HER2-Negative Breast Cancer – Global Drug Forecast and Market Analysis to 2028

Human epidermal growth factor receptor type 2 (HER2)-negative breast cancer is one of the most common cancer in the world and the most common cancer in women worldwide. HER2-negative breast cancer can generally be subdivided into two major groups: HER2-, estrogen receptor (ER)+ and/or progesterone receptor (PR)+ and HER2-, ER-, and PR- (triple-negative breast cancer, or TNBC). Historically HR+ breast cancer has typically been treated with hormone therapies which is the cornerstone of treatment for patients with this disease while physicians have typically relied on chemotherapy for patients with triple negative breast cancer. This has significantly changed in the last 5 years.

GlobalData is expecting a total of 9 new entrants to launch over the forecast period in the 8MM from 2018–2028 while specific marketed agents are expected to move into earlier lines of treatment. The competition will be particularly fierce in HER2-/HR+ breast cancer, with CDK4/6, PI3K/AKT, and HDAC inhibitors competing for market share with endocrine-based therapies in later lines of treatment. In TNBC, checkpoint inhibitors, PARP inhibitors and antibody drug conjugates will compete in specific patient segments, and are expected to ultimately lower the unmet needs in this patient population.

KEY QUESTIONS ANSWERED

Nine late-stage pipeline agents are going to enter the HER2-negative breast cancer market from 2018 onwards. Will the impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?

What are the current unmet needs in HER2-negative breast cancer, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?

What is the market outlook in the 8MM from 2018-2028? Considering major patent expiries, launch of new premium priced agents and expected label expansions.

What are the main corporate trends? Who are the current and future players?

Scope

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

Topline HER2-negative breast cancer market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting HER2-negative breast cancer therapeutics sales in the 8MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase III).

Analysis of the current and future market competition in the global HER2-negative 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

The main drivers of growth include the anticipated approval and launch of 9 pipeline therapies, in addition to label expansions of currently marketed therapies across the 8MM during the forecast period.

The main barriers to growth in the 8MM include the patent expiry of major brands and the high price of premium priced therapeutics entering the market.

Among the late-stage pipeline products and marketed agents, CDK4/6 inhibitors, checkpoint inhibitors and PI3K/AKT inhibitors are expected to generate the greatest revenues over the forecast period.

The most important unmet needs in the HER2-negative market include: Personalized therapies in TNBC, agents to tackle endocrine resistance and improved convenience for administration of hormone therapies.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global HER2-negative breast cancer therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2-negative breast cancer market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the global HER2-negative breast cancer therapeutics market from 2018-2028.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Pfizer

Roche

Astrazeneca

Novartis

Eli Lilly

Merck

 Eisai

 Celgene

 Chipscreen biosciences

OBI Pharma

PolyPhor

Syndax

Radius Health

Immunomedics 

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 HER2-Negative Breast Cancer: Executive Summary

2.1 The HER2-Negative Breast Cancer Market Will Expand to $12.22B in 2028

2.2 A Focus on Establishing Greater Market Access, Label Expansions for Premium Products, and New Products in Later Lines

2.3 Opportunities Remain for More Effective and Conveniently Administered Therapies in HER2-Negative Breast Cancer

2.4 Checkpoint Inhibitors and PI3K/AKT Inhibitors Are Well Positioned for Significant Market Penetration Over the Forecast Period

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.3.4 China (Urban)

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Sources Not Used – 5EU

5.4.3 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for HER2-Negative Breast Cancer (2018–2028)

5.5.1 Diagnosed Incident Cases of All Invasive Breast Cancer

5.5.2 Age-Specific Diagnosed Incident Cases of All Invasive Breast Cancer

5.5.3 Diagnosed Incident Cases of HER2-/HR+ Breast Cancer

5.5.4 Diagnosed Incident Cases of TN Breast Cancer

5.5.5 Proportion of Diagnosed Incident cases of HER2-/HR+ Breast Cancer by Stages

5.5.6 Proportion of Diagnosed Incident cases of TN Breast Cancer by Stages

5.5.7 Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Menopausal Status

5.5.8 Diagnosed Incident cases of HER2-Negative Breast Cancer by PD-1 and PD-L1 Expression

5.5.9 Diagnosed Incident Cases of HER2-Negative Breast Cancer with BRCA Mutation

5.5.10 Diagnosed Incident Cases of HER2-Negative Breast Cancer with PI3KCA Mutation

5.5.11 Diagnosed Incident Cases of HER2-Negative Breast Cancer by Bone Metastasis

5.5.12 Diagnosed Incident Cases of HER2-Negative Breast Cancer with Brain/CNS Metastasis

5.5.13 Five-Year Diagnosed Prevalent Cases of All Invasive Breast Cancer

5.5.14 Five-Year Diagnosed Prevalent Cases of HER2-Negative Breast cancer

5.5.15 10-Year Diagnosed Prevalent Cases of All Invasive Breast Cancer

5.5.16 10-Year Diagnosed Prevalent Cases of HER2-Negative Breast cancer

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.2 US

6.3 5EU

6.4 Japan

6.5 China

7 Competitive Assessment

7.1 Overview

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Developing More Personalized Treatment Options for TNBC Patients

8.3 Developing Novel Strategies to Tackle Endocrine Resistance in HR+ Disease

8.4 Improved Convenience for Administration of Hormonal Agents

8.5 Effective Treatment Strategies for Patients with Brain Metastases

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Pfizer

10.4 Novartis

10.5 Eli Lilly

10.6 AstraZeneca

10.7 Roche

10.8 Merck & Co

10.9 Other Players

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 China

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – Key Opinion Leaders Interviewed for This Report

12.4.1 Key Opinion Leaders

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: HER2-Negative Breast Cancer Key Metrics in the 8MM

Table 2 : Inherited Gene Mutations Associated With Lifetime Breast Cancer Risk

Table 3: Established and Probable Risk Factors Associated With Breast Cancer Development

Table 4: Molecular Subtypes of Breast Cancer

Table 5: AJCC Stage Definitions for Breast Cancer

Table 6: Risk Factors and Comorbidities for All Invasive Breast Cancer

Table 7: Treatment Guidelines for HER-/HR+ Breast Cancer

Table 8: Country Profile – US

Table 9: Country Profile – 5EU

Table 10: Country Profile – Japan

Table 11: Country Profile – China

Table 12: Leading Treatments for HER2-Negative Breast Cancer

Table 13: Pfizer’s HER2-Negative Breast Cancer Portfolio Assessment, 2019

Table 14: Novartis’s Disease Portfolio Assessment, 2019

Table 15: Eli Lilly’s Disease Portfolio Assessment, 2019

Table 16: AstraZeneca’s Disease Portfolio Assessment, 2019

Table 17: Roche’s Disease Portfolio Assessment, 2019

Table 18: Merck’s Disease Portfolio Assessment, 2019

Table 19: Eisai’s, Celgene’s, R-Pharm’s, Radius Health’s, Immunomedics’, OBI Pharma’s, and Polphor’s Disease Portfolio Assessment, 2019

Table 20: HER2-Negative Breast Cancer Market – Global Drivers and Barriers, 2018–2028

Table 21: Key Events Impacting Sales for HER2-Negative Breast Cancer in the US, 2018–2028

Table 22: HER2-Negative Breast Cancer Market – Drivers and Barriers in the US, 2018–2028

Table 23: Key Events Impacting Sales for HER2-Negative Breast Cancer in the 5EU, 2018–2028

Table 24: HER2-Negative Breast Cancer Market – Drivers and Barriers in the 5EU, 2018–2028

Table 25: Key Events Impacting Sales for HER2-Negative Breast Cancer in Japan, 2018–2028

Table 26: HER2-Negative Breast Cancer Market – Drivers and Barriers in Japan, 2018–2028

Table 27: Key Events Impacting Sales for HER2-Negative Breast Cancer in China, 2018–2028

Table 28: HER2-Negative Breast Cancer Market – Global Drivers and Barriers in China, 2018–2028

Table 29: Key Historical and Projected Launch Dates for HER2-Negative Breast Cancer

Table 30: Key Historical and Projected Patent Expiry Dates for HER2-Negative Breast Cancer

Table 31: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for HER2-Negative Breast Cancer in 2018 and 2028

Figure 2: Analysis of the Company Portfolio Gap in HER2-Negative Breast Cancer During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of HER2-Negative Breast Cancer During the Forecast Period

Figure 4: 8MM, Diagnosed Incidence Rates of All Invasive Breast Cancer, Ages ≥18 Years, Women, Cases per 100,000 Population, 2008‒2028

Figure 5: Sources Used for Diagnosed Incident Cases of All Invasive Breast Cancer

Figure 6: Sources Used for Diagnosed Incident Cases of HER2-/HR+ and TN Breast Cancer

Figure 7 : Sources Used for Diagnosed Incident Cases of HER2-/HR+ and TN Breast Cancer by Stage

Figure 8: Sources Used for Diagnosed Prevalent Cases of All Invasive Breast Cancer

Figure 9 : Diagnosed Incident Cases of All Invasive Breast Cancer, 8MM, Women, Ages ≥18 Years, 2018

Figure 10: 8MM, Age-Specific Diagnosed Incident Cases of All Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2018

Figure 11: Diagnosed Incident Cases of HER2-/HR+ Breast Cancer, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 12: Diagnosed Incident Cases of TN Breast Cancer, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 13: Proportion of Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Stage, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 14: Proportion of Diagnosed Incident Cases of TN Breast Cancer by Stage, 8MM, Women, Ages ≥18 Years, 2018

Figure 15: Proportion of HER2-/HR+ Breast Cancer by Menopausal Status, 8MM, Women, Ages ≥18 Years, 2018

Figure 16: HER2-Negative Breast Cancer by PD-1 and PD-L1 Expression, 8MM, Women, Ages ≥18 Years, 2018

Figure 17: Diagnosed Incident Cases of HER2-Negative Breast Cancer with BRCA Mutation, 8MM, Women, Ages ≥18 Years, 2018

Figure 18: HER2-Negative Breast Cancer by PI3K and AKT Mutation, 8MM, Women, Ages ≥18 Years, 2018

Figure 19: Diagnosed Incident Cases of HER2-Negative Breast Cancer by Bone Metastasis, 8MM, Women, Ages ≥18 Years, 2018

Figure 20: Diagnosed Incident Cases of HER2-Negative Breast Cancer with Brain/CNS Metastasis, 8MM, Women, Ages ≥18 Years, 2018

Figure 21 : Five-Year Diagnosed Prevalent Cases of All Invasive Breast Cancer, 8MM, Women, Ages ≥18 Years, 2018

Figure 22 : Five-Year Diagnosed Prevalent Cases of HER2-Negative Breast Cancer, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 23 : 10-Year Diagnosed Prevalent Cases of All Invasive Breast Cancer, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 24 : 10-Year Diagnosed Prevalent Cases of HER2-Negative Breast Cancer, 8MM, Women, Ages ≥18 Years, N, 2018

Figure 25 : An Overview of the Treatment Algorithm in Non-invasive and Invasive Breast Cancer

Figure 26 : An overview of the neoadjuvant/adjuvant settings treatment paradigm

Figure 27 : An Overview of the Treatment Paradigm in the Metastatic HER2-Negative Setting

Figure 28: Unmet Needs and Opportunities in HER2-Negative Breast Cancer

Figure 29: Overview of the Development Pipeline in HER2-Negative Breast Cancer

Figure 30: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for HER2-Negative Breast Cancer in the 8MM During the Forecast Period

Figure 31: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of HER2-Negative Breast Cancer During the Forecast Period

Figure 32: Analysis of the Company Portfolio Gap in HER2-Negative Breast Cancer During the Forecast Period

Figure 33: Global (8MM) Sales Forecast by Country for HER2-Negative Breast Cancer in 2018 and 2028

Figure 34: Sales Forecast by Class for HER2-Negative Breast Cancer in the US in 2018 and 2028

Figure 35: Sales Forecast by Class for HER2-Negative Breast Cancer in the 5EU in 2018 and 2028

Figure 36: Sales Forecast by Class for HER2-Negative Breast Cancer in Japan in 2018 and 2028

Figure 37: Sales Forecast by Class for HER2-Negative Breast Cancer in China in 2018 and 2028

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