Liquid Embolics: A Small Market with Big Potential

New products must expand indications and reduce 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 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).

The US is the largest market for liquid embolic products, with an estimated market value of approximately $80m in 2018. As the demand for embolization therapies continues to increase, there is an opportunity to expand the market through a new generation of liquid embolic agents that improve patient lives with better clinical outcomes. The challenge? Companies need to overcome the limitations that are plaguing the current products on the market, chiefly cost and indications.

The Current State of the Liquid Embolic Market

Despite the fact that liquid embolics have been around for nearly two decades, interventional radiologists (IRs) in the US have been slow to adopt widespread use of these products. When asked how frequently they use liquid embolics in their procedures, 77% of IRs reported employing liquid embolics in less than 20% of the procedures they perform. They indicate cost as the number one reason for not using them more often, with a mix of utility concerns falling behind price.

Market forecasts estimate that the majority of liquid embolic product sales are 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 better 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 that, despite 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.

Factors Driving and Restraining the Market

When examining the opportunity in liquid embolics, consider the following:

Multi-disciplinary application. The transcatheter embolization market is a ~$3 Billion market globally, with solutions for indications across many branches of medicine that include oncology, PVD, neurology, and urology. Clipping and coiling products have been the gold standard for vessel embolization for many years, primarily due to the cost-effectiveness of the devices.

Product complications and lack of data are stunting the market. Liquid embolic 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 still a factor in adoption.

Liquid embolics have shown to be safe and effective. Commercially available liquid embolics have been used to successfully treat hypervascular tumors^{1, 2}, peripheral vascular lesions^{3, 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.

Expanded regulatory approval is needed. Primary research supports the available clinical data – IRs recognize that the efficacy and value of liquid embolic agents extends into off-label indications. Therefore, companies developing liquid embolic agents could expand market share and accelerate sales by pursuing regulatory approval for indications beyond neurointerventional.

Neurovascular disease is on the rise. The increasing incidence of neurovascular disease, particularly brain aneurysm, is driving the need for liquid embolics. In the US, the growing elderly demographic is pushing cases of neurovascular disease, cancer, and PVD higher. At the same time, the number of Americans over the age of 65 is projected to more than double by 2060. This group 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.

If costs can be reduced, there is market share up for grabs. 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 restrained 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 preferred to treat neurovascular indications, particularly brain aneurysm, due to a lower average sale price with equivocal clinical efficacy. Liquid embolics are chosen over alternative devices in patients on anticoagulants or those with impaired coagulation.

Liquid Embolics’ Current Competitive Landscape

Competition is steep from MedTech giants (i.e. Medtronic and Johnson & Johnson), as well as alternative embolization products. 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 aneurysms.

Both Medtronic and DePuy Synthes have been inactive in the liquid embolics market since the introduction of their products over a decade ago.

Table 1: Commercially Approved Liquid Embolic Agents in the US

Product Name	Company	Embolizing Agent	Indications
Onyx	Medtronic	EVOH	Cerebral AVM, brain aneurysm
TRUFILL	DePuy Synthes/ Johnson & Johnson	n-BCA	Cerebral AVM

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.

Despite the hurdles that need to be overcome to capture market shares, there is still room for improvement upon existing embolization technologies. It is worthwhile to continue to develop new embolization products to address the limitations of current products and improve patient outcomes.

Emerging Products Could Invigorate the Liquid Embolics Market

Each 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 market.

Table 2: 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

Opportunities for New Solutions

The liquid embolic market may be small, but it is rich with opportunities for the right innovation. Developers of novel liquid embolic agents appear to be addressing existing challenges when designing the products of the future. 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 need in the market is there, and without an all-encompassing therapy for cases requiring embolization, there is a significant opportunity for entrepreneurs to create new liquid embolic products that meet patient demand while addressing cost and expanding indications.

For further information on the liquid embolic market, please contact us or send an inquiry to intelligence@jauntup.com.

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Jaunt LLC is a management consulting firm focused on new and emerging medical markets. We 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.

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