Global HER2 Positive Breast Cancer Market Size To Exeed USD 64.55 Billion by 2035 | CAGR of 7.53% : Forecast Analysis Report

RELEASE DATE: Jul 2025 Author: Spherical Insights
The Global HER2 Positive Breast Cancer Market Size is expected to grow from USD 31.22 Billion in 2024 To USD 64.55 Billion by 2035, at a CAGR of 7.53% during the forecast period 2025-2035

Table of Contents

Global HER2 Positive Breast Cancer Market Size, Share, and COVID-19 Impact Analysis, By Diagnosis Type (Immunohistochemistry [IHC], Fluorescence in situ hybridization [FISH], and Polymerase chain reaction [PCR]), By Treatment Type (Chemotherapy, Targeted Therapy, Hormonal Therapy, and Surgical Therapy) and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035


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  • As per Spherical Insights & Consulting, The Global HER2 Positive Breast Cancer Market Size is expected to grow from USD 31.22 Billion in 2024 to USD 64.55 Billion by 2035, at a CAGR of 7.53% during the forecast period 2025-2035, owing to the launch of new therapies in the market and the rise in the number of cases.

 

  • The leading HER2 Positive Breast Cancer Market Companies such as Immunomedics, Bayer, Odonate Therapeutics, Millennium Pharmaceuticals, Roche Group, Radius Pharmaceuticals, Jiangsu HengRui Medicine, Pfizer, AstraZeneca Pharmaceuticals, Merrimack Pharmaceuticals, Novartis, Eagle Pharmaceuticals, Syndax Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Merck, and Others.

 

 

HER2 Positive Breast Cancer Treatment Market: Understanding and Treatment Algorithm:

HER2 Positive breast cancer is a type of breast cancer where cancer cells overproduce the HER2 protein, which promotes cell growth. This leads to more aggressive tumor growth. It accounts for about 20% of breast cancers. Targeted therapies like trastuzumab are effective in treating it by specifically blocking the HER2 protein and slowing cancer progression.

 

HER2 Positive Breast Cancer Diagnosis:

HER2 Positive breast cancer diagnosis involves testing tumor tissue for HER2 protein overexpression or HER2 gene amplification. Common methods include immunohistochemistry (IHC) to measure protein levels and fluorescence in situ hybridization (FISH) to detect gene amplification. Accurate diagnosis guides treatment decisions, ensuring patients receive targeted therapies like trastuzumab for better outcomes.

 

HER2 Positive Breast Cancer Treatment

HER2 Positive breast cancer treatment typically includes targeted therapies such as trastuzumab and pertuzumab, which specifically block the HER2 protein. These are often combined with chemotherapy to improve effectiveness. In some cases, newer drugs like ado-trastuzumab emtansine or tucatinib are used. Surgery and radiation may also be part of the treatment plan, depending on the cancer stage.

 

HER2 Positive Breast Cancer Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Incident Population of HER2 Positive Breast Cancer, Gender-specific Diagnosed Incidence of HER2 Positive Breast Cancer, Type specific Diagnosed Incidence of HER2 Positive Breast Cancer, Age specific Diagnosed Incidence of HER2 Positive Breast Cancer, Diagnosed Incident Population based on Primary Site of HER2 Positive Breast Cancer, and Diagnosed Incident Population based on Histologic Classification of HER2 Positive Breast Cancer Tumour in the global market covering North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa from 2024 to 2035.

 

Principal Insights

This section offers a global overview of HER2 Positive breast cancer epidemiology in major markets worldwide.

 

Country Wise HER2 Positive Breast Cancer Multiforme Epidemiology

  • The epidemiology segment provides HER2 Positive Breast Cancer prevalence data and findings across key regions worldwide, including North America, Europe (Germany, France, Italy, Spain, and the United Kingdom), Asia-Pacific (including Japan), Latin America, the Middle East, and Africa.

 

HER2 Positive Breast Cancer Recent Developments:

  • In July 2022, AstraZeneca received European approval for Enhertu (trastuzumab deruxtecan) to treat HER2 Positive metastatic breast cancer. This approval marked a significant advancement, offering patients a new targeted therapy option after prior treatments, improving outcomes in this aggressive cancer subtype.

 

HER2 Positive Breast Cancer Marketed Drugs:

  • Enhertu: AstraZeneca and Daiichi Sankyo

Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate targeting HER2 receptors. It delivers a chemotherapy payload directly to cancer cells, offering improved outcomes for patients with HER2 Positive metastatic breast cancer who have received prior treatment. Approved in multiple regions worldwide.

 

  • Kadcyla: Roche

Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate combining trastuzumab with a chemotherapy agent. It specifically targets HER2 Positive cancer cells and is approved for patients with HER2 Positive early and metastatic breast cancer after prior therapies.

 

  • Trazimera: Pfizer

Trazimera is a trastuzumab biosimilar approved to treat HER2 Positive breast cancer. It works similarly to Herceptin by binding to HER2 receptors and inhibiting tumor growth. It offers a more accessible and cost-effective treatment option.

 

HER2 Positive Breast Cancer: Emerging Therapies

  • BNT327: It is a bispecific antibody in late-stage trials for HER2 Positive breast cancer. It targets two immune checkpoints to enhance T-cell activation and tumor response, aiming to improve outcomes in patients resistant to standard PD-1/PD-L1 therapies.

 

  • Danvatirsen: It is an antisense oligonucleotide targeting STAT3, currently under investigation for HER2 Positive breast cancer. It is designed to inhibit tumor growth and overcome resistance to existing therapies.

 

  • Sacituzumab govitecan: It is an antibody-drug conjugate targeting Trop-2, showing promise in ongoing trials for HER2-low and HER2 Positive breast cancers, expanding treatment options beyond triple-negative subtypes.

 

  • Datopotamab deruxtecan: It is an antibody-drug conjugate in late-stage clinical trials targeting Trop-2 in HER2 Positive breast cancer. It aims to deliver cytotoxic agents directly to tumor cells, improving treatment effectiveness in patients resistant to current HER2 therapies.

 

HER2 Positive Breast Cancer Market Outlook

  • The HER2 Positive breast cancer market defines the therapies targeting tumors that overexpress the HER2 protein. It includes drugs, diagnostics, and emerging treatments designed to improve diagnosis, treatment effectiveness, and patient outcomes in HER2 Positive breast cancer globally.

 

  • Key drivers of the market include rising cancer prevalence, advancements in targeted therapies, increased awareness and early diagnosis, supportive government initiatives, and growing adoption of personalized medicine improving treatment outcomes and patient survival rates globally.

 

  • Opportunities in the HER2 Positive breast cancer market include the development of novel targeted therapies, expansion into emerging markets, increasing investment in research and clinical trials, and the integration of precision medicine and immunotherapy to address treatment resistance and improve patient outcomes.

 

  • Governments worldwide have launched awareness campaigns and screening programs to promote early detection of HER2 Positive breast cancer. They also support funding for research and approval of innovative therapies to improve patient access and treatment outcomes.

 

  • High treatment costs and drug resistance remain major challenges in managing HER2 Positive breast cancer effectively.

 

  • The market is projected to grow significantly, driven by advancements in targeted therapies and increasing global patient awareness.

 

HER2 Positive Breast Cancer Market Segmentation

By Diagnosis Type:

  • Immunohistochemistry [IHC]
  • Fluorescence in situ hybridization [FISH]
  • Polymerase chain reaction [PCR]

 

 

The Immunohistochemistry (IHC) segment dominates the global HER2 Positive breast cancer diagnosis market due to its cost-effectiveness, ease of use, and wide availability. It provides rapid and reliable detection of HER2 protein overexpression, making it the preferred first-line diagnostic method worldwide.

By Treatment Type:

  • Chemotherapy
  • Targeted Therapy
  • Hormonal Therapy
  • Surgical Therapy

 

 

The Targeted Therapy segment dominates the HER2 Positive Breast Cancer treatment market due to its high specificity in attacking HER2 proteins, improved patient outcomes, and fewer side effects compared to traditional treatments, making it the preferred and most effective approach for managing this aggressive cancer subtype.

 

Regional Segment Analysis of the HER2 Positive Breast Cancer Market

North America holds the largest share of the global HER2 Positive breast cancer market. This dominance is driven by factors such as the high prevalence of breast cancer, widespread adoption of advanced diagnostic technologies like Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH), and early availability of innovative targeted therapies. Additionally, strong healthcare infrastructure, favourable reimbursement policies, and significant investments in cancer research and clinical trials support market growth. The region also benefits from high awareness and screening programs, enabling early detection and effective management of HER2 Positive breast cancer, contributing to its leading market position.

 

The Asia-Pacific region is the fastest-growing market for HER2 Positive breast cancer. Rapid economic development, improving healthcare infrastructure, and increasing awareness about breast cancer screening are key growth drivers. Expanding patient population, coupled with rising adoption of advanced diagnostic tools and targeted therapies, is accelerating market growth. Governments in countries like China, India, and Japan are investing heavily in healthcare reforms, cancer research, and drug approvals, making innovative treatments more accessible.

 

HER2 Positive Breast Cancer Market Key Companies

  • Immunomedics
  • Bayer
  • Odonate Therapeutics
  • Millennium Pharmaceuticals
  • Roche Group
  • Radius Pharmaceuticals
  • Jiangsu HengRui Medicine
  • Pfizer
  • AstraZeneca Pharmaceuticals
  • Merrimack Pharmaceuticals
  • Novartis
  • Eagle Pharmaceuticals
  • Syndax Pharmaceuticals
  • Eli Lilly
  • GlaxoSmithKline
  • Merck
  • Others

 

HER2 Positive Breast Cancer Therapeutics Market Report Scope

  • The HER2 Positive Breast Cancer therapeutics market report provides a detailed overview, covering its causes, symptoms, disease progression, and existing treatment options.
  • Detailed insights into HER2 Positive Breast Cancer’s epidemiology and therapeutic approaches are included.
  • Additionally, a comprehensive review of existing and emerging HER2 Positive Breast Cancer therapies is provided, including an evaluation of new treatments expected to influence the current HER2 Positive Breast Cancer treatment market landscape.
  • The report includes a detailed review of the HER2 Positive Breast Cancer therapeutics market, both historical and forecasted, highlighting the global drug reach.
  • The Patient-Based HER2 Positive Breast Cancer Market Forecasting report offers valuable insights into trends shaping the global HER2 Positive Breast Cancer market, helping to develop effective business strategies.

 

HER2 Positive Breast Cancer Treatment Market Report Insights

  • Forecasting Market Trends Based on Patient Data and Disease Rates
  • HER2 Positive Breast Cancer Therapeutic Approaches in HER2 Positive Breast Cancer
  • Review Of Drugs in Development for HER2 Positive Breast Cancer
  • Market, Growth, and Trends in HER2 Positive Breast Cancer
  • Market Opportunities in HER2 Positive Breast Cancer Treatment
  • Effects Of Future Therapies on HER2 Positive Breast Cancer Treatment.

 

HER2 Positive Breast Cancer Treatment Market Report Key Strengths

  • 15 Years HER2 Positive Breast Cancer Market Forecast
  • Global Coverage
  • HER2 Positive Breast Cancer Epidemiology Segmentation
  • Key Cross Competition

 

HER2 Positive Breast Cancer Treatment Market Report Assessment

  • Present Practices in the HER2 Positive Breast Cancer Treatment Market
  • Review of Investigational HER2 Positive Breast Cancer Drugs
  • Attractiveness of the HER2 Positive Breast Cancer Drug Market
  • HER2 Positive Breast Cancer Market Drivers
  • HER2 Positive Breast Cancer Market Barriers
  • SWOT
  • Attribute Analysis

 

Market Segment

This study forecasts revenue at the global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the HER2 Positive breast cancer market based on the following segments:

 

Global HER2 Positive Breast Cancer Market, By Diagnosis Type

  • Immunohistochemistry [IHC]
  • Fluorescence in situ hybridization [FISH]
  • Polymerase chain reaction [PCR]

 

Global HER2 Positive Breast Cancer Market, By Treatment Type

  • Chemotherapy
  • Targeted Therapy
  • Hormonal Therapy
  • Surgical Therapy

 

Global HER2 Positive Breast Cancer Market, By Regional Analysis

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of the Middle East & Africa

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