PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer – Global Drug Forecast and Market Analysis to 2025

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Human epidermal growth factor receptor type 2 (HER2-) breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. HER2-negative breast cancer can be subdivided into hormone receptor-positive (HER2-/HR+), and triple negative breast cancer (TNBC). The prognoses of HER2-/HR+ and TNBC differ dramatically, as patients with TNBC progress more rapidly towards metastatic disease and only respond to chemotherapy agents. A large number of pipeline agents are being developed in HER2-/HR+ and/or TNBC, and are likely to change the treatment paradigm for these patients.

This report highlights the significant unmet need for expansion in the HER2- breast cancer marker across the eight major markets; it also discusses the associated commercial opportunities for new market entrants to gain a foothold in the market. GlobalData anticipates the HER2- breast cancer market to almost double, from $5.43B to $10.58B, over the forecast period of 2015-2025. The key drivers will be the incorporation of CDK4/6 inhibitors into the first-line metastatic setting and the rise of new targeted therapies and immunotherapies.


Overview of HER2- breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, treatment guidelines and disease management.

Annualized HER2- breast cancer therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2015 and forecast for seven years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HER2- breast cancer therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of middle- to late-stage pipeline drugs.

Analysis of the current and future market competition in the global HER2- breast cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

In HER2-/HR+ breast cancer, the recent launch of CDK4/6 inhibitors in the US market has changed the paradigm of treatment in metastatic setting in these patients. How will new late-stage drugs will be positioned in comparison to the CDK 4/6 inhibitor Ibrance (palbociclib)? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

Chemotherapy agents used in breast cancer are mostly well-established generics used in combination or as monotherapy. How will the advent of new therapies change the drug treatment landscape for HER2-negative breast cancer?

Several new late-stage agents target specific patients population. How will these agents will compete against chemotherapies in terms of efficacy and market size?

Array BioPharma
Astellas Pharma
Chipscreen Biosciences
Eli Lilly
Innocrin Pharmaceuticals
Merck & Co
NewLink Genetics
OncoMed Pharmaceuticals
Syndax Pharmaceuticals

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures



2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology



3.1.3Basic Breast Anatomy

3.2Disease Classification/Staging Systems



3.5Quality of Life


4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends




4.3.4China (Urban)

4.3.5Prevalence and Survival

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for Non-Invasive DCIS Breast Cancer (2015–2025)

4.5.1Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer

4.5.2Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status

4.6Epidemiological Forecast for Invasive Breast Cancer (2015–2025)

4.6.1Diagnosed Incident Cases of Invasive Breast Cancer

4.6.2Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer

4.6.3Age-Standardized Diagnosed Incidence of Invasive Breast Cancer

4.6.4Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer

4.6.5Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis

4.6.6Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status

4.6.7Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Menopausal Status, and Site of Metastasis

4.6.8Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Stage at Diagnosis, Menopausal Status, and Type of Biomarker Expression

4.6.9Diagnosed Incident Cases of TN Breast Cancer by Stage at Diagnosis and BRCA Expression


4.7.1Epidemiological Forecast Insight

4.7.2Limitations of the Analysis

4.7.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Screening and Diagnosis

5.1.2Treatment Overview of Loco-Regional Breast Cancer

5.1.3Neoadjuvant and Adjuvant Treatment Regimen

5.1.4Treatment of Metastatic HR+ Disease

5.1.5Treatment of Metastatic TNBC

5.1.6Treatment Guidelines and Leading Prescribed Drugs



5.2.2Clinical Practice



5.3.2Clinical Practice



5.4.2Clinical Practice



5.5.2Clinical Practice



5.6.2Clinical Practice



5.7.2Clinical Practice



5.8.2Clinical Practice



5.9.2Clinical Practice

6Competitive Assessment


6.2Product Profiles (Branded Therapies)

6.2.1Ibrance (palbociclib)

6.2.2Abraxane (nab-paclitaxel)

6.2.3Afinitor (everolimus)

6.2.4Avastin (bevacizumab)

6.2.5Halaven (eribulin mesylate)

6.2.6Ixempra (ixabepilone)

6.2.7Faslodex (fulvestrant)

6.2.8Doxil/Caelyx (pegylated liposomal doxorubicin)

6.3Product Profiles (Hormonal Agents)


6.3.2Aromatase Inhibitors

7Unmet Needs and Opportunities


7.1.1Defined Treatment Plan for BRCA+ Patients and the Prevention of Prophylactic Surgeries

7.1.2Targeted Treatment Options for Triple Negative Breast Cancer Patients

7.1.3Treatment of Brain Metastasis

7.1.4For HR+ Patients, Reduced Resistance to Hormonal Agents

7.1.5Improved Convenience of Administration of Hormonal Agents

8Pipeline Assessment


8.2CDK4/6 inhibitors

8.2.1Abemaciclib (LY2835219)

8.2.2Ribociclib (LEE011)

8.3Poly ADP-Ribose Polymerase Inhibitors

8.3.1Lynparza (olaparib)

8.3.2Talazoparib (BMN 673)

8.3.3Veliparib (ABT-888)

8.3.4Niraparib (MK4827)

8.4Phosphoinositide 3 Kinase Inhibitors

8.4.1Buparlisib (BKM- 120)

8.4.2Alpelisib (BYL-719)

8.4.3Taselisib (GDC-0032)

8.5PD-1/PD-L1 Checkpoint Inhibitors

8.5.1Tecentriq (atezolizumab)

8.5.2Keytruda (pembrolizumab)

8.6Histone Deacetylase Inhibitors


8.6.2Epidaza (chidamide)

8.7Antibody Drug Conjugates

8.7.1Sacituzimab govitecan (IMMU-132)

8.7.2Glembatumumab vedotin (CDX-011)


8.8.1Xtandi (enzalutamide)

8.9Promising Drugs in Early Stage Clinical Development




8.9.4IDO Checkpoint Inhibitors

9Current and Future Players


9.2Trends in Corporate Strategy

9.3Company Profiles





10Market Outlook

10.1Global Markets


10.1.2Drivers and Barriers – Global Issues



10.2.2Key Events

10.2.3Drivers and Barriers



10.3.2Key Events

10.3.3Drivers and Barriers



10.4.2Key Events

10.4.3Drivers and Barriers



10.5.2Key Events

10.5.3Drivers and Barriers





11.4Forecasting Methodology

11.4.1Diagnosed Patients with HER2- Breast Cancer

11.4.2Percent Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiration Dates

11.4.5General Pricing Assumptions

11.4.6Average Body Weight and Surface Area Across the 8MM

11.4.7General Forecast Assumptions

11.4.8Individual Drug Assumptions

11.4.9TS-1 Assumptions

11.4.10Generic Erosion

11.4.11Pricing of Pipeline Agents

11.5Primary Research – Key Opinion Leaderss Interviewed for This Report

11.6Primary Research – High-Prescribers Surveyed for this Report

11.7About the Authors



11.7.3Therapy Director

11.7.4Epidemiology Director

11.7.5Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData


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