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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634499

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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634499

HER2-Mutant, Recurrent/Metastatic Cervical Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

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About 5% of cervical malignancies have somatic HER2 mutations, which are oncogenic and associated with a poor prognosis. An important target for anticancer treatments, elevated HER2 receptor activation is crucial for cellular transformation, carcinogenesis, and maintaining the malignant phenotype. In the US, 14,100 women will be diagnosed with invasive cervical cancer. Globally, 604,127 women were projected to receive a cervical cancer diagnosis in 2020. There aren't many treatment options available outside of the US for patients with distant metastatic or recurrent illness who progress on first-line chemotherapy and Avastin. Currently, there is no accepted standard of care for the second line; patients instead receive either the best possible supportive care or ineffective chemotherapy.

Description

A somatic HER2 mutation, which is oncogenic and associated with a poor prognosis, is present in about 5% of cervical malignancies. Increasing HER2 receptor activation, a key target for anticancer therapies, is crucial for cellular transformation, carcinogenesis, and maintaining the malignant phenotype. Any of these factors alone, in combination, or as a result of an activating mutation in the HER2 gene, HER2 protein, or both can cause it. Somatic CC HER2 gene mutations were discovered to be an effective target for some inhibitors in preclinical models and clinical research.

HER2-Mutant, Recurrent/Metastatic Cervical Cancer (Epidemiology)

According to projections, 14,100 women in the US will be diagnosed with invasive cervical cancer. The estimated number of cervical cancer diagnoses in women worldwide in 2020 was 604,127. There will probably be 4,280 deaths from this illness in the US this year. Since the mid-1970s, the death rate in the United States has decreased by about 50%, mirroring the decline in incidence rates. Part of this decline can be attributed to an earlier diagnosis of cervical cancer because of increased screening. Less than 1% per year was lost in the death rate between 2010 and 2019. 341,831 women are anticipated to die from cervical cancer worldwide in 2020.

HER2-Mutant, Recurrent/Metastatic Cervical Cancer -Current Market Size & Forecast Trends

The market for HER2-positive recurrent or metastatic cervical cancer is expected to grow as new treatment options emerge, particularly with the inclusion of neratinib, a pan-HER tyrosine kinase inhibitor, now recommended in the NCCN guidelines for this indication. In 2024, the market size for HER2-mutant cervical cancer is estimated to be around USD 120 million, driven by the increasing recognition of HER2 mutations in cervical cancer, which occur in approximately 3-6% of cases. The response rates observed in clinical trials, such as an objective response rate of 18.2% and a clinical benefit rate of 45.5% from neratinib, highlight the potential for effective treatments in this patient population. As awareness grows and more targeted therapies are developed, including novel agents like Enhertu, the market is positioned for substantial growth through 2035, with projections indicating a significant increase in demand for effective therapies tailored to HER2 mutations in cervical cancer.

There are few treatment options available outside of the US for patients who progress on first-line chemotherapy and Avastin for distant metastatic or recurrent illness. There is currently no accepted standard of care for the second line; patients instead receive either the best supportive care or chemotherapy that is ineffective. If Tivdak and Keytruda were approved outside of the US, patients would fare better. HER2 mutations are an important subset of oncogenic drivers in cervical cancer, particularly in adenocarcinomas. A166 (Klus Pharma), HMBD 001 (Hummingbird Bioscience), Tebotelimab (MacroGenics), Tucatinib (Array BioPharma/Seagen), and others that have the potential to drive the market growth in an upward trend are some of the emerging drugs that are on the upcoming list.

Report Highlights

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Current Market Trends

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Current & Forecasted Cases across the G8 Countries

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Market Opportunities and Sales Potential for Agents

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Patient-based Market Forecast to 2035

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Untapped Business Opportunities

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - Product Positioning Vis-a-vis Competitors' Products

HER2-Mutant, Recurrent/Metastatic Cervical Cancer - KOLs Insight

Table of Content

1. HER2-Mutant, Recurrent/Metastatic Cervical Cancer Background

  • 1.1. HER2-Mutant, Recurrent/Metastatic Cervical Cancer Definition
  • 1.2. Signs and Symptoms
  • 1.3. Pathogenesis
  • 1.4. Clinical Manifestation
  • 1.5. HER2-Mutant, Recurrent/Metastatic Cervical Cancer biomarkers
  • 1.6. Diagnosis

2. Epidemiology Estimated and Forecast to 2035

  • 2.1. Epidemiology Research Method & Data Sources Used
  • 2.2. United States
    • 2.2.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.2.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.3. United Kingdom
    • 2.3.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.3.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.4. Spain
    • 2.4.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.4.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.5. Germany
    • 2.5.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.5.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.6. France
    • 2.6.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.6.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.7. Italy
    • 2.7.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.7.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.8. Japan
    • 2.8.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.8.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.9. China
    • 2.9.1. Incident Cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer
    • 2.9.2. Diagnosed and treatable cases of HER2-Mutant, Recurrent/Metastatic Cervical Cancer by line of therapies (LOT)
  • 2.10. Current Unmet Needs in HER2-Mutant, Recurrent/Metastatic Cervical Cancer

3. Current Treatment Paradigm

  • 3.1. Treatment/Prevention guidelines
  • 3.2. Regulatory Approvals/Indication and Current Benchmarks

4. KOLs Insight (US, EU, JP, CH)

  • 4.1. Unmet Needs
  • 4.2. Analysis of the progress in terms of approvals & current pipeline
  • 4.3. Impact on the treatment algorithm and product positioning
  • 4.4. Relevance of new targets/platforms/ Therapy Uptake Share %
  • 4.5. Physicians Preferences for the new pharmacological agents

5. What's New in 2024/2025

6. Future Treatment Paradigm

  • 6.1. HER2-Mutant, Recurrent/Metastatic Cervical Cancer Competitor Landscape and Approvals Anticipated
  • 6.2. Future Treatment Algorithms and Competitor Positioning
  • 6.3. Key Data Summary for Emerging Treatment

7. Late Phase Therapies Strategic Considerations in HER2-Mutant, Recurrent/Metastatic Cervical Cancer

8. Total Market Forecast

  • 8.1. Key Summary Findings
    • 8.1.1. G8 total Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 8.1.2. G8 total Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)

9. Market Forecast by Country

  • 9.1. United States
    • 9.1.1. United States Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.1.2. United States Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.2. Germany
    • 9.2.1. Germany Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.2.2. Germany Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.3. France
    • 9.3.1. France Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.3.2. France Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.4. Italy
    • 9.4.1. Italy Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.4.2. Italy Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.5. Spain
    • 9.5.1. Spain Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.5.2. Spain Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.6. United Kingdom
    • 9.6.1. United Kingdom Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.6.2. United Kingdom Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.7. Japan
    • 9.7.1. Japan Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.7.2. Japan Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)
  • 9.8. China
    • 9.8.1. China Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer 2022-2035 (USD Million)
    • 9.8.2. China Market for HER2-Mutant, Recurrent/Metastatic Cervical Cancer by Therapies 2022-2035 (USD Million)

10. Market Drivers and Barriers

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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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