Trastuzumab-dkst - Biologic Drug Details

Summary for trastuzumab-dkst

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for trastuzumab-dkst

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	HER2/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

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 trastuzumab-dkst Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Trastuzumab-DKST

Introduction to Trastuzumab-DKST

Trastuzumab-DKST, a biosimilar of the biologic drug trastuzumab, has revolutionized the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer and metastatic gastric cancer. Here, we delve into the market dynamics and financial trajectory of this crucial therapeutic agent.

Market Growth and Projections

The global trastuzumab biosimilars market is experiencing exponential growth. In 2021, the market was valued at $2.08 billion and is expected to reach $2.64 billion in 2022, with a compound annual growth rate (CAGR) of 27.1%. By 2026, the market is projected to grow to $6.90 billion, maintaining the same CAGR[1].

Regional Market Performance

• North America: This region was the largest in the trastuzumab biosimilar market in 2021.
• Middle East: Expected to be the largest growing region in the forecast period.
• Asia-Pacific, Western Europe, Eastern Europe, South America, and Africa: These regions are also significant contributors to the market growth[1].

Driving Factors

Increasing Prevalence of Breast and Gastric Cancer

The rising prevalence of breast and gastric cancer is a major driver of the trastuzumab biosimilars market. According to the World Health Organization (WHO), breast cancer affected 2.3 million women globally in 2020, resulting in 685,000 fatalities. In India, breast cancer accounts for 14% of all cancers in women, further increasing the demand for trastuzumab biosimilars[1][3].

Cost-Effectiveness

Trastuzumab biosimilars offer a cost-effective alternative to the expensive reference product, trastuzumab. Studies have shown significant cost savings when switching from trastuzumab-IV to trastuzumab-DKST, ranging from $2,272,189 to $31,506,804 in one-year savings, depending on the conversion rate and patient weight[2].

Regulatory Approvals and Market Penetration

Regulatory approvals and the expansion of biosimilar pipelines are key factors driving market growth. For instance, the launch of Ogivri (trastuzumab-DKST) by Biocon and Mylan in the USA in December 2019 increased access to this treatment[1].

Market Share and Pricing Trends

Dominance of Biosimilars

As of Q1 2024, the biosimilar share of the trastuzumab market has reached 86%, with biosimilars maintaining the dominant market share due to their lower prices. The average sales price (ASP) of all trastuzumab products has decreased significantly, with biosimilars alone averaging $1,288, a 70% reduction from the reference product's ASP at the time of the first biosimilar launch[4].

Product-Specific Market Share

• Ogivri: Gaining market share with recent increases in its wholesale acquisition cost (WAC) and ASP.
• Herzuma, Kanjinti, Trazimera, Ontruzant: Other biosimilars that contribute to the market share, with Ogivri and Herzuma being notable players[4].

Economic Impact and Cost Savings

Cost-Efficiency Modeling

Economic simulation modeling has demonstrated that converting from trastuzumab-IV or trastuzumab-SC to trastuzumab-DKST can generate substantial cost savings. These savings can be used to provide additional treatments, thereby expanding access to more patients on a budget-neutral basis[2].

Real-World Cost Savings

A cost analysis from the PERSEPHONE trial estimated an average savings of $12,800 for 6 months of trastuzumab treatment versus 12 months, highlighting the potential for significant cost savings with biosimilar adoption[5].

Healthcare Expenditure and Market Growth

Increasing Healthcare Spending

The growth of the trastuzumab biosimilars market is also driven by increasing healthcare expenditure. For example, the UK saw a 9.4% increase in nominal terms and 9.7% in real terms in healthcare spending between 2020 and 2021, which fosters the development and adoption of cost-effective biosimilars[3].

Strategic Initiatives by Market Players

Major players in the trastuzumab biosimilars market are engaging in various strategic initiatives to maintain their competitive position. These include:

• New Product Development: Launching new biosimilars in untapped regions.
• Partnerships: Collaborations to enhance market penetration.
• Geographical and Product Portfolio Expansion: Expanding into new markets and diversifying product portfolios[1].

Patient and Physician Acceptance

Educational Campaigns and Market Segmentation

Educational campaigns and strategies for market segmentation are crucial in increasing acceptance among physicians and patients. As more physicians become aware of the efficacy and cost-effectiveness of trastuzumab biosimilars, adoption rates are expected to rise[3].

Key Takeaways

• The trastuzumab biosimilars market is projected to grow significantly, driven by the increasing prevalence of breast and gastric cancer.
• Cost-effectiveness and regulatory approvals are key drivers of market growth.
• Biosimilars dominate the market with lower prices, leading to substantial cost savings.
• Increasing healthcare expenditure supports the development and adoption of trastuzumab biosimilars.
• Strategic initiatives by market players are essential for maintaining competitive positions.

FAQs

Q: What is the projected market size for trastuzumab biosimilars by 2026?

A: The market is expected to reach $6.90 billion by 2026, growing at a CAGR of 27.1%[1].

Q: How do trastuzumab biosimilars impact healthcare costs?

A: Trastuzumab biosimilars offer significant cost savings, ranging from $2,272,189 to $31,506,804 in one-year savings, depending on the conversion rate and patient weight[2].

Q: Which regions are expected to drive the growth of the trastuzumab biosimilars market?

A: North America was the largest region in 2021, while the Middle East is expected to be the largest growing region in the forecast period[1].

Q: What role do educational campaigns play in the adoption of trastuzumab biosimilars?

A: Educational campaigns are crucial in increasing acceptance among physicians and patients, thereby driving market growth[3].

Q: How has the average sales price (ASP) of trastuzumab biosimilars changed over time?

A: The ASP of trastuzumab biosimilars has decreased significantly, with a 70% reduction from the reference product's ASP at the time of the first biosimilar launch[4].

Sources

1. Trastuzumab Biosimilars Global Market Report 2022 - ResearchAndMarkets.com
2. Cost-efficiency and expanded access modeling of conversion to trastuzumab-dkst - PubMed
3. Trastuzumab Biosimilars Global Market Size & Competitors - ResearchAndMarkets.com
4. Biosimilar Market Dynamics - SAMSUNG BIOEPIS
5. Integrating Trastuzumab Biosimilars and HER2-Directed Therapies into HER2-Positive Breast Cancer Management - AJMC

Last updated: 2024-12-20