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Last Updated: April 13, 2025

Trastuzumab - Biologic Drug Details


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Summary for trastuzumab
Recent Clinical Trials for trastuzumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Jeeyun LeePhase 1/Phase 2
Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt VogelPhase 2
MSD Sharp & Dohme GmbH, GermanyPhase 2

See all trastuzumab clinical trials

Recent Litigation for trastuzumab

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.2023-11-17
Genentech, Inc. v. Biogen MA Inc.2023-07-13
Janssen Biotech, Inc. v. Amgen Inc.2022-11-29

See all trastuzumab litigation

PTAB Litigation
PetitionerDate
GEMoaB Monoclonals GmbH et al.2019-12-20
2018-04-24
2018-03-20

See all trastuzumab litigation

Pharmacology for trastuzumab
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 trastuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Trastuzumab Biosimilars

Introduction

Trastuzumab, a biologic drug used to treat HER2-positive breast and gastric cancers, has seen a significant surge in its biosimilars market. This article delves into the market dynamics, financial trajectory, and key factors driving the growth of trastuzumab biosimilars.

Market Size and Growth

The trastuzumab biosimilars market has experienced exponential growth in recent years. As of 2023, the market size was valued at $4.27 billion and is projected to increase to $5.43 billion in 2024, with a compound annual growth rate (CAGR) of 27.1%[4].

By 2028, the market is expected to reach $14.69 billion, driven by a CAGR of 28.3%. This robust growth is attributed to several factors, including intensified market competition, the development of biosimilar pipelines, regulatory approvals, standardizations, global market penetration, and patterns of physician adoption and prescribing[1][4].

Key Drivers of Growth

Increasing Prevalence of Breast and Gastric Cancer

The rising incidence of breast and gastric cancer is a significant driver of the trastuzumab biosimilars market. For instance, the American Cancer Society reported approximately 297,790 new cases of invasive breast cancer in women in 2023, leading to about 43,700 deaths. In countries like India, breast cancer constitutes 14% of cancers in women, increasing the demand for cost-effective treatments like trastuzumab biosimilars[1].

Healthcare Expenditure

Increased healthcare expenditure is another crucial factor. The surge in healthcare spending, such as the 9.4% increase in nominal terms and 9.7% in real terms in the UK between 2020 and 2021, fosters the development and adoption of trastuzumab biosimilars by providing cost-effective alternatives to biologics[1].

Regulatory Approvals and Standardizations

Regulatory approvals and standardizations play a pivotal role in the growth of the trastuzumab biosimilars market. These approvals facilitate market entry and ensure the quality and efficacy of biosimilars, enhancing trust among healthcare providers and patients[1][4].

Market Segmentation and Distribution Channels

The market is segmented by product (e.g., Ogivri, Herzuma, Ontruzant, Trazimera), indication (adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer), and distribution channels (hospital pharmacy, online pharmacy). This segmentation helps in targeting specific patient needs and improving access to these biosimilars[4].

Cost-Effectiveness and Economic Impact

Cost-Effectiveness Analysis

Studies have consistently shown that trastuzumab plus chemotherapy is cost-effective compared to chemotherapy alone. For example, a study found that trastuzumab plus chemotherapy resulted in incremental savings of $11,024 per patient, with higher quality-adjusted life years (QALYs) and life years gained (LYG). The incremental cost-effectiveness ratio (ICER) was $6,842 per QALY and $5,510 per LYG, which is below the willingness-to-pay threshold of three times the Gross Domestic Product (GDP) per capita[2].

Country-Specific Cost-Effectiveness

Cost-effectiveness varies by country due to differences in healthcare systems, cost structures, and modelling methodologies. For instance, in Indonesia, a one-year course of trastuzumab combined with chemotherapy was found to be cost-effective at a willingness-to-pay threshold of three times GDP per capita, especially for patients under 40 years old[2].

Price Competitiveness

Trastuzumab biosimilars compete significantly on price, offering a more affordable alternative to the original biologic. This price competitiveness is a major factor in their market share, as healthcare systems and patients seek cost-effective treatments without compromising efficacy[3].

Market Trends and Strategies

Improved Access and Market Penetration

Efforts to improve access to trastuzumab biosimilars, including educational campaigns and market segmentation strategies, are key trends. These initiatives help in increasing awareness and acceptance among physicians and patients, thereby enhancing market penetration[1][4].

Physician Adoption and Prescribing Patterns

The adoption and prescribing patterns of physicians play a crucial role in the growth of the trastuzumab biosimilars market. Educational campaigns and clinical efficacy validation are essential in influencing physician preferences towards biosimilars[1][4].

Patient Preference

Patient preference for biosimilars is also on the rise, driven by the cost-effectiveness and comparable efficacy of these drugs. As patients become more informed, their preference for biosimilars is expected to drive market growth[1][4].

Regional Market Analysis

Western Europe and North America

In regions like Western Europe and North America, the trastuzumab biosimilars market is segmented by product, indication, and distribution channels. These regions see significant growth due to high healthcare expenditure, advanced healthcare infrastructure, and strong regulatory frameworks[1].

South America and Asia

In South America and Asia, the market is growing rapidly due to increasing healthcare expenditure and the need for cost-effective cancer treatments. Countries like India and Indonesia are witnessing a rise in the adoption of trastuzumab biosimilars due to their cost-effectiveness and regulatory approvals[1][4].

Conclusion

The trastuzumab biosimilars market is poised for significant growth driven by increasing cancer prevalence, healthcare expenditure, regulatory approvals, and cost-effectiveness. As the market expands globally, strategies such as improved access, market segmentation, and educational campaigns will continue to play a vital role.

Key Takeaways

  • The trastuzumab biosimilars market is expected to grow from $4.27 billion in 2023 to $14.69 billion by 2028.
  • The market is driven by the increasing prevalence of breast and gastric cancer, healthcare expenditure, and regulatory approvals.
  • Trastuzumab biosimilars are cost-effective, offering significant savings and improved health outcomes.
  • Market segmentation, educational campaigns, and physician adoption are key strategies for market growth.
  • Regional markets, especially in Western Europe, North America, South America, and Asia, are seeing rapid expansion.

FAQs

What is the current market size of trastuzumab biosimilars?

The current market size of trastuzumab biosimilars is $4.27 billion as of 2023 and is expected to reach $5.43 billion in 2024[1][4].

What are the key drivers of the trastuzumab biosimilars market?

Key drivers include the increasing prevalence of breast and gastric cancer, increased healthcare expenditure, regulatory approvals, and the development of biosimilar pipelines[1][4].

Are trastuzumab biosimilars cost-effective?

Yes, trastuzumab biosimilars are cost-effective, offering significant savings and improved health outcomes compared to chemotherapy alone. The ICER is often below the willingness-to-pay threshold of three times GDP per capita[2].

Which regions are seeing significant growth in the trastuzumab biosimilars market?

Western Europe, North America, South America, and Asia are seeing significant growth due to various factors including healthcare expenditure, regulatory frameworks, and the need for cost-effective cancer treatments[1][4].

What strategies are being used to enhance market penetration of trastuzumab biosimilars?

Strategies include improved access, market segmentation, educational campaigns, and influencing physician adoption and prescribing patterns[1][4].

Sources

  1. Research and Markets: Trastuzumab Biosimilars Global Market Size & Competitors.
  2. PLOS ONE: Economic evaluation of trastuzumab in HER2-positive early breast cancer.
  3. ResearchGate: Cancer Drug Trastuzumab And Its Biosimilars Compete On Price For Market Share.
  4. The Business Research Company: Trastuzumab Biosimilars Global Market Report 2024.

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