Major markets such as cardiovascular and orthopaedic devices have witnessed immense innovation over the past decade in terms of procedural ease of use and catering to previously unmet needs.

Advancements in interventional cardiology technology and grafting procedures for orthopaedic applications has meant that these markets are now saturated, and will be deemed as mature in the next five years.

Many of those cardiovascular and orthopaedic firms are now looking towards new areas to sustain or bolster growth. Market analyst GlobalData’s “The US Neurology Devices Market to Present Opportunities for Growth” report says huge growth and investment opportunities in the future will be found in neurology devices.

Major cardiovascular technologies such as cardiac rhythm management and stents are now being explored for use in conditions of the nervous system in an effort to create new growth opportunities. Recent market events show that competition within the neurovascular and neurostimulation device markets is on the rise.

To date the market has been dominated by companies traditionally focused in the cardiovascular device arena such as Medtronic, Boston Scientific and St Jude Medical.

“The pipeline for neurovascular devices is one of the strongest compared to other markets.”

A look at the clinical trial scenario for neurostimulation devices and neurovascular stents reinforces this trend. Together these companies have more than 15 major clinical trials underway, investigating neurology devices for various indications.

This trend of cardiovascular firms shifting into new markets such as neurology is expected to be all the more accentuated in the US. The US has always enjoyed high acceptance rates for new and innovative technologies in the past and device manufacturers are banking on the same for growth in the neurology field.

The pipeline for neurovascular devices is one of the strongest when compared to other markets and products in the pipeline are mainly first-in-class devices that cater to unmet needs. GlobalData has found that neurovascular stents, embolic systems and neurostimulation devices are the most popular segments in terms of growth opportunities.

A stimulating market

The neurostimulation market is a high-potential market for medical device manufacturers. It was first developed in the 1970s as a treatment for Parkinson’s disease but because of excessive side effects it was later stopped as a form of therapy.

Over the past five years, neurostimulation has entered a renaissance period, not only because the technology has been completely overhauled but also due to the newly realised potential of how many diseases it can now offer treatment for.

“The revenue potential associated with a wide range of disease indications is pushing cardiovascular players into the neurostimulation market.”

Neurostimulation is being cited as the best treatment option for indications such as Parkinson’s, Tourettes syndrome, migraines, chronic pain and major depression. The revenue potential associated with this wide range of disease indications is pushing many major cardiovascular players into the neurostimulation market.

Extensive clinical research continues to identify and prove efficacy for new indications related to implantable neurostimulators. There are more than 15 major clinical trials studying the efficacy of neurostimulation devices on these diseases. In addition, favourable reimbursement policies from governments around the world coupled with advances in the fields of post-cancer pain therapy and in other diseases such as epilepsy are expected to bolster market growth.

Medtronic was the leading competitor in the area in 2008, controlling more than half of market share. St Jude Medical and Boston Scientific have also made inroads into this market with a strong pipeline portfolio, especially in the spinal cord stimulation market. Both companies have clinical studies underway on neurostimulation for a number of emerging indications.

The neurostimulation devices market in the US was valued at $919m in 2008. Driven by positive clinical trial outcomes and an increasing number of diseases that look to be treatable with neurostimulation, the market is forecast to grow with a combined annual growth rate (CAGR) of 11% until 2015 to reach $1.9bn.

The right vein

The embolotherapy market is a high-growth market driven by a large patient population and the introduction of a number of innovative products.

“A recent trend in the embolotherapy market is the use of embolisation products to treat new areas such as uterine fibroids.”

These products are being used in indications that vary from tumours to vascular trauma and peripheral malformations. These products are targeted towards an estimated population of more than five million individuals in the US each year.

Embolotherapy has been used for more than 20 years by interventional radiologists to block the flow of blood in the treatment of certain peripheral tumours and arteriovenous malformations. A recent trend in the embolotherapy market is the use of embolisation products to treat new areas such as uterine fibroids, where it is replacing the traditional methods of hysterectomy and myomectomy.

A number of key factors are driving the embolic systems market:

  • A global ageing population and the resulting increase in the target population for embolotherapy is expected to play a key role in the growth of this market in the US. The “baby boomer” generation, which is hitting retirement age, will continue feeding into the target patient population for embolotherapy.
  • Increasing incidence of aortic and cerebral aneurysms is another factor that will fuel the embolotherapy market.
  • The use of the devices in new disease indications such as uterine fibroids and varicoceles will increase the target patient population. Varicoceles affect 10–15% of the adult male population in the US. As varicocele embolisation is a minimally invasive procedure, it is driving the market as an alternative treatment to open surgery.
  • Physician demand is the key force driving volume sales in the embolotherapy market. Industry experts from various geographic regions agree that the acceptance of the technology by doctors and the ease of training are driving the growth in this market.

The embolic systems market in the US was valued at $164m in 2008. Driven by increasing acceptance and new technologies such as pipeline embolisation devices, liquid and particle embolic systems, the market is forecast to grow at a CAGR of 9% until 2015 to reach $290m.

Stent technology: one to watch

The US market for neurovascular stents is small and is valued at just over $30m in 2008. This market is, however, generating interest from many cardiovascular companies because of an increasing patient population and advances in technology.

“Intracranial atherosclerotic disease is prevalent in the US and neurovascular stent technology is expected to play an important role.”

Intracranial atherosclerotic disease is increasingly prevalent in the US and neurovascular stent technology is expected to play an important role in treating the disease.

Today, there is only one device approved for treating the disease in the US and it has only been approved for humanitarian use. This huge unmet gap will provide ample opportunities for growth.

The only barrier for this technology and the market alike appears to be the limited number of qualified neurosurgeons performing the procedure and the associated high risk of the devices.

Also, as yet there are no long-term clinical trial results that support the use of neurovascular stenting.

New and emerging players are expected to increase in the coming years. The interest generated in this market was reiterated by the acquisition of Chestnut Medical by ev3 to gain access to Chestnut Medical’s pipeline embolisation device that offers treatment for large aneurysms of the intracranial vasculature.

This report and more can be found at GlobalData’s Report Store.