HER2-Positive Breast Cancer Market Report 2025

This HER2-Positive Breast Cancer market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

The HER2-positive breast cancer market size has grown strongly in recent years. It will grow from $10.21 billion in 2024 to $10.96 billion in 2025 at a compound annual growth rate (CAGR) of 7.34%. The growth observed during the historical period can be linked to factors such as the increasing rates of early detection and diagnosis, greater awareness of HER2-positive subtypes, rising investments in research and development, the growing adoption of precision medicine, and a heightened focus on enhancing patient outcomes.

The HER2-positive breast cancer market size is expected to see strong growth in the next few years. It will grow to $14.41 billion in 2029 at a compound annual growth rate (CAGR) of 7.08%. Looking ahead, growth in the forecast period is expected to be driven by factors such as the rising demand for liquid biopsy for non-invasive monitoring, the increasing adoption of combination therapies, a growing emphasis on immunotherapies and novel drug formulations, and the expanding use of liquid biopsy techniques. Additionally, the rising number of specialized cancer treatment centers is contributing to this growth. Key trends in the forecast period include advancements in targeted therapies, new drug formulations, innovations in immunotherapy approaches, the development of novel HER2-targeted therapies, and progress in biomarkers to improve patient stratification.

The growing adoption of immunotherapy is expected to drive significant growth in the HER2-positive breast cancer market. Immunotherapy is a treatment that boosts or modifies the immune system's natural ability to fight diseases, including cancer. It works by enhancing the immune system’s capacity to identify and eliminate cancer cells, offering improved efficacy and fewer side effects compared to traditional treatments. For HER2-positive breast cancer, immunotherapy helps by enabling the body’s immune system to target and attack HER2-overexpressing cancer cells, improving patient outcomes and reducing the risk of recurrence. According to the American Association for Cancer Research, in 2023, the FDA approved 11 immune checkpoint inhibitors (ICIs), with at least one authorized for the treatment of 20 different cancer types and for any solid tumor with specific molecular markers. This strong adoption of immunotherapy is helping to expand the HER2-positive breast cancer market.

Companies in the HER2-positive breast cancer market are focused on developing innovative therapies to improve treatment efficacy and patient outcomes. One such therapy is HER2-directed antibody-drug conjugates (ADCs), which combine antibodies targeting HER2 with cytotoxic drugs, delivering the drug directly to HER2-positive cancer cells for more precise and effective treatment. For example, in January 2024, AstraZeneca India Pharma Ltd. launched Trastuzumab deruxtecan, a HER2-directed ADC developed in collaboration with Daiichi Sankyo. Trastuzumab deruxtecan targets HER2-positive cancer cells and delivers a cytotoxic drug directly to the site, offering a more targeted approach to treatment.

In May 2023, Roche Holding AG, a Switzerland-based pharmaceutical company, acquired the rights to Zion Pharma’s lead program, ZN-A-1041, for an undisclosed amount. This acquisition aims to accelerate the development and commercialization of ZN-A-1041, a blood-brain-barrier-penetrant HER2 inhibitor designed to treat brain metastases in HER2-positive breast cancer patients. Zion Pharma, based in China, specializes in developing drugs for HER2-positive breast cancer, and this collaboration with Roche focuses on advancing treatment options for patients with brain metastases, a common complication in HER2-positive breast cancer.

Major players in the her2-positive breast cancer market are Johnson & Johnson Services Inc., F. Hoffmann-La Roche AG, Merck & Co. Inc., Bayer AG, Sanofi S.A., AstraZeneca plc, Novartis International AG, GlaxoSmithKline plc, Eli Lilly and Company, Amgen Inc., Boehringer Ingelheim GmbH, Daiichi Sankyo Co. Ltd., Incyte Corporation, BioNTech SE, MacroGenics Inc., CStone Pharmaceuticals Co. Ltd., Sorrento Therapeutics Inc., Syndax Pharmaceuticals Inc., Fate Therapeutics Inc., Ambrx Biopharma Inc.

North America was the largest region in the HER2- positive breast cancer market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in HER2- positive breast cancer report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the HER2- positive breast cancer market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

HER2-positive breast cancer is a form of breast cancer distinguished by an excess of the human epidermal growth factor receptor 2 (HER2) protein. This protein accelerates the growth of cancer cells and is present in about 15-20% of breast cancer cases. Generally, HER2-positive breast cancer tends to be more aggressive compared to HER2-negative types but can be treated using targeted therapies that block HER2 activity.

The primary treatment options for HER2-positive breast cancer include targeted therapy, chemotherapy, endocrine therapy, immunotherapy, and other methods. Targeted therapy is a treatment that specifically targets certain molecules, such as proteins or genes that drive cancer growth, while minimizing damage to healthy cells. These medications can be administered through different methods, including intravenous, oral, and other routes. They are distributed through various outlets such as hospital pharmacies, retail pharmacies, and online platforms, and are utilized by different end users such as hospitals, home care services, specialty clinics, and more.

The HER2-positive breast cancer market research report is one of a series of new reports that provides HER2- positive breast cancer market statistics, including the HER2- positive breast cancer industry global market size, regional shares, competitors with the HER2- positive breast cancer market share, detailed HER2- positive breast cancer market segments, market trends, and opportunities, and any further data you may need to thrive in the HER2- positive breast cancer industry. This HER2- positive breast cancer market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The HER2-positive breast cancer market consists of sales of small molecule inhibitors, antibody-drug conjugates, and monoclonal antibodies. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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