[Research Report] The PTA Balloon Catheter Market size is expected to grow from US$ 2,175.00 million in 2022 to US$ 4,138.54 million by 2031; the market is estimated to register a CAGR of 8.5% from 2022 to 2031.

Analyst’s Viewpoint

The PTA Balloon Catheter Market analysis entails market drivers, restraints, and opportunities in the market. The rise in the number of cardiovascular diseases (CVDs) such as atherosclerotic disease and its resultant complications, such as myocardial infarction, strokes, renal failure, and limb ischemia across the globe, has resulted in increasing heart surgeries like angioplasty. In addition, the demand for minimally invasive procedures intended for CVDs has grown owing to its advantages over traditional methods. These factors are driving the growth of the PTA balloon catheter market from 2022 to 2031. However, product recalls are expected to hinder the growth of the market during the forecast period. Further, the launch of advanced innovations to improve visualization and integration of drug-coated balloons (DCB) is emerging as a trend in the PTA Balloon Catheter Market during 2023–2031.

Market Insights

The PTA (Percutaneous Transluminal Angioplasty) balloon catheter is a medical device that improves blood flow in peripheral arteries in patients with vascular problems. The PTA balloon catheter is a minimally invasive technique used to treat vascular illnesses such as peripheral artery disease, stenosis, and thrombosis. This novel gadget is a safe, effective, and dependable therapeutic option for individuals with vascular problems.

Market Drivers

Increasing Number of Atherosclerotic Disease and Rising Demand for Minimally Invasive Heart Surgeries Propel Market Growth

Atherosclerosis, also known as coronary artery disease (CAD), is the most prevalent kind of cardiovascular disease (CVD). It is characterized by cholesterol buildup and inflammation of the major arteries, which can eventually lead to clinical problems such as myocardial infarction (MI) and stroke. Smoking, high blood pressure, raised cholesterol levels, and diabetes can hasten the arteriosclerotic process. Individuals over 50 years of age are more likely to develop arteriosclerosis or have a positive family history of coronary heart disease. According to an article published by StatPearls in August 2023, atherosclerosis is a chronic inflammatory condition of the arteries that accounts for approximately 50% of all fatalities in Westernized societies, resulting in the deaths of about 370,000 individuals. In the United States, over 610,000 individuals die every year due to heart disease, representing one out of every four deaths. Stroke is the fifth-highest cause of mortality and the top cause of significant long-term disability in the United States. Ischemic stroke, the most common kind of stroke, is caused by ASCVD.

Every year, ~795,000 people in the United States suffer from stroke, resulting in around 140,323 fatalities. Angioplasty is a minimally invasive procedure that uses a PTA balloon catheter to open blocked or narrowed coronary arteries caused by underlying atherosclerosis. Angioplasty works well in over 90% of patients to open coronary arteries as it forces atherosclerotic intraluminal plaque against the artery wall, restoring luminal diameter. According to an article published by StatPearls in February 2023, Percutaneous Transluminal Coronary Angioplasty (PTCA) has low morbidity and mortality rates, shorter recovery times, and lower costs. With a 90% success rate, it effectively removes arterial narrowing.

Additionally, a study, “Procedural comparison of a standard PTA balloon for fistula and graft maintenance procedures with the novel Chameleon PTA balloon catheter,” published in December 2019, was carried out including 68 consecutive patients with similar rates of hypertension, coronary artery disease, and diabetes as national averages. The study concluded that using a PTA balloon with an integrated injection port has the potential to significantly reduce contrast dose, fluoroscopy time, and procedure time.

Therefore, the applications of PTA catheter balloons for angioplasty and rising cases of atherosclerotic diseases are driving the growth of the PTA balloon catheter market.

Moreover, the preference for minimally invasive surgeries over open surgeries is growing due to their lower costs, minimal trauma, faster recovery, and low risk of complications. The increasing prevalence of cardiovascular diseases in emerging markets, such as India and Brazil, along with the rising affordability and preference for minimally invasive surgeries in these countries, is driving industry growth.

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PTA Balloon Catheter Market: Strategic Insights

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Market Trends

Integration of Drug-Coated Balloons (DCB) with the PTA Balloon Catheters

Drug-coated balloons (DCB) are becoming increasingly popular as a non-stent method of treating atherosclerotic lesions. DCBs are considered an important tool in interventional cardiology, delivering antiproliferative drugs (such as paclitaxel or sirolimus) directly to the local arterial tissue through a single, prolonged coated-balloon angioplasty inflation. This approach theoretically reduces the risk of late inflammatory responses to device components while also promoting positive remodeling. They offer the advantage of better local drug absorption and potentially less vessel distortion than stenting. They may be useful for lesions that cannot be treated with stents (such as in-stent restenosis, small vessels, and complex carinal bifurcation lesions). Many key players are engaged in launching DCBs for angioplasty indicated in atherosclerotic diseases.

A few technological advancements by the players in the PTA catheter balloon devices are mentioned below:

• In October 2023, Boston Scientific announced positive results from the pivotal AGENT IDE clinical trial of its AGENT Drug-Coated Balloon (DCB) to treat coronary in-stent restenosis (ISR). The trial resulted in promising 12-month primary endpoint findings and is the first of its kind in the US. The trial evaluated the safety and effectiveness of using a DCB to treat coronary in-stent restenosis (ISR), and these primary endpoint findings were presented at the annual scientific symposium of the Cardiovascular Research Foundation.
• In June 2023, Surmodics, Inc., a top provider of medical devices and in vitro diagnostic technologies to the healthcare industry, received approval from the US Food and Drug Administration (FDA) for its SurVeil drug-coated balloon (DCB).
• In July 2021, Medtronic launched Prevail drug-coated balloon (DCB) Catheter, its newest-generation drug-coated balloon catheter in Europe, which is used to treat coronary artery disease. The Prevail DCB utilizes paclitaxel to treat de novo lesions, small vessel disease, and in-stent restenosis (ISR).

Therefore, these technological advancements are fueling the growth of the PTA balloon catheter market.

Report Segmentation and Scope

The “Global PTA Balloon Catheter Market” is segmented based on material type, applications, and end-user. Based on material type, the PTA balloon catheter market is segmented into polyurethane, nylon, and others. Based on applications, the PTA balloon catheter market is segmented into coronary artery disease and peripheral artery disease. Based on end-users, the market is segmented into hospitals, ambulatory surgical centers, and others. The PTA balloon catheter market based on geography is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America)

Material Type-Based Insights

Based on material type, the PTA balloon catheter market is segmented into polyurethane, nylon, and others. The nylon segment held the largest market share in 2022; it is anticipated to register the highest CAGR during 2022–2031.

Applications-Based Insights

Based on applications, the PTA balloon catheter market is bifurcated into coronary artery disease and peripheral artery disease. The peripheral artery disease segment held the largest market share in 2022 owing to the rise in atherosclerosis in the geriatric population, smoking, and sedentary lifestyles of people. Peripheral arterial disease (PAD) is caused by the accumulation of fatty plaque in the arteries, a condition known as atherosclerosis. It is a narrowing or blockage of the veins that convey blood from the heart to the legs. According to the Centers for Disease Control and Prevention (CDC), in 2021, ~6.5 million people over the age of 40 in the United States suffered from PAD.

End User-Based Insights

In terms of end-users, the PTA balloon catheter market is classified into hospitals, ambulatory surgical centers, and others. The hospital's segment held the largest share of the market in 2022, and the ambulatory surgical center's segment is anticipated to register the highest CAGR during 2022–2031, owing to the rising number of cardiovascular surgeries. The rising prevalence of chronic diseases, the growing geriatric population, and the increasing number of hospitals primarily contribute to the growth of the balloon catheter market for the hospital segment. In the geriatric population, the need for hospitalization is almost double the need in adults of middle age; approximately 17% of Americans aged 65 and above get hospitalized at least once a year, while only 8% of adults aged 45–64 require hospitalization. Thus, the higher number of patients getting admitted to hospitals is likely to boost the growth of the market for the hospital segment during the forecast period.

Regional Analysis

The North American PTA Balloon Catheter market is segmented into the US, Canada, and Mexico. The market growth is attributed to the increasing number of CAD and PAD and rising technological advancements. The US has emerged as a major contributor to the growth of the market in North America. According to the statistics released by the American Heart Association in 2021, more than 500,000 percutaneous coronary interventions, including percutaneous transluminal coronary interventions, are performed annually in the United States.

Additionally, the presence of several key manufacturers, the introduction of new technologically advanced equipment, and favorable reimbursement policies are boosting the growth in the region.

Further, the Asia-Pacific region is anticipated to grow with the highest CAGR in the global PTA Balloon Catheter market.

The report profiles leading players operating in the global PTA balloon catheter market. These include Medtronic, Tuermo Corporation, Cardinal Health, Boston Scientific, Becton Dickinson and Co., Corporation, Natec Medical, Cook Medical, Biotronik, Surmodics, Inc., and Andratec. These players focus on expanding and diversifying their market presence and acquiring a novel customer base, tapping prevailing business opportunities in the PTA balloon catheter market.

A few of the examples of recent developments in the PTA balloon catheter market are mentioned below:

• In June 2023, Cook Medical launched Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter in the United States and Canada. The device is manufactured by Surmodics and distributed by Cook Medical. The Advance Serenity catheter is specifically designed to treat peripheral artery disease, including below-the-knee disease. The catheter portfolio comes in two different wire guide platforms, with diameters of 0.014 and 0.018 inches, respectively, and will be available in a variety of balloon lengths and diameters.
• In March 2023, BrosMed’s Tiche 0.035” High-Pressure PTA Balloon Dilatation Catheter received European Medical Device Regulation (MDR) certification. It is a highly deliverable percutaneous transluminal angioplasty (PTA) catheter of 0.035 inches, designed for a wide range of peripheral angioplasty procedures. This certification marks the first MDR certificate of BrosMed. The company received clearance from the US Food & Drug Administration through the 510(k) process for its Tiche 0.035" PTA Balloon Dilatation Catheter in July 2022. The product is set to be launched in the United States first.
• In March 2021, Medtronic launched its Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter in Germany, Italy, Portugal, South Africa, Spain, and Turkey. The device is designed for use in both native and synthetic arteriovenous dialysis fistulae, as well as femoral, iliac, and renal arteries. The catheter features an integrated injection port located proximal to the balloon, allowing for the infusion of diagnostic or therapeutic fluids.