The melanoma market has experienced moderate growth since 2016, and is expected to increase further, from $5.59bn in 2019 to $7.42bn in 2029 across the eight major markets (8MM*) at a compound annual growth rate of 2.9%, according to GlobalData, a leading data and analytics company. Growth will be driven by the anticipated launch of 12 pipeline agents, the expansion of currently approved therapies into earlier lines of treatment, and increased use of novel combinatorial regimens.

GlobalData’s latest report, ‘Melanoma – Global Drug Forecast and Market Analysis to 2029’ notes that the expiry of multiple patents of market-leading brands, followed by the emergence of generics and biosimilars will substantially temper growth, particularly in the European markets.

Jessica McCormack, PhD, Oncology and Hematology Analyst at GlobalData, comments: “Despite the patent expiries of Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Yervoy (ipilimumab), BMS is forecast to remain the current market leader, and Opdivo will witness the highest sales over the next decade. Although Merck & Co’s Keytruda (pembrolizumab) has substantial sales across the 8MM, and Opdivo and Keytruda are regarded as fairly equivalent, the high use of Opdivo + Yervoy in the metastatic setting, and the launch of six novel pipeline agents in combination with one of Opdivo or Yervoy, means BMS’s position will be hard to surpass.”

Significant unmet needs are expected to remain in the melanoma market, which present considerable commercial opportunities. The lack of options for patients who progress on immune checkpoint inhibitors is a particular issue. While new market entrants are expected to go some way to addressing this, key opinion leaders interviewed by GlobalData have indicated that more innovation will be required to tackle this problem.

McCormack continues: “The problem of how to treat patients who progress on immune checkpoint inhibitors is a tough one. Around 50% of patients on this therapy will progress, and while BRAF-positive patients have the option of receiving targeted BRAF/MEK inhibitors, there are no good options here for BRAF wild-type patients. Most pipeline agents are being investigated in combination with a PD-1 inhibitor and there have been promising results in refractory patients with some of these therapies, but that does still mean that patients are being treated with a drug combination featuring an agent they have previously failed on.”

Twelve novel pipeline agents are forecast to enter the market in the period to 2029. The most important of these are expected to be Nektar Therapeutics/BMS’s bempegaldesleukin, Iovance Biotherapeutics’s tumor infiltrating lymphocyte therapy, lifileucel, and Eisai/Merck & Co’s Lenvima.

McCormack adds: “The data from bempegaldesleukin + Opdivo so far is very promising, and the relatively good tolerability of this combination could see this take sales from the more toxic combination of Opdivo + Yervoy. Both lifileucel and Lenvima have demonstrated compelling results in refractory patients, which could see these therapies do well in the second line setting. Lifileucel in particular is really exciting, with sales in the US expected to reach $164m by 2029. Lifileucel will potentially be the first cell therapy approved for use in a solid tumor, showing once again that the melanoma pipeline is at the forefront of innovation in oncology.”

* 8MM = US, France, Germany, Italy, Spain, UK, Canada and Australia.