Drug Eluting Balloon
Drug Eluting Balloon Market by Type (Coronary Drug Eluting Balloon, Peripheral Drug Eluting Balloon), Coating Technology (EnduraCoat, FreePac, Paccocath), End User - Global Forecast 2024-2030
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[181 Pages Report] The Drug Eluting Balloon Market size was estimated at USD 965.84 million in 2023 and expected to reach USD 1,098.31 million in 2024, at a CAGR 15.51% to reach USD 2,650.47 million by 2030.

A drug eluting balloon (DEB) is an innovative medical device designed for use in angioplasty procedures to treat narrowed or blocked arteries. This catheter-based technology incorporates a balloon at its tip, which is coated with an anti-proliferative medication. When the balloon is inflated within the affected artery, it mechanically dilates the vessel to restore blood flow and also delivers the therapeutic agent directly to the arterial walls. This local drug delivery helps prevent restenosis, the re-narrowing of the artery, by inhibiting the growth of neointimal hyperplasia, a common cause of vessel re-occlusion. DEBs provide a targeted pharmacological approach that complements the mechanical intervention, offering an alternative to traditional therapies such as bare-metal or drug-eluting stents. The growth of the drug eluting balloon market is primarily driven by the rising prevalence of cardiovascular diseases globally and the subsequent increase in demand for minimally invasive surgical procedures. However, the stringent regulatory approval processes can impede the market's progression. Additionally, high costs associated with DEB treatments may deter potential markets in developing countries. Despite challenges, technological advancements improving the efficacy and safety of DEBs, along with enhanced patient recovery times, present future market opportunities. Rising reimbursement policies favoring DEB procedures in developing nations create new avenues for market expansion.

Regional Insights

In the Americas, the market for drug-eluting balloons (DEBs) has been experiencing robust growth driven by several factors, including the rising prevalence of peripheral and coronary artery diseases and increased awareness of the benefits of DEBs over traditional therapies. The United States is a major contributor in this region owing to its advanced healthcare infrastructure, favorable reimbursement policies, and presence of significant market players. The region's growth is further supported by numerous clinical trials and research studies validating the efficacy and safety of DEB therapy. The EMEA region presents a diverse market landscape for DEBs. In Europe, the adoption of DEBs is gaining momentum, especially in Western European countries, with higher accessibility to new medical devices and a strong presence of established companies. The Middle East and Africa present untapped opportunities with gradual growth, propelled by improving healthcare infrastructure and increasing investment in the healthcare sector. The Asia-Pacific market for DEBs is showing significant growth potential, with the burgeoning population, the increasing incidence of diabetes-induced vascular diseases, and escalating healthcare expenditures. Moreover, APAC's market is being stimulated by the rising number of local manufacturers and favorable government initiatives to enhance healthcare infrastructure.

Drug Eluting Balloon Market
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Market Dynamics

The market dynamics represent an ever-changing landscape of the Drug Eluting Balloon Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

  • Market Drivers
    • Increasing Geriatric Population Leading to Cardiovascular Diseases
    • Rising Prevalence of Peripheral and Coronary Artery Diseases
    • Favorable Approvals to Support the Growth of DEBs
  • Market Restraints
    • Issues Associated to Product Recalls of Drug-Eluting Balloons
  • Market Opportunities
    • New Developments in the Clinical Use of Drug-Coated Balloon Catheters
    • Advancement, Innovation, and Research in Drug-Coated Balloons
  • Market Challenges
    • Lack of Availability for Skilled and Trained Professionals
Market Segmentation Analysis
  • Type: Significance of coronary DEBs in enhancing deliverability and drug transfer

    Coronary drug eluting balloons (DEBs) is an innovative medical device used in percutaneous coronary interventions (PCIs) to treat coronary artery disease. They are carefully designed to deliver anti-proliferative drugs directly to the site of arterial blockage, facilitating the inhibition of neointimal hyperplasia and thus preventing restenosis. Peripheral drug eluting balloons are deployed to treat peripheral artery disease (PAD), particularly in the femoral and popliteal arteries. Similar to their coronary counterparts, these DEBs release medication that helps prevent restenosis by minimizing the growth of the vascular smooth muscle tissue.

  • Coating Technology: Growing preferences for enduraCoat with better local drug release profile

    EnduraCoat technology is a coating designed to provide a uniform and controlled drug transfer to the arterial wall. This technology typically offers a durable, low-dose coating that minimizes particulate loss and ensures a consistent drug release profile. FreePac is a type of coating that combines a synthetic polymer and an antiproliferative drug, ensuring consistent drug transfer and bioavailability. FreePac is typically designed to address the challenges of restenosis in peripheral arterial disease. Paccocath technology incorporates a mixture of a chemotherapeutic drug and a specific excipient encapsulated within a matrix. This matrix coating allows for controlled drug release to the target lesion, preventing neointimal hyperplasia. TransPax is a newer coating technology that uses a bioresorbable carrier for drug delivery. TransPax may be preferred for patients who could benefit from a bioresorbable drug delivery system. This system is potentially advantageous where the long-term presence of non-resorbable polymers can be undesirable.

  • End User: Higher adoption of DEBs in Cath Labs owing to ease of use and speed of the procedure

    Ambulatory surgery centers (ASCs) prioritize DEBs owing to their focus on outpatient surgical care, where efficiency and patient turnover are key factors. Patients benefit from the minimally invasive nature of DEB procedures, which aligns with the ASC model of reducing hospital stays and promoting quick recovery. Cath labs are specialized hospital units or stand-alone facilities where cardiac catheterizations and other endovascular procedures are performed. DEBs are preferred in these facilities for their ability to reduce the likelihood of restenosis without the long-term commitment of a stent. Hospitals represent the broadest end-user segment for DEBs owing to the variety of services offered and patient cases handled. Hospitals require DEBs that are versatile and can be used for complex and high-risk patient populations.

Market Disruption Analysis

The market disruption analysis delves into the core elements associated with market-influencing changes, including breakthrough technological advancements that introduce novel features, integration capabilities, regulatory shifts that could drive or restrain market growth, and the emergence of innovative market players challenging traditional paradigms. This analysis facilitates a competitive advantage by preparing players in the Drug Eluting Balloon Market to pre-emptively adapt to these market-influencing changes, enhances risk management by early identification of threats, informs calculated investment decisions, and drives innovation toward areas with the highest demand in the Drug Eluting Balloon Market.

Porter’s Five Forces Analysis

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Drug Eluting Balloon Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

Value Chain & Critical Path Analysis

The value chain of the Drug Eluting Balloon Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of the <> market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.

Pricing Analysis

The pricing analysis comprehensively evaluates how a product or service is priced within the Drug Eluting Balloon Market. This evaluation encompasses various factors that impact the price of a product, including production costs, competition, demand, customer value perception, and changing margins. An essential aspect of this analysis is understanding price elasticity, which measures how sensitive the market for a product is to its price change. It provides insight into competitive pricing strategies, enabling businesses to position their products advantageously in the Drug Eluting Balloon Market.

Technology Analysis

The technology analysis involves evaluating the current and emerging technologies relevant to a specific industry or market. This analysis includes breakthrough trends across the value chain that directly define the future course of long-term profitability and overall advancement in the Drug Eluting Balloon Market.

Patent Analysis

The patent analysis involves evaluating patent filing trends, assessing patent ownership, analyzing the legal status and compliance, and collecting competitive intelligence from patents within the Drug Eluting Balloon Market and its parent industry. Analyzing the ownership of patents, assessing their legal status, and interpreting the patents to gather insights into competitors' technology strategies assist businesses in strategizing and optimizing product positioning and investment decisions.

Trade Analysis

The trade analysis of the Drug Eluting Balloon Market explores the complex interplay of import and export activities, emphasizing the critical role played by key trading nations. This analysis identifies geographical discrepancies in trade flows, offering a deep insight into regional disparities to identify geographic areas suitable for market expansion. A detailed analysis of the regulatory landscape focuses on tariffs, taxes, and customs procedures that significantly determine international trade flows. This analysis is crucial for understanding the overarching legal framework that businesses must navigate.

Regulatory Framework Analysis

The regulatory framework analysis for the Drug Eluting Balloon Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Drug Eluting Balloon Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Drug Eluting Balloon Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • Advanced NanoTherapies (ANT) Secures USD 4 Million Strategic Investment to Accelerate Clinical Development of SirPlux Duo Drug-Coated Balloon (DCB) for Treating de novo Coronary Artery Disease (CAD)

    Advanced NanoTherapies Inc., an innovator in nanotechnology for vascular disease treatment, announced the successful completion of a USD 4 Million Series A funding extension from a reputable yet undisclosed strategic medical device company. This injection of funds is expected to fortify ANT's clinical development activities and expedite its trajectory toward securing U.S. IDE approval for its SirPlux Duo Drug-Coated Balloon (DCB). [Published On: 2023-08-22]

  • Translumina further Strengthens Its Technology Portfolio with Acquisition of Blue Medical Devices, Netherlands

    Translumina recently announced the strategic acquisition of Blue Medical Devices, a pioneer in producing state-of-the-art balloon catheters, including Drug Coated Balloons (DCB), situated in Helmond, Netherlands. With this purchase, Translumina expands its European footprint but also enhances its portfolio of coronary intervention solutions by incorporating Blue Medical's advanced DCB technologies. [Published On: 2023-06-29]

  • Surmodics Receives FDA Approval for the SurVeil Drug-Coated Balloon

    Surmodics, Inc. announced a significant advance with the FDA's approval of its state-of-the-art SurVeil drug-coated balloon (DCB). Specifically designed for treating peripheral artery disease, the SurVeil DCB can now be distributed in the United States for percutaneous transluminal angioplasty procedures on femoral and popliteal arteries. [Published On: 2023-06-20]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Drug Eluting Balloon Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Drug Eluting Balloon Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, B. Braun Melsungen AG, Balton Sp. z o. o., Bayer AG, Becton, Dickinson and Company, Biosensors International Group, Ltd., Biotronik SE & Co. KG, Boston Scientific Corporation, Cardionovum GmbH, Concept Medical, Cook Medical, Inc., Eurocor Tech GmbH, Invamed, iVascular S.L.U., Johnson & Johnson Services, Inc., Koninklijke Philips N.V., Laborie Medical Technologies, Inc., Lepu Medical Technology, M.A. Med Alliance SA by Cordis Corporation, Medtronic PLC, SurModics, Inc., Terumo Corporation, Wellinq, and Zylox-Tonbridge Medical Technology Co., Ltd..

Drug Eluting Balloon Market - Global Forecast 2024-2030
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Market Segmentation & Coverage

This research report categorizes the Drug Eluting Balloon Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Type
    • Coronary Drug Eluting Balloon
    • Peripheral Drug Eluting Balloon
  • Coating Technology
    • EnduraCoat
    • FreePac
    • Paccocath
    • TransPax
  • End User
    • Ambulatory Surgery Centers
    • Cath Labs
    • Hospitals

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

This research report offers invaluable insights into various crucial aspects of the Drug Eluting Balloon Market:

  1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
  2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
  3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
  4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
  5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

Additionally, the report addresses key questions to assist stakeholders in making informed decisions:

  1. What is the current market size and projected growth?
  2. Which products, segments, applications, and regions offer promising investment opportunities?
  3. What are the prevailing technology trends and regulatory frameworks?
  4. What is the market share and positioning of the leading vendors?
  5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Drug Eluting Balloon Market, by Type
  7. Drug Eluting Balloon Market, by Coating Technology
  8. Drug Eluting Balloon Market, by End User
  9. Americas Drug Eluting Balloon Market
  10. Asia-Pacific Drug Eluting Balloon Market
  11. Europe, Middle East & Africa Drug Eluting Balloon Market
  12. Competitive Landscape
  13. Competitive Portfolio
  14. List of Figures [Total: 22]
  15. List of Tables [Total: 286]
  16. List of Companies Mentioned [Total: 24]
Understanding the Role of Drug Eluting Balloon in Cardiovascular Disease Management
December 25, 2023
Understanding the Role of Drug Eluting Balloon in Cardiovascular Disease Management
Cardiovascular diseases are on the rise, thanks to our increasingly sedentary lifestyle and aging population. With each passing year, millions of people worldwide suffer from chronic heart ailments that can lead to serious complications if not treated in time. Unfortunately, traditional treatments like stents and angioplasty are not always effective in managing the symptoms of these conditions, especially in patients with complex lesions.

What is a drug eluting balloon?

A drug eluting balloon is a medical device that opens up blocked blood vessels and improves blood flow in patients with cardiovascular disease. Unlike traditional balloons that only inflate and press against the arterial walls, drug eluting balloons release medication into the surrounding tissue that prevents restenosis (re-narrowing) of the blood vessels. The medication is delivered from the balloon surface to the arterial wall during balloon inflation, where it is deposited, controlled, and targeted.

How do drug eluting balloons work?

Drug eluting balloons work by combining two technologies- balloon angioplasty and drug delivery. During the procedure, a drug eluting balloon is inserted into the artery and inflated to compress the fatty deposits blocking the blood flow. As the balloon is inflated, it releases the medication that dissolves the fatty tissue and prevents restenosis. The medication is transferred from the balloon to the arterial wall by a process known as diffusion. The drug coating remains on the arterial wall for a specific duration, usually a few weeks, before it is gradually absorbed and cleared from the body.

What are the advantages of using drug eluting balloons?

Drug eluting balloons offer several advantages over traditional stents and angioplasty:
They provide a better option for patients with complex and heavily calcified lesions that cannot be treated adequately with stents or angioplasty.
They reduce the risk of restenosis and the need for repeat interventions.
They are associated with a lower risk of bleeding complications and other adverse events.

Are there any limitations to using drug eluting balloons?

While drug eluting balloons are an effective treatment option for certain patients, they may not suit everyone. Patients with severe calcification or thrombus (blood clot) in the artery may not benefit from this treatment. In addition, drug eluting balloons are more expensive than traditional treatments, which may limit their use in certain healthcare settings.

What is the future of drug eluting balloons?

Drug eluting balloons are a relatively new technology still being studied, and improvements in their design and drug delivery systems are ongoing. Future developments may include new drugs and biodegradable coatings that the body can absorb without causing any adverse effects. Researchers are also exploring the use of drug eluting balloons to treat other diseases, such as pulmonary arterial hypertension and peripheral artery disease.

Drug eluting balloons offer a promising new approach to the management of cardiovascular disease, particularly in patients with complex or heavily calcified lesions. While there are limitations to their use, the benefits of drug eluting balloons outweigh their drawbacks in many cases.

Frequently Asked Questions
  1. How big is the Drug Eluting Balloon Market?
    Ans. The Global Drug Eluting Balloon Market size was estimated at USD 965.84 million in 2023 and expected to reach USD 1,098.31 million in 2024.
  2. What is the Drug Eluting Balloon Market growth?
    Ans. The Global Drug Eluting Balloon Market to grow USD 2,650.47 million by 2030, at a CAGR of 15.51%
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