Malignant Melanoma – Landscape & Forecast – Disease Landscape & Forecast
The introduction of the immune checkpoint inhibitors Keytruda (Merck & Co.), Opdivo ± Yervoy (Bristol Myers Squibb), and Tecentriq (Roche / Genentech; U.S. only), as well as BRAF/MEK inhibitor combinations such as Roche / Genentech’s Zelboraf plus Cotellic, Novartis’s Tafinlar plus Mekinist, and Pfizer / Array BioPharma’s Braftovi plus 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.
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 prescribed and why?
- Which drugs in late-phase development are poised to change the treatment of malignant melanoma and how? What sales / uptake could these drugs secure in the malignant melanoma market?
- What are the key drivers of / constraints in the malignant melanoma therapy market, and how will the market evolve over the forecast period?
Content highlights
Geographies: United States, EU5, Japan.
Primary research: 16 country-specific interviews with thought-leading medical oncologists, supported by survey data collected for this and other Clarivate research.
Epidemiology: Incidence of malignant melanoma by country, segmented by BRAF mutation status, disease stage, and line of therapy.
Forecast: 10-year, annualized, drug-level sales and patient share of key malignant melanoma therapies through 2031, segmented by brands / generics / biosimilars and epidemiological subpopulations.
Emerging therapies: Phase III: 4 drugs; Phase II: 3 drugs; coverage of select early-phase products.
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.
Solution enhancement
Disease Landscape & Forecast features continual updates to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Malignant Melanoma - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Key updates
- Q4 2022
- November 2022
- Q3 2022
- September 2022
- Q2 2022
- June 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Q4 2022
- Market outlook
- Key findings
- Market share of drug classes for malignant melanoma: 2021
- Market share of drug classes for malignant melanoma: 2031
- Drug-treatable population share and major-market sales share in malignant melanoma: 2021
- Drug-treatable population share and major-market sales share in malignant melanoma: 2031
- Population positioning of current therapies in malignant melanoma
- Population positioning of emerging 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: 2021-2031
- Major-market sales of immune checkpoint inhibitors in malignant melanoma: 2021-2031
- Major-market share of malignant melanoma sales by patient population: 2021-2031
- Major-market share of immune checkpoint inhibitors in malignant melanoma by patient population: 2031
- Share of major-market sales of nivolumab and pembrolizumab in malignant melanoma by therapeutic use: 2031
- Segment-specific trends
- Patient-share dynamics of agents in resectable BRAF-mutation-positive stage IIB-III malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of agents in resectable BRAF-mutation-positive stage IIB-III malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of agents in resectable BRAF-mutation-positive stage IIB-III malignant melanoma in Japan: 2021-2031
- Patient-share dynamics of agents in resectable BRAF wild-type stage IIB-III malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of agents in resectable BRAF wild-type stage IIB-III malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of agents in resectable BRAF wild-type stage IIB-III malignant melanoma in Japan: 2021-2031
- Patient-share dynamics of key therapies in first-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in first-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of key therapies in first-line BRAF wild-type unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in first-line BRAF wild-type unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of key therapies in second-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in second-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of key therapies in third- and fourth-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in third- and fourth-line BRAF-mutation-positive unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of key therapies in second-line BRAF wild-type unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in second-line BRAF wild-type unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Patient-share dynamics of key therapies in third- and fourth-line BRAF wild-type unresectable or metastatic malignant melanoma in the United States: 2021-2031
- Patient-share dynamics of key therapies in third- and fourth-line BRAF wild-type unresectable or metastatic malignant melanoma in Europe: 2021-2031
- Key findings
- 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
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition
- Methods
- Sources used for diagnosed incidence of malignant melanoma
- Diagnosed incident cases of malignant melanoma: 2021-2031
- Disease definition
- Methods
- Sources used for stage distribution of malignant melanoma
- Diagnosed incident cases of malignant melanoma by stage distribution: 2021-2031
- Disease definition
- Methods
- Sources used for incidence of recurrent malignant melanoma
- Recurrent incident cases of malignant melanoma in the major pharmaceutical markets: 2021-2031
- Malignant melanoma patient flow
- Drug-treatable cases of malignant melanoma: 2021-2031
- Drug-treated cases of malignant melanoma: 2021-2031
- Key findings
- 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 for malignant melanoma
- Key results from select trials investigating Yervoy for 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
- Key results from select clinical trials investigating Tecentriq for the treatment of malignant melanoma
- Ongoing clinical development of Tecentriq
- Key ongoing clinical trials of Tecentriq in the treatment of malignant melanoma
- Expert insight: Tecentriq
- Key results from select clinical trials investigating Opdualag for the treatment of malignant melanoma
- Ongoing clinical development of Opdualag
- Key ongoing clinical trials of Opdualag in the treatment of malignant melanoma
- Expert insight: Opdualag
- Advantages and disadvantages of Zelboraf
- Expert insight: Zelboraf
- Advantages and Disadvantages of Tafinlar
- Advantages and disadvantages 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
- 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
- Key ongoing clinical trials of Braftovi Plus Mektovi in the treatment of malignant melanoma
- 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
- Patient characteristics influencing drug selection in malignant melanoma
- Treatment decision tree for malignant melanoma: United States
- Treatment decision tree for malignant melanoma: Europe
- Treatment decision tree for malignant melanoma: Japan
- Key findings
- Unmet need overview
- Current and future attainment of unmet needs in malignant melanoma
- Top unmet needs in malignant melanoma: current and future attainment
- Expert insight: Unmet need in malignant melanoma
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- 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 fianlimab / Libtayo for the treatment of malignant melanoma
- Analysis of the clinical development program for fianlimab / Libtayo
- Key ongoing clinical trials of fianlimab / Libtayo in the treatment of malignant melanoma
- Expectations for launch and sales opportunities of fianlimab + Libtayo in malignant melanoma
- Key results from select clinical trials investigating seviprotimut-L for the treatment of malignant melanoma
- Analysis of the 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 IO102-IO103 for the treatment of malignant melanoma
- Analysis of the clinical development program for IO102-IO103
- Key ongoing clinical trials of IO102-IO103 in the treatment of malignant melanoma
- Expert insight: IO102-IO103
- Expectations for market authorization and sales opportunity of IO102-IO103 in malignant melanoma
- Key results from select clinical trials investigating vidutolimod for the treatment of malignant melanoma
- Analysis of the clinical development program for vidutolimod
- Key ongoing clinical trials of vidutolimod in the treatment of malignant melanoma
- Expert insights: vidutolimod
- Expectations for market authorization and sales opportunity of vidutolimod in malignant melanoma
- Key results from select clinical trials investigating tavokinogene telseplasmid for the treatment of malignant melanoma
- Analysis of the clinical development program for tavokinogene telseplasmid
- Key ongoing clinical trials of tavokinogene telseplasmid in the treatment of malignant melanoma
- Expert insight: tavokinogene telseplasmid
- Expectations for launch and sales opportunities of tavokinogene telseplasmid 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
- 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
- Key results from select clinical trials investigating RP1 for the treatment of malignant melanoma
- Analysis of the clinical development program for RP1
- Key ongoing clinical trials of RP1 in the treatment of malignant melanoma
- Expert insight: RP1
- Expectations for the market authorization and sales opportunity of RP1 in malignant melanoma
- 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 insight: Lenvima
- Expectations for the market authorization and sales opportunity of Lenvima in malignant melanoma
- Key results from select clinical trials investigating HBI-8000 for the treatment of malignant melanoma
- Analysis of clinical development program for HBI-8000
- Key ongoing clinical trials of HBI-8000 in the treatment of malignant melanoma
- Expert insight: HBI-8000
- Expectations for the market authorization and sales opportunity of HBI-8000 in malignant melanoma
- Key results from select clinical trials investigating lifileucel for the treatment of malignant melanoma
- Analysis of the clinical development program for lifileucel
- Key ongoing clinical trials of lifileucel in the treatment of malignant melanoma
- Expert insight: Lifileucel
- Expectations for the market authorization and sales opportunity of lifileucel in malignant melanoma
- Early-phase pipeline analysis
- Select compounds in early-phase development for malignant melanoma
- Key findings
- Access & 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- Malignant melanoma bibliography
- Key findings
Saurabh Virdi, B.Tech., Lead Healthcare Research & Data Analyst, Oncology. Mr. Virdi has more than seven years working in the pharmaceutical industry providing analytical support in various therapy areas, including oncology, HIV, vaccines, specialty pharma, and rare diseases. Prior to joining Clarivate, he was an assistant project manager at DelveInsight Business Research LLP, where he was responsible for developing and delivering customized market and asset value forecasts. Before DelveInsight, he worked at WNS GSK Knowledge center and SmartAnalyst, where, as part of multifunctional teams, he helped clients’ decision making throughout the development journey from early-stage to marketed drugs. He obtained his bachelor’s degree in biotechnology from Delhi Technological University in India.
Surup Dey, M.L.T., M.P.H., is an epidemiologist at Clarivate. A former microbiologist, he 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 earned a postgraduate degree in public health specializing in epidemiology from Manipal University. He specializes in real-world data analysis, cancer epidemiology, rare disease epidemiology, and targeted therapies in cancer.