Structural Heart Devices Market

Structural Heart Devices Market Outlook (2023-2033)

Increasing at an impressive CAGR of 11%, the global structural heart devices market is expected to increase from a valuation of US$ 12.17 billion in 2023 to US$ 36.06 billion by 2033-end.

Structural heart devices are further bifurcated into heart valve devices, surgical heart valves, transcatheter heart valves, and occluders & delivery systems. Worldwide demand for heart valve devices is expected to rise rapidly at a CAGR of 11.5% from 2023 to 2033.

The heart valve makes sure that the blood is flowing correctly and under the proper pressure. The backward flow of blood via a valve as opposed to the usual unidirectional flow is known as valve regurgitation. The need for prosthetic heart valves has increased due to the rising prevalence of cardiac valve disorders.

Cardiovascular problems are more common because of sedentary lifestyles, physical inactivity, and other habits such as smoking. The need for minimally-invasive procedures for cardiac abnormalities has consequently grown significantly over the world. A structural heart condition is a non-coronary heart problem that does not impact the heart's blood arteries. The majority of structural cardiac abnormalities are present at birth, but they can also develop later in life as a result of infection-related wear and tear.

Transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR) are two minimally-invasive procedures that have replaced open heart surgical procedures as a result of medical advancements. Transcatheter heart valve demand is rising as a result of a steady movement toward minimally-invasive procedures among patients who are becoming more aware of their therapeutic options. Furthermore, the development of new products and technological advancements will probably accelerate the growth of transcatheter heart valves.

• Edward Lifesciences got the CE mark for Edwards SAPIEN 3 in November 2019 to increase its use in the treatment of aortic stenosis patients who are at a lesser risk for open heart surgeries.

Patients who require full or partial valve replacement have a new and cutting-edge therapeutic option available to them in the form of biological valves, also known as tissue-engineered heart valves (TEHV). A fresh example of a live heart valve made of the host's tissues and cells is a tissue-engineered heart valve.

Demand for cardiac ablation technologies is growing in a highly favourable environment due to recent innovations such as D electro-anatomical mapping systems and robotic catheter navigation systems, as well as the widespread acceptance of catheter ablation as the first line of therapy.

Report Attributes	Details
Market Size (2023E)	US$ 12.17 Billion
Forecasted Market Value (2033F)	US$ 36.06 Billion
Global Market Growth Rate (2023-2033)	11% CAGR
China Market Growth Rate (2023-2033)	10% CAGR
Japan Market Growth Rate (2023-2033)	10% CAGR
Germany Market Growth Rate (2023-2033)	8.5% CAGR
Key Companies Profiled	Abbott Laboratories, Inc. Boston Scientific Corporation Braile Biomedica CryoLife, Inc. Edwards Lifesciences Corporation Lepu Medical Technology (Beijing) Co., Ltd. LivaNova PLC Medtronic PLC Micro Interventional Devices, Inc. TTK Healthcare Ltd.

Why are Sales of Structural Heart Devices Increasing Rapidly?

“High Demand for Minimally-invasive Procedures”

Transcatheter valve replacement is a minimally-invasive treatment in which the damaged or old valve is left in situ and a new one is inserted. Patients with symptomatic aortic stenosis who are at low, intermediate, or high risk for routine valve replacement can undergo the procedure, which is similar to inserting a stent in the artery.

Furthermore, the transcatheter valve replacement procedure's main benefit is that it may be performed with tiny incisions, leaving all of the chest bones in situ. Patients who have not been given a chance to have a valve replacement procedure are also benefiting from this method of treatment.

Compared to conventional valve replacement, these procedures necessitate a shorter hospital stay for the patients. Furthermore, the treatment is advantageous to patients of all risk levels and provides a viable choice for those who might otherwise have few options for aortic valve surgery.

“Huge Investments in R&D Activities and Advancements in Structural Heart Devices”

The development of the market for structural heart devices is being shaped by interventional catheter technologies. The demand for structural heart devices is expanding as a result of hybrid treatments, healthcare reforms, and partnerships between surgeons, interventionalists, and cardiologists.

The catheter lab or hybrid operating room will emerge as a result of the development of hybrid procedures, which combine surgical and interventional techniques. These will be constructed employing a combination of contemporary technology, sterility, superior imaging system, and ventilation to support both processes. This will be a time- and money-saving strategy with multidisciplinary competence, decreasing healthcare expenses and driving the growth of the structural heart devices market.

Improved CT scan machines have a positive effect on catheter technologies in the market for structural cardiac devices. Cardiologists and surgeons can map out the complete coronary tree with a single CT scan due to non-invasive measurements.

Furthermore, it will allow for the placement of virtual stents and a visual representation of how it would affect flow. This gadget speeds up the process, saves money on labour, and increases sales of structural heart devices.

Complete integration of 3D rotational angiography into other imaging programs is now possible. Transcatheter procedures inside the body are better visualised as a result. A significant 3D integration will be a highly efficient corrective action for the management of chronic complete occlusions (CTO). With the use of contemporary 3D rotational angiography, the demand for structural heart devices is increasing quickly.

What Do Structural Heart Device Providers Need to Tackle?

“High Prices Associated With Heart-related Disorder Treatment & Devices”

Being an intrusive procedure, replacing a heart valve is associated with potential risks, which is a primary issue limiting the sales of structural heart medical devices. Replacement surgeries have several risks, including severe bleeding, arrhythmia, renal issues, stroke, cardiac arrest, infection, clotting, and others.

Although there are reduced risks and consequences associated with minimally-invasive procedures, the cost of the surgeries is still relatively high when compared to invasive surgical procedures. These challenges may, to some extent, have a serious effect on the patient population having surgical treatment.

However, the global demand for structural heart devices is being constrained by concerns such as strict governmental laws for product approvals and a lack of qualified specialists in some developing or poor nations.

Country-wise Analysis

Which Aspects are Supporting the Sales of Structural Heart Devices in the U.S.?

“Rising Prevalence of Cardiovascular Disorders”

The United States leads the North American market due to factors such as expanding healthcare spending, escalating research and development activities, and an increase in the prevalence of heart disorders. Another key driver boosting the sales of structural heart devices in the U.S. is the growing geriatric population in the country.

• According to data updated by Cedars-Sinai in January 2022, coronary artery bypass graft surgery (also known as coronary artery bypass, or bypass surgery), or CABG, is the most common type of heart surgery. In the United States, over 300,000 people undergo successful bypass surgery each year. Thus, the prevalence of cardiovascular diseases is increasing across the nation.
• Additionally, according to data from the Centers for Disease Control and Prevention (CDC) updated in July 2022, coronary heart disease is the most prevalent form of heart condition, affecting about 20.1 million individuals in the country who are 20 years of age and older.
• Also, according to the same source, a heart attack occurs every 40 seconds, and every year, nearly 805,000 Americans experience a heart attack.

Because of the significant prevalence of cardiovascular disorders, structural heart device demand is increasing in the American healthcare system.

How is Demand for Structural Heart Devices Progressing in European Region?

“Growing Rate of Senior Population and Advancements in Structural Heart Devices”

Some of the profitable marketplaces in the European region are Germany, the U.K., France & Italy.

• For instance, the "UK Factsheet January 2022" released by the "British Heart Foundation (BHF)" indicates that approximately 7.6 million people in the UK are affected by heart and circulation disorders.
• Additionally, according to the same source, the country's population of 3.6 million women and 4 million men had heart and circulatory disease diagnoses in 2021.

For patient survival, the high prevalence of heart and circulatory disease patients drives the need for further treatment procedures including angioplasty and cardiac operations. Thus, this is opening new opportunities in the structural heart devices market such as the introduction of advanced structural heart valves and annuloplasty rings.

Due to the country's growing senior population and improving healthcare infrastructure, the market in Germany is predicted to grow rapidly. Statistics from several studies show that more than 25,000 replacement procedures are performed annually in Germany. The clinical use of TAVR and TAVI implantations is likewise leading the way in Germany.

Sales of structural heart devices in Germany are predicted to rise at a CAGR of 8.5% from 2023 to 2033.

Furthermore, the country's availability of highly qualified multidisciplinary cardiac experts is assisting Germany's market growth and, in turn, the development of the European market.

Why is Asia Pacific the Fastest-Growing Market for Structural Heart Devices?

“Rapid Developments in Healthcare Infrastructure”

Asia Pacific is expected to be the fastest-emerging market for structural heart devices, with India, China, Japan, and South Korea being the top economies in the region.

Key growth factors include significant market participant investment and advancements in healthcare infrastructure. Due to improved life expectancy and low pricing, structural heart devices and techniques are anticipated to command the largest market share in terms of volume.

Because there is a greater prevalence of cardiovascular disease in developing nations, manufacturers of structural heart devices are looking into the untapped development potential in these nations. Longer life expectancy is ensured by these devices.

The healthcare systems of several Asian nations are rapidly developing. To better treat its population, respective governmental organisations are concentrating on developing their healthcare infrastructure. This aspect is directly boosting the demand for structural heart devices.

Demand for structural heart devices in China and Japan is expected to increase at a similar CAGR of 10%, respectively, during the next 10 years.

Category-wise Analysis

Why Do Patients Prefer Hospitals Over Other Facilities?

“Availability of Innovative Medical Devices”

Demand for structural heart devices from hospitals is primarily driven by the rise in hospital procedures, advantageous health reimbursement policies, and better government standards for the management of vulvar disorders.

The rapid rise is linked to people looking for effective treatments that shorten hospital visits and recovery times. Additionally, the widespread use of innovative medical technologies and heart repair devices in hospitals promotes sales growth.

Competitive Landscape

Some of the key players in the structural heart devices market are Abbott Laboratories, Centerline Biomedical, Inc., Medtronic Inc., Boston Scientific Corporation, and more.

Leading companies are embracing novel strategies to increase their market share, including cutting-edge marketing tactics, technological breakthroughs, mergers, and acquisitions.

• Abbott Laboratories unveiled a novel, minimally-invasive vascular heart valve repair device in May 2022. New information was also provided by the company about Amplatzer Amulet and MitraClip, two essential items in its market-leading Abbott structural heart devices portfolio.
• For instance, Centerline Biomedical, Inc. finished the second animal study in a series on structural heart navigation in May 2022. The viability of using the company's augmented reality picture guidance technology to navigate structures in a beating heart was assessed by doctors from Cleveland Clinic's Heart, Vascular and Thoracic Institute.
• In 2022, Medtronic Inc. announced that it will purchase Affera, a company that develops therapies for cardiac arrhythmias. This acquisition is probably going to increase the company's portfolio of heart ablation procedures, allowing for the development of maps to identify arrhythmias. This will also increase the Medtronic structural heart device offerings.

Segments of Structural Heart Devices Industry Research

• By Product :

  • Heart Valve Devices
  • Surgical Heart Valves
  • Transcatheter Heart Valves
  • Occluders & Delivery Systems

• By Procedure: 

  • Replacement Procedures
  • Repair Procedures

• By Age Group :

  • Pediatrics
  • Adults
  • Geriatrics

• By Indication :

  • Atrial Septal Defect (ASD)
  • Ventricular Septal Defect (VSD)
  • Patent Foramen Ovale (PFO)
  • Aortic Valve Stenosis

• By End User :

  • Hospitals
  • Ambulatory Surgical Centers
  • Cardiac Centers

• By Region :

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Oceania
  • MEA