Author: Nick Talamantes, Market Intelligence Manager at Jaunt LLC
New products must look to expanding indications and reducing costs in order to capture adoption
The history of embolotherapy dates back to the early 1970s, when a team from the Oregon Health Sciences University led by Dr. Charles Dotter performed the first embolization procedure with an autologous blood clot. Since that seminal procedure, a number of embolization therapies have been developed to intentionally occlude arteries and veins for therapeutic purposes, with simple mechanical devices first flooding the market for this technique. The first commercially approved liquid embolic received regulatory approval from the FDA in 2005 for the treatment of neurovascular defects, such as cerebral aneurysm and arteriovenous malformation (AVM). In spite of the fact that liquid embolics have been around for nearly two decades, interventional radiologists (IRs) have been slow to adopt widespread utilization of these products, leaving the market smaller than one may think. However, there is still a large opportunity for liquid embolic agents if they can overcome the limitations of current products on the market, chiefly cost and indications.
The US is the largest market for liquid embolic products, with an estimated market value of approximately $90m in 2018. Market forecasts estimate that the majority of liquid embolic sales are attributable to products for the treatment of approved neurovascular indications. However, primary research suggests that off-label usage of liquid embolic agents accounts for a significant percentage of overall utilization.
Jaunt conducted two surveys to understand how IRs are utilizing liquid embolic agents. Results from these surveys indicated that IRs frequently use liquid embolic agents off-label for the embolization of hypervascular tumors and peripheral lesions. It can be inferred based on the data collected that despite their cost and lack of approval beyond neurovascular indications, IRs view liquid embolic agents as a useful tool for achieving embolization of larger vessels and lesions.
Liquid embolic agents are underutilized among IRs in the US. When asked how frequently they use liquid embolics in their procedures, 77% of IRs reported employing liquid embolics in <20% of procedures they perform, stating cost as the number one reason for not using them more often, with a mix of utility concerns following that. The relatively low rate at which IRs are using liquid embolics could be improved upon as manufacturers work to expand utility through additional indications and bring down costs.
Factors driving and restraining the liquid embolics market
The transcatheter embolization market is reportedly a ~$3 Billion market globally, featuring solutions for indications across many branches of medicine, including oncology, PVD, neurology, and urology. Clipping and coiling products have been the gold standard for vessel embolization for many years – primarily as a result of the cost-effectiveness of these devices. However, these products are limited by a number of complications, such as balloon deflation, catheter entrapment, and difficulties in deploying the device to the targeted lesion. Despite the large number of embolization products that are commercially available, clinical data comparing products is limited, which may be one reason why cost is apparently still a significant factor for adoption.
Commercially available liquid embolics have been successfully utilized in treating hypervascular tumors1, 2, peripheral vascular lesions3, 4, and varicoceles5. Clinical data evaluating the safety and efficacy of off-label applications of commercial liquid embolics have demonstrated positive results, which should encourage developers of liquid embolics to pursue expanded indications for use. Primary research supports available clinical data – IRs recognize that the efficacy and value of liquid embolic agents extends into off-label indications. Therefore, competitors developing liquid embolic agents could expand their market share and accelerate sales by pursuing regulatory approval for indications beyond neurointerventional.
The rising incidence of neurovascular disease, particularly brain aneurysm, in the US is another factor influencing the potential growth of the liquid embolics market. Cases of neurovascular disease, cancer, and PVD, are all increasing in the US as a result of demographic changes – primarily due to the growing elderly demographic. The number of Americans over the age of 65 is projected to more than double by 2060. The elderly demographic also happens to be at high risk for developing vascular disease and cancer. The burden of these diseases is further compounded by the fact that Americans are living increasingly unhealthy lifestyles that are elevate their risk for developing these chronic conditions.
While the US is the largest market for liquid embolic sales for neurovascular indications, these products only accounted for approximately 17% of total neurovascular embolization device sales in 2018. Competition from alternative transcatheter embolization devices has had a significant restraining effect on product sales growth. Alternative transcatheter embolization devices include:
- aneurysm clips
- embolic coils
- embolic microspheres
- flow diverting stents
- intrasaccular flow disruptors
Of these alternatives to liquid embolics, aneurysm clips and embolic coils are favored for the treatment of neurovascular indications, particularly brain aneurysm, due to a lower average sale price with equivocal clinical efficacy in comparison to liquid embolics. Liquid embolics are chosen over alternative devices in patients on anticoagulants or those with impaired coagulation.
Emerging products could invigorate the liquid embolics market
There are a number of liquid embolic agents in development. See Table 1 for a summary of liquid embolics in development.
All of the next-generation liquid embolic products listed below are currently in the pre-clinical development stage. The majority of these products utilize novel embolizing agents which may help to address the limitations of currently available liquid embolics. Products in development will require robust clinical comparison data in order to overcome the hurdles that have historically restrained the liquid embolics market.
Table 1: Liquid Embolic Agents in Development
|Product Name||Company||Embolizing Agent||Indications||Development Stage|
|GPX||Fluidx Medical Technology||EVOH||Embolization||Pre-clinical|
|Hydrogel Embolic System (HES)||Instylla||Functionalized polyethlene glycol precursors||Embolization of tumors, organs, & specific segmental embolizations||Pre-clinical|
|SELP||Theratarget||Silk Elastin Protein Polymer (SELP)||Chemoembolization||Pre-clinical|
|Shear-Thinning Biomaterial||Mayo Clinic Arizona & UCLA Bioengineering||Gelatin & silicate nanoplatelets||Embolization||Pre-clinical|
Liquid embolics’ competitive landscape
Sales of Medtronic’s Onyx liquid embolic accounted for the majority of total liquid embolic sales in the US in 2018. It is currently the only liquid embolic approved for the treatment of cerebral AVMs and brain aneurysm. The other key player in the US liquid embolics market in 2018 was Johnson & Johnson subsidiary DePuy Synthes, offering the TRUFILL liquid embolic. Both Medtronic and DePuy Synthes have been inactive in the liquid embolics market since the introduction of their products over a decade ago. Table 2 provides a summary of commercially approved liquid embolics in the US.
Table 2: Commercially Approved Liquid Embolic Agents in the US
|Product Name||Company||Embolizing Agent||Indications|
|Onyx||Medtronic||EVOH||Cerebral AVM, brain aneurysm|
Johnson & Johnson
Terumo’s subsidiary MicroVention obtained Humanitarian Use Device (HUD) designation from the FDA for its PHIL Embolic System in 2016 – the first regulatory designation for a liquid embolic agent in over a decade.
Competition is steep from medtech giants (i.e. Medtronic and Johnson & Johnson), as well as alternative embolization products. Despite the hurdles that need to be overcome in order to capture market shares, there is still room for improvement upon existing embolization technologies. It is worthwhile to continue to develop new embolization products in order to address limitations of current products and improve patient outcomes.
Opportunities for new solutions
A next-generation of liquid embolic agents could potentially expand this market segment. Developers of novel liquid embolic agents appear to be taking into consideration the flaws of existing products when designing their products. New embolizing agents, indications for use, and applications for use (e.g. chemoembolization) are all promising steps in the right direction that can lift the prospects for this industry. The demand for embolization therapies continues to increase, and without an all-encompassing therapy for cases requiring embolization, there is significant opportunity to introduce solutions that improve patient lives with better clinical outcomes compared to current transcatheter embolization devices.
For further information on the liquid embolics market, please contact Jaunt at email@example.com.
Jaunt LLC is a management consulting firm focused on new and emerging medical markets. They solve product-market-fit problems by partnering with companies and investors to define market opportunities and to successfully bridge the gap between technology and its customer. Located in Mesa, AZ, Jaunt services clients across the country. For additional information visit JauntUp.com.