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

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GlobalData valued the 8MM HER-2 + breast cancer market at $10.4 billion in 2020 and expects the market to increase at a low compound annual growth rate (CAGR) of more than 1%. This growth will be driven by the anticipated launches of five pipeline agents, the expansion of several currently approved agents into earlier lines of therapy, and a collective increase in the diagnosed incident population across the 8MM. Growth will be substantially inhibited by generic and biosimilar erosion following the expiry of multiple patents of market-leading brands. These include Roche/Genentech’s Perjeta (pertuzumab), Herceptin (trastuzumab), and Kadcyla (T-DM1), which constitute the majority of sales across the 8MM in 2020. Furthermore, expected patent expiries of Puma Biotechnology’s Nerlynx (neratinib) and Seagen’s Tukysa (tucatinib) will further suppress market growth.

The US is the largest market, accounting for more than 50% of total HER2+ breast cancer sales in 2020. GlobalData expects the US market share to remain stable over the forecast period, as the 5EU markets will see their market share decline, while China will see its market share increase.

Overview of HER2+ breast cancer global drug market

Overview of HER2+ breast cancer global drug market

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What are the market dynamics in the HER2+ breast cancer market?

Breast cancer is not a single disease, but rather a group of several different tumor subtypes. Although many subtypes exist, they are generally categorized by the presence or absence of hormonal receptors (HRs), including estrogen receptor (ER) and the progesterone receptor (PR), in addition to human epidermal growth factor receptor 2 (HER2).

In the 8MM, Italy had the highest diagnosed incidence of HER2+/HR+ breast cancer in 2020 (27.43 cases per 100,000 population), and urban China had the lowest diagnosed incidence in women in 2020 (10.10 cases per 100,000 population). The rate of increase was the highest in Spain, rising from 13.26 in 2010 to 18.23 in 2020. On the other hand, Germany had a decrease in the incidence rate from 2010-2020.

The major drivers of growth in the forecast period in the 8MM are:

  • Approval and launch of premium-priced therapeutics in the 8MM during the forecast period: two small molecule inhibitors (Ibrance and Piqray), two antibody-drug conjugates (trastuzumab duocarmazine and disitamab vedotin), and a checkpoint inhibitor (Tecentriq)Label expansion of established drugs like Enhertu and Tukysa into earlier, more lucrative lines of therapy
  • Label expansions of established drugs like Enhertu and Tukysa into earlier, more lucrative lines of therapy
  • Reformulation of established blockbusters like Perjeta and Herceptin into a branded subcutaneous, fixed-dose form which will reduce the impact of biosimilar erosion
  • Increased disease incidence across the 8MM

The major barriers to growth in the forecast period in the 8MM are:

  • Patent expiries of the leading brands across the 8MM, in particular Perjeta, Herceptin, and Kadcyla, which constituted the majority of sales in 2020
  • Increased cost-consciousness limiting the uptake of branded therapies and novel agents in Europe and Asia
  • Very efficacious and tolerable therapies in the treatment paradigm, which means the indication is a highly competitive space to enter

What are the key regions and countries in 8MM HER-2 + breast cancer market?

In 2020, the US led the sales of HER2+ breast cancer therapies followed by, Germany, China, and Japan.

The US, 5EU, and Japan’s relative global market shares are expected to remain constant over the forecast period while China’s global market share is expected to increase.

The US market is the largest of the 8MM and accounted for an estimated more than 50% of sales in 2020. This is due to the large patient population and comparatively higher prices in the country. Sales in the HER2+ market are dominated by HER2-directed monoclonal antibodies (Herceptin and Perjeta) and an antibody-drug conjugate (Kadcyla), due to extensive use in the adjuvant and metastatic settings.

The HER2+ breast cancer market in the 5EU is forecast to grow at a CAGR of 0.2% during the forecast period and will experience the weakest growth out of the 8MM. Due to earlier the patent expiry of Herceptin in Europe (2017) than in the US and subsequent higher biosimilar erosion, Perjeta and Kadcyla are market leaders across the 5EU markets, although this may differ depending on the individual region.

The Urban China market is expected to increase significantly in size by 2030. GlobalData anticipates China to become the fastest-growing market among the 8MM, with a CAGR of more than 5% during the forecast period. Distinct drivers of growth in the Chinese market include a significant increase in the diagnosed incident population over the forecast period and the development of domestically developed drugs in China.

Market report scope

Market size (Year – 2020) $10.4 billion
Growth rate CAGR >1% from 2021 to 2030
Base year for estimation 2020
Forecast period 2021-2030
Key players Genentech/Roche, AstraZeneca, Daiichi Sankyo, Pfizer (Ibrance), Novartis (Piqray), Byondis (trastuzumab duocarmazine), and Remegen (disitamab vedotin)
Countries Covered US, France, Germany, Italy, Spain, UK, China and Japan.

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.

  • Overview of HER2+ breast cancer including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline HER2+ market revenue, the 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 a 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 counterstrategies 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.

Roche (Genentech)
AstraZeneca and
Daiichi Sankyo
Puma Biotechnology Novartis
Seattle Genetics
Jiangsu HengRui Medicine
Byondis BV

Table of Contents

Table of Contents

| About GlobalData

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

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