A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon.
Global drug eluting balloon market is estimated to be valued at US$ 616.6 million in 2022 and is expected to exhibit a CAGR of 8.3% during the forecast period (2022-2030).
Figure 1. Global Drug Eluting Balloon Market Share (%), by Product Type, 2022
Increasing prevalence of coronary artery disease is expected to propel growth of the drug eluting balloon market.
Increasing prevalence of coronary artery disease and diabetes is expected to propel growth of the drug eluting balloon market over the forecast period. Drug eluting balloon is an angioplasty balloon, which plays a vital role in treatment of coronary artery disease. High prevalence of coronary artery disease is expected to propel demand for angioplasty and other treatments, which in turn is expected to drive the market growth. According to the World Health Organization (WHO), in 2019 around 3.8 million men and 4.4 million women die, annually from coronary heart disease worldwide. Moreover, the number of deaths from age 15 to 59 is around 1332 Mn and for above 60 years of age is around 5825 million. Furthermore, according to the Center for Disease Control and Prevention, in July 2022, coronary heart disease is the most common type of heart disease, killing 382,820 people in 2020 globally. About 20.1 million adults age 20 and older have CAD (about 7.2%). In 2020, about 2 in 10 deaths from CAD happen in adults less than 65 years old.
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2021 | Market Size in 2022: | US$ 616.6 Mn |
| Historical Data for: | 2017 to 2020 | Forecast Period: | 2022 to 2030 |
| Forecast Period 2022 to 2030 CAGR: | 8.3% | 2030 Value Projection: | US$ 1,163.0 Mn |
| Geographies covered: |
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| Companies covered: |
Medtronic, Becton Dickinson and Company (BD), Boston Scientific Corporation, Cook Medical, B. Braun Melsungen AG, Koninklijke Philips N.V., Opto Circuits (India) Limited, Terumo Corporation, Surmodics, Inc., and Biotronik. |
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Figure 2. Global Drug Eluting Balloon Market Share (%), by Region, 2022
Increasing prevalence of diabetes is expected to propel growth of the drug eluting balloon market.
Diabetes can damage blood vessels and nerves associated with heart and can lead to cardiovascular disease. Therefore, increasing prevalence of diabetes is expected to propel growth of the drug eluting balloon market over the forecast period. For instance, according to WHO’s, October 2018 report, around 1.6 million deaths are registered due to diabetes globally. According to Center for Disease Control and Prevention, diabetes around the world in 2021 was 537 million adults (20-79 years) were living with diabetes - 1 in 10. China is the country with the highest number of diabetics worldwide, with around 141 million people suffering from the disease. By the year 2045, it is predicted that China would have around 174 million people with diabetes.
Furthermore, according to Center for Disease Control and Prevention, in 2019, for both men and women, prevalence of diagnosed diabetes was highest among American Indians and Alaska Natives (14.5%), followed by non-Hispanic Blacks (12.1%), people of Hispanic origin (11.8%), non-Hispanic Asians (9.5%) and non-Hispanic Whites. According to the World Health Organization, in 2019, 3.1 million adults aged 20 years or older—or 10.8% of all U.S. adults with diagnosed diabetes, started using insulin within a year of their diagnosis.
Global Drug Eluting Balloon Market– Impact of Coronavirus (COVID-19) Pandemic
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.
COVID-19 can affect the economy in three main ways: by directly affecting production and demand of drugs, medical devices, nutrition supplements, etc. by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others, are facing problems with regards to the transportation of drugs from one place to another.
However, the COVID-19 pandemic had a negative impact on the global drug eluting balloon market, owing to the disruption in supply chain due to COVID 19 pandemic. For instance, in July 2020, according to National Centre for Biotechnology Information, COVID-19 was disrupting distribution on a global scale. Increased border controls and customs regulations resulted in longer wait times, and lack of capacity for long-haul and last-mile fulfillment create extreme challenges. The unprecedented supply chain disruption caused by COVID-19 has had severe operational and financial consequences, with planners having to address issues including:
Global Drug Eluting Balloon Market: Key Developments
In July 2021, Medtronic plc., a medical device company, launched the Prevail drug coated balloon (DCB) Catheter in Europe following CE (Conformité Européene) mark. The coronary DCB in market, the Prevail DCB is used during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (CAD). During the catheter-based procedure, the balloon inflates within the artery, while the drug is delivered to the arterial tissue where it is absorbed. The Prevail DCB utilizes a rapid absorption drug – paclitaxel – to enable treatment of de novo lesions, small vessel disease, and in-stent restenosis (ISR). DCB angioplasty does not require a permanent implant and is often used in cases where the implantation of a drug-eluting stent (DES) is not desirable or is technically challenging.
Global Drug Eluting Balloon Market: Restraint
The major factors that hinder growth of the global drug eluting balloon market include adverse effects Drug Eluting Balloon such as coronary artery lesion and lumen enlargement. For instance, in May 2017, Abbott recalled three balloon catheters due to difficulty in removing balloon sheath, which caused 19 reports of injury and 1 death.
Key Players
Major players operating in the global drug eluting balloon market include Medtronic, Becton, Dickinson and Company (BD), Boston Scientific Corporation, Cook Medical, B. Braun Melsungen AG, Koninklijke Philips N.V., Opto Circuits (India) Limited, Terumo Corporation, Surmodics, Inc., and Biotronik.
Drug eluting balloons are angioplasty balloons that are coated with an anti-proliferative drug, which is eluted in vessel walls during the inflation of balloon, usually at nominal pressure with a specific minimal inflation time. The active substance coated on the drug eluting balloon should be lipophilic in nature to have a high absorption rate through the vessel wall. Mostly paclitaxel is used as active ingredient due to its high pharmacokinetic transfer rate into the vessel wall and it is actively used in drug eluting balloons in the U.S. market and has been already approved for use in Europe. Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high restenosis rates in peripheral vessels. They also have been investigated in clinical trials to prevent coronary artery in-stent restenosis. The balloons carry an antiproliferative drug that is delivered to the wall of arteries when the balloon is expanded. The drug helps prevent neointimal hyperplasia (scar tissue growth) caused by trauma when the vessel segment is treated for atherosclerotic lesions with balloon angioplasty. DCBs can be used to treat hyperplasia in arteriovenous (AV) access fistulae in dialysis patients, where the vessel undergoes repeated trauma from regular punctures. DCBs are also used to treat in-stent restenosis due to scar tissue proliferation inside stents, which can cause a vessel to occlude. Angioplasty using percutaneous coronary intervention techniques revealed satisfying result compared to conservative medical treatment.
Market Dynamics
Increasing product launches by key players in market are expected to drive the global drug eluting balloon market growth. For instance, in October 2019, Koninklijke Philips N.V., a health technology company, launched two new Stellarex Drug-Coated Balloon Sizes. Royal Philips introduced two new balloons to its Stellarex 0.035” low-dose drug-coated balloon (DCB) portfolio. The new 200mm and 150mm Stellarex 0.035” low-dose DCBs have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries, both arteries in the upper leg. The new balloons broadened physicians’ treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis and expand the Stellarex portfolio.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
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