Melanoma is the deadliest and most aggressive form of skin cancer. The major treatments for melanoma are categorized into immunotherapies and BRAF mutation-targeted therapies. Publisher estimates the 2013 sales for melanoma at approximately $1.34 billion across the 8MM covered in this report. The market will increase by four-fold over the forecast period, reaching $5.64 billion in 2023 at a CAGR of 15.5%. This growth will be driven by an increase in melanoma incident cases as well as the approval and uptake of premium-priced products, such as PD-1-targeting mAbs and BRAF/MEK inhibitor combinations. Publisher expects, by the end of the forecast period, the checkpoint immunotherapy drug class to dominate the melanoma market (including both BRAF wild-type and mutation-positive patient segments) with an overall 67% share of the melanoma market.
Report URL: http://www.reportsweb.com/melanoma-japan-drug-forecast-and-market-analysis-to-2023
Japan represents the smallest melanoma market in the 8MM across the forecast period, because of the small number of incident cases and the lack of branded melanoma therapies. Publisher expects no Japanese sales in 2013, because there were no branded melanoma therapies in Japan, and the interferon adjuvant treatment segment is saturated with generic interferons. In 2014, the September launch of BMS’ immunotherapy Opdivo generated a revenue of $1m within a month (Bristol-Myers Squibb, 2014c).
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Scope
– Overview of Melanoma including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
– Detailed information on the key drugs in Japan including product Melanomacription, safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for the top drugs in Japan from 2013-2023.
– Analysis of the impact of key events as well the drivers and restraints affecting Japan Melanoma market.
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Reasons to buy
– Understand and capitalize by identifying products that are most likely to ensure a robust return
– Stay ahead of the competition by understanding the changing competitive landscape for Melanoma.
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– Make more informed business decisions from insightful and in-depth analysis of drug performance
– Obtain sales forecast for drugs from 2013-2023 in Japan.
Table of Contents
1.1 List of Tables 6
1.2 List of Figures 10
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 14
3.1.3 Melanoma Biomarkers 15
3.2 Clinical Staging 16
3.3 Symptoms 18
3.4 Prognosis 18
3.5 Quality of Life 20
4 Disease Management 21
4.1 Diagnosis Overview 21
4.2 Treatment Overview 22
4.2.1 Localized Melanoma: Stage 0 to Stage IIC 24
4.2.2 Regional Melanoma: Stage IIIA to Stage IIIC 25
4.2.3 Unresectable and Metastatic Melanoma: Stage III and Stage IV 28
4.3 Japan 35
4.3.1 Screening and Diagnosis 35
4.3.2 Clinical Practices 36
5 Competitive Assessment 37
5.1 Overview 37
5.2 Interferon-based Adjuvant Therapies 39
5.2.1 Roferon-A (Interferon Alfa-2a) 39
5.2.2 Intron A (Interferon Alfa-2b) 43
5.2.3 Sylatron (Peginterferon Alfa-2b) 48
5.3 Immune Checkpoint Inhibitors 54
5.3.1 Yervoy (Ipilimumab) 54
5.3.2 Opdivo (Nivolumab) 64
5.3.3 Keytruda (Pembrolizumab) 73
5.4 BRAF Mutation-targeted Therapies 81
5.4.1 Zelboraf (Vemurafenib) 81
5.4.2 Tafinlar (Dabrafenib) 88
5.4.3 Mekinist (Trametinib) 94
5.5 Other Therapeutic Classes 105
6 Unmet Need and Opportunity Analysis 107
6.1 Overview 107
6.2 Therapeutic Options for BRAF Wild-Type Patients 109
6.2.1 Unmet Need 109
6.2.2 Gap Analysis 110
6.2.3 Opportunity 111
6.3 Therapies for Non-responders to PD-1 Immunotherapy 112
6.3.1 Unmet Need 112
6.3.2 Gap Analysis 113
6.3.3 Opportunity 115
6.4 Adjuvant Therapies for High-Risk Resectable Melanoma 117
6.4.1 Unmet Need 117
6.4.2 Gap Analysis 118
6.4.3 Opportunity 120
6.5 Effective Treatment for Brain Metastases 122
6.5.1 Unmet Need 122
6.5.2 Gap Analysis 123
6.5.3 Opportunity 125
6.6 Predictive Markers for Therapeutic Response to Immunotherapies 126
6.6.1 Unmet Need 126
6.6.2 Gap Analysis 127
6.6.3 Opportunity 129
7 Pipeline Assessment 130
7.1 Overview 130
7.2 Promising Drugs in Clinical Development 131
7.3 RAF/RAS/MEK Pathway-Targeting Therapies 133
7.3.1 Cobimetinib (GDC-0973) 133
7.3.2 Encorafenib (LGX818) 140
7.3.3 Binimetinib (MEK162) 146
7.4 Immune-Related Therapies 153
7.4.1 Talimogene Laherparepvec 153
7.4.2 Eltrapuldencel-T (NSB20) 161
7.4.3 Seviprotimut-L (POL-103A) 167
7.4.4 PV-10 173
7.5 Promising Drugs in Early-Stage Development 179
7.5.1 PI3K/Akt/mTOR Pathway-Targeting Therapies 179
7.5.2 Cell Cycle Checkpoint Inhibitors 181
7.5.3 Next-Generation BRAF Inhibitors 183
7.5.4 Immunotherapies 185
7.5.5 Antibody-Drug Conjugates 188
7.6 Other Drugs in Development 190
8 Market Outlook 192
8.1 Japan 192
8.1.1 Forecast 192
8.1.2 Key Events 194
8.1.3 Drivers and Barriers – Japan 194
9 Appendix 197
9.1 Bibliography 197
9.2 Abbreviations 224
9.3 Methodology 229
9.4 Forecasting Methodology 229
9.4.1 Diagnosed Melanoma Patients 229
9.4.2 Percent Drug-Treated Patients 230
9.4.3 Drugs Included in Each Therapeutic Class 230
9.4.4 Launch and Patent Expiry Dates 231
9.4.5 General Pricing Assumptions 232
9.4.6 Average Body Weight and Surface Area Across the 8MM 233
9.4.7 Individual Drug Assumptions 234
9.4.8 Generic Erosion 248
9.4.9 Pricing of Pipeline Agents 248
9.5 Primary Research – KOLs Interviewed for this Report 250
9.6 Primary Research – Prescriber Survey 253
9.7 About the Authors 254
9.7.1 Analyst 254
9.7.2 Therapy Area Director 254
9.7.3 Epidemiologist 255
9.7.4 Global Head of Healthcare 255
9.8 About Publisher 256
9.9 Disclaimer 256
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