New Research Shows Cardiac Sector Will Grow Very Little

Millennium Research Group (MRG) has determined the large global market for cardiac rhythm management (CRM) devices will see only minimal growth through 2016, to a value of more than $9.6 billion. The CRM market is mature and saturated, with little anticipated growth in procedure volumes, and a significant downward pressure exists on selling prices, MRG claims in a new report. Some technological improvements will allow for premium-priced sales, particularly in Europe and the United States.

Bradycardia, tachycardia and heart failure, the three main indications for pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, are correlated with age and obesity. The over-65 and obese populations will continue to grow in all of the countries covered in MRG’s report. However, in developed economies, a large proportion of the potential patient population already has an implanted CRM. With no untapped population segment, growth will come incrementally from newly eligible patients.

Recent audits from the U.S. Department of Justice (DOJ) and the Centers for Medicare and Medicaid Services (CMS) have raised questions about the clinical indications for pacemaker implantation. The CMS audit concluded that dual-chamber pacemaker implantations often were performed without a clinical indication. The DOJ audit investigated the overuse of ICD implantations. The tighter evidence-based requirements imposed will reduce procedure growth for the affected devices, MRG’s report concludes.

A recent concern has been the safety profile of several ICD leads, providing an opportunity for devices such as Cameron Health’s S-ICD, which eliminates the connecting wires between the generator and the heart. These devices were introduced in Europe and CE marked in 2009. Premarket approval has been recommended, though not yet granted, in the United States. Approval in Japan will come last, because of that country’s long approval process, alleges MRG.

“Competitors will try to offset price declines through technical innovations,” said MRG Analyst Mirel Giugaru. “Until recently, for example, magnetic resonance imagining scanners (MRIs) were contraindicated for CRM users, meaning that some patients who could have benefited from an MRI couldn’t get one, but MRI-compatible devices will proliferate over the next five years. In addition, generator lifespans are getting longer, devices are getting smaller, and remote monitoring is growing more common. The premium prices such devices command will to some extent counteract the overall selling price declines.”

MRG’s Global Markets for Cardiac Rhythm Management Devices 2012 report includes unit, average selling price and revenue information, along with market drivers and limiters and competitive landscape for pacemakers, ICDs and CRT devices in the United States, France, Germany, Italy, the United Kingdom and Japan.

Based in Toronto, Canada, MRG is a Decision Resources Group company.