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Atherosclerotic Cardiovascular Disease (ASCVD) - Market Insight, Epidemiology and Market Forecast - 2034

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    Report

  • 255 Pages
  • April 2024
  • Region: Global
  • DelveInsight
  • ID: 5524396

Key Highlights

  • The Atherosclerotic Cardiovascular Disease (ASCVD) market is projected to witness consistent growth throughout the forecast period (2023-2034). The market size of Atherosclerotic Cardiovascular Disease in the 7MM is expected to increase, driven by better diagnosis and launch of emerging therapies.
  • The analyst projects that among the total cases of ASCVD in 7MM approximately 47% of cases were from the US. As per our estimations, in 2022, the US accounted for 26 million diagnosed prevalent cases of ASCVD.
  • As per the analysis, EU4 and the UK comprised around 38% of the diagnosed prevalent cases of Atherosclerotic Cardiovascular Disease in 2022 among the 7MM.
  • Japan accounted for more than 8.2 million diagnosed prevalent cases of Atherosclerotic Cardiovascular Disease in 2022.
  • In the 7MM, the market mainly consisted of statins, which generated nearly USD 20,600 million in 2022.
  • The total market size of the Atherosclerotic Cardiovascular Disease is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely, Olpasiran, Ziltivekimab, and Obicetrapib, among others.
The “Atherosclerotic Cardiovascular Disease (ASCVD) - Market Insights, Epidemiology, and Market Forecast - 2034” report delivers an in-depth understanding of the ASCVD, historical and forecasted epidemiology and the Atherosclerotic Cardiovascular Disease market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Atherosclerotic Cardiovascular Disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Atherosclerotic Cardiovascular Disease market size from 2020 to 2034. The report also covers current Atherosclerotic Cardiovascular Disease treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Atherosclerotic Cardiovascular Disease (ASCVD) Overview

ASCVD is a progressive and chronic condition that can affect various arteries throughout the body, including those supplying the heart (coronary arteries), brain (cerebral arteries), and legs (peripheral arteries). The most common manifestations of ASCVD include coronary artery disease (CAD), cerebrovascular disease (stroke), and peripheral arterial disease (PAD).

The development of ASCVD is influenced by a number of risk factors, such as poor diet, inactivity, cigarette use, obesity, family history, and alcohol abuse. The early stages of ASCVD are without symptoms, but later on as the artery narrows and blood flow is reduced, symptoms start to show. The type of artery that is affected and how much blood flow is impeded may also alter the symptoms. Angina, cold chills, dizziness, acute exhaustion, shortness of breath, and heart palpitations are a few typical symptoms.

Atherosclerotic Cardiovascular Disease (ASCVD) Diagnosis

In addition to symptoms, risk assessment is also used to make the diagnosis of ASCVD. Apolipoprotein E [APOE], LDLR, APOB, PCSK9, or LDLRAP1 genes; genotyping to study variations in contributing genes; and morphological examinations (ultrasonography, computed tomography, magnetic resonance imaging/angiography, or catheterization) are typically used to make a clinical diagnosis of ASCVD. Genetic testing, biomarker testing, and imaging can all be used to confirm an ASCVD diagnosis if a doctor has a suspicion. However, the cost and accessibility of genetic testing and biomarker testing may restrict their use.

Atherosclerotic Cardiovascular Disease (ASCVD) Treatment

Treatment strategies for Atherosclerotic Cardiovascular Disease occur at the population level but also engage individual adults to slow the development of ASCVD. Promoting a healthy lifestyle throughout life is the most important way to prevent ASCVD. Treatment other than lifestyle modification is based on pharmacotherapy and invasive procedures. A comprehensive patient-centered approach that addresses all aspects of a patient’s lifestyle habits and estimated risk of a future ASCVD event is the first step in deciding where there may be a need for pharmacotherapy. For clinical ASCVD, revascularization procedures such as angioplasties and bypass are warranted, among others.

Atherosclerotic Cardiovascular Disease (ASCVD) Epidemiology

As the market is derived using the patient-based model, the Atherosclerotic Cardiovascular Disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Atherosclerotic Cardiovascular Disease, (ASCVD), Gender-specific Diagnosed Prevalent Cases of Atherosclerotic Cardiovascular Disease (ASCVD), Age-specific Diagnosed Prevalent Cases of Atherosclerotic Cardiovascular Disease (ASCVD) and Comordidity-specific Diagnosed Prevalent Cases of Atherosclerotic Cardiovascular Disease (ASCVD) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034. As per the estimations, the total diagnosed prevalent cases of Atherosclerotic Cardiovascular Disease in the 7MM was approximately 55 million cases in 2022 and are projected to increase during the forecast period.
  • In 2022, among the 7MM, the US recorded the highest number of diagnosed prevalent cases of Atherosclerotic Cardiovascular Disease, with approximately 26 million cases, these cases are projected to increase by 2034.
  • Among EU4 and the UK, Germany had the highest diagnosed prevalent population of ASCVD, with 5.7 million cases, followed by France and Italy in 2022. On the other hand, Spain had the lowest prevalent population in the European region in 2022.
  • In Japan, there were around 8.2 million diagnosed prevalent cases in 2022. These cases are expected to decrease at substantial CAGR due to a decline in the population.
  • The highest proportion of ASCVD cases was observed in the 65 years and above age group in the 7MM, while the least cases were in the age group 18-44 years.
  • The United States has the highest number of diagnosed cases of Atherosclerotic Cardiovascular Disease in males compared to females. In 2022, of all Atherosclerotic Cardiovascular Disease cases, approximately 56% were males, while around 44% of males were diagnosed with the condition.
  • The comorbidity-specific cases of ASCVD were divided into recent ACS, ischemic stroke, PAD, other CHD, and other comorbidities comprising CKD. Other CHD had the highest number of cases, 28 million in 2022 in the 7MM.

Atherosclerotic Cardiovascular Disease (ASCVD) Drug Chapters

The drug chapter segment of the Atherosclerotic Cardiovascular Disease report encloses a detailed analysis of Atherosclerotic Cardiovascular Disease marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands Atherosclerotic Cardiovascular Disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

LEQVIO (Inclisiran): Novartis Pharmaceuticals Corporation

LEQVIO (Inclisiran) is a sole small-interfering RNA (siRNA) therapy designed to lower LDL cholesterol. The drug utilizes the RNA interference mechanism and directs the catalytic breakdown of mRNA for PCSK9. This increases LDL-C receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.

Note: Detailed marketed therapies assessment will be provided in the final report of ASCVD.

Emerging Drugs

Olpasiran (AMG 890): Amgen Inc.

Olpasiran (formerly AMG 890) is a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a). It is being investigated for treating ASCVD; the drug is administered subcutaneously as a solution. Currently, the company is recruiting for Phase III clinical trial to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with ASCVD and elevated lipoprotein (a).

Obicetrapib (TA-8995): NewAmsterdam Pharma

Obicetrapib is a novel, selective CETP inhibitor that potently decreases low-density lipoprotein-cholesterol (LDL-C) as well as increases high-density lipoprotein-cholesterol (HDL-C) and the number of ApoA1-containing lipoproteins. The drug candidate is designed to be administered orally. Currently, the company is recruiting for Phase III clinical trials to evaluate the effect of obicetrapib on the risk of major adverse cardiovascular events (MACE), including cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or non-elective coronary revascularization.

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

Atherosclerotic Cardiovascular Disease (ASCVD) Market Outlook

Atherosclerotic Cardiovascular Disease has a diverse treatment classification associated with the disease landscape. ASCVD treatment aims to mitigate cardiovascular risk factors through lifestyle modifications, pharmacological interventions, and invasive procedures as needed.

Statins and PCSK9 inhibitors are major revenue generators in the current treatment landscape. The use of statins and PCSK9 inhibitors is guided by clinical practice guidelines, which provide evidence-based recommendations to healthcare professionals to manage ASCVD.

The market for Atherosclerotic Cardiovascular Disease is expected to experience positive growth with the approval of potential drugs like MK-0616, Obicetrapib (TA-8995), and TQJ230 (pelacarsen).
  • The Atherosclerotic Cardiovascular Disease (ASCVD) market’s total size in the 7MM reached approximately USD 23,000 million in 2022. Projections indicate a substantial CAGR from 2022 to 2034.
  • Out of the 7MM, the United States dominated the market in 2022, representing the largest share at 51%.
  • In 2022, EU4 and the UK captured nearly 35% and Japan around 13% of the total market share in the 7MM.
  • Among the forecasted emerging therapies, Olpasiran (formerly AMG 890) is expected to capture the highest market in the 7MM by 2034.

Atherosclerotic Cardiovascular Disease (ASCVD) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Obicetrapib (TA-8995) in the US is expected to have medium drug uptake with a probability-adjusted peak share of around 1%, and years to the peak is expected to be 7 years from the year of launch.

Atherosclerotic Cardiovascular Disease (ASCVD) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Atherosclerotic Cardiovascular Disease emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Atherosclerotic Cardiovascular Disease evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Rollins School of Public Health, Emory University, Atlanta, Georgia; Department of Epidemiology and Health Monitoring, Robert Koch Institute; Cardiovascular Prevention Institute, Paris; Teikyo Academic Research Center, Teikyo University, Itabashi-ku, Tokyo, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Atherosclerotic Cardiovascular Disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

  • The report covers a segment of key events, an executive summary, descriptive overview of Atherosclerotic Cardiovascular Disease (ASCVD), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the Atherosclerotic Cardiovascular Disease (ASCVD) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preference that help shape and drive the 7MM Atherosclerotic Cardiovascular Disease (ASCVD) market.

Atherosclerotic Cardiovascular Disease (ASCVD) Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Atherosclerotic Cardiovascular Disease Pipeline Analysis
  • Atherosclerotic Cardiovascular Disease Market Size and Trends
  • Existing and Future Market Opportunity

Atherosclerotic Cardiovascular Disease (ASCVD) Report Key Strengths

  • 12 years Forecast
  • The 7MM Coverage
  • Atherosclerotic Cardiovascular Disease Epidemiology Segmentation
  • Key Cross Competition
  • Attribute Analysis
  • Drugs Uptake and Key Market Forecast Assumptions

Atherosclerotic Cardiovascular Disease (ASCVD) Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

  • What was the Atherosclerotic Cardiovascular Disease (ASCVD) total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
  • What unmet needs are associated with the current treatment market of Atherosclerotic Cardiovascular Disease (ASCVD)?
  • What will be the impact of the NEXLETOL patent expiry in the market?
  • How will MK-0616 compete with the existing therapies for Atherosclerotic Cardiovascular Disease (ASCVD) during the study period?
  • Which drug is going to be the largest contributor in 2034?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

  • What are the disease risk, burdens, and unmet needs of Atherosclerotic Cardiovascular Disease (ASCVD)? What will be the growth opportunities across the 7MM concerning the patient population of Atherosclerotic Cardiovascular Disease (ASCVD)?
  • What is the historical and forecasted Atherosclerotic Cardiovascular Disease (ASCVD) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
  • Why do only limited patients appear for diagnosis?
  • Which country is more prevalent for Atherosclerotic Cardiovascular Disease (ASCVD) and why?
  • What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for treating Atherosclerotic Cardiovascular Disease (ASCVD)? What are the current guidelines for treating Atherosclerotic Cardiovascular Disease (ASCVD) in the US and Europe?
  • How many companies are developing therapies for treating Atherosclerotic Cardiovascular Disease (ASCVD)?
  • How many emerging therapies are in the mid-stage and late stage of development for treating Atherosclerotic Cardiovascular Disease (ASCVD)?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the key designations that have been granted for the emerging therapies for Atherosclerotic Cardiovascular Disease (ASCVD)?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
  • What are the 7MM historical and forecasted markets of Atherosclerotic Cardiovascular Disease (ASCVD)?

Reasons to Buy

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Atherosclerotic Cardiovascular Disease (ASCVD) 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
  • Detailed analysis and ranking of 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights2. Report Introduction
3. Atherosclerotic Cardiovascular Disease (ASCVD) Market Overview by Therapies
3.1. Market Share (%) Distribution of ASCVD by Therapies in 2020
3.2. Market Share (%) Distribution of ASCVD by Therapies in 2034
4. Methodology of ASCVD Epidemiology and Market5. Executive Summary of Atherosclerotic Cardiovascular Disease (ASCVD)6. Key Events
7. Disease Background and Overview: ASCVD
7.1. Introduction
7.2. Associated Diseases
7.3. Pathophysiology of Atherosclerosis
7.4. Risk Factors of ASCVD
7.5. Symptoms of ASCVD
7.6. Diagnosis
7.6.1. Risk Assessment
7.6.2. Diagnostic Guidelines
7.6.2.1. Kaiser Permanente Washington Guideline for Management of ASCVD
7.6.2.2. ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease: 2020
7.6.2.3. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017
7.6.2.4. ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice 2021
7.7. Treatment
7.7.1. Treatment Algorithm
7.7.2. Treatment Guidelines
7.7.2.1. ACC/AHA Guidelines on the Primary Prevention of ASCVD
7.7.2.2. Major Treatment Recommendations of the 2018 AHA/ACC Multisociety Cholesterol Guideline and the 2020 ESC/EAS Guidelines for Secondary ASCVD Prevention
7.7.2.3. Kaiser Permanente Washington Guideline for the management of ASCVD
7.7.2.4. Japan Atherosclerosis Society (JAS) Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases 2017
7.7.2.5. ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice 2021
8. Epidemiology and Patient Population
8.1. Key Findings
8.2. Assumptions and Rationale: The 7MM
8.2.1. Diagnosed Prevalent Cases of ASCVD
8.2.2. Gender-specific Diagnosed Prevalent Cases of ASCVD
8.2.3. Age-specific Diagnosed Prevalent Cases of ASCVD
8.2.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD
8.2.5. Treatment Rate of Diagnosed ASCVD Patient
8.3. Total Diagnosed Prevalent Cases of ASCVD in the 7MM
8.4. The United States
8.4.1. Total Diagnosed Prevalent Cases of ASCVD in the US
8.4.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in the US
8.4.3. Age-specific Diagnosed Prevalent Cases of ASCVD in the US
8.4.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the US
8.5. EU4 and the UK
8.5.1. Germany
8.5.1.1. Total Diagnosed Prevalent Cases of ASCVD in Germany
8.5.1.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in Germany
8.5.1.3. Age-specific Diagnosed Prevalent Cases of ASCVD in Germany
8.5.1.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Germany
8.5.2. France
8.5.2.1. Total Diagnosed Prevalent Cases of ASCVD in France
8.5.2.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in France
8.5.2.3. Age-specific Diagnosed Prevalent Cases of ASCVD in France
8.5.2.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in France
8.5.3. Italy
8.5.3.1. Total Diagnosed Prevalent Cases of ASCVD in Italy
8.5.3.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in Italy
8.5.3.3. Age-specific Diagnosed Prevalent Cases of ASCVD in Italy
8.5.3.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Italy
8.5.4. Spain
8.5.4.1. Total Diagnosed Prevalent Cases of ASCVD in Spain
8.5.4.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in Spain
8.5.4.3. Age-specific Diagnosed Prevalent Cases of ASCVD in Spain
8.5.4.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Spain
8.5.5. The UK
8.5.5.1. Total Diagnosed Prevalent Cases of ASCVD in the UK
8.5.5.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in the UK
8.5.5.3. Age-specific Diagnosed Prevalent Cases of ASCVD in the UK
8.5.5.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the UK
8.6. Japan
8.6.1. Total Diagnosed Prevalent Cases of ASCVD in Japan
8.6.2. Gender-specific Diagnosed Prevalent Cases of ASCVD in Japan
8.6.3. Age-specific Diagnosed Prevalent Cases of ASCVD in Japan
8.6.4. Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Japan
9. Patient Journey
10. Marketed Drugs
10.1. Key Cross
10.2. LEQVIO (inclisiran): Novartis Pharmaceuticals Corporation
10.2.1. Product Description
10.2.2. Regulatory milestones
10.2.3. Other Developmental Activities
10.2.4. Clinical Development
10.2.5. Clinical Trials Information
10.2.6. Safety and Efficacy
10.2.7. Product Profile
10.3. NEXLETOL/NILEMDO (bempedoic acid): Esperion Therapeutics/Daiichi Sankyo, Ltd
10.3.1. Product Description
10.3.2. Regulatory Milestones
10.3.3. Other Developmental Activities
10.3.4. Clinical Development
10.3.5. Clinical Trials Information
10.3.6. Safety and Efficacy
10.3.7. Product Profile
10.4. NEXLIZET/NUSTENDI (bempedoic acid and ezetimibe): Esperion Therapeutics/Daiichi Sankyo, Ltd
10.4.1. Product Description
10.4.2. Regulatory Milestones
10.4.3. Other Developmental Activities
10.4.4. Clinical Development
10.4.5. Clinical Trials Information
10.4.6. Safety and Efficacy
10.4.7. Product Profile
10.5. PRALUENT (alirocumab): Regeneron Pharmaceuticals/Sanofi
10.5.1. Product Description
10.5.2. Regulatory Milestones
10.5.3. Other Developmental Activities
10.5.4. Clinical Development
10.5.5. Clinical Trials Information
10.5.6. Safety and Efficacy
10.5.7. Product Profile
10.6. XARELTO (rivaroxaban): Bayer/Johnson & Johnson
10.6.1. Product Description
10.6.2. Regulatory Milestones
10.6.3. Other Developmental Activities
10.6.4. Clinical Development
10.6.5. Clinical Trials Information
10.6.6. Safety and Efficacy
10.6.7. Product Profile
11. Emerging Drugs
11.1. Key Cross Competition
11.2. Olpasiran (AMG 890): Amgen Inc.
11.2.1. Product Description
11.2.2. Other Developmental Activities
11.2.3. Clinical Development
11.2.4. Clinical Trials Information
11.2.5. Safety and Efficacy
11.2.6. Product Profile
11.2.7. Analysts’ Views
11.3. Ziltivekimab (COR 001): Novo Nordisk A/S
11.3.1. Product Description
11.3.2. Other Developmental Activity
11.3.3. Clinical Development
11.3.4. Clinical Trials Information
11.3.5. Safety and Efficacy
11.3.6. Product Profile
11.3.7. Analysts’ Views
11.4. Obicetrapib (TA-8995): NewAmsterdam Pharma
11.4.1. Product Description
11.4.2. Other Developmental Activities
11.4.3. Clinical Development
11.4.4. Clinical Trials Information
11.4.5. Safety and Efficacy
11.4.6. Product Profile
11.4.7. Analysts’ Views
11.5. MK-0616: Merck Sharp & Dohme Corp.
11.5.1. Product Description
11.5.2. Other Developmental Activities
11.5.3. Clinical Development
11.5.4. Clinical Trials Information
11.5.5. Safety and Efficacy
11.5.6. Product Profile
11.5.7. Analysts’ Views
11.6. LIB003 (Lerodalcibep): LIB Therapeutics LLC
11.6.1. Product Description
11.6.2. Clinical Development
11.6.3. Clinical Trials Information
11.6.4. Safety and Efficacy
11.6.5. Product Profile
11.6.6. Analysts’ Views
11.7. Olezarsen: Ionis Pharmaceuticals, Inc.
11.7.1. Product Description
11.7.2. Other Developmental Activities
11.7.3. Clinical Development
11.7.4. Clinical Trials Information
11.7.5. Safety and Efficacy
11.7.6. Product Profile
11.7.7. Analysts’ Views
11.8. CSL112: CSL Behring
11.8.1. Product Description
11.8.2. Clinical Development
11.8.3. Clinical Trials Information
11.8.4. Safety and Efficacy
11.8.5. Product Profile
11.8.6. Analysts’ Views
11.9. Apabetalone (RVX-208): Resverlogix Corp
11.9.1. Product Description
11.9.2. Other Development Activities
11.9.3. Clinical Development
11.9.4. Clinical Trials Information
11.9.5. Safety and Efficacy
11.9.6. Product Profile
11.9.7. Analysts’ Views
11.10. TQJ230 (pelacarsen): Ionis Pharmaceuticals/Novartis Pharmaceuticals
11.10.1. Product Description
11.10.2. Other Development Activities
11.10.3. Clinical Development
11.10.4. Clinical Trials Information
11.10.5. Safety and Efficacy
11.10.6. Product Profile
11.10.7. Analysts’ Views
11.11. Milvexian (BMS-986177; JNJ-70033093): Janssen Research & Development, LLC/Bristol-Myers Squibb
11.11.1. Product Description
11.11.2. Other Developmental Activities
11.11.3. Clinical Development
11.11.4. Clinical Trials Information
11.11.5. Safety and Efficacy
11.11.6. Product Profile
11.11.7. Analysts’ Views
11.12. Zerlasiran (SLN360): Silence Therapeutics Plc
11.12.1. Product Description
11.12.2. Other Developmental Activities
11.12.3. Clinical Development
11.12.4. Clinical Trials Information
11.12.5. Safety and Efficacy
11.12.6. Product Profile
11.12.7. Analysts’ Views
12. ASCVD: Market Analysis
12.1. Key Findings
12.2. Key Market Forecast Assumptions
12.3. Market Outlook
12.4. Conjoint Analysis
12.5. Total Market Size of ASCVD in the 7MM
12.6. Market Size of ASCVD by Therapies in the 7MM
12.7. Market Size of ASCVD in the United States
12.7.1. Total Market Size of ASCVD
12.7.2. Market Size of ASCVD by Therapies in the United States
12.8. Market Size of ASCVD in EU4 and the UK
12.8.1. Germany
12.8.1.1. Total Market Size of ASCVD
12.8.1.2. Market Size of ASCVD by Therapies in Germany
12.8.2. France
12.8.2.1. Total Market Size of ASCVD
12.8.2.2. Market Size of ASCVD by Therapies in France
12.8.3. Italy
12.8.3.1. Total Market Size of ASCVD
12.8.3.2. Market Size of ASCVD by Therapies in Italy
12.8.4. Spain
12.8.4.1. Total Market Size of ASCVD
12.8.4.2. Market Size of ASCVD by Therapies in Spain
12.8.5. The UK
12.8.5.1. Total Market Size of ASCVD
12.8.5.2. Market Size of ASCVD by Therapies in the UK
12.9. Market Size of ASCVD in Japan
12.9.1. Total Market Size of ASCVD
12.9.2. Market Size of ASCVD by Therapies in Japan
13. Key Opinion Leaders’ Views14. SWOT Analysis15. Unmet Needs
16. Market Access and Reimbursement
16.1. The United States
16.1.1. Center for Medicare and Medicaid Services (CMS)
16.2. EU4 and the UK
16.2.1. Germany
16.2.2. France
16.2.3. Italy
16.2.4. Spain
16.2.5. The United Kingdom
16.3. Japan
16.3.1. MHLW
17. Appendix
17.1. Bibliography
17.2. Acronyms and Abbreviations
18. Report Methodology19. Publisher Capabilities20. Disclaimer
List of Tables
Table 1: Summary of ASCVD Market and Epidemiology (2020-2034)
Table 2: Key Events
Table 3: Lipid Screening for Patients Not Already on Statins
Table 4: Classification of Evidence Levels of Epidemiological Studies
Table 5: Comprehensive Risk Assessment
Table 6: Classes of Recommendation
Table 7: Level of Evidence
Table 8: Class (Strength) of Recommendations
Table 9: Level (Quality) of Evidence
Table 10: Comparison of Major Treatment Recommendations of the 2018 AHA/ACC Multisociety Cholesterol Guideline and the 2020 ESC/EAS Guidelines for Secondary ASCVD Prevention
Table 11: Statin Therapy Recommendations for Primary Prevention of ASCVD
Table 12: STANDARD (moderate-intensity) Statin Dosing for Primary Prevention of ASCVD
Table 13: REDUCED (low-intensity) Statin Dosing for Primary Prevention of ASCVD
Table 14: Patients With Diabetes and Elevated Risk: ACE Inhibitor or ARB Therapy for Primary Prevention of ASCVD
Table 15: Recommendation Levels
Table 16: Classes of Recommendation
Table 17: Level of Evidence
Table 18: Total Diagnosed Prevalent Cases of ASCVD in the 7MM, in ‘000’ (2020-2034)
Table 19: Total Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Table 20: Gender-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Table 21: Age-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Table 22: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Table 23: Total Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Table 24: Total Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Table 25: Total Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Table 26: Total Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Table 27: Total Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Table 28: Total Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Table 29: Gender-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Table 30: Gender-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Table 31: Gender-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Table 32: Gender-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Table 33: Gender-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Table 34: Gender-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Table 35: Age-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Table 36: Age-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Table 37: Age-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Table 38: Age-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Table 39: Age-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Table 40: Age-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Table 41: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Table 42: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Table 43: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Table 44: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Table 45: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Table 46: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Table 47: Total Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Table 48: Gender-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Table 49: Age-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Table 50: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Table 51: Key cross competition
Table 52: Inclisiran: Clinical Trial Description, 2024
Table 53: NEXLETOL/NILEMDO (bempedoic acid); Clinical Trial Description, 2024
Table 54: NEXLETOL/NILEMDO (bempedoic acid); Clinical Trial Description, 2024
Table 55: Alirocumab: Clinical Trial Description, 2024
Table 56: XARELTO: Clinical Trial Description, 2024
Table 57: Comparison of Emerging Drugs
Table 58: Olpasiran, Clinical Trial Description, 2024
Table 59: Ziltivekimab, Clinical Trial Description, 2024
Table 60: Obicetrapib, Clinical Trial Description, 2024
Table 61: Median Percentage Change From Baseline
Table 62: MK-0616, Clinical Trial Description, 2024
Table 63: LIB003 (lerodalcibep), Clinical Trial Description, 2024
Table 64: Olezarsen, Clinical Trial Description, 2024
Table 65: CSL112, Clinical Trial Description, 2024
Table 66: Apabetalone, Clinical Trial Description, 2024
Table 67: Pelacarsen, Clinical Trial Description, 2024
Table 68: Milvexian, Clinical Trial Description, 2024
Table 69: Zerlasiran, Clinical Trial Description, 2024
Table 70: Key Market Forecast Assumptions for LEQVIO
Table 71: Key Market Forecast Assumptions for Olpasiran
Table 72: Key Market Forecast Assumptions for Ziltivekimab
Table 73: Key Market Forecast Assumptions for Olezarsen
Table 74: Key Market Forecast Assumptions for Obicetrapib
Table 75: Key Market Forecast Assumptions for Apabetalone (RVX000222)
Table 76: Key Market Forecast Assumptions for LIB003 (Lerodalcibep)
Table 77: Key Market Forecast Assumptions for CSL112
Table 78: Key Market Forecast Assumptions for TQJ230 (pelacarsen)
Table 79: Key Market Forecast Assumptions for MK-0616
Table 80: Total Market Size of ASCVD in the 7MM, in USD million (2020-2034)
Table 81: Market Size of ASCVD by Therapies in the 7MM, in USD million (2020-2034)
Table 82: Total Market Size of ASCVD in the US, in USD million (2020-2034)
Table 83: Market Size of ASCVD by Therapies in the US, in USD million (2020-2034)
Table 84: Total Market Size of ASCVD in Germany, in USD million (2020-2034)
Table 85: Total Market Size of ASCVD in France, in USD million (2020-2034)
Table 86: Total Market Size of ASCVD in Italy, in USD million (2020-2034)
Table 87: Total Market Size of ASCVD in Spain, in USD million (2020-2034)
Table 88: Total Market Size of ASCVD in the UK, in USD million (2020-2034)
Table 89: Total Market Size of ASCVD in EU4 and the UK, in USD million (2020-2034)
Table 90: Market Size of ASCVD by Therapies in Germany, in USD million (2020-2034)
Table 91: Market Size of ASCVD by Therapies in France, in USD million (2020-2034)
Table 92: Market Size of ASCVD by Therapies in Italy, in USD million (2020-2034)
Table 93: Market Size of ASCVD by Therapies in Spain, in USD million (2020-2034)
Table 94: Market Size of ASCVD by Therapies in the UK, in USD million (2020-2034)
Table 95: Market Size of ASCVD by Therapies in EU4 and the UK, in USD million (2020-2034)
Table 96: Total Market Size of ASCVD in Japan, in USD million (2020-2034)
Table 97: Market Size of ASCVD by Therapies in Japan, in USD million (2020-2034)
List of Figures
Figure 1: Stages of Atherosclerosis
Figure 2: A Illustration of Ischemic Stroke
Figure 3: Atherosclerosis Process
Figure 4: Risk Factors of ASCVD
Figure 5: Common Symptoms of ASCVD
Figure 6: Risk Assessment of CVD
Figure 7: Treatment Approaches for ASCVD
Figure 8: LDL-C Management
Figure 9: Treatment Algorithm of ASCVD
Figure 10: Total Diagnosed Prevalent Cases of ASCVD in the 7MM, in ‘000’ (2020-2034)
Figure 11: Total Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Figure 12: Gender-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Figure 13: Age-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Figure 14: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the US, in ‘000’ (2020-2034)
Figure 15: Total Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Figure 16: Total Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Figure 17: Total Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Figure 18: Total Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Figure 19: Total Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Figure 20: Total Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Figure 21: Gender-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Figure 22: Gender-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Figure 23: Gender-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Figure 24: Gender-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Figure 25: Gender-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Figure 26: Gender-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Figure 27: Age-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Figure 28: Age-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Figure 29: Age-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Figure 30: Age-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Figure 31: Age-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Figure 32: Age-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Figure 33: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Germany, in ‘000’ (2020-2034)
Figure 34: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in France, in ‘000’ (2020-2034)
Figure 35: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Italy, in ‘000’ (2020-2034)
Figure 36: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Spain, in ‘000’ (2020-2034)
Figure 37: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in the UK, in ‘000’ (2020-2034)
Figure 38: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in EU4 and the UK, in ‘000’ (2020-2034)
Figure 39: Total Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Figure 40: Gender-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Figure 41: Age-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Figure 42: Comorbidity-specific Diagnosed Prevalent Cases of ASCVD in Japan, in ‘000’ (2020-2034)
Figure 43: Patient Journey of ASCVD
Figure 44: Total Market Size of ASCVD in the 7MM, in USD million (2020-2034)
Figure 45: Total Market Size of ASCVD in the 7MM by Therapies (2020-2034)
Figure 46: Total Market Size of ASCVD in the US (2020-2034)
Figure 47: Total Market Size of ASCVD by Therapies in the US (2020-2034)
Figure 48: Total Market Size of ASCVD in EU4 and the UK (2020-2034)
Figure 49: Total Market Size of ASCVD in Germany (2020-2034)
Figure 50: Total Market Size of ASCVD in France (2020-2034)
Figure 51: Total Market Size of ASCVD in Italy (2020-2034)
Figure 52: Total Market Size of ASCVD in Spain (2020-2034)
Figure 53: Total Market Size of ASCVD in the UK (2020-2034)
Figure 54: Market Size of ASCVD by Therapies in EU4 and the UK (2020-2034)
Figure 55: Market Size of ASCVD by Therapies in Germany (2020-2034)
Figure 56: Market Size of ASCVD by Therapies in France (2020-2034)
Figure 57: Market Size of ASCVD by Therapies in Italy (2020-2034)
Figure 58: Market Size of ASCVD by Therapies in Spain (2020-2034)
Figure 59: Market Size of ASCVD by Therapies in the UK (2020-2034)
Figure 60: Total Market Size of ASCVD in Japan (2020-2034)
Figure 61: Market Size of ASCVD by Therapies in Japan (2020-2034)
Figure 62: SWOT Analysis
Figure 63: Unmet Needs
Figure 64: Health Technology Assessment
Figure 65: Reimbursement Process in Germany
Figure 66: Reimbursement Process in France
Figure 67: Reimbursement Process in Spain
Figure 68: Reimbursement Process in the United Kingdom
Figure 69: Reimbursement Process in Japan

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Amgen Inc.
  • Novo Nordisk A/S
  • NewAmsterdam Pharma
  • Merck Sharp & Dohme Corp.
  • LIB Therapeutics LLC
  • Ionis Pharmaceuticals, Inc.
  • CSL Behring
  • Resverlogix Corp
  • Ionis Pharmaceuticals
  • Novartis Pharmaceuticals
  • Janssen Research & Development, LLC
  • Bristol-Myers Squibb
  • Silence Therapeutics Plc