+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

HER2+ Breast Cancer - Global Drug Forecast and Market Analysis to 2030

  • ID: 5440002
  • Report
  • September 2021
  • Region: Global
  • 152 pages
  • GlobalData

FEATURED COMPANIES

  • AstraZeneca and
  • Byondis BV
  • Celgene
  • Daiichi Sankyo
  • Eisai
  • Jiangsu HengRui Medicine
1h Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

Breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. Human epidermal growth factor receptor 2-positive (HER2+) breast cancer constitutes approximately 20% of breast cancer cases and was historically associated with poor prognosis in the absence of effective treatments. The realization that introducing HER2-targeted therapies earlier into the disease management strategy could improve disease-free survival (DFS) has created a large market for HER2-directed therapies. Today, HER2+ breast cancer patients are living longer with their disease, thanks to established disease management strategies using regimens with Herceptin, Perjeta, and the antibody-drug conjugate Kadcyla. During the forecast period 2020-2030, each of these agents are expected to face patent expiries and biosimilar erosion, which will represent the biggest barrier of market growth to date. To combat biosimilar erosion, Roche/Genentech is developing subcutaneous fixed-dose formulations of Herceptin/Perjeta to provide convenience for patients and physicians. This will act to consolidate revenues for Roche/Genentech and maintain their presence as market leader throughout the forecast period. Daiichi Sankyo and AstraZeneca’s agent, Enhertu is expected to make a large impact of clinical practice by replacing Kadcyla in the second-line metastatic setting and threatening it’s patient share in the adjuvant setting. The publisher anticipates 5 pipeline agents to be launched across the 8MM over the forecast period 2020-2030. The HER2+ market is forecast to grow to $12.1B by 2030, at a Compound Annual Growth Rate (CAGR) of 1.5%.

This report covers opportunities for various marketed agents and pipeline agents in development across the 8MM, clinical and commercial assessments for agents in late-stage clinical development, R&D strategies, and innovative approaches in development for HER2+ breast cancer. This edition provides an update to the previous sales forecast for marketed and pipeline agents and highlights expected market dynamics by country and class of therapy across the forecast period, 2020-2030.

Key Questions Answered

  • 5 late-stage pipeline agents are going to enter the HER2+ market from 2020 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+ 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 2020-2030? 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?

Key Highlights

  • The main drivers of growth include the anticipated label expansion of currently marketed therapies, subcutaneous reformulations of blockbuster drugs and the approval and launch of 5 pipeline therapies and greater market access across the 8MM for premium priced agents
  • The main barriers to growth in the 8MM are the patent expiries of the leading brands across the 8MM, in particular Perjeta, Herceptin and Kadcyla, which constituted the majority of sales in 2020
  • The most important unmet needs in the HER2+ market include: Efficacious treatments for patients with brain metastases, tackling intratumor heterogeneity and improving patient outcomes

Scope

  • Overview of HER2+ breast cancer including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline HER2+ 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+ 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+ 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+ therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2+ 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+ therapeutics market from 2020-2030.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • AstraZeneca and
  • Byondis BV
  • Celgene
  • Daiichi Sankyo
  • Eisai
  • Jiangsu HengRui Medicine
1 HER2+ Breast Cancer: Executive Summary
1.1 The HER2+ Breast Cancer Market Will Expand to 12.1B in 2030
1.2 Roche/Genentech to Maintain its Leading Position Despite Competition from Biosimilars and Enhertu
1.3 Treatment of Brain Metastases, Intratumor Heterogeneity, and Improving Patient Outcomes Remain the Unmet Needs
1.4 Novel Antibody-Drug Conjugates and Established Breast Cancer Drugs Populate the Late-Stage Pipeline
1.5 What Do Physicians Think?

2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports

3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems

4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Forecast Assumptions and Methods
4.5 Epidemiological Forecast for All Invasive and HER2-Positive Breast Cancer (2020-2030)
4.5.1 Diagnosed Incident Cases of All Invasive Breast Cancer
4.5.2 Age-Specific Diagnosed Incident Cases of All Invasive Breast Cancer
4.5.3 Diagnosed Incident Cases of HER2+/HR+ Breast Cancer
4.5.4 Diagnosed Incident Cases of HER2+/HR- Breast Cancer
4.5.5 Diagnosed Incident Cases of HER2+/HR+ Breast Cancer by Stages
4.5.6 Diagnosed Incident Cases of HER2+/HR- Breast Cancer by Stages
4.5.7 Diagnosed Incident Cases of HER2+/HR+ Breast Cancer by Menopausal Status
4.5.8 Diagnosed Incident Cases of HER2+/HR- Breast Cancer by Menopausal Status
4.5.9 Diagnosed Incident Cases of HER2-Positive Breast Cancer by PD-1 and PD-L1 Expression
4.5.10 Diagnosed Incident Cases of HER2-Positive Breast Cancer with Ki67 Expression
4.5.11 Diagnosed Incident Cases of HER2-Positive Breast Cancer with NTRK and RET Expression
4.5.12 Diagnosed Incident Cases of HER2-Positive Breast Cancer with Bone Metastasis
4.5.13 Diagnosed Incident Cases of HER2-Positive Breast Cancer with Brain/CNS Metastasis
4.5.14 Diagnosed Incident Cases of HER2-Positive Breast Cancer with IHC3+ Expression
4.5.15 Five-Year Diagnosed Prevalent Cases of HER2-Positive Breast Cancer
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impact
4.6.3 Limitations of Analysis
4.6.4 Strengths of Analysis

5 Disease Management
5.1 Diagnosis and Treatment Overview
5.2 KOL Insights on Disease Management
5.2.1 Testing
5.2.2 Neoadjuvant/Adjuvant Treatment Paradigm
5.2.3 Metastatic

6 Current Treatment Options
6.1 Overview

7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Improving Curative Options and Patient Outcomes
7.3 Treatment of Patients with Brain Metastases
7.4 Stratifying Patients According to Molecular Profiles and Reducing Toxicities of Existing Regimens
7.5 Treating Intratumor Heterogeneity

8 R&D Strategies
8.1 Overview
8.1.2 Development of Subcutaneous and Fixed Dose Formulations of Blockbusters
8.1.3 Label Expansions into Earlier Lines of Therapy
8.1.4 Novel Therapeutic Approaches to Treating HER2+ Breast Cancer
8.2 Clinical Trials Design
8.2.1 Preferred Primary Outcomes Measures Dependent on Line of Therapy
8.2.2 Increased Utility of Quality of Life and Patient Reported Outcome Measures
8.2.3 Assessment of Novel Biomarkers to Predict Response

9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive Assessment

11 Current and Future Players
11.1 Overview
11.2 Deal-Making Trends

12 Market Outlook
12.1 Global Markets
12.1.1 Forecast
12.1.2 Drivers and Barriers - Global Issues
12.2 US
12.2.1 Forecast
12.2.2 Key Events
12.2.3 Drivers and Barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key Events
12.3.3 Drivers and Barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key Events
12.4.3 Drivers and Barriers
12.5 China
12.5.1 Forecast
12.5.2 Key Events
12.5.3 Drivers and Barriers

13 Appendix
13.1 Bibliography
13.2 Abbreviations
13.3 Methodology
13.3.1 Forecasting Methodology
13.4 Primary Research - KOLs Interviewed for This Report
13.4.1 KOLs
13.5 Primary Research - Prescriber Survey
13.6 About the Authors
13.6.1 Analyst
13.6.2 Therapy Area Director
13.6.3 Epidemiologist
13.6.4 Managing Epidemiologist
13.6.5 Global Director of Therapy Analysis and Epidemiology
13.6.6 Global Head and EVP of Healthcare Operations and Strategy

List of Tables
Table 1: HER2+ 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 HER2-Positive Breast Cancer
Table 7: Treatment Guidelines for HER2+ Breast Cancer
Table 8: Overview of Key Pivotal Phase II/III Trials in HER2+ Breast Cancer
Table 9: Top 10 Deals by Value, 2018-2020
Table 10: HER2+ Breast Cancer Market - Global Drivers and Barriers, 2020-2030
Table 11: Key Events Impacting Sales for HER2+ Breast Cancer in the US, 2020-2030
Table 12: HER2+ Breast Cancer Market - Drivers and Barriers in the US, 2020-2030
Table 13: Key Events Impacting Sales for HER2+ Breast Cancer in the 5EU, 2020-2030
Table 14: HER2+ Breast Cancer Market - Drivers and Barriers in the 5EU, 2020-2030
Table 15: Key Events Impacting Sales for HER2+ Breast Cancer in Japan, 2020-2030
Table 16: HER2+ Breast Cancer Market - Drivers and Barriers in Japan, 2020-2030
Table 17: Key Events Impacting Sales for HER2+ Breast Cancer in China, 2020-2030
Table 18: HER2+ Breast Cancer Market - Drivers and Barriers in China, 2020-2030
Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures
Figure 1: Global Sales Forecast by Country for HER2+ Breast Cancer in 2020 and 2030
Figure 2: Analysis of the Company Portfolio Gap in HER2+ 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+ Breast Cancer During the Forecast Period Compared to the Current Standards of Care
Figure 4: Mechanism of Action of Agents Targeting HER2
Figure 5 : 8MM, Diagnosed Incidence of HER2+/HR+ Breast Cancer, Ages ≥18 Years, Women, Cases per 100,000 Population, 2010‒2030
Figure 6: 8MM, Diagnosed Incidence of HER2+/HR- Breast Cancer, Ages ≥18 Years, Women, Cases per 100,000 Population, 2010‒2030
Figure 7: 8MM, Sources Used and Not Used for Diagnosed Incident Cases of All Invasive Breast Cancer
Figure 8: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer
Figure 9: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by Stage
Figure 10: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by Menopausal Status
Figure 11: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by PD-1 and PD-L1 Expression
Figure 12: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by Ki67, NTRK, and RET Expression
Figure 13: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by Bone and Brain Metastasis
Figure 14: 8MM, Sources Used for Diagnosed Incident Cases of HER2+/HR+ and HER2+/HR- Breast Cancer by IHC3+ Expression
Figure 15: 8MM, Sources Used for Five-Year Diagnosed Prevalent Cases of HER2+/HR+ and HER2+/HR- Breast Cancer
Figure 16: 8MM, Diagnosed Incident Cases of All Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2020
Figure 17: 8MM, Age-Specific Diagnosed Incident Cases of All Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2020
Figure 18: 8MM, Diagnosed Incident Cases of HER2+/HR+ Breast Cancer, Women, Ages ≥18 Years, N, 2020
Figure 19: 8MM, Diagnosed Incident Cases of HER2+/HR- Breast Cancer, Women, Ages ≥18 Years, N, 2020
Figure 20: 8MM, Proportion of Diagnosed Incident Cases of HER2+/HR+ Breast Cancer by Stage, Women, Ages ≥18 Years, N, 2020
Figure 21: 8MM, Proportion of Diagnosed Incident Cases of HER2+/HR- Breast Cancer by Stage, Women, Ages ≥18 Years, N, 2020
Figure 22: 8MM, Proportion of Diagnosed Incident Cases of HER2+/HR+ Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, %, 2020
Figure 23: 8MM, Proportion of Diagnosed Incident Cases of HER2+/HR- Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, %, 2020
Figure 24: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer by PD-1 and PD-L1 Expression, Women, Ages ≥18 Years, N, 2020
Figure 25: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer with Ki67 Expression, Women, Ages ≥18 Years, N, 2020
Figure 26: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer with NTRK and RET Expression, Women, Ages ≥18 Years, N, 2020
Figure 27: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer with Bone Metastasis, Women, Ages ≥18 Years, N, 2020
Figure 28: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer with Brain/CNS Metastasis, Women, Ages ≥18 Years, N, 2020
Figure 29: 8MM, Diagnosed Incident Cases of HER2-Positive Breast Cancer with IHC3+ Expression, Women, Ages ≥18 Years, N, 2020
Figure 30: 8MM, Five-Year Diagnosed Prevalent Cases of HER2-Positive Breast Cancer, Women, Ages ≥18 Years, N, 2020
Figure 31: Generalized Treatment Algorithm for HER2+ Breast Cancer
Figure 32: Unmet Needs and Opportunities in HER2+ Breast Cancer
Figure 33: Overview of the Development Pipeline in HER2+ Breast Cancer
Figure 34: Key Late-Stage Trials for the Promising Pipeline Agents that the Publisher Expects to Be Licensed for HER2+ Breast Cancer in the 8MM During the Forecast Period
Figure 35: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of HER2+ Breast Cancer During the Forecast Period
Figure 36: Analysis of the Company Portfolio Gap in HER2+ Breast Cancer During the Forecast Period
Figure 37: Global (8MM) Sales Forecast by Country for HER2+ Breast Cancer in 2020 and 2030
Figure 38: Sales Forecast by Class for HER2+ Breast Cancer in the US in 2020 and 2030
Figure 39: Sales Forecast by Class for HER2+ Breast Cancer in the 5EU in 2020 and 2030
Figure 40: Sales Forecast by Class for HER2+ Breast Cancer in Japan in 2020 and 2030
Figure 41: Sales Forecast by Class for HER2+ Breast Cancer in Urban China in 2020 and 2030
Note: Product cover images may vary from those shown

A selection of companies mentioned in this report includes:

  • Roche (Genentech)
  • AstraZeneca and
  • Daiichi Sankyo
  • Celgene
  • Eisai
  • Puma Biotechnology Novartis
  • Macrogenics
  • Seattle Genetics
  • Jiangsu HengRui Medicine
  • Pfizer
  • RemeGen
  • Byondis BV
Note: Product cover images may vary from those shown
Adroll
adroll