Pacemakers are medical devices that are used to impart electrical pulses to the heart, so as to ensure normal heart rate. These devices are used for the treat heart medical complications/conditions such as arrhythmias and heart failure.
The global pacemakers market size was worth $ 4.8 billion in 2018 and is forecasted to reach $ 5.3billion by 2026, at a CAGR of 2.3% during the forecast period.
Market Dynamics: Drivers, Restraints, Opportunities Challenges
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%). People with cardiovascular disease or who are at high cardiovascular risk (due to the presence of one or more risk factors such as hypertension, diabetes, hyperlipidaemia or already established disease) need early detection and management using counselling and medicines, as appropriate.
In addition, rising prevalence of arrhythmias is also driving the demand for pacemakers globally. According to the American Heart Association’s statistics, the prevalence rate of Atrial fibrillation (AF) in people younger than 65 years of age is approximately 2%, while the rate increases to about 9% in people aged more than 65 years. Also, the increasing use of alcohol, tobacco, a sedentary lifestyle and certain over-the-counter drugs are leading to the risk of arrhythmias.
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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.
However, high cost of pacemaker devices is a major restraint hindering the growth of the market. Implanted heart devices like pacemakers and stents costs two to six times more in the U.S. than in Germany, where costs are among the lowest in Europe. A commonly used pacemaker cost $4,200 in the U.S. and $1,400 in Germany. For patients not covered by insurance, a pacemaker and heart-assist implant can cost $19,000-$96,000 or more, depending on the type of pacemaker, the location and length of the hospital stay. For example, the Healthcare Bluebook estimates a total price of $19,651 for patients in the Columbus, OH, area, including placement of the pacemaker, surgery, anesthesia and a five-day hospital stay.
Pacemakers are not affordable by everyone due to its high cost. According to Mexican government reports, more than half of the population does not have access to social security or private insurance that covers a pacemaker implant, and 44% live in poverty. Recycling donated, explanted pacemakers offers a new option for these patients. In November 2017, according to a study presented at the 30th Mexican Congress of Cardiology, the Mexican doctors have safely reused donated pacemakers after sterilization. Thus, it creates the possibility for patients to receive a pacemaker who otherwise could not afford.
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.
Pacemakers Market Segment Analysis
Pacemakers Market By Technology:
• Single Chamber Pacemaker
• Dual-Chamber Pacemaker
• 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. For instance, in November 2017, Medtronic plc received U.S. Food and Drug Administration (FDA) approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM) technology. Available in both single chamber and dual chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 years (dual chamber) or 27 percent longer than its predecessor, so patients likely need fewer device replacements. The new pacemakers also allow patients to have MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.
The biventricular/CRT pacemaker is a fastest growing segment with estimated market share around 2.1X times by 2026 from 2019, owing to the presence of multiple leads. Biventricular pacemaker, also known as a cardiac resynchronization therapy (CRT) device, has three leads connected to the right atrium and both ventricles. It is used to treat people with arrhythmias caused by advanced heart failure. With rising advancement in technology, the key players are launching new CRT pacemakers in the market. For instance, in August 2017, Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI (magnetic resonance imaging) AutoDetect technology.
Pacemakers Market, By Application
• Atrial Fibrillation
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.
For instance, in November 2017, Medtronic plc received the U.S. FDA approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM) technology. The Azure XT pacemaker features the Medtronic Reactive ATP(TM) (atrial-based antitachycardia pacing) algorithm, which was shown in the MINERVA Trial and real-world studies to slow the progression of atrial fibrillation (AF) in patients with implanted cardiac devices.
Pacemakers Market Geographical Analysis
North America accounted for 49% market share in 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.
Pacemakers Market Competitive Landscape
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.
- In November 2017, LivaNova pulled out of the cardiac rhythm management devices segment by selling the business to Shanghai-based company MicroPort for $190 million.
- In February 2017, Medtronic received CE Mark certification for its Next Generation Cardiac Resynchronization Therapy-Pacemakers.
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