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Last Updated: December 26, 2024

TRAZIMERA Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
NRG OncologyPhase 2
Academic and Community Cancer Research UnitedPhase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 1

See all TRAZIMERA clinical trials

Pharmacology for TRAZIMERA
Mechanism of ActionHER2/Neu/cerbB2 Antagonists
Established Pharmacologic ClassHER2/neu Receptor Antagonist
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 TRAZIMERA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

TRAZIMERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Trastuzumab Biosimilars: A Focus on Trazimera

Introduction

The trastuzumab biosimilars market has been experiencing exponential growth, driven by several key factors including the increasing prevalence of breast and gastric cancer, patent expiries, and the development of biosimilar pipelines. This article will delve into the market dynamics and financial trajectory of trastuzumab biosimilars, with a particular focus on Trazimera, one of the prominent biosimilars in this market.

Market Size and Growth

The global trastuzumab biosimilars market is projected to grow significantly. In 2023, the market size was valued at $4.27 billion, and it is expected to reach $5.43 billion in 2024, with a compound annual growth rate (CAGR) of 27.1%. By 2028, the market is forecasted to expand to $14.69 billion at a CAGR of 28.3%[1][3].

Drivers of the Market

Several factors are driving the growth of the trastuzumab biosimilars market:

Increasing Prevalence of Breast and Gastric Cancer

The rising incidence of breast and gastric cancer, particularly those with human epidermal growth factor receptor 2 (HER2) overexpression, is a significant driver. For instance, the American Cancer Society reported approximately 297,790 new cases of invasive breast cancer in women in 2023, leading to a heightened demand for cost-effective treatments like trastuzumab biosimilars[1][3].

Patent Expiry and Market Entry

The expiry of patents for the original biologic drug, Herceptin, has opened the market for biosimilars. This has allowed multiple biosimilar products, including Trazimera, to enter the market, increasing competition and reducing prices[1].

Regulatory Approvals and Standardizations

Regulatory approvals and standardizations have facilitated the entry of biosimilars into the market. These approvals ensure that biosimilars meet the required safety and efficacy standards, enhancing physician and patient confidence in these products[1][3].

Competitive Pricing

Biosimilars offer a cost-effective alternative to biologics, which is a major factor in their adoption. The average sales price (ASP) of trastuzumab biosimilars has decreased significantly, making them more accessible to patients. For example, as of Q3 2024, the average ASP of trastuzumab biosimilars was $1,288, a 70% reduction from the reference product's ASP at the time of the first biosimilar launch[4].

Market Segmentation

The trastuzumab biosimilars market is segmented by product, indication, and distribution channel.

By Product

Key products in the market include Ogivri, Herzuma, Ontruzant, Trazimera, and other biosimilars. Trazimera, developed by Pfizer and Biocon, is one of the prominent biosimilars that has gained significant market share due to its competitive pricing and clinical efficacy[1][3].

By Indication

The market is segmented by indications such as adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer, and other indications. Trazimera is approved for the treatment of HER2-positive breast cancer and metastatic gastric cancer, aligning with the primary indications driving the market[1].

By Distribution Channel

The distribution channels include hospital pharmacies and online pharmacies. The ease of access through these channels has contributed to the increased adoption of trastuzumab biosimilars, including Trazimera[1].

Financial Trajectory of Trazimera

Trazimera, as a part of the broader trastuzumab biosimilars market, benefits from the overall market growth trends.

Revenue Growth

Given the market's projected growth to $14.69 billion by 2028, Trazimera is expected to contribute significantly to this revenue. The competitive pricing strategy and increasing market share of Trazimera are key factors driving its financial performance[1][3].

Market Share

As of Q3 2024, the biosimilar share of the trastuzumab market has reached 86%, with Trazimera being one of the products gaining market share. The recent increase in the ASP of Ogivri and Herzuma has also impacted Trazimera's market dynamics, but it remains a competitive player in the market[4].

Cost-Effectiveness

The cost-effectiveness of Trazimera compared to the original biologic, Herceptin, is a significant financial advantage. This cost-effectiveness not only attracts patients but also influences physician prescribing patterns, contributing to the financial trajectory of Trazimera[1][3].

Trends and Future Outlook

Several trends are expected to shape the future of the trastuzumab biosimilars market, including Trazimera:

Enhanced Access

Educational campaigns and market segmentation strategies are expected to enhance access to trastuzumab biosimilars. This increased access will likely drive further adoption and revenue growth for Trazimera[1][3].

Physician Acceptance

The acceptance of biosimilars among physicians is on the rise, driven by clinical efficacy validation and regulatory approvals. This trend is expected to continue, benefiting Trazimera and other biosimilars in the market[1][3].

Global Market Penetration

The global market penetration of trastuzumab biosimilars is expected to increase, driven by the intensification of market competition and the development of biosimilar pipelines. Trazimera, with its global reach and competitive pricing, is well-positioned to benefit from this trend[1][3].

Regulatory Environment

The regulatory environment plays a crucial role in the growth of the trastuzumab biosimilars market. Regulatory approvals and standardizations ensure that biosimilars meet stringent safety and efficacy standards, which is essential for maintaining market confidence in products like Trazimera.

"Regulatory approvals and standardizations have facilitated the entry of biosimilars into the market, ensuring that these products meet the required safety and efficacy standards"[1].

Conclusion

The trastuzumab biosimilars market, including Trazimera, is poised for significant growth driven by increasing demand, competitive pricing, and regulatory approvals. As the market continues to expand, Trazimera is expected to play a substantial role due to its cost-effectiveness, clinical efficacy, and increasing market share.

Key Takeaways

  • The global trastuzumab biosimilars market is expected to grow to $14.69 billion by 2028.
  • Trazimera is a key player in this market, benefiting from competitive pricing and increasing market share.
  • The rising prevalence of breast and gastric cancer drives the demand for trastuzumab biosimilars.
  • Regulatory approvals and standardizations are crucial for the growth of the market.
  • Enhanced access, physician acceptance, and global market penetration are expected to drive future growth.

FAQs

What is the current market size of trastuzumab biosimilars?

The current market size of trastuzumab biosimilars was $4.27 billion in 2023 and is expected to reach $5.43 billion in 2024[1][3].

What are the key drivers of the trastuzumab biosimilars market?

Key drivers include the increasing prevalence of breast and gastric cancer, patent expiries, regulatory approvals, and competitive pricing[1][3].

Which are the prominent trastuzumab biosimilars in the market?

Prominent biosimilars include Ogivri, Herzuma, Ontruzant, and Trazimera[1][3].

How does Trazimera benefit from the market trends?

Trazimera benefits from competitive pricing, increasing market share, and the overall growth trends in the trastuzumab biosimilars market[1][3][4].

What is the expected market share of biosimilars in the trastuzumab market?

As of Q3 2024, the biosimilar share of the trastuzumab market has reached 86%, with Trazimera being one of the products gaining market share[4].

Sources

  1. The Business Research Company, Trastuzumab Biosimilars Global Market Report 2024.
  2. AstraZeneca, Full-year and Q4 2023 results announcement.
  3. Research and Markets, Trastuzumab Biosimilars Global Market Size & Competitors.
  4. Samsung Bioepis, Biosimilar Market Dynamics - SAMSUNG BIOEPIS.
  5. Pfizer, Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.

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