HER-2 NEGATIVE BREAST CANCER MARKET ANALYSIS

The global HER-2 negative breast cancer market was valued at US$ 12,647.0 Mn in 2022 and is forecast to reach a value of US$ 27,201.2 Mn by 2030 at a CAGR of 10.1% between 2023 and 2030. The global HER-2 negative breast cancer market is experiencing strong growth due to the rise in burden of breast cancer and increase in number of clinical trials across the globe. Moreover, rise in demand for safe & effective treatment and rise in focus on the development of novel drugs or therapies is expected to boost the growth of the market. However, factors such as high cost of treatment and lack of awareness among people are expected to hamper the market growth.

Global HER-2 Negative Breast Cancer Market: Regional Insights

Based on geography, the global HER-2 negative breast cancer market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the increasing growing burden of breast cancer, increase in demand for safe and effective treatment, and increase in research and development in the region. For instance, HER2-negative negative breast cancer means that the cancerous cells do not contain high levels of the protein HER2. In April 2021, the Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).

Europe and Asia Pacific are also expected to witness robust growth in the global HER-2 negative breast cancer market due to the rise in incidence of breast cancer, increase in demand for safe and effective treatment, and introduction of novel drugs or therapies in these regions. For instance, in January 2023, Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 breast cancer who have received prior chemotherapy. This in turn is driving the growth of the HER-2 negative breast cancer market in Europe.

Figure 1. Global HER-2 Negative Breast Cancer Market Share (%), by Region, 2023

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Global HER-2 Negative Breast Cancer Market Drivers:

Growing burden of breast cancer to augment market growth

One of the key factors expected to augment the growth of the global HER-2 negative breast cancer market over the forecast period is the rise in burden of breast cancer across the globe. For instance, according to the American Cancer Society, more than 15% to 20% of breast tumors have higher levels of the protein known as HER2. These cancer are called HER2-positive breast cancer. Most breast cancers are HER2-negative. Cancer that may be HER2 negative are breast, bladder, ovarian, pancreatic, and stomach cancer. According to the National Cancer Institute (NCI), around 78% of breast cancers are HER2-negative and don't produce too much HER2.

Rise in number of clinical trials to underpin market growth

Another factor which is driving the growth of the global HER-2 negative breast cancer market is the rise in number of clinical trials. For instance, with the increase in burden of breast cancer, the number of clinical trials is also increasing with the rapid pace. According to the ClinicalTrials.gov, March 2022 report, ZB716 is in phase II development as monotherapy and in combination with palbociclib in patients with HER2-negative locally advanced or metastatic breast cancer. For the people with HER-2 negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. This in turn is driving the market growth.

Global HER-2 Negative Breast Cancer Market Opportunities:

Rise in demand for safe & effective treatment is expected to offer significant growth opportunities for players in the global HER-2 negative breast cancer market. For instance, with the increase in awareness among people about HER-2 negative breast cancer, demand for safe, effective treatment is also increasing rapidly. In December 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for the use of Enhertu (fam-trastuzumab deruxtecan-nxki) monotherapy for adults with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting.

Rise in focus on the development of novel drugs or therapies is expected to offer lucrative growth opportunities for players in the global HER-2 negative breast cancer market. For instance, players in the market are focusing on developing or launching novel drugs or therapies in the market to meet increasing demand. In October 2021, the U.S. Food & Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test.

Global HER-2 Negative Breast Cancer Market Trends:

High demand for chemotherapy drugs is a recent trend

Chemotherapy is the most common and aggressive form of drug therapy that is used to destroy cancer cells in the body and prevent them from further dividing and growing. Chemotherapy drugs travel through the bloodstream and damage cancer cells throughout the body and have a high effect on cancer cells. Several chemotherapy drugs are used to treat HER2-negative breast cancer, either alone or in combination with other drugs. This trend is expected continue over the forecast period, driving the HER-2 negative breast cancer market growth.

Increase in research and development (R&D) is another trend

Players in the market are involved in various research and development (R&D) activities for the development of novel drugs and therapies for the treatment of HER-2 negative breast cancer. With the growing research and development activities, the pipeline products and product approvals are increasing by the market players, which in turn is expected have a positive impact on the market. This trend is also expected continue over the forecast period.

Global HER-2 Negative Breast Cancer Market Restraints:

High cost of treatment to hinder growth of the market

One of the key factors expected to hamper the growth of the global HER-2 negative breast cancer market is the high cost of treatment. According to the National Cancer Institute (NCI), per patient cost was US$ 292,155 for HER2-positive and $ 224,955 for negative tumors, respectively. HER-2 positive cancers are amenable to treatment with targeted biological agents such as trastuzumab. These biological agents are very effective but also very expensive. Thus, they are combined with chemotherapy to make them effective at killing cancer cells.

Lack of awareness to hamper the market growth

Another factor which is hampering the growth of the global HER-2 negative breast cancer market is the lack of awareness among people about HER-2 negative breast cancer. Because of the various difficulties in the diagnosis and treatment of HER-2 negative breast cancer, there is a greater lack of awareness among individuals concerning HER-2 cancer, which has an impact on treatment and diagnosis. Moreover, people in developing & underdeveloped countries have less awareness about HER-2 negative cancer due to a lack of proper healthcare facilities.

Figure 2. Global HER-2 Negative Breast Cancer Market Share (%), by Type of Treatment, 2023

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Global HER-2 Negative Breast Cancer Market Segmentation:

The global HER-2 negative breast cancer market report is segmented into Type of Treatment, and Geography.

Based on Type of Treatment, the market is segmented into Chemotherapy, Radiation, Hormonal Therapy, and Other Types of Treatments. Out of which, Chemotherapy Segment is expected to dominate the HER-2 negative breast cancer market over the forecast period and this is attributed to the increase in demand or use of chemotherapy drugs.

Hormonal Therapy Segment is also expected to witness significant growth in the near future and this is owing to the rise in demand for safe and effective treatment. Hormonal therapy is considered the standard initial treatment for HER2-negative metastatic breast cancer.

Global HER-2 Negative Breast Cancer Market: Key Developments

In September 2022, Gilead Sciences Inc. reported new data from a posthoc subgroup analysis of Phase III TROPiCS-02 study comparing Trodelvy (sacituzumab govitecan- hziy) with comparator chemotherapies in patients with HR+/HER2- metastatic breast cancer who progressed on at least two chemotherapies and endocrine-based therapies.

In August 2022, the FDA approved Enhertu, a radiation therapy targeted to patients with HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

In March 2022, AstraZeneca and MSD's Lynparza (Olaparib) was approved in the United States for the adjuvant treatment of patients with germline BRCA-mutated HER2-negative high-risk early breast cancer who have already undergone chemotherapy either before or after surgery.

In November 2021, Olema Pharmaceuticals Inc. reported the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, the complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of HER2-negative breast cancer and other women’s cancers.

Global HER-2 Negative Breast Cancer Market: Key Companies Insights

The global HER-2 negative breast cancer market is highly competitive. This is attributed to the rise in burden of HER-2 negative breast cancer worldwide, as a result, players in the market are focusing on launching novel products in the market. Some of the key players in the global HER-2 negative breast cancer market are Pfizer Inc., Novartis AG, Merck & Co. Inc., GSK PLC, AstraZeneca, Eli Lilly and Company, and Bristol-Myers Squibb Company (Celgene Corporation), among others.

*Definition: HER2-negative negative breast cancer means that the cancerous cells do not contain high levels of the protein HER2. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface.