Report

The Global HER-2 Negative Breast Cancer Market size is estimated at USD 15.03 billion in 2024, and is expected to reach USD 23.32 billion by 2029, growing at a CAGR of 9.17% during the forecast period (2024-2029).

The emergence of the COVID-19 pandemic had an adverse effect on the world economy and healthcare system. The lockdown all over the globe has affected the supply chain of pharmaceuticals, medical devices, and biotechnological products largely. On the other hand, research and development have come into focus and all the government agencies and healthcare players come forward to support the development of diagnostics and treatment methods for COVID-19. For instance, according to the study titled 'Impact of the COVID-19 Pandemic on the Diagnosis and Surgery of Breast Cancer: A Multi-Institutional Study' published in the Journal of Breast Cancer in December 2021, at the start of the COVID-19 pandemic, more patients had advanced and aggressive kinds of breast cancer, including HER-2 positive and HER-2 negative disease. In South Korea, the number of breast cancer diagnoses decreased by 9.9% by 2020. Most routine preventative actions, including active screening programs, have been decreased. Furthermore, breast cancer screening has dropped by 89.2%. Thus, this is expected to negatively impact breast cancer drug manufacturers, as their demand has reduced significantly due to the decline in diagnosis. Thus, restricting the chemotherapy used in HER-2 negative cancer with covid-19 infection, hampered the market growth. However, the utilization of specific therapeutic medicines used in the treatment of HER-2-negative cancer has increased. COVID-19 has had sightly negative impact on market growth, while it has slightly delayed the rate of growth of the global HER-2 negative breast cancer market throughout the forecast period.

Furthermore, the incidence and prevalence are growing rapidly due to lifestyle changes and certain factors increase the risk of breast cancer including increasing age, obesity, harmful use of alcohol, family history of breast cancer, history of radiation exposure, reproductive history (such as age that menstrual periods began and age at first pregnancy), tobacco use and postmenopausal hormone therapy. For instance, according to the National Institutes of Health data published in March 2022, HER-2 Negative cancer accounted for around 15-20% of the total breast cancer cases across the United States. It is anticipated that 287,850 new cases of female breast cancer would be diagnosed in 2022.

Additionally, as per the 2020 report of the Global Cancer Observatory (Globocan), breast cancer was the most prevalent form of cancer worldwide in 2020. About 2,261,419 new cases of breast cancer were diagnosed in 2020. The incidence of breast cancer cases is expected to increase from 2,261,419 in 2020 to 3,025,471 new cases by 2040. This data shows an increasing burden of breast cancer worldwide. Therefore, due to the increasing prevalence of breast cancer around the world, the HER-2-negative breast cancer market is expected to grow over the forecast period of the study.

A number of advanced targeted medicines for HER2-positive breast cancer are approved by the FDA. For instance, in August 2022, the Food and Drug Administration (FDA) approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other regions of the body) HER2-breast cancer.

Additionally, rising clinical activity is likely to support the market growth. For instance, according to the ClinicalTrials.gov, updates in March 2022, ZB716 is in phase II development as monotherapy and in combination with palbociclib in patients with HER2-negative locally advanced or metastatic breast cancer, with a completion date of 2024. This is likely to opens up the growth horizons to the market studied.

However, the high cost of treatment and availability of alternative treatments are expected to restrict the growth of this market.

HER- 2 Negative Breast Cancer Market Trends

Chemotherapy Is Identified as the Most Lucrative Segment of HER-2 Negative Breast Cancer Market

Chemotherapy is one of the most common and aggressive form of drug therapy that is used to destroy cancerous cell in the body and stops them from further division and growth. Chemotherapy drugs are systemic treatments; the drugs travel through the bloodstream and damage cancer cells throughout the body due to which they have high impact on the cancerous cells. For the treatment of HER2-negative breast cancer, different types of chemotherapy drugs are used, either in combination with others or alone depending upon the past treatments, risk of side effects and other conditions.

The growing burden of HER2-negative breast cancer, availability of chemotherapy drugs and ongoing research and development activities in the area are expected to be major factors, fueling growth in the chemotherapy segments. For instance, according to a research study published in February 2022, titled 'The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer-a pooled analysis of the randomized clinical trials PlanB and SUCCESS C', in most patients with HER2-negative early breast cancer, six cycles of docetaxel/cyclophosphamide (TC6) were found to be equally effective to an anthracycline-containing regimen and to have a much lower incidence of overall grade 3/4 toxicities. Hence, positive result from studies like these are further expected to increase the awareness and adoption of the chemotherapy which is expected to boost segment's growth. Also, as per the above-mentioned source, the recommended adjuvant therapy for HER2-negative early breast cancer is anthracycline/cyclophosphamide-taxane chemotherapy (AC-T) (EBC). Hence, the use of chemotherapy is expected to increase over the forecast period.

With the growing research and development activities in the area, the product approval and pipeline products are increasing by the key players in the market, which is further expected ton have a significant impact on the segment's growth over the forecast period. For instance, in October 2021, the United States FDA approved abemaciclib (Verzenio) in combination with endocrine therapy (either an aromatase inhibitor or tamoxifen) for adjuvant 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.

Therefore, owing to the new product approvals and ongoing research and development activities, the chemotherapy segment is expected to growth over the forecast period in the studied market.

North America is Expected to Hold a Significant Share in the Market with Similar Trend in the Forecast Period

North America is expected to hold a significant market share in the global HER-2 negative breast cancer market owing to better healthcare infrastructure, and a growing number of foundations and independent venture groups supporting the biopharmaceutical manufacturers.

The presence of significant manufacturers across the different states, and getting funding from various venture partners drive the market related to HER-2 negative breast cancer. For instance, according to the data published by the Organization for Economic Co-operation and Development (OECD), in June 2022, United States healthcare spending was 17.8% of the total gross domestic product (GDP) of the United States in 2021.

Additionally, as per the data published by the Centers for Medicare & Medicaid Services, in March 2022, titled 'CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures', it has been observed that the annual growth in national health spending is expected to be average 5.1% over 2021-2030. Thus, the increasing health spending is expected to increase the availability of technologically advanced therapies and systems to treat HER-2 negative breast cancer cases among the population, thereby propelling the market growth.

While the increasing product launches and developments are further propelling regional growth. For instance, in October 2021, the Food and Drug Administration approved Eli Lilly's Verzenio (abemaciclib), a CDK 4/6 inhibitor, with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Also, In April 2021, the Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy) for some patients with triple-negative breast cancer (TNBC).

Furthermore the increasing cases of HER-2 negative breast cancer is driving the regional growth. For instance, according to the January 2022 update by breastcancer.org, around 1 in 8 women in the country (about 13%) develop invasive breast cancer over their lifetime. These high cases of breast cancer will have a positive impact on the usage of treatment options that help in the market growth. According to the 2022 statistics published by Breastcancer.org, an estimated 287,850 new cases of invasive breast cancer and 51,400 new cases of non-invasive (in situ) breast cancer are expected to be diagnosed in the United States, in 2022. Thus, owing to the rising prevalence of breast cancer, the use of treatment options is increasing which is anticipated to boost the market growth over the forecast period.

Therefore, owing to the aforementioned factors, the studied market is expected to grow over the forecast period.

HER- 2 Negative Breast Cancer Industry Overview

The primary focus among the companies is to develop combination therapies that shall overcome the resistance of existing drug therapies in the market thus boosting the targeted disease treatment. This is done via collaboration and partnerships among the market players. Some major companies in this segment include AstraZeneca, Bristol-Myers Squibb Company (Celgene Corporation), Eli Lilly and Company, GSK plc., Merck & Co., Inc., Novartis AG, and Pfizer Inc.

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