The global market is forecast to exceed $5 billion by 2018 having grown at a Compound Annual Growth Rate (CAGR) of 4% from 2011, driven by a growing patient pool due to the aging population, and other risk factors such as diabetes, obesity and lack of physical activity. Rising demand for endovascular procedures and the launch of new innovative devices such as Drug-Eluting Balloons (DEBs) will also drive market growth.
The following figure gives the forecast revenues for the global peripheral vascular devices market.
The launch of advanced products such as DEBs has resulted in growing demand for non-stent treatments for Peripheral Arterial Disease (PAD) and below-the-knee disorders in which stents cannot be used.
Factors such as the shorter dual antiplatelet therapy regimen required by DEBs and the high risk of thrombosis associated with other treatment options are some of the favorable factors that will drive their adoption. DEBs are also able to overcome various issues associated with stents, such as high risk of restenosis, incomplete drug delivery and limited area coverage for drug delivery. These advantages are encouraging physicians to opt for DEBs for the treatment of Peripheral Vascular Diseases (PVDs), and the market is forecast to grow in the near future as a result.
Due to the high risk of stent thrombosis, patients are prescribed anti-platelet therapy to prevent clot formation, making it unsuitable for elderly patients, pregnant women and those at high risk of bleeding. DEBs are preferable in this case as they require approximately three months of therapy in contrast to the 12 months required for Drug-Eluting Stents (DESs). This has increased demand for DEBs around the world.
DEBs such as Paccocath from Bayer, SeQuent Please by B. Braun Melsungen, Advance PTX from Cook Medical, Dior from Eurocor and In.Pact Amphirion paclitaxel-eluting PTA balloon catheter from Medtronic have been launched and are available in Europe.
DEBs are yet to be approved in the US, Canada and Japan. As such, these countries offer opportunities for growth for PVD manufacturers, and in order to expand into new geographies all the major PVD companies are working towards launching their products in these countries. Lutonix, acquired by Bard, initiated the first Food-and-Drug-Administration (FDA)-approved trial in the form of Levant II, an Investigational Devices Exemption (IDE) study comparing Lutonixs drug-coated balloon to a standard balloon angioplasty for the treatment of PVD. Participants will be monitored for five years, with the company expecting to file for a Pre-Market Approval (PMA) submission for Moxy DEB a year after the follow-up, likely to take place in 2014 (C. R. Bard, press release, July 25, 2012).
Medtronic also has a Phase II trial in progress in the form of the In.Pact SFA II study, which is the first clinical trial in the US for its line of In.Pact DEBs. The outcomes will be combined with the SFA I study (in Europe) for the PMA application to the FDA (Medtronic, press release, April 13, 2012). The expected completion date for the study is 2018 (Medtronic Endovascular, NCT01566461).
The approval of DEBs in the US and other geographies such as Canada and Japan is expected to accelerate market growth in the near future.
The peripheral vascular stents and stent grafts segments together constitute more than 50% of the pipeline products in the peripheral vascular devices market.
It is expected that the launch of innovative products in these segments will result increase the adoption of advanced products, leading to overall market growth in terms of revenues.
There are 45 pipeline products in the peripheral vascular stents segment and 37 pipeline products in the stent grafts segment.
The growing demand for minimally invasive treatment options such as angioplasty with stents for treating PVD and endovascular treatment options such as Endovascular Aortic Repair (EVAR) for treating Abdominal Aortic Aneurysms (AAAs) or Thoracic Aortic Aneurysms (TAAs) are the main driving factors for peripheral vascular stents and stent grafts. Companies are focusing on R&D for these projects in order to meet growing demand.
Minimally invasive procedures such as Percutaneous Transluminal Angioplasty (PTA) and EVAR for treating AAAs and TAAs have seen higher global adoption due to their improved patient comfort and minimally invasive nature. The associated risk of morbidity and mortality is also very low in comparison to open surgery.
EVAR procedures have the following advantages:
As a result, more patients are opting for less invasive procedures over traditional open surgery, driving demand for devices used in these procedures, such as PTA peripheral DEBs, peripheral vascular stents, stent grafts and PTA balloons. According to in-house analysis, the global stent grafts market volume increased from 90,169 in 2004 to 157,932 in 2011.
The launch of innovative products such as DEBs for use in PTA will also result in market growth in the near future as physician acceptance for DEBs in Europe is high, resulting in increased revenues for companies.
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