Pharmapoint: HER2-Positive Breast Cancer - Global Drug Forecast and Market Analysis to 2025

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. Today, HER2-positive breast cancer patients are living longer with their disease, thanks to established disease management strategies using numerous combinations of chemotherapy with Herceptin, Perjeta, and the tyrosine kinase inhibitor (TKI) Tykerb (lapatinib). During the forecast period from 2015–2025, GlobalData expects that the HER2-positive market will grow due to the launch of HER2-targeted agents in the early disease setting and the aging populations in the US, 5EU (France, Germany, Italy, Spain, and the UK), Japan, and China.

Following the patent expiry of Herceptin and the subsequent highly anticipated introduction of trastuzumab biosimilars during the forecast period, the market is expected to face its biggest barrier to growth to date. Despite a lack of game-changing innovation in the HER2-positive market, the pipeline is diverse with several agents being investigated in the extended adjuvant and metastatic settings. A number of these agents are looking to address the greatest unmet need for HER2-positive breast cancer patients—brain metastases—which typically occur in the later lines of metastatic therapy and are caused by increasingly resistant disease.

Key Questions Answered

How will biosimilar penetration impact the HER2-positive breast cancer market, especially following the launch of trastuzumab biosimilars in the 8MM?

How will new pipeline agents such as Ibrance and neratinib impact the HER2-positive breast cancer market?

The HER2-positive breast cancer market is characterized by a number of unmet needs in the current treatments. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil these unmet needs?

What impact will the approval of Roche’s Perjeta in the adjuvant setting following data from the Aphinity trial have on the HER2-positive breast cancer market? What will be the drug’s peak sales, and why?

Scope

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

Annualized HER2-positive breast cancer therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in nine patient segments and two treatment strategies (episodic and prophylactic treatment), forecast from 2016 to 2026.

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

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for HER2-positive breast cancer. The most promising candidate in Phase III development is profiled.

Analysis of the current and future market competition in the global HER2-positive breast cancer 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 through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

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

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

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

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

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

Allergan

Amgen

AstraZeneca

Beijing Biostar Technologies

Biocad

Biocon

Cascadian Therapeutics

Celgene

Celltrion

DM Bio

Daiichi Sankyo

Eisai

Eli Lilly

Galena Biopharma

Genentech

Genor BioPharma

Hanwha ...

Allergan

Amgen

AstraZeneca

Beijing Biostar Technologies

Biocad

Biocon

Cascadian Therapeutics

Celgene

Celltrion

DM Bio

Daiichi Sankyo

Eisai

Eli Lilly

Galena Biopharma

Genentech

Genor BioPharma

Hanwha Chemical Corp

Jiangsu HengRui Medicine

MacroGenics

Medivation

Merck & Co

Mylan

Nektar Therapeutics

Novartis

OBI Pharma

Pfizer

Prestige Biopharma

Puma Biotechnology

Richter Gedeon Nyrt

Roche

R-PHARM

Samsung Bioepis

Shanghai CPGuojian Pharmaceutical Co.

Shanghai Henlius Biotech

Teva

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 HER2-Positive Breast Cancer ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 HER2-Positive Breast Cancer Market to Increase by 50% by 2025

2.2 Perjeta Will Be the Strongest Driver of Market Growth

2.3 The Launch of Biosimilar Trastuzumab

2.4 Roche Will Continue to Monopolize the HER2-Positive Breast Cancer Market, Despite Herceptin Patent Loss

2.5 Improved Treatment for Brain Metastases Remains a Pressing Unmet Need

2.6 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 Basic Breast Anatomy

4.3 Breast Cancer Staging

4.4 Prognosis

4.5 Quality of Life

4.6 Symptoms

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.3.4 China (Urban)

5.3.5 Prevalence and Survival

5.4 Forecast Methodology

5.4.1 Sources Used Tables

5.4.2 Forecast Assumptions and Methods

5.4.3 Sources Not Used

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

5.5.1 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer

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

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

5.6.1 Diagnosed Incident Cases of Invasive Breast Cancer

5.6.2 Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer

5.6.3 Age-Standardized Diagnosed Incidence of Invasive Breast Cancer

5.6.4 Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer

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

5.6.6 Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status

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

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

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

5.7 Discussion

5.7.1 Epidemiological Forecast Insight

5.7.2 Limitations of the Analysis

5.7.3 Strengths of the Analysis

6 Disease Management

6.1 Treatment Overview

6.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB)

6.1.2 Treatment of Locally Advanced and Regional Breast Cancer (Stage IB to IIIA)

6.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV)

6.2 US

6.2.1 Diagnosis

6.2.2 Clinical Practice

6.3 France

6.3.1 Diagnosis

6.3.2 Clinical Practice

6.4 Germany

6.4.1 Diagnosis

6.4.2 Clinical Practice

6.5 Italy

6.5.1 Diagnosis

6.5.2 Clinical Practice

6.6 Spain

6.6.1 Diagnosis

6.6.2 Clinical Practice

6.7 UK

6.7.1 Diagnosis

6.7.2 Clinical Practice

6.8 Japan

6.8.1 Diagnosis

6.8.2 Clinical Practice

6.9 China

6.9.1 Diagnosis

6.9.2 Clinical Practice

7 Competitive Assessment

7.1 Overview

7.2 Product Profiles – HER2-Targeted Therapies

7.2.1 Herceptin (Trastuzumab)

7.2.2 Tykerb (Lapatinib)

7.2.3 Perjeta (Pertuzumab)

7.2.4 Kadcyla (Ado-trastuzumab Emtansine, T-DM1)

7.3 Product Profiles – General Targeted Therapies

7.3.1 Halaven (Eribulin Mesylate)

7.3.2 Abraxane (Nab-Paclitaxel)

7.3.3 Ixempra (Ixabepilone)

7.4 Hormonal Agents

7.4.1 Tamoxifen

7.4.2 Faslodex (Fulvestrant)

7.4.3 Aromatase Inhibitors

8 Unmet Need and Opportunity

8.1 Overview

8.2 Treatment of Brain/CNS Metastases

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Resistance to HER2-Targeted Therapies

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Effective Alternatives to Chemotherapy

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 HER2-Targeted Therapies

9.2.1 Neratinib

9.2.2 Margetuximab

9.2.3 Tucatinib (ONT-380)

9.2.4 Pyrotinib

9.3 Other Therapies

9.3.1 Utidelone (Depoxythilone; UTD-1)

9.3.2 Ibrance (Palbociclib)

9.3.3 Onzeald (Etirinotecan Pegol)

9.4 Drugs in Early-Stage Development

9.4.1 Abemaciclib

9.4.2 Adagloxad Simolenin (OBI-822/821)

9.4.3 Patritumab

9.4.4 NeuVax (nelipepimut-S)

9.4.5 Alpelisib

9.4.6 Buparlisib

9.4.7 Xtandi (Enzalutamide)

9.4.8 DS-8201a

9.5 Biosimilars

9.5.1 Overview

9.5.2 Nomenclature

9.5.3 EU

9.5.4 US

9.5.5 Japan

9.5.6 China

9.5.7 Ex-8MM Trastuzumab Biosimilars

9.5.8 Ongoing 8MM Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Roche/Genentech

10.3.2 Novartis

10.3.3 Pfizer

10.3.4 Puma Biotechnology

10.3.5 The Biosimilar 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

12.4 Forecasting Methodology

12.4.1 Diagnosed Patients with HER2-Positive Breast Cancer

12.4.2 Percent Drug-Treated Patients

12.4.3 Drugs Included in Each Therapeutic Class

12.4.4 Launch and Patent Expiration Dates

12.4.5 General Pricing Assumptions

12.4.6 Average Body Weight and Surface Area Across the 8MM

12.4.7 General Forecast Assumptions

12.4.8 Individual Drug Assumptions

12.4.9 Generic Erosion

12.4.10 Pricing of Pipeline Agents

12.5 Primary Research – KOLs Interviewed for this Report

12.6 Primary Research – Prescriber Survey

12.7 About the Authors

12.7.1 Analysts

12.7.2 Epidemiologist

12.7.3 Therapy Area Director

12.7.4 Epidemiology Director

12.7.5 Global Director of Therapy Analysis and Epidemiology

12.7.6 Global Head of Healthcare

12.8 About GlobalData

12.9 Contact Us

12.10       Disclaimer

List of Tables

Table 1: HER2-Positive Breast Cancer: Key Metrics in the Eight Major Pharmaceutical Markets, 2015–2025

Table 2: Definitions of HER2 Status by IHC Staining

Table ...

Table 1: HER2-Positive Breast Cancer: Key Metrics in the Eight Major Pharmaceutical Markets, 2015–2025

Table 2: Definitions of HER2 Status by IHC Staining

Table 3: AJCC Stage Definitions for Breast Cancer

Table 4: Prognosis for Breast Cancer in the US

Table 5: Risk Factors and Comorbidities for Breast Cancer

Table 6: 8MM, Most Recent Five-Year Relative Survival for Invasive Breast Cancer, Women (%)

Table 7: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Non-Invasive DCIS Breast Cancer

Table 8: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status

Table 9: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Invasive Breast Cancer

Table 10: 8MM, Sources of Epidemiological Data Used to Forecast Invasive Breast Cancer by HER2 Status

Table 11: 8MM, Sources of Epidemiological Data Used to Forecast the Relative Survival of Invasive Breast Cancer

Table 12: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Stage at Diagnosis

Table 13: 8MM, Sources of Epidemiological Data Used to Forecast HER2-, HR+ Invasive Breast Cancer by Stage at Diagnosis

Table 14: 8MM, Sources of Epidemiological Data Used to Forecast TN Invasive Breast Cancer by Stage at Diagnosis

Table 15: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Menopausal Status

Table 16: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Site of Metastasis

Table 17: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Type of Biomarker Expression

Table 18: 8MM, Sources Not Used in Epidemiological Analysis of Breast Cancer

Table 19: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015–2025

Table 20: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages ≥18 Years, N, 2015

Table 21: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015–2025

Table 22: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N (Row %), 2015

Table 23: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015–2025

Table 24: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, N, 2015

Table 25: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status, Women, Ages ≥18 Years, N, 2015

Table 26: Treatment Guidelines for HER2-Positive Breast Cancer

Table 27: Product Profile – Herceptin

Table 28: Clinical Studies for Herceptin in the Adjuvant Setting

Table 29: Efficacy of Herceptin + chemotherapy in untreated metastatic HER2-positive breast cancer

Table 30: Safety of Herceptin Monotherapy in Early-Stage HER2-Positive Breast Cancer

Table 31: Safety Profile of Herceptin + Chemotherapy in Untreated Metastatic HER2-Positive Breast Cancer

Table 32: Herceptin SWOT Analysis, 2017

Table 33: Product Profile – Tykerb

Table 34: Efficacy of Tykerb in Combination with Capecitabine for the Second-line Treatment of HER2-Positive Metastatic Breast Cancer

Table 35: Safety Profile of Tykerb in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer

Table 36: Safety Profile of Tykerb in Combination with Letrozole for the Treatment of Metastatic Breast Cancer

Table 37: Tykerb SWOT Analysis, 2017

Table 38: Product Profile – Perjeta

Table 39: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of HER2-positive Metastatic Breast Cancer (CLEOPATRA, NCT00567190)

Table 40: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of Locally Advanced HER2-positive Breast Cancer (NeoSphere, NCT00545688)

Table 41: Safety Profile of Perjeta in Combination with Herceptin and Docetaxel for the Treatment of Metastatic Breast Cancer (CLEOPATRA, NCT00567190)

Table 42: Perjeta SWOT Analysis, 2017

Table 43: Product Profile – Kadcyla

Table 44: Efficacy of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166)

Table 45: Safety Profile of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166)

Table 46: Kadcyla SWOT Analysis, 2017

Table 47: Product Profile – Halaven

Table 48: Efficacy of Halaven in the Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726)

Table 49: Efficacy of Halaven in the Second-Line Treatment of Metastatic Breast Cancer (Study 301, NCT00337103)

Table 50: Safety Profile of Halaven in the Third-line Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726)

Table 51: Halaven SWOT Analysis, 2017

Table 52: Product Profile – Abraxane

Table 53: Efficacy of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer

Table 54: Safety of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer

Table 55: Abraxane SWOT Analysis, 2017

Table 56: Product Profile – Ixempra

Table 57: Efficacy of Ixempra in Combination with Xeloda for the Treatment of Metastatic Breast Cancer

Table 58: Safety of Ixempra in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer

Table 59: Ixempra SWOT Analysis, 2017

Table 60: Summary of Minor Therapeutic Classes Used to Treat HER2-Positive Breast Cancer, 2017

Table 61: Unmet Need and Opportunity in HER2-Positive Breast Cancer

Table 62: Product Profile – Neratinib

Table 63: Efficacy of Neratinib from the Phase III ExteNET Trial (Two-Year Data Set)

Table 64: Efficacy of Neratinib from the Phase III ExteNET Trial (Five-Year Data Set)

Table 65: Safety of Neratinib Monotherapy Compared to Placebo from the ExteNET trial in HER2-Positive Breast Cancer Patients Who Received Adjuvant Herceptin Therapy

Table 66: Treatment-Emergent Diarrhea from the Phase III CONTROL Trial

Table 67: Neratinib SWOT Analysis, 2016

Table 68: Product Profile – Margetuximab

Table 69: Safety of Margetuximab Monotherapy in Metastatic HER2-Positve Breast Cancer Patients

Table 70: Margetuximab SWOT Analysis

Table 71: Product Profile – ARRY-380

Table 72: Efficacy of Tucatinib from the Phase I Trial in HER2-Positive Metastatic Breast Cancer

Table 73: Safety Profile of Tucatinib Administered at the MTD (600mg or 650 mg BID) from the Phase I Trial in HER2-Positive Metastatic Solid Cancers

Table 74: Tucatinib SWOT Analysis

Table 75: Product Profile – Pyrotinib

Table 76: Efficacy of Pyrotinib from the Phase I Clinical Trial (NCT01937689)

Table 77: Pyrotinib SWOT Analysis, 2017

Table 78: Product Profile – Utidelone

Table 79: Efficacy of Utidelone as a Monotherapy and in Combination with Capecitabine in the Treatment of Metastatic Breast Cancer

Table 80: Safety of Utidelone in Combination with Capecitabine and as a Monotherapy for the Treatment of Metastatic Breast Cancer from the Phase II Trial (CHiCTR-TRC-13004205)

Table 81: Utidelone SWOT Analysis, 2017

Table 82: Product Profile – Ibrance

Table 83: Efficacy of Ibrance from the Phase II Study, NA-PHER2

Table 84: Efficacy of Ibrance from the Phase II Study (NCT01037790)

Table 85: Ibrance SWOT Analysis, 2017

Table 86: Product Profile – Onzeald

Table 87: Efficacy of Onzeald from the Phase III Study, BEACON

Table 88: Safety of Onzeald from the Phase III Study, BEACON

Table 89: Onzeald SWOT Analysis, 2017

Table 90: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2017

Table 91: HER2-Positive Breast Cancer – Early-Phase Pipeline, 2017

Table 92: Safety of Adagloxad Simolenin in Combination with Cyclophosphamide for the Treatment of Metastatic Breast Cancer

Table 93: Trastuzumab Biosimilars, 2017

Table 94: Trastuzumab Biosimilars, 2016

Table 95: Key Companies in the HER2-Positive Breast Cancer Market in the 8MM, 2015–2025

Table 96: Roche’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 97: Roche SWOT Analysis, 2017

Table 98: Novartis’ HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 99: Novartis SWOT Analysis, 2017

Table 100: Pfizer’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 101: Pfizer SWOT Analysis, 2017

Table 102: Puma Biotechnology’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 103: Puma Biotechnology SWOT Analysis, 2017

Table 104: Mylan’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 105: Mylan/Biocon SWOT Analysis, 2017

Table 106: Teva’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 107: Teva/Celltrion SWOT Analysis, 2017

Table 108: Merck & Co.’s HER2-Positive Breast Cancer Portfolio Assessment, 2017

Table 109: Merck & Co./Samsung Bioepsis SWOT Analysis, 2017

Table 110: Global HER2-Positive Breast Cancer Market – Drivers and Barriers, 2015–2025

Table 111: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2015–2025

Table 112: US HER2-Positive Breast Cancer Market – Drivers and Barriers, 2015–2025

Table 113: Key Events Impacting Sales for HER2-Positive Breast Cancer in the 5EU, 2015–2025

Table 114: 5EU HER2-Positive Breast Cancer Market – Drivers and Barriers, 2015–2025

Table 115: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2015–2025

Table 116: Japanese HER2-Positive Breast Cancer Market – Drivers and Barriers, 2015–2025

Table 117: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2015–2025

Table 118: Chinese HER2-Positive Breast Cancer Market – Drivers and Barriers, 2015–2025

Table 119: Key Launch Dates in HER2-Positive Breast Cancer

Table 120: Key Patent/Exclusivity Expiries

Table 121: Average Body Weight and Surface Area Across the 8MM

Table 122: Average Cost of Therapy of Generic Chemotherapy in the 8MM

Table 123: Average Cost of Therapy of Liposomal Doxorubicin in the 8MM

Table 124: Cost of Therapy of Generic Capecitabine in the US

Table 125: Average Cost of Therapy of Herceptin in the 8MM

Table 126: Average Cost of Therapy of Perjeta in the 8MM

Table 127: Average Cost of Therapy of Tykerb/Tyverb in the 8MM

Table 128: Average Cost of Therapy of Kadcyla in the 8MM

Table 129: Average Cost of Endocrine Therapy in the 8MM

Table 130: Average Cost of Therapy of Faslodex in the 8MM

Table 131: Average Cost of Therapy of Halaven in the 8MM

Table 132: Average Cost of Therapy of Abraxane in the 8MM

Table 133: Average Cost of Therapy of Ixempra in the 8MM

Table 134: Average Cost of Therapy of Neratinib in the 8MM

Table 135: Average Cost of Therapy of Ibrance in the 8MM

Table 136: Average Cost of Therapy of Onzeald in the 8MM

Table 137: Average Cost of Therapy of Tucatinib in the 8MM

Table 138: Average Cost of Therapy of Margetuximab in the 8MM

Table 139: Average Cost of Therapy of Pyrotinib in the 8MM

Table 140: Average Cost of Therapy of UTD-1 in the 8MM

Table 141: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of Figures

Figure 1: Global Sales for HER2-Positive Breast Cancer by Region, 2015–2025

Figure 2:Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2015–2025

Figure ...

Figure 1: Global Sales for HER2-Positive Breast Cancer by Region, 2015–2025

Figure 2:Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2015–2025

Figure 3: Competitive Assessment of Most Promising Agents for HER2-Positive Breast Cancer, 2015–2025

Figure 4: Basic Breast Anatomy, Including Key Lymph Nodes

Figure 5: 8MM, Crude Diagnosed Incidence Rates of Invasive Breast Cancer, Ages ≥18 Years, Women, Cases per 100,000 Population, 2005‒2014

Figure 6: Case Flow Map

Figure 7: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages ≥18 Years, Selected Years, 2015–2025

Figure 8: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages ≥18 Years, 2015

Figure 9: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, Selected Years, 2015–2025

Figure 10: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2015

Figure 11: 8MM, Age-Standardized Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2015

Figure 12: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, Select Years, 2015–2025

Figure 13: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015

Figure 14: 8MM, Diagnosed Incident Cases of Breast Cancer by HER2 Status, Women, Ages ≥18 Years, 2015

Figure 15: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015

Figure 16: 8MM, Proportion of HER2+/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015

Figure 17: 8MM, Proportion of HER2+/HR- Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015

Figure 18: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Site of Metastasis, Women, Ages ≥18 Years, 2015

Figure 19: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015

Figure 20: 8MM, Proportion of HER2-/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015

Figure 21: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Type of Biomarker Expression, Women, Ages ≥18 Years, 2015

Figure 22: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015

Figure 23: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer with BRCA Expression, Women, Ages ≥18 Years, 2015

Figure 24: Active Late-Stage Clinical Trials for Herceptin

Figure 25: Active Late-Stage Clinical Trials for Tykerb

Figure 26: Active Late-Stage Clinical Trials for Perjeta

Figure 27: Active Phase III Clinical Trials for Kadcyla

Figure 28: Active Phase III Clinical Trials for Halaven

Figure 29: Active Phase III Clinical Trials for Abraxane

Figure 30: Overview of the Development Pipeline in HER2-Positive Breast Cancer

Figure 31: HER2-Positive Breast Cancer – Phase II–III Pipeline, 2015

Figure 32: Competitive Assessment of Late-Stage Pipeline Agents in HER2-Positive Breast Cancer, 2015–2025

Figure 33: Neratinib’s Clinical Development

Figure 34: Clinical and Commercial Positioning of Neratinib

Figure 35: Margetuximab’s Clinical Development

Figure 36: Clinical and Commercial Positioning of Margetuximab

Figure 37: Tucatinib’s Clinical Development

Figure 38: Clinical and Commercial Positioning of tucatinib

Figure 39: Pyrotinib’s Clinical Development

Figure 40: Clinical and Commercial Positioning of pyrotinib

Figure 41: Utidelone’s Clinical Development

Figure 42: Clinical and Commercial Positioning of utidelone

Figure 43: Ibrance’s Clinical Development

Figure 44: Clinical and Commercial Positioning of Ibrance

Figure 45: Onzeald’s Clinical Development

Figure 46: Clinical and Commercial Positioning of Onzeald

Figure 47: Global Sales ($m) of Branded Products for HER2-Positive Breast Cancer by Company, 2015–2025

Figure 48: Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013–2023

Figure 49: Global Sales for HER2-Positive Breast Cancer, by Region, 2015 and 2025

Figure 50: Global Sales for HER2-Positive Breast Cancer by Drug Class, 2015 and2025

Figure 51: Sales ($m) for HER2-Positive Breast Cancer in the US, by Drug Class, 2015–2025

Figure 52: Sales for HER2-Positive Breast Cancer in the 5EU, by Drug Class, 2015–2025

Figure 53: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2015–2025

Figure 54: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2015–2025

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