Balloon Valvuloplasty Devices Market

Global Balloon Valvuloplasty Devices Market Size (2024 to 2029)

The Market Size is valued at USD 2397.3 Million in 2024 and is anticipated to reach USD 2987.5 Million by 2029 with a CAGR of 4.5% during the forecast period.

The Balloon aortic valvuloplasty (BAV) devices are characterized by a sustained upward trend in procedures performed worldwide, despite the emergence of transcatheter aortic valve replacement (TAVR) as a prominent alternative treatment option. BAV remains a standard procedure due to its effectiveness in improving hemodynamics and clinical status, particularly as a prominent therapy for aortic valve replacement (AVR) or noncardiac surgery. With low rates of procedural mortality, stroke, and vascular complications, BAV is considered a safe intervention. Recent advancements in BAV techniques, including alternative access sites, balloon catheters, and lithotripsy, have expanded their applicability to broader patient populations and contributed to improved complication rates.

Global Balloon Valvuloplasty Devices Market Drivers:

The Balloon Valvuloplasty Devices Market is witnessing significant growth driven by various factors. Firstly, the increasing prevalence of valvular heart diseases, such as aortic stenosis and mitral regurgitation, significantly contributes to the market growth. As these conditions become more prevalent, there is a growing need for effective treatment options, increasing the demand for minimally invasive procedures like balloon valvuloplasty.

Secondly, continuous advancements in balloon technology are pivotal in expanding the market. Innovations in materials, designs, and delivery systems enhance the safety and efficacy of balloon valvuloplasty procedures, making them more attractive to healthcare providers and patients. These advancements improve patient outcomes and drive adoption rates in medical professionals. All these factors are enhancing the growth of global market share. Moreover, other factors, such as the aging population with heart diseases contribute to the market's growth. With the global population aging, the incidence of valvular diseases tends to increase, further fueling the demand for treatment options like balloon valvuloplasty. Additionally, the preference for minimally invasive procedures continues to rise due to factors like shorter recovery times and reduced risks compared to traditional open-heart surgeries fuels the market revenue globally. 

Furthermore, efforts to raise awareness about valvular heart disorders and favorable clinical evidence and regulatory support are bolstering market expansion. With the increasing healthcare infrastructure, especially in emerging markets, access to advanced medical treatments like balloon valvuloplasty has become more widespread, driving demand for the devices by propelling the market value. These combined factors drive significant growth in the balloon valvuloplasty device market, with promising prospects in the forecast period.

Advancements in balloon aortic valvuloplasty (BAV) techniques, particularly exploring alternative access sites such as brachial and radial arteries, present significant opportunities for the balloon valvuloplasty device market. With a growing emphasis on minimizing risks associated with femoral access, the development of devices compatible with brachial and radial approaches can expand the applicability of BAV to a broader patient population, including those with peripheral artery disease (PAD). 

The introduction of novel technologies like intravascular lithotripsy (IVL) for vascular access in calcified PAD patients not only facilitates the safe passage of large bore sheaths for transcatheter aortic valve replacement (TAVR) procedures but also opens avenues for applications in BAV. The expected prevalence of heart diseases in the upcoming years is expected to augment the market growth during the forecast period.

Global Balloon Valvuloplasty Devices Market Restraints:

Major significant restraints in the balloon valvuloplasty device market arise from the declining incidence of rheumatic heart disease, particularly in industrialized nations. As rheumatic mitral stenosis remains a primary indication for balloon valvuloplasty, the decreasing prevalence of this condition limits the patient pool eligible for the procedure by limiting the market expansion. Additionally, the trend toward a decline in percutaneous mitral balloon valvuloplasty (PMV) procedures, as evidenced by reduced utilization rates over the years, presents a challenge for market growth. This decline may be attributed to several factors, including advancements in transcatheter mitral valve replacement (TMVR) techniques and technologies, which offer alternative treatment options for patients and are expected to hamper market growth.

The major challenge facing the balloon valvuloplasty device market is the evolving patient demographics presenting for PMV procedures. With an increasing number of older populations and those with less favourable mitral valve anatomical features undergoing PMV, there is a heightened risk of procedural complications and adverse outcomes. Additionally, the emergence of TMVR as a potential alternative for patients with severe mitral annular calcification (MAC) presents a challenge for the balloon valvuloplasty device market. While TMVR offers a less invasive option for high-risk patients, challenges related to device complexity, anatomical considerations, and procedural outcomes must be addressed to optimize its role in mitral valve disease management and impact the market dynamics of balloon valvuloplasty devices.

Impact of COVID-19 on the balloon valvuloplasty devices market:

The COVID-19 pandemic significantly impacted the Balloon Valvuloplasty Device Market, causing disruptions in healthcare systems worldwide. Elective procedures, including balloon valvuloplasty, have been cancelled in many regions to prioritize resources for COVID-19 patients and reduce the risk of virus transmission. This has led to a decline in procedural volumes and delayed diagnoses, affecting market growth. Additionally, supply chain disruptions and logistical challenges have hampered the production and distribution of balloon valvuloplasty devices, further impacting market share. However, post-pandemic is experiencing promising growth and is estimated to grow steadily in the forecast period. 

REPORT COVERAGE:

This research report on the global balloon valvuloplasty devices market has been segmented and sub-segmented based on size, type, end-user, and region.

Global Balloon Valvuloplasty Devices Market - By Size:

• 23mm
• 26mm
• 29mm

The 23mm segment held the most significant global market share in 2023. These devices treat stenotic heart valves by widening the narrow opening, improving blood flow. The high effectiveness of the device is gaining traction among people, boosting the segment's growth. 

The 29mm segment is estimated to have prominent growth with CAGR during the forecast period. These are specially designed for patients requiring more enormous balloons to dilate their stenotic heart valves. The other segment is expected to grow steadily during the forecast period due to the design and materials used in the balloon catheter, which makes it easy to navigate through the vasculature. 

Global Balloon Valvuloplasty Devices Market - By Type:

• Aortic Valvuloplasty 
• Pulmonary Valvuloplasty 

The aortic valvuloplasty segment accounted for a significant market share in the global balloon valvuloplasty market revenue. Increasing product launches associated with stenosis treatment and various strategic initiatives by the market players are propelling segment growth. The growing cases of valvular heart diseases are enhancing the segment growth by raising the global market revenue. 

The pulmonary valvuloplasty segment is estimated to maintain steady growth during the forecast period. 

Global Balloon Valvuloplasty Devices Market - By End-User:

• Hospitals 
• Ambulatory Surgical centers 
• Others 

The hospital segment dominated the global market revenue with a dominant market share due to the presence of numerous facilities with advanced technological equipment. The quality of care, presence of skilled professionals, and nursing staff with the financial incentives offered by the health insurance companies are enhancing the segment growth due to patients' high preferences.

Global Balloon Valvuloplasty Devices Market - By Region:

• North America
• Europe
• Asia Pacific 
• Latin America 
• Middle East and Africa 

North American region accounted for the most significant global balloon valvuloplasty market share in 2023. The growing older population and the rising prevalence of valvular heart diseases drive the market growth. The presence of prominent market players in the region and advanced surgical procedures with effective treatment fuel the growth of market revenue. Increasing innovative procedures for developing medical devices and continuous product launches and approvals propels regional market expansion. For instance, Medtronic, a leading medical technology company, launched its Adapta Balloon Expander catheter in 2021 to treat aortic stenosis. According to data published by the Centers for Disease Control and Prevention, around 2.5% of the population suffers from valvular heart disease in the U.S., which raises the adoption of balloon valvuloplasty procedures in the region. 

Asia Pacific region is projected to have the fastest growth during the forecast period due to growing heart diseases, especially valvular heart diseases—the rapid approvals from the Chinese government are positively impacting the market growth. Increasing the establishment of top market player companies in the region fuels regional market growth. The growing advancements in the healthcare industry in countries like China, Japan, and India are driving market growth. The increasing medical tourism industry in Asia Pacific countries, which is raising the number of procedures in the region, enhances the expansion of the market. 

Key Market Players:

Medtronic plc., Terumo Corporation, Boston Scientific Corporation, Abbott Laboratories Ltd., Edwards Lifesciences, BVM Medical Ltd., Toray Industries Inc., Palex Medical are some of the key market players in the balloon valvuloplasty devices market.

Recent Market Developments:

• In March 2021, Keystone Heart Ltd., a medical device manufacturer, announced an exclusive distribution agreement with Intervalve Medical, Inc. to sell and market their balloon aortic valvuloplasty products in the U.S.