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Last Updated: December 23, 2024

HERCEPTIN Drug Profile


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Recent Clinical Trials for HERCEPTIN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
National Comprehensive Cancer NetworkPhase 2
The Netherlands Cancer InstitutePhase 1
Adrienne G. WaksPhase 2

See all HERCEPTIN clinical trials

Recent Litigation for HERCEPTIN

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 HERCEPTIN litigation

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

See all HERCEPTIN litigation

Pharmacology for HERCEPTIN
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 HERCEPTIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

HERCEPTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: HERCEPTIN

Introduction

HERCEPTIN, also known as trastuzumab, is a biologic drug used in the treatment of HER2-positive breast cancer and metastatic gastric cancer. The market for HERCEPTIN and its biosimilars is experiencing significant growth, driven by several key factors.

Increasing Incidence of HER2-Positive Breast Cancer

The rising incidence of HER2-positive breast cancer is a major driver of the HERCEPTIN market. This type of breast cancer exhibits aggressive growth and poor prognosis, leading to a high demand for effective therapies. According to the World Health Organization, approximately 627,000 women were diagnosed with breast cancer in 2019, with a significant portion being HER2-positive[1][3].

Growing Demand for Targeted Therapies

The global burden of breast cancer continues to rise, fueled by factors such as lifestyle changes and genetic predisposition. As a result, healthcare systems are increasingly focusing on targeted treatments like HERCEPTIN, which has been proven to improve survival rates. Continuous advancements in screening and diagnostics are also contributing to the early detection of HER2-positive cases, further augmenting the need for targeted therapies[3].

Market Size and Forecast

The global HERCEPTIN biosimilar market was valued at USD 1,795 million in 2021 and is predicted to reach USD 11,287 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 23.2% from 2022 to 2030[1][4].

Segmentation by Application

The breast cancer segment is expected to lead the global market growth due to the rising prevalence and incidence of breast cancer in women. HERCEPTIN is indicated for the treatment of HER2-overexpressing breast cancer, both in the adjuvant and metastatic settings[1][2].

Segmentation by End-User

Hospital pharmacies are expected to hold the highest market share, driven by the increasing number of individuals admitted to hospitals and medical centers for diagnosis and treatment. The infrastructural facilities provided by hospitals, such as ventilators and intensive care units (ICUs), also contribute to this trend[1].

Regional Outlook

The HERCEPTIN biosimilar market is segmented into several regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The Asia-Pacific region is particularly significant due to the growing incidence of breast cancer and the increasing demand for cost-effective treatments[1][4].

Drivers of Market Growth

Rising Incidence of Cancer

The increasing prevalence of breast cancer and other HER2-positive cancers is a primary driver of the market. This rise is attributed to factors such as lifestyle changes, increasing pollution, and the adoption of smoking[1][4].

Increasing Access to Therapy and Cost Effectiveness

HERCEPTIN biosimilars can significantly reduce the financial burden of treatment, making it more accessible to patients. These biosimilars are generally priced lower than the originator drug, leading to cost savings for healthcare systems, patients, and payers[4].

Emerging Markets

Emerging markets, such as Asia-Pacific and Latin America, offer substantial growth opportunities due to the growing incidence of breast cancer and the increasing demand for cost-effective treatments[4].

Restraints and Challenges

Stringent Regulations

The authorization of HERCEPTIN biosimilars is governed by stringent regulations, which can limit market growth. Regulatory hurdles and the need for FDA-approved companion diagnostics can slow the approval process[1].

Availability of Alternative Treatments

The presence of alternative treatments can also slow the growth of the HERCEPTIN biosimilar market. Patients and healthcare providers may opt for other therapies, especially if they are perceived as more effective or have fewer side effects[1].

Negative Consequences of Biologic Drugs

HERCEPTIN and its biosimilars can have significant side effects, including cardiomyopathy, infusion reactions, and pulmonary toxicity. These adverse effects can deter some patients and healthcare providers from using these treatments[2][5].

Financial Assistance and Support

To mitigate the financial burden, programs such as the Genentech Oncology Co-pay Assistance Program offer eligible patients with commercial insurance the opportunity to pay as little as $0 per treatment for HERCEPTIN. These programs are designed to reduce out-of-pocket costs for patients[2][5].

Impact of Biosimilars

The emergence of multiple biosimilars has intensified competition in the market, leading to price reductions. As patents for HERCEPTIN expire, the adoption of biosimilars is likely to increase, driving growth in this segment and expanding treatment availability for a broader patient population[3].

Growing Adoption of Personalized Medicine

Increased healthcare expenditure globally is a critical driver for the HERCEPTIN market. As nations prioritize healthcare and cancer treatment, funding for research, development, and patient access to innovative therapies surges. This trend supports the demand for advanced cancer therapies like HERCEPTIN[3].

Key Statistics

  • Market Size 2021: USD 1,795 million
  • Forecasted Market Size 2030: USD 11,287 million
  • CAGR 2022-2030: 23.2%
  • Breast Cancer Prevalence: Over 12.4% of American women develop breast cancer in their lifetime[1][4].

Illustrative Example

The significant rise in cancer patient pools and the increasing demand for targeted therapies have driven the growth of the HERCEPTIN biosimilars market. For instance, the Asia-Pacific region, with its growing incidence of breast cancer and increasing demand for cost-effective treatments, presents a substantial opportunity for market expansion[1][4].

"According to the U.S. breast cancer Statistics, over 12.4% of the total American woman develops breast cancer in their lifetime"[1].

Quotes from Industry Experts

Industry experts emphasize the importance of biosimilars in expanding access to cancer treatments. For example, "Biosimilars are biologic medical products highly similar to an already approved reference product... but may have minor differences in clinically inactive components. They are designed to offer comparable efficacy and safety, usually at a lower cost to improve accessibility for patients"[3].

Conclusion

The HERCEPTIN biosimilar market is poised for significant growth driven by the increasing incidence of HER2-positive breast cancer, the need for cost-effective treatments, and the emergence of biosimilars. Despite challenges such as stringent regulations and the availability of alternative treatments, the market is expected to expand substantially over the next decade.

Key Takeaways

  • The HERCEPTIN biosimilar market is projected to grow from USD 1,795 million in 2021 to USD 11,287 million by 2030.
  • The breast cancer segment dominates the market due to the rising prevalence of HER2-positive breast cancer.
  • Hospital pharmacies hold the highest market share due to the increasing number of hospital admissions.
  • Emerging markets, especially in Asia-Pacific and Latin America, offer significant growth opportunities.
  • Biosimilars play a crucial role in reducing treatment costs and expanding access to therapy.

FAQs

What is HERCEPTIN used for?

HERCEPTIN (trastuzumab) is used in the treatment of HER2-positive breast cancer and metastatic gastric cancer. It is indicated for adjuvant treatment of HER2-overexpressing breast cancer and for the treatment of metastatic breast cancer and gastric cancer[2][5].

What are the side effects of HERCEPTIN?

HERCEPTIN can cause significant side effects, including cardiomyopathy, infusion reactions, pulmonary toxicity, and low white blood cell counts. It also carries risks such as embryo-fetal toxicity and severe lung problems[2][5].

How does the HERCEPTIN biosimilar market benefit from emerging markets?

Emerging markets, such as Asia-Pacific and Latin America, offer significant growth opportunities due to the growing incidence of breast cancer and the increasing demand for cost-effective treatments. These regions are expected to drive market expansion as they seek affordable and effective cancer therapies[4].

What role do biosimilars play in the HERCEPTIN market?

Biosimilars are biologic medical products highly similar to HERCEPTIN but are generally priced lower. They offer comparable efficacy and safety, improving accessibility for patients and reducing the financial burden of treatment. As patents for HERCEPTIN expire, the adoption of biosimilars is expected to increase, driving market growth[3].

How does financial assistance impact the HERCEPTIN market?

Financial assistance programs, such as the Genentech Oncology Co-pay Assistance Program, help reduce out-of-pocket costs for patients, making HERCEPTIN more accessible. These programs are crucial in mitigating the financial burden of cancer treatment and supporting market growth[2][5].

Sources

  1. Acumen Research and Consulting - Herceptin Biosimilar Market Size, Share and Analysis | Forecast - 2030
  2. Genentech - Financial Assistance Options | Herceptin® (trastuzumab)
  3. Verified Market Research - Trastuzumab Market Size, Scope, Growth, Trends and Forecast
  4. Data Bridge Market Research - Herceptin Biosimilars Market Size, Share, Value & Growth Drivers
  5. Genentech - Financial Assistance Options | Herceptin (trastuzumab)

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