The poor prognosis of advanced malignant melanoma (melanoma) patients means that there is a significant need for effective therapies to treat patients in this indication and a large commercial opportunity for drug developers. Immunotherapy treatments have actively been researched in melanoma and have received approval. Furthermore, the launch of BRAF and MEK inhibitors for BRAF-mutation-positive melanoma has segmented the market according to patients’ BRAF-mutation status, a trend that looks set to continue. With the entry of novel immunotherapies and BRAF and MEK inhibitors, the melanoma market is set to become increasingly competitive as agents vie for patient share.

Questions Answered in This Report:

  • The melanoma market is set to see rapid growth through 2023. What is driving growth of the melanoma market? What factors are constraining sales? Where do key drug development opportunities lie in this market?

  • Ipilimumab was the highest selling therapy in the melanoma market in 2013. How will this situation change through 2023? How will the emergence of anti-PD-1 therapies impact the use of ipilimumab? What sales will ipilimumab garner at the end of the forecast period?

  • Two anti-PD-1 therapies, Bristol-Myers Squibb/Ono Pharmaceutical’s nivolumab (Opdivo) and Merck & Co.’s pembrolizumab (Keytruda), were approved in 2014 for melanoma. In what settings are these agents likely to receive uptake? How will their use change over the next ten years? How will use of these agents affect prescribing of other agents in the melanoma market?

  • Combination use of BRAF and MEK inhibitors has demonstrated improved efficacy and a favorable safety profile in Phase III clinical trials for BRAF-mutation-positive unresectable/metastatic melanoma. How much uptake will these combinations see? Several combinations are in development; how will they perform against one another across different geographies?

  • The resectable melanoma population currently has few treatment options. Will any therapies be approved in this setting during the forecast period? Which drug classes hold the most promise in this setting?


Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 27 country-specific interviews with thought leaders. We also surveyed malignant melanoma specialists (including dermatologists) in each market on their treatment practices.

Epidemiology: Diagnosed incidence of malignant melanoma by stage of disease and resectability. Clinical- and market-relevant drug-treatable populations.

Population segments in market forecast: Resectable (stage II-III), first-line unresectable BRAF-mutation-negative, first-line unresectable BRAF-mutation-positive, second-line unresectable BRAF-mutation-negative, second-line unresectable BRAF-mutation-positive, third-line unresectable BRAF-mutation-negative, third-line unresectable BRAF mutation-positive.

Emerging therapies: Phase II: 27 drugs; Phase III/Preregistration: 8 drugs.

Author(s): Amy Duval, M.Res.
Kimberly Martin, Ph.D.

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