Pacemakers Market Size By Product (Implantable Pacemakers, External Pacemakers), By Technology (Single-chamber, Dual-chamber, Biventricular/CRT), By Application (Congestive Heart Failure, Arrhythmias, Bradycardia, Tachycardia), End-use & Forecast, 2021 - 2027

Industry Trends

Pacemakers Market size exceeded USD 3.2 billion in 2020 and is anticipated to grow at a CAGR of over 4.2% between 2021 and 2027. In recent years, the dominance of chronic diseases including cardiovascular conditions have emerged as a major contributor to the global mortality and is significantly surging the chronic disease burden. According to the World Health Organization (WHO) estimates, by 2030, researchers project that non-communicable diseases are expected to account for over 75% of global deaths. Among these, cardiovascular diseases alone are projected to be responsible for more deaths in low income countries than infectious diseases, maternal & perinatal conditions, and nutritional disorders combined together.
 

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However, several product recalls associated with pacemakers and high cost of these devices may negatively impact the market growth. The U.S. FDA initiates recall of the products that are associated with adverse events post marketing approval. For instance, the U.S. FDA recalled Abbott’s Assurity and Endurity cardiac pacing systems for potential moisture ingress that might lead to electrical short-circuit and poor battery life. This recall belonged to the Class I category that is recognized as the most serious type of recall and the use of such device might lead to serious injuries or even death. Product recalls might hamper the brand image and reputation of the company, thereby affecting pacemakers adoption rate.
 

The U.S. FDA closely regulates the R&D activities, approval and post-market surveillance for adverse effects related to medical devices including pacemakers. These devices are classified as Class III medical devices that require premarket approval (PMA) to get approval for commercial use of the product. The PMA process is complex process that requires clinical data submission to validate the device claims.
 

The COVID-19 outbreak emerged as a serious health concern significantly distorting the global economy and several sectors including healthcare sector. The pandemic has soared the disease burden and inflicted immense financial adversities & strain on healthcare services, including electrophysiology practice. The coronavirus outbreak has impacted and forced several transitions in healthcare systems, further inflicting enormous burden on emergency, intensive, and intermediate care units.
 

Many healthcare units, including cardiology & electrophysiology, have redistributed their services and human capital for COVID-19 associated care & services. This resource allocation and COVID-19 prioritization measures, such as redirecting the medical personal, protective medical supplies and hospital beds for COVID-19 patients has resulted in substantial delay of elective cardiac procedures. The Centers for Disease Control and Prevention (CDC), the Arrhythmia Committee of the American Heart Association and the American College of Cardiology’s Electrophysiology department’s guidelines also suggested postponing the elective cardiac procedures. These developments have limited the industry growth during the forecast timeframe.
 

Increasing prevalence of cardiovascular diseases will facilitate the pacemakers market expansion

Rising prevalence of cardiovascular ailments is predicted to augment the need for pacemakers, thereby driving the industry revenue. High prevalence of cardiovascular conditions such as coronary heart disease, cerebrovascular disease, rheumatic heart disease, and congenital heart disease among others are contributing to the global disease burden. The cardiovascular disease are leading cause of mortalities globally.
 

Significant rise in the prevalence and incidence of cardiovascular diseases is owing to the behavioural risk factors such as high consumption of tobacco, alcohol, obesity, unhealthy diet and physical inactivity among others. Around 85% of the deaths associated with cardiovascular diseases are due to cardiac arrests and strokes. These numbers are further set to surge in the coming years.
 

Growing acceptance of implantable pacemakers to expedite the market progression

The implantable pacemakers segment was valued at USD 2.86 billion in 2020 led by the increasing usage of implantable pacemakers and additional benefits offered by implantable devices over external counterparts. An implantable cardiac pacing devices are implanted (internally) in the body to offer electrical stimuli, thereby promoting the cardiac contraction and regulating the irregular intrinsic myocardial electrical activity. These devices offer multiple leads that ensure normal physiology of the heart, even in case when one of the leads malfunctions.
 

Higher prevalence of cardiovascular conditions such as atrial fibrillation and bradycardia will fuel the pacemakers market demand

The dual-chamber pacemakers segment dominated more than 72% of the market share in 2020 impelled by the growing prevalence of bradycardia and associated atrial fibrillation. These pacemakers connects to both ventricles to regulate the contractions and helps the two chambers work together, further enabling the blood to flow properly. These devices are exclusively used for the treatment of bradycardia and atrial fibrillation. The rising prevalence of atrial fibrillation is thus projected to prove conducive for the industry expansion.
 

Rising prevalence of congestive heart failure to boost the market value

The congestive heart failure segment captured 35% of the revenue share in 2020 propelled by the growing prevalence of congestive heart failure and associated deaths. According to the Radcliffe Cardiology 2017 article, the heart failure represents a complex clinical syndrome characterised by the hampered ability of the heart to pump blood and affects approximately 26 million people globally & is expected to affect more individuals in the coming years. Around 5.7 million people in the U.S. suffer due to heart failure and the projections indicate more than 8 million people would suffer from this condition by 2030, indicating a 46 % rise. The rising prevalence of heart failure is slated to play anchoring role in surging the demand for these devices to regulate the cardiac rhythm.
 

Growing number of hospital admissions will surge the market revenue

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The hospitals segment in the pacemakers market crossed USD 1.56 billion in 2020 on account of the increasing hospital admissions for cardiovascular disease management and availability of well-equipped & advanced healthcare services. According to the Australian Institute for Health and Welfare (AICW), in 2017-18, there were around 1.2 million hospital admissions associated with cardiovascular diseases. These statistics represents approximately 11% of total hospital admission in Australia.
 

High prevalence of cardiovascular disorders in the North America region to stimulate the regional growth

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U.S. dominated North America pacemakers market and is poised to reach USD 1.86 billion by 2027 owing to the several factors such as rise in incidence of cardiovascular conditions, growing number of hospital admissions and favourable reimbursement scenario for development & adoption of advanced medical technologies across the country. Additionally, the presence of Medicare reimbursement policy in the country further encourages the patients to opt for advanced pacemaker implantation procedures.
 

Strategies adopted by major players are set to foster the industry progression

Some of the major companies operating in the market are Medtronic, Boston Scientific Corporation, Abbott Laboratories, BIOTRONIK, Lepu Medical, LivaNova, and Oscor, Inc., These prominent leaders concentrate on strategic developments such as agreements, mergers, new product launch and commercialization for business expansion. Furthermore, these participants are heavily investing in research that enables them to launch innovative products and garner maximum revenue in the industry.
 

Recent industry developments:

• In October 2020, Medtronic launched its Azure pacemakers integrated with BlueSync technology in India. This product was intended to precisely diagnose and minimize the risk of atrial fibrillation. This product launch drove the revenue prospects of the company in the Indian market and reinstated its industrial position.
   
• In January 2020, Medtronic received FDA clearance for the product Micra AV, atrioventricular (AV) synchrony integrated pacemakers. It is proposed to treat AV block condition that features impairment between electrical signals among the atria and the ventricle. This product offered higher safety and effectiveness, thereby adding to the strength of the pacemakers product portfolio.
   

Pacemakers market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:

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Market, By Product, 2016 - 2027 (USD Million)

• Implantable Pacemakers
• External Pacemakers

Market, By Technology, 2016 - 2027 (USD Million)

• Single-chamber Pacemakers
  • Single-chamber Atrial
  • Single-chamber Ventricular
• Dual-chamber Pacemakers
• Biventricular/CRT Pacemakers

Market, By Application, 2016 - 2027 (USD Million)

• Congestive Heart Failure
• Arrhythmias
• Bradycardia
• Tachycardia
• Others

Market, By End-use, 2016 - 2027 (USD Million)

• Hospitals
• Cardiac Care Centers
• Ambulatory Surgical Centers
• Clinics
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Poland
  • Russia
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Taiwan 
• Latin America
  • Brazil
  • Mexico
  • Argentina 
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE