세계 심혈관 중재시술 기기 시장 규모는 예측 기간 동안 연평균 8.37%의 연평균 복합 성장률(CAGR)로 성장하여 2023년 162억 2,000만 달러에서 2031년 308억 6,000만 달러로 성장할 것으로 예상됩니다.
심혈관 질환의 유병률 증가, 심장병 치료기기의 기술 발전, 규제 당국의 승인 증가, 노인 인구 증가, 심장 질환 및 치료 옵션에 대한 인식 증가, 의료비 지출 증가 등의 요인으로 인해 심혈관 중재시술 기기 시장은 견조한 성장세를 보이고 있습니다. 심장 질환의 부담 경감, 의료 인프라 강화를 위한 정부의 이니셔티브, 비영리 의료 단체의 기부금도 시장 성장에 긍정적인 영향을 미치고 있습니다.
심장 장치의 기술 발전
최근 몇 년동안 심혈관 중재시술 기기의 기술 발전이 눈부시게 발전했습니다. 이러한 발전에는 로봇 기술, 외과 의사가 제어하는 소형 수술 로봇, 정밀도를 향상시키는 내비게이션 센서, 바이오센서가 장착된 무선 기술 등의 사용이 포함됩니다. 또한, 로봇을 이용한 경피적 관상동맥 중재술(PCI) 기술에서도 와이어 조작, 가이드 카테터 제어, IVUS 영상 처리 등의 개선이 이루어지고 있습니다. 또한, 무선 기술 및 바이오센서는 모니터링 및 진단 등 다양한 용도로 사용될 수 있어 심장 중재술에서 유망한 기술입니다.
심혈관 질환의 유병률 증가
심혈관 질환은 전 세계 주요 사망 원인으로 매년 1,790만 명의 목숨을 앗아가는 것으로 추정됩니다. 인구 증가와 고령화 등의 요인으로 인해 심혈관 질환의 유병률은 크게 증가할 것으로 예상됩니다. 심혈관 질환 환자 증가는 심혈관 질환과 위험 요인에 대한 기존 지식이 실제 진료로 환원되지 않았기 때문입니다. 심혈관 질환의 부담은 특히 중저소득 국가에서 심혈관 질환의 부담이 크고, 빈곤의 한 요인으로 작용하여 경제적으로도 큰 부담이 되고 있습니다. 건강에 해로운 식습관, 운동 부족, 담배 사용, 알코올 섭취는 심혈관 질환의 가장 중요한 행동학적 위험 요인 중 하나입니다. 심혈관 질환의 유병률이 증가함에 따라 심혈관 중재시술 기기에 대한 수요가 크게 증가할 것으로 예상됩니다.
북미가 지배적인 지역으로
북미는 심혈관 중재시술 기기의 주요 지역이 될 것으로 예상됩니다. 이 지역은 심혈관 질환의 유병률이 높으며, 이는 심장 장치에 대한 큰 수요로 이어지고 있습니다. 또한, 북미는 최소 침습 수술의 채택률이 높고, 심혈관 중재시술 기기 시장에서 선도적인 제조업체들의 존재감이 강합니다. 북미의 의료비 지출 증가와 높은 가처분 소득도 이 지역 시장 지배력에 기여하고 있습니다.
세계 심혈관 중재시술 기기(Interventional Heart Devices) 시장을 조사했으며, 시장 정의와 개요, 시장 규모 추이 및 예측, 각종 부문별/지역별 상세 분석, 산업 구조, 시장 성장에 영향을 미치는 요인 분석, 사례 연구, 경쟁 구도, 주요 기업 개요 등의 정보를 정리하여 전해드립니다.
Global interventional cardiology devices market is projected to witness a CAGR of 8.37% during the forecast period 2024-2031, growing from USD 16.22 billion in 2023 to USD 30.86 billion in 2031. The interventional cardiology devices market is thriving due to factors like a growing prevalence of cardiovascular disorders, technological advancements in cardiology devices, an increasing number of regulatory approvals, a growing geriatric population, rising awareness about cardiac conditions and treatment options, and increasing healthcare expenditure. Government initiatives and contributions from non-profit medical organizations to reduce the cardiac disease burden and strengthen the healthcare infrastructure are some other factors positively impacting the interventional cardiology devices market growth.
However, the dominance of first-line alternative treatment options pushes back the demand for interventional cardiology devices. The high cost of surgical procedures and instruments used for cardiac surgery makes it the terminal choice for middle and lower-class patients. Alongside, risks associated with cardiac surgeries and interventional devices hinder the growth of this market.
In November 2023, Argon Medical Devices, a trusted provider of device solutions for interventional radiology, vascular surgery, interventional cardiology, and oncology, introduced the Kodiak Dual Port Coaxial Introducer Kit. This innovative kit enables precise and streamlined introduction of diagnostic and therapeutic devices into the vasculature, ensuring optimum results for patients.
Technological Advancements in Cardiology Devices
Technological advancements in interventional cardiology devices have been significant in recent years. These advancements include the use of robotic technologies, miniature surgical robots controlled by surgeons, navigational sensors for precision, and wireless technologies with biosensors. Additionally, advancements in robotic percutaneous coronary intervention (PCI) technology, including improvements in wire manipulation, guide catheter control, and IVUS imaging, have been observed. Furthermore, wireless technologies and biosensors hold promise for interventional cardiology, as they can be used for various applications such as monitoring and diagnosis. These advancements are enhancing the precision, safety, and effectiveness of interventional cardiology procedures, ultimately benefiting interventional cardiology devices. Key players are designing products with enhanced technologies to cater to the market needs.
In September 2023, Canon Medical launched the Alphenix Sky 12 HD interventional system with the new high-definition (Hi-Def) detector. The Alphenix Sky 12 HD features a 12"X12" Hi-Def detector to improve visualization for interventional procedures, including pediatric cases, in cardiology, neurology, oncology, and radiology.
Growing Prevalence of Cardiovascular Diseases
Cardiovascular diseases are the leading cause of death globally, taking an estimated 17.9 million lives each year. The prevalence of cardiovascular diseases is expected to increase substantially due to factors such as population growth and aging. The rise in cardiovascular disease cases is attributed to a lack of translation of existing knowledge about cardiovascular diseases and risk factors into practice. The burden of cardiovascular diseases is particularly heavy on low- and middle-income countries, where they contribute to poverty and place a significant economic strain. Unhealthy diet, physical inactivity, tobacco use, and alcohol consumption are among the most important behavioral risk factors for cardiovascular diseases. The demand for interventional cardiology devices is expected to increase significantly with the growing prevalence of cardiovascular diseases.
For instance, according to the World Heart Report 2023 published by the World Heart Federation, cardiovascular diseases have been the leading cause of death worldwide for many years. In 2021, more than 20 million people died from a cardiovascular condition, which accounted for about one-third of all global deaths. This figure is significantly higher than the 12.1 million cardiovascular disease deaths recorded in 1990. Ischemic heart disease is now the leading cause of premature death in 146 countries for men and 98 countries for women.
Dominance of Stents Segment
The stents segment is anticipated to be the leading segment in the interventional cardiology devices market. Stents are commonly used in interventional cardiology to treat coronary artery disease. They are expandable tubular metallic devices introduced into clogged coronary arteries, a procedure known as percutaneous coronary intervention (PCI) or coronary stenting. The most widely used stents are drug-eluting stents (DES), which have significantly reduced the incidence of restenosis in native stable coronary arteries. Stents have been shown to reduce angina and improve survival in patients with coronary artery disease. Innovative stent products from market players have significantly developed the market.
In October 2023, Medinol announced the United States Food and Drug Administration (FDA) approval for its EluNIR-PERL drug-eluting stent (DES), which is meant for the treatment of coronary artery disease. EluNIR-PERL has four radiopaque markers, two at each end, and a hybrid polymer-metal radiopaque catheter tip. These unique features allow excellent visualization during PCI procedures, whether navigating through complex anatomies or placing the stent precisely.
Ambulatory Surgical Centers to be the Fastest Growing End-user Segment
Cardiology procedures are increasingly being performed in ambulatory surgery centers (ASCs) due to various factors such as improved patient experiences, strong reimbursement rates, and cost savings. These procedures include the placement of pacemakers, loop recorders, AICD, diagnostic and interventional coronary procedures, peripheral vascular interventions, right and left heart catheterizations, coronary interventions, and defibrillator and pacemaker implants. The Centers for Medicare and Medicaid Services (CMS) support this shift to ASCs by adding cardiology procedures to the ASC-covered procedure list. This has led to a faster growth rate for ambulatory surgical centers. For instance, as per an article published by HMP Global in July 2023, around 2% of major cardiovascular procedures are being performed in ambulatory surgical centers and the traction is steadily rising.
North America to be the Dominating Region
North America is anticipated to be the leading region in interventional cardiology devices. The region has a high prevalence of cardiovascular diseases, leading to a significant demand for cardiology devices. Additionally, North America has a high adoption rate of minimally invasive procedures and a strong presence of top manufacturers in the interventional cardiology device market. The rising healthcare expenditure and high disposable incomes in North America also contribute to the dominance of the region in the interventional cardiology devices market. Alongside, prominent players in the interventional cardiology device market, such as Medtronic, Boston Scientific Corporation, and Abbott, have a strong presence in North America, further contributing to its dominance.
As per the American Heart Association, by 2035, almost 45% of the United States population is expected to experience heart disease due to unhealthy factors such as high obesity rates, smoking, and poor lifestyle choices. These factors may increase the risk of heart attacks and other related health issues.
Future Market Scenario (2024 - 2031F)
In recent years, notable regulatory emphasis has been helpful for novel marketed products. Several reforms have been made to speed up the approval process of interventional cardiology devices. The FDA has been granting several regulatory approvals for interventional cardiology devices. The classification of interventional cardiovascular implant simulation software devices has been updated to class II (special controls). Most class III devices require FDA approval of a PMA before they can be legally marketed. The classification of cardiovascular devices intended for human use that are in commercial distribution is outlined in 21 CFR Part 870. The number of cardiac device approvals for children seems to be growing, with most approvals being granted through the humanitarian device exemption (HDE) pathway.
In November 2023, Medtronic plc received approval from the United States Food and Drug Administration (FDA) for its Symplicity Spyral renal denervation (RDN) system, which is also known as the Symplicity blood pressure procedure. This system has been approved for use in treating hypertension. As a result of the approval, Medtronic will start the commercialization of the product right away. The device is mainly meant to reduce hypertension through relaxing nerves connected to the kidneys and reducing its activity.
Key Players Landscape and Outlook
The key players in the interventional cardiology devices market include Abbott Laboratories, Terumo Corporation, Teleflex Incorporated, and B. Braun SE, among others. Many companies are working on developing new products and expanding their business through collaborations, partnerships, mergers, and strategic alliances. The market value of these players is driven by the successful implementation of these strategies. Additionally, regulatory approvals for new products and services also contribute to the growth of both the players and the market.
In October 2023, Haemonetics offered USD 253 million for sensor equipped TAVR guidewire maker OpSens. The deal is expected to close in January 2024. Haemonetics is a Boston-based medical device maker, while OpSens is a Canadian developer of optical sensor-equipped devices for both medical and industrial uses.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.