Single Ventricle Heart Disease Market

• The Single Ventricle Heart Disease Treatment Market Size is projected to sustain a consistent Compound Annual Growth Rate (CAGR) during the forecast period (2024 to 2034). This growth in market revenue is primarily driven by advancements in diagnostic methods, increased awareness of the condition, and a rising number of reported cases.
• Single Ventricle Heart Disease Market is increasing due to various factors, including genetic mutations and other congenital heart defects.
• The burden of single ventricle heart disease is substantial, yet there is a notable scarcity of data regarding long-term outcomes and economic impact. A comprehensive resource that encompasses the full spectrum of this condition is currently lacking.
• To drive the Single Ventricle Heart Disease Market in future years, several Single Ventricle Heart Disease Companies such as Mezzion Pharma, Metcela, and others are developing their assets in the mid-late stage of development. The anticipated approval of Single Ventricle Heart Disease therapies, including Udenafil and JRM-001, among others, during the forecast period (2024–2034), is expected to further drive the market growth.
• There is growing evidence supporting the therapeutic potential of stem cell administration in children with congenital heart disease (CHD), especially those with single ventricle physiology. Preclinical studies have verified the benefits of various stem cell types in animal models relevant to CHD, and have identified the secretome as the functional unit of various stem cell types.

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DelveInsight’s comprehensive report titled “Single Ventricle Heart Disease Market Insights, Epidemiology, and Market Forecast – 2034” offers a detailed analysis of single ventricle heart disease. The report presents historical and projected epidemiological data covering Total Incident Cases of Single Ventricle Heart Disease further segmented by Type and Gender. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The Single Ventricle Heart Disease Treatment Market Report analyzes the existing treatment practices and unmet medical requirements in single ventricle heart disease. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the Single Ventricle Heart Disease Drugs Market.

Single Ventricle Heart Disease Treatment Market 

According to Boston Children’s Hospital, a single ventricle defect is a type of heart defect that a child is born with. It occurs when one of the two pumping chambers in the heart, called ventricles, isn’t large enough or strong enough to work correctly. In some cases, the chamber might be missing a valve. There are several types of single ventricle heart disease, which include tricuspid atresia, hypoplastic left heart syndrome (HLHS), mitral valve atresia (usually associated with HLHS), single left ventricle, double inlet left ventricle (DILV), double outlet right ventricle (DORV), pulmonary atresia with intact ventricular septum (PA/IVS), Ebstein’s anomaly, and atrioventricular canal defect (AV Canal) among others.

The exact cause of single ventricle heart disease is unknown. The origin of each condition varies by type and is influenced by multiple factors. The development process for each variation is not entirely understood. Cardiac structural abnormalities are commonly associated with lateralization disorders, such as situs inversus totalis and heterotaxy. In rare instances, it may occur in families but no genetic link has been identified. Most often, single ventricle disease occurs sporadically.

Single ventricle heart disease defects can cause children to become cyanotic (turn a blue color) since a mixture of oxygen-poor (blue) and oxygen-rich (red) blood vessels leaves the heart and goes to the body. Just how much oxygen or how little oxygen depends on the type, location, and severity of the defect. Some children will only be mildly cyanotic, while others won’t have enough oxygen in the blood to meet the body's needs and will need early treatment.

Single Ventricle Heart Disease Diagnosis and Algorithm

Prenatal diagnosis is made through routine ultrasound techniques for gestation and fetal echocardiography. Visualization of structural abnormalities or deviations from standard flow patterns may distinguish a single ventricle in utero. Post-natal diagnosis is made through a variety of techniques. Echocardiography is the best modality for the diagnosis of a single ventricle. Other techniques may aid in the diagnosis of a single ventricle, including electrocardiography, plain chest films, and pulse oximetry. Physical exam findings may also support the diagnosis. Computed tomography (CT), cardiac catheterization, magnetic resonance imaging (MRI), and cardiac magnetic resonance imaging might also reveal a single ventricle but are typically reserved for indeterminant investigations or treatment.

Treatment options for single ventricle heart depends on the time of discovery, prognosis, and goals of care. Prognosis must be discussed in depth before proceeding with treatment, as an intervention may be futile in some instances. There are various types of single ventricle heart disease that are very different, and treatment for each must be customized. Catheter-based management is based on underlying etiology, time of discovery, and prognosis. When discovered in utero, catheter-based structural interventions and valvuloplasty can mitigate sequala by correcting anomalies during the developmental process. Many interventions can also be performed after delivery, though further development is less influenced.

Single ventricle heart disease requires a series of open-heart procedures, performed over several years, which is called “staged reconstruction” and includes three surgeries: the Norwood procedure, the hemi-Fontan or Glenn operation, and the Fontan procedure. In patients with severe disease, palliative surgery may be the best option and is typically preferred over strict comfort measures. Patients should be referred to tertiary care centers for specialized evaluation and treatment. Cardiac transplantation may be considered, albeit associated with suboptimal outcomes due to comorbidities. Cardiac transplantation may also be required despite previous alternative procedures.

Single Ventricle Heart Disease Epidemiology

The Single Ventricle Heart Disease epidemiology section of the Market Report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of single ventricle heart disease. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Single Ventricle Heart Disease Market: Key Findings

• The total number of diagnosed incident cases of single ventricle heart in the United States was around 1,500 approximately cases in 2023.
• The United States and EU-4 and the UK contributed diagnosed incident cases of single ventricle of ~41%, 42% of the total diagnosed incident cases in the 7MM in 2022. 
• Whereas Japan accounted for around 17% of the total diagnosed incident cases share, respectively, in 2023.
• Among the EU4 countries, France accounted for the largest number of the diagnosed incident cases of single ventricle heart cases, followed by Germany, whereas Spain accounted for the lowest number of cases in 2023.
• The total 7MM treatable cases of Single Ventricle Heart Disease in 2020 were approximately 3,600. Which is expected to reach approximately 3,900 cases by 2034 for the study period of 2020–2034.
• In the EU4 & UK, the total procedure numbers of Norwood Procedure, Glenn Procedure, and Fontan procedure are expected to rise to approximately 1,600, 1,300, and 1,200, respectively by the year 2034.
• The total 7MM diagnosed incident cases of Single Ventricle Heart Disease in 2020 were approximately 3,700 out of which the highest cases of this disease were seen in the United States.
• In Germany the total gender specific cases of male and female was approximately 200 and 170 in 2020, respectively. It is estimated that the population number of Single Ventricle Heart Disease of males will expected to reach to 230 cases and that of female will reach to 190 cases by 2034.

Single Ventricle Heart Disease Market Outlook

The single ventricle heart disease therapeutics market is further expected to increase by the major drivers, such as the rising incident population, technological advancements, and upcoming therapies in the forecast period [2024–2034].

In May 2021, the US FDA accepted the NDA filing of Udenafil for the treatment of single ventricle heart disease in patients 12 years of age and older who have undergone Fontan palliation.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Single ventricle heart disease market in the 7MM is expected to change significantly during the study period 2020–2034.

Single Ventricle Heart Disease Drug Chapters

Single Ventricle Heart Disease Emerging  Drugs

The single ventricle heart disease drugs market is expected to experience gradual changes, mainly due to the limited availability of emerging therapies in this area. Key Single Ventricle Heart Disease Companies such as Mezzion Pharma, Metcela, and others, have demonstrated a keen interest in this condition and are actively pursuing the development of potential treatments.

• Udenafil: Mezzion Pharma

Udenafil is a long-acting highly selective phosphodiesterase-5 inhibitor that is orally administered. Inhibition of PDE5 results in the relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed. In 2021, Mezzion announced positive data from a Phase III efficacy and safety trial (FUEL Trial) and its open-label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle heart disease (SVHD) who have Fontan physiology was presented to the FDA in a Type C meeting. In September 2015 and December 2016, Udenafil was granted orphan drug designation by the US FDA and EMA, respectively for use in patients who have undergone the Fontan surgical palliation for single ventricle heart defects. Recently, Mezzion Pharma received a clear FDA path forward for the approval of udenafil for single ventricle heart disease. Currently, Mezzion is evaluating the safety and efficacy (FUEL-2) of Udenafil in a Phase III clinical trial in adolescents with single ventricle heart disease who have undergone Fontan surgical palliation.

• JRM-001: Metcela

JRM is developing a new cell therapy product JRM-001 for serious cardiac diseases, namely pediatric congenital heart disease, using cardiac stem cells (CSCs). JRM-001 is targeting single ventricle, which is one of the most common pediatric congenital heart diseases affecting about 400-500 patients annually. Currently, JRM-001 is going through a Phase III APOLLON clinical trial in Japan to evaluate the improvement of cardiac function after standard surgical heart repair.

Note: Detailed emerging therapies assessment will be provided in the final report....

Single Ventricle Heart Disease Market Segmentation

DelveInsight’s ‘Single Ventricle Heart Disease Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future single ventricle heart disease market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Single Ventricle Heart Disease Market Size by Countries

The single ventricle heart disease market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2023, the United States held a significant share of the overall 7MM (Seven Major Markets) single ventricle heart disease market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Country-wise Market Size Distribution of Single ventricle heart disease

Single Ventricle Heart Disease Market Size by Therapies

Single ventricle heart disease Market Size by Therapies is categorized into current and emerging markets for the study period 2020–2034. One of the emerging drugs anticipated to launch during the forecast period is Udenafil under the developmental pipeline of Mezzion Pharma.

Note: Detailed market segment assessment will be provided in the final report...

Single Ventricle Heart Disease Drugs Uptake

This section focuses on the sales uptake of potential single ventricle heart disease drugs that have recently been launched or are anticipated to be launched in the single ventricle heart disease market between 2020 and 2034. It estimates the market penetration of single ventricle heart disease drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the single ventricle heart disease drugs market.

The emerging single ventricle heart disease therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the single ventricle heart disease market.

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on single ventricle heart disease...

Single Ventricle Heart Disease Therapeutics Market Access and Reimbursement

DelveInsight’s ‘Single ventricle heart disease Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of single ventricle heart disease. This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current single ventricle heart disease market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the single ventricle heart disease domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or single ventricle heart disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the single ventricle heart disease unmet needs.

Single Ventricle Heart Disease Drugs Market Insights

DelveInsight's analysts engaged with over 50 Key Opinion Leaders (KOLs) to obtain insights, with interviews conducted specifically with more than 15 KOLs across the Seven Major Markets (7MM). These KOLs represented various prestigious organizations, institutes, and hospitals, including but not limited to the American Heart Association, Children's Hospital of Philadelphia, Boston Children's Hospital, Adult Congenital Heart Association, The Brooklyn Hospital Center, Aventura Hospital and Medical Center, McGovern Medical School at the University of Texas-Houston, and Children’s Memorial Hermann Hospital in the United States, among others.

“Many prescribers and patients are awaiting the approval of upcoming therapies.”

“Even though management of patients happens with the combination of therapy, novel targeted therapies is a positive opportunity for patients of this disease group.”

“Single ventricle heart disease can be life-threatening in many patients.”

Note: Detailed assessment of KOL Views will be provided in the full report on single ventricle heart disease....

Single Ventricle Heart Disease Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the single ventricle heart disease Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Single Ventricle Heart Disease Pipeline Development Activities

The Single Ventricle Heart Disease therapeutics market report offers an analysis of Single Ventricle Heart Disease clinical trials within Phase II and III stages and examines Single Ventricle Heart Disease Companies involved in developing targeted therapeutics for single ventricle heart disease. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Single Ventricle Heart Disease Pipeline Development Activities

The Single Ventricle Heart Disease clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, patent details, and other information for emerging single ventricle heart disease therapies.

Single Ventricle Heart Disease Treatment Market Report Insights

• Patient-based Single Ventricle Heart Disease Market Forecasting
• Single Ventricle Heart Disease Therapeutic Approaches
• Single ventricle heart disease Pipeline Drugs Analysis
• Single ventricle heart disease Market Size
• Single Ventricle Heart Disease Market Trends
• Single Ventricle Heart Disease Drugs Market Opportunities
• Impact of Upcoming Single Ventricle Heart DiseaseTherapies

Single Ventricle Heart Disease Treatment Market Report Key Strengths

• 11 Years Single Ventricle Heart Disease Market Forecast
• The 7MM Coverage
• Single ventricle heart disease Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Single Ventricle Heart Disease Drugs Market
• Single Ventricle Heart Disease Drugs Uptake

Single Ventricle Heart Disease Treatment Market Report Assessment

• Current Single Ventricle Heart Disease Treatment Market Practices
• Single Ventricle Heart Disease Unmet Needs
• Single ventricle heart disease Pipeline Drugs Analysis Profiles
• Single Ventricle Heart Disease Drugs Market Attractiveness
• Single Ventricle Heart Disease Market Drivers
• Single Ventricle Heart Disease Market Barriers

Key Questions Answered In The Single Ventricle Heart Disease Market Report:

• How common is single ventricle heart disease?
• What are the key findings of single ventricle heart disease epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020–2034)?
• What are the currently available treatments for single ventricle heart disease?
• What is the disease risk, burden, and Single Ventricle Heart Disease unmet needs?
• At what CAGR is the single ventricle heart disease market and its epidemiology expected to grow in the 7MM during the forecast period (2024–2034)?
• How would the unmet needs impact the single ventricle heart disease market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of single ventricle heart disease in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2024–2034)?
• How many Single Ventricle Heart Disease Companies are currently developing therapies for the treatment of single ventricle heart disease?

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