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Last Updated: December 15, 2025

TACE Drug Patent Profile


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Which patents cover Tace, and when can generic versions of Tace launch?

Tace is a drug marketed by Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in TACE is chlorotrianisene. There are four drug master file entries for this compound. Additional details are available on the chlorotrianisene profile page.

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Summary for TACE
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,032
DailyMed Link:TACE at DailyMed
Drug patent expirations by year for TACE

US Patents and Regulatory Information for TACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 008102-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 011444-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 016235-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for TACE in the Pharmaceutical Sector

Last updated: July 27, 2025

Introduction

Transarterial Chemoembolization (TACE) constitutes a minimally invasive, locoregional therapy predominantly utilized for treating primary and secondary liver cancers, especially hepatocellular carcinoma (HCC). As an innovative intervention, TACE combines targeted chemotherapy delivery with embolization to restrict tumor blood supply, thereby achieving tumor necrosis. Over recent years, the global landscape of TACE has experienced notable shifts driven by advances in medical technology, regulatory evolutions, and expanding indications. This analysis explores the intricate market dynamics and financial trajectory associated with TACE, elucidating key drivers, challenges, and future growth prospects for stakeholders.

I. Market Dynamics

A. Growing Incidence of Liver Cancer and Rationale for TACE Adoption

Liver cancer, predominantly HCC, ranks as the sixth most common cancer worldwide and the third leading cause of cancer-related mortality [1]. The World Health Organization estimates over 900,000 new cases annually, with rising incidences in Asia, Africa, and increasingly in Western countries. The increased burden of liver cirrhosis and hepatitis B/C infections fuels this trend, positioning TACE as a frontline locoregional therapy.

TACE’s prominence stems from its effectiveness in managing intermediate-stage HCC, especially where surgical options or systemic therapies are contraindicated. Its minimally invasive approach offers a favorable safety profile and symptom palliation, reinforcing widespread clinical adoption.

B. Technological Innovation and Procedural Refinement

Recent innovations bolster TACE's clinical efficacy and procedural efficiency:

  • Drug-Eluting Beads (DEB-TACE): Provides controlled release of chemotherapeutic agents, reducing systemic toxicity and enhancing local drug concentration [2].
  • Image-Guided Navigation: Integration of advanced imaging modalities (e.g., cone-beam CT) allows precise targeting, increasing procedural success rates.
  • Combination Therapies: Combining TACE with systemic agents like sorafenib or immunotherapies is showing promising results, potentially expanding indications.

These advancements are instrumental in elevating clinical outcomes, thus augmenting adoption rates and reinforcing market growth.

C. Regulatory Landscape and Reimbursement Policies

Regulatory approvals and reimbursement frameworks significantly influence TACE deployment. Although TACE procedures have been standard for decades, new device innovations—particularly drug-eluting beads—must secure approval from authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Reimbursement policies also vary across regions, with countries like Japan and Germany providing favorable coverage, thereby driving procedure volumes. Conversely, inconsistent reimbursement can impede adoption in emerging markets.

D. Competitive Landscape and Market Players

The market features a mix of established medical device companies and emerging specialty players:

  • Key Companies: Boston Scientific, Merit Medical, Terumo, and Terumo's subsidiaries dominate DEB-TACE markets.
  • Device Innovations: Partnerships between device manufacturers and pharmaceutical firms aim to develop combination products, fostering competitive differentiation.

The competitive environment propels continuous innovation, aiming for improved safety, efficacy, and cost-effectiveness.

E. Market Challenges

Despite promising growth, several challenges temper expansion:

  • Limited Access in Low-Income Regions: High procedural costs and limited infrastructure curtail TACE utilization in developing countries.
  • Alternative Therapies: Advancements in systemic treatments (e.g., immunotherapies, targeted agents) begin to challenge TACE's exclusivity.
  • Operator Dependency and Procedural Variability: Success hinges on operator expertise, influencing outcomes and market perception.

These factors necessitate targeted strategies to optimize market penetration.

II. Financial Trajectory

A. Revenue Growth and Market Size

The global TACE market is experiencing robust growth. According to a recent report by MarketsandMarkets, the global interventional radiology market—including TACE—was valued at approximately USD 6 billion in 2021, with a compound annual growth rate (CAGR) forecast of around 6.5% through 2026 [3].

The increasing procedural volumes and device sales underpin this expansion. Specifically, the rising adoption of drug-eluting beads as standard-of-care instruments enhances revenue streams for device manufacturers.

B. Impact of Technological Adoption

High-value devices, such as drug-eluting bead systems, command premium pricing, augmenting revenue. As clinical evidence accrues supporting the superior efficacy of DEB-TACE, market uptake is anticipated to accelerate, propelling financial growth.

Furthermore, region-specific expansion strategies—particularly targeting Asia-Pacific markets with high disease prevalence—are expected to yield substantial revenue increments.

C. Cost Dynamics and Pricing Strategies

Device costs, procedural expenses, and reimbursement rates considerably influence profitability. Manufacturers are increasingly adopting competitive pricing models and value-based offerings to gain market share, especially in cost-sensitive regions.

Cost-effective innovations—such as reusable delivery catheters and simplified procedural kits—further enhance margins while expanding access.

D. Potential Revenue Disruptors

Emerging systemic therapies with comparable or superior efficacy could limit procedural volumes, impacting revenue forecasts. Additionally, regulatory delays or unfavorable reimbursement policies could hinder market growth.

Intense market competition may also drive pricing pressures, necessitating continuous innovation to maintain profit margins.

III. Future Outlook

The integration of TACE within multimodal treatment paradigms, such as combining with systemic immunotherapies, portends a paradigm shift, potentially expanding its scope beyond conventional indications. Advances in personalized medicine, including image-guided precision interventions, are poised to enhance treatment effectiveness, subsequently influencing financial trajectories positively.

Moreover, healthcare policy reforms aimed at expanding coverage, coupled with technological innovations reducing procedural costs, are expected to facilitate broader adoption globally. Emerging markets represent significant growth vectors, especially as infrastructure and clinician expertise evolve.

Key Takeaways

  • Market Expansion Driven by Rising Liver Cancer Incidence: The escalating global burden of HCC fuels demand for minimally invasive, effective therapies like TACE.
  • Innovation Enhances Therapeutic Efficacy and Market Competitiveness: Advances such as drug-eluting beads, image-guidance, and combination therapies are critical growth catalysts.
  • Regional Discrepancies in Adoption: Developed regions exhibit higher procedure volumes, whereas expanding access in emerging markets presents both opportunities and challenges.
  • Revenue Growth is Supported by Device Innovation and Regional Penetration: The global interventional radiology market, inclusive of TACE, is projected to grow steadily at a CAGR of approximately 6.5% through 2026.
  • External Factors May Influence Financial Trajectory: Regulatory, reimbursement, and competitive dynamics necessitate strategic adaptation to secure sustained growth.

FAQs

1. What are the main factors driving the growth of TACE procedures globally?
The rise in liver cancer incidence, technological advancements in delivery systems, and expanding clinical indications underpin TACE's growth trajectory.

2. How do drug-eluting beads influence the financial landscape of TACE?
They command premium pricing due to enhanced efficacy and safety profiles, propelling revenue growth for device manufacturers and increasing procedural profitability.

3. What challenges might impede the future expansion of TACE?
Limited access in low-income regions, competition from systemic therapies, regulatory hurdles, and operator dependency can restrict growth.

4. How is the COVID-19 pandemic affecting TACE market dynamics?
The pandemic temporarily slowed procedural volumes due to healthcare resource reallocations but also spurred innovations and telehealth integration, fostering long-term resilience.

5. What strategic approaches can stakeholders adopt to capitalize on TACE market opportunities?
Investing in technological innovation, expanding regional access, forging strategic partnerships, and engaging with evolving reimbursement policies are pivotal.


References

[1] World Health Organization. (2020). Global cancer statistics 2020.
[2] Varela-Camarena, L. et al. (2020). Drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma. J Liver, 9(1), 12-27.
[3] MarketsandMarkets. (2022). Interventional radiology market report.

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