Description

The global advanced balloon catheter market size is expected to grow from USD 2,893.3 million in 2021 to USD 5,381.1 million by 2030, at a CAGR of 7.1% from 2022 to 2030. A balloon catheter is defined as “a PTCA catheter is a device that operates on hydraulic pressurization principle applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of proper compliance for the clinical application, made from a polymer. The balloon is designed to expand to a specified diameter and length at an exact pressure as labeled, with well-characterized rates of inflation and deflation and a defined burst pressure”. The FDA defines a balloon catheter as a Class II (special controls) medical device. An advanced balloon catheter is a sub-segment of the balloon catheter that is technologically advanced compared to a normal balloon catheter. The advanced balloon catheter includes cutting and scoring balloon catheter, drug-coated balloon (DCB) catheter, and stent-graft catheter.

Over the past few decades, the balloon catheter paradigm has witnessed the development of various novel balloon catheters, such as cutting and scoring balloon catheters, drug-coated balloon catheters, and stent-graft balloon catheters. The novel catheters were developed to cater to indications with increasing prevalence.

The increasing prevalence of cardiovascular and peripheral artery diseases, increasing demand for minimally invasive surgeries, advancements in balloon catheters, and favorable reimbursement landscape in the developed economies are the primary drivers for the global advanced balloon catheter market. The advancements in the balloon catheters are anticipated to have a medium and a medium-low impact in the midterm and long term on the market. The medium-impact is owing to the prolonged dominance of normal balloon catheters in the treatment unless in case of a specific indication.

COVID-19 Impact on the Global Advanced Balloon Catheter Market

The balloon catheters' adoption rate has significantly declined due to the global restriction on elective procedures. For instance, according to a paper titled, “Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic” published by the American College of Cardiology’s Interventional Council and the Society for Cardiovascular Angiography and Interventions (SCAI) in March 2020, in the U.S., the elective procedures, such as angioplasty were restricted in the catheterization laboratories, especially in areas having a high number of COVID-19 patients. Only a few procedures, such as percutaneous coronary intervention (in case of stable ischemic heart disease), endovascular intervention (in case of the iliofemoral disease in patients with claudication), and patent foramen ovale closure were allowed in the catheterization laboratories. However, the procedure was conducted based on the physician’s discretion and the posed risk of COVID-19 to the patient’s health.

Moreover, the new product launches have also been delayed due to the pandemic. For instance, Medtronic plc has delayed the commercial launch of IN. PACT Admiral drug-coated balloon catheter owing to the pandemic. The company has received FDA approval for the product in May 2018 and has launched the product only in Japan in 2018. However, various opportunities have also emerged for the global advanced balloon catheter market. The increased focus on the local manufacturing of medical devices has led to various regional companies in the global advanced balloon catheter market. Moreover, the companies can also develop novel coated balloon catheters for COVID-19 patients requiring medical intervention, such as angioplasty.

Global Advanced Balloon Catheter Market Dynamics

Drivers: Favorable Reimbursement Landscape in Developed Economies

In developed countries, healthcare services are often reimbursed. The reimbursement depends on the citizen's fulfillment of the pre-requisites required for reimbursement. Developed countries, such as the U.S., U.K., Canada, and Japan, have guidelines to provide reimbursement in medical device procedures, including angioplasty. Moreover, various private insurance providers, such as Cigna Health, also reimburses medical procedures requiring balloon catheters. Additionally, in the U.S., other than angioplasties, procedures such as kyphoplasty and sinuplasty are also reimbursed, hence propelling the procedure volumes.

Moreover, in Europe, in case of usage of advanced balloon catheters, such as drug-coated balloon catheters for a procedure, additional reimbursement is also offered considering the high cost of the device. Thus, the favorable reimbursement landscape for angioplasties and other balloon catheter procedures will significantly impact the sales of advanced balloon catheters.

Restraints: Risk and Complications Associated with Catherization Procedures

The catheterization procedures are considered safe, having an acceptable associated risk factor. However, the associated risk and complications could have a prolonged impact on the patient's life quality. Additional risks, such as re-narrowing of the treated artery, in-stent restenosis, and non-expansion of stents, are also associated with the catheterization procedures. Often these complications could be life-threatening as well. For instance, according to a study conducted by American Heart Association, titled “Mortality After Percutaneous Coronary Intervention,” in 2018, the overall mortality rate associated with coronary balloon angioplasty was approximately 10%. The risk was considered low immediately after the procedure; however, it increased as the time duration increased. Thus, the significant mortality rate and the prolonged impact of the complications of a catheterization procedure can restrain the growth of the global advanced balloon catheter market.

Opportunities: Development of Novel Drug-Coated Balloon Catheters

The drug-coated balloon catheters are usually coated with paclitaxel to prevent restenosis after the angioplasty procedure. However, the drug is often not uniformly spread across the vessel walls, increasing the probability of re-narrowing the treated artery.

The companies can investigate the development of drug-coated balloon catheters coated with other antiproliferative drugs, such as Sirolimus. For instance, Concept Medical is one of the companies offering a Sirolimus coated balloon catheter, MagicTouch. Moreover, B.Braun Medical International Trading Company Ltd (a subsidiary of B.Braun Melsungern AG in China) is conducting a clinical trial (ID: NCT04240444) on the efficacy and safety of the Sirolimus coated balloon catheter usage in the treatment of coronary in-stent restenosis patients.

Scope of the Advanced Balloon Catheter

The study categorizes the advanced balloon catheter market based on product, component, patient age, end-users, and application at the regional and global levels.

By Product Type Outlook (Sales, USD Million, 2017-2030)

• Normal Balloon Catheter
• Cutting and Scoring Balloon Catheter
• Drug-Coated Balloon Catheter
• Stent-Graft Balloon Catheter

By Component Outlook (Sales, USD Million, 2017-2030)

• Over the Wire (OTW) Balloon Catheter
• Rapid Exchange (Rx) Balloon Catheter
• Fixed Wire Balloon Catheter

By Patient Age Outlook (Sales, USD Million, 2017-2030)

• Adult
• Pediatric

By End-Users Outlook (Sales, USD Million, 2017-2030)

• Hospitals and Ambulatory Surgery Centers
• Catheterization Laboratories
• Others (Academic and Research Institutes)

By Application Outlook (Sales, USD Million, 2017-2030)

• Coronary Procedures
  • Balloon angioplasty
  • Transcatheter aortic valve implantation or replacement
  • Drug Delivery
  • Stent Delivery
• Peripheral Procedures
  • Balloon angioplasty
  • Drug Delivery
  • Stent Delivery
• Neurovascular Procedures
• Other Procedures
  • Balloon sinuplasty
  • Balloon kyphoplasty
  • Balloon carpal tunnelplasty

By Region Outlook (Sales, USD Million, 2017-2030)

• North America (US, Canada, Mexico)
• South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
• Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, the Netherlands, Norway, Sweden, Denmark, Rest of Europe)
• Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, the Philippines, Singapore, Australia & New Zealand, Rest of Asia Pacific)
• The Middle East & Africa (Saudi Arabia, UAE, South Africa, Northern Africa, Rest of MEA)

The normal balloon catheter segment had the largest market share by  product type

Based on the product type, the global advanced balloon catheter market is segmented into normal balloon catheter, cutting and scoring balloon catheter, drug-coated balloon catheter, and stent-graft balloon catheter. In 2021, the normal balloon catheter segment accounted for the largest market share of 55.5% in the global advanced balloon catheter market. A normal balloon catheter is the most widely used for various coronary, peripheral, and neurovascular procedures. The device's low cost, favorable reimbursement, and the presence of a large product portfolio are the primary propellers for the growth of this segment.

The stenting procedure often follows the balloon angioplasty done by using a normal catheter to avoid the re-narrowing of the artery; however, the consequent complications, such as in-stent restenosis and non-expansion of the stent in the artery, has limited the usage of normal balloon catheters.

Asia Pacific accounts for the highest CAGR during the forecast period

The global advanced balloon catheter market is segmented as North America, Asia-Pacific, Europe, South America, and the Middle East & Africa based on regions. Globally, Asia Pacific is estimated to hold the highest CAGR of 7.8% in the global advanced balloon catheter market during the forecast period. The primary factor propelling the market's growth is the increasing prevalence of CVD and PAD.

Additionally, other factors propelling the growth of the region’s market include a favorable reimbursement landscape in developed economies, technological advancements in the developing economies, the presence of local and multinational companies in the region. Another key factor for the growth of the region’s advanced balloon catheter market is raw material availability. For instance, China is considered one of the leading raw material providers for various medical devices globally.

Key Market Players

The advanced balloon catheter market is mildly concentrated in nature with few numbers of global players operating in the market such as Abbott Laboratories, B. Braun Melsungen AG, Becton, Dickinson and Company, Boston Scientific Corporation, Cardinal Health, Inc., Koninklijke Philips N.V., Medtronic plc, MicroPort Scientific Corporation, Terumo Corporation, Biotronik AG, Cardionovum GmbH, Concept Medical Inc., Cook Group, Hexacath, and OrbusNeich Medical.

Recent Developments

• In February 2020, Abbott Laboratories recalled various NC Trek RX coronary dilatation catheters and the NC Traveler coronary dilatation catheter. The recall was due to the manufacturing error in balloons impacting their deflation. The recall was classified as Class I recall by the Food and Drug Administration (FDA).
• In August 2019, B. Braun Interventional Systems Inc. (BIS), a division of B. Braun USA (a subsidiary of B. Braun Melsungen AG), was awarded “Breakthrough Device Designation” by FDA for the SeQuentPlease ReX drug-coated PTCA balloon catheter. The balloon catheter is used to treat coronary in-stent restenosis (ISR).
• In April 2020, Cardionovum GmbH’s APERTO OTW drug-coated balloon received approval from the Chinese regulatory authority, the National Medical Products Administration (NMPA).
• In April 2019, BD launched UltraScore 014 Focused Force PTA balloon in the U.S. The product is the first scoring balloon with sheath compatibility (as small as 4F) in the U.S.

Key Issues Addressed

• What is the market size by various segmentation of the advanced balloon catheter by region and its respective countries?
• What are the customer buying behavior, key takeaways, and Porter's 5 forces of the advanced balloon catheter market?
• What are the key opportunities and trends for manufacturers involved in the advanced balloon catheter supply chain?
• What are the fundamental dynamics (drivers, restraints, opportunities, and challenges) of the market?
• What and how regulations, schemes, patents, and policies are impacting the growth of the market?
• What are the upcoming technological solutions influencing market trends? How will existing companies adapt to the new change in technology?
• The market player positioning, top winning strategies by years, company product developments, and launches will be?
• How has COVID-19 impacted the demand and sales of the advanced balloon catheters in the global market? Also, the expected BPS drop or rise count of the market and market predicted recovery period.
• Detailed analysis of the competitors and their latest launch, and what are the prominent startups introduced in the target market? Also, detailed company profiling of 25+ leading and prominent companies in the market.