대동맥 협착증 시장 - 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• The aortic stenosis market is anticipated to sustain a steady Compound Annual Growth Rate (CAGR) during the forecast period (2025-2034). This growth in market revenue is primarily propelled by an aging global population driving a higher incidence of aortic stenosis, expanding adoption of minimally invasive transcatheter aortic valve replacement procedures, and the development of novel pharmacologic therapies aimed at slowing disease progression.
• The increasing cases of aortic stenosis may be attributed to an aging population with more valve degeneration, improved detection through advanced imaging and screening, and a rising burden of comorbidities such as hypertension, diabetes, and chronic kidney disease.
• No novel patented drugs are marketed for aortic stenosis; management relies on off-label generics such as enalapril or losartan for afterload reduction and furosemide for volume control, alongside device-based interventions like surgical and transcatheter valve replacements.
• The aortic stenosis landscape is poised for disruption by emerging pharmacotherapies-ataciguat, evogliptin, pelacarsen, and others in early development-each targeting calcification or lipoprotein(a) pathways; as these agents secure approval, competition with device-based interventions will intensify and accelerate market growth at a robust CAGR.

DelveInsight's comprehensive report titled "Aortic Stenosis - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of aortic stenosis. The report presents historical and projected epidemiological data covering total prevalent cases of aortic stenosis, total diagnosed prevalent cases of aortic stenosis, severity-specific cases of aortic stenosis, and treated cases of aortic stenosis. 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 report analyzes the existing treatment practices and unmet medical requirements in aortic stenosis. 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 market.

Aortic Stenosis Overview

Aortic stenosis is a prevalent valvular heart disease characterized by obstruction of left ventricular outflow. It is defined by an anterograde transvalvular velocity of at least 2 m/sec, distinguishing it from aortic valve sclerosis, which involves valve thickening and calcification without significant obstruction. The condition may arise from congenital malformations (such as bicuspid or unicuspid valves), age-related calcific degeneration, or rheumatic heart disease. After a prolonged asymptomatic period lasting 10 to 20 years, patients typically develop symptoms like exertional dyspnea and fatigue, followed by chest pain, syncope, or heart failure. Once symptoms appear, prognosis worsens significantly, with mortality exceeding 90% within a few years. The only definitive treatment is aortic valve replacement, performed either surgically or via transcatheter intervention.

Aortic Stenosis Diagnosis and Treatment Algorithm

Echocardiography remains the cornerstone for diagnosing and monitoring aortic stenosis, offering detailed assessment of valve anatomy, calcification severity, and direct visualization of the aortic valve orifice. It also provides critical measurements to guide surgical risk stratification. Longitudinal systolic strain imaging, a more sensitive indicator of left ventricular function, has been shown to better predict adverse outcomes, including mortality. Exercise testing can help reveal latent symptoms in asymptomatic patients but is contraindicated in those who are already symptomatic. Cardiac computed tomography is increasingly utilized, particularly in cases of calcific aortic valve disease when echocardiographic findings are inconclusive. Cardiac magnetic resonance imaging serves as a valuable adjunct for evaluating left ventricular mass, function, and volumes, especially when echocardiographic data are suboptimal.

Medical therapy has limited impact on the progression of aortic stenosis, and aortic valve replacement (AVR)-either surgical or transcatheter-is the definitive treatment for severe symptomatic cases, offering significant improvements in survival, symptoms, and functional capacity. While hypertension often coexists with aortic stenosis, agents like ACE inhibitors and ARBs are generally preferred, and diuretics may provide short-term relief in patients with heart failure prior to AVR. Balloon aortic valvuloplasty offers only temporary benefit. AVR is indicated not only in symptomatic patients but also in select asymptomatic individuals with severe aortic stenosis-such as those with reduced LVEF (<50%), abnormal stress tests, high transvalvular gradients, or those undergoing other cardiac surgeries. Surgical AVR has a low operative mortality, particularly in younger, low-risk patients, and age alone should not preclude intervention. Transcatheter AVR (TAVR), now the standard for inoperable or high-risk patients, has shown comparable or superior outcomes in intermediate-risk groups, though long-term durability remains under evaluation. The choice between surgical and transcatheter approaches should be guided by a multidisciplinary heart valve team based on anatomical, clinical, and procedural factors.

Aortic Stenosis Epidemiology

The epidemiology section of the aortic stenosis 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 prevalence of aortic stenosis. 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.

Key Findings

According to the secondary research, more than 13% of Americans aged 75 years and older are affected by aortic stenosis. The condition is also common in individuals over the age of 65, and if left untreated, it can lead to heart failure and death.

As per the analysis, the population prevalence of aortic stenosis in individuals aged 75 years and older was estimated at 12.4%, with 3.4% experiencing severe aortic stenosis, based on studies conducted predominantly in Europe and the US.

In the UK, the point prevalence of severe aortic stenosis among individuals aged 55 years and older was estimated at 1.48% in 2019.

The estimated prevalence of aortic stenosis in the adult population of France is approximately 1.17%, based on its proportion among all valvular heart disease cases.

The epidemiology of aortic stenosis is expected to change during the forecast period (2025-2034).

Aortic Stenosis Market Outlook

The aortic stenosis therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

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 aortic stenosis market in the 7MM is expected to change significantly during the forecast period 2025-2034.

Aortic Stenosis Drug Chapters

Emerging Aortic Stenosis Drugs

The aortic stenosis market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as ataciguat, evogliptin, and pelacarsen, among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.

Ataciguat: Kardigan

Ataciguat is an oral activator of oxidized soluble guanylate cyclase (sGC) that targets impaired nitric oxide signaling, aiming to slow calcification and disease progression in aortic valve tissue.

It is currently being evaluated in a Phase III trial in adults with moderate calcific aortic stenosis to determine its effectiveness in slowing valve calcification, preserving valve function, and maintaining exercise capacity.

Evogliptin: REDNVIA

Evogliptin is a dipeptidyl-peptidase-4 (DPP4) inhibitor originally developed for type 2 diabetes that preclinical and early clinical studies suggest may slow the calcification process in aortic valve tissues, potentially delaying stenosis progression.

It is currently under investigation in a Phase II/III adaptive multicenter, double-blind, placebo-controlled trial (EVOID-AS) in patients with mild to moderate calcific aortic stenosis, assessing its efficacy and safety over approximately two years of daily dosing.

Pelacarsen: Novartis Pharmaceuticals

Pelacarsen is an investigational antisense oligonucleotide therapy designed to lower high lipoprotein(a) [Lp(a)] levels-a genetic risk factor implicated in both cardiovascular disease and calcific aortic valve stenosis. Administered as a subcutaneous injection once monthly, pelacarsen has demonstrated up to 80 % reductions in Lp(a) in early-phase studies and is generally well tolerated

It is currently being evaluated in a Phase II multicenter, randomized, double-blind, placebo-controlled trial in patients aged 50-80 with mild to moderate calcific aortic stenosis and elevated Lp(a), aiming to determine whether monthly pelacarsen injections can slow progression of valve calcification and decline in valve function over three years.

Aortic Stenosis Market Segmentation

DelveInsight's 'Aortic Stenosis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future aortic stenosis 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.

Aortic Stenosis Market Size by Countries

The aortic stenosis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) aortic stenosis market, primarily attributed to the country's higher prevalence 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.

Aortic Stenosis Drugs Uptake

This section focuses on the sales uptake of potential aortic stenosis drugs that have recently been launched or are anticipated to be launched in the aortic stenosis market between 2020 and 2034. It estimates the market penetration of aortic stenosis 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 aortic stenosis market.

The emerging aortic stenosis 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 aortic stenosis market.

Aortic Stenosis Market Access and Reimbursement

DelveInsight's 'Aortic Stenosis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of aortic stenosis.

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 aortic stenosis market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the aortic stenosis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or aortic stenosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the aortic stenosis unmet needs.

Aortic Stenosis: KOL Insights

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US, University Hospital Tubingen, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, University of Leeds, Leeds, UK, and University of Occupational and Environmental Health, Japan, among others.

"In aortic stenosis, narrowing of the aortic valve causes obstruction to blood flow from the left ventricle, leading to increased systolic pressure, prolonged ejection time, and elevated end-diastolic pressure within the ventricle. This heightened pressure and volume load stimulate thickening of the heart muscle, which initially compensates but eventually results in impaired pumping function and heart failure. As the heart muscle mass and contraction duration increase, so does its oxygen demand, while the time available for blood flow to the heart muscle decreases. This mismatch between oxygen supply and demand contributes to progressive deterioration of heart function."

"Aortic stenosis results from both congenital and acquired factors. In developed countries, bicuspid aortic valve is the leading cause before age 70, while rheumatic valve disease predominates in developing regions. Age-related calcification, metabolic disorders, and mineral imbalance from conditions like end-stage renal disease further contribute to valve narrowing. Obstruction can also occur above or below the valve, with hypertrophic cardiomyopathy causing dynamic subvalvular stenosis."

"Aortic stenosis presents with exertional dyspnea, angina, and syncope, typically earlier in bicuspid valves. Symptoms reflect pressure overload, reduced cardiac output, and oxygen mismatch. Non-cardiac features include gastrointestinal bleeding and cerebral emboli. Key exam findings are a delayed carotid pulse and systolic murmur radiating to the neck. Bicuspid valves carry a higher risk of infective endocarditis."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the aortic stenosis 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.

Aortic Stenosis Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for aortic stenosis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging aortic stenosis therapies.

Aortic Stenosis Report Insights

• Aortic Stenosis Patient Population
• Therapeutic Approaches
• Aortic Stenosis Pipeline Analysis
• Aortic Stenosis Market Size and Trends
• Aortic Stenosis Market Opportunities
• Impact of Upcoming Therapies

Aortic Stenosis Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Aortic Stenosis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Aortic Stenosis Market
• Aortic Stenosis Drugs Uptake

Aortic Stenosis Report Assessment

• Aortic Stenosis Current Treatment Practices
• Unmet Needs
• Aortic Stenosis Pipeline Product Profiles
• Aortic Stenosis Market Attractiveness

Key Questions:

• How common is aortic stenosis?
• What are the key findings of aortic stenosis 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 aortic stenosis?
• What are the disease risk, burden, and unmet needs of aortic stenosis?
• At what CAGR is the aortic stenosis market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the aortic stenosis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of aortic stenosis 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 (2025-2034)?
• How many companies are currently developing therapies for the treatment of aortic stenosis?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the aortic stenosis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for aortic stenosis?

The primary objectives in treating aortic stenosis are to relieve left ventricular outflow obstruction, alleviate symptoms such as dyspnea and angina, prevent disease progression, and reduce the risk of heart failure and mortality.

2. What are the challenges in managing aortic stenosis?

Managing aortic stenosis presents challenges such as delayed diagnosis due to a long asymptomatic phase, limited effectiveness of medical therapy in halting disease progression, and the need to carefully select between surgical and transcatheter valve replacement based on patient age, comorbidities, and procedural risk.

3. What are the key factors driving the growth of the aortic stenosis market?

The aortic stenosis market is driven by the rising prevalence of the disease due to an aging population, increased adoption of transcatheter aortic valve replacement as a less invasive alternative to surgery, and growing awareness and diagnosis through advanced imaging technologies. Additionally, ongoing clinical development of novel pharmacologic therapies offers the potential to expand treatment options beyond procedural intervention.

4. How will the Aortic Stenosis Market and Epidemiology Forecast Report benefit the clients?

The report will provide comprehensive insights into the current aortic stenosis market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

3.1.. Market Share (%) Distribution by Therapies in 2024

3.2.. Market Share (%) Distribution by Therapies in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

7.1.. Introduction

• 7.2. Types

7.3.. Causes

7.4.. Pathophysiology

7.5.. Symptoms

7.6.. Risk Factor

7.7.. Diagnosis

7.7.1.. Diagnostic Algorithm

7.7.2.. Diagnostic Guidelines

7.8.. Treatment and Management

7.8.1.. Treatment Algorithm

7.8.2.. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
  • 8.2.1. Total Prevalent Cases of Aortic Stenosis
  • 8.2.2. Total Diagnosed Prevalent Cases of Aortic Stenosis
  • 8.2.3. Severity-specific Cases of Aortic Stenosis
  • 8.2.4. Treated Cases of Aortic Stenosis
• 8.3. Total Prevalent Cases of Aortic Stenosis in the 7MM
• 8.4. Total Diagnosed Prevalent Cases of Aortic Stenosis in the 7MM
• 8.5. The US
  • 8.5.1. Total Prevalent Cases of Aortic Stenosis
  • 8.5.2. Total Diagnosed Prevalent Cases of Aortic Stenosis
  • 8.5.3. Severity-specific Cases of Aortic Stenosis
  • 8.5.4. Treated Cases of Aortic Stenosis
• 8.6. EU4 and the UK
  • 8.6.1. Total Prevalent Cases of Aortic Stenosis
  • 8.6.2. Total Diagnosed Prevalent Cases of Aortic Stenosis
  • 8.6.3. Severity-specific Cases of Aortic Stenosis
  • 8.6.4. Treated Cases of Aortic Stenosis
• 8.7. Japan
  • 8.7.1. Total Prevalent Cases of Aortic Stenosis
  • 8.7.2. Total Diagnosed Prevalent Cases of Aortic Stenosis
  • 8.7.3. Severity-specific Cases of Aortic Stenosis
  • 8.7.4. Treated Cases of Aortic Stenosis

9. Patient Journey

10. Emerging Therapies

• 10.1. Key Cross Competition
• 10.2. Ataciguat: Kardigan
  • 10.2.1. Drug Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy
• 10.3. Evogliptin: REDNVIA
  • 10.3.1. Drug Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy
• 10.4. Pelacarsen: Novartis Pharmaceuticals
  • 10.4.1. Drug Description
  • 10.4.2. Other Development Activities
  • 10.4.3. Clinical Trials Information
  • 10.4.4. Safety and Efficacy
  • 10.4.5. Analysts' Views

11. Aortic Stenosis: Seven Major Market Analysis

• 11.1. Key Findings
• 11.2. Key Market Forecast Assumptions
  • 11.2.1. Cost Assumptions and Rebates
  • 11.2.2. Pricing Trends
  • 11.2.3. Analogue Assessment
  • 11.2.4. Launch Year and Therapy Uptake
• 11.3. Market Outlook
• 11.4. Attribute Analysis
• 11.5. Total Market Size of Aortic Stenosis in the 7MM
• 11.6. Market Size of Aortic Stenosis by Therapies in the 7MM
• 11.7. The US Market Size
  • 11.7.1. Total Market Size of Aortic Stenosis
  • 11.7.2. Market Size of Aortic Stenosis by Therapies
• 11.8. Market Size of Aortic Stenosis in the EU4 and the UK
  • 11.8.1. Total Market Size of Aortic Stenosis
  • 11.8.2. Market Size of Aortic Stenosis by Therapies

11.9.. Japan Market Size

• 11.9.1. Total Market Size of Aortic Stenosis
• 11.9.2. Market Size of Aortic Stenosis by Therapies

12. Key Opinion Leaders' Views

13. Unmet Needs

14. SWOT Analysis

15. Aortic Stenosis Market Access and Reimbursement

• 15.1. United States
  • 15.1.1. Centre for Medicare and Medicaid Services (CMS)
• 15.2. EU4 and the UK
  • 15.2.1. Germany
  • 15.2.2. France
  • 15.2.3. Italy
  • 15.2.4. Spain
  • 15.2.5. United Kingdom
• 15.3. Japan
  • 15.3.1. MHLW

16. Appendix

• 16.1. Bibliography
• 16.2. Abbreviations and Acronyms
• 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight