The malignant melanoma treatment landscape is dynamic and continues to undergo significant changes. Since 2011, three immune checkpoint inhibitors and four BRAF- or MEK-targeted agents have gained regulatory approval for unresectable or metastatic malignant melanoma. Among the most-recent market entrants, anti-PD-1 inhibitors Opdivo (Bristol-Myers Squibb/Ono Pharmaceutical’s nivolumab) and Keytruda (Merck & Co.’s pembrolizumab) are now in the spotlight. Numerous label expansions for currently marketed therapies are expected to further shape the malignant melanoma market, and as emerging combination therapies demonstrate impressive results, the market will become increasingly competitive. Drawing on insights from interviewed thought leaders, this report provides a comprehensive analysis of current treatment of melanoma in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) and a detailed analysis of key therapies in development. The report provides a ten-year annualized sales forecast extending to 2024, based on market-relevant patient populations.

Questions Answered in This Report:

  • The melanoma therapy market is set to experience rapid growth through 2024. What factors are driving and constraining market growth? Which new classes of agents will emerge over the forecast period, and what impact will they have on the overall market? What are the key unmet needs, and where do key drug development opportunities lie in this market?

  • Ipilimumab (Yervoy) was the top-selling therapy in the melanoma market in 2014. Two other immune checkpoint inhibitors, nivolumab (Opdivo) and pembrolizumab (Keytruda), were approved in 2014 for melanoma. How have these novel therapies affected the use of ipilimumab since their approval, and what will their impact be over the forecast period? What sales will the PD-1 inhibitors garner at the end of the forecast period? How will the use of immune checkpoint inhibitors change over the next ten years? How will use of these agents affect prescribing of other agents for melanoma?

  • Combinational use of BRAF and MEK inhibitors dabrafenib (Tafinlar) and trametinib (Mekinist) was approved for BRAF-mutation-positive unresectable/metastatic melanoma in 2014 in the United States and in 2015 in Europe. How has this combination performed in the melanoma market, and what are the expectations for it over the forecast period? More BRAF/MEK inhibitor combinations are in development; how will they perform against one another across different geographies?

  • The resectable melanoma population has few treatment options. How much uptake is expected for Yervoy as an adjuvant therapy? Will any other therapies be approved in this setting during the forecast period? Which drug classes hold the most promise in this setting?

Scope:

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 or metastatic BRAF wild-type, first-line unresectable or metastatic BRAF-mutation-positive, second-line unresectable or metastatic BRAF wild-type, second-line unresectable or metastatic BRAF-mutation-positive, third-line unresectable or metastatic BRAF wild-type, third-line unresectable or metastatic BRAF-mutation-positive.

Emerging therapies: Phase II: 22 drugs; Phase III: 8 drugs; registered: 20 drugs. Coverage of 24 select Phase I products.

Author(s): Gemma McConnell, Ph.D.
Sarah Anderson, M.Sc.

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