The Atherosclerotic Cardiovascular Disease Market is on a trajectory of substantial growth, projected to surge from its 2023 valuation of US$ 150.8 billion to a staggering US$ 195.8 billion by the year 2030. This growth is anticipated to transpire at a steady Compound Annual Growth Rate (CAGR) of 3.8% over the forecast period spanning from 2022 to 2030.

 Atherosclerotic cardiovascular disease (ASCVD) encompasses a spectrum of conditions triggered by the accumulation of plaque within arteries, which, in turn, leads to restricted blood flow. This multifaceted disease category includes coronary artery disease, carotid artery disease, peripheral arterial disease, and cerebrovascular disease, collectively constituting a global healthcare challenge as ASCVD stands as the primary cause of mortality across the globe. The therapeutic strategies employed in combating ASCVD primarily revolve around cholesterol management, antihypertensive medications, antiplatelet agents, and revascularization procedures.

The Atherosclerotic Cardiovascular Disease Market exhibits a structured segmentation based on several key parameters, namely disease type, diagnostics, therapeutics, end-user, and geographic region. Within this segmentation, the coronary artery disease segment is projected to dominate the market landscape during the forecast period. This prevalence can be attributed to the escalating incidence of risk factors such as obesity, hypertension, diabetes, and sedentary lifestyles among the global population. A noteworthy development in this context occurred in 2021 when Amgen secured approval from the U.S. Food and Drug Administration (FDA) for its PCSK9 inhibitor, Leqvio (inclisiran), designed for the treatment of both heterozygous familial and nonfamilial hypercholesterolemia. This achievement exemplifies the ongoing efforts within the industry to combat ASCVD effectively and underscores the significance of advancements in therapeutic interventions.

Epidemiology Insights:

• ASCVD represents the leading cause of mortality in developed countries. Over 17 million annual deaths are attributed to CVDs worldwide, with coronary artery disease being the most common type.
• Key factors driving the epidemiological burden include obesity, hypertension, diabetes, smoking, and sedentary lifestyles. Developed countries like the U.S. and those in Western Europe have a high prevalence compared to developing countries.
• As per the CDC, around 18.2 million adults above 20 years of age have coronary artery disease in the U.S. The prevalence of carotid artery stenosis is around 2.5% in adults above 70 years.
• The EU5 countries show a prevalence of >10% for symptomatic peripheral arterial disease. Atrial fibrillation prevalence is around 2% in adults.
• The increasing rates of risk factors indicate substantial growth opportunities regarding patient pool and treatment demand. However, ASCVD represents a non-rare disease group.

Market Landscape:

• Unmet needs exist for treating complex plaque lesions and overcoming restenosis despite revascularization procedures. The therapies focus on relieving symptoms rather than targeting the pathology.
• Current options comprise antiplatelets like aspirin, antihypertensives such as ACE inhibitors, and statins for lowering cholesterol. CABG, stenting, and atherectomy are used for revascularization.
• Novel therapies in the pipeline include gene therapies, RNA interference, vaccines, and nanomedicine to target the atherosclerosis process. Advanced stents, drug-coated balloons, andExternal counterpulsation devices are upcoming technologies.
• Breakthrough options focus on stimulating HDL functions, inducing atherosclerotic plaque regression, and promoting vascular reparative therapy using stem cells.
• The market comprises branded prescription medications, generics, surgical devices, and diagnostics. Statins dominate the therapeutics segment. Device makers like Medtronic, Abbott, and Boston Scientific lead the market.

Atherosclerotic Cardiovascular Disease Market Drivers:

Rising prevalence of risk factors

The rising prevalence of risk factors like obesity, hypertension, diabetes, smoking, and physical inactivity is a major driver for the Atherosclerotic Cardiovascular Disease (ASCVD) Market. Obesity rates have tripled globally since 1975, with 39% of adults being overweight and 13% being obese in 2016. Hypertension affects 30-45% of adults worldwide. Diabetes prevalence has risen from 4.7% in 1980 to 8.5% in 2014. These risk factors cause systemic inflammation and metabolic changes that accelerate atherosclerosis.

According to an American Heart Association (AHA) study, ideal cardiovascular health prevalence declined from 15% to 7.5% in the US from 1988 to 2014. The growing prevalence of risk factors is indicative of a significant patient pool needing treatment, thereby driving market growth.

Aging population and changing demographics

The geriatric population is at a greater risk of developing ASCVD due to age-related cardiac and metabolic changes. According to United Nations data, the global population above 65 years is projected to grow from 727 million in 2020 to 1.5 billion in 2050. Developed regions like North America, Europe, and East Asia are experiencing rapid growth in the aging demographic. Moreover, urbanization and changing lifestyles associated with nutrition transition in developing economies are contributing to ASCVD incidence.

As per an AHA study, over 130 million Americans are expected to have some form of CVD by 2035. The demographic shifts and aging trends associated with higher ASCVD vulnerability will considerably influence market growth.

Advancements in treatment and diagnostics

The ASCVD market is driven by continuous advances in therapies, devices, and diagnostics techniques for improved patient outcomes. For instance, PCSK9 inhibitor monoclonal antibodies like evolocumab and alirocumab have shown unprecedented LDL cholesterol reduction. Further, FHIR-enabled wearables allow remote monitoring of ASCVD patients. AI and machine learning are leveraged to analyze cardiac imaging data and predict adverse events. Robot-assisted PCI procedures enable precision. Advances in genomics and proteomics facilitate personalized ASCVD management. Such innovative treatment approaches that enhance patient compliance and outcomes are fueling rapid market expansion.

Increasing healthcare expenditure

Developed countries spend a major portion on cardiovascular diseases. For instance, the total costs of CVD and stroke are set to increase from USD 352 billion in 2030 to USD 1.1 trillion in 2035 in the US, as per the AHA. The adoption of value-based reimbursement models also improves access to ASCVD therapy. Moreover, the expanding middle-class population in emerging economies indicates significant growth opportunities. Rising healthcare spending on ASCVD will thus propel market growth.

Atherosclerotic Cardiovascular Disease Market Opportunities:

Targeting atherosclerosis root cause

Current ASCVD therapeutics like statins, antihypertensives, and antiplatelets focus on managing risk factors and symptoms. However, therapies targeting the root pathology of atherosclerosis represents an area of high unmet need. Plaque regression through HDL stimulation, inducing cholesterol efflux, immuno-modulatory approaches, and promoting vascular healing offer significant opportunities. For instance, CergenXis working on an oral vaccine platform for treating atherosclerosis. Companies are also evaluating gene therapies, RNA interference, vaccines, and nanomedicine for selectively targeting plaque lesions and arterial wall inflammation. Focusing on the underlying disease pathology presents a promising opportunity.

Emerging markets

Developing countries represent largely untapped markets for ASCVD treatment, indicating growth opportunities. Currently, over 75% of global CVD deaths occur in low and middle-income countries. These countries are witnessing epidemiological transition with changing lifestyle patterns. Further, economic growth in countries like China, India, Mexico, Brazil, Indonesia, and South Africa is expanding the middle-class population and healthcare access. As per WHO, emerging economies will account for close to 70% of projected cardiovascular deaths by 2030. Leveraging the high unmet need and improving penetration will foster market growth. Companies are expanding production facilities in these countries.

Early screening and diagnosis

Early screening and diagnosis in high-risk individuals before disease onset provides an opportunity for better ASCVD management. AHA recommends using coronary artery calcium scoring for predicting short-term CVD event risks. Advances in CT imaging and AI tools like machine learning improve plaque characterization and enable personalized predictions. Polygenic risk scores based on genetic polymorphisms are emerging for ASCVD risk assessment. Companies are developing novel protein and metabolite biomarkers for the non-invasive diagnosis of unstable plaque and ruptures. Point-of-care diagnostic tests also enhance the detection of peripheral arterial disease. Such screening advancements allow timely initiation of preventive therapies.

Digital health and connected devices

Digital health solutions provide opportunities for improved ASCVD monitoring and patient engagement. For instance, Apple Watch allows ECG measurement for arrhythmia detection. KardiaMobile is an FDA-cleared smartphone ECG monitor. Smart packaging by companies like AdhereTech connects with mobile apps for drug adherence monitoring. Nokia has partnered with Withings to integrate health metrics from connected devices into an automated ASCVD risk assessment model. Big data analytics enables patient stratification and tailored care pathways. Telemedicine also improves access and affordability. Integration of digital health with ASCVD management will likely gain significant traction.

Atherosclerotic Cardiovascular Disease Market Trends:

Increasing adoption of minimally invasive procedures

The ASCVD treatment landscape is witnessing a major shift from invasive surgeries towards minimally invasive catheter-based procedures driven by lower risk of complications and faster recovery. For instance, transcatheter aortic valve replacement (TAVR) is emerging as the preferred choice over surgical valve replacement in high-risk elderly patients with aortic stenosis. Robot-assisted coronary angioplasty enables superior precision and control. Further, clinical trials have demonstrated the safety and efficacy of percutaneous superficial femoral artery stenting for peripheral arterial disease. Device miniaturization and advanced navigation allow such procedures. Patient preference for minimally invasive approaches will further their uptake.

Combination therapies gaining prominence

The use of combination drug regimens and multimodal approaches is increasing for comprehensive ASCVD risk reduction. For instance, the Improve-IT trial demonstrated that adding ezetimibe to statin therapy provides greater cardiovascular benefits. The CANTOS trial revealed the potential of combo therapeutic strategies. Guidelines recommend a polypill comprising statins, aspirin, ACE inhibitors, and diuretics for high-risk patients. Antiplatelets like ticagrelor and vorapaxar are combined with statins. Further, hybrid revascularization combines minimally invasive CABG and PCI. Combination therapy provides synergistic effects owing to different mechanisms of action.

Shift towards value-based care

Healthcare systems are shifting from volume to value-based models that emphasize patient outcomes. Value-based purchasing links hospital payments to care quality and cost control in ASCVD management. The expansion of ACOs also enables population health management. Companies are collaborating with payers and providers for risk-sharing agreements. For instance, Amgen partnered with Harvard Pilgrim for an outcomes-based contract for its PCSK9 inhibitor Repatha. Adoption of evidence-based clinical pathways improves resource utilization. Further, digital health solutions allow the transition to preventive care. These trends are revolutionizing ASCVD treatment approaches.

Growing industry consolidation

The Atherosclerotic Cardiovascular Disease Market is undergoing integration as key players seek to expand treatment portfolios and access to newer therapies. Pharmaceutical companies are collaborating with medical device majors. For instance, Abbott acquired St. Jude Medical to form a leading cardiovascular devices company. J&J’s acquisition of Synthes expanded its surgical offerings. Further, digital health partnerships are rising, like Nokia and Withings collaboration for ASCVD risk assessment. Smaller firms focused on niche areas are being acquired by leading companies, like Medtronic’s takeover of Affera. The synergies provided by such consolidations will define the future market landscape.

Atherosclerotic Cardiovascular Disease Market Restraints:

Stringent approval process

The ASCVD therapeutics and devices space is strictly regulated, which acts as a restraint for rapid product development and launch. For instance, the withdrawal of Merck’s anacetrapib after Phase 3 failure shows the uncertainties and high costs involved. ADDPLAN study evaluating Crenezumab for Alzheimer's prevention did not meet endpoints. Further, several PCSK9 inhibitors and CETP inhibitors have faced regulatory hurdles. Medical devices like ascending aortic stent grafts also face stiff approval criteria. The long product development timeframe and low approval rates discourage investments, thereby hampering growth.

High costs of targeted therapies

While emerging therapies like PCSK9 inhibitors, MTP inhibitors, ApoA-I upregulators offer superior efficacy, the high costs limit their adoption and uptake. For instance, the PCSK9 inhibitors alirocumab and evolocumab are priced at around $14,000 per year. Patisiran, the first RNAi-based drug for ATTR amyloidosis, costs $450,000 per year. Gene-editing approaches are also expected to be highly expensive. Lack of reimbursement coverage further restricts access, especially in emerging economies. The premium pricing of novel therapeutics limits their potential reach.

Failure of late-stage clinical programs

The market growth is impeded by the discontinuation of many promising therapies and devices in late-stage trials due to lack of safety or efficacy. For instance, Merck & Co. aborted the TRAVERSE outcomes trial for its investigational CETP inhibitor anacetrapib in 2017. InterCure halted the DELTA-2 trial of its hypertension treatment device. Further, companies like Esperion faced regulatory hurdles for their ASCVD drugs. The opportunity costs and diminished investor confidence associated with trial failures pose a key restraint for market expansion.

Recent Developments:

Atherosclerotic Cardiovascular Disease Market Regional Insights:

The Atherosclerotic Cardiovascular Disease (ASCVD) Market is significantly influenced by regional dynamics, reflecting the varying prevalence of ASCVD and the healthcare infrastructure in different parts of the world. ASCVD, a group of arterial disorders with potentially life-threatening consequences, constitutes a substantial portion of global cardiovascular disease cases. This disease places a substantial burden on healthcare systems globally, necessitating advanced therapeutic interventions to mitigate its impact.

North America emerged as the largest market for Atherosclerotic Cardiovascular Disease, holding over 40% of the market share. The robust growth of this market in North America can be attributed to several factors, including the alarmingly high rates of obesity, hypertension, and diabetes within the region. These risk factors contribute to a larger pool of patients grappling with ASCVD, driving the demand for diagnostics, therapeutics, and innovative treatment modalities.

Europe closely follows as the second-largest market for Atherosclerotic Cardiovascular Disease, accounting for over 30% of the market share in 2023. The European market's growth is fueled by demographic shifts, particularly the increasing aging population, which is more susceptible to ASCVD, as well as sedentary lifestyles prevalent in certain regions. These factors contribute to the rising prevalence of ASCVD, necessitating effective disease management and treatment strategies.

Meanwhile, the Asia Pacific region is poised to experience the most rapid growth in the Atherosclerotic Cardiovascular Disease Market, with a projected Compound Annual Growth Rate (CAGR) exceeding 5% during the forecast period. Several factors underpin this growth, including substantial improvements in healthcare infrastructure, increased healthcare expenditure, and a growing awareness of ASCVD and its risk factors. As economies in the Asia Pacific region continue to develop, the demand for advanced diagnostics, therapeutics, and preventative measures against ASCVD is expected to surge, making it a pivotal region in the global ASCVD market landscape.

In conclusion, regional disparities in the prevalence of ASCVD, coupled with varying healthcare infrastructure and risk factors, exert significant influence on the dynamics of the Atherosclerotic Cardiovascular Disease Market, with North America, Europe, and Asia Pacific emerging as key players in this critical healthcare sector.

Atherosclerotic Cardiovascular Disease Market Segmentation:

By Therapeutics

• Anti-platelet Agents
• Beta-blockers
• ACE Inhibitors
• ARBs
• Statins
• Calcium Channel Blockers
• Others

By Disease Type

• Coronary Artery Disease
• Carotid Artery Disease
• Peripheral Arterial Disease
• Cerebrovascular Disease
• Renal Artery Stenosis
• Aortic Aneurysm
• Others

By Distribution Channel

• Hospitals Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC Countries
  • Israel
  • South Africa
  • North Africa
  • Central Africa
  • Rest of the Middle East

Top companies in the Atherosclerotic Cardiovascular Disease Market:

• Amgen
• AstraZeneca
• Bayer
• Johnson & Johnson
• Merck
• Novartis
• Pfizer
• Sanofi
• Abbott Laboratories
• Teva Pharmaceuticals