Hormone Receptor (HR)-positive/ Human Epidermal Receptor 2 (HER2)-negative Breast Cancer is the most prevalent form of breast cancer. This type accounts for a higher percentage among all breast cancers. Hormone receptors are proteins that receive hormone signals and cue the cancer cells to grow. If breast cancer cells get signals from the hormone estrogen that could promote tumor growth, it is known as estrogen receptor-positive (ER+) breast cancer. If cancerous cells get signals from the hormone progesterone that could promote growth, it is known as progesterone receptor-positive (PR+) breast cancer. Breast cancer that is ER-positive or PR-positive falls under the category of hormone receptor-positive (HR+) breast cancer. In addition to this, there is another factor that is also responsible for breast cancer which is known as human epidermal growth factor receptor 2 (HER2). HER2 is a gene that helps control how cells grow, divide, and repair themselves.

HR-positive cancer is usually treated with hormone therapies or a combination of hormone therapy with targeted therapy to help stop tumor growth first. However, sometimes, cancer outfoxes the treatment and becomes resistant to hormonal therapy and stops working. There are many causes to occur breast cancer in women observed in comparison to the men.

Hormone Receptor (HR)-positive/ Human Epidermal Receptor 2 (HER2)-negative Breast Cancer epidemiology

According to DelveInsight, HR-positive/ HER2-negative Breast Cancer incident population in the 7MM is expected to grow at CAGR of 0.83%, during the study period [2017–2028]. The United States shows a higher Breast Cancer incidence in the United States with 266,120 cases in 2017. Among the EU-5 countries, Germany ranked first with 71,585 cases in 2017, followed by Italy, and France, in 2017. On the other hand, Spain has the least number of breast cancer incident cases which was equivalent to 11.99% of the total EU-5 breast cancer cases. Among the 7MM countries, Japan accounts for the second-highest breast cancer incident cases. In 2017, it was observed that the Breast Cancer incident population in Japan was found to be 89,100, which was equivalent to 14.21% of the total breast cancer incident population. Apart from Japan, in all other 7MM countries, among the various subtypes of the disease, HR-positive/HER2-negative breast cancer occupies the maximum patient pool, followed by the number of those with Triple-negative and HR-positive/HER2-positive. On the other hand, HR-negative/HER2-positive accommodated the least number of cases. Furthermore, from the category of HR-positive/HER2-negative, ER+ is primarily responsible for HR-positive cases.

HR-positive/ Human Epidermal Receptor 2 Negative Breast Cancer Market

HR-positive/ HER2-negative Breast cancer market size in the 7MM countries was observed to be USD 5,237.2 million in 2017. Among the 7MM countries, the United States had the highest Hormone Receptor positive/ Human Epidermal Receptor 2 Negative Breast Cancer market size in 2017, which accounts for approximately 83.96% of the total market. At present, the growth of HR-positive/HER2-negative breast cancer market size is attributed to drugs that have been approved for HR-positive breast cancer by the US FDA. The HR-positive/HER2-negative breast cancer market size was found to be USD 4216.4 million in 2017.

Among the EU-5 countries, Germany had the highest HR-positive/HER2-negative breast cancer market size in 2017, which accounts for approximately 25.51% of the total market. Of the therapies prescribed as first-line treatment, we have observed that CDK4/6 inhibitors occupy the largest HR-positive/HER2-negative breast cancer market share, of which Ibrance contributed the majority of the share, followed by Kisqali and Verzenio. The second position in the first-line treatment options is occupied by SERD class (Faslodex). Among the second and higher lines of therapy, CDK4/6 inhibitors occupy the largest HR-positive/HER2-negative breast cancer market share. Additionally, Kisqali and Verzenio shall dominate the HR-positive/HER2-negative breast cancer market, a post that, for both first-line and second-line treatments.

Currently, Ibrance (palbociclib) is approved as a new treatment option for women with advanced or metastatic disease. It is to be used for that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. The mechanism of Ibrance is by stopping the activity of the protein known as cyclin-dependent kinases (CDK) 4 and 6. This halts the division of cancer cells and helps to stop tumour growth. In postmenopausal women, Ibrance is to be used in combination with an aromatase inhibitor or with fulvestrant in cases where the patient has gone under prior hormone therapy. For women in stages preceding menopause, hormone therapy should be combined with a luteinizing hormone-releasing hormone (LHRH).

Currently prescribed drugs are prone to resistance. However, new therapies are being developed to restore endocrine sensitivity in resistant tumors by targeting signal transduction pathways thought to be involved in the ligand-independent activation of hormone receptors. These include cyclin-dependent kinase (CDK) 4/6 inhibitors (e.g. palbociclib, ribociclib, abemaciclib), phosphoinositide 3 kinases (PI3K) inhibitors (e.g. buparlisib) and mammalian target of rapamycin inhibitors (e.g. temsirolimus, everolimus)

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