Although improvements have been made in non-vascular stent technology, unmet clinical needs and current device limitations will continue to restrict market growth in the United States. Meanwhile, emerging markets China, Brazil and India are expected to expand and account for 24% of the market in 2021, according to a recent report by research and consulting firm GlobalData, The U.S., EU (France, Germany, Italy, Spain, and the UK), and Japan will account for 76%.
Although the United States is expected to experience less growth than other markets, it remains the leader worldwide. In 2013, the market for non-vascular stents was worth $205.5 million, with a projected 3.3% compound annual growth rate (CAGR) taking the market to nearly $266 million by 2021. Conversely, a 4.5% CAGR is expected in France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India.
“Barriers to more heightened growth in the U.S., as opposed to the EU, include the slower adoption of newer stent technology, due to increased regulatory scrutiny by the Food and Drug Administration and an expensive product approval cycle,” says Priya Radhakrishnan, director of medical devices at GlobalData.
Non-vascular stents include enteral, airway, urinal tract, and pancreatic and biliary stents. In 2013, global sales were estimated at nearly $489 million and are expected to grow to $695 million by 2021. Market drivers include a growing elderly population with increased life expectancy, expanded use of stents (including a rise in removable metal stents in gastrointestinal applications), improvements in stent design and delivery systems, and increased adoption of minimally invasive techniques.
A large patient population is driving higher stent procedure volumes in China, Brazil and India. These emerging markets are expected to continue to expand as households see an increase in income and thus want a higher quality of healthcare.
Newer technologies need to integrate designs that have high radial strength and minimal fracture to reduce post-procedure complications and improve clinical outcomes. The introduction of biodegradable stents could be a future market driver, but the lack of long-term clinical data and high average selling price is a current limitation.
All market figures provided by GlobalData