Breast Cancer Monoclonal Antibodies Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, France, China, The Netherlands, Canada - Size and Forecast 2024-2028

Breast Cancer Monoclonal Antibodies Market Size 2024-2028 

The breast cancer monoclonal antibodies market size is forecast to increase by USD 19.2 billion at a CAGR of 13.97% between 2023 and 2028.

• The breast cancer monoclonal antibodies market is witnessing significant growth due to the increasing prevalence of breast cancer and the approval of an expanding product pipeline for monoclonal antibody (mAb) drugs. These therapies, which target specific proteins on cancer cells, are becoming increasingly popular as systemic treatments for breast cancer, particularly for those with hormonal receptors, such as estrogen receptor (ER) and progesterone receptor (PR) positive tumors.
• Additionally, the identification of BRCA gene mutations has led to the development of mAb drugs that specifically target these mutations, further expanding the market. However, the high cost of mAb treatments compared to traditional therapies remains a challenge for patient access and market penetration. The use of hybridoma technology in the production of mAb drugs continues to drive innovation and advancements in breast cancer treatment. Key players in the market include Roche, and Pfizer, among others.

What will be the Size of the Market During the Forecast Period?

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• Monoclonal antibodies have emerged as a significant class of therapeutic drugs in the fight against cancer. These antibodies are produced using hybridoma technology, which involves the fusion of an antibody-producing B cell with a myeloma cell to create a stable clone that produces identical antibodies. Cancer cells express specific antigens that differentiate them from normal cells. Monoclonal antibodies are antigen-specific, making them ideal for targeting these cells while minimizing damage to healthy cells. One common target for monoclonal antibody drugs is the Her2 protein overexpressed in certain breast cancers.
• However, monoclonal antibodies can have side effects. Some common side effects include fever, trembling, itching, weakness, chills, and low blood pressure. These reactions are typically due to the immune system's response to the foreign antibodies. Inflammation at the injection site is also common. To enhance the therapeutic efficacy of monoclonal antibodies, conjugated antibodies and naked monoclonal antibodies have been developed. Conjugated antibodies are linked to other therapeutic agents, such as toxins or radionuclides, to improve their ability to destroy cancer cells. Naked monoclonal antibodies, on the other hand, do not require conjugation and can be used in combination with other systemic therapies, such as hormonal therapy.
• Moreover, hormonal receptors, such as estrogen and progesterone receptors, are also common targets for monoclonal antibodies. These receptors play a role in the growth and survival of some breast cancers. Monoclonal antibodies can block the interaction between the cancer cells and the hormones, preventing their growth. BRCA gene mutations are linked to an increased risk of breast cancer. Monoclonal antibodies can be used to target the proteins produced by these mutations, making them a potential treatment option for patients with hereditary breast cancer. Monoclonal antibodies are a type of targeted therapy, which means they specifically target cancer cells while minimizing damage to healthy cells. This targeted approach reduces the overall side effects associated with traditional systemic therapies.
• In conclusion, monoclonal antibodies are a promising class of therapeutic drugs for the treatment of breast cancer. Their antigen specificity makes them ideal for targeting cancer cells while minimizing damage to healthy cells. However, they can have side effects, which can be managed through the development of conjugated and naked monoclonal antibodies. Monoclonal antibodies can also be used in combination with other systemic therapies, such as hormonal therapy, to enhance their therapeutic efficacy.

How is this market segmented and which is the largest segment?

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• End-user
  • Hospitals
  • Research institutes
  • Others
• Type
  • Humanized
  • Human
  • Chimeric
  • Murine
• Geography
  • North America
    • Canada
    • US
  • Europe
    • France
  • Asia
    • China
  • Rest of World (ROW)

By End-user Insights

• The hospitals segment is estimated to witness significant growth during the forecast period.

Monoclonal antibodies have emerged as a promising therapeutic approach in the field of breast cancer treatment. Research institutions are at the forefront of advancing knowledge in this area, conducting extensive research and development (R&D) activities. Their role extends to preclinical and clinical studies, evaluating the efficacy and safety of monoclonal antibodies for breast cancer treatment. These institutions benefit from increasing investments in breast cancer research by government and non-profit organizations.

For instance, Susan G. Komen, a leading breast cancer organization in the US, granted USD 21.7 million in June 2022 to fund 48 new research projects at 26 distinguished academic medical institutions. These projects aim to enhance patient outcomes, particularly for individuals with aggressive breast cancer or those experiencing recurrence or metastasis. Monoclonal antibodies are complex biotherapeutics, consisting of antigen-binding fragments (Fabs), antigen-binding sites formed by variable heavy (VH) and light (VL) chains, and the constant region, including the Fc region. The stereospecificity of monoclonal antibodies ensures precision medicine, making them a valuable tool in neoadjuvant therapy for breast cancer.

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The hospitals segment was valued at USD 6.30 billion in 2018 and showed a gradual increase during the forecast period.

Regional Analysis

• North America is estimated to contribute 41% to the growth of the global market during the forecast period.

Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The North American market for breast cancer monoclonal antibodies represents a substantial and expanding sector within the healthcare industry. Fueled by technological advancements and the escalating prevalence of breast cancer, this market is experiencing significant growth in North America. Key drivers include the increasing implementation of personalized medicine, the importance of early cancer detection, and the emergence of targeted therapies. North America's healthcare infrastructure, extensive expertise in genomics research, and extensive availability of monoclonal antibodies contribute to this market's expansion.

Furthermore, the increasing incidence of breast cancer in the region will continue to propel market growth during the forecast period. Monoclonal antibodies, which are laboratory-produced molecules, play a crucial role in cancer treatment by targeting cancer cells and inhibiting blood vessel growth. They are often used in conjunction with radiation treatment and chemotherapy, and can help healthy cells remain unharmed while the chemotherapy drug attacks cancer cells. The immune system cells that monoclonal antibodies mimic also help strengthen the body's natural defense against cancer.

Market Dynamics

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

What are the key market drivers leading to the rise in adoption of Breast Cancer Monoclonal Antibodies Market ?

The increasing prevalence of breast cancer is the key driver of the market.

• Breast cancer is the most common cancer diagnosed in women globally, according to the World Health Organization (WHO), with an estimated 2.3 million new cases and 685,000 deaths in 2020. In the United States, the National Cancer Institute projects that approximately 441,000 new cases will be diagnosed among women aged 30-84 years by 2030.
• Despite early diagnosis efforts, the risk of developing breast cancer remains a concern. Monoclonal antibodies, a type of therapeutic drug, have emerged as a promising solution in the fight against breast cancer. These antibodies work by targeting specific antigens on cancer cells, such as HER2, and inhibiting the immune system's response. However, side effects such as fever and trembling may occur. It is essential to consult healthcare professionals for proper administration and management of these treatments.

What are the market trends shaping the Breast Cancer Monoclonal Antibodies Market?

An increase in number of product approvals and expanded product pipeline is the upcoming trend in the market.

• Monoclonal antibodies have become a significant component of breast cancer treatment, with an increasing number of approvals from regulatory bodies. These antibodies, developed using hybridoma technology, target specific markers such as estrogen receptors (ER) and progesterone receptors (PR) to provide systemic therapy for breast cancer patients. The presence of a BRCA Gene mutation further necessitates the use of monoclonal antibody drugs in targeted therapies. The market is witnessing substantial growth due to the expanding product pipeline and continuous research and development efforts.
• For instance, in July 2021, the US Food and Drug Administration (FDA) approved Merck's pembrolizumab (Keytruda) for neoadjuvant and adjuvant treatment of high-risk, early-stage triple-negative breast cancer (TNBC). This approval underscores the market's potential to deliver innovative therapies, catering to the demand for effective and targeted treatments for breast cancer patients.

What challenges does Breast Cancer Monoclonal Antibodies Market face during the growth?

The high cost of breast cancer monoclonal antibody treatment when compared to traditional therapies is a key challenge affecting the market growth.

• The expense associated with breast cancer monoclonal antibody treatments may hinder the expansion of the global market during the forecast period. Monoclonal antibodies provide targeted therapy with enhanced efficacy and fewer side effects, yet their high cost could restrict accessibility and adoption rates. 
• For example, the National Institutes of Health (NIH) reports that Trastuzumab costs approximately USD 49,915 and USD 28,350 per patient in the adjuvant and metastatic breast cancer stages, respectively, in Canada. In contrast, the cost of chemotherapy for cancer treatment typically ranges from USD 12,618 to USD 17,564. The production of monoclonal antibodies involves intricate biologic processes and substantial R&D investments, leading to increased production costs compared to conventional chemotherapy or hormone therapy.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, market forecast , partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Amgen Inc.
• AstraZeneca Plc
• Boehringer Ingelheim International GmbH
• Bristol Myers Squibb Co.
• Celldex Therapeutics Inc
• Celltrion Co. Ltd.
• Daiichi Sankyo Co. Ltd.
• Eisai Co. Ltd.
• F. Hoffmann La Roche Ltd.
• Gilead Sciences Inc.
• Johnson and Johnson Services Inc.
• MacroGenics Inc.
• Merck KGaA
• Novartis AG
• Pfizer Inc.
• Puma Biotechnology Inc.
• Sanofi SA
• Seagen Inc.
• Teva Pharmaceutical Industries Ltd.
• Viatris Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Research Analyst Overview

Monoclonal antibodies are laboratory-produced molecules that can identify and target specific antigens on cancer cells. These therapeutic drugs are designed to enhance the immune system's ability to fight cancer by inhibiting the growth and spread of cancer cells. Monoclonal antibodies are particularly effective against breast cancer cells that express specific antigens, such as HER2. The antigen specificity of monoclonal antibodies makes them valuable tools in precision medicine. However, they can cause side effects, including fever, trembling, fatigue, headache, muscle pain, nausea/vomiting, difficulty in breathing, rashes, bleeding, and allergic reactions. These side effects are often a result of the immune system's response to the antibodies.

Moreover, monoclonal antibodies can be produced using various technologies, including hybridoma technology, which involves the fusion of mouse and human cells to create cells that produce a single type of antibody. Monoclonal antibodies can be conjugated with other molecules, such as toxins or radionuclides, to enhance their therapeutic effects. Monoclonal antibodies can be used in systemic therapy and targeted therapies for breast cancer. They can also be used in neoadjuvant therapy, which is administered before surgery to shrink the tumor. Monoclonal antibodies can target various proteins, including estrogen receptors, progesterone receptors, and BRCA gene mutations. Monoclonal antibodies can be classified based on their structure, including Fabs, FC, VH and VL domains, and stereo-specificity. They can also be produced as naked monoclonal antibodies or conjugated with other molecules, such as trispecific monoclonal antibodies. The production process can also vary, including the use of murine, chimeric, humanized, or human monoclonal antibodies. Monoclonal antibodies can interfere with cancer growth and blood vessel growth, making them effective in combination with radiation treatment and chemotherapy. However, they can also affect healthy cells, leading to side effects. It is important to carefully consider the benefits and risks of monoclonal antibody therapy for breast cancer treatment.

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What are the Key Data Covered in this Market Research and Growth Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies

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