HER2-Negative Breast Cancer: Global Drug Forecast and Market Analysis to 2028
Summary
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.
The publisher 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
Scope
Reasons to Buy
The report will enable you to -
Summary
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.
The publisher 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.
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.
Table of Contents
1 Table of Contents1.1 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 $13.04B 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
12 Appendix
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 the publisher 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 the publisher 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 the publisher 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
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Pfizer
- Roche
- Astrazeneca
- Novartis
- Eli Lilly
- Merck
- Eisai
- Celgene
- Chipscreen biosciences
- OBI Pharma
- PolyPhor
- Syndax
- Radius Health
- Immunomedics
