The introduction of immune checkpoint inhibitors Keytruda (Merck & Co.), Opdivo ± Yervoy (Bristol Myers Squibb), and Tecentriq (Roche / Genentech; United States only), as well as BRAF/MEK inhibitor combinations, such as Roche / Genentech’s Zelboraf + Cotellic, Novartis’s Tafinlar + Mekinist, and Pfizer / Array BioPharma’s Braftovi + Mektovi, has significantly changed the treatment landscape for malignant melanoma in both the resectable and metastatic settings. Nonetheless, opportunities remain for novel agents specifically targeting the underrepresented BRAF wild-type unresectable or metastatic population. With the expected introduction of novel agents and combination regimens, the malignant melanoma treatment paradigm will continue to evolve. In such a dynamic indication, marketed drugs need to be carefully positioned to achieve optimal uptake.

Questions Answered:

  • How large are the clinically and commercially relevant malignant melanoma drug-treatable populations? Will drug-treatment rates increase over the forecast period?
  • What is the current treatment landscape in malignant melanoma? Which currently approved drugs are the most important, and why?
  • Which drugs in late-phase development are poised to change the treatment landscape for malignant melanoma, and how? What sales/uptake could these drugs secure in the malignant melanoma market?
  • What are the key drivers and constraints in the malignant melanoma market, and how will the market evolve over the forecast period?

Content Highlights

Geographies: United States, EU5, Japan.

Primary research: 20 country-specific interviews with thought-leading medical oncologists, supported by survey data collected for this and other DRG research.

Epidemiology: Diagnosed incidence of malignant melanoma by country, segmented by disease stage and BRAF mutation status.

Forecast: 10-year, annualized, drug-level sales and patient share of key malignant melanoma therapies through 2029, segmented by brands/generics and epidemiological subpopulations.

Emerging therapies: Phase III: 8 drugs; Phase II: 19 drugs.

Product Description

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Malignant Melanoma - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • November 2020
      • Q3 2020
        • August 2020
      • Q2 2020
        • May 2020
    • Key Findings
      • Market Outlook
        • COVID-19: Areas of Potential Forecast Impact
          • Expert Insights on Areas of Potential Impact from COVID-19
        • Key Findings
          • Major-Market Share of Malignant Melanoma Drug Classes: 2019
          • Major-Market Share of Malignant Melanoma Drug Classes: 2029
          • Drug-Treatable Population Share and Major-Market Sales Share in Malignant Melanoma: 2019
          • Drug-Treatable Population Share and Major-Market Sales Share in Malignant Melanoma: 2029
          • Population Positioning of Therapies in Malignant Melanoma
          • Malignant Melanoma SWOT Analysis
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Malignant Melanoma?
          • What Factors Are Constraining the Market for Malignant Melanoma?
          • Major-Market Sales of Key Agents Excluding Immune Checkpoint Inhibitors in Malignant Melanoma: 2019-2029
          • Major-Market Sales of Immune Checkpoint Inhibitors in Malignant Melanoma: 2019-2029
          • Major-Market Share of Malignant Melanoma Sales by Patient Population: 2019-2029
          • Major-Market Share of Immune Checkpoint Inhibitors in Malignant Melanoma by Patient Population: 2029
          • Share of Major-Market Sales of Nivolumab and Pembrolizumab in Malignant Melanoma by Therapeutic Use: 2029
        • Segment-Specific Trends
          • Patient-Share Dynamics of Agents in Resectable BRAF Mutation-Positive Stage IIB-III Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Agents in Resectable BRAF Mutation-Positive Stage IIB-III Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Agents in Resectable BRAF Mutation-Positive Stage IIB-III Malignant Melanoma in Japan: 2019-2029
          • Patient-Share Dynamics of Agents in Resectable BRAF Wild-Type Stage IIB-III Malignant Melanoma in the United States: 2019-2029
          • Patient Share Dynamics of Agents in Resectable BRAF Wild-Type Stage IIB-III Malignant Melanoma in Europe: 2019-2029
          • Patient Share Dynamics of Agents in Resectable BRAF Wild-Type Stage IIB-III Malignant Melanoma in Japan: 2019-2029
          • Patient-Share Dynamics of Key Therapies in First-Line BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Key Therapies in First-Line BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Key Therapies in First-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Key Therapies in First-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Second-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient Share Dynamics of Key Therapies in Second-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Third- and Fourth-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Third- and Fourth-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Second-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Second-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Third- and Fourth-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in the United States: 2019-2029
          • Patient-Share Dynamics of Key Therapies in Third- and Fourth-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in Europe: 2019-2029
      • Forecast
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Disease Pathophysiology
            • Progression of Malignant Melanoma
            • Progression of Malignant Melanoma
          • Staging and Classification
            • Classification and Staging of Malignant Melanoma
            • AJCC TNM Classification System for Cutaneous Malignant Melanoma: Eighth Edition
            • AJCC Staging System for Cutaneous Malignant Melanoma: Eighth Edition
            • Current WHO Histological Classification of Malignant Melanoma Subtypes
            • Histopathological and Clinical Prognostic Factors for Malignant Melanoma
            • Survival Rates for Malignant Melanoma
          • Key Pathways and Drug Targets
            • Immune Checkpoint Inhibitors
            • Drug Targets for Malignant Melanoma
            • Key Targets and Signaling Pathways for Malignant Melanoma
        • Epidemiology
          • Key Findings
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Incidence of Malignant Melanoma
              • Diagnosed Incident Cases of Malignant Melanoma: 2019-2029
              • Disease Definition
              • Methods
              • Sources Used for Stage Distribution of Malignant Melanoma
              • Diagnosed Incident Cases of Malignant Melanoma by Stage Distribution: 2019-2029
              • Disease Definition
              • Methods
              • Sources Used for Malignant Melanoma Recurrent Incidence
              • Recurrent Incident Cases of Malignant Melanoma in the Major Pharmaceutical Markets: 2019-2029
              • Malignant Melanoma Patient Flow
              • Drug-Treatable Cases of Malignant Melanoma: 2019-2029
              • Drug-Treated Cases of Malignant Melanoma: 2019-2029
          • Current Treatment
            • Key Findings
              • Treatment Goals
                • Key Endpoints Used in Clinical Trials for Malignant Melanoma
              • Key Current Therapies
                • Overview
                • Mechanism of Action of Key Current Drug Classes Used for Malignant Melanoma
                • Current Treatments Used for Malignant Melanoma
                • Market Events Impacting the Use of Key Current Therapies in Malignant Melanoma
                • Key Results from Select Trials Investigating Yervoy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Yervoy
                • Key Ongoing Clinical Trials of Yervoy in the Treatment of Malignant Melanoma
                • Expert Insight: Yervoy
                • Key Results from Select Clinical Trials Investigating Keytruda for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Keytruda
                • Key Ongoing Clinical Trials of Keytruda in the Treatment of Malignant Melanoma
                • Expert Insight: Keytruda
                • Key Results from Select Clinical Trials Investigating Opdivo for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Opdivo
                • Key Ongoing Clinical Trials of Opdivo in the Treatment of Malignant Melanoma
                • Expert Insight: Opdivo
                • Key Results from Select Clinical Trials Investigating Opdivo plus Yervoy Combination Therapy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Opdivo and Yervoy Combination Therapy
                • Key Ongoing Clinical Trials of Opdivo and Yervoy Combination Therapy in the Treatment of Malignant Melanoma
                • Expert Insight: Opdivo and Yervoy Combination Therapy
                • Tecentriq and Zelboraf Plus Cotellic Combination Therapy
                • Key Results from Select Clinical Trials Investigating Tecentriq and Zelboraf Plus Cotellic Combination Therapy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Tecentriq and Zelboraf Plus Cotellic Combination Therapy
                • Key Ongoing Clinical Trials of Tecentriq and Zelboraf Plus Cotellic Combination Therapy in the Treatment of Malignant Melanoma
                • Expert Insight: Tecentriq in Combination with Zelboraf Plus Cotellic for the Treatment of Malignant Melanoma
                • Advantages and Disadvantages of Zelboraf
                • Ongoing Clinical Development of Zelboraf
                • Expert Insights: Zelboraf
                • Advantages and Disadvantages of Tafinlar
                • Ongoing Clinical Development of Tafinlar
                • Expert Insight: Tafinlar
                • Advantages and Disadvantages of Mekinist
                • Ongoing Clinical Development of Mekinist
                • Key Results from Select Clinical Trials Investigating Tafinlar and Mekinist Combination Therapy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Tafinlar and Mekinist Combination Therapy
                • Key Ongoing Clinical Trials of Tafinlar and Mekinist Combination Therapy in the Treatment of Malignant Melanoma
                • Expert Insight: Tafinlar and Mekinist Combination Therapy
                • Key Results from Select Clinical Trials Investigating Zelboraf and Cotellic Combination Therapy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Zelboraf and Cotellic Combination Therapy
                • Expert Insight: Zelboraf and Cotellic Combination Therapy
                • Key Results from Select Clinical Trials Investigating Braftovi and Mektovi Combination Therapy for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Braftovi and Mektovi Combination Therapy
                • Expert Insight: Braftovi and Mektovi Combination Therapy
                • Key Results from Select Clinical Trials Investigating Imlygic for the Treatment of Malignant Melanoma
                • Ongoing Clinical Development of Imlygic
                • Key Ongoing Clinical Trials of Imlygic in the Treatment of Malignant Melanoma
                • Expert Insight: Imlygic
                • Advantages and Disadvantages of Cytokines
                • Advantages and Disadvantages of Cytotoxic Agents
              • Medical Practice
                • Resectable Malignant Melanoma: Stage llB-lll
                • First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
                • First-Line Unresectable or Metastatic BRAF Wild-Type Malignant Melanoma
                • Second-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
                • Second-Line Unresectable or Metastatic BRAF Wild-Type Malignant Melanoma
                • Third- and Fourth-Line Unresectable or Metastatic Malignant Melanoma
                • Country-Specific Malignant Melanoma Treatment Guidelines
                • Patient Characteristics Influencing Drug Selection in Malignant Melanoma
                • Region-Specific Treatment Practices
                • Treatment Decision Tree for Malignant Melanoma: United States
                • Treatment Decision Tree for Malignant Melanoma: Europe
                • Treatment Decision Tree for Malignant Melanoma: Japan
            • Unmet Need Overview
              • Current and Future Attainment of Unmet Needs in Malignant Melanoma
              • Top Unmet Needs in Malignant Melanoma: Current and Future Attainment
              • Expert Insights: Unmet Need in Malignant Melanoma
            • Emerging Therapies
              • Key Findings
                • Pipeline Trends for Malignant Melanoma
              • Key Emerging Therapies
                • Key Therapies in Development for Malignant Melanoma
                • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of Malignant Melanoma
                • Key Results from Select Clinical Trials Investigating Spartalizumab for the Treatment of Malignant Melanoma
                • Analysis of Clinical Development Program for Spartalizumab
                • Key Ongoing Clinical Trials of Spartalizumab in the Treatment of Malignant Melanoma
                • Expert Insight: Spartalizumab
                • Expectations for Market Authorization and Sales Opportunity of Spartalizumab in Malignant Melanoma
                • Key Results from Select Clinical Trials Investigating Relatlimab for the Treatment of Malignant Melanoma
                • Analysis of the Clinical Development Program for Relatlimab
                • Key Ongoing Clinical Trials of Relatlimab in the Treatment of Malignant Melanoma
                • Expert Insight: Relatlimab
                • Expectations for Market Authorization and Sales Opportunity of Relatlimab in Malignant Melanoma
                • Seviprotimut-L
                • Key Results from Select Clinical Trials Investigating Seviprotimut-L for the Treatment of Malignant Melanoma
                • Analysis of Clinical Development Program for Seviprotimut-L
                • Key Ongoing Clinical Trials of Seviprotimut-L in the Treatment of Malignant Melanoma
                • Expert Insight: Seviprotimut-L
                • Expectations for Market Authorization and Sales Opportunity of Seviprotimut-L in Malignant Melanoma
                • Key Results from Select Clinical Trials Investigating PV-10 for the Treatment of Malignant Melanoma
                • Analysis of Clinical Development for PV-10
                • Key Ongoing Clinical Trials of PV-10 in the Treatment of Malignant Melanoma
                • Expert Insight: PV-10
                • Expectations for Market Authorization and Sales Opportunity of PV-10 in Malignant Melanoma
                • Key Results from Select Clinical Trials Investigating Modtylso for the Treatment of Malignant Melanoma
                • Analysis of the Clinical Development Program for Modtylso
                • Key Ongoing Clinical Trials of Modtylso in the Treatment of Malignant Melanoma
                • Expert Insights: Modtylso
                • Expectations for Market Authorization and Sales Opportunity of Modtylso in Malignant Melanoma
                • Nidlegy
                • Key Results from Select Clinical Trials Investigating Nidlegy for the Treatment of Malignant Melanoma
                • Analysis of the Clinical Development Program for Nidlegy
                • Key Ongoing Clinical Trials of Nidlegy in the Treatment of Malignant Melanoma
                • Expert Insight: Nidlegy
                • Expectations for Launch and Sales Opportunities of Nidlegy in Malignant Melanoma
                • Lenvima
                • Key Results from Select Clinical Trials Investigating Lenvima for the Treatment of Malignant Melanoma
                • Analysis of the Clinical Development Program for Lenvima
                • Key Ongoing Clinical Trials of Lenvima in the Treatment of Malignant Melanoma
                • Expert Insights: Lenvima
                • Expectations for Launch and Sales Opportunities of Lenvima in Malignant Melanoma
                • Bempegaldesleukin
                • Key Results from Select Clinical Trials Investigating Bempegaldesleukin for the Treatment of Malignant Melanoma
                • Analysis of the Clinical Development Program for Bempegaldesleukin
                • Key Ongoing Clinical Trials of Bempegaldesleukin in the Treatment of Malignant Melanoma
                • Expert Insight: Bempegaldesleukin
                • Expectations for Launch and Sales Opportunities of Bempegaldesleukin in Malignant Melanoma
              • Early-Phase Pipeline Analysis
                • Select Compounds in Phase II Development for Malignant Melanoma
            • Access and Reimbursement Overview
              • Region-Specific Reimbursement Practices
                • Key Market Access Considerations in Malignant Melanoma: United States
                • General Reimbursement Environment: United States
                • Key Market Access Considerations in Malignant Melanoma: EU5
                • General Reimbursement Environment: EU5
                • Key Market Access Considerations in Malignant Melanoma: Japan
                • General Reimbursement Environment: Japan
            • Appendix
              • Key Abbreviations Related to Malignant Melanoma
              • Brands, Marketers, and Generic Availability of Current Therapies Used for Malignant Melanoma by Market
              • Malignant Melanoma Bibliography

          Author(s): Liseth Parra; Surup Dey

          Liseth Parra, Ph.D., is an analyst on the Oncology team at Clarivate. She has extensive background in oncology research and market analysis. She completed a postdoctoral fellowship in oncology at Brigham and Women’s Hospital in Boston, along with commercial work as an oncology research analyst for Kantar Health and as an independent consultant. She also worked as a research fellow at the Novartis Institutes for BioMedical Research in Basel, Switzerland, and at the Fritz Lipmann Institute in Jena, Germany. Dr. Parra completed her doctorate in neurosciences at the University of California in San Diego.

          Surup Dey, M.L.T., M.P.H., is an epidemiologist at Clarivate. Previously, he worked in the field of medical diagnostic microbiology and was involved in the diagnosis of rare hematological disorders. Mr. Dey has a background in medical laboratory science from Christian Medical College in Vellore and a postgraduate degree in public health specializing in epidemiology from Manipal University.


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