ER+/ HER2 -ve Breast Cancer - Market Insight, Epidemiology, and Market Forecast - 2036

Key Highlights:

• Breast Cancer is the second most common cancer in women and men worldwide, and among all types of Breast Cancer, estrogen receptor-positive (ER+) Breast Cancer is the most common type of cancer diagnosed in patients with Breast Cancer.
• The total incident population of Breast Cancer in the United States is 256,431 in 2022.
• The total market size of ER+/HER2- Breast Cancer in the United States is USD 6,759 million in 2022 and is projected to grow during the forecast period (2026-2036)

The ER+/HER2- Breast Cancer pipeline possessed multiple potential drugs in late- and mid-stage developments to be launched shortly. Key players involved in robust research and development include Radius Pharmaceuticals (Elacestrant), AstraZeneca (Camizestrant (AZD9833)), Roche (Giredestrant), Sermonix Pharmaceuticals (Lasofoxifene), AstraZeneca and Daiichi Sankyo (Datopotamab deruxtecan), Eli Lilly (Imlunestrant), Veru (Enobosarm), Roche/Genentech (Inavolisib), Tyme (SM-88), Gilead Sciences (TRODELVY) are some of the major players that are going to alter the market dynamics in the coming years.

DelveInsight's "ER+/HER2- Breast Cancer - Market Insights, Epidemiology and Market Forecast- 2036" report delivers an in-depth understanding of the ER+/HER2- Breast Cancer, historical and forecasted epidemiology as well as the ER+/HER2- Breast Cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

ER+/HER2- Breast Cancer market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM ER+/HER2- Breast Cancer market size from 2022 to 2036. The report also covers current ER+/HER2- Breast Cancer treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

ER+/HER2- Breast Cancer Disease Understanding and Treatment Algorithm

ER+/HER2- Breast Cancer Overview

Breast cancer begins when abnormal cells in the breast start growing and multiplying uncontrollably, forming a tumor. It often originates in the ducts or lobules of the breast. Cancer cells receive various signals that stimulate their growth, and some of these signals are hormones.

Hormone receptors are proteins that detect hormone signals and instruct cancer cells to grow. When breast cancer cells respond to estrogen signals, it is called estrogen receptor-positive (ER+) breast cancer. Similarly, if they respond to progesterone, it is called progesterone receptor-positive (PR+) breast cancer. Breast cancers that are ER+ or PR+ are collectively classified as hormone receptor-positive (HR+) breast cancer.

On the other hand, hormone receptor-negative (HR-) breast cancer refers to tumors whose cells lack hormone receptors. These HR- cancer cells grow independently of estrogen or progesterone.

Another important factor in breast cancer is the human epidermal growth factor receptor 2 (HER2). HER2 is a gene that regulates cell growth, division, and repair. Its protein product acts as a receptor on breast cells. Breast cancers that test positive for HER2 are called HER2-positive (HER2+), and they tend to grow faster, spread more easily, and have a higher risk of recurrence than HER2-negative (HER2-) cancers. HER2- cancers have low levels of the HER2 protein, often grow more slowly, and are less likely to spread or return. Determining a patient's HER2 status helps guide treatment decisions.

ER+/HER2- Breast Cancer Diagnosis

The diagnosis of breast cancer is determined by the detection of a lesion through mammography, other imaging methods such as ultrasound, or physical examination. In every case, it is essential to integrate radiologic evaluation of both the affected and the opposite breast with the patient's overall health, clinical examination of the breast and lymph nodes, and pathological findings. Treatment decisions for breast cancer are based on the combined results of these assessments.

ER+/HER2- Breast Cancer Treatment

Estrogen receptor (ER) expression is the primary marker for predicting responses to hormonal therapy, as most human breast cancers are hormone-dependent and ER-positive. Several classes of anti-estrogen agents are available for patients with early, advanced, or metastatic breast cancer, including selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and selective estrogen receptor degraders (SERDs). Currently, clinical research is focused on combining anti-estrogen therapies with targeted agents that inhibit key signaling pathways, such as the PI3K/AKT/mTOR pathway or the CDK4/6 pathway at the G1/S cell cycle checkpoint, particularly in patients with hormone receptor-positive breast cancer who experience recurrence or disease progression.

ER+/HER2- Breast Cancer Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total incident population of Breast Cancer, incidence of Breast Cancer cases by menopausal status, stage-specific incidence of Breast Cancer, subtype-specific incidence of Breast Cancer, and treatment eligible pool for localized and metastatic Breast Cancer in the 7MM market covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2022 to 2036.

Key Findings

This section provides glimpse of the ER+/HER2- Breast Cancer epidemiology in the 7MM

Country Wise- ER+/HER2- Breast Cancer Epidemiology

The epidemiology segment also provides the ER+/HER2- Breast Cancer epidemiology data and findings across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

• The total incident population of Breast Cancer in the United States is 256,431 in 2022.
• In the United States, more cases were observed for postmenopausal Breast Cancer, with 205,145 cases in 2022.
• In 2022, cases of localized, regional, distant and unknown stage were observed to be 164,116, 74,365, 15,386 and 2,564 respectively. This number might increase during forecast period.
• Among the various subtypes of the disease (localized and regional), ER+/HER2- occupies the maximum patient pool, with 147,977 cases of this category, followed by the number of those with 24,325 cases of Triple-negative and 20,271 cases of ER+/HER2+. On the other hand, HR-/HER2+ accommodated the least number of cases.

ER+/HER2- Breast Cancer Drug Chapters

Drug chapter segment of the ER+/HER2- Breast Cancer report encloses the detailed analysis of ER+/HER2- Breast Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the ER+/HER2- Breast Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

KISQALI (ribociclib): Novartis

KISQALI is a kinase inhibitor approved for use in adults with HR-positive, HER2-negative advanced or metastatic cancer. It can be used in combination with:

An aromatase inhibitor as first-line endocrine therapy

Fulvestrant, either as first-line endocrine therapy or after disease progression on prior endocrine therapy, in postmenopausal women or men

IBRANCE (palbociclib): Pfizer

IBRANCE is a kinase inhibitor that has received regulatory approval in the United States from the FDA, in Europe from the EMA, and in Japan from the PMDA. It is indicated for treating adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer, either in combination with an aromatase inhibitor as first-line endocrine therapy for postmenopausal women or men, or with fulvestrant for patients whose disease has progressed following prior endocrine therapy. IBRANCE is currently approved in over 90 countries worldwide.

AFINITOR (everolimus): Novartis

AFINITOR is a kinase inhibitor prescribed for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC). It is used alongside exemestane when treatment with letrozole or anastrozole has been unsuccessful. Generic versions of AFINITOR became available in the US in 2019.

LYNPARZA (olaparib): AstraZeneca

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor targeting PARP1, PARP2, and PARP3. It is indicated for patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAm) who have HR+ HER2- metastatic breast cancer and have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with HR+ breast cancer may also have received prior endocrine therapy or may be deemed unsuitable for it. Additionally, LYNPARZA is used as a first-line maintenance therapy for BRCA-mutated advanced ovarian cancer. It is now also approved as an adjuvant treatment for adult patients with deleterious or suspected deleterious gBRCAm HER2- high-risk early breast cancer who have undergone neoadjuvant or adjuvant chemotherapy.

Emerging Drugs

Elacestrant: Radius Pharmaceuticals

Elacestrant, a selective estrogen receptor degrader (SERD) licensed to Menarini Group, is being investigated as a once-daily oral therapy for HR+ breast cancer. Current studies suggest it may be effective both as a standalone treatment and in combination with other therapies. In October 2017, Radius Health announced that the US FDA had granted elacestrant Fast Track Designation for treating women with ER+ and HER2- advanced or metastatic breast cancer.

Giredestrant (RG6171, GDC-9545): Roche

Giredestrant is an experimental selective estrogen receptor degrader (SERD) designed to fully inhibit estrogen receptor (ER) signaling with strong receptor engagement. In HR+ breast cancer, estrogen promotes tumor cell growth by binding to the ER. Giredestrant blocks this receptor, preventing estrogen's effect and triggering degradation of the receptor itself. This investigational therapy has demonstrated activity regardless of ESR1 mutation status, which is a key mechanism of resistance to hormone therapies. In December 2020, the US FDA granted giredestrant Fast Track Designation for ER+, HER2- metastatic breast cancer in patients receiving second- or third-line treatment.

Camizestrant (AZD9833): AstraZeneca

Camizestrant (AZD9833) is an orally administered selective estrogen receptor degrader (SERD) that has demonstrated antitumor activity across multiple preclinical breast cancer models. The compound has been shown to be a highly potent SERD, exhibiting a pharmacological profile similar to fulvestrant in its ability to degrade ERa in MCF-7 and CAMA-1 cell lines. Careful optimization of its lipophilicity contributed to favorable physicochemical and preclinical pharmacokinetic properties suitable for oral dosing. Additionally, it showed strong in vivo efficacy in mouse xenograft models. In June 2021, AstraZeneca launched the Phase III SERENA-6 trial to assess the safety and effectiveness of AZD9833 in combination with a CDK4/6 inhibitor (either palbociclib or abemaciclib) for patients with HR-positive, HER2-negative metastatic breast cancer harboring an ESR1 mutation.

LY3484356 (imlunestrant): Eli Lilly

LY3484356 (imlunestrant) is a chemical compound that acts as an oral selective estrogen receptor degrader (SERD). It is under investigation for the treatment of second-line ER-positive, HER2-negative metastatic breast cancer (mBC). The drug is currently being evaluated in a Phase III clinical trial (NCT04975308; EMBER-3). The main goal of the study is to assess the effectiveness of imlunestrant compared to standard hormone therapy, and to evaluate the combination of imlunestrant with abemaciclib versus imlunestrant alone in patients with ER-positive, HER2-negative breast cancer.

Lerociclib (EQ132): EQRx

Lerociclib (EQ132) is a novel, orally administered, highly potent, and selective small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). In July 2020, EQRx acquired the exclusive rights from G1 Therapeutics to develop and commercialize lerociclib in the United States, Europe, Japan, and all other global markets, except for the Asia-Pacific region (excluding Japan). Meanwhile, Genor Biopharma (Genor) holds the rights to develop and commercialize lerociclib across the Asia-Pacific region, excluding Japan.

ER+/HER2- Breast Cancer Market Outlook

Breast cancer is the second most prevalent cancer globally among both women and men. Among its subtypes, estrogen receptor-positive (ER+) breast cancer is the most commonly diagnosed. ER+ cancer cells have receptors that bind to estrogen, promoting tumor growth. According to the American Cancer Society, roughly two-thirds of breast cancer cases are hormone receptor-positive (HR+), with the majority being ER+.

The stage of breast cancer plays a critical role in guiding treatment decisions. For most women with Stage I-III breast cancer, surgery is the primary treatment, often followed by radiation. Drug therapy is also commonly used, tailored to the tumor's hormone receptor and HER2 status. This may include chemotherapy, hormone therapy (tamoxifen or aromatase inhibitors), HER2-targeted therapies like trastuzumab (Herceptin) or pertuzumab (Perjeta), or combinations of these.

In Stage I HR+ cancers, hormone therapy is typically recommended as an adjuvant treatment regardless of tumor size, though those larger than 0.5 cm may gain more benefit. Hormone therapy usually lasts at least five years. Adjuvant chemotherapy may be suggested for tumors over 1 cm or for smaller tumors with high-risk features, such as rapid growth, HR-/HER2+ status, or high gene panel scores. For HER2+ tumors, 6-12 months of trastuzumab is generally advised.

For Stage II breast cancer, systemic therapy is indicated, either before surgery (neoadjuvant) to shrink tumors or after surgery (adjuvant). Neoadjuvant therapy can allow for breast-conserving surgery in women with larger tumors, though it does not improve overall survival compared to post-surgery treatment. Sometimes systemic therapy spans both pre- and post-surgery periods.

Stage III cancers are commonly treated with neoadjuvant chemotherapy. HER2+ tumors receive trastuzumab, often with pertuzumab, to reduce tumor size and enable breast-conserving surgery. If tumors remain large, a mastectomy is performed, and nearby lymph nodes are examined. Sentinel lymph node biopsy is often unsuitable in Stage III cases, so axillary lymph node dissection is typically performed.

Current drug options include tamoxifen (blocking estrogen binding), aromatase inhibitors (letrozole, anastrozole, exemestane) that reduce estrogen production, luteinizing hormone-releasing hormone analogs (goserelin, leuprolide) that suppress ovarian hormone production, and fulvestrant, a selective ER degrader for patients resistant to prior hormone therapy. Endocrine therapies are generally administered sequentially until rapid response or resistance requires chemotherapy.

The ER+/HER2- breast cancer pipeline is active, with several mid- and late-stage drugs nearing launch. Key companies driving research and development include Radius Pharmaceuticals (Elacestrant), AstraZeneca (Camizestrant/AZD9833), Roche (Giredestrant, Inavolisib), Sermonix Pharmaceuticals (Lasofoxifene), AstraZeneca/Daiichi Sankyo (Datopotamab deruxtecan), Eli Lilly (Imlunestrant), Veru (Enobosarm), Tyme (SM-88), and Gilead Sciences (TRODELVY). These innovations are expected to significantly reshape the market in the coming years.

Key Findings

This section includes a glimpse of the ER+/HER2- Breast Cancer in 7MM market.

The total market size of ER+/HER2- Breast Cancer in the United States is USD 6,759 million in 2022 and is projected to grow during the forecast period (2022-2034)

The total market size of ER+/HER2- Breast Cancer in first-line setting in the United States is USD 3,471 million in 2022

The United States Market Outlook

The total market size of ER+/HER2- Breast Cancer in the United States is expected to increase during the study period (2022-2036).

EU4, the UK Market Outlook

The total market size of ER+/HER2- Breast Cancer in EU4, and the UK is expected to increase during the study period (2022-2036).

Japan Market Outlook

The total market size of ER+/HER2- Breast Cancer in Japan is expected to increase during the study period (2022-2036).

Analyst Commentary

• The emergence of several novel CDK4/6 inhibitors in ER+/HER2- Breast Cancer space has demonstrated a widespread potential for this patient population in combination and as monotherapy
• Approval of VERZENIO, the only CDK4/6 inhibitor in the adjuvant setting, is expected to reap benefits of first mover advantage in this setting
• Pfizer's IBRANCE is expected to dominate the first (1L) and second line (2L) market even after the entry of Next generation SERDs during the forecast years
• Upcoming pipeline of ER+, HER2- Breast cancer comprises many next-generation SERD drug candidates. They will face a strong competition from the existing CDK4/6 inhibitors that have a strong hold over majority of the market share. This could lead to their slow growth
• The only SERM in the second-line and the third-line setting is Lasofoxifene which is given in combination with abemaciclib

ER+/HER2- Breast Cancer Drugs Uptake

This section focuses on the rate of uptake of the potential ER+/HER2- Breast Cancer drugs expected to get launched in the market during the study period 2022-2036. The analysis covers ER+/HER2- Breast Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- Enobosarm, is an oral, first in class, new chemical entity that is a member of a new class of endocrine drugs called selective androgen receptor targeting agonists - it is both an agonist and an antagonist depending on the tissue type. In January 2022, Veru announced that the US FDA had granted Fast Track Designation (FTD) to enobosarm for the treatment of AR+ ER+ HER2- Metastatic Breast Cancer. As per our analysis, enobosarm drug uptake in the US for 3L+ is expected to be medium-fast with a probability adjusted peak share of 15.8%, years to peak would be 6 years.

ER+/HER2- Breast Cancer Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for ER+/HER2- Breast Cancer emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center. Their opinion helps to understand and validate current and emerging therapies treatment patterns or ER+/HER2- Breast Cancer market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the ER+/HER2- Breast Cancer market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report:

• The report covers the descriptive overview of ER+/HER2- Breast Cancer, explaining its causes, signs and symptoms, pathogenesis and currently available therapies
• Comprehensive insight has been provided into the ER+/HER2- Breast Cancer epidemiology and treatment
• Additionally, an all-inclusive account of both the current and emerging therapies for ER+/HER2- Breast Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of ER+/HER2- Breast Cancer market; historical and forecasted is included in the report, covering the 7MM drug outreach
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM ER+/HER2- Breast Cancer market

Report Highlights:

• In the coming years, ER+/HER2- Breast Cancer market is set to change due emerging therapies in the pipeline, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence ER+/HER2- Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• As per DelveInsight's analysis, the major types of Breast Cancer include invasive, non-invasive, ductal carcinoma, lobular carcinoma, and others
• The report also encompasses other major segments, i.e., total incident population of Breast Cancer, incidence of Breast Cancer cases by menopausal status, stage-specific incidence of Breast Cancer, subtype-specific incidence of Breast Cancer, and treatment eligible pool for localized and metastatic Breast Cancer
• Expected launch of potential therapies such as Elacestrant (Radius Pharmaceuticals), Giredestrant (Roche), Lasofoxifene (Sermonix Pharmaceuticals), and others might change the landscape in treatment of ER+/HER2- Breast Cancer
• The US FDA-approved drugs, which are currently available, include KISQALI, PIQRAY, VERZENIO, LYNPARZA, IBRANCE, and others

ER+/HER2- Breast Cancer Report Insights

• ER+/HER2- Breast Cancer Report Insights
• Patient Population
• Therapeutic Approaches
• ER+/HER2- Breast Cancer Pipeline Analysis
• ER+/HER2- Breast Cancer Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

ER+/HER2- Breast Cancer Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• ER+/HER2- Breast Cancer Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

ER+/HER2- Breast Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• SWOT
• Attribute Analysis

Key Questions:

Market Insights:

• What was the ER+/HER2- Breast Cancer market share (%) distribution in 2025 and how it would look like in 2036?
• What would be the ER+/HER2- Breast Cancer total market size as well as market size by therapies across the 7MM during the study period (2026-2036)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest ER+/HER2- Breast Cancer market size during the study period (2026-2036)?
• At what CAGR, the ER+/HER2- Breast Cancer market is expected to grow at the 7MM level during the study period (2026-2036)?
• What would be the ER+/HER2- Breast Cancer market outlook across the 7MM during the study period (2026-2036)?
• What would be the ER+/HER2- Breast Cancer market growth till 2036 and what will be the resultant market size in the year 2036?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of ER+/HER2- Breast Cancer?
• What is the historical ER+/HER2- Breast Cancer patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What would be the forecasted patient pool of ER+/HER2- Breast Cancer at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to ER+/HER2- Breast Cancer?
• Out of the above-mentioned countries, which country would have the highest incident population of ER+/HER2- Breast Cancer during the study period (2026-2036)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2026-2036)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of ER+/HER2- Breast Cancer? What are the current treatment guidelines for the treatment of ER+/HER2- Breast Cancer in the US and Europe?
• What are the ER+/HER2- Breast Cancer marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of ER+/HER2- Breast Cancer?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of ER+/HER2- Breast Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the ER+/HER2- Breast Cancer therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for ER+/HER2- Breast Cancer and their status?
• What are the key designations that have been granted for the emerging therapies for ER+/HER2- Breast Cancer?
• What are the 7MM historical and forecasted market of ER+/HER2- Breast Cancer?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the ER+/HER2- Breast Cancer
• To understand the future market competition in the ER+/HER2- Breast Cancer market and Insightful review of the SWOT analysis of ER+/HER2- Breast Cancer
• Organize sales and marketing efforts by identifying the best opportunities for ER+/HER2- Breast Cancer in the US, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for ER+/HER2- Breast Cancer market
• To understand the future market competition in the ER+/HER2- Breast Cancer market