Tuesday, 21 October 2014

Aortic Stent Grafts - Global Analysis and Market Forecasts, New Report Launched

Aortic Stent Grafts - Global Analysis and Market Forecasts

Sales for Aortic Stent Grafts

The total aortic stent graft sales market in 2013 was estimated to be $1,224m across the 10MM.

By the end of the forecast, the stent graft sales market will grow to over $1,930m, with a Compound Annual Growth Rate (CAGR) of 6.7%.

The key drivers for the market in the forecast are:
  • The growing prevalence of aortic aneurysms along with the aging population across the globe with hypertension and obesity.
  • The growing technological advancement in minimally invasive procedures and the desire to eliminate the need for open surgical procedures for aneurysms.
  • The major underserved population for minimally invasive aneurysm treatment in the emerging markets that is driving the procedural numbers up.
  • The unmet need for better clinical outcomes and long-term studies to reduce the risk of endoleaks and other complications.

The US market consists of the largest portion of the aortic stent graft market. The US and European Union (EU) combined formed close to 70% of the global share in 2013. In the remaining markets, Japan is the largest with China and Brazil to follow. India is by far, the smallest market. The EU is technologically the most advanced market, with the best availability of fenestrated and custom stent grafts on the market. The emerging markets see the most open surgical procedures, but stent use is restricted due to the cost of the products and procedures. As training programs for surgeons increase and product prices decrease, the emerging markets will present a strong opportunity for additional revenue for manufacturers. The overall CAGR across all 10 markets is 6.7%, with Japan and China representing the biggest growth opportunities. The growing concerns for multinational companies reside with the need to better target the fast-growing markets and the need to continue to be the leader in development to combat the threat of rising local manufacturers.

Technological Trends

Within the last twenty years, endovascular products have dramatically changed with development relating to improved navigation, trackability, and flexibility, as well as with the stability of access, especially through tortuous anatomy. Imaging technology has had an immense impact on the treatment rates and detection of aneurysms as well. The advances in ultrasound technology have greatly reduced the incidence of aneurysm rupture. Within the emerging markets, these imaging techniques represent an opportunity for stent graft manufacturers to continue training programs for better detecting the aneurysms that are asymptomatic. As a result of better detection, there can be earlier intervention and fewer open surgeries, thereby resulting in more stent graft placement.

The technological developments in endovascular repair will essentially continue to result in positive growth. The primary technological drivers include the development of ultra-low profile systems to access difficult anatomies and arteries that are smaller in diameter, especially in the Asian population. The customized fenestrated products have provided a major opportunity for physicians to treat a new patient pool that was only subject to open repair. As more of these products are approved in the US and other markets, there can be a strong case for greater product adoption. Thoracic endovascular aneurysm repair (TEVAR) is also an area that is still in its infancy, thus yielding low procedure numbers. As there is more development in those product lines and as the abdominal aortic stent graft product matures, there can be a strong platform for development in the abdominal market as well. Generally, there is still much room for development in endovascular aortic repair (EVAR) and TEVAR, and as the products evolve, there will be continued growth in this market.

Unmet Needs Remain a Challenge

The complications in endovascular repair usually occur during or immediately after the procedure, which must be treated immediately through either interventional or open surgery methods. Endoleaks are the most common complication and area of focus; the remaining complications, such as paraplegia, infection, and limb thrombosis, amongst others, occur from time to time and knowledge of them can help enhance future product design.

Technological challenges also pose an opportunity for the development of better products with better clinical outcomes. The availability of lower profile systems will continue to improve accessibility. Customized fenestrated stent grafts will allow more complicated aneurysms to be treated, thereby enhancing the potential patient pool. Multi-branched systems will also allow for more tortuous anatomy to be treated. Finally, addressing the need for more long-term clinical data will allow more surgeons to be comfortable implanting stent grafts, with the assurance of durability in younger patients.

Key Players in the Aortic Stent Graft Market

At present, the aortic stent grafts market is still dominated by the top three players: Cook Medical, Gore Medical, and Medtronic. The products that are currently approved and on the market are all of high quality and each have their strengths with fixation types. The products in development by those outside of the top three players are all innovative in their own way, but a product that will show superior benefits with a lower or at least equal cost will be the one to grow the most.

The most talked about emerging player in the market, based on Publisher’s key opinion leaders (KOLs), is Endologix. Endologix has one of the strongest product pipelines with significantly new product features and a new approach to treatment that has the potential to grab a piece of market share. The next one to three years will determine the quality of the potential products for Endologix, based on approval and clinical trials. Globally, the top 88% of the EVAR market and top 91% in TEVAR market belongs to the three companies mentioned earlier. The emerging markets are still dominated by the top three manufacturers as well, although the emerging markets also have a growing number of local players within Brazil, China, and Japan. India represents the smallest of the emerging markets, with the potential to grow upon lower product prices and an increase of product availability. The ongoing trend in the aortic stent grafts market is that the leading players will continue to maintain market share, unless a disruptive technology in this segment dramatically changes clinical outcomes.

Aortic Stent Graft Market Future Outlook

The economic downturn has been a source of continued concern for high priced medical devices across the global market. The aortic stent grafts market is not one that is excluded from this trend. Despite the high product price, physicians still see a significant benefit in providing endovascular options versus performing open surgery. As physician education improves and they have access to more clinical trial data, the outlook for the aortic stent grafts looks strong with there being much room for product improvement.

The market outlook looks strong in the Western markets, as there is still much room for product adoption and growth. Regionally, one can expect slightly different drivers for growth. The US market is expected to see a significant amount of growth once there is more availability of the customized grafts. In some countries, the EU market is still restricted by cost, thereby making physicians choose their patients carefully before implantation of the device. Finally, the markets such as Japan, China, and Brazil are seeing emerging competition from smaller firms, which will provide a landscape for pressuring large firms to reduce product prices.

The aortic stent grafts market is a moderately growing market at a CAGR of 6.7% globally, with some individual markets boasting a stronger CAGR over others. Within the 10MM, it is the cardiovascular sector that is expected to continue to grow the most in response to the continual technological developments and physicians’ acceptance of the products’ successful clinical performance. The global market is based on, and will be driven by, the rising prevalence of aortic aneurysms and the aging population.

Countries to watch are India and China, but these markets depend heavily on physician comfort with the procedure itself and the availability of new products beyond the major cities and the distribution networks. Publisher expects continued growth in this niche market with the major deterrent, globally, to be product price once a product is accepted by a surgeon.

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