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Last Updated: December 22, 2024

TECARTUS Drug Profile


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Summary for Tradename: TECARTUS
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for TECARTUS
Recent Clinical Trials for TECARTUS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
H. Lee Moffitt Cancer Center and Research InstitutePhase 2
Kite, A Gilead CompanyPhase 2
Kite PharmaPhase 1

See all TECARTUS clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for TECARTUS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TECARTUS Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for TECARTUS Derived from Patent Text Search

No patents found based on company disclosures

TECARTUS Market Analysis and Financial Projection Experimental

The Biologic Drug TECARTUS: Market Dynamics and Financial Trajectory

Introduction to Biologic Drugs

Biologic drugs, including those like TECARTUS, are revolutionizing the healthcare industry with their targeted and effective treatments for various chronic and rare diseases. These drugs, derived from living organisms, offer a new frontier in medical therapy.

What is TECARTUS?

TECARTUS is a CAR-T cell therapy developed by Kite Pharma, a subsidiary of Gilead Sciences. It is FDA-approved for the treatment of certain types of blood cancers, including mantle cell lymphoma and relapsed or refractory B-cell acute lymphoblastic leukemia.

Market Size and Growth of Biologics

The biologics market, which includes CAR-T therapies like TECARTUS, is experiencing rapid growth. The global biologics market was valued at USD 349.6 billion in 2023 and is projected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% during the forecast period[1].

CAR-T Cell Therapy Market

The CAR-T cell therapy market, specifically, is rising rapidly. By 2032, the global CAR-T cell therapy market is expected to be worth around USD 88.52 billion, growing at a CAGR of 29.8% from 2023 to 2032[5].

Financial Performance of TECARTUS

In the recent quarter, TECARTUS delivered significant sales gains. The therapy generated $96 million in revenue, contributing to the overall growth of Kite Pharma's CAR-T portfolio. Yescarta, another CAR-T therapy from Kite, generated $391 million, although it missed analyst estimates[2].

Key Drivers of the Market

Several factors are driving the growth of the biologics market, including TECARTUS:

Increasing Burden of Chronic Diseases

The rising prevalence of chronic diseases such as cancer, autoimmune diseases, and genetic disorders is a significant driver. Biologic therapies like TECARTUS offer targeted treatments for these conditions[1][3][4].

Technological Advancements

Continuous technological advancements in drug delivery systems and manufacturing processes are enhancing the efficacy and accessibility of biologic drugs. For instance, Gilead's industry-leading manufacturing capabilities allow for a 16-day median U.S. turnaround time for CAR-T therapies[2].

Regulatory Approvals

The escalating approvals of biologics by regulatory agencies are also boosting market growth. TECARTUS, being FDA-approved, benefits from this trend[1][3].

Growing Adoption of Biosimilars

Biosimilars, which are biologic products that are highly similar to an already-approved biologic drug, are increasing accessibility and affordability. This trend is particularly significant in regions like the Asia-Pacific, where the adoption of biosimilars is driving market expansion[4].

Barriers to Uptake in the U.S.

Despite the strong clinical data and growing market, there are specific barriers to the uptake of CAR-T therapies like TECARTUS in the U.S.:

Fragmentation of the Healthcare System

The fragmented healthcare system in the U.S. hampers quick access to these therapies. Most authorized treatment centers are located in large academic hospitals, while around 80% of oncology patients are treated in their local communities[2].

Access and Reimbursement

Unlike in Europe, where socialized medicine systems facilitate quicker access and reimbursement, the U.S. faces challenges in this regard. Gilead is addressing this by expanding its roster of treatment centers to treat patients where they are[2].

Regional Market Dynamics

North America

The North American market for CAR-T cell therapies, including TECARTUS, was valued at USD 3.36 billion in 2023 and is expected to reach around USD 35.50 billion by 2032, growing at a CAGR of 29.9%[5].

Europe

Europe is expected to grow at the highest rate during the forecast period, driven by a high prevalence of cancer, a large and diverse population, and improving healthcare infrastructure. The European CAR-T cell therapy market was valued at USD 2.37 billion in 2023 and is projected to reach around USD 25.82 billion by 2032[5].

Asia-Pacific

The Asia-Pacific region is also experiencing significant growth, driven by the rising burden of diseases such as cancer, diabetes, and cardiovascular diseases, along with an increasing geriatric population. The APAC CAR-T cell therapy market was valued at USD 1.69 billion in 2023 and is expected to reach around USD 18.65 billion by 2032[5].

Future Outlook and Strategies

Expanding Treatment Centers

Gilead is focusing on expanding its network of authorized treatment centers to improve access to CAR-T therapies. By the end of 2024, the company aims to have around 140 authorized treatment centers in the U.S., with plans for further expansion[2].

Manufacturing Capabilities

Gilead's advanced manufacturing capabilities, honed through the launch of Yescarta, are expected to support future CAR-T launches, such as the Arcellx-partnered CART-ddBCMA. This molecule is being evaluated in multiple myeloma and is seen as a significant opportunity for growth[2].

Market Competition

Despite recent launches of new FDA-approved medicines, Gilead believes there is enough room for multiple competitors in the market. The company is confident in its data and manufacturing capabilities to drive growth in CAR-T adoption[2].

Key Takeaways

  • Rapid Market Growth: The biologics market, including CAR-T therapies like TECARTUS, is experiencing rapid growth driven by chronic diseases, technological advancements, and regulatory approvals.
  • Financial Performance: TECARTUS has shown significant sales gains, contributing to Kite Pharma's overall revenue.
  • Barriers to Uptake: The U.S. market faces challenges due to the fragmentation of the healthcare system and access issues, which are being addressed through the expansion of treatment centers.
  • Regional Dynamics: North America, Europe, and the Asia-Pacific region are key markets with varying growth rates and drivers.
  • Future Outlook: Gilead is focusing on expanding treatment centers and leveraging its manufacturing capabilities to drive future growth.

FAQs

What is TECARTUS used for?

TECARTUS is a CAR-T cell therapy used for the treatment of certain types of blood cancers, including mantle cell lymphoma and relapsed or refractory B-cell acute lymphoblastic leukemia.

How is the CAR-T cell therapy market growing?

The global CAR-T cell therapy market is expected to grow at a CAGR of 29.8% from 2023 to 2032, reaching around USD 88.52 billion by 2032.

What are the main barriers to the uptake of CAR-T therapies in the U.S.?

The main barriers include the fragmentation of the healthcare system and access issues, which result in most treatment centers being located in large academic hospitals while patients are treated in local communities.

How is Gilead addressing the barriers to CAR-T therapy uptake?

Gilead is expanding its network of authorized treatment centers to treat patients where they are, aiming to have around 140 centers in the U.S. by the end of 2024.

What is the future outlook for TECARTUS and similar CAR-T therapies?

The future outlook is positive, with Gilead focusing on expanding treatment centers and leveraging its advanced manufacturing capabilities to support future CAR-T launches and drive market growth.

Sources

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems. Biospace.
  2. Gilead execs detail CAR-T outlook, barriers to uptake in the US. FiercePharma.
  3. Big Growth Ahead Biologic Drugs Market to Hit 823.4 Billion by 2028. BCC Research.
  4. Biologics Market Size, Share & Growth Analysis Report, 2030. Grand View Research.
  5. CAR T-Cell Therapy Market is Rising Rapidly at CAGR 29.8% by 2032. Biospace.

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