We presented the following: (i) a detailed overview about the embolization microspheres and the therapies involved, (ii) in-depth market research (current market size, growth rates, and market projections); (iii) product research and their respective manufacturers; (iv) indications of use; (v) statistics related to liver cancer (hepatocellular carcinoma); (vi) overview of potential patient pool (consumer market research); (vii) cost of treatment in the USA, UK, and EU; (viii) cost-effectiveness analysis to demonstrate economically benefitial perspective; (ix) and an example sale price estimate obtained directly from the manufacturer.
Introduction to Embolization Microspheres:
Microsphere embolization is an interventional radiology procedure that involves injecting microspheres into an artery in the liver, to block the blood flow to a tumor in the liver. There is currently no standard treatment for patients with hepatocellular carcinoma (HCC). Currently, four therapies are available which have been categorized based on their mode of delivery and mechanism of action. The choice of the therapy depends upon clinician’s feasibility, patient’s tumor size, cancer staging, disease prognosis, and clinical condition. Most common therapies employed for the treatment of liver cancer are TACE, DEB-TACE, and TARE (refer to the description below)
1. Trans-arterial embolization (TAE) or Bland Embolization or Conventional Embolization: A thin, flexible tube (catheter) is inserted into the hepatic artery in the liver. Small particles (microspheres) are inserted into the artery which plugs off the artery, blocking the blood supply (carrying nutrients and oxygen) to the tumor for survival. Other indications of TAE therapy include: hypervascular tumors, uterine fibroids, and arteriovenous malformations.
2. Trans-arterial chemoembolization (TACE): This procedure is used for large liver cancers that cannot be treated with surgery or ablation. It combines embolization (TAE) with chemotherapy. The procedure is similar to TAE, except that chemotherapy is delivered alongside embolization microspheres.
3. Drug-eluting bead chemoembolization (DEB-TACE): This procedure is based on TACE, except that the chemotherapy drug is delivered in tiny drug-eluting beads. The drug-eluting beads slowly release the chemotherapy in a localized tumor region, which increases the chances of cancer cells to die. The most commonly employed chemotherapeutic agents include mitomycin C, cisplatin, and doxorubicin.
4. Transarterial radioembolization (TARE): A procedure that combines embolization with radiation therapy. Radioactive microspheres (isotope yttrium-90) are delivered to the localized tumor site by a similar TAE delivery phenomenon. The radioactive beads release small amounts of radiation to the tumor site for days to kill the cancer cells.
Product Research – Overview of Embolic Agents
- The modern embolic agents are categorized based on their mechanism of action: (i) temporary, or (ii) permanent. Temporary include gelfoam, collagen, and Thrombin. Whereas, permanent ones include particles (polyvinyl alcohol, embospheres), coils (pushable, injectable, detachable), and liquids (glue, onyx, alcohol, algel).
- Particle-based embolic agents are categorized based on the therapeutic mechanism of action: (I) Drug-eluting beads, (II) Radioembolization particles, (III) PolyVinyl Alcohol particles, and (IV) Microspheres. For the management and treatment of Liver Cancers, most commonly TACE and TARE therapies are employed.
- [I] First Category: In order to deliver chemotherapeutic agents to tumors, a therapy known as transarterial chemoembolization (TACE) is employed. It involves the use of drug-eluting beads (DEB) – a novel drug delivery system that allows fixed and sustained doses to be delivered to tumor regions. Three DEB’s are available: (i) Tandem (CeloNova Biosciences Inc., USA), (ii) DC-Beads (BTG, UK) and (iii) HepaSphere(®) (BioSphere Medical, Inc., USA).
- [II] Second Category: In order to deliver localized radiation therapy to a tumor region, a transarterial radioembolization (TARE) is used. It is efficient and safe for use in advanced liver cancers, and those with vascular complications. Two types of radioembolization microspheres are available: SIR-Spheres (Sirtex Medical Limited, Australia) and TheraSphere (BTG, UK).
- [III] Third category: is non-drug eluting, non-radiological, polyvinyl-alcohol-based Embolization particles, which are used for permanent embolization therapy. It comprise of following products: (i) Contour SE® particles (Boston Scientific, Natick, USA), (ii) Bead Block® (BTG, Surrey UK), (iii) DC/LC Bead® (BTG, Surrey UK), (iv) Embosphere® (Merit Medical, Rockland, MA, USA), and (v) Embozene® (CeloNova BioSciences Inc., Atlanta, GA, USA).
- Embolization particle is categorized into four segments based on the composition and mechanism of action: (i) Radioembolization particles or microspheres, (ii) Drug-eluting beads, (iii) PolyVinyl Alcohol particles, and (iv) Microspheres.
- Based on the application of embolization particles, the global market is segmented as (i) Liver Tumor Embolization , (ii) Trauma Embolization, (iii) Prostatic Artery Embolization , (iv) Uterine Fibroid Embolization, and (v) Others. The choice of particles mainly depends on patient age, portability, cost of the device, and treatment type.
- The global embolization particle market is divided into two broad categories: (i) radioembolization particles, and (ii) drug-eluting beads. According to the 2016 Market Research Futures Report, the market share for radioembolization particles was 45.8%, while for drug-eluting beads was 54.2%.
- According to the Millennium Research Group Report, the estimated growth projections for radioembolization market was $50 million (in 2011) to $128 million (in 2015). While the drug-eluting beads market was projected to grow from $11 million (in 2011) to $28 million (in 2015).
- The global market size for the embolization particle is expected to reach around USD 1909.76 million by 2023, with a compound annual growth rate (CAGR) projected around 9.64% (2017-2023).
- The Americas have the largest share of the embolization particle market size and are projected to USD 703.13 million by 2023.
- The compound annual growth rate (CAGR) for the radioembolization market is projected at 10.01%, during the forecast period from 2017 to 2023.
- Prominent players: Terumo, Guerbet, BTG International Ltd, Boston Scientific Corporation, Medtronics, Sirtex, Cook Medical, Varian Medical, and Merit Medical are prominent players of the global embolization particle market.
- Detailed market research regarding the embolization market is available after purchase on this website.
Hepatocellular Carcinoma Statistics:
- One of the most common uses of embolization particles is for the treatment of localized, intermediate-stage, inoperable liver cancers (hepatocellular carcinoma, or HCC). Clinical trial data support the use of transarterial chemo-embolization (TACE) as a therapeutic modality for intermediate-stage HCC, in 50%–60% of the cases.
- Risk factors for HCC include Viral Hepatitis (B or C), Alcohol consumption, Hemochromatosis, Aflatoxin exposure, Smoking, Diabetes, and Non-alcoholic fatty liver disease.
- In the United States, the estimated incidence of primary liver cancer in 2020 will be 42,810 adults (30,170 men and 12,640 women). Whereas, mortality estimates for 2020 will be around 30,160 people (20,020 men and 10,140 women)
- In a study from Japan, the incidence of intermediate-stage HCC was 12.87%, amongst new cases of HCC.
- The median survival rate for unresectable HCC, treated with transarterial chemo-embolization (TACE) is 34 months, with a 5-year survival of 26%.
- The chemoembolization therapy will most likely not eliminate cancer, but has shown to improve patient survival rate. The therapy is also used for patients on the waiting list for liver transplantation.
Consumer Market Research for TACE:
The estimated annual patient pool of intermediate-stage HCC, in the U.S. (specifically for 2020) can be calculated using the following calculation:
- 42810(estimated incidence of primary liver cancer)*0.1287(estimated percentage of intermediate-stage HCC cases) = 5509 potential cases of intermediate-stage HCC in the USA in 2020.
- 5509 * 0.6 (percentage of cases treated with TACE) = 3305 potential cases treated with TACE in 2020.
- For an estimated treatment cost with TACE therapy: 3305 * 74,788(cost of one TACE therapy) = USD 247.17 million
Estimated total annual medical cost of treating HCC patients with TACE therapy in the USA = USD 247.17 million (representative of total consumer market size)
Cost of TACE & Cost-Effectiveness of TACE therapy in the USA:
- As indicated earlier, recent years’ searches and scientific papers do not reveal much information about the cost of embolization particles. However, the cost of the overall treatment, and per-session treatment has been obtained from some cost-effectiveness-based scientific publications.
- According to a U.S-based research publication from 2013, which used Medicare database and SEER database (Surveillance, Epidemiology and End-Results Program), to estimate the treatment expenditure for primary HCC patients treated with TACE therapy (without transplant or surgical resection), between 2000-2007.
– Cost of single course of TACE therapy (57% of patients) = $74,788 (95% confidence interval, CI: $71,890–$77,686)- Cost of two courses of TACE therapy (24% of patients) = $101,126 (95% CI $94,395–$107,856),- Cost of three courses of TACE therapy (11% of patients) = $111,776 (95% CI $101,931–$121,621)- Cost of four courses of TACE therapy (8% of patients) = $148,878 (95% CI $136,346–$161,409).
- According to Canadian-based scientific publication from 2013, presenting healthcare costs (in USD), and cost-effectiveness analysis of TACE therapy for the treatment of liver cancer (HCC), between 2002-2010.
– The average total cost of Monotherapy for the treatment of HCC per person:(i) Radiofrequency Ablation (RFA) = $55,925 ($52,123–$59,727)(ii) Surgical Resection (SR) = $119,032 ($115,799–$122,265)(iii) Liver Transplantation (LT) = $211,286 ($203,566–$219,007)- The average total cost of “Dual-Treatment with TACE” for the treatment of HCC per person:(i) TACE + RFA = $48,485 ($43,663–$53,307)(ii) TACE + SR = $126,514 ($114,451–$138,577)(iii) TACE + LT = $178,354 ($163,494–$193,215)- The average total cost of no treatment for HCC would still be $38,472 per person
- Adjusted Incremental cost-effectiveness ratio or ICER ($/life-years gained): A cost-effectiveness ratio (ICER) is most commonly expressed in cost per life year saved or, if adjusted by patient functional gain, in a modification as cost per quality-adjusted life year saved.
Cost of TACE therapy in the UK and EU:
- According to a scientific article of 2017, the healthcare costs of transarterial chemoembolization in the treatment of hepatocellular carcinoma in the UK reveal the following costs:
- According to a scientific publication of 2016, the total costs of DC Beads for TACE therapy was € 11656.
- According to another publication of 2015, the total estimated costs of treatment per patient amounted to €13,418.49 with TACE, and €26,106.08 with TARE.
Cost of TARE therapy in the USA:
- Only two Y-90 radioactive microsphere products for TARE therapy are commercially available: (i) TheraSphere® (MDS Nordion, Ottawa) and (ii) SIR-Spheres® (Sirtex Medical Limited, Lane Cove, Australia). According to the ‘Canadian Agency for Drugs and Technologies in Health (CADTH)’ September 2007 issue, following costs have been obtained, which might have decreased over the years, given new technologies have emerged.
- The SIR-Spheres coding guide for January 2019 gave an insight about per session cost of microsphere administration which is detailed below. SIR-Spheres® Y-90 resin microspheres (by SIR TEX company) are based on the radioembolization procedure, indicated for unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy.
– Facility Payment: (i) For Hospital out-patient = $9,669(ii) For Ambulatory Surgery Center = $4056- Physician Payment: (i) For Hospital-based facility = $589(ii) For Non-facility or Office Environment = $9861
Direct Selling Price of Embolization Microspheres (USA):
As indicated earlier, the direct costs (or sale prices) for the embolic particles is not available. To get an idea of sale price, an attempt was done to reach out to customer services department of CeloNova BioSciences – manufacturer of Embozene microspheres. These microspheres are indicated for embolization for the following conditions: hepatocellular carcinoma, hypervascular tumors, arteriovenous malformations, uterine fibroids, tumors (of head, neck, torso, and skeletal system), bleeding and trauma, and pre-operative reduction of bleeding other than in the central nervous system.
- The direct sale price to most hospitals in the U.S. is USD 250
- For specific hospitals recieving a healthy discount, the sale price is around USD 165.