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

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