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市場調查報告書

黑色素瘤 :治療藥的預測與全球市場分析

PharmaPoint: Melanoma - Global Drug Forecast and Market Analysis to 2026

出版商 GlobalData 商品編碼 334909
出版日期 內容資訊 英文 433 Pages
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黑色素瘤 :治療藥的預測與全球市場分析 PharmaPoint: Melanoma - Global Drug Forecast and Market Analysis to 2026
出版日期: 2017年09月29日 內容資訊: 英文 433 Pages
簡介

黑色素瘤是皮膚癌中最有致命性的,侵略性最高。全球主要8個國家的黑色素瘤治療藥的市場,從2013年的13億4000萬美元,預計到2023年增加4倍達5億64000萬美元(其間年複合成長率(CAGR)為15.5%)。這個急速成長的原因之一,為PD-1標的單株抗體和BRAF/MEK抑制劑的配合之最新銳且高價格的治療藥的認證、普及。還有,預計今後含查核點免疫療法的藥物類別 (野生型BRAF/免疫陽性患者治療藥) 將佔市場67%。另一方面,今後的課題為,與目前主流的治療方法 (免疫療法、BRAF免疫標靶治療等) 的競爭,及開拓還未診斷的患者,免疫/標靶治療的新組合方法的開發等。

本報告提供全球的黑色素瘤治療藥市場現況與未來展望相關分析、調查與疾病概要和今後的流行病學的預測、在主要國家的預防體性、主要企業簡介代表性產品、市場未滿足需求與未來機會、現在臨床實驗中的開發中產品的資訊、今後的市場規模及影響要素等。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理
    • 病因
    • 病理生理學、病歷
    • 黑色素瘤的生物標記
  • 臨床階段
  • 症狀
  • 預後
  • 生活品質(QoL)

第4章 流行病學

  • 疾病的背景情況
  • 風險要素和共生病症
  • 全球各地的趨勢
    • 美國
    • 歐洲主要5個國家
    • 日本、澳洲
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法
  • 流行病學的預測(今後11年份)
    • 黑色素瘤的發病數量(總數)
    • 黑色素瘤的發病數量(各年齡)
    • 黑色素瘤的發病數量(男女)
    • 黑色素瘤的年齡已調整的發病率
    • 診斷時的分期階段
    • 盛行率黑色素瘤皮膚癌症的5年
    • 黑色素瘤皮膚癌症的5年盛行率 (遺傳異常造成)
  • 議論
    • 流行病學上的預測、考察
    • 分析的限制
    • 分析的優勢

第5章 疾病的管理

  • 診斷概要
  • 治療概要
    • 侷限性黑色素瘤:階段0∼IIC
    • 局部性黑色素瘤:階段IIIA∼IIIC
    • 不能切除/轉移性黑色素瘤:階段III∼IV
  • 美國
    • 診斷
    • 臨床診療
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 澳洲

第6章 競爭環境

  • 概要
  • 以干擾素為基礎的輔助性治療
    • Roferon-A (干擾素α2a)
    • Intron A (干擾素α2b)
    • Sylatron (Pegylated interferon-alpha2b)
  • 免疫查核點抑制劑
    • Yervoy (Ipilimumab)
    • Opdivo (noborumabu)
    • Keytruda (penburorizumabu)
  • BRAF突然變異標靶治療
    • Zelboraf (Vemurafenib)
    • Tafinlar (daburafenibu)
    • Mekinist (toramechinibu)
  • 其他治療層級

第7章 市場機會及未滿足需求

  • 概要
  • 野生型BRAF患者的治療選擇
    • 未滿足需求
    • 差距分析
    • 市場機會
  • 對PD-1免疫療法無反應者的治療
  • 對高風險、可切除的黑色素瘤的輔助性治療
  • 對腦轉移的有效治療
  • 對免疫療法的治療反應的預見標記

第8章 開發平台評估

  • 概要
  • 臨床實驗中有前途的醫藥品
  • RAF/RAS/MEK途徑標靶治療
    • Cobimetinib (GDC-0973)
    • Encorafenib (LGX818)
    • Binimetinib (MEK162)
  • 免疫相關療法
    • Talimogene Laherparepvec
    • Eltrapuldencel-T (NSB20)
    • Seviprotimut-L (POL-103A)
    • PV-10
  • 開發初期階段的潛力藥物
    • PI3k/Akt/mTOR途徑標靶治療
    • 細胞週期查核點抑制劑
    • 下一代型的BRAF抑制劑
    • 抗體-藥物結合體
  • 開發中的其他藥劑

第9章 現在、未來市場參與企業

  • 概要
  • 企業策略概要
  • 企業簡介
    • Bristol-Myers Squibb
    • Novartis
    • Roche
    • Merck

第10章 市場預測

  • 全球市場
    • 市場預測
    • 市場促進、阻礙因素:全球的課題
  • 美國
    • 市場預測
    • 近幾年主要的事件
    • 市場促進、阻礙因素
  • 歐洲主要5個國家
    • 市場預測
    • 近幾年主要的事件
    • 市場促進、阻礙因素:法國
    • 市場促進、阻礙因素:德國
    • 市場促進、阻礙因素:義大利
    • 市場促進、阻礙因素:西班牙
    • 市場促進、阻礙因素:英國
  • 日本
  • 澳洲

第11章 附錄

圖表一覽

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目錄
Product Code: GDHC159PIDR

Melanoma is the deadliest and most aggressive form of skin cancer. Melanoma is rare compared to other major cancer indications, but the incident cases are increasing because of the aging population and changes in lifestyle that result in more ultraviolet (UV) exposure. Although only 4-8% of patients in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Australia) are diagnosed with unresectableStage III or Stage IV metastatic disease, a significant proportion of resectableStage III disease (42-48%) progresses to metastatic melanoma.

It is estimated that the value of the melanoma market in the US, five major European markets (5EU: France, Germany, Italy, Spain, and the UK), and Australia in 2016 was about $3.3B. This market is defined as sales of the major branded drugs commonly prescribed for melanoma patients across the 7MM. Among these sales, over 65% (over $2B) were generated in the US, with the 5EU representing the next largest region by sales with an estimated 28% (over $900M).

By the end of the forecast period in 2026, melanoma projects sales to rise to about $5.5B in the 7MM, at a modest Compound Annual Growth Rate (CAGR) of just over 5%. In particular, the US melanoma market is expected to grow most rapidly, increasing to over $3.5B (around 70% share) by 2026, at a modest CAGR of 5.8%. Sales in the other regions are expected to increase by the end of the forecast period at CAGRs of around 4% for the 5EU and Australia.

It is expected that the approval of 10 pipeline agents would happen over the forecast period; however, few of these are expected to have a major impact on the overall melanoma market. Of these pipeline agents, Incyte's IDO inhibitor epacadostat represents the sales leader with peak-year sales of $383.4M in 2026.

The report "PharmaPoint: Melanoma - Global Drug Forecast and Market Analysis to 2026", provide overview of melanoma, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Furthermore, this report provides the following -

  • Annualized melanoma therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments, forecast from 2016 to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the melanoma therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for melanoma. The most promising candidates in Phase III development are profiled.
  • Analysis of the current and future market competition in the global melanoma market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report:AB Science, Amgen, Array BioPharma, AVAX Technologies, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Incyte, Merck & Co, Novartis

Scope

  • Overview of melanoma, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized melanoma therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments, forecast from 2016 to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the melanoma therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for melanoma. The most promising candidates in Phase III development are profiled.
  • Analysis of the current and future market competition in the global melanoma 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 melanoma market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global melanoma 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.

Table of Contents

1 Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 7
  • 1.2 List of Figures 10

2 Executive Summary 12

  • 2.1 Modest Growth in the Melanoma Market Expected from 2016-2026 12
  • 2.2 Despite Strong Competition, Bristol-Myers Squibb to Remain the Leader of the Checkpoint Immunotherapy and Overall Melanoma Market 15
  • 2.3 High Unmet Need Remains for Efficacious Treatment Options in BRAF Wild-Type Patients 17
  • 2.4 High Commercial Opportunity for Adjuvant Treatments that Improve Cure Rates in Early-Stage, Resectable Melanoma Patients 17
  • 2.5 Innovative Immune Checkpoint Inhibitor Combinations Strive for Market Penetration Due to a Crowded Melanoma Market 18
  • 2.6 Late-Stage Pipeline Agents to Have Limited Impact on the Future Melanoma Landscape 18
  • 2.7 What Do the Physicians Think? 20

3 Introduction 21

  • 3.1 Catalyst 21
  • 3.2 Related Reports 22
  • 3.3 Upcoming Related Reports 22

4 Disease Overview 23

  • 4.1 Etiology and Pathophysiology 23
    • 4.1.1 Etiology 23
    • 4.1.2 Pathophysiology 24
    • 4.1.3 Melanoma Biomarkers 24
  • 4.2 Clinical Staging 26
  • 4.3 Symptoms 29
  • 4.4 Prognosis 29
  • 4.5 Quality of Life 31

5 Epidemiology 32

  • 5.1 Disease Background 32
  • 5.2 Risk Factors and Comorbidities 32
  • 5.3 Global and Historical Trends 34
  • 5.4 Forecast Methodology 37
    • 5.4.1 Sources Used 38
    • 5.4.2 Forecast Assumptions and Methods 41
  • 5.5 Epidemiological Forecast for Melanoma (2016-2026) 46
    • 5.5.1 Diagnosed Incident Cases of Melanoma 46
    • 5.5.2 Age-Specific Diagnosed Incident Cases of Melanoma 47
    • 5.5.3 Sex-Specific Diagnosed Incident Cases of Melanoma 48
    • 5.5.4 Five-Year Diagnosed Prevalent Cases of Melanoma 49
    • 5.5.5 Diagnosed Incident Cases of Melanoma by Stage at Diagnosis 50
  • 5.6 Discussion 51
    • 5.6.1 Epidemiological Forecast Insight 51
    • 5.6.2 Limitations of the Analysis 51
    • 5.6.3 Strengths of the Analysis 52

6 Disease Management 53

  • 6.1 Diagnosis Overview 53
  • 6.2 Treatment Guidelines, Leading Prescribed Drugs, and Clinical Practice 54
    • 6.2.1 Localized Melanoma: Stage 0 to Stage IIc 56
    • 6.2.2 Regional Melanoma: Stage IIIa to Stage IIIc 58
    • 6.2.3 Advanced (Unresectable and Metastatic) Melanoma: Stage III and Stage IV 61
  • 6.3 US 68
    • 6.3.1 Screening and Diagnosis 68
    • 6.3.2 Clinical Practices 70
  • 6.4 France 72
    • 6.4.1 Screening and Diagnosis 73
    • 6.4.2 Clinical Practices 73
  • 6.5 Germany 75
    • 6.5.1 Screening and Diagnosis 75
    • 6.5.2 Clinical Practices 76
  • 6.6 Italy 79
    • 6.6.1 Screening and Diagnosis 80
    • 6.6.2 Clinical Practices 80
  • 6.7 Spain 82
    • 6.7.1 Screening and Diagnosis 82
    • 6.7.2 Clinical Practices 83
  • 6.8 UK 84
    • 6.8.1 Screening and Diagnosis 84
    • 6.8.2 Clinical Practices 85
  • 6.9 Australia 87
    • 6.9.1 Screening and Diagnosis 88
    • 6.9.2 Clinical Practices 89

7 Competitive Assessment 90

  • 7.1 Overview 90
  • 7.2 Interferon-Based Adjuvant Therapies 92
    • 7.2.1 Roferon-A (Interferon Alfa-2a) 92
    • 7.2.2 Intron A (Interferon Alfa-2b) 97
    • 7.2.3 Sylatron (Peginterferon Alfa-2b) 102
  • 7.3 Immune Checkpoint Inhibitors 108
    • 7.3.1 Yervoy (Ipilimumab) 108
    • 7.3.2 Opdivo (Nivolumab) 122
    • 7.3.3 Keytruda (Pembrolizumab) 136
  • 7.4 BRAF and MEK Targeted Therapies 152
    • 7.4.1 Zelboraf (Vemurafenib) 152
    • 7.4.2 Cotellic (Cobimetinib) 162
    • 7.4.3 Tafinlar (Dabrafenib) 169
    • 7.4.4 Mekinist (Trametinib) 180
  • 7.5 Oncolytic Viral Therapy 193
    • 7.5.1 Imlygic (Talimogene Laherparepvec) 193
  • 7.6 Other Therapeutic Classes 200

8 Unmet Need and Opportunity 202

  • 8.1 Overview 202
  • 8.2 Therapeutic Options for BRAF Wild-Type Patients 207
    • 8.2.1 Unmet Need 207
    • 8.2.2 Gap Analysis 208
    • 8.2.3 Opportunity 208
  • 8.3 Therapies for Non-responders to PD-1 Immunotherapy 210
    • 8.3.1 Unmet Need 210
    • 8.3.2 Gap Analysis 210
    • 8.3.3 Opportunity 212
  • 8.4 Neoadjuvant and Adjuvant Therapies for High-Risk Resectable Melanoma 215
    • 8.4.1 Unmet Need 215
    • 8.4.2 Gap Analysis 216
    • 8.4.3 Opportunity 218
  • 8.5 Effective Treatment for Brain Metastases 220
    • 8.5.1 Unmet Need 220
    • 8.5.2 Gap Analysis 221
    • 8.5.3 Opportunity 223
  • 8.6 Predictive Markers for Therapeutic Response to Immunotherapies 225
    • 8.6.1 Unmet Need 225
    • 8.6.2 Gap Analysis 225
    • 8.6.3 Opportunity 227

9 Pipeline Assessment 229

  • 9.1 Overview 229
  • 9.2 Promising Drugs in Clinical Development 231
  • 9.3 Immune Checkpoint Inhibitors 234
    • 9.3.1 Epacadostat 234
    • 9.3.2 Tecentriq (Atezolizumab) 241
    • 9.3.3 PDR-001 247
  • 9.4 Molecular Targeted Therapies 253
    • 9.4.1 Encorafenib (LGX818) 253
    • 9.4.2 Binimetinib (MEK162) 260
    • 9.4.3 Masitinib (AB-1010) 267
  • 9.5 Other Immune-Related Therapies 272
    • 9.5.1 Seviprotimut-L 272
    • 9.5.2 PV-10 277
    • 9.5.3 M-Vax 282
    • 9.5.4 Daromun (L19-IL2 + L19-TNF) 287
  • 9.6 Promising Drugs in Early-Stage Development 292
    • 9.6.1 Immunotherapies 292
    • 9.6.2 Molecular Targeted Therapies 294
    • 9.6.3 Oncolytic Viral Therapies, Adoptive T-cell Therapies, and Immunostimulants 299
  • 9.7 Other Drugs in Development 301

10 Current and Future Players 305

  • 10.1 Overview 305
  • 10.2 Trends in Corporate Strategy 309
  • 10.3 Company Profiles 310
    • 10.3.1 Bristol-Myers Squibb 310
    • 10.3.2 Novartis 312
    • 10.3.3 Merck & Co 314
    • 10.3.4 Roche 315
    • 10.3.5 Incyte 316

11 Market Outlook 318

  • 11.1 Global Markets 318
    • 11.1.1 Forecast 318
    • 11.1.2 Drivers and Barriers - Global 321
  • 11.2 US 323
    • 11.2.1 Forecast 323
    • 11.2.2 Key Events 326
    • 11.2.3 Drivers and Barriers- US 327
  • 11.3 5EU 328
    • 11.3.1 Forecast 328
    • 11.3.2 Key Events 330
    • 11.3.3 Drivers and Barriers -5EU 331
  • 11.4 Australia 334
    • 11.4.1 Forecast 334
    • 11.4.2 Key Events 336
    • 11.4.3 Drivers and Barriers - Australia 337

12 Appendix 338

  • 12.1 Bibliography 338
  • 12.2 Abbreviations 388
  • 12.3 Methodology 395
  • 12.4 Forecasting Methodology 395
    • 12.4.1 Diagnosed Melanoma Patients 395
    • 12.4.2 Percent Drug-Treated Patients 395
    • 12.4.3 Drugs Included in Each Therapeutic Class 396
    • 12.4.4 Launch and Patent Expiry Dates 398
    • 12.4.5 General Pricing Assumptions 399
    • 12.4.6 Average Body Weight and Surface Area Across the 7MM 400
    • 12.4.7 Individual Drug Assumptions 400
    • 12.4.8 Pricing of Pipeline Agents 422
  • 12.5 Primary Research - KOLs Interviewed for This Report 423
  • 12.6 Primary Research - Prescriber Survey 427
  • 12.7 About the Authors 428
    • 12.7.1 Analyst 428
    • 12.7.2 Therapy Area Directors 428
    • 12.7.3 Epidemiologist 429
    • 12.7.4 Epidemiology Reviewers 429
    • 12.7.5 Global Director of Therapy Analysis and Epidemiology 430
    • 12.7.6 Global Head and EVP of Healthcare Operations and Strategy 431
  • 12.8 About GlobalData 432
  • 12.9 Contact Us 432
  • 12.10 Disclaimer 433

List of Tables

1.1 List of Tables

  • Table 1: Melanoma: Key Metrics in Seven Major Pharmaceutical Markets 12
  • Table 2: Pathologic Stage Definitions for Melanoma 28
  • Table 3: The ABCED Rule of Melanoma Detection 29
  • Table 4: Prognosis of Melanoma 30
  • Table 5: Risk Factors for Melanoma 33
  • Table 6: 7MM, Diagnosed Incident Cases of Melanoma, Men and Women, Ages ≥18 Years, Select Years 2016-2026 46
  • Table 7: 7MM, Five-Year Diagnosed Prevalent Cases of Melanoma, Men and Women, Ages ≥18 Years, Select Years 2016-2026 49
  • Table 8: Clinical Guidelines for Melanoma 56
  • Table 9: Most Prescribed Drugs for Melanoma in the Global Markets by Class, 2016 67
  • Table 10: Country Profile - US 68
  • Table 11: Country Profile - France 72
  • Table 12: Country Profile - Germany 75
  • Table 13: Country Profile - Italy 79
  • Table 14: Country Profile - Spain 82
  • Table 15: Country Profile - UK 84
  • Table 16: Country Profile - Australia 87
  • Table 17: Leading Treatments for Melanoma, 2016 91
  • Table 18: Product Profile - Roferon-A 92
  • Table 19: Efficacy of Roferon-A 94
  • Table 20: Safety of Roferon-A 95
  • Table 21: Roferon-A SWOT Analysis, 2016 95
  • Table 22: Product Profile - Intron A 97
  • Table 23: Efficacy of Intron A from the Phase III E1684 Trial 99
  • Table 24: Safety of Intron A (E1684, E1690, and E1694) 100
  • Table 25: Intron A SWOT Analysis, 2015 100
  • Table 26: Product Profile - Sylatron 103
  • Table 27: Efficacy of Sylatron from the EORTC 18991 Trial 104
  • Table 28: Head-to-Head Comparison Between Sylatron and Low-Dose Interferon 105
  • Table 29: Safety of Sylatron from the EORTC 18991 Trial 106
  • Table 30: Sylatron SWOT Analysis, 2015 106
  • Table 31: Product Profile - Yervoy 109
  • Table 32: Yervoy Key Regulatory and Reimbursement Milestones in the US Melanoma Market 111
  • Table 33: Yervoy Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 112
  • Table 34: Yervoy Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 112
  • Table 35: Efficacy of Yervoy from the Phase III CA184-002 Trial 115
  • Table 36: Comparison of Higher Dose Yervoy and DTIC from the CA184-024 Trial 116
  • Table 37: Network Meta-analysis of Yervoy in the Advanced Setting 117
  • Table 38: Efficacy Data Comparing Yervoy 3mg/kg to Yervoy 10mg/kg from the CA184-169 Trial 117
  • Table 39: Efficacy of Yervoy in the Adjuvant Melanoma Setting from the CA184-029 Trial 118
  • Table 40: Safety of Yervoy at 3mg/kg in the Advanced Melanoma Setting from the CA184-002 trial 119
  • Table 41: Safety Data Comparing Yervoy 3mg/kg to Yervoy 10mg/kg from the CA184-169 Trial 119
  • Table 42: Safety of Yervoy in the Adjuvant Setting from the CA184-029 Trial 120
  • Table 43: Yervoy SWOT Analysis, 2017 121
  • Table 44: Product Profile - Opdivo 122
  • Table 45: Opdivo's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 125
  • Table 46: Opdivo's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 126
  • Table 47: Opdivo's Key Regulatory Milestones in the Australian Melanoma Market 126
  • Table 48: Efficacy of Opdivo in 1L BRAF-WT Advanced Melanoma from the CheckMate 066 Trial 129
  • Table 49: Efficacy of Opdivo + Yervoy from the CheckMate 067 Trial 131
  • Table 50: Safety Data from the CheckMate 037 Trial 132
  • Table 51: Safety Data from the CheckMate 066 Trial 133
  • Table 52: Safety Data from the CheckMate 067 Trial 134
  • Table 53: Opdivo SWOT Analysis, 2017 134
  • Table 54: Product Profile - Keytruda 137
  • Table 55: Keytruda Key Regulatory and Reimbursement Milestones in the US Melanoma Market 139
  • Table 56: Keytruda Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 140
  • Table 57: Keytruda Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 140
  • Table 58: Survival Data from the Phase Ib KEYNOTE-001 Trial 142
  • Table 59: Efficacy of Keytruda from the KEYNOTE-002 Trial 143
  • Table 60: Efficacy of Keytruda from the KEYNOTE-006 Trial 145
  • Table 61: Efficacy of Keytruda in Combinations in the 1L Setting 147
  • Table 62: Safety Data from the KEYNOTE-001 Trial 148
  • Table 63: Safety of Keytruda from the KEYNOTE-002 Trial 149
  • Table 64: Safety Data from the KEYNOTE-006 Trial 149
  • Table 65: Safety of Keytruda in the 1L Setting from 2016 ASCO Annual Meeting 150
  • Table 66: Keytruda SWOT Analysis, 2017 151
  • Table 67: Product Profile - Zelboraf 153
  • Table 68: Zelboraf's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 154
  • Table 69: Zelboraf's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 155
  • Table 70: Zelboraf's Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 156
  • Table 71: Efficacy of Zelboraf 158
  • Table 72: Safety of Zelboraf 159
  • Table 73: Zelboraf SWOT Analysis, 2017 160
  • Table 74: Product Profile - Cotellic 162
  • Table 75: Cotellic's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 163
  • Table 76: Cotellic's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 164
  • Table 77: Cotellic's Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 164
  • Table 78: Efficacy of Cotellic in BRAF V600 Mutation-Positive Advanced Melanoma from the coBRIM Trial 166
  • Table 79: Safety Data of Cotellic from the coBRIM Trial 167
  • Table 80: Cotellic SWOT Analysis, 2017 168
  • Table 81: Product Profile - Tafinlar 170
  • Table 82: Tafinlar's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 172
  • Table 83: Tafinlar's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 173
  • Table 84: Tafinlar's Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 174
  • Table 85: Efficacy of Tafinlar Monotherapy from the BREAK-3 Trial 176
  • Table 86: Safety of Tafinlar 177
  • Table 87: Tafinlar SWOT Analysis, 2017 178
  • Table 88: Product Profile - Mekinist 180
  • Table 89: Mekinist's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 182
  • Table 90: Mekinist's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 183
  • Table 91: Mekinist's Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 184
  • Table 92: Efficacy of Mekinist from the Phase III METRIC Trial 186
  • Table 93: Efficacy Results of Tafinlar + Mekinist from the Phase II NCT01072175 Trial 187
  • Table 94: Efficacy Results of the COMBI-d Trial 188
  • Table 95: Efficacy Results of Tafinlar + Mekinist from the COMBI-v Trial 189
  • Table 96: Safety of Mekinist from the Phase III METRIC Trial 190
  • Table 97: Safety Results of the COMBI-d Trial 191
  • Table 98: Safety Results of the COMBI-v Trial 191
  • Table 99: Mekinist SWOT Analysis, 2017 192
  • Table 100: Product Profile - Imlygic 193
  • Table 101: Imlygic's Key Regulatory and Reimbursement Milestones in the US Melanoma Market 195
  • Table 102: Imlygic's Key Regulatory and Reimbursement Milestones in the EU Melanoma Market 195
  • Table 103: Imlygic's Key Regulatory and Reimbursement Milestones in the Australian Melanoma Market 196
  • Table 104: Efficacy of Imlygic from the Phase III OPTiM Trial 198
  • Table 105: Exploratory Subgroup Analyses from the Phase III OPTiM Trial 199
  • Table 106: Safety of Imlygic from the Phase III OPTiM Trial 199
  • Table 107: Imlygic SWOT Analysis, 2017 200
  • Table 108: Summary of Minor Therapeutic Classes, 2017 201
  • Table 109: Product Profile - Epacadostat 235
  • Table 110: Efficacy of Keytruda + Epacadostat from the Phase I/II KEYNOTE-037/ECHO-202 Trial 237
  • Table 111: Safety Data of Keytruda + Epacadostat from the Phase I/II KEYNOTE-037/ECHO-202 Trial 238
  • Table 112: Epacadostat SWOT Analysis, 2017 240
  • Table 113: Product Profile - Tecentriq 242
  • Table 114: Tecentriq SWOT Analysis, 2017 245
  • Table 115: Product Profile - PDR-001 248
  • Table 116: PDR-001 SWOT Analysis, 2017 251
  • Table 117: Product Profile - Encorafenib 254
  • Table 118: Efficacy of Encorafenib from the Phase III COLUMBUS Trial 256
  • Table 119: Safety of Encorafenib Regimens from the Phase III COLUMBUS Trial 257
  • Table 120: Encorafenib SWOT Analysis, 2017 258
  • Table 121: Product Profile - Binimetinib 261
  • Table 122: Efficacy of Binimetinib from the Phase III NEMO Trial 263
  • Table 123: Safety of Binimetinib from the Phase III NEMO Trial 264
  • Table 124: Binimetinib SWOT Analysis, 2017 266
  • Table 125: Product Profile - Masitinib 268
  • Table 126: Masitinib SWOT Analysis, 2017 270
  • Table 127: Product Profile - Seviprotimut-L 273
  • Table 128: Efficacy of Seviprotimut-L from the Phase II POL 89-38 Trial 274
  • Table 129: Seviprotimut-L SWOT Analysis, 2017 275
  • Table 130: Product Profile - PV-10 278
  • Table 131: Efficacy of PV-10 from the PV-10-MM-02 Trial 279
  • Table 132: Safety of PV-10 280
  • Table 133: PV-10 SWOT Analysis, 2017 281
  • Table 134: Product Profile - M-Vax 283
  • Table 135: Efficacy of M-Vax from the Phase I/II NCT00257465 Trial 284
  • Table 136: M-Vax SWOT Analysis, 2017 286
  • Table 137: Product Profile - Daromun (L19-IL2 + L19-TNF) 288
  • Table 138: Efficacy of Daromun from the Phase II NCT02076633 Trial 289
  • Table 139: Daromun SWOT Analysis, 2017 291
  • Table 140: Clinical Settings of Early-Stage Immunotherapies 294
  • Table 141: Clinical Settings of Early-Stage Next-Generation BRAF Inhibitors 296
  • Table 142: Clinical Settings of Early-Stage Drugs Targeting the PI3K/Akt/mTOR Pathway 297
  • Table 143: Clinical Settings of Early-Stage Drugs Targeting Cell Cycle Checkpoints 298
  • Table 144: Clinical Settings of Early-Stage Oncolytic Viral, Adoptive T-cell and Immunostimulants 300
  • Table 145: Drugs in Development, 2017 301
  • Table 146: Key Companies in the Melanoma Market in the 7MM, 2017 306
  • Table 147: BMS' Melanoma Portfolio Assessment, 2017 311
  • Table 148: Novartis' Melanoma Portfolio Assessment, 2017 313
  • Table 149: Merck & Co's Melanoma Portfolio Assessment, 2017 314
  • Table 150: Roche's Melanoma Portfolio Assessment, 2017 316
  • Table 151: Incyte's Melanoma Portfolio Assessment, 2017 317
  • Table 152: Melanoma Market in the 7MM - Drivers, 2016-2026 321
  • Table 153: Melanoma Market in the 7MM - Barriers, 2016 322
  • Table 154: Key Events Impacting Sales for Melanoma in the US, 2016-2026 326
  • Table 155: Melanoma Market in the US - Drivers and Barriers, 2016-2026 327
  • Table 156: Key Events Impacting Sales for Melanoma in the 5EU, 2016-2026 330
  • Table 157: Melanoma Market in the 5EU - Drivers and Barriers, 2016-2026 331
  • Table 158: Melanoma Market in the 5EU - Country-Specific Drivers, 2016-2026 332
  • Table 159: Melanoma Market in the 5EU - Country-Specific Barriers, 2016-2026 333
  • Table 160: Key Events Impacting Sales for Melanoma in Australia, 2016-2026 336
  • Table 161: Melanoma Market in Australia - Drivers and Barriers, 2016-2026 337
  • Table 162: Key Launch Dates 398
  • Table 163: Key Patent Expiries 399

Table 164 Average Body Weight and Surface Area Across the 7MM 400

  • Table 165: High-Prescribing Physicians Surveyed by Country 427
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