The drug-eluting balloon market size was estimated to be US$ 762.56 million in 2021 and US$ XX million in 2023 and is expected to reach US$ 3663.64 million by 2031; it is estimated to record a CAGR of 17.5% till 2031. The introduction of DCB therapy is likely to remain a key drug-eluting balloon market trend.
Drug-Eluting Balloon Market Analysis
Drug-eluting balloons represent a cutting-edge technology that has revolutionized the treatment of various chronic conditions, including cardiovascular and peripheral vascular diseases. This advancement in medical technology has simplified the management of obstructions within blood vessels. The increasing prevalence of conditions such as cardiovascular, peripheral vascular, and neurovascular diseases is a key driver behind the growth of the drug-eluting balloons market. For instance, there has been a significant surge in cardiovascular disease rates globally. Contributing factors include obesity, reduced physical activity, heightened stress levels, and changes in lifestyle, all of which have led to an uptick in cardiovascular disease occurrences. The European Society of Cardiology has identified atrial fibrillation as the most prevalent form of arrhythmia and it accounts for 0.28–2.6% of healthcare budgets in Europe. Furthermore, individuals with atrial fibrillation face a risk of stroke that is 5 times more than average, with atrial fibrillation being a contributing factor in 20–30% of all stroke incidents across Europe. A 2016 study by the same society revealed that around 7.6 million people aged 65 or older were affected by atrial fibrillation in the EU. Projections suggest a significant increase in these numbers, with an estimated 14.4 million people affected by 2060, marking an 89% increase. The prevalence of atrial fibrillation is also expected to rise from 7.8% in 2016 to 9.5% by 2060. Furthermore, a 2019 report by Biosense Webster titled “The Impact of Atrial Fibrillation in Asia Pacific” indicated that approximately 16 million people in the Asia Pacific had atrial fibrillation, with projections estimating a rise to nearly 72 million by 2050. This condition is notably more prevalent among the elderly and middle-aged populations, who are at higher risk of developing it. Therefore, drug-eluting balloons have played a crucial role in managing cardiovascular conditions. According to the Centers for Disease Control and Prevention, deep vein thrombosis (DVT) affects approximately 1-2 individuals per 1,000 annually in the US. With the rising incidents of vascular diseases, the demand for drug-eluting balloons is expected to grow significantly in the near future.
Drug-Eluting Balloon Market Overview
Global drug-eluting balloon market is segmented by region into North America, Asia Pacific, Europe, Middle East & Africa and South & Central America. The largest market for the drug-eluting balloons is held by the North American region. The key factor driving growth of the market include significantly rising vascular disease incidences, rising geriatric population, and growing product innovations. Whereas, the market is projected to have slow growth due to the stringent regulations for approval and high cost of procedures and products during the forecast period.
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Drug-Eluting Balloon Market: Strategic Insights
Market Size Value in US$ 516.65 Million in 2018 Market Size Value by US$ 1,870.60 Million by 2027 Growth rate CAGR of 15.6% from 2019-2027 Forecast Period 2019-2027 Base Year 2019
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Drug-Eluting Balloon Market: Strategic Insights
| Market Size Value in | US$ 516.65 Million in 2018 |
| Market Size Value by | US$ 1,870.60 Million by 2027 |
| Growth rate | CAGR of 15.6% from 2019-2027 |
| Forecast Period | 2019-2027 |
| Base Year | 2019 |
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Drug-Eluting Balloon Market Drivers and Opportunities
Growing Product Innovations, Approvals and Launches to Favor Market
The drug-eluting balloons market includes both established market leaders and emerging companies. Among the leading players are Cook Medical, and Royal Philips (which is part of Koninklijke Philips N.V.), Medtronic plc, and Boston Scientific Corporation while numerous emerging companies are also making their mark in this space. These companies are actively involved in the ongoing development of diverse medical devices, continuously advancing their products to maintain and enhance their position in the global market.
For instance, in March 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval for the AGENT Drug-Coated Balloon (DCB), for its use in the treatment of coronary in-stent restenosis (ISR) among patients suffering from coronary artery disease. ISR involves the blockage or narrowing of a vessel that has been previously stented, due to the buildup of plaque or scar tissue.
In June 2023, Surmodics, Inc. received approval from the U.S. Food and Drug Administration (FDA) for its SurVeil drug-coated balloon (DCB). This approval allows the SurVeil DCB to be marketed and sold within the US. It is designed for use by physicians in the percutaneous transluminal angioplasty, following proper vessel preparation, to treat new or recurring lesions up to 180 mm in length in the femoral and popliteal arteries, which have reference vessel diameters ranging from 4 mm to 7 mm.
The growth of the drug-eluting balloon market is being propelled by the introduction of innovative products from both established companies and new entrants. This is mainly attributed due to these products have expanded treatment options for physicians to treat cardiovascular conditions, peripheral artery diseases (PADs), and renal artery conditions, and so on.
Rising Use of Drug-eluting Balloons Over Drug Eluting Stents – An Opportunity in Drug-Eluting Balloon Market
Drug-eluting balloons show various advantages over the drug-eluting stents. The balloons are developed with long-awaited new transcatheter technologies that have shown promising factors to reduce high restenosis rates in peripheral artery diseases.
Therefore, the drug-eluting balloons are enabled with various developments that are not available with the drug-eluting stents. For instance, drug delivery through the balloon does not require polymer or stent to deliver drugs, and can reduce the vascular inflammatory response. The responses are further directly related to very late thrombosis events, whereas drug-eluting stents require polymer-based drug coatings.
The other advantages of the drug-eluting balloons include faster delivery of drug kinetics to the vessel, and the intima is within 30–60 seconds of balloon inflation. Whereas, the drug delivery through DES is slow and have controlled release of drug kinetics to block cell proliferation. Thus, the advantages of drug-eluting balloons over the drug-eluting stents are expected to increase the adoption of drug-eluting balloons in coming years.
Drug-Eluting Balloon Market Report Segmentation Analysis
Key segments that contributed to the derivation of the drug-eluting balloon market analysis are product type and end user.
- Based on product type, the drug-eluting balloon market is segmented into coronary drug-eluting balloons, peripheral drug-eluting balloons, and other product types.The peripheral drug-eluting balloons segment held a larger market share in 2023.
- In terms of end user, the market is segmented into hospitals, cath labs & cardiac centers, ambulatory surgical centers. The hospitals segment dominated the market in 2023.
Drug-Eluting Balloon Market Share Analysis by Geography
The geographic scope of the drug-eluting balloon market report is mainly divided into five regions: Asia Pacific, Europe, North America, Middle East & Africa, and South & Central America.
North America has dominated the drug-eluting balloon Market. In the US, drug-eluting balloon market is projected to grow due to increasing incidences of peripheral artery diseases (PAD), growing FDA approvals, rising developments in the medical device industry, and others. The majority of the market growth is estimated due to the significantly increased incidences of peripheral artery diseases. The growing elderly population in the US is expected to increase the incidences of peripheral artery diseases. The Cleveland Clinic reports that heart valve disease impacts approximately 2.5% of the population in the US which encompasses conditions like valve regurgitation and stenosis. Over 2 million Americans are affected by a leaking heart valve. Asia Pacific is anticipated to grow with the highest CAGR in the coming years.
Drug-Eluting Balloon Market Report Scope
Drug-Eluting Balloon Market News and Recent Developments
The drug-eluting balloon market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for innovations, business expansion, and strategies:
- In November 2023, OrbusNeich Medical Group Holdings Limited acquired Eucatech AG, a company based in Germany that specializes in the creation, production, and distribution of minimally invasive products for cardiovascular and endovascular therapy. Following this transaction, Eucatech AG will operate as a fully owned subsidiary of the Group. (Source: OrbusNeich Medical Group Holdings, 2023)
- In October 2022, Cordis announced acquired MedAlliance, a company located in Switzerland known for its innovative drug-eluting balloons. This acquisition enables Cordis to potentially reach two million patients worldwide by 2027 with its SELUTION SLR (Sustained Limus Release) drug-eluting balloon. (Source: Cordis, 2022)
Drug-Eluting Balloon Market Report Coverage and Deliverables
The “Drug-Eluting Balloon Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering the following areas:
- Drug-eluting balloon market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Market dynamics such as drivers, restraints, and key opportunities
- Drug-Eluting Balloon Market trends
- Detailed PEST and SWOT analysis
- Drug-Eluting Balloon market analysis covering key market trends, Global and regional framework, major players, regulations, and recent market developments
- Drug-Eluting Balloon Market Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Product Type ; End User , and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- 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.
- 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:
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.
- 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.
- 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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