• Pacemakers are medical devices used to deliver electrical pulses to the heart, in order to maintain a normal heart rate. These devices are used for the treat heart medical complications/conditions such as arrhythmias and heart failure.
Market Dynamics
• The global pacemakers market growth is driven by several factors such as, rising prevalence of heart diseases, favorable reimbursement scenario, growing geriatric population, and technological advancements in the devices.
• According to World Health Organization (WHO), cardiovascular diseases (CVDs) are one of the major causes of death globally. An estimated 17.9 million people died from CVDs in 2016, representing 31% of all global deaths. Of these deaths, 85% are due to heart attack and stroke. Over three quarters of CVD deaths take place in low- and middle-income countries. Out of the 17 million premature deaths (under the age of 70) due to non-communicable diseases in 2015, 82% are in low- and middle-income countries, and 37% are caused by CVDs. Between 2013 and 2016, 121.5 million American adults had some form of cardiovascular disease. In 2016, Coronary Heart Disease was the leading cause (43.2%) of deaths attributable to cardiovascular disease in the US, followed by stroke (16.9%), High Blood Pressure (9.8%), Heart Failure (9.3%), diseases of the arteries (3.0%), and other cardiovascular diseases (17.7%).
• The pacemaker market is also growing due to rising advancements in pacemaker technologies over the past few years. One of the biggest trends in the pacemaker technology is battery free pacemaker. Pacemakers rely on bulky batteries, which have to be swapped out at regular intervals due to their short lifespans. To overcome the challenge, in April 2019, researchers from China and the U.S. developed an alternative battery-free pacemaker which gathers its required electricity from the energy of heartbeats.
• There is a shift in the adoption of conventional pacemakers towards technologically advanced non-invasive ultrasound-based pacemakers, cardiac resynchronization therapy pacemakers (CRT-P), implantable cardioverter defibrillator (ICD) and the leadless pacemakers. The leadless pacemaker was developed to avoid the complications associated with the leads and surgical pocket required when placing a traditional pacemaker. In April 2016, Medtronic won Food and Drug Administration (FDA) approval of Micra leadless pacemaker to the market. The device is 25.9 mm long, 6.7 mm wide, and weighs 2 grams. It is inserted with a catheter through the femoral vein with a 23 French introducer, advanced into the right ventricle, then attached to the endocardium. These new technological pacemakers are expected to create various opportunities for the pacemaker market globally.
• On the basis of technology, the global pacemaker market is segmented into single chamber pacemaker, dual-chamber pacemaker, and biventricular/CRT pacemaker. Single-chamber pacemaker has one lead that connects the pulse generator to one chamber of the heart. Dual-chamber pacemaker is a device with two leads which regulates the pace of contractions of both chambers. The dual-chamber pacemakers held significant market share in 2018, owing to some factors such as reduced post-surgical complications and presence of two leads in order to assure normal physiology of the heart. Manufacturers are developing new technological pacemakers which are driving the growth of the market.
• On the basis of application, the pacemakers market is segmented into Atrial Fibrillation, Bradycardia, Arrhythmia, and Tachycardia. Among these, Atrial fibrillation holds a significant market share over the forecast period (2019-2026). Atrial fibrillation, often called AFib or AF, is the most common type of heart arrhythmia. According to CDC, an estimated 2.7–6.1 million people in the United States have AFib. With the aging of the U.S. population, this number is expected to increase. Approximately 2% of people younger than age 65 have AFib, while about 9% of people aged 65 years or older have AFib. African Americans are less likely than those of European descent to have AFib. Because AFib cases increase with age and women generally live longer than men, more women than men experience AFib. The major players are launching advanced technological pacemakers for patients having Artrial Fibrillation, hence leading to growth of the market.
• North America is dominating the global pacemakers market in 2018 and estimated to hold largest market size over the forecast period (2019-2026), owing to the rising prevalence of cardiovascular disease, high obesity rates, and a favorable reimbursement environment. According to Centers for Disease Control and Prevention (CDC) statistics, more than three million people in the United States suffer from atrial fibrillation, which is the most common type of abnormal heart rhythm, and the number is expected to quadruple by 2050. According to the American Heart Association, cardiovascular disease accounted for 840,678 deaths in the US in 2016, approximately 1 of every 3 deaths.
• In the last few years, the introduction of U.S. Food and Drug Administration (FDA)-cleared MRI-conditional models is a trend in the pacemakers market. According to Biotronik, more than 6 million people aged 65 or older undergo an MRI scan in the United States every year, and 20% of pacemaker patients need an MRI within the first two years of implant. According to the Mayo Clinic, approximately 75% of patients who have an implantable cardiac device will need an MRI in their lifetime. In April 2016, Boston Scientific received FDA clearance for a suite of products deemed safe for use in MRI environments. It allows patients to undergo MR imaging exams without harm to the device or changes to the device settings. Pacemakers without MRI-conditional use technology usually prevented patients from being able to get an MRI.
• In Sweden, most pacemakers per million inhabitants were implanted in Northern Sweden in 2017, where 990 patients per million inhabitants got a pacemaker implanted. Second most common was in Southern Sweden, where 721 per million inhabitants implanted a pacemaker. More than 700,000 pacemakers are implanted annually worldwide, including about 35,000 in the UK.
Competitive Analysis
• Some of the major players in the Pacemakers market are: Abbott Inc. (ST. Jude Medical), Medtronic PLC, Boston Scientific Corporation, Biotronik, and Lepu Medical Co. Ltd, Livanova, Osypka Medical, Shree Pacetronix, Oscar, and Medico Spa. The key players are adopting various key strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the pacemakers market globally. For instance,
• In May 2019, The US FDA and India’s CDSCO flagged battery issues with Medtronic Inc’s CRT-P’s. The FDA raised an alarm over premature battery depletion associated with certain models, which could lead to the devices losing power and triggering a medical emergency.
• In January 2019, MicroPort Scientific Corporation agreed to invest 350 million euros in France over the next five years towards developing pacemakers and defibrillators in the country.
• In March 2018, Biotronik Inc launched their 1 st 3-Tesla Full body MRI scan approved pacemakers in Japan. The new pacemakers will allow patients full access to MRIs without exclusion zone restrictions.
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