PTA Balloon Catheter Market Analysis Report | Size, Trends & Growth Outlook 2031

Coverage: PTA Balloon Catheter Market covers analysis By Material Type (Polyurethane, Nylon, and Others), Applications (Coronary Artery Disease and Peripheral Artery Disease), End-user (Hospitals, Ambulatory Surgical Centers, and Others) and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South & Central America)

  • Report Code : TIPRE00019594
  • Category : Medical Device
  • Status : Upcoming
  • No. of Pages : 150
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[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 2030; the market is estimated to register a CAGR of 8.5% from 2022 to 2030.

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 2030. 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 2023–2030.

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 2020, 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.

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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 2022–2030.

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 2022–2030, 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.

PTA Balloon Catheter Market by Applications – 2022 and 2030

PTA Balloon Catheter Market by Applications – 2022 and 2030
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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.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

The List of Companies

1. Medtronic plc
2. Terumo Corporation
3. Cardinal Health
4. Boston Scientific Corporation
5. Natec Medical and Surmodics, Inc
6. Cook Medical
7. Biotronik
8. Andratec
9. Stron Medical.
10. Freudenberg Medical

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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