December 2013

Malignant Melanoma - 2013

Report Authors
Karen Pomeranz, M.Sc., Ph.D.
Joanne Graham, Ph.D.
Michael Hughes, M.Sc., Ph.D.
  • Pages:254
  • Tables:31
  • Figures:29
  • Citations:236
  • Drugs:39
  • Interviews:26


Last Updated 19 December 2013
The malignant melanoma market has undergone significant changes in the last two years owing to the launch of three targeted therapies and one immunotherapy for treatment of unresectable or metastatic disease. The launch of vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) in the United States and Europe for patients with a BRAF V600 mutation quickly resulted in the segmentation of the unresectable and metastatic patient population by BRAF mutation status. The subsequent launches of dabrafenib in the United States and Europe and of trametinib in the United States for the same patient population—and ongoing development of targeted agents for this segment—will ensure that this clinical practice continues. The expected launch of novel immunotherapies will further increase the competition for patient share across the unresectable and metastatic market, and emerging therapies will need to differentiate and position themselves to gain maximum traction in this small indication.

Questions Answered in This Report:

  *   We forecast robust annual growth in the malignant melanoma market over the ten-year forecast period (2012-2022). What factors are driving and constraining market growth? Which new agents will launch for malignant melanoma, and how will they impact the market?

  *   The BRAF/MEK/ERK signaling pathway is the focus of much R&D, in particular the development of BRAF inhibitor/MEK inhibitor combination therapy. What do experts think of this drug class and the possibility of using two targeted agents in combination? How will agents in this drug class compete for market share? What is the commercial potential of these agents, particularly if combination therapy gains uptake?

  *   Several agents, such as ipilimumab and vemurafenib, are being developed for treatment of high-risk resectable disease (adjuvant therapy). What do thought leaders think about the prospects of emerging therapies targeting the resectable patient population? Which agents, if any, are likely to be clinically and commercially successful in this setting?

  *   Several immunotherapies are in development for malignant melanoma. Which immunotherapies do thought leaders think hold most promise and in which patient populations? How will immunotherapies position themselves and compete for market share not only in the immunotherapy drug class but also in the overall malignant melanoma population?

  *   Ipilimumab is currently the leading agent in malignant melanoma. How will use of this agent and its positioning in the malignant melanoma market change during the course of our forecast period? Will ipilimumab successfully compete in the unresectable and metastatic setting with novel immunotherapies expected to launch during our forecast period?


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

Primary research: 26 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-negative.

Emerging therapies: Phase II: 15 drugs; Phase III: 11 drugs.

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Mentioned in this report:

  • - AB Science
  • - Abraxis BioScience
  • - Altor Bioscience
  • - Amgen
  • - Array BioPharma
  • - Avax Technologies
  • - Bayer HealthCare
  • - bioMerieux
  • - Biovex
  • - Bristol-Myers Squibb
  • - California Stem Cell
  • - Celegene
  • - Chugai Pharmecuticals
  • - CK Life Sciences International
  • - CureTech
  • - Daiichi Sankyo
  • - Dendreon
  • - Eisai
  • - Emcure Pharmaceuticals
  • - Exelixis
  • - Genentech
  • - GlaxoSmithKline
  • - Glycart
  • - Immunocore
  • - Italfarmaco
  • - Lion Biotechnologies
  • - Merck & Co.
  • - Merck EMD
  • - Millennium
  • - Nippon Kayaku
  • - Novartis
  • - Oncosec Medical
  • - Oncothyreon
  • - Ono
  • - Philogen
  • - Polynoma
  • - Prometheus
  • - Provectus Pharmaceuticals
  • - Roche
  • - Scancell
  • - Servier
  • - Takeda
  • - Threshold Pharmaceuticals
  • - Viralytics
  • - Ziopharm
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