Brexucabtagene autoleucel - Biologic Drug Details

Summary for brexucabtagene autoleucel

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for brexucabtagene autoleucel

Recent Clinical Trials for brexucabtagene autoleucel

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
H. Lee Moffitt Cancer Center and Research Institute	Phase 2
Stanford University	Phase 1
Kite Pharma	Phase 1

See all brexucabtagene autoleucel clinical trials

Note on Biologic Patents

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1. Brand-side disclosures in response to biosimilar applications

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 brexucabtagene autoleucel Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Brexucabtagene Autoleucel

Introduction

Brexucabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy, has been making significant waves in the oncology treatment landscape. This therapy, marketed as Tecartus, is specifically designed to target the CD19 antigen and is used in the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL) and other B-cell malignancies. Here, we delve into the market dynamics and financial trajectory of brexucabtagene autoleucel.

Market Size and Growth

The global CAR T-cell therapy market, which includes brexucabtagene autoleucel, is projected to experience substantial growth. As of 2023, the global CAR T-cell therapy market was valued at USD 8.44 billion and is expected to reach approximately USD 107.92 billion by 2033, growing at a CAGR of 30% from 2024 to 2033[1].

Segment Performance

Within the CAR T-cell therapy market, brexucabtagene autoleucel is a significant player. In 2023, the revenue generated by brexucabtagene autoleucel was USD 1,808.5 million, following a trend of increasing adoption and sales. This growth is attributed to its efficacy in treating R/R MCL and other B-cell lymphomas[1].

Indication and End-User Segmentation

The market for CAR T-cell therapies, including brexucabtagene autoleucel, is segmented by indication and end-user. The lymphoma segment, which includes MCL, dominates the market and is expected to continue growing due to an increase in non-Hodgkin lymphoma cases. Hospitals and cancer treatment centers are the primary end-users of these therapies[1].

Regional Outlook

The Asia Pacific region is expected to play a crucial role in the growth of the CAR T-cell therapy market, including brexucabtagene autoleucel. This growth is driven by developing healthcare infrastructure, increased awareness of CAR T-cell therapies, and significant investments by companies in this region[1].

Cost-Effectiveness and Economic Outcomes

Brexucabtagene autoleucel has been evaluated for its cost-effectiveness in treating R/R MCL. A study in the Italian Healthcare System compared brexucabtagene autoleucel with Rituximab, bendamustine, cytarabine (R-BAC) and found that brexucabtagene autoleucel provided a higher quality-adjusted life expectancy (QALY) at 6.40 versus 1.20 for R-BAC, although at a higher lifetime cost of €411,403 versus €74,415. The cost per QALY gained was approximately €64,798, indicating a need for further validation with longer follow-up data[2].

Financial Performance of Key Players

Gilead Sciences, the company behind Tecartus (brexucabtagene autoleucel), has seen significant growth in its cell therapy product sales. In 2020, cell therapy product sales, which include Yescarta (axicabtagene ciloleucel) and Tecartus, increased by 34% to $163 million for the fourth quarter and by 33% to $607 million for the full year, compared to the same periods in 2019. This growth was driven by the continued uptake of these therapies in Europe and the U.S.[3].

Regulatory Support

Regulatory support has been a critical factor in the growth of the CAR T-cell therapy market. For instance, the South Korean government's Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine, passed in August 2020, has strengthened regulatory support for regenerative medicine development, including CAR T-cell therapies[1].

Challenges and Opportunities

Despite the promising growth, the market for brexucabtagene autoleucel faces challenges such as high treatment costs and the need for improved safety and efficacy. However, these challenges also present opportunities for innovation and cost mitigation. Streamlining the treatment process, including outpatient administration and reducing pre-infusion costs, could make these therapies more accessible and cost-effective[5].

Patient Outcomes and Health Gains

Studies have shown that brexucabtagene autoleucel and other CAR T-cell therapies offer significant health gains compared to standard care. For example, in patients with B-cell ALL, tisagenlecleucel (another CAR T-cell therapy) was associated with greater health gains, although at a higher cost. Similar outcomes are expected for brexucabtagene autoleucel, making it a valuable treatment option despite the higher costs[5].

Future Projections

The future of brexucabtagene autoleucel looks promising, with continued growth expected in the CAR T-cell therapy market. As more patients become eligible for these treatments and as healthcare systems adapt to incorporate these therapies, the market is likely to expand further. The Asia Pacific region, in particular, is anticipated to drive significant growth due to its developing healthcare infrastructure and increasing awareness of CAR T-cell therapies[1].

Key Takeaways

• Market Growth: The global CAR T-cell therapy market, including brexucabtagene autoleucel, is expected to grow significantly, reaching USD 107.92 billion by 2033.
• Segment Performance: Brexucabtagene autoleucel is a key player in the CAR T-cell therapy market, with significant revenue growth.
• Cost-Effectiveness: While brexucabtagene autoleucel is costly, it offers higher QALYs compared to standard treatments, making it a valuable option.
• Regulatory Support: Government regulations and support are crucial for the growth of the CAR T-cell therapy market.
• Challenges and Opportunities: High treatment costs and the need for improved safety and efficacy present both challenges and opportunities for innovation.

FAQs

What is brexucabtagene autoleucel used for?

Brexucabtagene autoleucel, marketed as Tecartus, is used for the treatment of relapsed or refractory mantle cell lymphoma (MCL) and other B-cell malignancies.

How does brexucabtagene autoleucel compare to other CAR T-cell therapies in terms of cost-effectiveness?

Brexucabtagene autoleucel has been shown to provide higher quality-adjusted life expectancy (QALYs) compared to standard treatments, although at a higher cost. The cost per QALY gained is approximately €64,798, indicating a need for further validation with longer follow-up data[2].

What are the key drivers of the growth of the CAR T-cell therapy market?

The growth of the CAR T-cell therapy market is driven by factors such as developing healthcare infrastructure, increased awareness of CAR T-cell therapies, and significant investments by companies, particularly in the Asia Pacific region[1].

How does regulatory support impact the CAR T-cell therapy market?

Regulatory support, such as the South Korean government's Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine, strengthens the regulatory framework for CAR T-cell therapies, facilitating their development and approval[1].

What are the challenges associated with brexucabtagene autoleucel and how can they be addressed?

The high treatment costs and the need for improved safety and efficacy are significant challenges. Addressing these through innovations such as outpatient administration, streamlined treatment processes, and cost mitigation strategies can make these therapies more accessible and cost-effective[5].

Sources

1. Precedence Research: CAR T-Cell Therapy Market Size, Share, and Trends 2024 to 2033.
2. PubMed: Cost-Effectiveness of brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma.
3. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results.
4. Grand View Research: CAR T-cell Therapy Market Size And Share Report, 2030.
5. AJMC: Improving Outcomes and Mitigating Costs Associated With CAR T Cell Therapy.

Last updated: 2024-12-20