Global Bradycardia Treatment Devices Market - 2023-2030

Overview

Global Bradycardia Treatment Devices market reached US$ 8.9 billion in 2022 and is expected to reach US$ 13.07 billion by 2030, growing with a CAGR of 5.0% during the forecast period 2023-2030.

The global bradycardia treatment devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Rising cardiovascular disorders such as slow heart rate, research and development and government investments in medical devices are among the key drivers impacting bradycardia treatment devices globally. After the challenging year of 2020, the bradycardia treatment devices industry showed decent resilience and adaptability.

Government investments in cardiovascular disorders, particularly in developing economies, will continue to drive utilization of pacemakers and boost the global bradycardia treatment devices market. The global bradycardia treatment devices industry is placing increasing emphasis on better management of bradycardia. The respective initiatives includes the use of other devices, such as defibrillators for treatment of bradycardia as sometimes they function as pacemakers.

The sinus bradycardia, accounts for over one third of the market share. Similarly, the North America dominates the bradycardia treatment devices market, capturing the largest market share of over 1/3rd. The region's rapid investments in healthcare and rising major players in the bradycardia treatment devices market globally, makes it the largest market share holder. United States has the largest pool of manufacturers as well as consumers.

Dynamics

Growing Novel Product Launches and Regulatory Approvals

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high income levels, investments and infrastructure development. Several countries have experienced substantial demand for bradycardia treatment devices, reflecting their expanding healthcare industries. Rising novel product launches along with regulatory approvals for the same will be a crucial factor driving the growth of the market.

On May 18, 2023, the Alizea and Celea implantable pacemakers, which are currently the longest-lasting pacemakers for their size on the market, as well as its associated products, SmartTouch XT tablet-based programmer, the Vega pacing leads, and SmartView Connect Bluetooth home monitor, have all received FDA approval, according to MicroPort CRM, a global pioneer in the field of Cardiac Rhythm Management with headquarters in France. This represents a huge victory for patient care and illustrates the firm's dedication to the American market. The AutoMRI mode, a ground-breaking algorithm created by MicroPort CRM, is a feature of the Alizea and Celea products.

It improves patient safety and quality of life while undergoing an MRI scan. To activate the MRI mode, patients just need to see their cardiologist once in the ten days before to their scan. Once the mode is set up, the pacemaker automatically shifts to the MRI mode while entering the MRI field and returns to its default settings after the exam, greatly enhancing the efficiency of both patients and medical personnel. These devices are approved for use in 1.5 or 3 Tesla MRI scanners when implanted with Vega pacing leads.

Rising Number of Technological Advancements in Devices

Rising technological advancements in the devices for treatment of bradycardia will drive the growth of the market in coming period of time. For instance, on May 20, 2023, the first dual-chamber leadless pacemaker in the world received late-breaking outcomes from the dual-chamber (DR) AVEIR i2i Investigational Device Exemption (IDE) research from Abbott, demonstrating that the pacemaker met its three predetermined primary endpoints for safety and performance. The information also implies that AVEIR DR might provide new advantages for those who have slower-than-normal heart rhythms.

With the first-of-its-kind i2i (implant-to-implant) technology, Abbott created the AVEIR DR leadless pacemaker-the DR standing for dual-chamber rate response-with the intention of enabling beat-to-beat communication and harmony between two leadless pacemakers, the cornerstone of dual-chamber leadless pacing therapy. By communicating with one another, the two devices are able to sense a missed or delayed heartbeat and subsequently pace the proper heart chamber, unlike other leadless pacemakers.

Frequent Recalls Associated with the Devices

Several recalls have been linked with these pacemakers owing to different reasons frequently in past few years. Foe instance, pacemakers from the Boston Scientific INGENIO family, also known as cardiovascular resynchronization therapy pacemakers (CRT-Ps), are used in patients with low heart rates and those who have moderate to severe heart failure, a disease in which the heart is unable to pump enough blood to meet the body's requirements.

On August 10, 2021, due to the possibility of entering safety mode, Boston Scientific has recalled CRT-Ps and pacemakers from the INGENIO family. If the device in question is broken, safety mode is meant to act as a backup. Due to the detection of muscle contractions, there is a danger of inadvertent pacing loss in safety mode. The device must be replaced if it enters safety mode since it cannot be reprogrammed.

The use of the impacted product may have severe negative health effects, such as the need for promptly device replacement, loss of heart rate control or pacing with serious or life-threatening injury (for instance, the requirement for temporary pacing in which a healthcare provider administers controlled electric pulses to regulate a heart), worsening heart failure, and death. There have been 65 documented incidences, three of which required temporary external pacing for the injured patients. There haven't been any reported fatalities.

Complications or Risks Related to the Device

A blood clot occurs in about 2% of pacemaker users. This typically occurs in the region of the arm on the side the pacemaker was implanted. The arm may enlarge as a result of this. However, it normally disappears within a few days. Rarely is it a major issue. A pacemaker infection affects 1% of those who have one. Within the initial year of using the device, this typically occurs. There is a chance that the surgery will unintentionally rupture the lung. This implies that air can seep into the chest from the lung. The term pneumothorax refers to this.

Only 1% of persons are affected. Usually, the leak is really little. One won't need therapy because it will get better on its own. The pacemaker has a tiny probability of failing, much like any electronic device. This is known as a pacemaker error. A pacemaker can malfunction if the lead is pushed out of place, the pulse generator's battery dies, or the pacemaker's control circuits are harmed by being subjected to powerful magnetic fields.

Segment Analysis

The global bradycardia treatment devices market is segmented based on type, devices, end user and region.

High Advantages and Advancements of Pacemaker Devices

A pacemaker keeps track of the beat of the heart. It sends electrical signals to the heart to enhance pace and bring about a normal rhythm if it notices an anomaly. Some pacemakers use leads, which are a number of wires surgically attached to the heart, to connect to the heart. A leadless pacemaker, which doesn't need wires, is implanted into the heart. Leadless pacemakers are implanted straight inside the heart and contain no wires. The physician makes a tiny incision through the groin to implant these pacemakers. He or she directs the heart with a catheter, a long, slender, hollow tube. The device, which is about the dimensions of a large vitamin, travels down the catheter. The right ventricular wall is where the leadless pacemaker is fixed.

A tiny device called a pacemaker containing leads is inserted beneath the skin of the chest. This pacemaker, which is about the size of a pair of half-dollars pushed together, is equipped with a small battery and computer that are connected via one or two leads, which are thin, flexible wires with insulation. The device's leads extend into the heart, wherein the tips include electrode sensors that track cardiac rhythm and transmit data to the pacemaker.

Geographical Penetration

North America Accounted for Largest Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for bradycardia treatment devices in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for bradycardia treatment devices.

Increasing expenditure on healthcare and rising research studies, advancement of technologies for different devices for bradycardia, and increase in pharmaceutical and medical devices business establishment across the region are also contributing to the growth of bradycardia treatment devices market share of this region.

The key healthcare organizations' and businesses' joint research initiatives are also expected to contribute to the rising demand, as will new product development, which constantly looks to improve present options. The market in this area is growing as people become more aware of various novel devices such as defibrillator, for treatment purposes. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global bradycardia treatment devices market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising cardiovascular disorders have fueled the demand for bradycardia treatment devices in the region. United States have been proactive in executing several initiatives or researches, stimulating bradycardia treatment devices demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global bradycardia treatment devices market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the medical device sector, with a significant consumer of bradycardia treatment devices, was significantly impacted.

Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020. Major pharmaceutical or medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for bradycardia treatment devices. As a result, many medical device plants either suspended or reduced production to align with the reduced demand.

The COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials to the pharmaceuticals manufacturing plants. Movement limitations and border closures caused production and supply delays. Additionally, some nations experienced a lack of raw resources as a result of supply chain network interruptions.

With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages as workers fell sick or were unable to travel to work due to lockdown restrictions. To curb the spread of the virus, pharmaceutical plants implemented stringent safety measures, reducing the number of workers allowed on-site at a time. However, these measures were vital to safeguard the health of the workforce and maintain essential operations during the pandemic.

Russia-Ukraine War Impact Analysis

The medical device businesses are starting to worry regarding their capacity to continue operating, much like other parts of the world. Russia's invasion of Ukraine has an effect on millions of people not only in this nation in Eastern Europe but also all around the world. Device developers will thus experience delays in the development process, a loss of business consistency, and the possibility of non-compliance for devices/drugs already on the market.

For many years, clinical trials in several therapeutic fields have benefited significantly from the participation of Ukraine, Russia, and other CIS nations. Clinical trial durations can frequently be accelerated by incorporating more patients into studies when there is availability to skilled investigators, high-quality patient populations, and big patient populations. Trials that are delayed in Russia and Ukraine as well as relocation to other regions of Europe for fresh trials are currently viable choices. These factors will impact the global bradycardia treatment devices market.

By Type

• Sinus Bradycardia
• Sinus Pause
• Sick Sinus Syndrome
• Tachy-brady Syndrome
• Heart Block

By Devices

• Pacemakers
  • Single Chamber Pacemaker
  • Dual Chamber Pacemaker

• Defibrillator

By End User

• Hospitals
• Specialty Clinics
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• On July 5, 2023, the AVEIR dual chamber leadless pacemaker system, the first dual chamber leadless pacing system in the world that serves patients with aberrant or sluggish heart rhythms, has received FDA approval, according to a statement from Abbott. The approval dramatically expands the availability of leadless pacing for hundreds of thousands of people across the United States because more than 80% of persons who require a pacemaker require pacing both in the right atrium and the right ventricle.
• On May 1, 2023, the FDA has given the green light to the next generation of the company's industry-leading miniaturized, lead-free pacemakers, the Micra AV2 and Micra VR2, according to Medtronic plc, an international innovator in healthcare technology. The Micra AV2 and Micra VR2, the smallest pacemakers in the world, provide more battery life and easier programming than earlier Micra models while still offering the many benefits of leadless pacing, including fewer issues than conventional pacemakers.

Competitive Landscape

The major global players in the market include: Abbott, BIOTRONIK, NIHON KOHDEN CORPORATION, Lepu Medical Technology (Beijing) Co Ltd., MEDICO S.R.L., OSCOR Inc, OSYPKA MEDICAL, MicroPort Scientific Corporation, Boston Scientific Corporation and Medtronic.

Why Purchase the Report?

• To visualize the global bradycardia treatment devices market segmentation based on type, devices, end user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of bradycardia treatment devices market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global bradycardia treatment devices market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies