Strong Pipeline will Welcome New Therapies for Adjuvant Setting

Monday 12 March 2012, Amsterdam

The report is an essential source of information and analysis on the global melanoma therapeutics market. The report identifies the key trends shaping and driving the global melanoma therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global melanoma therapeutics sector.

The Melanoma Therapeutics Market is forecast to Show Robust Growth Until 2019

They estimates that the global melanoma therapeutics market was worth $0.8 billion in 2011, after increasing at a Compound Annual Growth Rate (CAGR) of 22.8% during 2006-2011. During 2011-2019, the market is expected to record a CAGR of 16.6%, from $0.8 billion in 2011 to $2.6 billion in 2019. The current treatment options for melanoma include:

· Newly approved targeted therapies such as Yervoy (ipilimumab) and Zelboraf (vemurafenib)
· Adjuvant therapies such as Intron-A (interferon alfa-2b) and Sylatron (peg-interferon alfa-2b)
· Immunotherapy such as Proleukin (aldesleukin)
· Cytotoxics such as dacarbazine and off-label drugs including temozolomide, cisplatin and paclitaxel.

The growth of the market is primarily due to new product approvals and an increase in incidence rates during the forecast period. Due to these factors, the melanoma therapeutics market is expected to show robust growth until 2019.

2011 marked the beginning of a new era for the treatment of melanoma with three new drug approvals after more than a decade. In March 2011, the FDA approved Yervoy in the US for the treatment of unresectable or metastatic melanoma. It received approval in the EU in July 2011 for the treatment of adults with previously-treated advanced melanoma. Zelboraf was approved by the US FDA in August 2011 for the treatment of patients with BRAFV600E mutation-positive inoperable or metastatic melanoma, while the European Medicines Agency recommended the granting of marketing authorization for Zelboraf on December 16, 2011. Sylatron recieved approval in the US in March 2011 for the adjuvant treatment of melanoma.

See figure: Melanoma Therapeutics Market, Global, Revenue and Forecasts ($bn), 2006-2019

Strong Pipeline will Encourage Competition for the Advance Stages of the Disease and Address the Unmet Need for this Melanoma Population Segment

An analysis of the melanoma pipeline landscape shows that the overall pipeline of the melanoma is very strong with 213 molecules in development. There are eight first-in-class products in late stage development, which include Abraxane, Allovectin-7, bevacizumab, GSK1120212, MAGE-A3, Masitinib, OncoVEXGM-CSF and Tasigna. MAGE-A3 and Yervoy are being developed for the adjuvant treatment of melanoma.

In the future, competition for advanced melanoma is set to intensify as these pipeline molecules would compete with Yervoy and Zelboraf, addressing their limitations in terms of better safety and a likely improvement in efficacy. Zelboraf will face stiff competition from two new molecules targeting BRAF mutation positive melanoma, GSK1120212 and GSK2118436. GSK1120212 is expected to be the first MEK inhibitor in the market for melanoma. GSK2118436 is anticipated to be the second BRAF inhibitor in the market after Zelboraf. The preliminary results of the Phase I study of GSK2118436 have shown an approximate 50% tumor reduction in BRAF mutation positive patients. There are two products in Phase III targeting c-KIT mutations, masitinib and Tasigna. Most of these Phase III molecules are expected to impact the market during the forecast period.

A healthy pipeline of immunotherapies and oncogene targeted therapies is expected to drive the future metastatic melanoma market.

Strong Pipeline will Welcome New Therapies for Adjuvant Setting

An analysis of the pipeline landscape shows that the adjuvant therapies in late stage development for melanoma are expected to change the entire treatment paradigm for melanoma patients in adjuvant setting. There are two products in Phase III which are being developed for adjuvant treatment - MAGE-A3 (Melanoma associated antigen A3) and Yervoy. MAGE-A3 is an immunotherapeutic vaccine which is being developed by GSK as an adjuvant treatment in patients with resected melanoma. BMS is further developing Yervoy for adjuvant treatment of patients with high-risk stage III or stage IV melanoma that has been removed by surgery.