classifies them based on their level of risk into the following four classes: Class I for low degree of risk, Class IIa for moderate degree of risk, Class IIa for high potential of risk, and Class III for very serious potential of risk.

The National Union of Health Insurance Funds of France (UNCAM, Union Nationale des Caisses d'Assurance Maladie) is the organization which is responsible for France’s public health insurance system. The UNCAM manages the several social security health insurance funds in charge of reimbursing healthcare costs for French nationals and residents. The French Health High Authority evaluates a medicine’s Medical Benefit (Service Médical Rendu, SMR) considering the severity of disease, safety and clinical efficacy, therapeutic innovation. The Committee on Economic Products for Health (CEPS) negotiates with pharmaceutical firms on the cost of medications. Lastly, the Ministry of Health, based on the recommendations of HAS and CEPS, renders the ultimate decision about reimbursement.

Competitive Landscape

Key Players

Here are some of the major key players in the France Brugada Syndrome Market:

• Abbott Laboratories
• Medtronic
• Siemens Healthcare
• F. Hoffmann-La Roche
• MicroPort Scientific Corporation
• Medtronic
• Eversana
• Sanofi
• Abivax
• Bristol Myers Squibb